and health volunteers, facilities are offered for

research.

Hospital  Patient care

 Complex organization utilizing combination of  Diagnosis, preventive and treatment, rehab,
intricate, specialized scientific equipment, and dental, personalized services.
functioning corps of trained people educated to  Education
the problem of modern medical science.  Patient and colleagues
 Restoration and Maintenance of Good Health  Research
 Advancement of medical knowledge against
Present day modern hospitals fulfills the following disease
functions:  Administration
1. It provides for diagnosis and treatment of
diseases of the patients– both in-patient and out- Such practice involves:
patient cases.  Supplying medicines for In-patient and
2. Provides facilities for hospitalization outpatient Preparing of sterile medications
3. Acts as immunization center in the prevention of  Narcotic and prescribed drugs are dispensed
diseases  Bulk compounding
4. Co-ordinates various disciplines of medicines and  Pre-packing
improves the standards of medical practice.  Drug formulation
5. Provides advices on matters like family planning,  Professional supplies are stocked and
STD, AIDS, etc. for the improvement of social dispensed.
aspects and rehabilitation.  Maybe defined according to its form; physical
6. Takes care of the community at large and make-up, quantitative nature of service.
contributes a lot in the preventive and social  Maybe also define according to its purpose/
medicine. Educates the people. mission.
7. By its early detection, treatment and advice,
lowers the incidence of diseases.
 Teaching and Research
8. Acts as a link between masses and policies of
 Drug therapy information
government.
 Patient education programs
9. Smaller hospitals gets cooperation from bigger
 Poison control center activities
hospitals.
 Parenteral program participation
General hospitals gets guidance from specialist
 Communicating new product information
hospitals, where more sophisticated and costly
to nurses
equipments are available. Private hospitals
 Radiopharmaceuticals
cooperate with public hospitals. All hospitals
function in unison to achieve the same ultimate
goal of “Health for all”
 The earliest organized hospital of the world was
10. Bigger hospitals help in the growth of medical
the one in Tamil Nadu.
science by training doctors, nurses, pharmacists,
 The inscriptions found by the archaeology
department in the Vishnu temple of
Tirumukoodal village, Chingleput District of Tamil
Nadu gives details about a 15 bed hospital
existed 1000 years before.
 Ancient man learned from instinct, from
observation of birds and beasts. Cool water, a
leaf, dirt, or mud was his first soothing
application.
 Babylon, jewel of ancient Mesopotamia, often
called the cradle of civilization, provides the
earliest known record of practice of the art of the
apothecary.
 Practitioners of healing of this era (about 2600
B.C.) were priest, pharmacist and physician, all in
one
(1500 B.C.), a collection of 800 prescriptions,
mentioning 700 drugs.
Theophrastus (about 300 BC)
 Among the greatest early Greek philosophers
and natural scientists.
 Called as the "father of botany.
Mithridates IV, King of Pontus (about 100 BC)
 Found time to make not only the art of
poisoning, but also the art of preventing and
counteracting poisoning, subjects of intensive
study.
Gertrude and George Urdang
 First recognized representative of the
pharmaceutical profession.
 Adler Apotheke in Rosenberg/Prussia

Shen Nung (about 2000 B.C.)

 An emperor who sought out and investigated the
medicinal value of several hundred herbs.
 Written the first Pen T-Sao, or native herbal,
recording 365 drugs.
 Examined many herbs, barks, and roots brought
in from the fields, swamps, and woods that are
still recognized in Pharmacy today
 Medicinal plants include: podophyllum,
1751
rhubarb, ginseng, stramonium, cinnamon
 Colonial America's first hospital
bark, and, ma huang, or Ephedra.
(Pennsylvania) was established in
Philadelphia
1752
 First Hospital Pharmacy began operations
Pennsylvania Hospital- first hospital in North
America
 Jonathan Roberts- hospital pharmacist

John Morgan
 Though Egyptian medicine dates from about  Importance to the development of professional
2900 B.C., best known and most important pharmacy in North America.
pharmaceutical record is the "Papyrus Ebers"
 As physician, he advocated prescription writing - Graduated in 1875 from Ateneo Municipal de
and championed independent practice of two Manila.
professions. San Lazaro Hospital- established in 1578
Enfermeria de Naga- in 1583
Hospital de San Juan de Dios in 1586
1565- Hospital 1891- Chinese general
Militar, Cebu Hospital 3. The Public Interest in Hospitals
1571- Hospital 1911- Philippine  Led to production of finances for further
Militar, Manila general Hospital development, expansion and improvement.
1577- Hospital de 1957- Government 4. Significant Government
San Juan de Dios Hospital Association  Adoption of the HOSPITAL SURVEY AND
1577- Hospital de 1960- Private Hospital CONSTRUCTION ACT (1946)
San Lazaro Pharmacist Association  Commonly known as HILL BURTON
1588- Hospital de Philippine Society of PROGRAM
San Gabriel Hospital Pharmacist  Provide federal funds for hospital
(PSHP)
construction
 Philippine Society of Hospital Pharmacist (PSHP)
5. National Planning and resources
Developmental Act (1975)
 One dominant factor- Religious Influence  Created the development of health systems
 Doctrines of Jesus Christ intensified the agencies (HAS)
emotions and virtues of love, pity and
Responsibilities of HAS
charity.
1. Improving the health of residents of its health
 Another factor- Military Influence
service area
 Urgent need for care of the wounded on
2. Increasing the accessibility, acceptability,
the battlefield
continuity and quality of services provided.
 Other factors:
3. Restraining increase in the cost of these
1. Flexner report
services.
 On medical education caused revolutionary
4. Preventing unnecessary duplication of health
developments in medical education and
resources.
medical internship training.
 Beyond the 3 basic essentials of human existence
2. Activities of Florence of Nightingale
(food, clothing and shelter), the hospital has
 Quality of NURSING CARE/ nursing school
become a necessary instrument for the fourth
basic element of survival- HEALTH.
Botica Boie
- First and largest drugstore during19th century.
- Founded by Dr. Loren Negrao in Manila in  Provide benefit of a qualified hospital
1830. pharmacist to patients and health care
Leon Maira Guererro y Leogardo institution, allied health profession and to
- First licensed pharmacist in the country pharmacy profession.
 Assist a high quality of professional practice
thru establishment and maintenance of standards
 of professional ethics, education, attainment and 4. By Bed Capacity
economic welfare. - Under 50 beds - 400-499 beds
 Promote research in hospital pharmacy - 50-90 beds - 500 beds and over
practices and in pharmaceutical sciences in - 100-199 beds
general. - 200-299 beds
 To disseminate pharmaceutical knowledge by  Philhealth category
providing for interchange of information among  Level 1
hospital pharmacist and with members of the  Level 2
allied specialties and profession.  Level 3
 Expand and Strengthen Institutional  Level 4
Pharmacists abilities
 Increase knowledge an understanding of
A. Departments which the services involve primarily
contemporary institutional pharmacy practice
the professional care of the patient.
 Promote compensation and benefits
 Ambulatory care  Medical library
 Ensure healthcare reimbursement and payment  Anaesthesia  Medical records
system do not inhibit pharmaceutical services  Blood bank  Medical social
 Assist In the development and advancement of  Central sterile service
pharmacy practice. supply  Nuclear medicine
 Clinical laboratory  Nursing service
 Dental service  OT
1. Type of Service  Dietary & nutrition  Pharmacy
a. General Hospital- provides care to patients service  Physical medicine
 ECG  Radiology and X-
with any type of illness
 ER ray therapy
b. Special Hospital- those which restrict the  Respiratory therapy
care they provide to the special conditions
such as cancer, psychiatric etc B. Departments which deal with the business
2. Length of Stay management or administrative side of the
- Short term hospital (less than 30 days) Hospital
 Accounting  Engineering and
- Long term hospital (30 days or longer)
 Admitting maintenance
3. Ownership  Biomedical  Housekeeping
- Government hospitals engineering  Information
a. Federal (armed forces, public health services)  Business office service
b. State  Cafeteria and  Personnel and
coffee shop payroll
c. County
 Central  Post office
d. City
transportation  Purchase and
e. City county  Credit and store room
f. District collection  Telephone
- Non-government hospitals  Computer services switchboard
a. Non-profit  Volunteer service

b. For profit
 3. Designated space and equipment suitable for the
1. The procurement, distribution, and control of all preparation of sterile products and other drug
pharmaceuticals used within the facility compounding and packaging operations.
2. The evaluation and dissemination of 4. Should have a private area for pharmacist patient
comprehensive information about drugs and consultations.
their use to the institution’s staff and patients 5. Current drug information resources must be
3. The monitoring evaluation, and assurance of the available.
quality of drug use
 The pharmacy shall be responsible for the
a. Administration
procurement, distribution, and control of all
b. Facilities
drugs used within the institution.
c. Drug distribution and control
Pharmacist routinely be present in all patient-care
d. Drug information
areas, establish rapport with the personnel, and
e. Assuring rational drug therapy
become familiar with and contribute to medical and
f. Research
nursing procedures
g. Plants, facilities, equipment, and other materials

 The pharmacy is responsible for providing the

 The hospital Pharmacy Service shall be under the
institution’s staff and patients with accurate,
general supervision of the administrative officer
comprehensive information about drugs and
or Chief of Hospital (COH); it will be directly be
their use and shall serve as its center for drug
administered and supervised by a licensed
information
pharmacist
1. Setting the long- and short-range goals of the
pharmacy
2. Developing a plan and schedule for achieving
these goals.
3. Supervising the implementation of the plan and
the day-to-day activities associated with it
4. If the goals and schedule are being met and
instituting corrective actions where necessary

 There shall be adequate space, equipment and

supplies for the professional and administrative
functions of the pharmacy
1. Shall be located in an area that facilitate the
provision of services to patients.
2. Space and equipment, in an amount and type to
provide secure, environmentally controlled
storage of drugs.
 appropriate to the goals ,objectives, and
resources of the pharmacy and the institution

Philippine law on Opening a Hospital Pharmacy

General Requirement Order no. 56 1989
 Standard petition form
 Proof of registration as an establishment
 Valid certificate of registration
 Certificate of attendance to a BFAD
sponsored seminar on Licensing of Drug
Outlets
 Affidavit of undertaking
 Tentative list of products to be sold using GN
with BN
 Authenticated photocopy of contract of Lease
of space to be occupied if renting

 Must comply with the FDA minimum standard

requirements for the issuance of LTO in the
establishment of the hospital pharmacy.

Why? (Purpose of standards)

- To assure patient safety through the proper
 Pharmacist, in concert with the medical staff, storage, preparation (compounding, packaging
must develop policies and procedures for and labelling) and dispensing of drugs.
assuring the quality of drug therapy.
 Drugs are stored under proper condition of
sanitation, temperature, light, ventilation,
segregation and security.
 The pharmacy must develop a design which
would be accessible to both in and out-patients,
business offices and frontline services.
 Premises must be well-ventilated and should
have concrete tiles or wooden flooring.
 There must be suitable areas for compounding,
manipulating parenteral medications,
dispensing, and adequate storage of drugs
with wooden pallets for drug boxes and
 Pharmacist should conduct, participate in, and
biological products as specified in the label, for
support medical and pharmaceutical research
flammables and for administrative functions.
 It must be provided with suitable cabinets for
storing poison and/or dangerous drugs with
sectional type of cabinets and must have an
adequate supply of water.
Facilities and equipments
 Smaller hospitals- one room- one pharmacist
 Sterile products- separate room or area
 Hospitals with more than 200 beds
 Separate area for in patient and unit dose
dispensing
 Chief pharmacist (office)
 Compounding ,prepackaging, labelling
 A storeroom, sterile products and IV admixture
room
 Drug info service room Hospitals of more than
500 or 1000 beds
 Increase space requirements for pharmaceutical
services
 Books  Laminar flow hood
 Laboratory supplies  Telephones/shelves
 Office supplies  Internet service
 Biological refrigerator  Computer
3. Bureau of Licensing and Regulations in
compliance with the legal requirements for
hospital pharmacy based on the Hospital
Licensure Act (RA 4226)
4. Professional Regulation Commission (PRC) in
compliance with the ethical and professional
practices and the continuing education program
requirement
5. HOMS and other services under the OHFS
consultative/advisory services on Hospital
Pharmacy enhancement standards, Hospital
Operations and Management of Hospital
Pharmacy, etc.
Abilities required for Hospital Pharmacist
1. Thorough knowledge of drugs and their actions.
2. Ability to develop and conduct a pharmaceutical
manufacturing program.
3. An intimate knowledge of control procedures.
4. Ability to conduct and participate in research.
5. Ability to conduct teaching and in-service
training programs
6. Ability to administer and manage.

Relationship with other agencies relevant to the

practice of pharmacy:
1. BFAD in compliance with the legal requirements
of the BFAD based on the Food, Drugs, Devices,
and Cosmetics Act as amended; RA 3720 in the
issuance of the License to Operate (LTO) and
regular inspection/monitoring and in compliance
with the Generics Act of 1998 (RA 6675), and the
Pharmacy Law (RA 5921) as amended
2. The Dangerous Drugs Board (DDB) in compliance
with the legal requirements of the Dangerous
Drugs Act (DDA) as amended (RA 6425) relevant
to the practice of pharmacy
Pharmacy Services Position Chart
1. Administrative Services Division
2. Education and Training Division
3. Pharmaceutical Research Division
4. In-patient Services Division
5. Out-patient Services Division
6. Drug Information Services Division
7. Departmental Services Division
8. Purchasing and Inventory Control Division
9. Central Supply Services Division
10. Assay and Quality Control Division
11. Manufacturing and Packaging Division
12. Sterile Products Division
13. Radiopharmaceutical Services Division
14. Intravenous Admixture Division

 Plant and coordinate departmental activities

 Develop policies
 Schedule personnel and provide supervision
 Coordinate administrative needs of the Pharmacy
and Therapeutics Committee
 Supervise departmental office staff
 Consists of:
 Administrator
 Director
 Superintendent
 Medical director
 Chief administrative officer

 Coordinate programs of undergraduate and

graduate pharmacy students
 Participate in hospital-wide educational programs
involving nurses, doctors, etc.
 Train newly employed pharmacy department
personnel
 Consists of:
 Clinical pharmacist
 Chief pharmacist
  Coordinate and control all drug deliver and
 Develop new formulation of drugs, especially distribution systems
dosage forms not commercially available, and of  Consists of:
research drugs  Pharmacy technician
 Improve formulations of existing proucts  Pharmacy aids
 Cooperate with the medical research staff of  Pharmacy interns
projects involving drugs
 Consists of:  Maintain drug inventory control
 Compounding pharmacist  Purchase all drugs
 Clinical pharmacist  Receive, store, and distribute drugs
 Interview medical service representatives
 Provide medications for all in-patient in the  Consists of:
hospital on a 24-hour per day basis  Warehouse pharmacist
 Inspection and control of drugs on all treatment  Pharmacy clerk
areas
 Cooperate with medical drug research  Develop and coordinate distribution of medical
 Consists of: supplies and irrigating fluids
 Unit-dose pharmacist
 Perform analyses on products manufactured and
 Compound and dispense out-patient purchased
prescriptions  Develop and revise assay procedures
 Inspect and control all clinic and emergency  Assist research division in special formulations
service medication stations
 Maintain prescription records  Manufacture wide variety of items in common
 Provide drug consultation services to staff and use at the hospital
medical students  Operate an overall drug packaging and
 Consists of: prepackaging program
 Dispensing pharmacist  Undertake program in product development
 Maintain a unit dose program
 Provide drug information on drugs and drug  Consists of:
therapy to doctors, nurses, medical, and nursing  Compounding pharmacist
students and the house staff  Unit dose pharmacist
 Maintain the drug information center
 Prepare the hospital’s pharmacy newsletter  Produce small volume parenterals
 Maintain literature files  Manufacture sterile ophthalmologic, irrigating
 Consists of: solutions, etc.
 Clinical pharmacist  Prepare aseptic dilution of lyophylizal and other
“unstable” sterile injections for administration to
 Control and dispense intravenous fluids patients
 Control and dispense controlled substances  Consists of:
 Oncology pharmacists
 Centralize the procurement, storage, and
dispensing of radioisotopes used in clinical
practice
 Centralize the preparation of intravenous solution
admixture
 Review each IV admixture for physio-chemical
incompatibilities
 Consists of:
 Oncology pharmacist
 IV admixing
Staffing
100 beds- 1 pharmacist
300 beds- director, assistant director, 7-12 staff
pharmacist, 5-15 non-pharmacist, secretary
700 beds- director, assistant director (2 or more),
supervisor pharmacist (2 or more), 40-60 staff
pharmacist
Qualifications mean:
 A restriction in meaning or application: a limiting
modification.
 A condition or standard that must be complied
with (as for the attainment of a privilege)
 BS Degree in Pharmacy
 Duly licensed by law to practice pharmacy
 MS in pharmacy or its equivalent
 With 6 year experience-3 years supervisory work
and 3 years as dispensing pharmacist with on the
job training/continuing education
 Physically, mentally, emotionally, and morally fit
to work
 BS Degree in Pharmacy
 Duly licensed by law to practice pharmacy
 With 4 year experience-2 years supervisory work
and 2 years as dispensing pharmacist with at
least 12 units of M.A. and on the job
training/continuing education
 Physically, mentally, emotionally, and morally fit
to work
 BS Degree in Pharmacy
 Duly licensed by law to practice pharmacy
 With at least three(3) years experience, 1 year on
supervisory work and 2 years as a dispensing
pharmacist with on the job training/continuing
education
 Physically, mentally, emotionally, and morally fit
to work
 BS Degree in Pharmacy
 Duly licensed by law to practice pharmacy
 New graduate/or at least 1 year pharmacy
practice, orientation with further on-the-job
training/continuing education
 Physically, mentally, emotionally, and morally fit
to work
 Completion of at least two(2) years of college
studies
 Two(2) years experience in a pharmacy, and
 Physically, mentally, emotionally, and morally fit
to work

 Completion of two(2) years of college studies

 One(1) year experience in the preparation of
routine office correspondence, endorsements,
reports or other related clerical work
 Career Service (sub professional) Relevant
Eligibility for First Level Position
 Physically, mentally, emotionally, and morally fit
to work

 Completion of elementary school course or must

be able to read, write, count, and interpret verbal
or written instruction of normal complexity
 Six(6) months of experience in manual work
 Civil Service Eligibility not required
 Physically, mentally, emotionally, and morally fit
to work

 Receives written prescriptions or refills

 Verify info on the prescription
 Counting, weighing, measuring and mixing
medication
 Preparing prescription labels
 Establishing and maintaining patient profiles
 Order and stocking
 Assisting drug studies
 Taking order over the telephone
 Transferring prescriptions
 Tracking and reporting errors
 Tech check tech

 In these days of modern medicine, a large
number of drugs are available for the treatment
of a disease.
 Considering the complexities surrounding their
effective use, it is necessary for the hospital to
establish a system to bring the best medicinal
agents to the attention of the medical staff and
help them in proper selection of therapeutic
substances.
 In order to ensure proper rationality in the use of
drugs a “PHARMACY AND THERAPEUTIC
COMMITTEE” need to be organized and
constituted in a hospital.
 Standing committee:
 Executive committee
 Hospital committee
 Finance committee
 Public relations committee
 Infection Control committee
 A policy framing and recommending body to the
medical staff and the administration of hospital
on matters related to the therapeutic use of
drugs.
 It also serves as a means of communication
between the healthcare professional and
pharmacy department.
Objectives/Purposes:
 The main objective of PTC is to achieve
optimal patient care and safety through
rational drug therapy.
1. Advisory: It recommends the adoption of
policies regarding evaluation, selection and
therapeutic use of drugs.
2. Educational: It assists in the preparation of
programs for healthcare professionals to
update their current knowledge on matters
related to drugs and its use.
Organization:
 Pharmacy and therapeutic committee is
composed of:
1. At least 3 physicians from the medical staff
(one is the chairman).
2. A chief pharmacist (secretary).
3. A representative from nursing staff (joint-
secretary).
4. A hospital administrator, who should be an
ex-officio member of the committee.
 The committee should meet at least 6 times in a
year and also as & when necessary.
 The committee should invite persons from inside
or outside hospital to its meetings, who can
contribute specialized or unique knowledge,
skills.
 An agenda should be prepared by secretary and
submitted to the committee members in
sufficient time before meeting.
 An agenda may consist of :
o minutes of previous meeting
o review of contents of hospital formulary
o review of adverse drug reactions, drug
interactions, toxic effects reported in the
hospital
 Minutes of the meeting should be prepared by
the secretary and maintained in the permanent
records of the hospital.
 Recommendations of the committee shall be
presented to the medical staff.
Functions:
 To provide advice to the medical staff on usage
of drugs.
 To develop a formulary of drugs accepted for use
in the hospital.
 To plan/establish suitable educational programs.
 To review adverse drug reactions.
 To make recommendations concerning drugs to
be stocked in hospital patient care areas.
 To advise the pharmacy in the implementation of
effective drug distribution and control
procedures.
 In order to avoid misunderstanding amongst
members and medical staff, these policies were
developed.
 Policies should be reviewed periodically to ensure
that they are up-dated.
 Proposal of a new drug for the hospital
formulary shall be submitted to the pharmacy
department by any medical staff. Committee
decides whether to accept or to reject.
 Drugs evaluated and approved by committee
will be assigned to one of the following
categories:
1. Formulary drug
2. Drugs approved on a conditional trial
period
3. Investigational drugs
4. Specialized formulary drugs
 Drugs which cannot be placed under the above
categories are considered as Non-formulary
drug.
 The pre-signing of prescription blanks is
prohibited.
 All drugs should be dispensed on the basis of
generic names to achieve cost-savings.
 It is a continually revised compilation of
pharmaceuticals that reflects the current clinical
judgement of the medical staff
 Formulary system- Medical staff of an
institution, working through the PTC, evaluates,
appraises, and selects from among the numerous
available drug entities and drug products those
that are considered most useful in patient Care.
Advantages  Therapeutic
 Economic
 Educational
 Rational drug use
Disadvantages  Deprive the physician of his
right and privilege to prescribe
and obtain the brand of his
choice.
 Permits the pharmacist to act as
the sole judge of which brands of
drugs are to be purchased &
dispensed.
 The governing body of the hospital should
appoint a PTC.
 PTC shall sponsor and outline the purpose,
organization function and scope of the hospital
formulary system, it should adopt the principle as
per the need of particular hospital.
 PTC develop policies and procedures - medical
staff adopt these - subject to administrative
approval.
 The policy and procedures shall afford guidance
in the appraisal, selection, procurement, storage,
distribution, use, safety procedures and other
matter relating to drug in the hospital and shall
be published in the hospital’s formulary or other
media available to the member of medical team.
 Prescribers should be strongly encouraged to
prescribe drugs by their nonproprietary names.
 Generic equivalents & therapeutic equivalents.
a. Pharmacist is responsible for selecting from
available generic equivalents.
b. That the prescriber has the option, to specify
the brand for that particular prescription.
c. PTC is responsible for determining those drug
products and entities.
 Medical & nursing staffs are informed about the
changes in the HOSPITAL FORMULARY system.
 Labeling of medicine with non-proprietary
names, followed by decided formats
 To develop an effective formulary system, PTC
has to consult various references on a drug
regarding its pharmacokinetic profile,
interactions, ADR, etc.
 Primary objectives:
a. Information of a drug
b. Information on hospital policies & procedures
c. Special information about drugs
In accordance with these objectives, the formulary
should consist of three main parts:
a. Information on hospital policies & procedures
concerning drugs.
b. Drug products listing
c. Special information
 Drug use
 Description of PTC
 Hospital regulations about prescribing,
dispensing & administration of drug, rules for
Medical Reps, emergency drug products,
 Pharmacy operating procedures
 Information on using formulary
 Formulary item entries
 Alphabetically by generic name
 Alphabetically within therapeutic class
 Type of information
 Dosage form, strength, packaging
 Active ingredients
 Adult/pediatric dose
 Route of administration
 Cost
 Indexes to the drug products listing:
 Generic name/brand name
 Therapeutic /pharmacological index
 Equivalent dosages of similar drugs
 Hospital approved abbreviations
 Rules for calculating pediatric dosages
 List of sugar free drugs
 List of dialyzable poisons
 Metric conversion tables
 Poison control information
 Table of drug interactions
 Visually pleasing, easily readable and professional
in appearance.
A typical formulary must have the following
composition:
1. Title page
2. Names & titles of the members of the PTC
3. Table of contents
4. Information on hospital policies & procedures
concerning drugs
5. Products accepted for use at hospital
6. Appendix
A. Introduction
 List of abbreviations
 List of drugs used in the formulary
B. Basic Information on each Drug
 Efficacy for the treatment of specific
conditions
 Safety profile of the item
 Interaction profile
 Adverse effects
 Pharmacokinetic profile
 Availability of the item
 Available dosage form
 Cost
 Acceptability to patients
C. Supplementary Information on each Drug
 Storage guidelines
 Patient counseling information
  Labeling information Information provided is According to their
 Brand names and prices subject to local needs and pharmacological
desires properties
D. Prescribing and Dispensing Guidelines
 Principles of prescription writing
 Reporting of ADR 1. Different color of the paper (recommended)
 Prevention of ADR 2. Using an edge index
E. General Drug Use and Advice 3. Pocket size (4 x & cm)
 Use of IV drugs 4. Generic name in BOLD
 Special situations like pregnancy, breast
feeding, liver/kidney diseases
 Poisoning information and antidotes 1. Pharmaceutical representatives obtain application
 Treatment of snakebites and insect bites form and list of requirements from the PTC
F. Miscellaneous Section Secretary
 Children’s dose  Metric units 2. Completed requirements submitted to the PTC
 Renal adjustments  Diagnostic aids Secretary on or before the deadline set which is
one (1) month before the next scheduled PTC
meeting
 Drug selection 3. All applications with complete documents
 Promoting formulary adherence endorsed to and reviewed by the PTC members
 Review and take action on all nonformulary
drug use in the hospital.
 Provide a copy of the hospital formulary to all
doctors in the hospital.
 Involve the medical staff in various formulary-
implementing programs.
 Give much advertisement and publicity
regarding formulary.
 Revision of formulary

Formulary Drug list

Listing of drugs by their
generic names followed by
information on strength,
form, posology, toxicology,
use & recommended
quantity to be dispensed.
Prepared locally by its own
clinical staff
Generic names
followed by data on
strength & form.
Prepared by country’s
outstanding clinicians,
pharmacologists and
pharmacists

 Only one brand shall be carried per generic of a
dangerous drug at a time.
 Non-formulary drugs are purchased upon
request of the attending physicians when as the
following have been made or approved:
 When referrals for available formulary drugs have
been made to attending physicians who still opt
to use the specific non-formulary drug of their
choice.
 Non-formulary form is completely filled up and
passed to the pharmacy. Indicating the concrete
advantage the drug has over the available
formulary drugs we have in the pharmacy
 The Pharmacy will not cater herbal supplements
and preparation of no therapeutic claims.
 All procured Non-formulary drugs will
automatically charged to the patient’s account
and cannot be returned to the Pharmacy.
 All drugs must undergo Drug evaluation by the
Pharmacy and Therapeutics committee before it
can become a formulary drug
 Formulary Drugs are the only drugs that can be
stocked in the Pharmacy.
 A maximum of 5 brands per generic entity
excluding the innovator brand can be included in
the Formulary Drug list
 Drugs that are in the list are subject for deletion if
deemed to be slow moving even after 3 months
grace period given for the company to promote
the specific drug.
 Deleted drugs are required to undergo similar
process and pass all requirements again if the
company wishes to reapply for product inclusion.
 A different dose and preparation of an existing
brand in the pharmacy need not apply but
required to submit Certificate of Analysis, Product
registration and their stock donation.
 Endorsements from different medical
departments will no longer be entertained if the
maximum slot has been filled.
 If a drug is deleted in the same category, the slot  Non-pharmacist should not be permitted to
shall be open. dispense drugs.
 Sufficient number of qualified staff should be
employed for adequate coverage of
 Inpatient-prescribing:
pharmacy.
 routine drug orders; intravenous orders
 The hospital should provide adequate, safe
 self-medication
work space and safe storage facilities.
 medications brought to hospital by patients
 automatic stop order for dangerous drugs  The hospital must have an autonomic stop
order regulation for dangerous drugs.
 a new medication order must be written by
 The hospital should have a drug formulary,
physician if any change in dosage or route of
periodically revised and updated.
administration is wanted
 The poisons and poisonous materials should
 discharge prescriptions
be separated from non-poisonous materials,
 emergency orders
similarly external and internal preparations.
 Outpatient prescribing should be written only on
hospital prescriptions and should contain details  The hospital should permit pharmacist to
engage in a teaching program to medical
of patient, drug information and name &
staff.
signature of physician.
 All nursing drug stations should be
 For control drug prescriptions, it requires
periodically inspected for the purpose of
physician’s S2 number.
removing deteriorated and outdated drugs.
 In case of schedule 2 drugs (narcotics), are
limited to 30-day supply, no refills
 Schedule 3 drugs (barbiturates) and schedule 4  All drug orders for narcotics, sedatives, hypnotic,
drugs (benzodiazepines), limited to 30 day anticoagulants and antibiotics should be
supply, refilled up to 5 times within 6 months of automatically discontinued after 48 hours unless
issue date. a.) order indicates exact number of doses
b.) exact period of time
PTC in the hospital:
c.) attending physician reorders
 Drug safety
 All P.R.N (pro re nata) and standing order
 ADRs monitoring
medications shall expire as determined by the
 Emergency drug lise
pharmacy and therapeutic committee in
 Drug utilization review
consultation with concerned medical staff and
 Drug product defect reporting
recommend the hospital administration

 Drug safety includes responsibility from

dispensing of drugs to drug administration and
 An adverse reaction is defined as any unusual or
to observe possible adverse effects.
unexpected harmful reaction from a drug.
 Following guidelines can help in inducing drug
 Every case of adverse reaction must be first
safety:
reported by attending physician to chairman of
 A qualified, registered pharmacist should be
PTC.
employed for supervision of pharmacy.
 The attending physician should complete the
‘Adverse drug reaction report form’.
 It is absolutely necessary for the PTC of a hospital
to prepare “emergency drug boxes or stat boxes”
containing emergency drugs, readily available at
bed-side for use.
 It should be checked daily either by pharmacist
or nursing supervisor responsible for the ward.
A. Supplies to be maintained in emergency box:
- syringes- 1, 2, 5 ml; 10,20ml
- needles- 16’, 18’, 20’, 23’, 26’ files for
breaking ampoules
B. Drugs for emergency box:
- These are selected in consultation with
physician.
- Examples-aminophylline, atropine sulphate,
heparin, epinephrine, nalorphine,
pentazocine, pentobarbitone, digoxin,
mannitol, saline for injection, water for
injection
C. Supplies for cabinet utility room:
- Venous cannulation set, venous catheters,
oxygen catheters, razor with blades.
D. Other emergency supplies:
- Oxygen equipments, resuscitation carts,
tracheotomy sets, burn sheets.
 Drug utilization includes prescribing, dispensing,
administering and ingesting of prescription of
drugs.
 Hospital pharmacist should take medication
history, that should include following
information:
1. Medication being taken at time of admission,
during admission and OTC drugs
2. Any drug or food related allergies.
 Patient medication profile will serve for following
purposes
a. to help improved drug prescribing practices
by promoting safe and rational use of drugs
b. to detect and prevent drug-interactions,
adverse reactions
c. to detect drug induced diseases
d. it helps to detect potential drug toxicities
 Within patient medication profile, patient history
and laboratory procedure, pharmacist is in an
excellent position to monitor proper drug
utilization.
 The drugs purchased by hospital can have the
following defects like deteriorated, contaminated,
inferior or defective quality drugs, inadequate
 labeling, inaccurate filling of product or faulty
delivery.
 It is the responsibility of committee to get
information about the defective drug products
and to inform it to the manufacturer or supplier
for appropriate action.
 If satisfactory answer is not obtained from
manufacturer or supplier then it should be
reported to Food & drug control administration.

Drug Supply
Management
Cebu Doctors’ University
College of Pharmacy
FACTS
 1/3 of the World’s population lack access
to medicines
 Up to 70% of antibiotics are
inappropriately prescribed
 Only 50%, take their medicines correctly
 Antimicrobial resistance
8/12/2020
Drugs are of particular importance
because:
 Saves lives & improves health
 Promotes trust and participation in health
services
 Costly
 Different from other commodities
 Improvements in supply
Quality and safety issues
 Less than 1 in 3 developing countries
have fully functioning drug regulatory
authorities
 10-20% of sampled drugs fail QC tests
 Failure in CGMP results in toxic
sometimes lethal products
 Expanding global trade makes it difficult
to implement Quality Assurance
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Four strategic objectives of

pharmaceutical procurement
How drug store is prepared?

 Procure the most cost-effective drugs in
right quantities
 Select reliable suppliers at high quality
products
 Ensure timely delivery
 Achieve the lowest possible total cost
 Drugs and supplies are expensive and
valuable
 Needs care or else they will deteriorate,
they lose their potency or have Adverse
effect on pxs
Separate storage space, Locked, Good
condition and Organized.

To prepare the hospital pharmacy:

1. Choose a secured area.

- Double lock the door and cabinets
- Keep the pharmacy locked at all times per
entry and exit
2. Keep the establishment in good condition
- Temperatures, light or humidity may deteriorate
the supplies
- Heat affects liquids, ointments and suppositories.

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To prepare the hospital pharmacy:

2. a. Inspect the physical structure

regularly. Repair any damages to roof,
walls, door, windows and floor.
b. Control the temperature in the
pharmacy. Check that there is a ceiling.
Allow warm air to escape. Put air vents
in the walls or ceiling. Use screens to
keep out insects

To prepare the hospital pharmacy: To prepare the hospital pharmacy:

2. c. Secure all openings with grills or bars
to prevent theft.
d. Control light in the store.
e. Control humidity and prevent water
damage.
Ex. Good drainage, roof gutters, secure air
vents and windows, Repair leaks
2. f. Tablets and capsules may be packed
with a sachet of desiccant.
g. Keep the pharmacy free of pests
(rats, roaches, ants and wasps)
Ex. Spilled items may attract them, clean
spills and remove broken containers
immediately

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To prepare the hospital pharmacy:

3. Keep your store clean and organized.

a. Establish cleaning schedules
(Dust, spills and breakages)
b. Store supplies on shelves
c. Keep the refrigerator in good condition
d. Store narcotics and psychotropic drugs
in double-lock storage space.

WAREHOUSE

4

Inspection checklist for drugs
received in the warehouse
LABELLING:
1. English; or any other language
approved by WHO.
2. All labels shall display at least the ff
information:
-INN of the active ing
-Dosage form
-Quantity of active ing
Inspection checklist for drugs
received in the warehouse
4. Directions for use, warnings and precautions in
leaflets
5. For articles requiring reconstitution prior to use
(powders for injection); suitable beyond-use
tome for the constituted product should be
indicated.
8/12/2020
Inspection checklist for drugs
received in the warehouse
2- batch no., date of manufacture, expiry
date, Pharmacopeia standard,
instructions for storage, name and
address of manufacturer
3. A printed label of each ampule should
contain the following:
-INN of active ing, quantity of active ing,
batch no. name of manufacturer, expiry
date
Inspection checklist for drugs
received in the warehouse
PACKAGING:
1. Tablets and capsules- should be
packed in waterproofed containers with
replaceable lid, protecting the contents
against light and humidity
2. Liquids- packed in unbreakable leak
proof bottles or containers
3. Containers
4. Ampules- break off necks
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Inspection checklist for drugs

received in the warehouse
EXPIRY DATE
At time of shipment, the product shall have
at least 75% of its shelf life.
- Must be written in large letters and
numbers.
- Return to supplier prior to expiry date

Inspection checklist for drugs Inspection checklist for drugs

received in the warehouse received in the warehouse
APPEARANCE OF THE PRODUCT - Drug in its corresponding DF is correct
All shipment: - Dosage strength
Compare the goods with suppliers invoice - No evidence of damage
and original PO or contract (note
discrepancies) CHECK THAT:
-No. of containers delivered
-no of packages in each container
-quantity in each package

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Inspection checklist for drugs Inspection checklist for drugs

received in the warehouse received in the warehouse
Tablets Capsules
- Identical in size, shape and color. - Identical in size, shape and color.
- Markings (scoring, lettering, numbering) -Markings are identical
are similar - There are no defects
- No defects (check for spots, pits, chips, - No empty capsules
breaks, uneven edges, cracks, - There are no open or broken capsules
embedded or adherent foreign matter,
stickiness)
- No abnormal odor

Inspection checklist for drugs

received in the warehouse
Parenteral
-refer to all products for injection
- Solutions should be clear
- Dry solids are entirely free from visible
foreign particles
- No leaking containers

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ARRANGING HEALTH
COMMODITIES
Arrange the storeroom and shelves as
follows:
- If using pallets: (flat transport structure)
At least 10 cm (4 inches) off the floor
At least 30 cm ( 1 foot) away from the walls
and other stacks
No more than 2.5 m ( 8 feet high)

For all storage: For all storage:

1. Follow the manufacturer’s or shipper's 4. Store attractive and controlled products in

directions when stacking and follow
labels for storage conditions.
2. Place liquid products on the lower
shelves or on the bottom of stacks.
3. Store products that require cold
storage in appropriate temperature
controlled zones.
appropriate security zones.
5. Separate damaged or expired products from
the usable stock without delay and dispose of
using established disposal procedures.
6. FEFO/ FIFO
7. Arrange cartons so arrows point up and
identification labels, expiry dates,
manufacturing date are visible.

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HOW SUPPLIES ARE ORGANIZED

The organization of supplies in the hospital

pharmacy should accommodate the services
offered at the health facility.

Anyone who works in the hospital pharmacy

should be able to find drugs easily.

HOW SUPPLIES ARE

ORGANIZED
Similar supplies should be shelved
together, arranged in alphabetical order
by generic name.

Items with shorter shelf life (short expiry

dates or older stock) should be placed in
front of similar items with longer shelf life
(later expiry dates or newer stock)

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 Removal of unnecessary items

 Stock is arranged mostly likely according to
classification:
- Oral drugs
- Injectable drugs
Organizing the store room in a - Infusions

logical way - Drugs for external use and disinfectant

- Small consumable materials

After each category, products are classified

ALPHABETICALLY

Organizing the store room in a

EXAMPLE: logical way
Tranexamic acid
HEMOSTAN 500 mg capsule Arrangement should allow fast inspection:
If possible to note the number of each box and evaluate in a few minutes,
current stock or monthly consumption of a product.
Clarithromycin
KLARICID 500 mg tablet An empty space behind a label means a stock
rupture:

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SPECIAL STORAGE SPECIAL STORAGE

CONDITIONS CONDITIONS
1. Controlled substances a. Documentation “log”
- Locked cupboard or safe, per entry is b. Labelling and containers
recorded in register c. Receipt of incoming materials and
2. Attractive items (Expensive) pharmaceutical products
- Antibiotics, minor medical equipment, d. Stock control
record books e. Control of obsolete and outdated
3. Flammables/ Corrosives materials
-separate from drugs

TO ORGANIZE DRUGS and

SUPPLIES IN HOSPITAL Rx
1. Store similar items together on the
shelves.
Ex. Tetracycline ointment
Tetracycline tablet

External, Internal, Injectables, Tablets and

Capsules, other supplies

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 8/12/2020

 Dry drugs (ORS packets)

- Make sure items are not light sensitive TO ORGANIZE DRUGS and SUPPLIES
TOP SHELVES and not randomly dispense. IN HOSPITAL Rx

2. Find generic name of each drug in your

• Liquids (injectables, ointments)
MIDDLE SHELVES
hospital pharmacy

3. Arrange and label the supplies on the

• Supplies ( surgical items, condoms and
labels) shelves
BOTTOM SHELVES

TO ORGANIZE DRUGS and TO ORGANIZE DRUGS and

SUPPLIES IN HOSPITAL Rx SUPPLIES IN HOSPITAL Rx
3. –Within each group, arrange supplies in 3. – Attach label to the front of the items on
alphabetical order by generic name the shelves.
- Allow enough space for each item 4. Store drugs with expiry dates by using
- group identical item in amounts that are FEFO.
easy to count, such as pairs or by 5’s or
10’s Expiry date- tells when a drug no longer
works and may be dangerous.
- Store injectables in groups of 10
- print the generic name of each item on
a label.

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TO ORGANIZE DRUGS and

SUPPLIES IN HOSPITAL Rx
4. – A drug may still be effective for a short
time after the expiry date, but it is not
guaranteed.
- Check all drugs in the hospital
pharmacy during inventory.
- Removed all drugs with near expiry for
possible refund or replacement
- Put the drugs with shorter expiry dates
in front of those with longer E.D.

Store drugs with expiry dates

TO ORGANIZE DRUGS and
SUPPLIES IN HOSPITAL Rx
4.- If drugs have the same expiry date, put
the newly received drug behind those
already on the shelves.
5. Store drugs with expiry dates by using
FIFO. (First in First Out)
- Store items with no expiry dates in the
order received.
- Put the newly received items behind the
items already on the shelves
by using FEFO.
5.- There may be a manufacture date on
the container.
- The date indicates older stock that
should be used first.
6. Remove expired and poor quality drugs.
- May have adverse or reduced effects on
pxs

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Store drugs with expiry dates by

using FEFO.
6.- Some have no effect at all and should
be removed.
- Return to medical supplier for
destruction or burn them at your facility.
- Remove overstocked items and any
items that are no longer used.
-Keep a record of drugs, including date
and time, witness and manner of
removal.

Flammables and Corrosives

-alcohol, ether, acetone, kerosene must be

stored in special buildings or rooms.
-well ventilated and fireproof and fitted with
explosion hatch
- A small working stock of flammables may
be kept in a steel cabinet in well-
ventilated premises, away from open
flames and electrical appliance.

14

Flammables and Corrosives
- Cabinets should be marked “highly
flammable liquid” and bear the
international hazard symbol.
- Always store flammables in their original
container.
- Flammable liquids each have a flash
point (minimum temperature with liquid
gives off vapor)
8/12/2020
Flammables and Corrosives
Flash points:
1. Acetone and anaesthetic ether- 15 ºC
2. Undiluted alcohol- 18-23ºC
3. Kerosene- 23- 61ºC
Never store in direct sunlight and place in
the coolest place possible.
Flammables and Corrosives
Corrosive or oxidant substances
- Stored away from flammables in
separate steel cabinets.
- Industrial-type protective gloves and face
masks should be used when handling
corrosives.
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 8/12/2020

Examples of Corrosive Indicators of Quality problems

Trichloracetic acid Light sensitive products (x-ray films)

-torn or ripped packaging
Glacial acetic acid
Latex products
Concentrated ammonia solution - Dry
Silver nitrate - Brittle

Sodium Nitrite - Cracked

All products
Sodium hydroxide pellets - Broken or ripped
- Missing, incomplete, unreadable labels

Indicators of Quality problems Indicators of Quality problems

Liquids Lubricated latex products

-discoloration -sticky packaging
-cloudiness -discolored product or lubricant
- Stained packaging
-sediments
- Leakage of lubricant (moist or damp)
- Broken seal on bottle
Pills (tablets)
- Cracks on ampule, bottle or vial
- Discoloration
- Dampness or moisture
- Crumbled pills

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Indicators of Quality problems Indicators of Quality problems

Cont. pills Sterile products

- Missing pill (blister pack) -torn or ripped packaging
- Stickiness - Missing parts
- Broken or bent parts
- Unusual smell
- Moisture inside
Injectables
- Stained packaging
- Liquid does not return to suspension
Capsules
upon shaking
- discoloration, stickiness, crushed
capsules

Indicators of Quality problems EXPIRED DRUGS

Tubes -refer to drugs which potency have

- Sticky decreased, chances of an increased
- Leaking contents allergic reactions, formation of a toxic
- Perforation in the tubes substance, decrease in solubility, or
Foil packs even a change in the formulation.
- Perforation
Chemical reagents
-discoloration

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Pharmaceutical waste Storing Health Commodities

a. Redistribution to the manufacturer - Follow manufacturer’s storage

b. Reuse/ donation instruction as much as possible.
c. Flushing down the drain/ toilet - Consult manufacturer before violating
d. Disposal in landfills recommended storage conditions
e. Incineration
f. Containers in the pharmacy

Recommended storage Meaning If no specific storage instructions are given-

condition NORMAL STORAGE CONDITIONS
Do not store over 30 ºC +2 ºC -- +30 ºC

Do not store over 25 ºC +2 ºC -- +25 ºC

*storage in dry, well, ventilated premises at
Do not store over 15 ºC +2 ºC -- +15 ºC temperatures of +15 ºC to + 25 ºC
* Extraneous odor, other indications of
Do not store over 8 ºC +2 ºC -- +8 ºC contamination and intense light must be
excluded.
Do not store below 8 ºC +6 ºC -- +25 ºC

Protect from moisture No more than 60% humidity

Protect from light Light-resistant container

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CONTROLLING TEMPERATURE Humidity

Factors affecting temperature  Ventilation

1. Humidity -open windows or air vents.
2. Sunlight -ensure windows are screened
3. Heat -windows have bars for security purposes
-boxes on pallets
• Packaging
-secure all lids

Humidity Sunlight

 Circulation Light-sensitive drugs and supplies:

- Use a fan to circulate fresh air.  Multivitamins
- Standing fan (smaller rooms) Ceiling  Furosemide
fans (bigger rooms) in storerooms  Chlorpheniramine maleate
 Air-conditioners or may use dehumidifier  Hydrocortisone
 Intravenous solutions
 Plastic or latex products

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Sunlight Heat

To protect products from sunlight:  Melts ointments, creams and

suppositories thus les some products be
Shade the window or use curtains useless.
Keep products in cartons
Do not store or pack products in sunlight

MONITOR TEMPERATURE Drugs that have Stability problems

Consistently monitor the temperature of  Oral solids

the different areas within the storeroom. - ASA, Amoxicillin, Ampicillin, Penicillin,
Vitamin A
Keep thermometers in the hottest places. • Oral Liquids
-Paracetamol
•Injectables
- Ergometrine and Methylergometine

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Preventing Damage and

Drugs that have Stability problems
Contamination
 Cloxacillin ( tablet, capsule, or powder PHYSICAL DAMAGE
for suspension) -Avoid crushing products stored in bulk.
 Nitroglycerine Products should be stacked no more than
 Vitamin K 2.5 m (8 feet high). Heavier or fragile
 Paracetamol tablets (gray or black items should be placed in smaller stacks.
discoloration) - Bind sharp edges or corners with tape.
- Proper waste disposal

Preventing Damage and Preventing Damage and

Contamination Contamination
DIRT DIRT
Write and post the schedule and Wipe down the shelves and products to
instructions for cleaning the storeroom in remove dirt and dust
multiple locations around the facility.
Dispose garbage and other waste often
Sweep, mop, scrub the floors of the
storeroom regularly. Infrastructure- ensure easy access for
cleaning

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Preventing Damage and PROTECTING AGAINST

Contamination FIRE
DIRT 1. Strictly prohibit smoking in the facility
Cleaning materials 2. Conduct fire drills at least twice a year
-Industrial detergents, Chlorine once a 3. Mark emergency exits and check
month regularly that they remained
unblocked.
4. Display precaution signs in appropriate
places in the storage facility
5. Minimize the number of flammables
stored in the facility.

PROTECTING AGAINST
FIRE
6. Fire extinguishers available in the
storage facility according to national
regulations
7. Visually inspect extinguishers every 2-3
months to ensure pressure are
maintained and ready to use.
8. Smoke detectors should be placed and
checked every 2-3 months.
9. Use sand to extinguish fires when there
are no extinguishers

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PROTECTING AGAINST PESTS PROTECTING AGAINST PESTS

(inside) (inside)
1. Design or modify storeroom to facilitate 6. Use pallets and shelves
cleaning and preventing moisture, 7. Inspect storeroom regularly for evidence
2. Maintain a clean environment of pests
3. Do not store or leave food in the
storage facility.
4. Keep interior of the building as dry as
possible.
5. Paint or varnish wood as needed

PROTECTING AGAINST PESTS

PROTECTING AGAINST THEFT
(outside)
1. Regularly inspect and clean the During transport:
outside premised of the storage facility -verify document
esp. where garbage is stored.
2. Check for any stagnant water in and -packaging seals are used
around the premises. -provide reliable vehicles
3. Treat wood frame facilities with water -Drivers are reliable
sealant -ensure rapid clearance at air and sea
4. Use mercury vapor lighting where ports
possible

23

PROTECTING AGAINST THEFT
At storage facilities
- Limit access to only designated staff
- Limit the number of keys made
- Secure locks and doors
- Make unannounced spot checks
- Provide independent stock count/
inventory control
Monitor selected drug products
 As additional protection against theft,
monitor items that are fast moving,
chronically in short supply, in high
demand by patients, expensive, life
saving, and easy to hide or disguise.
8/12/2020
PROTECTING AGAINST THEFT
In health centers:
-Lock the storeroom/cupboards
- Have stock cards for each product
- Set maximum dispensing quantities
- Have dispenser record individual
prescriptions and maintain prescription
or dispensing registers
- Limiting dispensing to authorized staff
members
Common Security Breaches
By health staff:
- Petty theft
- Systematic Diversion of larger quantities
for illicit markets or for use in private
practice
- Writing multiple prescriptions
- Systematic over-ordering of drugs for
private practice
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Common Security Breaches Techniques to Monitor Medicines

By patients: 1. Check inventory records for stock on

- Faking illnesses hand
- Visits by patients to several health 2. Compare stock records with prescription
centers or dispensing records.

HOW RECORDS ARE KEPT

 Prescription book
 Additional Opium Book
 Dangerous Drug Book
 Poison Book
 Exempt Preparations book
 FDA special record book

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Budgeting, Purchasing and Inventory Developing the budget

Control in Hospital Pharmacy Budget- Short-range plan for future operations

CEBU DOCTORS’UNIVERSITY
COLLEGE OF PHARMACY

 Define purpose of the unit

 Establish policies for its operation
 Project the hospital’s growth

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BUDGET INCOME ACCOUNT

Three parts
a. Income
accounts
b. Expense
accounts
c. Capital
Equipment
Requests

EXPENSE ACCOUNT PHARMACY DEPARTMENT

Categories
a. Administration and general

b. Professional care of patients

c. Out-patient and emergency

1. Salaries and wages
d. Other expenses
2. Supplies and expenses
3. Drugs and Pharmaceutical
4. Purchased Services
5. Miscellaneous

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EQUIPMENT and CONSTRUCTION

BUDGET Purchasing and Inventory

Assures standard and specification for all drugs,

chemicals, diagnostic agents etc used in pxs

Definition of terms: DEFINITION OF TERMS

COMPETITIVE BIDDING
--- drug is used in large amounts and future use
of the drug is certain.

QUOTATION REQUEST
----directed to manufacturer or supplier that
would offer the drug at its lowest price

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Annual inventories Duties of a purchaser

1. Issues purchase orders
2. Maintains purchase records
3. Follows up on delayed orders
4. Initiates competitive bidding procedures
5. Obtains quotations from specified sources

Procurement and Requisition Procurement and Requisition

 Determine, accredit and monitor supply sources

 Evaluate suppliers’ performance
 Choose a buying strategy/ approach
 Monitor drug delivery
 Assess clinical pure outcomes
 Evaluate new product
 Consult PTC concerning modification of drugs
 Reject drug products based on a sound
judgement
 Obtain medicinal products which are required
in the trust premises.

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PURCHASING
1. PURCHASE TIHROUGH PUBLIC
BIDDING.

PURCHASING
2. EMERGENCY PURCHASE
 Are allowed only in cases where the need for
supplies, materials, furniture, equipment or repair of
an equipment is exceptionally urgent or absolutely
indispensable to prevent immediate danger to, or loss
of, life and/or property, or to avoid detriment to
public service.

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PURCHASING PURCHASING
3. NEGOTIATED PURCHASE 3. NEGOTIATED PURCHASE

PURCHASING
4. PROCUREMENT FROM DULY- LlCENSED
MANUFACTURERS AND EXCLUSIVE
DISTRIBUTORS
 Procurement may be made directly from duly-
licensed Philippine manufacturers.
 In cases where there are two or more
producers/suppliers of the supplies desired, bids of
the known manufacturers/distributors should be
made to obtain the lowest price for the quality
of supplies desired.

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Purchasing Purchasing
5.PROCUREMENT THROUGH THE 7. PURCHASE THROUGH REPEAT
PROCUREMENT SERVICE ORDER

6. PROCUREMENT FROM OTIHER

PHILIPPINEGOVERNMENTAGENCIES
OR FOREIGN GOVERNMENTS

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Control on Purchase

Control on Purchase Control on Purchase

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Control on Purchases
Inventory turnover- cost of goods sold over
fiscal period

Low turnover indicates:

1. Duplication of stock
2. Large purchases of slow moving items
3. Dead inventory
High turnover indicates:
Small volume purchasing

3 ways to get discount or savings

DEALS

VOLUME CONTRACTS

DISCOUNTS

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VOLUME CONTRACTS DEALS

- Contracts covering total purchases of parenteral -represent that type of transaction that involves
solutions, ampoules, tablets. the purchase of a specified volume and
-rebate check at the end of the year. receiving certain merchandise at no
additional cost.

Ex. 10 + 1 promo
3 + 2 promo

DISCOUNTS Markings of Merchandise

 -prompt payment of pharmaceutical bills <4- OVERSTOCKING
>5- UNDERSTOCKING
1- SOUND INVENTORY

Marking machine- date received, cost price &

selling price

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Markings of Merchandise DEFINITION OF TERMS

COST PRICE
12/13 ---Original price of an item
P35.00 SELLING PRICE
P47.25 ---What consumers pay for when purchased
directly
*30% income
PROFIT
(Mark-up may differ according to dosage forms)
---Selling Price- Cost Price

DEFINITION OF TERMS DEFINITION OF TERMS

ACTUAL COST AVERAGE COST
---- all expenses in acquiring an item are added ----old stock + new stock/ total no. of units
to the cost of items to establish what the
goods actually cost
COST
---- Actual value of the item when last purchased

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Ordering Procedures
EXAMPLE
PRE-PRINTED ORDER FORMS
Contains the ff information:
S 8125 •Name of the drug
•Dosage form
P 334,150 •Dosage
•Packaging (by box of 100s)
(minus tax) •Amount ordered
•Unit price

Ordering Procedures
 Three copies of the order should be made,
dated and countersigned by the person in
charge of the health facility.
 Two copies ( delivery note, invoice;
supplier’s record)
 Third copy - hospital pharmacy

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RECEIVING OF ORDER
 Accompanied with a delivery note or an
invoice showing the number of packages and
their contents.
 Number of packages should be checked
immediately. Then, their contents can be
checked.

Ex: Appearance, Expiry date, Labelling etc

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Pricing of Drugs Pharmacy Pricing Methods

1. Direct Personnel Costs 1. Percentage Mark-up method
2. Drug costs 2. Dispensing fee method
3. Other direct supply cost 3. Per diem charge method
4. Fixed overhead costs
5. Direct costs
6. Revenue Deductions
7. Profit margins

Considerations in designing a Considerations in designing a

pharmacy pricing system pharmacy pricing system
1. Collection of Charge data 5. Ease of logical revision
2. Clerical and administrative item 6. Explainability
requirements 7. Acceptance of third party payers
3. Generation of adequate charge detail
4. Assurance of adequate revenue

14

DEFINITION OF TERMS
 Inventory turns - the number of times per year
inventory is sold and replaced at cost.
 Procurement costs (ordering costs) - include but are
not limited to the costs of placing the
order, receiving goods, and processing payment.
 Carrying costs - all costs associated with carrying
maintaining inventories.
 Gross Margin Return On Investment (GMROI) –
measures the operational profitability of a pharmacy.
DEFINITION OF TERMS
 Monthly consumption
This is calculated from the exits recorded on the
stock cards: add the quantities in the outgoing
column from several months (3, 6 or 12) and divide
the total by the number of months.
 Working stock
corresponds to the amount of each drug consumed
between supply of the pharmacy.
Example:
Working stock = monthly consumption
/ 3 mos.
8/12/2020
DEFINITION OF TERMS
 Basic stock - is the amount of inventory
carried to meet an average demand level.
 Safety stock - the amount of inventory carried
to account for fluctuations in demand and in
order cycle times.
 Order cycle time - is the amount of time that
elapses between the placement of an order
and the receipt of the merchandise.
Problem solving
In a Hospital Pharmacy, Profurex 750 mg IV
seems to be fast moving. In the month of
August, it has reached 5,750 vials, in
September 5,777 vials and in October had
6,004 vials dispensed.
What is the working stock for Profurex?
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DEFINITION OF TERMS
 Quantity to order
The amount to order based on the information
on the stock cards. INVENTORY
0rder = (working stock + safety stock) -
remaining stock on the day the order was
made.

INVENTORY CYCLE

STORAGE

ACQUIRE DISPOSAL

USE

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Purchasing and Inventory control

 The pharmacist is also responsible for COMPOUNDING
developing an effective system in the control MATERIALS
of purchase, inventory, and adequate
maintenance of raw materials used for
compounding and for pharmaceuticals.

PHARMACEUTICALS

Taking a Physical Inventory PHYSICAL INVENTORY

 A spot check type inventory is sometimes
performed on high cost and fast moving
items.
 To avoid faulty inventories, the actual
physical inventory should be undertaken
placing a great deal of emphasis on planning
and giving due attention to details.
 Amount of stock or merchandise that is
available for sale to present and future
clientele.
Basic stock + safety stock
 The taking of total physical inventory in the
pharmacy is usually required by the auditing
firm employed to audit the hospital’s fiscal
operations.

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Taking a Physical Inventory

 Drug items' ordered prior to the date of the
inventory and received on the day of the
inventory or shortly thereafter, should not be
counted and should be clearly marked
received "post inventory".
 Maintaining a perpetual inventory is still ideal
if the record-keeping can be kept up-to-date.

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Taking a Physical Inventory

 Perpetual Inventory - a perpetual inventory
system may be applied to the bulk storage
areas. This means that when an item is
removed from the bulk storage areas to the
active storage area for use in the dispensing
area, it is recorded as being removed from
inventory.
 Inventory supply is used as the determining
factor of when to reorder.

Taking Physical Inventory Functions of Inventory Management

 A perpetual system may be facilitated either
through a manual system of visible index
cards (still the current practice) or by means
of an electronic data system.
 The use of any of these systems would
provide a hospital with a record of all
inventory items, a maintained balance in
quantity and monetary value.
 Increase Profitability
 Get the maximum amount for the business'
investment
 Balancing supply and demand
 Improving efficiency
 Establishing a safety stock and geographical
specialization

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METHODS OF INVENTORY METHOD OF INVENTORY

OPEN TO BUY METHOD
budget method limits purchases to a specific
amount of funds available for purchasing
pharmaceuticals during a specified period.
SHORT LIST METHOD
identifies the items that are in short supply
MINIMIUM and MAXIMUM METHOD
is to determine when and how much to order
of each item
STOCK RECORD CARD
used to record information on the movement of
goods in and out of the storage area.

STOCK CARD METHOD

 Movements of stock, in or out
 Theoretical stock level
 Consumption of consumers
 Orders to be correctly foreseen
 Assessment of what and how much has been
lost
LOSS= Theoretical- Actual Stocks

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Information on stock cards Return Policies and Procedures

 The name of the product with DF and dose • Ensure optimum health outcome of pxs
 Drug movements with dates • Continue to practice good business
 Orders made and the date • Develop relationship with manufacturers or
 Inventories and the date suppliers
 Safety stock • Maintain the credibility of pharmacists
 Maximum stock
 Storage area
 Price

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EXAMPLE Product Recall

 Seldane (Terfenedine) – 1998
United Laboratory
 Hismanal (Astemizole) – 1999
Amherst Laboratory
 Prepulsid (Cisapride) – 2000
Pascual Laboratory
 Baycol (Cerivastatin) – 2001
Glaxo Smith Klein  … most recently Vioxx (rofecoxib)
Pfizer Laboratory

PRODUCT RECALL Product recall

A request to return to the maker a batch or an
entire production run of a product, usually due
to the discovery of safety issues.

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Product recall

Product recall

25
 ’

 Recommended practices
1. RPh reviews M.D order before initial
administration.
2. Ready to use medications to be administered.
3. Facilities & equipment accessible only to
medical practitioners.
4. Facilities & equipment designed for routine
inspections.
5. Provisions are made to provide suitable
pharmaceutical services.
6. Repacking from manufacturer’s original
container should meet standards of good
pharmacy practice.
7. Distinguishing accounting practices vs.
dispensing practice.

1. Individual Prescription Order system

2. Complete Floor Stock system
3. Combination of 1 and 2.
4. The unit dose drug distribution system
Comparisons Individual Complete Combination UD
Rx floor stock  “Those medications which are ordered and
system
Advantage Reviewed Availability Division of packaged, handled, administered and charged in
by RPh tasks enables multiples of single dose units containing pre-
Drug personnel
Interaction Returns time to focus determined amount of drugs or supply sufficient
and give best for one regular dose application or use”
Inventory Rx personnel possible
service.
Disadvantages Time Medication Communicati
element errors on between
technicians
Incr cost Pilferages and
pharmacist
Drug
inventory

Drug
deterioration
 Dangerous Drugs Prescription for IN-PATIENT use
ONLY

1. 24 hr medicines
2. More time of nurses for patient’s care
3. Check medication order/ prescription
4. Paper work decreased
5. Eliminates credit ( decrease cost)
6. IV preparation and drug reconstitution
procedures to the pharmacy 1. Px entered into the system
7. Profession utilization 2. Medication order sent to pharmacist
8. Prevents revenue losses 3. Pharmacist check drug order
9. Nursing units conserved 4. Refer to dosing schedule
10. Eliminates pilferages and drug waste 5. Dispensing medicines
11. Extends pharmacy coverage 6. Medication carts
12. Communication of medication order Improved 7. Pharmacist check carts
13. Drug consultants 8. Nurse administers the drug then log
9. Cart is rechecked

 IV fluids  Dangerous drugs

 Ointment  Total parenteral solution (esp. 1. Assignation of station of Unit Dose Pharmacists
 Gargle(without large volume TPN) 2. Know the patients for UD
define dose or cc)  Once a week refrigerated drug 3. Prepare Patient Profile sheets.
 PRN medications
 Discharged patients- disregard and file
IV Drip  Transferred patients- endorse to other RPh
4. Read medication orders from 10 am or to the last
order written by the pharmacist.
5. Check medication area (specifically individual
cubicle of patients
6. Note down the number of meds in the cubicle
using the patient’s profile
7. Charge medicines in a 24h consumption.
8. Dispense the medicines and prepare for
individual packaging.
Unit Dose Waiver
9. Re-check your dispensed medicines ready for
distribution
10. Endorse the medicines to the nurses.
11. Check any discrepancies (billing or lacking
medicines)

FIRST DOSE- DOUBLE DOSE (Only applicable for Oral

and Vials)
Eg. One tab every 4 hours = 6x2 =12

COMMON ABBREVIATIONS
Tab Tablet T/C To consider
Cap Capsule tt/t/c To consume
 IVTT Intravenous //d/c Discontinue  Exception anticoagulants-time to be specified
thru tubing meds by physician, i.e. 0300-1500
IM Intramuscular //D/C Discharge  If time is not specified standard times will be
SQ Subcutaneous //shift Is used when a
used
previous order
in IV and 4. Q 12 hours= 0900…2100
changed into 5. TID= 0900…1400…2100
oral 6. 15 minutes AC= 0645…1145…1645
OD Once daily //revise Is used if 7. AC or 1 hour AC= 0600…1100…1600
there’s a
8. PC or 2 hours PC= 0900…1400…1900
change in
meds with
9. Q 8 hours= 0600…1400…2200
same 10. QID= 0900…1300…1700…2100
therapeutic 11. Q 6 hours= 0600… 1200…1800…2359
QO_OD Every other //complete Used to 12. Q 4 hours=
day indicate a 0200…0600…1000…1400…1800…2200
completed
regimen
Bid Twice daily //filled Used to Frequency of first dose Double dose
indicate if the 500 mg tabs BID- (one Dispense 4 tabs 500 mg
ordered med tab 2x a day) of a drug
has been fully
850 mg tab TID- (one Dispense 6 tabs of 850
dispensed
tab 3x a day) mg of a drug
Tid Three times a MGH May go home
day 500 mg tab ½ OD- Dispense one tab of 500
Qid Four times a Arrow up Increase (one-half tab a day) mg of a drug
day 500 mg 2OD- (2 tabs Dispense 4 tabs of 500
5x a Five times a Arrow Decrease once a day) mg of a drug
day day down
Q4hrtc Every four Q4hprn Every four
hours round hours as
the clock needed
Q6h Every six hours Q8h Every eight
hours
Q12h Every twelve
hours

1. Daily= 0900
 Exception: for anti-infectives-time doses from
the closest 9 o’clock-either 0900 or 2100)
2. HS= 2100
3. BID=0900…2100
 cardiac surgery, cancer management,
neurosurgery, complex medical and surgical
 Ambulatory- Refers to patients not occupying interventions etc
beds in hospitals or other in patient settings
 Physicians' offices or clinics
 Health centers
 Other places where ambulatory patients
usually go for health care

 Mainly focuses on health equity producing social

policy beyond the traditional healthcare system.
 Its main aim is to provide local care to a patient
because professionals related to primary care are
normal generalists, deals with a broad range of
psychological, physical and social problems etc. 1. ASHP (American Society of Hospital
rather than specialists in any particular disease Pharmacists)
area. I. Leadership and Practice Management
II. Medication Therapy and Pharmaceutical care
1. Health education 6. Sanitation, adequate III. Drug Distribution and control
2. MCH care & safe water supply IV. Facilities, Equipment and other Resources
3. Prevention of illness 7. Promotion of mental 2. JCI (Joint Commission International)
4. Prevention & health Accreditation for Ambulatory care
control of endemic 8. Adequate nutrition I. International Patient Safety Goals
diseases 9. Providing essential
II. Patient Access and Assessment
5. Treatment of minor drugs
III. Patient Care and Continuity of Care
injuries and illneses 10. Immunization
IV. Patients’ Rights and Responsibilities
V. Patient Record and Flow
 This healthcare is provided by the medical VI. Patient Service Contrasts
specialists and other health problems who do not VII. Patient and Family Education
have direct contact with a patient like urologists, VIII. Patient Anesthesia and Surgery
dermatologists, cardiologists etc. IX. Improvement in Quality and Patient Safety
X. Infection Control and Facility Safety
 This type of healthcare is known as specialized XI. Human Resource Management
consultative healthcare usually for inpatients and XII. Governance and Leadership
on referral from primary and secondary
healthcare for advanced medical investigation 1. Qualified Pharmacists
and treatment. following examples of tertiary
care services are plastic surgery, burn treatment,
  Appropriateness of the choice of drug and its
dosage, route of administration, and the
amount must be verified by the RPh.
 All dispensed medications to patients will be
completely and correctly labelled and
packaged.
2. Patient Counseling
3. Location of Dispensing Area

 Thermometer
 Diaper
 Curity pad
 Disposable mask
 Wipes
 Expired drugs

In patients Out patients

 Regular Drugs (Hospital  Regular Drugs ( From
Prescription pad) Doctor’s clinic)
 Dangerous/ Regulated  Dangerous/ Regulated
Drugs- Blue Drugs- DDB
prescription prescription or
(completely filled with Triplicate copies
MD’s License, PTR and (completely filled with
S2 License no) MD’s License, PTR and
S2 License no)
 Advantages
 Lay-out- An arrangement or a plan, especially
 More Product Exposure
the schematic arrangement of parts or areas.
 Possibility of self service
 It plays significant role in the development of the
 Familiarity with product that can be needed in
patient’s perceptions which may have a positive
future
impact on its sale potential.
 Simplified, Secured, Minimum pilferage
 Maximum utilization of available space
 To attract a large number of patients.
 To increase the sale and decrease the selling
expenses
 To have space for reserve for stock, office and
resting place for the employees
 Proper entrance for goods
 To minimize the movement of patients with
within the premises of the hospital pharmacy.

1. Clerk or personal service

 Exposure of product is less
 For prescribed drugs
 Maximum interaction between consumer and
the pharmacy personnel
2. Self-selection
 Consumer may see handle and select items
 For nutritional supplements cosmetic,
contraceptive OTC drugs
3. Self service
 Minimum Clerk service
 Maximum exposure of product to customers
 Not 100 % self service

1. Grid layout
 Products are displayed in straight and parallel Advantages
lines  Allowance for browsing and wandering freely
2. Free flow layout  Increased impulse purchases
 Fixture are irregularly shaped such as circles,  Visual appeal and Flexibility
archs, and triangle
Disadvantages
 Loitering encouraged
 Possible confusion
 Waste of floor space and Costly
Premises
 The word Pharmacy shall be displayed in white
writing on green colored sign board having
minimum length of 5 feet and width of 2.5 feet.
 The premises of a pharmacy shall be separated
from room for private use
 The premises shall be built dry, well lit and
ventilated and shall be of sufficient dimensions to
allow the goods in stock, especially drugs and
poisons to be kept in a clearly visible and
appropriate manner.
 The area of the section to be used at dispensing
department should not be less than shall not be
less than 6 sq meters for each additional person.
 The height of the premises shall at least be 2.5 sq
Meters.
 The floor of the pharmacy should be smooth and
washable.
 The walls shall be plastered or tiled or oil painted
so as to maintain smooth, durable and washable
surface devoid of holes, cracks and cervices.
 The dispensing department shall be separated by
a barrier to prevent the entry of the public.
 The department of the hospital which deals with
procurement, storage, compounding, dispensing,
manufacturing, testing, packaging and
distribution of drugs.
 In hospital premises so that patients and staff can
easily approach it.
 In multi storied building, on the ground floor
especially the dispensing unit.
 The manufacturing room should be adjacent to
the pharmacy.
 Outpatient pharmacy should give pleasant
appearance and must have enough space for
seating of patients who have to wait for
medicines.
 Medical stores of a pharmacy should be adjacent
to the pharmacy itself or should be directly
connected to pharmacy.
 A community pharmacy is a pharmacy that deals
directly with people in the local area. It has
responsibilities including compounding,
counseling, checking and dispensing of
prescription drugs to the patients with care,
accuracy, and legality.
 A needy town or city
 Site of pharmacy in a particular city should be
most suitable among those available.
 Convenient and accessible site to the majority of
consumers.
 Adequate free parking facility.

 Administrative office
 Bulk storage
 Narcotic or dangerous drug locker
 Manufacturing and repackaging
 Intravenous solution compounding
 Inpatient dispensing
 Outpatient dispensing (In case of Hospital
Pharmacy)
 Medicine information resource centre
 Emergency medicine storage
  without prescription or medication order

Key terms: 1. Sterile Compounding

1. Active ingredient  Strict aseptic technique
2. Batch record (or batch log) o Injections
3. Batch repackaging o Ophthalmic solutions
4. Beyond-use o Irrigation solutions
5. Blister packages 2. Nonsterile Compounding
6. Compounding  Oral & topical medications
7. Compounding environment
8. Compounding record
 United States Pharmacopeia-The National Formulary
9. Extemporaneous repackaging
 Guidelines & an enforceable set of standards
10. Formulation record
 Describes procedures/requirements for compounding
11. Geometric dilution
 Intent of USP is to protect both patients &
12. Graduates
pharmacists
13. Inactive ingredient
14. Levigation.
15. Manufacturing  Adequate space
16. Nonsterile compounding  Orderly placement & storage of equipment
17. Peristaltic pumps  Controlled temperature/lighting
18. Prescription compounding  Clean
19. Stability  Sink with hot & cold running water
20. Sterile compounding  Essential for hand washing & equipment cleaning
21. Trituration  Equipment must be:
22. Unit-dose package  appropriate in design & size for intended purpose
23. Unit-of-use packaging  must always be cleaned immediately after use
24. Volumetric pumps  must be properly maintained & calibrated
 Must have separate & distinct areas for compounding
sterile & nonsterile preparations
 Meets unique needs of patient
 Medication strength/dose not commercially
available  Primary packaging important
 Compounding associated with specialty practice areas:  Examples:
 veterinary medicine o light sensitive drugs or drugs that bind to
 dermatology container
 hormone replacement therapy  Beyond-use date (BUD) on label of all medications
 pain management  Determining beyond-use dates based on:
 hospice  aqueous (water-based) or nonaqueous
 home care  expiration dates of ingredients used
 storage temperature
 references with stability data
 Compounding: prepare small quantity of drug
 based on practitioner’s prescription
 for specific patient  USP or National Formulary (NF) chemicals
 Manufacturing: prepare bulk quantities  preferred
 Pharmacist responsible for selection  compounding record for each compounded
 Chemical must meet purity & safety standards preparation
 Formulation record-an individual record (like a
recipe)
 Guideline:
 filed alphabetically
 should contain between 90% & 110% of labeled
 listing of the:
active ingredient
o ingredients
 Guidelines specifically address these dosage forms:
o compounding equipment
 capsules, powders, lozenges, tablets, emulsions,
o instructions for preparing formula
solutions, suspensions, suppositories, creams,
 Log of an actual compounded preparation
topical gels, ointments, pastes
 based on an individual prescription
 batch may be prepared in anticipation of orders
 Goal of compounding process  includes manufacturer & lot numbers of chemicals
 “minimize error and maximize prescriber’s  date of preparation
intent”  internal identification number
 Pharmacist evaluates appropriateness of order  beyond-use date
 Only 1 preparation should be compounded at a time  names of individuals who prepared & verified
 avoid errors
 avoid cross-contamination
 Compounding record for batch (batch record)
 filed by lot number
1. Calculate amount of ingredients for preparation  Compounding record for an individual prescription
2. Identify equipment needed  chronological list of preparations made
3. Wash hands & wear proper attire  Formulation & compounding records
4. Clean compounding area & needed equipment  maintained as paper copies or electronically
5. Collect all materials & ingredients
6. Compound prep following formulation record
 Final check on preparation
7. Document name on compounding record/log
 Pharmacist must evaluate
8. Label final preparation appropriately
 finished preparation
9. Properly clean & store all equipment
 compounding procedure
 Discrepancies should be noted & evaluated
 Pharmacist is responsible for checking final prep  Patient Counseling
 weight variation  important with all medications
 proper mixing  correct use, storage, beyond-use date, evidence
 odor of instability in compounded medication
 color
 consistency
 Needed to prepare formulation not intended to cause
 pH if appropriate
pharmacologic response
 Pharmacist signs & dates prescription
 Diluents or fillers  Ointment slab (pill
 documenting/ensuring quality
 Binders tile) & spatulas
 Colorants o trituration
 USP Chapter 795 requires pharmacies to maintain  Lubricants o levigation
 formulation record (master formula)  Flavorants o geometric
 Sweeteners dilution
  Suspending agents  Electronic mortar  Flavoring & sweetening agents
 Vehicles & pestle
 Emulsifying agents  Hot plates  Suppositories may contain:
or surfactants  Refrigerator with  analgesics
 Coating agents freezer  hormones
 Preservatives  Stirring rods  anti-nausea agents
 Perfumes  Stir plates with  laxatives
 Acidifying agents magnetic stir bars
 vaginal anti-infectives
 Alkalizing agents  Strainers
 Once inserted, suppository melts or dissolves
 Wetting agents  Molds for
 suppositories must remain solid at room
 Electronic or class A suppository,
torsion balance troche temperature & melt at body temperature
 Powder papers or  Blenders
weigh boats  Capsule filling  Also known as pastilles
 Brass weight sets equipment  Small, medicated squares can be soft or hard
with class A torsion  Mixers  Intended to dissolve slowly between cheek & gum
balances  Motorized stirrers  Medication(s) absorbed through oral mucosa
 Graduates
 Mortars & pestles  Capsule-filling machine
 Powders mixed in mortar, zippered plastic bag, or
 Commonly compounded preparations: specialized blender
 ointments  Lids or capsule tops are removed
 creams  Capsules drop even with plate
 solutions  Powder is distributed into capsules
 suspensions  Lids or tops are replaced
 suppositories  Numerous capsule sizes & colors available
 lozenges/troches
 Powders are very fine, dry active & inactive ingredients
 capsules
 Granules are powders moistened & passed through
 One or more drug ingredients screen
 Mixed in homogenous or single phase  Emulsions are mixture of 2 immiscible liquids
 No visible undissolved particles  Gels are semi-solid systems consisting of suspensions
 Solutions  Tablets are made by compression
 Solid drug that dissolves in liquid
 Pharmacies repackage medications from bulk
 Suspensions
containers into patient-specific containers
 Two phases:
 unit-of-use
o insoluble solid particles (active ingredient)
 single-unit
o liquid
 unit-dose
 Insoluble particles settle to bottom
 Suspending agents
o added to allow insoluble particles to re-  Extemporaneous repackaging
suspend  quantities to be used within short period of time
 Suspensions  done on an “as needed” basis
o Levigate insoluble powder to smooth paste  based on anticipated immediate need
o Appropriate wetting agent  also known as “just-in-time” packaging
 Batch repackaging packaged or the expiration date on the manufacturer’s
 periodic repackaging of large quantities of container, whichever is earlier.”
medications
 unit-dose or single-unit packages  Current federal labeling requirements
 extended stability  Described in ASHP Technical Assistance Bulletin on
 prescribed more frequently Single Unit and Unit Dose Packages of Drugs
 Generic name & brand name
 Prepare in advance = pre-packaging
 Dosage form, strength, amount delivered in package,
 Saves:
notes
 Time
 Expiration date
 Materials
 Control number or lot number
 Money
 Bar code

 Must protect drug from

 Standards of practice & government regulations
 harmful external elements
 maintaining accurate, complete records
o light
 focal point for quality assurance program
o heat
 maximize technician’s role in repackaging
o moisture
 Repackaging record systems
o air
 computerized
o microbial contaminants
 individual state laws & regulations will dictate:
 USP defines containers & closures
o what needs to be kept, whether records may be
 based on degree to which contents protected
maintained as paper or electronic records,
how long records must be maintained
 Oral Solid Systems
 blister packages
 Ensures high-quality repackaged medications
 pouch packages
 Quality control
 Manual Systems
 written procedures
 Automated Systems
 formal training for operators of equipment
 Oral Liquid Systems
 maintenance of equipment
 Semi-automated Systems
 checkpoints during process
 Volumetric pumps
 end product testing
 Peristaltic pumps
 strict adherence to good manufacturing practices
(GMP)
 Labeling-responsibility of dispenser
 storage conditions
 Manufacturing/repackaging processes clearly defined
 beyond-use date
 Instructions/procedures are written in clear language
 USP offers standards for determining an
 Documentation of personnel training
appropriate expiration date in absence of
 Records: show procedures were followed
published stability data
 Storage & distribution of final product minimizes
negative effects to quality
“For nonsterile solid and liquid dosage forms that are  System for recalling any batch of product
packaged in single-unit and unit-dose containers, the  Written Procedures
beyond use date shall be one year from the date  Personnel Training and Competency
 Maintenance of Equipment
 End-Product Testing
1. Double-checking drug & dosage
2. Double-checking fill volumes
3. Double-checking calculations
4. Double-checking information on label
 Parenteral- refers to the injectable routes of
administration
 derived from the Greek words para (outside) and
enteron (intestine)
 Injections – are sterile, pyrogen limited, that is,
bacterial endotoxin units limit, preparations intended
to be administered parenterally.
 Hypodermic Morphine Solution
 The earliest injectable drug to receive official
recognition
 Appeared first in the 1874 and in 1888 in the first
edition of the national Formulary of the United
States (NF).
 Advantage
 Provide rapid action compared with other routes
of administration -the placement of the drug
directly into the circulation and the prompt action
that ensues
 Disadvantage
 Once a drug is administered intravenously, it
cannot be retrieved
 The basilic and cephalic veins on the back of the hand
and dorsal forearm are the best peripheral veins for IV
therapy.
 Most clinicians insert the needle with the bevel facing
upward, at the most acute angle possible with the
vein, to ensure that the direction of flow of the
injectable is that of the flow of the blood.
 Naturally, the IV route is used for blood transfusions,
and it also serves as the point of exit for removal of
blood from patients for diagnostic work and for
donation
Patient-Controlled Analgesia (PCA)
 Used to control the pain associated with a variety of
surgical procedures, labor, sickle cell crisis, and cancer.
 The advantage of the PCA is its ability to provide
constant and uniform analgesia.
 The PCA also permits patients to medicate themselves
for breakthrough pain.
 PCA devices can be used for IV, SC, or epidural
administration.
 Advantage
 Provide effects that are less rapid but generally
longer lasting than those obtained from IV
administration
 Disadvantage
 Injuries to patients from IM injection usually are
related to the point at which the needle entered
and where the medication was deposited.
 In adults, the upper outer quadrant of the gluteus
maximus is the most frequently used site for IM
injection
 In infants and young children, the deltoid muscles of
the upper arm or the midlateral muscles of the thigh
are preferred
 Gluteal area: maximum of 5mL
Deltoid: maximum of 2mL
 Advantage
 May be used for injection of small amounts of
medication
 Disadvantage
 amounts greater than 2mL will most likely cause
painful pressure
 irritating drugs and those in thick suspension may
produce induration, sloughing, or abscess and
may be painful
 Common Site of Administration: outer upper arm, the
anterior thigh, or the lower abdomen
 Maximum amount of medication: 1.3mL
 Also known as transdermal route
 The usual site for ID injection is the anterior forearm
 Usually, only about 0.1mL may be administered in this
manner
 When it is necessary to administer repeated injections
over time, it is prudent to employ devices that provide
continued access and reduce pain associated with
administration.
 Several types of central venous catheters are used in
institutions and on an outpatient basis for a variety of
parenteral medications (e.g., cancer chemotherapy,
long-term antibiotic therapy, TPN solutions
 Three types of catheters:
1. Plain plastic
2. Catheter over needle or catheter outside needle
3. Catheter inside needle
1. Injection: Liquid preparations that are drug
substances or solutions thereof (e.g., Insulin Injection,
USP)
2. For injection: dry solids that, upon addition of
suitable vehicles, yield solutions conforming in all
respects to the requirements for injections (e.g.,
Cefuroxime for injection, USP)
3. Injectable emulsion: Liquid preparation of drug
substance dissolved or dispersed in a suitable
emulsion medium (e.g., Propofol, USP)
4. Injectable suspension: Liquid preparation of solid
suspended in a suitable liquid medium (e.g.,
Methylprednisolone Acetate Suspension, USP)
5. For injectable suspension: Dry solid that, upon
addition of suitable vehicle, yields preparation
conforming in all respects to the requirements for
injectable suspensions (e.g., Imipenem and Cilastatin
for injectable suspension, USP)
The solutions and suspensions of drugs intended for
injection are prepared in the same general manner as
solutions and disperse systems, with the following
differences:
1. Solvents must meet special purity and other standards
ensuring their safety by injection.
2. The use of added substances, such as buffers,
stabilizers, and antimicrobial preservatives, fall under
specific guidelines of use and are restricted in
certain parenteral products. The use of coloring agents
is strictly prohibited.
3. Parenteral products are always sterilized, meet sterility
standards, and must be pyrogen limited.
4. Parenteral solutions must meet compendial standards
for particulate matter.
5. Parenteral products must be prepared in
environmentally controlled areas, under strict
sanitation standards, and by personnel specially
trained and clothed to maintain the sanitation
standards.
6. Parenteral products are packaged in special hermetic
containers of specific and high quality. Special quality
control procedures are used to ensure hermetic seal
and sterile condition.
7. Each container of an injection is filled to a volume in
slight excess of the labeled volume to be withdrawn.
This overfilling permits ease of withdrawal and
administration of the labeled volumes.
8. The volume of injection permitted in multiple-dose
containers is restricted, as are the types of containers
that may be used for certain injections.
9. Specific labeling regulations apply to injections.
10. Sterile powders intended for solution or suspension
immediately prior to injection are frequently packaged
as lyophilized or freeze-dried powders to permit ease
of solution or suspension upon addition of the solvent
or vehicle.
 Water for Injection, USP
 Purified by distillation or reverse osmosis
 Must be pyrogen free
 Should be stored in tight containers at
temperatures below or above the range in which
the microbial growth occurs
 The water should be collected in sterile and
pyrogen-free containers (glass or glass lined)
 Sterile Water for Injection, USP
 Packaged in single-dose containers not larger
than 1L
 May not contain any antimicrobial agent or other
added substance
 Intended to be used as a solvent, vehicle, or
diluent for already sterilized and packaged
injectable medications
 Bacteriostatic Water for Injection, USP
 Is sterile water for injection containing one or
more suitable antimicrobial agents.
 Packaged in prefilled syringes or in vials
containing not more than 30mL of the water
 The container label must state the names and
proportions of the antimicrobial agent or agents
 Employed as a sterile vehicle in the preparation of
small volumes of injectable preparations
 USP labeling requirements demand that the label
state NOT FOR USE IN NEONATES.
 Sodium Chloride Injection, USP
Is a sterile isotonic solution of sodium chloride in water for
injection.
 Contains no antimicrobial agents but has
approximately 154mEq each of sodium and
chloride ions per liter
 It may be used as a sterile vehicle in solution or
suspensions of drugs for parenteral
administration.
 Bacteriostatic Sodium Chloride Injection, USP
Is a sterile isotonic solution of sodium chloride in water for
injection
 Contains one or more suitable antimicrobial
agents, which must be specified on the labeling
 Also used to flush a catheter or IV line to maintain
its patency
 Carries the warning NOT FOR USE IN NEONATE
 Ringer’s Injection, USP
Is a sterile solution of sodium chloride, potassium chloride,
and calcium chloride in water for injection.
 Employed as a vehicle for other drugs or alone as
an electrolyte replenisher and plasma volume
expander.
 Lactated Ringer’s Injection, USP
 Has different quantities of the three salts in
Ringer’s injection, and contains sodium lactate.
 A fluid and electrolyte replenisher and a systemic
alkalizer
 Must be nonirritating, nontoxic in the amounts
administered, and not sensitizing
 Must not exert a pharmacologic activity of its own, nor
may it adversely affect the activity of the medicinal
agent
 The physical and chemical properties of the solvent or
vehicle must be considered, evaluated, and
determined to be suitable for the task at hand
 Solvent’s physical and chemical stability at various pH
levels, viscosity, which must be such as to allow ease
of injection
 Fluidity must be maintained over a fairly wide
temperature range
 Boiling point should be sufficiently high to permit heat
sterilization
 Miscibility with body fluids
 Low vapor pressure to avoid problems during heat
sterilization
 Constant purity or ease of purification and
standardization
 Antibacterial preservatives
 Buffers
 Solubilizers
 Antioxidants
 Other adjucts  Filters have various pore sizes, 14 to 0.025µm, to meet
specific requirements
 Sterilization- destruction of all living organisms and
their spores or their complete removal from the  Its speed in filtration of  Because the
preparation small quantities of membrane tends
1. Steam solution to be fragile, it is
2. Dry heat  Its ability to sterilize essential to
3. Filtration thermolabile materials determine that the
 Relatively inexpensive membrane was not
4. Gas
equipment ruptured or flawed
5. Ionizing radiation
 The development and during assembly,
proliferation of sterilization, or use.
 Conducted in an autoclave and employs steam under
membrane filter
pressure
technology
 Most autoclaves routinely operate at 121°C (250°F), as  Complete removal of
measured at the steam discharge line running from living dead
the autoclave. microorganisms and
 Applicable to pharmaceutical preparations and other particulate matter
materials that can withstand the required from the solution
temperatures and are penetrated by but not adversely
affected by moisture.  Gases like ethylene oxide and propylene oxide are
 Also applicable to bulk solutions, glassware, surgical highly flammable when mixed with air but can be
dressings, and instruments employed safely when properly diluted with an inert
gas such as carbon dioxide or a suitable fluorinated
 Usually carried out in ovens designed for this purpose hydrocarbon
and ovens may be heated either by gas or electricity  In general, sterilization with gas is enhanced, and the
and are generally thermostatically controlled exposure time required is reduced, by increasing the
 Less effective in killing microorganisms; Higher relative humidity of the system (to about 60% and by
temperatures and longer periods of exposure are increasing the exposure temperature to 50°C to 60°C
required
 Usually conducted at 150°C to 170°C for not less than  Techniques are available for sterilization of some types
2 hours of pharmaceuticals by gamma rays and by cathode
 Generally employed for substances that are not rays, but application of such techniques is limited
effectively sterilized by moist heat (fixed oils; glycerin; because of the highly specialized equipment required
various petroleum products, such as petrolatum, liquid and the effects of is irradiation on the products and
petrolatum (mineral oil), and paraffin; and various their containers
heat-stable powders, such as zinc oxide.
 The method of choice when dry apparatus or dry  The USP contains monographs and standards for
containers are required, as in the handling of biologic indicators of sterilization
packaging of dry chemicals or non-aqueous solutions  Biologic indicator – is a characterized preparation of
specific microorganisms resistant to a particular
 Depends on the physical removal of microorganisms sterilization process
by adsorption on the filter medium or by a sieving  Thermal Death Time – is defined as the time required
mechanism to kill a particular organism under specified conditions
 Used for heat-sensitive solutions
Pyrogens and Pyrogen Testing contents without changing the strength, quality, or
 Pyrogens / Bacterial Endotoxins – fever- purity of the remaining portion.
producing organic metabolic products arising
For labeling purposes, revised injectable product
from microbial contamination and responsible for
nomenclature became official in the USP 23 on January 1,
many of the febrile reactions in patients following
1995, and continues. The main points of the revised
injection.
process are as follows:
 Because pyrogens are organic, one of the more
I. The term Sterile was eliminated from the titles
common means of removing them is by oxidizing
of injectable products except appropriate
them to easily eliminated gases or to nonvolatile
monograph titles for water intended for
solids, both of which are easily separated from
parenteral use, such as sterile water for injection,
water by fractional distillation
USP.
 Potassium permanganate and barium hydroxide
II. For established names of injectable products, all
are added to water that has been distilled several
of which are suitable and intended for
times, and distillation is repeated, the chemical-
parenteral administration, USP established the
free distillate being collected under strict aseptic
following criteria in determining the product’s
conditions
title:
A. Liquids
A given test uses rabbits whose temperatures do not differ 1. Injection: Title for liquid preparations that
by more than 1°C from each other and whose body are drug substances or solutions thereof.
temperatures are considered not to be elevated. 2. Injectable suspension: Title for liquid
 If no rabbit shows an individual rise in temperature of preparations of solids suspended in a
0.5°C or more, the product meets the requirements for suitable liquid medium
the absence of pyrogens. 3. Injectable emulsion: Title for liquid
 If any rabbit shows an individual temperature rise of preparations of drug substances dissolved
0.5°C or more, continue the test using five other or dispersed in a suitable emulsion medium.
rabbits. B. Solids
 If not more than three of the eight rabbits show 1. For injection: Title for dry solids that, upon
individual rises in temperature of 0.5°C or more and if the addition of suitable vehicles, yields
the sum of the eight individual maximum temperature solution conforming in all respects to the
rises does not exceed 3.3°C, the material under requirements for Injections.
examination meets the requirements for the absence 2. For injectable suspension: Title for dry
of pyrogens. solids that, upon the addition of suitable
vehicles, yield preparations conforming in all
respects to the requirements for Injectable
 Single-dose container – a hermetic container holding Suspensions.
a quantity of sterile drug intended for parenteral
administration as a single dose; when opened, it
cannot be resealed with assurance that sterility has
been maintained
 Once opened, the ampule cannot be resealed and no
unused portion may be retained and used later.
 Multiple-dose container – a hermetic container that
permits withdrawal of successive portions of the
Introduction in Aseptic Technique

Objectives:
1. To define aseptic technique and enumerate its purpose and significance.
2. To know what are the definition of products by risk level.
3. To know the environmental requirements on sterile preparations and its parameters.
4. To know the general guidelines and principles of aseptic technique.
5. To know the types of laminar flow hood/ BSC and its use.
6. To acquire working knowledge of sterile techniques in hand washing, gowning, and
gloving.

Aseptic Technique

Aseptic preparation:
The technique involving procedures designed to preclude contamination (of drugs,
equipment, or supplies) by microorganisms during processing.

Aseptic Technique
Refers to the ability of personnel who prepare intravenous admixture to handle the
sterile components of these IV solutions in the clean environment of a laminar flow
hood without introducing viable microorganisms in the product.

Purpose of Aseptic Technique

1. Maintain asepsis/ sterility
2. Protect the patient from infection
3. Prevent the spread of pathogens
4. Minimize particles in the clean room

Importance of Aseptic technique

-Giving a patient a contaminated product can cause serious adverse effects including
DEATH.
- Parenteral administration bypasses the skin and gastrointestinal tract which are the
body’s natural barriers to infection.
- Parenteral medication account for > 40% of all medications administered in
institutional practice.

Quality Assurance Program

-The ASHP technical assistance bulletin describes three different levels of risk for
products.
- Products are classified into one of the three risk levels based on:
How they are prepared.
How long they can be stored.
Whether they are prepared for a single patient or as part of a batch, whether they are
from a sterile or non-sterile source.

Characteristics of Risk level

Risk level 1
-Sterile products without preservatives for individual patients or batch prepared with
preservatives for multiple patients.
Cont (Risk level 1)
-These are sterile products transferred into a sterile container (ex. Syringes, IV bag or
bottle)
- Storage time for these products, including administration time, should not exceed 28
hours at room temperature, 7 days under refrigeration, or 30 days if frozen.

Risk Level II
- These products are batch-prepared without preservatives for multiple patients.
- These include products that require multiple sterile ingredients that are
combined in a sterile container through a closed system transfer that are then
subdivided into multiple parts.
- Storage time for these products, including administration time, can exceed 28
hours at room temperature, 7 days under refrigeration, or 30 days frozen.

Risk Level III

-These products are compounded from non-sterile ingredients, containers or
equipment or prepared form sterile or non-sterile ingredients in an open system.
-The pharmacist is likely to be responsible for ensuring compliance with the
guidelines and other standards of practice.
- Areas of the document that affect the technician include training, policies and
procedures, garb, aseptic technique, process validation, and end-product evaluation.

Sources of Product contamination

People (MOST COMMON)
- Touch contamination
- Generation of particulates from shedding cells or hair
Natural air
- Heating, Ventilation and Air conditioning (HVAC)
Infiltration
- Particles form adjacent spaces (anteroom)
Equipment
- Microorganisms
Materials
- Metal bits, rubber core, particles, precipitate
Internal generation
- Walls, floors, ceilings, packaging, equipment

Environmental Requirements
1. Controlled area
-where unsterilized products, in process materials and containers are handled
Class 10,000 or 100, 000
2. Critical area
-where sterile products, containers and closures are exposed to their surroundings
Class 100

Seven Parameters
1. Temperature
2. Relative humidity
3. Air exchange
4. Percentage of fresh air
5. Pressure differential
6. Particulates
7. Microbial organism

Possible product contaminants

-Many commensal organisms exist in or on the skin, hair, respiratory tract and
alimentary tract of people.
- Major organisms include:
Staphylococcus spp. (S. aureus and S. Epidermis)
Micrococcus spp
Streptococcus spp
Corynebacterium spp.

-Various gram negative bacilli such as:

Enterobacter spp.
Klebsiella spp.
Serratia marcesens
Proteus mirabilis
Escherichia coli
Pseudomonas spp

-Together with a variety of fungi, inluding Candida albicans

Guidelines of Aseptic Technique

-Demands Meticulous NO TOUCH technique EVERYTIME

Aseptic technique Guidelines

1. Wash hands before compounding or re-entering the hood.
2. Remove any jewelry from the hands and wrists.
3. Needles should be used for a maximum of 8 to 10 punctures.
4. Always disinfect all rubber stoppers and ampule necks with alcohol before entering
with a needle.
5. Sterile products must be prepared with aseptic technique in the clean room.
6. Each ingredient and container should be inspected for defects, expiration date, and
product integrity before use.
7. Solution form ampules should be properly filtered to remove particles.
8. Do not use the same syringe more than five times for a single compounded dose.
9. Solution of reconstituted powders should be mixed carefully ensuring complete
dissolution of the drug with the appropriate diluent.
10. Packaging materials and items generating unacceptable amounts of particles (ex.
Carboard boxes, paper towels, reference books) should not be permitted in the
controlled area or critical area.
11. To maximize accuracy, the smallest syringe that can hold a desired amount of
solution should be used.
12. Always minimize clutter. Waste and other items should never enter the hood. All
calculations should be done before entering the hood.
13. Outer pouches and wraps should be removed at the edge of the work area as the
sterile contents are pulled into work area. Never bring these items into the main work
area.
Storage and handling of products and supplies
1. Products should be stored in accordance with manufacturer requirements.
2. Temperatures in refrigerators and freezers used to store ingredients and finished
sterile preparations should be monitored and documented daily to ensure that
compendial storage requirements are met.
3. Expired products should be removed from active storage areas.
4. Needles packages that are damaged should be discarded into sharp containers.

Equipment for Sterile product preparation:

1. Laminar Flow Hood/ Laminar Air-flow hood
2. Gloves boxes/ biological safety cabinets/ biohazard cabinets.

Laminar Flow hood

1. The air flowing out from the hood suspends and remove contaminants introduced
into the work area by the personnel.
2. The hood workspace is used to prevent the contamination of compounded sterile
products and parenteral preparations.
3. HEPA filter removes 99.97% of particles of 0.3 micron or larger.

Three ZONES of LFH

INNER ZONE - clean zone
MIDDLE ZONE - working zone
OUTER ZONE - dirty zone

Types of laminar flow hood

1. Horizontal Flow (Laminar flow hood)
- air blows towards worker
- used for non-chemotherapy preparations
-operator is facing the HEPA filter

2. Vertical flow (Biological safety cabinet or chemotherapy hood)

- air flow is downwards
- for Cytotoxic, radioactive preparations
- protects the operator from Cytotoxic fumes
- HEPA filter is located on top of the hood

Biological Safety Cabinet ( BSC)

HEPA filter
- removes particles of 0.3 micron
- 99.97% efficient
- Does not remove gases and vapors
Three types of HEPA filter
1. Class I BSC
2. Class II
3. Class III

Class I BSC
-protect personnel and the work environment but does not protect the product.
- negative pressure, ventilated cabinet
-similar to a chemical fume hood
Class II
- personnel protection (inward flow)
- Environmental protection (HEPA filtered exhausted air)
- Product protection (downward HEPA filtered laminar airflow

Class III
- Gas-tight with a non-opening view window
- Rubber gloves attached to ports
- Highest level of product, environmental and personnel protection
- 2 HEPA
- Isolator

General Principles for Proper operations of LFH

- All aseptic manipulations should be performed at least 6 inches within the
hood.
- At least 30 minutes warm up and thorough cleaning should be done to prepare
the hood for use.
- Only materials essential for preparing the sterile product should be place in the
LFH.
- Nothing should touch the HEPA filter, including cleaning solution, aspirate
from syringes and glass from ampules.
- Ampules should not be broken down directly toward the filter.
- Before use, all interior working surfaces of the hood should be cleaned with
70% isopropyl alcohol or another disinfecting agent and a clean, lint free
cloth. Throughout the compounding period, the room should be cleaned often.
- Hand and wrist jewelry should not be worn, jewelry may introduce bacteria or
particles.
- Actions such as talking and coughing should be directed away from the critical
area, and any unnecessary motion should be avoided to minimize airflow
turbulence.
- Food and drink should not be permitted with the aseptic preparation area.

SOP
Hand washing
Pre-washing preparation
1. Trim nails short- they should be scrubbed carefully since most microbes
come from beneath the fingernails. Artificial nails and nail polish are also should be
avoided.
2. Remove rings- they should not be worn because they interfere with
washing and may tear gloves.

Steps in hand washing

1. Pour an adequate amount of povidone-iodine cleanser or 4% chlorhexidine
gluconate solution on hand.
2. Brush fingernails and scrub hands, wrists and arms to the elbows for at least 10-15
seconds.
3. Hands should be washed once gloves are removed.
Effective hand washing
1. Wet hands with water and apply soap onto palm. Rub palm to palm.
2. Place right palm over left dorsum (top of the head) and vice versa
3. Place palm to palm, fingers interlaced.
4. Place back of fingers to opposing palm with dingers interlocked. Do likewise the
other hand.
5. Perform rotational rubbing of right thumb clasped in left palm and vice versa.
6. Perform rotational rubbing, backwards and forwards with clasped fingers of right
hand in left palm and vice versa.
7. Perform rotational rubbing of right wrist and vice versa. Rinse and dry thoroughly.

Gowning Procedures:
1. Remove shoes before entry into the anteroom.
2. Remove watches and jewelry before gowning.
3. Put on hair cover, tucking all hair inside.
4. Wash hands with Povidone-Iodine scrub.
5. Put on surgical mask. Bend nosepiece first for snug facial fit.
6. Put on gown. Make sure sleeves and upper garment do not touch bench or floor.
7. Put on shoe covers. Pull shoe covers over legs of overall.
8. Push up sleeves of gown. Wash and dry hands thoroughly as in step 4. Pull sleeves
back down to the wrists.
9. Choose a pair of surgical latex gloves that will fit snugly but will not impair
movement. Place hem of glove over cuff or sleeve.
10. Wash gloves with Povidone-Iodine scrub.

De-gowning Procedures:
1. Remove gloves and discard.
2. Remove shoe covers and gown. Place in a designated container/ bag for used
gowns. If gowns are to be reused, hang up in a controlled environment away from
outside clothing.
3. Remove hair cover and mask then discard.
4. Wash hands before leaving the anteroom.

Glove Recommendations
-Sterile vs Nonsterile gloves.
-Powdered vs non-powdered gloves.

For the first gloves, only the upper cuff area should be touched- and as little as
possible.

Only sterile areas of the second glove should be touched by sterile areas of the
previously gloved hand.

After pulling on gloves any traces of powder on outer site should be removed under
aseptic condition.

HOW TO APPLY ON STERILE GLOVES:

1. Open gloves packaging using outside edges only and tip out inside packaging onto
the sterile field, then wash your hands.
2. Open the inner packaging using outer edges of packaging only until gloves are
exposed.
3. Pick up the left gloves using your right hand, pick it up by the cuff only.
4. Hold the gloves at the fold of the cuff, insert your left hand and pull the gloves onto
your hand.
5. Once pulled onto your hand, adjust if necessary but only touch the inside of the
glove.
6. Pick up the right glove by tucking your gloved left hand in between the fold of th
cuff and pull the glove over your right hand. Readjust fingers once both gloves are in
place.

-When applying the right gloves, ensure that the sterile left gloves does not touch your
skin!!

SUMMARY
Aseptic technique is the manipulation of sterile products to prevent contamination.

Proper use of LFH, strict aseptic technique and conscientious work habits are the most
important factors in preventing contamination.
 8/12/2020

CEBU DOCTORS’UNIVERSITY
COLLEGE OF PHARMACY

 To achieve
 Is the IV administration of nutrients adequate
precisely formulated in such a manner that nutritional status
the totality of the patient’s nutritional and positive
needs were satisfied even though oral
nitrogen balance
intake has ceased.
 The solution was designed hypertonic so
until exercise and
that needed nutrients are provided in an the utilization of
amount of fluid that does not exceed daily nutrients via GIT is
fluid capacity of the body. possible

1
 8/12/2020

 Oral feeding is not feasible

 Oral feeding is not enough 1. Carbohydrates
 Oral feeding is not recommended  Potato, sugar,
 Oral feeding is dangerous starch
 Dextrose

2. Amino Acids 3. Water

 Meat, eggs, soya beans  Water for Injection
 Aminoplasmal, Aminosyn, Vamin glucose, 4. Electrolytes
Moriamin S2, Aminovenous  Gen. present in most foods
 NaCl, KCl, Ca gluconate, MgSO4

2
 8/12/2020

6. Fats
5. Vitamins
 Lipofundin 10%, 20%, Liposyn, Intralipids
 Essential in the metabolism of CHO,
CHON & fats
 Vit. B & C – Soluvit N, Lyovit C & Enervon
C
Vit. A,D,E & K – added once or twice a
week

 Central Venous Route

 Peripheral route ◦ Adv.: No complications of thrombophlebitis or
◦ Adv.: simple, straight forward procedure extravasation
◦ Disadv.: Hypertonic solutions will cause
◦ Disadv.: Catheter – related sepsis
thromboplebitis & severe tissue necrosis
◦ Management: ◦ Management:
1-Keep infusion site visible for regular inspection not 1-requires scrupulous aseptic technique at all times
concealed in dressing by a trained staff
2-Should be regularly re-sited, particularly in infants
3-Place infusion site where extravasations injuries are
less disfiguring
4-Follow established protocols for dressing &
management of wards

3

1. To standardize the practice of providing
nutritional support to hospitalized patients
in order to assure patients of maximum,
efficient & proper support for their
nutritional needs.
2. To centralize all activities regarding
nutritional support to a team of experts.
1. The Physician
◦ Ultimately responsible for the clinical
decision regarding the safety &
effectiveness of TPN therapy
◦ Identifies the candidates for TPN therapy
◦ Reviews the nutritional assessment data
◦ Responsible for catheter placement
◦ Prescribes appropriate formulations
◦ Establish goals of therapy
◦ Directs Px monitoring
8/12/2020
3. To recommend policies and guidelines to
the hospital regarding proper & up-to-date
practices in nutritional support of patients.
4. To provide expert advise & consult to
physicians needing help in the nutritional
support of their patients.
2. The Nurse
◦ Helps reassure the Px about the procedure
◦ Gathers the necessary items for catheter
placement
◦ Prepares the Px
◦ Assisst the physician in the insertion of the
catheter
◦ Arranges the appropriate IV apparatus
◦ Cares for the catheter site
◦ Participates in Px monitoring
4
 8/12/2020

3. The Pharmacist 4. The Dietician

◦ Preparation of TPN
◦ Knowledge of additive compatibility or
incompatibility & drug interactions
◦ Knowldege of various TPN substrates
◦ Helps in the Patient’s nutritional
assessment
◦ Enteral feeding
◦ Manages the transitional feedings from
parenteral to enteral or oral route

5. The Physical Therapist  Aseptic preparation

◦ Exercise program designer
◦ The technique involving procedures
6. The Social Worker designed to preclude contamination
◦ Emotional & financial support (of drugs, packaging, equipment, or
7. The Medical Technologist supplies) by microorganisms during
◦ Lab tests necessary for monitoring processing.

 ASHP Quality Assurance for Pharmacy-Prepared Sterile

Products Workbook p. 3

5
 8/12/2020

 Thorough hand-washing w/ appropriate

◦ Refers to the ability of personnel who
antimicrobial
prepare intravenous admixture to
 Wearing of protective clothing, mask, head
handle the sterile components of
cover, shoes & gloves
these IV solutions in the clean
environment of a Laminar Flow Hood  Disinfection of non-sterile materials to be
used
without introducing viable
microorganisms in the product.

 Proper use of Laminar Flow Hood

Demands
meticulous,
“NO-
TOUCH”
technique,
EVERY TIME!

6

All reports of aseptic complications involve
HUMAN ENTERIC or
HUMAN SKIN micro-organisms
8/12/2020
“Outbreak of K. pneumoniae, K. ozaenae
septicaemia following extrinsic contamination
of 10% lipid emulsion in a Neonatal Intensive
Care Unit”
 7 neonates in a NICU affected – death in 3
 Emulsion drawn serially, same bottle by nurse/s
 1 of 82 staff positive for KP, 4 for KO
Carberry P, Pharmacoepidemiol Drug Safety 1997:6(Suppl. 2);S34
7
 8/12/2020

Septic complications from parenteral nutrition

RCCT:1,101 sets at 72hr/1,112 sets at 24 hr Managed by Sepsis Rate %
Microbial contamination Ward personnel 21.3
Set change at: Lipid emulsion Aa/ gluc
TPN team 2.3
24 hours (15/1,112) (4/1,103)
Leeds General Infirmary, UK
1.35% 0.36% Team included:
 Pharmacist to prepare solutions
72 hours (39/1,101) (12/1,093)  Nurse specialist for catheter care
Freeman JB, Lemire A, McLean LD
3.54% 1.10% Surg Gynecol Obstet.1972;135:708

Mortality: 72 hr grp- 8% 24hr grp- 4% (p=0.05) Infection related

Matlow et al. Infect Control Hosp Tpidemiol 1990;20(7):487-93

 A specifically constructed room in which the

air supply, air distribution, dust & airborne
particle, room pressure, temperature &
humidity are environmentally regulated to
meet appropriate cleanliness level.

8
 8/12/2020

 Store below 25°c. Do not freeze.

 Do not administer simultaneously w/, before
or after an administration of blood through
the same infusion equipment due to pseudo-
agglutination
 Once prepared, use immediately or
refrigerate

 Remove from refrigeration 1 hour prior to 1.
infusion to reach approximately room temp
 Once hung, must be infused or discarded 2.
within 24 hours
 No medications should be added to TPN lines 3.
once they are infusing, except lipid emulsion
Start slowly, increased gradually; and end
vice versa.
Choice of administration route depends on
final osmolarity of mixture.
Clinical monitoring is required at the start of
any infusion. Any abnormalities, the infusion
is stopped.

9

4. Frequent clinical evaluation & lab tests
are necessary for correct monitoring
during drug administration, glucosuria, &
osmotic diuresisInappropriate use of
method, e.g. too high dosage, too rapid
infusion
5. IV flow rate should be maintained w/ 20%
of that ordered. Any sustained rapid
increase in fluid infusion can cause
hyperglycemia.
8. The catheter is changed every other day or
when clinically indicated
9.The Px should be ambulated when possible.
Exercise enhances the achievement of balance &
restitution of muscle mass
8/12/2020
6.Vital signs should be taken every 4 hours
round the clock
7. Weigh daily. Any weight gain in x’s of ½
pound per day may be due to x’s fluid
retention (Rales, hepatomegaly, jugular vein
distention, gallop rhythn, presacral &
peripheral edema.) Use same scale, same
time, w/ similar articles of clothing
1. Do not add antibiotics, steroids &
pressor agents
2. Na biacarbonate is not compatible w/ Ca
or MgSO4
3. High dextrose + whole blood =
clumping of RBCs
4. Vit. K is activated by Vit. C in solution
10

5. Ca gluconate may cause false depression in 7.
serum & urine Mg levels when Titian yellow
method for determining Mg is used
5. Insulin in TPN is effective, but it may be
unstable in the presence of Na bicarb.
Physical separation may occur if not mixed 8.
thoroughly
8/12/2020
Albumin – visually compatible for 24 hours,
but inc. risk for fungal & bacterial growth.
Occlusion of filters occur if conc. of Albumin
exceeds 25g/L
Lipids, infused by Y – line near the infusion
site.
11
 a. Alprazolam anti-anxiety, antidepression &
management of panic attack
b. Bromazepam for anxiety and tension,
depressive mood & insomia
 Dangerous Drugs c. Chlordiazepoxide hypnotic; sedative
d. Clonazepam epilepsy, gen. Tonic-clonic
 (accdg. To RA 9165) are those drugs listed in
seizure, status epilepticus
the schedules annexed to the 1961Single (anti-convulsant)
Convention on Narcotic Drugs & Schedules e. Clorazepate all forms of anxiety
annexed to the 1971 Single Convention on f. Diazepam for Anxiety, muscle spasm
Psychotropic Substances or; (adjunct in treatment), (anti-
 (in laymans term) these are drugs which convulsant)
g. Estazolam sleep disturbances
possess addicting potential when
h. Flurazepam insomia
administered in humans (animals). i. Midazolam disturbances in sleep rhythm,
 Ex. Opium & opioid derivatives insomia
 Morphine  Shabu
 Heroin  Marijuana 2. Barbiturates
 Cocaine  Ecstasy  Anticonvulsant (ex. Phenobarbital—most
common)
 Tonic-Clonic(Grand Mal) & partial (focal)
Dangerous
seizures
 Morphine and its derivatives
 To induce anesthesia (ex. Pentothal Na)
o Merepiridine HCl o Codeine
o Fentanyl o Oxycodone HCl (Oxycontin)
3. Morphine SO4
o Lomotil o Ephedrine  Relief of moderate to severe pain (esp.
associated w/ neoplastic disease); cough
Regulated
suppression; relief of dysentery & diarrhea,
 Benzodiazepines
drowsiness, sedation
o Alprazolam (Xanor) o Diazepam (Valium)
o Bromazepam (Lexotan) o Estazolam (Esligan)
4. Codeine
o Clonazepam (Rivotril) o Flurazepam (Dalmane)  For suppressing cough & for pain.
o Clorazepate (Tranxene) o Midazolam (Dormicum)  Is less potent than morphine
5. Meperidine HCl
 Barbiturates
o Phenobarbital o Rhinase  Less potent than Morphine & less
o Thiopental o Clarinase spasmogenic used in Obstetrics because it
o Zolpidem (Stilnox) o Ergotamine tartrate produces no more respiratory depression in
o Nalbuphine (Nubain) o Methylergometrine the fetus than in the mother
 (unlike morpine which produces depression
1. Benzodiazepines for both fetus & mother)
 Almost all are used as anxiolytic, hypnotic 6. Fentanyl
&/or sedative  80 times more potent than morphine but has
short duration of action.
  Used by anesthesiologist 5. S-5-I- License to Import
7. Zolpidem 6. S-5-C- License to Compound/Manufacture
 for sleeping problems 7. S-5-E- License to Export
8. S-5-D- License for Bulk Depot/Storage of
Dangerous Drugs
 most common
9. S-6- Dangerous Drugs used for research
 drowsiness  sedation
 headache  fatigue 10. S-7- Dangerous Drugs used for Diagnosis
 dependence  hallucination Who are the persons allowed to prescribe
 others Dangerous Drugs or Drug Preparations?
 mental  rash  Medical Practitioner, who prescribes the drug in
disturbances  excitation the ordinary course of treatment of another
 blurred vision (discontinue) person’s physical/mental condition
 urinary  Dentist, who prescribes the drug in the ordinary
retention course of treatment of another person’s dental
condition
 Almost all are available in oral form but some are  Veterinary Surgeon, who prescribes the drug in
only available in parenteral form. the ordinary course of treatment of an animal
Diazepam (Valium) Amp. Tab (2, 5, 10 mg)  Granted an S-2 license to prescribe such drugs
Alprazolam (Xanor) Tab (0.25, 0.5, 1 mg) by the PDEA.
Clonazepam (Rivotril) Tab (2 mg)
Midazolam Amp (15, 5 mg); tab (15  The official prescription form comes in 3 copies.
(Dormicum) mg)
This is called the DDB form 1-72.
Meperidine HCl Vial & amp
 Original (Yellow) – shall be retained by the
(Demerol)
Drugstore/ Hospital Pharmacist for a period of 1
Morphine SO4 Amp, tab (10, 20 mg)
yr. From the date of sole or delivery.
Fentanyl Amp, patch (25, 50 mg)
 Duplicate (Yellow) – shall be retained by the
Codeine Syrup
buyer or by the person to whom the drug is
Rhinase syrup
delivered until such drug is consumed.
 Triplicate (Blue) – shall be retained by the
person issuing the prescription.

1. S-1- License to sell, procure, acquire, deal with

drugs exempted from Special prescription
2. S-2- License to prescribe
3. S-3- License to sell, procure, acquire, deal with
specified dangerous drugs in retail
4. S-4- License to sell or distribute Dangerous
Drugs in Wholesale
1. Date of the Prescription
2. Name & Address of the Prescriber
3. S-2 License # & Date of Issue (renewable every 3
yrs.)
4. Name & Address of the Patient
5. Superscription - Rx symbol
6. Inscription – Medication prescribe & the Total
Quantity & its Strength
7. Subscription – Instruction to the pharmacist
8. Signa – Instruction to the patient (Proper Dosing)
9. Diagnosis – if cancer patient
10. Signature of the prescriber
11. PTR no. of the prescriber (renewable every year)

Annex in Dispensing Regulated Drugs

Dangerous Ordinary Cancer

cases cases
I. Benzodiazepines 30 tabs/caps
a. (anxiolytic/hypnotic/both) 10 amps x
1ml
1. Alprazolam (Xanor) 3 amps x 2
ml
2. Bromazepam (Lexotan) 2 amps x 3
ml
3. Chlorazepate 2 amps x 5
(Tranxene) ml
4. Diazepam (Valium) 1 amp x 10
Out-Patient Dispensing
ml
5. Estazolam (Esilgan)
 Prescribing of only one (1) Dangerous Drug 6. Midazolam (Dormicum)
preparation is allowed in a single Yellow
Prescription. More than one is considered b. (Muscle 90 tabs (5
prohibited (Accdg. To RA 9165). spasm/dystonia/tetanus) mg)

II. Others
1. Phenobarbital prep’s 2 bot (100
tabs each)
(2-wk supply) For epileptic
px
2. Zolpidem tab (Stilnox) 40 pcs.
3. Codeine (Codipront N 1-wk supply
syr)
4. Diphenoxylate 40 pcs
HCl/Atropine Sulfate
In-Patient Dispensing
(Lomotil tab)
5. Oxycontin 10 mg tab 120 tabs
6. Oxycontin 20 mg tab 60 tabs
 7. Morphine Sulfate 10 150 tablets 300
mg tab tablets
8. Morphine Sulfate 20 75 tabs 150 tabs
mg tab
9. Morphine Sulfate 30 50 tabs 100 tabs
mg tab
10. Morphine Sulfate 16mg 3 amps
amp
11. Durogesic patch 25 20 patches 30
mcg patches
12. Durogesic patch 50 10 patches 15
mcg patches
13. Fentanyl amp 3 amps 10 amps x
1ml
3 amps x
2ml
50 amps x
2 ml for
use in
patient
controlled
Analgesic
Machine
10 amps x
10ml for
use in PCA
14. Demerol amp 3 amps
15. Other dangerous drugs 3 amps 20 pcs
(amp/hypodermic tab)

S2 License only
1. Nalbuphine 3 amps
2. Loratadine/ 1 bottle for
Pseudoephedrine syr.
(Clarinase/Rhinase)
3. Ephedrine 3 amps
 GUIDE TO MEDICAL / PARAMEDICAL PRACTITIONERS
LIST OF DANGEROUS DRUG PREPARATIONS (DDPs)

ACQUISITION / DISPENSING / PRESCRIBING:

To be purchased through an approved PDEA Form 1-04 (Local Order Permit). To be prescribed and
dispensed through the DOH Special Prescription Form for Dangerous Drugs. Only one (1) dangerous
drug preparation shall be prescribed in one single prescription form. Partial filling allowed. STRICTLY NO
REFILL.

RECORDING / REPORTING:
To be recorded in an appropriate Dangerous Drugs Register in accordance with the PDEA-prescribed
format. To submit semi-annual report not later than January 15 and July 15 of each year.

LICENSE REQUIRED:
Prescribing Physician / Dentist / Veterinarian S2 License
Retail Dealer of DDPs S3 License
Wholesaler Dealer of DDPs S4 License
Manufacturer / Repacker of DDPs S5-C License
Importer of DDPs S5-I License
Exporter of DDPs S5-E License

Dangerous Drug Brand Name, Importer (I) / Distributor (D) /

(Active Ingredient) Dosage Form & Strength / CPR Manufacturer (M)
* ALTROX I/D:Torrent Pharmaceuticals,
ALPRAZOLAM 250mcg Tablet Ltd
Blister 10s, Box 100s
FDA Reg. No.: DRP 3132 Manufactured in: India
Valid until 11 APRIL 2022
* ALTROX I/D:Torrent Pharmaceuticals,
500mcg Tablet Ltd
Blister 10s, Box 100s
FDA Reg. No.: DRP 3180 Manufactured in: India
Valid until 26 JUNE 2021
* ZOLDAC I/D: Zydus Philippines, Inc
250mcg Tablet
Blister 10s, Box of 30s Manufactured in: India
FDA Reg. No.: DX- XY 45450
Valid until 16 JUN 2021
* ZOLDAC I/D: Zydus Philippines, Inc
500mcg Tablet
Blister 10s, Box 30s Manufactured in: India
FDA Reg. No.: DR-XY 45396
Valid until 23 MAY 2021
* ZOLGEN M: Lloyd Laboratories Inc
500mcg Tablet
Blister 10s, Box 100s T: Innogen Pharmaceuticals,
FDA Reg No.: DR-XY 39552 Inc
Valid until 01 JUNE 2018

Page 1 / 15/fytapr2019
 * XANOR I / D: Pfizer
250mcg Tablet
Blister 10s Box 100s Manufactured in: Italy
FDA Reg. No.: DRP 2146
Valid until 20 NOV 2021
* XANOR
500mcg Tablet
Blister 10s Box 100s
FDA Reg. No.: DR-XY 14607
Valid until 21 MAR 2020
* XANOR XR
500mcg Controlled Release Tablet
Blister 10s Box 100s
FDA Reg. No.: DRP-2048
Valid until 4 MAY 2023
* XANOR
1mg Tablet
Blister 10s Box 100s
FDA Reg. No.: DR-XY16774
Valid until 21 MAR 2020
* AXAL I/D: Sahar International
250mcg Tablet Trading, Paranaque, City
Blister 10s, Box 30s
FDA Reg. No.: DR-XY 38992 Manufactured in: Pakistan
Valid until 27 JAN 2021
* AXAL
500mcg Tablet
Blister 10s, Box 30s
FDA Reg. No.: DR-XY38855
Valid until 27 JAN 2021
* AXAL
1mg Tablet
Blister 10s, Box 30s
FDA Reg. No.: DR-XY 38993
Valid until 27 JAN 2021
* SERELAM I/D: Ambica Int’l Trading Corp,
250mcg Tablet Pque
Blister 10s, Box 100s
FDA Reg No. DRP-5103 Manufactured in: Bangladesh
Valid until 12 FEB 2019
RENEWED WITH OR# 1081631
DATED DEC 11, 2018
* SERELAM
500mcg Tablet
Blister 10s, Box 100s
FDA Reg No. DRP-3720
Valid until 17 APRIL 2017
RENEWED WITH OR# 0846187
DATED APRIL 7, 2017
* LEXOTAN I: Roche Phils., Inc.,
BROMAZEPAM 1.5mg Tablet Taguig City
Blister 10s, Box 100s
FDA Reg No: DR-XY40440
Valid until 22 DEC 2021

Page 2 / 15/fytapr2019
 ** NORSPAN I/D: Mundipharma
BUPRENORPHINE 5mg Transdermal Patch DistributionGmbH (Philippine
Box 2s Branch)
FDA Reg. No. DR-XY35292
Valid until 24 NOV 2020 Manufactured in: Germany
** NORSPAN
10mg Transdermal Patch
Box 2s
FDA Reg. No. DR-XY 35290
Valid until 24 NOV 2020
** NORSPAN
20mg Transdermal Patch
Box 2s
FDA Reg. No. DR-XY 35291
Valid until 24 NOV 2020
** TRANSTEC I/D: Mundipharma Distribution
20mg (35mcg/h) Transdermal Patch GmbH (Philippine Branch)
Box 1s, 2s, 4s
FDA Reg. No: DR-XY 46026 Manufactured in: Germany
Valid until 8 SEPT 2022
** TRANSTEC
30mg (52.5mcg/h) Transdermal Patch
Box 1s, 2s, 4s
FDA Reg. No: DR-XY 46027
Valid until 8 SEPT 2022
* CLONOTRIL-0.5 I/D: Torrent Pharma Phils Inc
CLONAZEPAM 500mcg (0.5mg) Tablet
Blister 10s, Box 20S & 100s M: Torrent, India
FDA Reg No: DRP-2810
Valid until 29 AUG 2023
* CLONOTRIL-2
2mg Tablet
Blister 10s, Box 20s & 100s
FDA Reg No: DRP-2809
Valid until 02 SEP 2023
* EPILINE 2 I/D: Zydus Healthcare
2mg Tablet Philippines, Inc,
Blister 10s
FDA Reg No: DR-XY 44549
Valid until 27 MAY 2020
* RIVOTRIL I: Roche Phils., Inc, Makati
2mg Tablet City
Bottle 100s D: Zuellig Pharma Corp.,
FDA Reg. No. DR-XY37012 Makati City
Valid until 19 NOV 2019 Manufactured in: Spain
* TRANXENE I: Sanofi-Aventis, Phil
CLORAZEPATE DIPOTASSIUM 5mg Capsules Manufacturer: Sanofi Aventis,
Blister 10s, Box 30s Spain
FDA Reg. No. DR-X1254
Valid until 14 OCT 2022 Repacker:Hizon Laboratories
DIAZEPAM ANXIOL I / D: Endure Medical Inc.,
5mg/mL, 2ml (10mg/ 2ml) Ampule Pasig City
Box 10s
FDA Reg. No. DR-XY29833 Manufactured in: Taiwan
Valid until 9 AUG 2022

Page 3 / 15/fytapr2019
 ANXOL I/D: Ambica Intl Trading Corp,
5mg/ml (10mg/2ml) IM/IV Ampule Paranaque
Box 10s
FDA Reg No DRP-4175 M: India
Valid until 16 DEC 2019
LORCAM I / D: Lordla Pharma Sales,
5mg/mL, 2mL Ampule Quezon City
Box 50s
FDA Reg. No. DR-XY22760-B M: Thailand
Valid until 20 NOV 2018
RENEWED WITH OR# 1048278
DATED NOV 7, 2018
TRANKIL I/D: Duopharma Trade Phils
5mg/mL, 2ml Ampule
Box 10s M: Rotexmedica, GmBH,
FDA Reg. No. DR-XY29949 Germany
Valid until 03 SEP 2019
VALIUM
5mg/mL, 2ml Ampule I: Roche Phils., Inc., Taguig
Box 10s City
FDA Reg No. DR-6298
Valid until 14 APR 2023 D: Zuellig Pharma
* VALIUM Corporation, Pque City
5mg Tablet
Blister 25s, Box 100s Manufactured in: France
FDA Reg. No. DR-XY37749
valid until 30 JAN 2020
* VALIUM
10mg Tablet
Blister 25s, Box 100s
FDA Reg. No. DR-XY37748
Valid until 7 APR 2021
*VEXEPAM I/D: Phil Pharmawealth, Inc
5mg Tablet
Blister 10s, Box 100s Manufactured in: India
FDA Reg No. DR-XY41080
Valid until 26 JULY 2020
*VEXEPAM
10mg Tablet
Blister 10s, Box 100s
FDA Reg No. DR-XY41081
Valid until 26 JULY 2020
FEDRIN I/D: Sahar International
EPHEDRINE 30mg/mL, 1mL Ampule
Box 5’s M: Pakistan
FDA Reg No. DR-XY41068
Valid until 18 JULY 2022
EPHEDRINE SULFATE M: Hizon Laboratories, Inc
50mg/mL, 1mL Ampule
Box 100s
FDA Reg No. DR-4468
Valid until 21 FEB 2023

Page 4 / 15/fytapr2019
 DUROGESIC D-TRANS Importer: Johnson & Johnson
FENTANYL 12mcg/hr Transdermal Patch Distributor: Zuellig Pharma
Box 5s Corp
FDA Reg No. DR-XY33326
Valid until 29 DEC 2020 Manufactured in: Belgium
DUROGESIC D-TRANS
25mcg/hr Transdermal Patch
Box 5s
FDA Reg No. DR-XY33327
Valid until 29 DEC 2020
DUROGESIC D-TRANS
50mcg/hr Transdermal Patch
Box 5s
FDA Reg No. DR-XY33325
Valid until 29 DEC 2020
FENDERMAL
12.5mcg/hr Transdermal Patch I: Sandoz Phils Corp, Makati
Box 5s
FDA Reg No. DRP-4099 M: Germany
Valid until 14 NOV 2022
FENDERMAL
25mcg/hr Transdermal Patch
Box 5s
FDA Reg No. DRP-4112
Valid until 22 NOV 2022
FENDERMAL
50mcg/hr Transdermal Patch
Box 5s
FDA Reg No. DRP-4111
Valid until 22 NOV 2022
ABSTRAL
100mcg Sublingual Tablet T: A.Menarini Philippines, Inc
Blister 10s, Box 10s & 30s
FDA Reg No. DR-XY45371 Manufactured in: United
Valid until 11 MAY 2021 Kingdom
ABSTRAL
200mcg Sublingual Tablet
Blister 10s, Box 10s & 30s
FDA Reg No. DR-XY45372
Valid until 11 MAY 2021
ABSTRAL
300mcg Sublingual Tablet
Blister 10s, Box 10s & 30s
FDA Reg No. DR-XY45370
Valid until 11 MAY 2021
ABSTRAL
400mcg Sublingual Tablet
Blister 10s, Box 10s & 30s
FDA Reg No. DR-XY45367
Valid until 11 MAY 2021
ABSTRAL
600mcg Sublingual Tablet
Blister 10s, Box 30s
FDA Reg No. DR-XY45369
Valid until 11 MAY 2021

Page 5 / 15/fytapr2019
 ABSTRAL
800mcg Sublingual Tablet
Blister 10s, Box 30s
FDA Reg No. DR-XY45368
Valid until 11 MAY 2021
FENTANYL CITRATE I: Pfizer
50mcg/mL, 2mL, Ampule M: in USA
10’s
FDA Reg No. DR-XY17752
Valid until 07 NOV 2022
FENTANYL CITRATE I/D: Pfizer
50mcg/ml, 2mL & 10mL Ampule
5’s M: in Germany
FDA Reg No. DR-XY32871
Valid until 06 FEB 2022
FENTYN Importer: Sandoz Philippines
25mcg/hr Transdermal Patch Corporation
Sachet, Box 5s Distributor: United
FDA Reg No. DRP-4112-01 Laboratories
valid until 22 NOV 2022 Manufactured in: Germany
FENTYN Importer: Sandoz Philippines
50mcg/hr Transdermal Patch Corporation
Sachet, Box 5s Distributor: United
FDA Reg No. DRP-4111-01 Laboratories
valid until 22 NOV 2022 Manufactured in: Germany
FRESANYL Importer/Distributor: Fresenius
50mcg/ml (100mcg/ 2ml) Kabi Philippines
Type 1 amber glass 2 ml ampule 10s
Type 1 amber glass 10 ml ampule 5s Manufactured in: Africa
FDA Reg No. DR-XY45908
Valid until 24 MAY 2022
TROFENTYL Importer/Distributor:
50mcg/mL, 2ml Pharmasan Inc
Ampule, Box 5s
FDA Reg No. DR-XY35224 Manufacturer:Troikaa
valid until 11 DEC 2020 Pharmaceuticals, India
SUBLIMAX I/D: Endure Medical Inc, Pasig
50mcg/mL, 2mL Ampule
Box 10s M: China
FDA Reg No. DR-XY43003
Valid until: 22 NOV 2023
SUBLIMAZE Importer: Johnson & Johnson
50mcg/mL, 2mL & 10mL Ampule Philippines, Inc
Box 5s D: Zuellig Pharma Corp
FDA Reg No. DR-XY22177 Manufactured by: GSK, Italy
Valid until 29 JULY 2023
ETAMINE M: Swiss Parenterals, India
*KETAMINE HCL 50mg/mL Vial I/D: Endure Medical, Inc
Box 1s
FDA Reg No: DR-XY41256
Valid until 19 SEPT 2022

Page 6 / 15/fytapr2019
 KETAMAX I/D: Duopharma Trade Phils
50mg/mL, 10mL Vial
Box 1’s Manufactured in: Germany
FDA Reg No. DR-XY19615
Valid until 17 FEB 2020
KETAROL I/D:Surestep Pharmaceuticals
50mg/mL, 10mL Vial Inc, Pque City
Box 1s
FDA Reg No. DR-XY41210 M: Pakistan
Valid until 11 SEPT 2022
UNIKET I/D: Claris Lifesciences Phils
50mg/mL, 10mL Vial
Box 5s Manufactured in India
FDA Reg No. DR-6820
Valid until 13 OCT 2023
CONCERTA I: Johnson & Johnson Phils
METHYLPHENIDATE HCL 18mg Extended Release Tablet Inc., Pque City
Bottle 30s D: Zuellig Pharma Corp, Pque
FDA Reg No. DR-XY27940 City
Valid until 03 AUG 2022 M: Puerto Rico
CONCERTA I: Johnson & Johnson Phils
27mg Extended Release Tablet Inc., Pque City
Bottle 30s D: Zuellig Pharma Corp, Pque
BFAD Reg No. DR-XY30659 City
Valid until 22 JULY 2019 M: Puerto Rico
RENEWED WITH OR# 1096208
DATED MARCH 5, 2019
CONCERTA I: Johnson & Johnson Phils
36mg Extended Release Tablet Inc., Paranaque City
Bottle 30s D: Zuellig Pharma Corp, Pque
FDA Reg No. DR-XY27941 City
Valid until 03 AUG 2022 M: Puerto Rico
RITALIN I: Novartis Healthcare Phils.,
10mg Tablet Inc., Makati City
Blister 15’s, Box 30s
FDA Reg No. DR-XY28528 Manufactured in: Spain
Valid until 10 APRIL 2023
RITALIN LA I: Novartis Healthcare Phils.,
20mg Modified Release Capsule Inc., Makati City
HDPE bottle of 30s
FDA Reg No. DR-XY43804 Manufactured in: USA
Valid until 14 OCT 2019
RITALIN LA
30mg Modified Release Capsule
HDPE bottle of 30s
FDA Reg No. DR-XY43805
Valid until 14 OCT 2019
RITALIN LA
40mg Modified Release Capsule
HDPE bottle of 30s
FDA Reg No. DR-XY43806
Valid until 14 OCT 2019

Page 7 / 15/fytapr2019
 DORMID Importer/Distributor: Endure
MIDAZOLAM 1mg/ml (5mg/5ml) Medical Inc
Ampule, Box 10s
FDA Reg No. DR-XY44212 Manufactured in: Indonesia
Valid until 15 FEB 2021
DORMID
5mg/ml (15mg/3ml)
Ampule, Box 5s
FDA Reg No. DR-XY44213
Valid until 15 FEB 2021
DORMICUM I/Trader: Roche Phils Inc.,
1mg/mL, 5mL (5mg/ 5ml) Ampule Taguig City
Box 10s
FDA Reg No: DR-XY28582 D: Zuellig Pharma Corp,
Valid until 28 APR 2023 Paranaque City
DORMICUM
5mg/mL, 3mL (15mg/3ml) Ampule Manufactured in: France /
Box 5s Switzerland
FDA Reg No: DR-XY28583
Valid until 28 APRIL 2023
DORMICUM
5mg/mL, 1mL Ampule
Box 10s
FDA Reg No: DR-XY28584
Valid until 28 APR 2023
* DORMICUM
15mg Tablet
Blister 10s, Box 100s
FDA Reg No: DR-XY3516
Valid until 10 JAN 2021
DORMIZOL I/D: Phil Pharmawealth, Inc.
5mg/mL, 1mL, 3mL Ampule
Box 10s M: India
FDA Reg No: DR-XY41527
Valid until 18 MAR 2023

HYPOZAM I/D: Sahar Intl Trading Inc,

1mg/mL, 3mL & 5ml, Ampule Pque City
Box 10s
BFAD Reg No.: DR-XY38463 Manufactured in: Pakistan
Valid until 14 SEPT 2020
MIDAZOLAM I/D: Int’l Apex Pharmls, Inc
1mg/mL, 5mL and 1mL, Vial
M: Pakistan
FDA Reg No: DR-XY41312
Valid until 05 NOV 2022
MIDAZOLEX I/D: Metrophil Drug and
1mg/mL, 5ml Ampule Chemical Trading
Box 10s M: Korea
FDA Reg No: DRP-4892
Valid until 05 APR 2023

Page 8 / 15/fytapr2019
 MIDAZOLEX I/D: Metrophil Drug and
5mg/mL, 3ml Ampule Chemical Trading
Box 5s M: Korea
FDA Reg No: DR-XYR1894
Valid until 05 APR 2023
MIZAM I:Surestep Pharmaceuticals
1mg/mL, 5mL Ampule Inc. (Paranaque City)
Box 10s
FDA Reg No : DR-XY40893 M: Pakistan
Valid until 02 AUG 2022
SEDACUM I: Glorious Dexa Mandaya
5mg/mL, 3ml Ampule
Box 5s
FDA Reg No : DR-XY42116
Valid until 13 JUNE 2021
SEDOZ I/D: Claris Lifesciences Phils.
1mg/mL, 5ml Ampule Inc., Makati City
Box 25s
FDA Reg No : DR-XY30768 Manufactured in: India
Valid until 23 MAY 2020
SEZOLAM
5mg/ml, 3 ml Ampule
Box of 5s,10s, 25s
FDA Reg No : DRP-6984
Valid until : 5 DEC 2023
MORPHINE SULFATE M: Hizon Labs, Antipolo City
MORPHINE SULFATE 10mg Tablet
Strip Foil 4s, Box 100s
FDA Reg No: DR-XY27441
Valid until 17 JUN 2019
MORPHINE SULFATE
30mg Tablet
Strip Foil 4s, Box 100s
FDA Reg No: DR-XY27463
Valid until 17 JUN 2019
MORPHINE SULFATE
(1/4grain) 16mg/mL, 1ml, Ampule

FDA Reg No: DR-9210

Valid until 05 SEP 2022
MORPHINE SULFATE
(1/6grain) 10mg/mL, 1ml, Ampule
Box 100s
FDA Reg No: DR-9208
Valid until 31 MAY 2020
MORPHINE SULFATE I/D: Pfizer (Hospira Phils)
10mg/mL, 1ml, Ampule
Box 5s M: in Germany
FDA Reg No: DR-XY33322
Valid until 18 MAY 2022
MST CONTINUS I: Mundipharma Distribution
10mg Modified Release Tablet GmbH (Philippine Branch)
Blister 30s, Box 60s
FDA Reg No: DR-XY13020 Manufactured in: United
Valid until 17 JUL 2021 Kingdom

Page 9 / 15/fytapr2019
 MST CONTINUS
30mg Modified Release Tablet
Blister 30s, Box 60s
FDA Reg No: DR-XY13019
Valid until 17 JUL 2020
MST CONTINUS
60mg Modified Release Tablet
Blister 30s, Box 60s
FDA Reg No: DR-XY13021
Valid until 16 JUL 2023
ANALIN I/D: Sahar Intl Trading
*NALBUPHINE 10mg/mL, 1ml, ampule
Box 10s M: Pakistan
FDA Reg. No. DR-XY35860
Valid until 21 MAY 2019
ANALIN
20mg/mL, 1mL, ampule
Box 10s
FDA Reg. No. DRXY-40127
Valid until 5 OCT 2021
ENDURPIN I: Metrophil Drug & Chemical
10mg/mL, 1mL Ampule Trading
Box 10s D: Delex Pharma Intl Inc,
FDA Reg No: DRP-2110 M: Korea
Valid until 28 SEP 2019
NALBULIN I/D:
10mg/ml, 1ml, Ampule Surestep Pharmaceuticals,
Blister pack, 5s Inc.
FDA Reg No: DR-XY41208
Valid until 4 SEPT 2022 Manufactured in: Pakistan
NALBUPHINE HYDROCHLORIDE I/D: I.E Medica, Inc
10mg/ml, 1ml
Box 10s Manufactured in: India
FDA Reg No: DRP-7177
Valid until 19 MAY 2022
NALBUPHINE HYDROCHLORIDE
20mg/ml, 1ml
Box 10s
FDA Reg No: DRP-7166
Valid until 19 MAY 2022
NALBUPHINE HYDROCHLORIDE I/D: Hospira Phils/ Pfizer Inc.
(Preservative and Anti-Oxidant Free)
10mg/mL, 1ml, Ampule Manufactured in: USA
Blister 10s
FDA Reg No. DR-XY25633
Valid until 03 NOV 2019
NUBAIN T: A. Menarini Phils, Inc.,
10mg/mL, 1ml, Ampule Taguig City
Box 10s and 100s Under license from A.
FDA Reg. No. DR-X3037 Menarini Asia Pacific Holdings
Valid until 14 NOV 2018 Pte Ltd.– Singapore
RENEWED WITH OR# 1046802 M: Hizon Labs, Antipolo City
DATED OCT 30, 2018

Page 10 / 15/fytapr2019
 NUKAINE I/D: International Apex
10mg/ml, 1ml Pharmaceuticals, Inc.
Box 100s
Blister 5s, Box 10s Manufactured in: Korea
FDA Reg No. DR-XY40522
Valid until 11 JAN 2020
SEDAFIN Importer/Distributor: Euro
10mg/ml, 1ml Generics International
Box 5s Philippines, Inc
FDA Reg No: DR-XY45030
Valid until: 4 FEB 2021 Manufactured: Bangladesh
OXYCONTIN I/D: Mundipharma Distribution
OXYCODONE HCL 10mg Prolonged Release Tablet GmbH (Philippine Branch)
Blister 14s, Box 28s Pasig City
FDA Reg No: DR-XY27751
Valid until 19 FEB 2021 Manufactured in: USA / UK
OXYCONTIN
20mg Prolonged Release Tablet
Blister 14s, Box 28s
FDA Reg No: DR-XY27748
Valid until 19 FEB 2021
OXYCONTIN
40mg Prolonged Release Tablet
Blister 14s, Box 28s
FDA Reg No: DR-XY27750
Valid until 19 FEB 2021
OXYCONTIN
80mg Prolonged Release Tablet
Blister 14s, Box 28s
FDA Reg No: DR-XY27749
Valid until 19 FEB 2021
OXYCONTIN NEO
10mg Controlled Release Tablet
Blister 10s, Box 20s, 30s, & 40s
FDA Reg No: DR-XY45704
valid until 15 DEC 2021
OXYCONTIN NEO
20mg Controlled Release Tablet
Blister 10s, Box 20s, 30s, & 40s
FDA Reg No: DR-XY45706
valid until 15 DEC 2021

OXYCONTIN NEO
40mg Controlled Release Tablet
Blister 10s, Box 20s, 30s, & 40s
FDA Reg No: DR-XY45708
valid until 15 DEC 2021
OXYCONTIN NEO
80mg Controlled Release Tablet
Blister 10s, Box 20s, 30s, & 40s
FDA Reg No: DR-XY45708
Valid until 15 DEC 2021

Page 11 / 15/fytapr2019
 OXYNORM
5mg Capsule
Blister Pack x 14s (Box of 28’s)
FDA Reg No: DR-XY32009
Valid until 20 JULY 2019
OXYNORM
10mg Capsule
Blister Pack x 14s (Box of 28’s)
FDA Reg No: DR-XY32011
Valid until 20 JULY 2019
OXYNORM LIQUID I/D: Mundipharma Distribution
5mg/5ml Oral Solution GmbH (Philippine Branch)
Amber glass bottle, 250ml (1’s) Pasig City
FDA Reg No: DR-XY41366 Manufactured in: Cyprus
Valid until: 21 DEC 2019
OXYNORM I/D:Mundipharma Distribution
10mg/ml (20 mg / 2ml) GmbH (Philippine Branch)
Colorless glass ampule, 1ml and 2ml Pasig City
(Box of 5’s)
FDA Reg No: DR-XY36393 Manufactured in: Israel
Valid until: 11 MAY 2023
TARGIN I/D:Mundipharma Distribution
OXYCODONE 5mg/2.5mg Prolonged-Released Tablet GmbH (Philippine Branch)
WITH NALOXONE Blister 14s, Box 28s Pasig City
FDA Reg No: DR-XY42646
Valid until 18 SEPT 2019 Manufactured in: USA / UK
TARGIN
10mg/5mg Prolonged-Released Tablet
Blister 14s, Box 28s
FDA Reg No: DR-XY40703
Valid until 28 FEB 2020
TARGIN
20mg/10mg Prolonged-Released Tablet
Blister 14s, Box 28s
FDA Reg No: DR-XY40700
Valid until 28 FEB 2020
TARGIN
40mg/20mg Prolonged-Released Tablet
Blister 14s, Box 28s
FDA Reg No: DR-XY40702
Valid until 28 FEB 2020
DEMEROL I/D: Pfizer (Hospira Inc )
PETHIDINE / MEPERIDINE 50mg/mL, 2mL, ampule
Box 25s Manufactured in: USA
FDA Reg No: DR-2148
Valid until 29 JULY 2019
DEMEROL
50mg/mL, 30mL, vial
Box 1s
FDA Reg No: DR-2149
Valid until 24 MAR 2023

Page 12 / 15/fytapr2019
 DOLETHAL Importer : Agfield International
PENTOBARBITAL SODIUM 200mg/ml, 100ml Corporation
Vial
FDA Reg No: VR-3537 Manufactured in : France
Valid until 15 SEPT 2019
LUMINAL I: Pfizer (Hospira Inc )
PHENOBARBITAL SODIUM 130mg/mL, 1mL, ampule
Box 5s D: Zuellig Pharma
FDA Reg No: DR-X7787
Valid until 24 MAR 2019 Manufactured in : USA
*DISCONTINUED BY MANUFACTURER
* PHENOBARBITAL D: Philusa Corporation
15mg, Tablet
Bottle 100s M: Amherst Laboratories, Inc
FDA Reg No: DR-X1824
Valid until 29 MAY 2023
* PHENOBARBITAL
30mg, Tablet
Bottle 100s
FDA Reg No: DR-5064
Valid until 29 MAY 2023
* PHENOBARBITAL
60mg, Tablet
Bottle 100s
FDA Reg No: DR-X2017
Valid until 29 MAY 2023
* PHENOBARBITAL
90mg, Tablet
Bottle 100s
FDA Reg No: DR-XY21882
Valid until 29 MAY 2023
* DUROMINE I/D: Metro Drug Inc, Taguig
PHENTERMINE RESIN 15mg capsule City
Blister 15s, Box 30s
FDA Reg No: DR-XY26998 Manufactured in: New
Valid until 26 MAR 2021 Zealand
* DUROMINE
30mg, capsule
Blister 15s, Box 30s
FDA Reg No: DR-XY26999
Valid until 26 MAR 2023
REMIFENTANIL SUBLIFEN I/D: Endure Medical Inc
HYDROCHLORIDE 1mg Vial
Box 5s Manufactured in: China
FDA Reg No: DR-XY45774
Valid until 2 FEB 2022
SUBLIFEN
2mg Vial,
Box 5s
FDA Reg No: DR-XY45773
Valid until 2 FEB 2022

Page 13 / 15/fytapr2019
ZOLPIDEM * DACTIVE I/D: Zydus Healthcare
10mg Tablet Philippines, Inc
Blister 100s
FDA Reg No: DRP-7184 Manfuactured In: India
Valid Until 19 JAN 2021
* SITINOX I/D: Sahar Int’l Trading, Inc.,
10mg, Film-Coated Tablet Paranaque City
Blister 10s, Box 10s
FDA Reg. No.: DR-39241 M: China
Valid Until 30 MAR 2019
RENEWED WITH OR# 0707661
DATED JANUARY 26, 2016
* STILNOX I/D: Sanofi-Aventis Phils,
10mg, Film-Coated Tablet Makati City
Blister 15s, Box 30s
BFAD Reg. No.: DRP-014
Valid Until: 13 ARPIL 2019
RENEWED WITH OR# 1097211
DATED MARCH 12, 2019
* ZOLDEM M: Amherst Laboratories, Inc
10mg, film coated tablet
Blister 10s, Box 30s Trader: UNILAB, Inc
BFAD Reg. No.: DR-XY32230
Valid until 16 NOV 2020

Page 14 / 15/fytapr2019
 LIST OF DRUG PREPARATIONS CONTAINING PHILIPPINE TABLE 1 CONTROLLED CHEMICALS

DISPENSING / PRESCRIBING / RECORDING / REPORTING:

Subject to Food and Drugs Administration (FDA) rules and regulations.

LICENSE REQUIRED:
Manufacturer / Repacker S5-C License
Importer S5-I License
Exporter S5-E License

Drug Preparation Brand Name, Importer (I) / Distributor (D) /

(Active Ingredient) Dosage Form & Strength / CPR Manufacturer (M)

***ERGOMETRINE / Various Pharmaceutical Drug Various Entities

ERGONOVINE Preparations

***ERGOTAMINE Various Pharmaceutical Drug Various Entities

Preparations

***NOREPHEDRINE / Various Pharmaceutical Drug Various Entities

PHENYLPROPANOLAMINE Preparations

LEGEND:

* All oral forms of Philippine Schedule 4 and 5 Dangerous Drugs are:

1. Exempted from DOH Special Prescription for Dangerous Drugs (SPFDD) per Section 4 (4a) Board
Regulation No. 1 Series 2014. To be prescribed in an ordinary prescription form in triplicate copies
containing the standard information of a prescription Section 31 (3) Board Regulation No. 1 Series
2014.
2. Exempted from PDEA Form 1-0A (Local Order Permit) for transactions between wholesaler and
retail drugstore or hospital pharmacy.

** Exempted from DOH Special Prescription for Dangerous Drugs (SPFDD). To be prescribed in ordinary
prescription form in triplicate copies, bearing the current S2 License of the prescribing medical practitioner.
Section 4 (2b) Board Regulation 1 Series 2014.

*** Only importer, exporter and manufacturer will require registration of license. For importation of a finished
product that exceeds the equivalent quantities of 0.010grams ergometrine / ergonovine, 0.020grams
ergotamine and / or 2.5Kg norephedrine per importation, an import permit shall be required. Each import or
export transaction shall be reported to PDEA not later than five (5) working days before date of importation
or exportation of the shipment.
Section 4 (5) Board Regulation 1 Series 2014.

ITEMS IN RED FONT – FOR REVALIDATION / AWAITING SUBMISSION OF UPDATED CPR

Noted by:

DIR II AGNES D. MANDAP

ACTING DIRECTOR, COMPLIANCE SERVICE

Page 15 / 15/fytapr2019
  Ask when and whom to contact when answer
becomes available
 Drug Information Services (DIS)- Refers to the Types of DI Questions
access, evaluation, selection and organization of  ADRs & ADE(eg. description, allergies)
drug literature for the use of health professionals,  Drug administration (dosage form, methods,
patients and the public  compatibility, stability)
 DIS also involves the interpretation & application  Indications & therapeutic use
of drug information to patient care problems  Product-specific Concerns
 Drug Literature- Is comprised of primary,  Dosing
secondary & tertiary literature that can be used  Drug interactions
as basis for optimizing the use of drugs in  Pharmacology & toxicology
patients  Miscellaneous (Availability, Foreign Drugs,
Why we need it?  Identification, Calculations, Pharmacokinetics)
 Vast drug literature
 Increasing drug therapy problems  Match question w/ sources of information
 Growth of clinical pharmacy practice  Determine if question is for approved,
investigational or unapproved drugs
 Support for clinical services  Identify appropriate search keywords, terms,
 Pharmacy and Therapeutics activities synonyms
 Publications  Be flexible in searching
 Education
 Drug usage evaluation  Oral
 Investigational drug control  Written or Printed
 Coordination of reporting programs  Primary literature
 Poison information o original article, research or case reports
published in journals, presentations and
1. Determining the primary question proceedings
2. Developing an appropriate strategy  Secondary literature
3. Choosing sources of information o abstracting and indexing services
4. Accessing printed sources of information  Tertiary literature
5. Critical Appraisal of information sources o textbooks, compendia, full-text databases
6. Formulating a response & review articles
7. Communicating a response
8. Documentation and follow-up  Textbooks
 Journals
 Ask clarifying questions  Individual Files
 Restate the question  Manual Indexes
 Computerized
 databases
 Internet
 Textbooks: date of publication, authorship,
 Biomedical Journals
agreement with other sources
 Lancet  New England Journal of
 Journal of American Medicine
 Literature Reviews: same as those for textbooks’
Medical Association  AJPE, AJHP methods of selection
 British Medical  Annals of  Original Research: abstract, basic research
Journal Pharmacotherapy design, setting, participants, outcome measures
 Annals of Internal  Clinical Pharmacy & & results *
Medicine Therapeutics
 Archives of Internal  Journal of the American Basic research Designs
Medicine Society of Health  Randomized controlled trials
 System Pharmacists
 Nonrandomized, concurrent cohort study
 Computerized databases  Nonrandomized historical cohort study
1. CD Format  Nonrandomized historical case control
 Micromedex  Case series without control
 Current Contents  Expert opinion
 Iowa Drug Information Service (IDIS)
 IPA
 Summary of information or evidence
 Medline
 Recommendations
 Clinical Pharmacology
 Mayo Family Pharmacist
2. Online Format  Oral
 Medline  Written
 Micromedex
 Medscape Fulltext  Document: drug information, the
 OVID recommendations and sources of information
 Health Notes Online  Follow-up the outcomes of recommendations
3. Websites
 www.medscape.com How do we start?
 www.nlm.nih.gov 1. Build up your resources
 www.usphrmacist.com 2. Be systematic in answering drug info questions
3. Develop good search strategies
 Specific Sources of Info 4. Update yourself regularly
 Pharmacotherapy  Interpretation of Lab
 Pediatric Dosing Results “An effective pharmacist is a good provider of drug
 Pharmacokinetics  Geriatric Dosing
information regardless of the area of practice.
 General Drug  AHFS Drug Information
Information  Handbook on Injectable
 Pharmacology Drugs
 Patient Counseling  Dosage Calculations,
Preparation &
 Administration
 OBJECTIVES
 Define common terminologies used in
Therapeutic Drug Monitoring TDM.
 Determine its significance in critical patient
case scenarios.
 Determine the indication, benefits and
concepts of TDM.
 Review important pharmacokinetic
concepts: Absorption, Distribution,
Metabolism and Excretion.

OBJECTIVES The Picture

 Review some significant and common PATIENT
Drug interactions in clinical settings. DRUG EFFECTS
DOSE
Therapeutic
Prescribed
Dispensed
Administered
Toxic

1
The Bigger Picture Recall….
DOSE PK CONC PD Therapeutic
Prescribed EFFECTS
Dispensed Absorption Toxic
DOSE CONC Therapeutic Administered Distribution
Drug + Receptor
Prescribed PK PD Metabolism
EFFECTS TARGET
Dispensed Toxic Excretion
Administered
Absorption Drug + Receptor TOXIC I
Distribution
Min Toxic Concentration
Metabolism
Excretion THERAPEUTIC II
Conc Min Effective Concentration

SUBTHERAPEUTIC III
Time

To Do Monitoring of levels
…. need to do

Therapeutic
Drug
Monitoring!!!

2
Lets Define! Lets Define!
Amount of drug present in the Dose of drug that should be administered
Loading dose
Bioavailability bloodstream to bring drug conc in the blood

Volume of blood cleared off of a Amount of drug to maintain Maintenance

drug per unit of time Clearance steady state conc
dose

Half-Life Time required for drug concentration in Amount of time consecutive doses
the blood to be reduced 50% Dosing interval of a regularly administered drug

Steady state Lowest conc of a drug within

Drug available= drug elimination Trough
Concentration a dosing interval

Lets Define! What is TDM?

Peak concentration TDM refers to the individualization and
optimization of dosage, maintaining
Highest drug concentration within a dosing interval blood drug concentrations within a
target range.

Volume of Distribution

Drug in body/ Plasma concentration

3
Indications of TDM Drugs commonly monitored
1. To provide a guide to the adjustment of
drug over dosage DRUG Therapeutic range
 Digoxin (mg/L)
2. To confirm toxicity for overdoses
including the use of illicit drugs  Theophylline 0.5-2.0 (microgram/L)
3. To monitor compliance of patients  Phenytoin 10-20
4. Before increasing to unusually large  Salicylate 10-20
doses  Sodium valproate 150-300
5. To investigate lack of efficacy 50-100
 Gentamicin,
tobramycin, trough <2; peak >5
netilmicin

Concepts of TDM When is TDM not useful?

1. Therapeutic response correlates with blood
concentration
2. There exists an optimum therapeutic range
within which the majority of patients
experience maximum benefit with minimum
toxic effect.
3. By adjusting the dose &/or timing of
administration on the basis of plasma
concentration, optimum drug therapeutic
range can be attained and maintained
 When an active metabolite contributes to
the effect
 Toxic effects are idiosyncratic & not related
to plasma level
 Action of drug is irreversible, the action will
occur even though the concentration has
fallen to zero
 Biologic effect can easily be monitored
e.g. oral antidiabetic agent
 When the concentration at the site of action
is unrelated to plasma concentration

4
Considerations TDM of LINEZOLID
 Assay methods
 Sample collection
 Timing of samples
 when steady state is reached
 pre-dose (trough level), although peak levels
(after dose is administered) are also
determined

TDM at UP Manila
 Assay methods
(HPLC, Spectrophotometer, TDx)
 Drugs monitored
Phenobarbital, Theophylline, Phenytoin, Diazepam,
Paracetamol, Salicylate, Isoniazid, Cyanide,
Methanol, Phencyclidine,
Amphetamine/Methamphetamine
 Cost: P 400–1,000/test

5
 PK Evaluation of Drug Concentration PK Evaluation of Drug Concentration
if conc is LOWER than anticipated if conc is HIGHER than anticipated
DOSE CONC Therapeutic DOSE CONC Therapeutic
PK PD EFFECTS PK PD EFFECTS
Toxic Toxic

 Patient compliance  Patient compliance

 Error in dosage regimen  Error in dosage regimen
 Wrong drug product (controlled vs immediate release)  Wrong drug product (immediate vs controlled release)
 Poor bioavailability  Higher bioavailability
 Rapid Elimination  Slow Elimination
 Drug interaction  Drug interaction
 Steady state not reached (timing of sample)

PD Evaluation of Drug Concentration

if conc is CORRECT but not effective Benefits of TDM

DOSE CONC Therapeutic

 Helps determine the proper and dosing
PK PD EFFECTS rate quickly
Toxic
 Helps determine the best possible dosage
regimen and avoid toxicity
 Altered receptor sensitivity (e.g.  Help maintain optimal therapy
tolerance)  Monitor patients with altered physiologic
 Drug interaction at receptor site and pharmacokinetic parameters.

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IMPAIRED RENAL FUNCTION IMPAIRED HEPATIC FUNCTION

1. Dosage modification may be necessary. 1. Dosage modification may be necessary:

2. Renal function declines with increasing - extent of hepatic impairment
age (middle aged or older pxs) -amount of drug normally metabolized
3. Creatinine clearance (Cockroft and Gault -contribution of metabolites to
eqtn) therapeutic efficacy & toxicity
2. Impaired hepatic albumin production
( drugs that are protein bound)

IMPAIRED HEPATIC FUNCTION Then,

3. (Only) measures the presence of hepatic  Congestive hert failure can impair ADME
injury of many drugs
 Disease states and other changes that
affect protein.

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 Routes of Administration

1mL

2-5mL

Routes of Administration Routes of Administration

1 mL

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Routes of Administration Factors that affect Absorption
 Dissolution drug enters in a solution
form
 Membrane transport carriers (enzymes)
Mechanism (passive and active diffusion)
 Blood Flow greater blood flow= rapid
drug entry
 Skin condition thick skin= low drug entry

Factors that affect Absorption

 pH dependence
Weak bases and weak acids
 Bioavailability oral, IM, rectal, topical
administration= incomplete absorption 100% absorbed= 100%
 Compliance BIOAVAILABILITY
 Food co-administration
Food increases gastric pH

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Distribution Distribution
 Concept of therapeutic concentration and Tissue Binding
therapeutic index Drugs bind to fat or muscles.

Distribution Distribution
 Body Composition  Protein binding

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The Blood-Brain barrier The Blood-Brain barrier
 Substances do not diffuse readily from  Characteristics of drugs that can pass-
the blood into the CNS (brain and spinal thru the BBB:
cord) 1. Low molecular weight
2. Lipophilicity
 Selectivity due to: 3. Non-ionized form
1. Astrocytes
2. Lack of extra-cellular space

Placental Barrier Albumin and AAG

 Placenta, or “afterbirth,” prevents the  Alb- 160 g/ 3L
diffusion of some substances from the  AAG- 2 to 4 mg/L
mother’s circulation into the fetus

 Characteristics of drugs that can pass-

thru the placental barrier:
1. Lipophilicity
2. Low molecular weight
3. Low protein binding

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Conditions that change Albumin
Drugs that bind to AAG
concentrations
 Amitriptyline
 Chlorpromazine
 Dipyridamole
 Lidocaine
 Meperidine
 Propranolol
 Quinidine

Conditions that change AAG

Distribution
concentrations
-The drug is being “pushed” out from the
protein by another drug
Ex. Aspirin with Phenylbutazone

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 Distribution
 Sample timing
-Approximate distribution
time
-Half life of the drug

Ex.
AMINOGLYCOSIDES
DIGOXIN (6-8 hrs)

Elimination Elimination

Liver- site of metabolism for some drugs Metabolic enzyme activity

Extraction ratio Enzyme induction
“ high” – drugs that are extensively Enzyme inhibition
metabolized during a single pass thru the
liver
Hepatic blood flow
Ex. H2 antagonist reduce HF (HERD ex
theophylline, propranolol, lidocaine)

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Metabolites
 Toxic effect or therapeutic

N-acetylprocainamide, Primidone,
diazepam, flurazepam, Imipramine
Normeperidine, ethanol, acetaminophen

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PRODRUGS EXCRETION
Is a pharmacological substance
administered in an inactive form and
subsequently converted to an active
pharmacological agent.
Examples:
Sulindac, clorazepate and ASA

EXCRETION

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EXCRETION
 Other routes
1. Exhalation- Halothane
2. Saliva
3. Milk
4. Tears
5. Sweat

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Pharmacokinetic drug interaction

 Co administration of drugs ENHANCE,

INHIBIT or NEGATE effects.

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Absorption
Rate of absorption decreased by
administered of drugs
Propantheline + Acetaminophen=
Acetaminophen absorbed more slowly
Metoclopramide + Acetaminophen=
( fasten/ speeds stomach emptying)
Acetaminophen absorbed faster
Absorption
Extent
Kaolin-pectin + Digoxin=
less Digoxin absorption
Ketoconazole + Antacids=
Lesser or no absorption
Absorption
Extent
Digoxin + Propantheline =
(Slow stomach empyting)
Improves the availability
Metal ions + Tetracycline=
Nonabsorbable complexes
Absorption
 Volume of distribution
Salicylic acid + Phenylbutazone=
Increase VD of S.A
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Absorption Absorption
 Metabolic clearance Renal Clearance
High Extraction ratio &Low Extraction ratio Secretion
Lidocaine + Cimetidine= Probenecid + Penicillin= increased Penicillin
(reduce hepatic flow)
Higher than expected Lidocaine Reabsorption
NH4Cl + Amphetamine (+)= O.D. Eliminated
Warfarin + Phenobarbital=
Low warfarin levels Urine acidification or alkalinization

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20
Types of Drug Interactions
1. Pharmaceutical Interactions
• Physical Incompatibility
• Solubility changes
• Container interactions
• Chemical Incompatibility
Drug Interactions
Pharmacological
Pharmacokinetic interaction
1. Alteration of DRUG ABSORPTION 
a. Changes in gastric pH
b. Changes in gastrointestinal motility/gastric
emptying time
c. Complexation and adsorption
Types of Drug Interactions
2. Pharmacological Interactions
a. Pharmacokinetic
(1) Alteration of drug ABSORPTION
(2) Alteration of drug DISTRIBUTION
(3) Alteration of drug METABOLISM
(4) Alteration of drug EXCRETION
b. Pharmacodynamic
(1) Drugs having ADDITIVE/SYNERGISTIC effects
(2) Drugs having ANTAGONISTIC effects
(3) Indirect effects
Drug Interactions
Pharmacological
Pharmacokinetic interaction
1. Alteration of Drug Absorption
2. Alteration of DRUG DISTRIBUTION 
MOA: Displacement from protein
binding sites
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 DRUG METABOLISM
Drug Interactions
Pharmacological Drug A Liver Drug A (active)
(object drug)
Pharmacokinetic interaction Metabolite
1. Alteration of Drug Absorption (inactive)
2. Alteration of Drug Distribution Drug B
3. Alteration of DRUG METABOLISM 
(precipitant drug)

a. Enzyme Induction QUESTION

b. Enzyme Inhibition 1. What if Drug B induces metabolism of Drug A...
will concentration  or  ?
2. What if Drug B inhibits metabolism of Drug A…
will concentration  or  ?

Enzyme INDUCING drugs/chemicals Ang tanong….

Phenobarbital
Carbamazepine
• Anong maipapayo ninyo kung ang pasyente
Phenytoin
Rifampicin ay umiinom ng...
Tobacco smoke
Alcohol (chronic) Rifampicin (inducer) + oral contraceptives?

Enzyme INHIBITING drugs • Paano kung ang iniinom naman ay...

Cimetidine
Erythromycin Erythromycin (inhibitor) + theophylline?
Ketoconazole

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 MGA TANONG (ulet)...
Drug Interactions A I
Min Toxic Conc
Pharmacological B
II
Conc
Pharmacokinetic interaction Min Effective Conc
III
1. Alteration of Drug Absorption
2. Alteration of Drug Distribution Time
3. Alteration of Drug Metabolism Change in PK process Effect on CONC Possible Effect
4. Alteration of DRUG EXCRETION 
 ABSORPTION ? ?
a. Changes in urinary pH  ? ?
e.g salicylates + sodium bicarbonate  METABOLISM ? ?
b. Competition at active transport site  ? ?
e.g. probenecid + penicillin  EXCRETION ? ?
 ? ?

Summary Drug Interactions

(Pharmacokinetic Drug Interactions) Pharmacological
1. Most significant are those involving drug metabolism and Pharmacodynamic Interaction
least significant are those involving drug distribution
1. ADDITIVE/SYNERGISTIC effects
2. Effect of an interacting drug can either be: e.g. benzodiazepines + sedating antihistamines
INCREASE in drug conc  TOXICITY 2. ANTAGONISTIC effects
(increase in bioavailability, effect of an enzyme inhibiting drug, e.g. propranolol + anti-asthma drugs
decrease in excretion)
3. Indirect effects
DECREASE in drug conc  TREATMENT FAILURE
e.g. digoxin + diuretics
(decrease in bioavailability, effect of an enzyme inducing drug,
increase in excretion)

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Example
Warfarin should not be taken concomitantly
with vitamin K-rich food such as spinach,
broccoli, table wine. Reducing the Risk
 Object Drug: Warfarin of Drug Interaction
 Precipitant Vitamin K-rich food
Drug: Pharmacodynamic,
 Mechanism: antagonism
 Management: Careful monitoring of the
international normalized
ratio (INR)

NOTE: NOTE:
 Patient related factors  Drug related factors
- disease state - multiple drugs
- age (children, elderly)
- fixed dose
- intake of other drugs combinations
and supplements
- multiple
- multiple prescribers
pharmacologic effects
- compliance (complex
drug regimen )

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AVOID DI’S
A lcohol
V itamins & other food supplements
O TC drugs
I llicit drugs
D rugs (Rx)
D iet
I E nvironmental agents
S ^ moking

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