Legal Aspects of

Pharmacology
ROLE IN NURSING CARE

1. PREVENTION
- First level
- Health impact of environment
- Health aspects of social, medicinal and illegal drug abuse

2. EARLY DETECTION OF DISRUPTION IN A HEALTHY CLIENT

- Second level
- Case finding and referral
- Seeks evidence of habituation, toxicity addiction and untoward side effects
3. CARE NEEDED FOR CLIENTS WITH ACUTE HEALTH NEEDS
- Third level
- Institutional setting
- Administering drugs to acutely ill patients

4. REHABILITATION AND RESUMPTION OF NORMAL LIVING

- Fourth level
- Focus 🡪 education and assistance
- Long term use of drugs necessary
PHARMACOLOGY IN NURSING EDUCATION
• Integrated in curriculum

PHARMACOLOGY IN RESEARCH
• Drug research
• Considerations in drug research
• Nurse - Fully informed
• Information available to physician
• Research and pharmacist
• Recommended dosage
• Route of administration
• Desired therapeutic effects
• Adhere to the study protocol
ETHICAL PRINCIPLES
• Respect for person
Individuals are independent meaning they are capable
of making decisions
• BENEFICENCE – duty to do good
• NON-MALEFICENCE - to do no harm
• JUSTICE – social benefits can be allocated objectively and that
those with equivalent circumstances should be treated equally
PRINCIPLES OF DRUG ADMINISTRATION

NURSE- should understand professional responsibilities

• Medical administrations
• Medication delivery systems
• Drug orders
PRINCIPLES OF DRUG ADMINISTRATION

NURSE- should understand professional responsibilities

• Medical administrations
• Medication delivery systems
• Drug orders
DRUG DISTRIBUTIONS SYTEM

1. FLOOR STOCK
• All medications are stocked at nursing station
• Except dangerous drugs
• Utilized in small hospitals, government hospitals

2. INDIVIDUAL PRESCRIPTION ORDER SYSTEM

• Medications dispensed from pharmacy
• Receipt prescription or drug order
3. COMPUTER-CONTROLLED DISPENSING SYSTEM
• Drug order sent to pharmacy
• Encode order to a computer system
• Nurse with the use of security code and password access the
system

4. UNIT DOSE SYSTEM

• Single unit packages of drugs
• Dispensed to fell each dose required
• Individual packages placed in individual labelled drawers kept in
• Refilled every 24 hours and large unit dose cabinet; 3 to 7 days
in long term facilities
NARCOTIC CONTROL SYSTEM

• Within hospitals
• It is a standard policy that controlled substances are
issued in single unit packages and are kept in separate
locked cabinet in each nursing unit
• Head nurse designated individuals is responsible for the
key
• When controlled substances are issued to a nursing unit
DRUG ORDERS

STAT
• emergency doses
• meds given ASAP but ONCE only

SINGLE ORDER
• Administration at a certain time only but once

STANDING ORDER
• Meds given for a specific number of doses
PRN (pro re nata)
• As needed
• Allows nurse to practice judgement to when a medication should
be administered

VERBAL ORDERS
• Should be avoided
• Physician should co-sign and date the order in 24 hours
RESPONSIBILITIES IN DRUG THERAPY

RIGHT
1. Patient
2. Drug
3. Time
4. Dose
5. Route
6. Documentation
LEGAL AND ETHICAL
• Practice under professional license

PATIENT’S CHART
• Primary source of information
THE NURSING PROCESS

ASSESSMENT
• Subjective and objective
• Prescriptions
• OTCs
• Herbals
• Responses to medications

NURSING DIAGNOSIS
• Decision about the needs/problems of patient
• Critical thinking, creativity and accurate data
PLANNING
• Goals and outcome criteria
• Specific and measurable
• Patient-centered
• Time-frame
• Prioritization

IMPLEMENTATION
• Initiation and completion of nursing plans
LEGAL REGULATIONS OF PHARMACOLOGY

1. US PHARMACOPEIA (USP)
• Drug standard revised every 5 years
• Drugs have high standards for therapeutic use
• International Pharmacopeia first published in 1951

2. FEDERAL LEGISLATION
• Public protected from drugs that are impure, toxic, ineffective or not tested prior to public use

3. FOOD, DRUG AND COSMETIC ACT 1938

• To monitor and regulate the manufacture and marketing of drug
• It is FDA’s responsibility to ensure that all drugs are tested for harmful effects have label with
accurate information, an enclose with drugs packaging detailed literature that explains adverse
effects
4. DURHAM-HUMPHREY AMENDMENT 1938 (1952)
• Distinguishes between drugs that are solid with or without prescription and those
that should not be refilled without new prescription

5. KEFAUVER-HARRIS AMENDMENT OF 1938 (1962)

• Taken during first trimester🡪 Babies were born with extreme limb deformities

6. COMPREHENSIVE DRUG ABUSE PREVENTION AND CONTROL

ACT
• Categorize substances into schedules
7. CONTROLLED SUBSTANCES ACT
• Designed to remedy the escalating problem of drug abuse,
included several provisions
• Promotion of drug education and research into the prevention and
treatment of drug dependence
• Strengthening of enforcement authority
• Establishment of treatment and rehabilitation facilities
• Designation of schedules or categories for controlled substances according
to abuse liability
CONTROLLED SUBSTANCES
• SCHEDULE I- not approved for medical use, abuse potential and extent of
physical and psychologic dependence are greater with schedule I
• SCHEDULE II to V- have accepted medical use
• SCHEDULE V- limited potential and extent of physical and psychologic
dependence

DRUG ENFORCEMENT ADMINISTRATION of the DOJ

• charged with the role of being the nation’s sole legal drug enforcement
agency
8. DRUG REGULATION REFORM ACT 1978
• Shortened the time in which new drugs could be developed and
marketed

9. DRUG RELATIONS ACCT 1992

• The regulations were change to increase the approval rate of
drugs used to treat AIDS and cancer
• Pharmaceutical companies pay a user fee at the time they file
the application for the new drug
10. THE FOOD AND DRUG ADMINISTRATION
MODERNIZATION ACT 1997
FIVE PROVISIONS
• Review and use of new drugs is accelerated
• Drugs can be tested in children before marketing
• Clinical trial data are necessary for experimental drug use for
serious or life-threatening health conditions
• Drug companies are required to give information on “off-label”
drugs and their uses and costs
• Drug companies that plan to discontinue drugs must inform health
professionals and clients at least 6 months before stopping drug
production
11. HEALTH INSURANCE PORTABILITY AND
ACCOUNTABILITY ACT (HIPPA) 2003
• Sets te standards for the privacy of individually indentifiable
health information as of 2003
• Gives clients more control over their health information,
including boundaries on the use and release of health records
• Limitations on access to information from the pharmacy
• Pharmacist must provide a private are for consultation with the
client and have all clients sign a statement that they have
received a copy of the privacy statement
12. PEDIATRIC RESEARCH EQUITY ACT 2003
• FDA is authorized to require testing of drugs and biologic
products for safety and effectiveness in children by drug
manufacturers
• One must not assume that children are small adults

13. MEDICARE PRESCRIPTION DRUG IMPROVEMENT AND

MODERNIZATION ACT 2003
• Serves to provide financial assistance to seniors to purchase
needed prescription medications
PHILIPPINE LAWS

1. NATIONAL DRUG POLICY 1987

• Ensures drugs are safe, effective and essential
• Reasonable and affordable

Components
• Quality assurance of drugs
• Rational use of drugs by health professionals and consumers
• Self reliance and self sufficiency
• Targeted drug procurement by government in support for the 1stof 3
pillars
2. GENERIC ACT OF 1988 (RA 6675)
• Identifies by their scientific and internationally recognized active
ingredients

ADVANTAGES
• Decreases prices
• Ensures adequate drug supply
• Promote safety
• For scientific basis use of drugs

DISADVANTAGES
• May have some variation in action or response
• Too long and difficult to pronounce
3. SENIOR CITIZEN ACT
• Provision in which senior citizen will be given 20% discount

4. RA 9502- UNIVERSALLY ACCESIBLE CHEAPER AND

QUALITY MEDS ACT OF 2008
• Effective September 2008
• Lowering of drug prices thru free competition and better access
to affordable brand
• Generic forms to test, produce and register generic versions of
patented drugs
• Prohibits ne patent of newly discovered uses of unknown drugs
Legal Aspects - Generic Act of 1988
R.A. 6675- An act to promote, require and ensure the production of an adequate supply,
distribution, use and acceptance of drugs and medicines identified by their generic names.
June 01- August 31, 1989- monitoring of Generic Act. Compliance.
September 01, 1989- full implementation of generic Act.
Pharmacy Act R.A. 5921- all prescription contain the following info.: name of the prescriber,
office address, PR #, PTR#, client name, age, sex, and date of prescription.
R.A. 3720- food , drugs, and devices and cosmetics act.
R.A. 2382- Philippine medical act of 1957, define the practice of medicine in the Philippines.
R.A.6425- dangerous drug act of 1972, article ll, sec. 4 states that sale, administration, delivery,
distribution, and transportation of prohibited drugs are punishable by law. The penalty of
imprisonment ranging from 12 years and 1 day to 20 years and fine ranging from 12 thousand
to 20 thousand pesos shall be imposed.
Philippine Nursing Act of 1991 Section 28- administration of intravenous injections, special
training shall be required according to protocol of established.