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Pdis Finals
Pdis Finals
Leaching
- Leaching plasticizer from plastics — for drugs that
contain surfactants or cosolvents = carcinogenic
Deliquesce material (absorbs moisture then liquefy):
based on study in animals
sodium permanganate and chlorides of magnesium,
- Strategy includes: Use container substitute (glass,
aluminum, zinc, calcium and metacholine chloride. polyvinyl, polyethylene, polyurethrane)
Hygroscopic material (absorbs moisture) – sorbitol, Vaporization
CMC, dextran - AKA volatilization
- liberation of the active ingredients
Loss of Water o Control pH
- Common in liquid dosage forms o Separate drugs that are easily oxidized from
- Emulsions (phase inversions in O/W emulsions) those easily reduced
- Suspensions and solutions (increased potency)
Hydrolysis
General Remedies for Physical Incompatibilities - Most common type of incompatibility and drug
- Modify the order of mixing degradation
- Change the kind or concentration of the solvent - Triggered by presence of water, acids, bases, catalyst
- Change in the form of ingredient e.g., dextrose
- Add therapeutically inactive substance - Drugs susceptible to hydrolysis:
- Omit an inactive ingredient o Amides especially with lactam rings —
- Change the dosage form penicillins and cephalosporins
- Separate dispensing o Esters — procaine, tetracaine, aspirin,
belladonna
CHEMICAL INCOMPATIBILITY - Strategies include:
o For solid — control exposure to moisture by
- Occurs as a result of chemical interaction among the using light containers and desiccants
ingredients of a given prescription. o Control the pH
- Visible change in the reaction is not necessarily o Check appropriate references
observed but can be determined by analytical o Consider the drug’s concentration
method. o Control storage temperatures
- Oxidation
- Reduction Evolution of Gas
- Hydrolysis - Commonly caused by NaHCO3 and carbonate buffers
- Evolution of Gas = effervescence
- Complexation - Desired use in some powders and tablets e.g. Alka
- Racemization seltzer
- Epimerization - Strategy:
- Precipitation (physical and chemical - Do not combine drug products that generate acid pH
incompatabilities) with sodium bicarbonate or drug products that
contain carbonate buffers
Oxidation - For vulnerable products, store in tight container
- Occurs when one drug loses electron to the other
- Triggered by light, heavy metals, oxygen, oxidizing Complexation
agents - Forming inactive complex e.g., tetracycline with
- Drug products undergo oxidation usually changed in multivalent ions
color and they will become inactive - Strategy: Avoid combining tetracycline with drug or
- Drugs susceptible to oxidation includes: food containing multivalent ions
o Catecholamine e.g., epinephrine (oxidation
turns it to pink) Racemization
o Phenolics e.g., phenylephrine, morphine - The conversion of one enantiomer to a racemate
o Phenothiazines, chlorpromazine - Racimic mixture – combination of equal amount of
o Thiols e.g., captopril dextro and levo isomers that makes them optically
o Others: Ampthotericin B, tetracycline, inactive
furosemide, etc. - Example: Epinephrine- the I-enantiomer is
approximately 15-20x more active than d-
- Strategies enantiomer
o Protect from oxygen - Other drugs: bupivacaine, albuterol, levalbuterol,
o Protect from light omeprazole, and esomeprazole
o Add metal-chelating agent e.g., edetate - Problem exists when one enantiomer is more
disodium physiologically active than the other and
o Add an antioxidant racemization easily takes place
o Control storage temperature - Pharmacist should review literatures
suboptimal quality of life and wasted resources for
Epimerization our society.
- Formation the pair of diastereomers (not mirror - An undesirable event experienced by a patient that
images of each other, not super imposable) that involves or is suspected to involves drug therapy and
differ only in the configuration about one carbon actually or potentially interferes with a desired
atom (epimers) patient outcome
- Example: Tetracycline undergoes reversible
epimerization to epitetracycline (of little CLASSIFICATION OF MEDICATIONRELATED PROBLEMS
antibacterial activity) in a solution - Pharmacist providers of pharmaceutical care assume
- Rate is dependent on pH and presence of citrates and responsibility to identify, prevent, and resolve
phosphate ions medication- related problems on behalf of their
- Remedy: patients.
o Prepare suspension of tetracyline - These problems have been defined broadly as
o Add buffer to maintain the pH undesirable events that are of psychological,
physiological, social, or economic origin and may be
the function of a patient:
- The pharmacist’s primary responsibility in the - The definition and prioritization of patients’
delivery of pharmaceutical care is to identify, medication-related problems requires a systematic
prevent, and resolve medication problems. approach to prevent problems from being
- A key factor in the fulfillment of this obligation is the overlooked.
availability of essential patient data. This ensures - This also helps to avoid omissions in the patient’s
that all potentially useful information is considered medication-related problem list and in the
for each patient. subsequent formulation of therapeutic goals.
Patient Information for the Provision of If this problem was defined simply as a drug
Pharmaceutical Care interaction, the pharmacist would not know whether the
solution is to
1. Discontinue a drug and recommend a new one
2. Increase the dose
3. Decrease the dose
4. Add a new drug
5. Discontinue all therapy
6. Implement some other appropriate action (eg,
stagger medication doses)
Once the pharmacist has articulated the desired In this context the pharmacist’s
pharmacotherapeutic outcome for each medication- recommendation for the solution of each medication-
related problem, he or she must define appropriate related problem should include:
indicators for each goal. Indicators are measurable - chosen medication
variables that can be used to monitor the effectiveness - dosage form
of the pharmacotherapeutic solutions to medication- - dose frequency and duration
related problems - any special instructions (eg, uncommon
administration procedures) for the patient.
To be optimally useful in this regard, indicators must be - At this point it is especially important to involve the
designed to include: patient in the selection of appropriate therapy. This
A patient factor helps to ensure that the patient is able and willing to
- can be measured to determine the impact of therapy comply with all associated therapeutic and
and include reports of symptoms, laboratory values, monitoring instructions.
and the results of quality-of-life assessments.
A progress factor DESIGN OF A MONITORING PLAN TO DETERMINE IF THE
- describe the degree of improvement in patient DESIRED PHARMACOTHERAPEUTIC OUTCOME HAS
variables that can reasonably be expected to result BEEN ACHIEVED
from the pharmacotherapy.
A time factor - Prior to implementing any therapeutic
- the time frame in which the pharmacotherapy recommendation, the pharmacist must develop a
should have achieved the desired degree of plan to monitor the patient’s progress toward each
improvement. goal established in a previous step.
- This plan should include appropriate
DETERMINATION OF FEASIBLE pharmacotherapeutic monitoring parameters,
PHARMACOTHERAPEUTIC ALTERNATIVES TO ACHIEVE realistic endpoints for each parameter, and the
EACH DESIRED OUTCOME frequency with which each parameter will be
- Following articulation of a goal for each assessed.
medicationrelated problem, the pharmacist must
generate a list of all feasible problem solutions.
The number and nature of each plan component REPORTING OF SUSPECTED ADVERSE DRUG REACTION
depends on the: - Under Republic Act No. 9711, the Food and Drug
1. Properties of the recommended medications Administration (FDA) is mandated to strengthen the
2. Patient’s background characteristics postmarketing surveillance (PMS) system in
3. Availability of practical, cost-effective monitoring monitoring health products.
methods. - PMS refers to activities in safety, efficacy, and quality
monitoring of health products, including drug
- Pharmacotherapeutic monitoring parameters are products. This shall also include among others
either quantitative or qualitative assessments of adverse events reporting, product safety update
patient progress toward specific therapeutic goals. reporting, collection and testing of health products
- Quantitative assessments are objective measures of in the market.
a particular variable and include - To operationalize this mandate, under the same law,
o blood pressure, pulse, temperature, serum drug all drug establishments, including consumers and
levels, and blood glucose determinations. non-consumer user (e.g. healthcare professionals)
- Qualitative assessments are subjective are enjoined to take part in PMS, by reporting to FDA
determinations of change in a particular variable any incident that reasonably indicates that a health
o patient self-reported changes in symptoms such product has caused or contributed to the death,
as nausea, pain, and sedation serious illness, or serious injury to a consumer, a
patient, or any person.
IMPLEMENTATION OF INDIVIDUALIZED
PHARMACOTHERAPEUTIC AND MONITORING PLANS Thus, in the interest of protecting public health
and safety, the FDA reiterates to all consumers and
This involves: healthcare professionals to report any suspected adverse
1. securing physician approval for any changes in the reactions on the use of medicines, and any suspected
originally prescribed therapy adverse events on the use of vaccines, using the
2. Counseling the patient about the proper use of the prescribed adverse drug reaction (ADR) form
recommended therapy (https://ww2.fda.gov.ph/industrycorner/downloadables
3. Collecting monitoring data to evaluate the efficacy of /625-suspected-adverse-reaction). Reports may be
the pharmacotherapeutic plan. submitted via:
- mail at adr@fda.gov.ph
FOLLOW-UP EVALUATION AND DOCUMENTATION OF - fax: +63 2 809-5596
THE RESULTS OF PHARMACOTHERAPEUTIC AND - phone: + 63 2 809-5596
MONITORING PLANS - online reporting using the ADR tab at
- At predetermined intervals, the pharmacist must http://ww.fda.gov.ph/adr-rport- new
review collected monitoring data to determine if - courier at FDA Central office at Civic Drive, Filinvest
satisfactory progress is being made toward the City, Alabang 1781 Muntinlupa City, Philippines
desired medication-related goals. - or though the nearest DOH-FDA Regional Office
- The pharmacist must ascertain if any new problems
have developed since the last review. PATIENT COUNSELING
- If the desired outcomes have not been met or if new
problems have occurred, the pharmacist, physician, - It is the provision of verbal or written information
and patient may need to make changes in the about drugs and other health related information by
original pharmacotherapeutic and monitoring plans. a pharmacist to a patient or an agent of the patient
- Final step: the pharmacist document all during pharmacist-patient interaction
interventions and outcomes in the patient’s record. - The pharmacist acts as both sender and receiver of
- This information then becomes baseline information the message
upon which subsequent adjustments and/or new - Transmission of messages needs to be clear and
therapeutic decisions are made. accurate.
- This information also may be required if the
pharmacist attempts to obtain reimbursement for Factors which necessitates Patient Counseling
pharmaceuticalcare services from a third party. - Increase in drug use-related problems
- Increase in the number of drugs
- Increase in the number of drug regimens
- Inappropriate prescribing to complete a medication history interview at
- Increase in self-medication practice the time the prescription is dispensed
- Increase in the use of alternative medicines
Main Concerns in Patient Counseling: HOW AND WHAT
DESIRED OUTCOMES OF PATIENT COUNSELING
- Results of a properly conducted counseling PROCESS
interaction: 1. Introduce yourself and identify the patient
o Patient will recognize why a prescribed 2. Ask patient to talk with you about the medication.
medication is helpful for maintaining or Explain the purpose and the importance of the
promoting well being counseling session
o Patient will develop the ability to make more 3. Update the patient’s medication profile
appropriate medication-related decisions 4. Assess what the patient already knows about the
concerning compliance or adherence newly prescribed drug and the reason it was
o Patient will become a more informed, efficient, prescribed.
active participant in disease treatment and self- 5. Assess whether the patient knows how to take the
care management medication
o Patient will show motivation toward taking 6. Assess the patient’s understanding of what to expect
medications to improve his or her health status from medication including the expected outcomes of
the therapy as well as its potential adverse effects
PATIENT BENEFITS FROM PATIENT COUNSELING 7. Ask the patient if he or she has any concerns or
- Improved therapeutic outcomes and decreased questions that have not been addressed in the
adverse effects previous discussion
- Improve patient adherence to the treatment plan 8. Check patient understanding of the information
- Decrease medication errors and misuse discussed in the counseling session
- Enhanced self-management by involving the patient 9. Close the session
in designing the therapeutic plan
CONTENT OR SCOPE OF PATIENT COUNSELING
PHARMACISTS BENEFITS FROM PATIENT COUNSELING - Any counseling episode may contain one or more of
- Enhanced professional status in the view of the the following information as deemed appropriate:
patients and other health care providers o Trade name or generic name of drug
- Establishment of an essential component of patient o Use, action, and onset of action
care that cannot be replaced by technicians or o Route, dosage form, and storage
automation o Direction for use
- Enhanced Job satisfaction through improving patient o Action in case of missed dose
outcomes o Precautions
- A value-added service to offer patients o Side effects and adverse effects
- Revenue generation through payment for counseling o Techniques for self-monitoring
services – limited at present but growing o Potential drug interactions
- Fulfillment of legal responsibility to counsel patients o Contraindications
o Relationship with laboratory and other
PREPARING FOR THE COUNSELING SESSION procedures
- Pharmacists should spend few moments mentally o Disposal of drug and devices
preparing for the interchange that is about to occur o Any other health information unique to an
- Determine the physical state of the patient individual patient, disease or medication
- Have as much information as possible about the
patient ASSESSING THE SUCCESS OF THE PROCESS
o In the hospital setting – review the medical - During the counseling process:
chart and get information from health care o Check if the information is being understood by
providers the patient
o In the community setting – review the o Watching the patient’s body language and
prescription and patient’s medication record; maintaining eye contact can give useful clues to
for a first pharmacy visit, ask the patient to fill whether the message is being understood and
out medication history form if there is no time whether it is likely to be complied with
AIDS IN COUNSELING - Be patient and listen carefully when interacting with
- Patient information leaflets – should be used where a person who has difficulty speaking, use questions
appropriate, important points should be highlighted that require brief responses.
- Placebo devices
- Warning cards PATIENT COUNSELING SETTING
- Community pharmacy
COUNSELING CHILDREN AND ADOLESCENTS - Hospital
- Talk to parents and children about how to protect
young children from accidental poisoning and what COMMUNITY PHARMACY
to do if it occurs
- When children are old enough to understand, speak - Lack of expectation by costumers for counseling and
directly with them about their medicines. Tell advice should not be a barrier
children what you expect them to do and why. - Counseling on medication is not optional but an
- Encourage children to ask you questions about their integral part of the dispensing of a prescription
illness and treatment - Pharmacists must ensure that they are visible and
accessible in community pharmacies to provide it.
COUNSELING THE ELDERLY PATIENT
- Elderly Patient may have functional barriers Disadvantages of community Setting
- Vision and hearing are often impaired - No formal screening takes place.
- Patient may have difficulty removing child- proof - The process is random
tops, self-injecting insulin, or applying creams and
ointments. HOSPITAL SETTING
- Many elderlies have low literacy skills
- Cognitive impairments become more common with - Opportunities for patient counseling in hospital:
increasing age - On admission
- AS patients age, chronic condition and the number of - On discharge
medication prescribed increase, - At outpatient clinics
- Additional time may be required to address the - Rehabilitation groups
needs of the patient
- Written information and compliance reminder aids Advantages of Hospital Setting
are particularly helpful with large number if - Access to a considerable amount of information
prescription products. about the patient.
- Provide small pieces of specific information coupled o Details of disease states, current therapy, home
with a reminder aid and verbal reinforcement of the circumstances
information. - Counseling in hospital can be approached in a more
- Consider their own feelings about aging. One formalized way
recommendation to increase empathy for elderly
patient is to consider what the patient and the world Concerns in Hospital Setting
were like when he/she was younger and to - Financial pressure in hospitals affect manpower
remember that patient was not always old levels – staffing level may be reduced/
- Limited access to a pharmacist
COMMUNICATING WITH PERSONS WITH DISABILITIES - Patients in hospital often have their medication
- Speak and interact directly with the person changed and they should be fully aware of any
- Identify yourself and other persons in the group to alterations.
the person who is virtually impaired. - Patients may be discharged from hospital without
- Stoop or squat to communicate with a person in a the knowledge if the pharmacists – little guidance on
wheelchair; position yourself in front and at an eye the use of medicines
level - Due to limited resources, patients are screened to
- Avoid leaning or sitting on a person’s wheelchair; use prioritize who is counseled
care for handling assistive aids
- Make the person who has hearing impairment aware
of your presence
PLANNING FOR DISCHARGE MEDICATION COUNSELING - To reach therapeutic goals that are endorsed by
patients as well as by health care providers
R – reason for admission
- Is it due to a drug-related problem or THE IMPORTANCE OF COMMUNICATION IN PATIENT
noncompliance? CARE
- How many and what kind of disease does the patient - It establishes the ongoing relationship between the
have? provider and the patient
- What medications are currently prescribed? - It provides the exchange of information
- Asses the patient’s physical, emotional, and mental
states in light of patient history RESPONSIBILITIES OF PHARMACISTS IN PATIENT CARE
Obtain information about the patient and provide
E – Evaluate current medication for drug related information to patient for the purpose of identifying,
problems including noncompliance. resolving, and preventing potential medication
- Prioritize questioning, beginning with the most related problems.
important medication that relate to the primary Maintain patient profiles that contains the following:
problem. Patient demographic information
- Prioritize questioning, also focusing on those drugs Comprehensive list of medications
with multiple daily dosing regimen and those with Patient’s allergies, ADR, disease states
special administration technique such as inhaler Pharmacist comments relevant to an individual
patient’s drug therapy – prospective DUR
A – Asses the patient’s knowledge base and skills to self- - Offer to engage in discussion of a patient’s therapy
medicate, asses compliance whenever a medication is dispensed
- promoting strategies. Counsel patients on their medication (both new
and refill)
P – Plan to avoid drug-related problems after discharge.
COMPONENTS OF THE INTERPERSONAL
Discharge Counseling Session COMMUNICATION MODEL
- Includes review of the following for each prescribed - The SENDER
medication: - Transmits message to another person
- Indication - Formulates or encodes the message before
- Dosage transmitting it.
- Administration
- The MESSAGE
- Self-monitoring
- The element that is transmitted from one person to
- Follow-up laboratory tests (if necessary)
another.
- Follow-up appointment (if necessary)
- Can be thoughts, ideas, emotion, information, or
other factors that can be transmitted verbally or non-
COMMUNICATION IN PATIENT CARE
verbally
- The RECEIVER
COMMUNICATION
- Receives and decodes the message and assigns a
- Communication between and among persons is a
particular meaning to it. w
primary function of life w For a pharmacists and
other care givers, communication with patients, - The FEEDBACK
family members, other practitioners, and coworkers - The process of initial receiver’s communicating back
is necessity. to the original sender his/her understanding of the
sender’s message
COMMUNICATION IN THE CONTEXT OF PATIENT CARE - Can be verbal, non-verbal, or both
Patient – centered care depends on the pharmacist’s - BARRIERS – Refer to interferences that affect the
ability: accuracy of the communication exchange
- To develop trusting relationships with patients
- To engage in an open exchange of information PHARMACIST’S ROLE IN COMMUNICATION
- To involve patients in the decision making process - As a sender - assure that the message is transmitted
regarding treatment in the clearest form, in terminology understood by
the other person, and in an environment conducive Time Barriers
to clear transmission - Timing of the interaction; inappropriate time may
- As a receiver – Listen to what is transmitted by the lead to communication failure
sender and provide feedback to describe how you - Examples: patient is in a hurry; lack of time the
understand the message pharmacists to talk to the patient