CLIN PHARMACY & PHARMACOTHERAPEUTICS 1 BY NGILAY, OCTAVIO, RASGO

TOPIC 1: PHARMACOTHERAPY CARE PLAN Pharmacist’s responsibility

Objectives ● Drug monitoring

● Disease monitoring
1. Identify health risk factors and document ● Drug therapy
patient’s progress and response to treatment as ● Disease management/collaborative practice
components of MTM
◦What is the impact of clinical pharmacist to the
2. Discuss the concepts of pharmacotherapy care patient’s outcomes and his attending physician?
planning
Essential Components of Pharmaceutical Care
a. CORE
b. PRIME 1. Pharmacist-patient relationship - a collaborative
c. SOAP/ FARM effort between pharmacist & patient

PHARMACOTHERAPY CARE PLAN ● Empathy

Medication therapy management (MTM)
▪MTM was defined as a distinct service or group of
services that optimize therapeutic outcomes for
individual patients.
● Caring
2. Pharmacist’s workup of drug therapy (PWDT) -
Provision of pharmaceutical care is centered
around this, although the methods used for this
purpose may vary.

▪It encompasses a broad range of professional Components of PWDT (Pharmacist’s workup of

activities and responsibilities within the scope of drug therapy )
practice of the licensed pharmacist or other
qualified health care providers.

▪Goal: to develop a documentation format that

meets individual patient’s needs that can be useful
in achieving the optimum therapeutic outcomes.

Pharmaceutical care

“A practice in which a practitioner takes

responsibility for a patient’s drug related needs and
holds him or herself accountable for meeting these
needs.” - Linda Strand 1997

Pharmaceutical care

It uses a process through which a pharmacist

cooperates with a patient and other health care
professionals in designing, implementing, and
monitoring a therapeutic plan that will produce
specific therapeutic outcomes for the patient.
This process involves three major functions:
1. Identifying potential and actual drug-related
problems.
2. Resolving actual drug-related problems.
3. Preventing potential drug-related problems.
I. Data collection
Collect, synthesize & interpret relevant information
such as patient’s:
1. Demographic data: age, sex, race,etc. and
other pertinent medical information
2. Pertinent medical information
a. Medical history (current & past)
b. Family history
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CLIN PHARMACY & PHARMACOTHERAPEUTICS 1 BY NGILAY, OCTAVIO, RASGO

c. Dietary history O- OBJECTIVE FINDINGS

d. Medication history (prescription,
OTC, allergies) A- ASSESSMENT
e. Physical findings (weight, height,
B.P) P- PLAN
f. Lab results (serum drug levels,
potassium levels, serum creatinine - Traditional documentation primarily by physicians.
levels relevant to drug therapy) _________________________________________

3. Patient complaints, signs & symptoms The first step in the construction of a FARM note is
to clearly state the nature of the drug-related
II. Develop or identify the CORE problem(s).
pharmacotherapy plan
Each problem in the FARM note should be
● C = condition or patient need addressed separately and assigned a sequential
● O = outcome desired for that condition number to facilitate identification of
● R = regimen selected to achieve that pharmacotherapy problems
outcome
● E = evaluation parameters to assess Seven types of medication-related problems
outcome achievement have been identified.

III. Identify PRIME Pharmacotherapy Problems 1. Unnecessary drug therapy

2. Needs additional drug therapy
● P = pharmaceutical based problems 3. Ineffective drug
● R = risks to patient 4. Dosage too low
● I = interactions 5. Adverse drug reaction
● M = mismatch between medication & 6. Dosage too high
condition or patient needs 7. Noncompliance
● E = efficacy
2 advantages of FARM
This includes pharmacist's intervention.
1. it presents a framework, applicable in any
The goal is to identify actual or potential problems practice setting, to assure that the
that could compromise the desired patient outcome pharmacist has considered each possible
type of problem.
Documentation of pharmaceutical care 2. categorization allows optimal data analysis
and retrieval capabilities
Formulate a FARM progress note or SOAP
progress note Components of FARM

- it describe or document the interventions F = Findings

needed or provided by pharmacist
● Demographic data that may be reported
F- FINDINGS include a patient identifier (e.g., name,
initials, or medical record number), age,
A- ASSESSMENT race (if pertinent), and gender.
● include both subjective and objective
R- RESOLUTION findings that indicate a drug-related
problem.
M- MONITORING ● Ex. Joint pains, headache, n/v, shortness of
breath, etc
- a pharmacist equivalent of a physician’s progress ● Patient-specific information - gives basis
note for recognition of pharmacotherapy

S- SUBJECTIVE FINDINGS
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CLIN PHARMACY & PHARMACOTHERAPEUTICS 1 BY NGILAY, OCTAVIO, RASGO

problems or indication for pharmacist This should include

intervention
✔ The parameters to be followed (e.g. pain,
A = Assessment depressed mood, serum levels)

● the pharmacist’s evaluation of the current ✔ The intent of monitoring e.g. efficacy, toxicity,
situation (i.e., the nature, extent, type, and adverse events
clinical significance of the problem)
● The short term & long term goals of the ✔ How the parameters will be monitored e.g.
intervention proposed interview patients, serum drug
● any additional information needed to best
assess the problem to make ● Frequency of monitoring—weekly or
recommendation monthly
● Duration of monitoring e.g. until resolved,
Short term goals: while on antibiotics, then monthly for one
year
● Elimination of symptoms , Lowering of BP ● Anticipated or desired finding e.g. no pain,
● Management of acute asthma without healing of lesion
requiring hospitalization ● Decision point to alter therapy when or if
outcome is not achieved e.g. pain still
Long term goals: present after 3 days, mild hypoglycemia
more than 2 times a week.
● Prevent recurrence of disease, Control B.P.
● Prevent progression of diabetes Clinical skills & pharmacist’s role in
Pharmaceutical Care
R = Resolution ( including prevention)
1.Patient assessment based skills
The intervention plan includes actual or proposed
actions by pharmacist or recommendation to other ● Physical assessment
health care professionals. The rationale for ● Barriers to adherence
choosing a specific intervention should be stated. If ● Psychosocial issues
pharmacotherapy is recommended, a specific drug,
dose, route, schedule, and duration of therapy 2. Education & counseling based skills
should be specified.
● Interview skills
Intervention options may include: ● Communication skills (e.g. empathy,
listening, speaking or writing at patient's
a. Observation, reassessing, or follow ups: if level of understanding)
no intervention necessary at this time. ● Ability to motivate & inspire
● Develop & implement patient education plan
If no action was taken or recommended, the based on an initial education assessment
FARM note serves as a record of the event ● Identification & resolution of compliance
and should constitute part of the patient’s barriers
pharmacy chart or database.
3. Patient Specific Pharmacist Care Plan based
b. Counseling or educating the patient or care skills
giver
c. Making recommendations to the prescriber ● Recognition, prevention & management of
d. Informing the prescriber drug interactions
e. Withholding medication or advising against ● Pharmacology & therapeutics
use ● Interpretation of lab tests
● Knowledge of community resources,
M = Monitoring to assess the efficacy, safety & professional referrals
outcome of the intervention

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● Communication & support with community
medical providers
4. Drug Treatment Protocol based skills
● Develop & maintain (update) protocols
● Follow protocols as clinical pharmacist -
clinician
● Monitor, aggregate adherence to the
treatment protocols - e.g. drug utilization,
evaluation, especially for managed care or
health system facility
5. Dosage adjustment based skills
● Identify patients at high risk for exaggerated
or Subtherapeutic response
● Apply pharmacokinetic principles to
determine patient specific dosing
6. Selection of therapeutic alternatives
● use drug information resources effectively
● review and critique drug literature
● construct comparative analyses to support
therapeutic decisions
7. Prescriptive authority
● In designated practice site and positions
8. Preventive services
● Immunizations
● Screenings
● Health and wellness education
IMPORTANCE OF PHARMACEUTICAL CARE IN
TODAY’S PHARMACY PRACTICE
1. The potential for medication errors is growing,
and one professional group must assume a primary
role in addressing this issue. The pharmacist is
trained specifically to address these therapeutic
issues.
- The use of prescription and nonprescription
medications is growing and now constitutes
the primary therapeutic modality available to
health care practitioners and patients.
- The number, complexity, and potency of
prescription and non prescription drug
products is increasing.
BY NGILAY, OCTAVIO, RASGO
2. The need for pharmaceutical care secures an
enduring role for the pharmacist. Every encounter
with patients, regardless of practice setting,
provides pharmaceutical care.
3. Pharmaceutical care activities integrate
pharmacists into the health care system of the
future.
High Profile Examples
A patient with leukaemia received Intrathecal
vincristine instead of intravenously. Died
beginning of February 2001, 14th such case over
the last 16 years.
Patient being operated for a AAA received
bupivicaine intravenously rather than epidurally.
Patient died 3 days later.
A 3 year old girl, who had a convulsion post flu
vaccine. Attended hospital to get “checked out”.
Received nitrous oxide instead of oxygen in
casualty
Elderly lady was prescribed Methotrexate in 1997
for her rheumatoid arthritis. Dose increased to
17.5mg WEEKLY over a 6 month period. Jan 2000
patient undergoes right TKR in hospital. MTX given
as one tablet a week (only 2.5mg). Prescription for
MTX 10mg/daily written and dispensed. 30th April
patient dies.
Human Error (Mistakes, Slips, Lapses)
Photosensitivity from Amiodarone
Severe extravasation of amiodarone infusion
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“The same error, even a minor one, can

have quite different consequences in
different circumstances”

Sources of Error

1. Prescribing error - selecting the wrong or

inappropriate drug/ dose/ formulation/ duration etc

2. Communicating those instructions

Goitre - Hypothyroidism
Secondary to Amiodarone 3. Supply error - timely; wrong drug, dose, route;
Bleeding due to anticoagulation expired medicines, labelling.
NSAID induced peptic ulcer
4. Administration error - timing; wrong route;
wrong rate/technique.

5. Lack of user education - actions to take.

Drug therapy assessment

Six types of problems which may result in treatment

failure:

1. Inappropriate selection of medication

2. Inappropriate formulation of medication
3. Inappropriate administration of drug therapy
4. Inappropriate medication-taking behaviour
Erythemal rash from penicillin - in patient with a
5. Inappropriate monitoring of drug therapy
previous known allergy/adverse drug reaction
6. Inappropriate response to drug therapy
Acute Liver failure from Black Cohosh - herbal
Patient Assessment Questions
medicine
1. Does the patient need this drug?
Necrotising fascititis - secondary to infection at the
2. Is this drug the most effective and safe?
site of IV injection
3. Is this dosage the most effective and safe?
4. If side effects are unavoidable does the
Error is inevitable due to “our” limitations:
patient need additional
5. drug therapy for these side effects?
● limited memory capacity
6. Will drug administration impair safety or
● limited mental processing capacity
efficacy?
● negative effects of fatigue other
7. Are there any drug interactions?
● stressors
8. Will the patient comply with prescribed
We all make errors all the time regimen?

● Generalized lack of awareness that causes Ideal Pharmacist Candidate?

errors
● Patients suffer adverse events much more Competent
often than previously realised Motivated/Enthusiastic
● Errors often NOT immediately observed Teamwork spirit
Good communication skills
Responsible
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Problem solver Thus, can result to serious morbidity and mortality

Dedicated
Pharmaceutical Management Cycle
TOPIC 2: PRESCRIBING AND RATIONAL DRUG
USE Importance of Rational Drug Use in the Drug
Management Cycle
Prescribing, Dispensing, Counseling and
Adherence

Objective: Discuss proper prescribing and rational

drug use

What is prescribing?

To prescribe is to authorize by means of a written

prescription the supply of a medicine.

● It incorporates decision making before

prescribing.
● Prescribing a medicine is one of the most Definition of Rational Drug Use (RDU)
common interventions in health care used to
treat patients. The rational use of drugs requires that:

Rational and effective prescribing - patients receive medications appropriate to

their clinical needs,
The prescriber should have these 4 aims: - in doses that meet their own individual
requirements
1. Maximize effectiveness - for an adequate period of time, and
2. Minimize risks - at the lowest cost to them and their
3. Minimize costs community.
4. Respect the patient’s choices
Rational use of drugs should ensure:
Another framework to support rational prescribing
decisions ● correct drug
● appropriate indication
STEPS: ● appropriate drug considering efficacy,
safety, suitability for the patient, and cost
● Safety ● appropriate dosage, administration, duration
● Tolerability ● no contraindications
● Effectiveness ● correct dispensing, including appropriate
● Price information for patients
● Simplicity ● patient adherence to treatment
Inappropriate or irrational prescribing Many Factors Influence Use of Medicines
● Poor choice of medicine
● Polypharmacy or co-prescribing of
interacting medicine
● Prescribing for a self-limiting condition
● Continuing to prescribe for a longer period
than needed
● Prescribing too low a dose of a medicine
● Prescribing without taking account of the
patient’s wishes.

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Irrational Drug Use Adherence: Why do Patients Miss Doses?

(Barriers to adherence 1)
Diagnosis: Aspects that lead to Irrational Drug Use

● Inadequate examination of patient

● Incomplete communication between patient
and doctor
● Lack of documented medical history
● Inadequate laboratory resources

Prescription: Types of Irrational Drug Use

● Under-prescribing
● Incorrect prescribing
● Extravagant prescribing
● Over-prescribing
● Multiple prescribing

Dispensing: Types of Irrational Drug Use

● Incorrect interpretation of the prescription Other Barriers to Adherence

● Retrieval of wrong ingredients
● Inaccurate counting, compounding, or
pouring
● Inadequate labeling
● Unsanitary procedures
● Packaging:
- Poor-quality packaging materials
- Odd package size, which may
require repackaging
- Unappealing package
Adherence vs. Compliance
● Adherence: The act or quality of sticking to
something; steady devotion; the act of
adhering
- The acceptance of an active role in
ones health care
● Communication difficulties
● Literacy levels
● Inadequate knowledge of disease
● Inadequate understanding of effectiveness
of medications
● Lack of social support
● Discomfort with disclosure of disease status
● Difficult life conditions
● Alcohol and drug use
● Depression and other psychiatric problems
● System barriers
Adherence Multi-disciplinary Roles
- Same message from all!

● Compliance: the act of yielding conforming,

or acquiescing
- There is sharing in the decision
made between provider and client

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To Achieve Optimal Treatment Outcomes,
Patients Need to:
1. Understand the diagnosis and correctly
assess its potential impact
2. Be interested in their health and believe in
the efficacy of the prescribed treatment
3. Find ways of using the medication that are
not more troublesome than the disease
Drug Procurement and Rational Drug Use: What
is the influence of one on another?
Pharmacists as prescribers and the legal
framework
Supplementary prescribing - allows pharmacists
and nurses to prescribe, and was extended to allow
optometrists, podiatrists, physiotherapists..
- this is in partnership with the independent
prescribers which are the doctors or dentists
ACCOUNTABILITY - It covers the 3 aspects :
1. the law
2. the statutory professional body
3. and the employer
Ethical framework
I. Autonomy - it recognizes individual patient’s
right to self-determination in making judgements
and decisions for themselves and encompasses
informed patient consent.
II. Non-maleficence - not causing harm to the
patient as expressed in the Hippocratic Oath.
BY NGILAY, OCTAVIO, RASGO
III. Beneficence - the principle of doing good and
the obligation to act for the benefit of others that is
set out in the code of conducts. Ex. Pharmacist’s
Code of Ethics
IV. Justice and Veracity - relates to the distribution
of resources that ensure equity and fairness
While medicines have the capacity to improve
health, they also have the potential to cause harm.
Prescribing of medicines need to be rational and
effective in order to maximize benefit and minimize
harm.
Good prescribing should ensure the patient’s ideas,
concerns and expectations are taken into account.
TOPIC 3: CLINICAL ANALYSIS OF ADVERSE
DRUG REACTIONS
Objectives:
- Define adverse drug reactions
- Discuss epidemiology and classification of
ADRs
- Describe basic methods to detect, evaluate,
and document ADRs
Definition
Adverse Drug Reactions (WHO)
- response to a drug that is noxious and
unintended and that occurs at doses used in
humans for prophylaxis, diagnosis, or
therapy of disease, or for the modification of
physiologic function
- excludes therapeutic failures, overdose,
drug abuse, noncompliance, and medication
errors
Adverse events vs. ADRs
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All ADRs are adverse events but not all adverse ● Latent - > 2 days
events are ADRs
Classification - Severity
Adverse events injury resulting from medical
intervention related to a drug Severity of reaction:

1. Adverse events that are not reaction to
medicines
2. ADRs (not from medical errors)
3. ADRs (From medical errors)
4. Medication errors that cause harms that are
not ADRs
5. Other medication errors that do not cause
adverse events
Adverse events = 24+3+4
An adverse event is an adverse outcome that
occurs while the patient is taking a drug but it is not
necessarily attributable to the drug itself.
IMPORTANT CONCEPT IN CLINICAL TRIALS!!
Not every event are drug related; not always
possible attributing causality
WHO definition of ADR: a response to a drug that is
noxious and unintended and occurs at doses
normally used in humans for the prophylaxis
diagnosis and therapy of disease, or for
modification of physiological function
Epidemiology of ADRs
- substantial morbidity and mortality
- estimates of incidence vary with study
methods, population, and ADR definition
- 4th to 6th leading cause of death among
hospitalized patients*
- 6.7% incidence of serious ADRs*
- 0.3% to 7% of all hospital admissions
- 30% to 60% are preventable
*JAMA. 1998;279:1200-1205.
● Mild - bothersome but requires no change
in therapy
● Moderate - requires change in therapy,
additional treatment, hospitalization
● Severe - disabling or life-threatening
Classification - Severity
FDA Serious ADR
● Result in death
● Life-threatening
● Require hospitalization
● Prolong hospitalization
● Cause disability
● Cause congenital anomalies
● Require intervention to prevent permanent
injury
Classification-Reaction Types
• Type A reactions
● extension of pharmacologic effect – drug
overdose
● often predictable and dose dependent
● responsible for at least two-thirds of ADRs
- e.g., propranolol and heart block
- anticholinergics and dry mouth
Classes of TYPE A reactions
1. Toxicity of overdose (drug overdose) -
caused by excessive dosing
- ex. hepatic failure with increase
dose of paracetamol
- Headache with antihypertensives
- Hypoglycemia with sulfonylurea;

Classification 2. Side effects – nearly unavoidable produced

- Onset by therapeutic doses, intensity is dose
- Severity dependent
- Type - Occur immediately after initial taking
of drug or may be weeks after
Classification-onset initiation
Onset of event: - Sedation w/ antihistamines
● Acute - within 60 minutes
● Sub-acute - 1 to 24 hours

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CLIN PHARMACY & PHARMACOTHERAPEUTICS 1
3. Secondary effects
- Ex. Development of diarrhea with
antibiotic therapy due to altered GIT
bacterial flora
- Orthostatic hypotension with
phenothiazide
4. Drug interactions – when 2 drugs taken
together & they effect each other’s response
pharmacologically or kinetically
- One drug slow metabolism of 2nd
drug → increase blood concentration
toxicity → toxicity
- Ex. Theophylline toxicity in presence
of Erythromycin
• Type B Reactions
● Often caused by idiosyncratic or
immunologic reactions
● rare and unpredictable
● Not related to dosage
● May cause serious illness or death
- e.g., chloramphenicol and aplastic
anemia
Classes of TYPE B reactions
1. Drug intolerance – lower threshold to
normal pharmacological action of a drug
- Ex. Tinnitus in single average dose
of ASA
2. Hypersensitivity (Immunological reaction)-
immune mediated response to a drug agent
in sensitized patient
- ex. Anaphylaxis with penicillin
3. Pseudoallergic reaction – direct mast cell
activation & degranulation by drugs (ex.
Opiates, vancomycin, radiocontrast media)
- Clinically indistinguishable from Type
I hypersensitivity but does not
involve IgE (non immunologic
reactions)
Hypersensitivity Types and Their Mechanisms
Type I
Immune reactant IgE IgG or IgM
BY NGILAY, OCTAVIO, RASGO
4. Idiosyncratic reaction
- An uncommon & abnormal response
to drug
- Usually due to genetic abnormality
- Affect drug metabolism & receptor
sensitivity
- Harmful/fatal, appear in low doses
- Ex. Anemia (hemolysis) by
antioxidant drugs (G6PD deficiency)
- Paralysis due to succinylcholine
(enzyme deficiency)
• Type C (chronic) Reactions
● associated with long-term use
● involves dose accumulation
● Well known,can be anticipated
● Adaptation occurs → discontinuation of drug
- e.g., phenacetin and interstitial
nephritis or antimalarials and ocular
toxicity
- Opoiods, alcohol, barbiturates
Classification-Type
• Type D (delayed) reactions
● delayed effects/onset (dose independent)
● Very rare
● Carcinogenicity (e.g., immunosuppressants)
● Teratogenicity (e.g., fetal hydantoin
syndrome)
- Types of allergic reactions (Gell & Coombs)
● Type I - immediate, anaphylactic (IgE)
- e.g., anaphylaxis with penicillins
● Type II - cytotoxic antibody (IgG, IgM)
- e.g., methyldopa and hemolytic
anemia
● Type III - serum sickness (IgG, IgM)
- antigen-antibody complex
- e.g., procainamide-induced lupus
● Type IV - delayed hypersensitivity (T cell)
- e.g., contact dermatitis
Type II Type III Type IV
IgG and IgM T cells
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Antigen form Soluble antigen Cell-bound antigen Soluble antigen Soluble or

cell-bound antigen

Mechanism of Allergen-specific IgG or IgM antibody Antigen-antibody Ty1 cells secrete

activation IgE antibodies bind binds to cellular complexes are cytokines, which
to mast cells via antigen, leading to deposited in activate
their Fe receptor. complement tissues. macrophages and
When the specific activation and cell Complement cytotoxic T cells.
allergen binds to lysis. IgG can also activation provides
the IgE, mediate ADCC with inflammatory
cross-linking of IgE cytotoxic T cells, mediators and
induces natural killer cells, recruits neutrophils.
degranulation of macrophages, and Enzymes released
mast cells. neutrophils. from neutrophils
damage tissue.

Examples of Local and systemic Red blood cell Post-streptococcal Contact dermatitis,
hypersensitivity anaphylaxis, destruction after glomerulonephritis, type | diabetes
reactions seasonal hay fever, transfusion with rheumatoid arthritis, mellitus, and
food allergies, and mismatched blood and systemic lupus multiple sclerosis
drug allergies types or during erythematosus
hemolytic disease
of the newborn.

_______________________________________________________________________________________

Common Causes of ADRs 4. Cardiovascular drugs* 9. CNS drugs*

5. Hypoglycemics
1. Antibiotics 6. Antihypertensives *account for 69% of fatal ADRs
2. Antineoplastics* 7. NSAID/Analgesics
3. Anticoagulants 8. Diagnostic agents
________________________________________________________________________________________
- laboratory test
Body Systems Commonly Involved - diagnostic procedure
3.) Medication order screening
1. Hematologic ● abrupt medication discontinuation
2. CNS ● abrupt dosage reduction
3. Dermatologic/Allergic ● orders for “tracer” or “trigger”
4. Metabolic substances
5. Cardiovascular ● orders for special tests or serum
6. Gastrointestinal drug concentrations
7. Renal/Genitourinary 4.) Spontaneous reporting
8. Respiratory 5.) Medication utilization review
9. Sensory ● Computerized screening
● Chart review and concurrent audits
ADR Detection
Preliminary Assessment
1.) Subjective report
● patient complaint Preliminary description of event:
2.) Objective report
● direct observation of event ● Who, what, when, where, how?
● abnormal findings ● Who is involved?
- physical exam
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● What is the most likely causative agent? Components of an ADR Report

- Is this an exacerbation of a
pre-existing condition? 1. Product name and manufacturer
- Alternative explanations / differential 2. Patient demographics
diagnosis 3. Description of adverse event and outcome
● When did the event take place? 4. Date of onset
● Where did the event occur? 5. Drug start and stop dates/times
● How has the event been managed thus far? 6. Dose, frequency, and method
7. Relevant lab test results or other objective
Determination of urgency: evidence
8. De-challenge and re-challenge information
● What is the patient’s current clinical status? 9. Confounding variables
● How severe is the reaction?
MEDWATCH 3500A
Appropriate triage: (degree of urgency) Acute:
ER,ICU,Poison Control) Reporting Form

Management Options https://www.accessdata.fda.gov/scripts/medwat

ch
1.) Discontinue the offending agent if:
● it can be safely stopped
● the event is life-threatening or
intolerable
● there is a reasonable alternative
● continuing the medication will further
exacerbate the patient’s condition

2.) Continue the medication (modified as

needed) if:
● it is medically necessary
● there is no reasonable alternative
● the problem is mild and will resolve
with time

3.) Discontinue non-essential medications

4.) Administer appropriate treatment

● e.g., atropine, benztropine, dextrose,
antihistamines, epinephrine,
naloxone, phenytoin, phytonadione,
protamine, sodium polystyrene
sulfonate, digibind, flumazenil,
corticosteroids, glucagon

5.) Provide supportive or palliative care

● e.g., hydration, glucocorticoids,
warm / cold compresses, analgesics
or antipruritics
MedWatch Online Voluntary Reporting Form
6.) Consider rechallenge or desensitization
Welcome

Health professionals, consumers and patients can

voluntarily report observed or suspected adverse events
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 CLIN PHARMACY & PHARMACOTHERAPEUTICS 1
for human medical products to FDA. Voluntary reporting
can help FDA identify unknown risk for approved
medical products. Reporting can be done through our
online reporting portal or by downloading, completing
and then submitting FDA Form 3500 (Health
Professional) or 3500B (Consumer/Patient) to
MedWatch: The FDA Safety Information and Adverse
Event Reporting Program.
While not mandatory, FDA encourages reporters to
provide their contact information in case FDA needs to
gather more information. Note that reporters can
request, within the report, FDA not release their contact
information to the manufacturer.
MedWatch Online now allows reporters to start a report
and complete it within 3 days. Reporters can save an
incomplete report and provide an email address to
receive instructions on how to complete & submit a
report with Report ID and Report Date.
Information You Should Report to MedWatch
● Unexpected side effects or adverse
events can include everything from skin
rashes to more serious complications.
● Product quality problems such as
information if a product isn't working
properly or if it has a defect.
● Product Use/Medication Errors that can
be prevented. These can be caused by
various issues, including choosing the
wrong product because of labels or
packaging that look alike or have similar
brand or generic names. Mistakes also can
be caused by difficulty with a device due to
hard-to-read controls or displays, which may
cause you to record a test result that is not
correct.
● Therapeutic failures. These problems can
include when a medical product does not
seem to work as well when you switch from
one generic to another.
Types of FDA Regulated Products You Can Report
Through MedWatch
● Prescription and over-the-counter
medicines including those administered in
a hospital or outpatient infusion centers.
● Biologics such as blood components,
blood/plasma derivatives, blood
transfusions, gene therapies, and human
cells and tissue transplants.
BY NGILAY, OCTAVIO, RASGO
● Medical devices such as diabetes
glucose-test kit, hearing aids, breast pumps,
and many more products.
● Combination products such as prefilled
drug syringe, auto-injectors, metered-dose
inhalers, contact lens coated with a drug
and nasal-spray.
● Special nutritional products such as
dietary supplements, medical foods and
infant formulas.
● Cosmetics such as moisturizers, makeup,
shampoos, conditioners, hair dyes and
tattoos.
● Food such as beverages and ingredients
added to foods.
Where to Report Other FDA Regulated Product
Safety Information
Other products that the FDA regulates such as
Tobacco Products, Vaccines and Animal/Livestock
medicine and feed utilize different reporting
pathways. It is recommended that reports
concerning these products be submitted directly to
the appropriate portals below.
● Tobacco, E-cigarettes or Vaping: Report
problems or adverse health events and
tobacco product problems, include problems
with e-cigarettes (also known as "vapes"),
e-liquids, heated tobacco products,
cigarettes, roll-your-own cigarettes, cigars,
little cigars, pipes, waterpipes (also known
as hookah), chewing tobacco, snuff, or
snus. Report issues to the Safety Reporting
Portal.
● Vaccines: Report vaccine events to the
Vaccine Adverse Event Reporting System
(VAERS) online at
https://vaers.hhs.gov/reportevent.html.
● Animal Drug, Device, Pet Food and
Livestock Feed Problems (pet food and
livestock feed): For information on how to
report visit
www.fda.gov/vetproductreporting.
Note that submissions for these products through
MedWatch will be accepted and directed to the correct
center or office.
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