MIDTERMS

PUBLIC HEALTH PHARMACY

PHARM 325

UNIT 3.1.2: PHARMACOEPIDEMIOLOGY

OUTLINE the rational and cost-effective use of drugs in the
I. Pharmacoepidemiology population, thereby improving health outcomes.
A. History o Rational: use of drug is appropriate
B. Etymology  In almost every aspect: appropriate
C. Definition drug given to a certain disease or
II. Key Points Related to Pharmacoepidemiology condition, use, indication, regimen,
A. Adverse Drug Reactions ROA, DF
B. Pharmacoepidemiological Research
 Good framework study: Drug Use
C. Aims of Pharmacoepidemiology
Evaluation (about rationality of Ds)
D. Role Players in Pharmacoepidemiology
 Treatment guidelines: specific
steps/procedures followed when using
I. PHARMACOEPIDEMIOLOGY medications
A. HISTORY OF PHARMACOEPIDEMIOLOGY  Ex. Before physicians choose a
 The driving forces why field of pharmacoepidemiology medicine, they follow specific
was developed. steps/algorithm (vital signs: BP,
THE 1937 ELIXIR SULFANILAMIDE INCIDENT PR, etc.; comorbid; best

F
 “Elixir of Sulfanilamide” recommended D)
 107 deaths (renal failure), 208 survivors  When selecting OTC drugs/non-
 Nonexistent FD&C Act and clinical trials Rx meds, ask and counsel
patients
THALIDOMIDE TRAGEDY
CK  Assess if medication is appropriate or
 Pregnant: Morning sickness, anti-nausea drug not for the patient
 Lack of teratogenic studies and pre-marketing
studies/clinical trials Pharmacists, prescribers, and patients have a
 Reports of limb abnormalities (phocomelia) responsibility in attaining rational use of drugs.

These incidents led to the creation of:
 1938: Food, Drug, and Cosmetic Act (FD&C)
O
o Requires a new drug to undergo Pre-Marketing
Studies
o Pre-marketing studies: Clinical Trials
 Post-Marketing Drug Studies
BL
o Cost-effective: giving the public a choice on
alternatives; affordability (money & resources)
 Generic and branded Ds have the
same content, dosage strength, and
efficacy
 Generic counterparts are cost-

effective to their branded alternatives

VIOXX® CONTROVERSY  Porta and Hartzema: The application of epidemiologic
 GN: Rofecoxib (NSAID knowledge, methods, and reasoning on the study of
the effects (beneficial and adverse) and use of drugs in
 MOA: Selective COX-2 inhibitor → inhibit prostacyclin →
human populations.
thrombotic events
 It is the bridge between Clinical Pharmacology and
 Reports of myocardial infarction and increased risk of
Epidemiology.
thrombotic events
 Happened in 2000s: did not drive the creation of FD&C
Act but made an impact in pharmacoepidemiology

B. ETYMOLOGY OF PHARMACOEPIDEMIOLOGY
 Greek words:
o Pharmakon: Drug
o Epi: Upon or Among
o Demos: People
o Logos: Study
C. DEFINITION OF PHARMACOEPIDEMIOLOGY
 One of the novel or new added topic in the curricula Figure 1. Pharmacoepidemiology, Epidemioogy, and Clinical
 Strom: The study of the use and effects of medications Pharmacology
in large number of people. o Pharmacology: the study of the effects of drugs.
o Epidemiology: diseases o Clinical Pharmacology/Pharmacotherapeutics: the
o PE: use and effects of drugs in a large # of study of concerned with the use of drugs in the
people treatment of diseases. Part of its task is to provide a
 WHO (2019): The study of the use and effects of drugs in risk-benefit assessment for the effects of drugs in
large number of people with the purpose of supporting patients.

BERNAS, M.A.B. 1
 UNIT 2: EPIDEMIOLOGY

II. KEY POINTS RELATED TO B. PHARMACOEPIDEMIOLOGICAL RESEARCH IN

PHARMACOEPIDEMIOLOGY PRACTICE
 Basic tasks done in pharmacoepidemiological studies. 1. EVALUATION OF SPECIFIC DRUG USE IN
A. ADVERSE DRUG REACTIONS (ADRs) CERTAIN CONDITIONS
 ADRs: reactions that are not yet written in the drug’s
packaging 2. PATTERNS OF DRUG USE, THAT IS, HOW IT IS
o Not yet known as effects of Ds
BEING USED – HOW MUCH, WHERE, WHEN,
 The harm that drugs can cause has led to the
AND BY WHOM
development of the field of Pharmacoepidemiology.
 All drugs have adverse effects  PE: both effects and use of Ds
o Pharmacoepidemiology will never succeed in  Prescribing frequency
preventing them. o What D is mostly prescribed by physicians?
o ADRs: Cannot be prevented o How physicians prescribe drugs?
 Pharmacoepidemiology can only detect them, hopefully o Is it rational prescribing?
early, and thereby educate health care providers and the 3. DRUG TAKING BEHAVIORS IN SOCIETY
public – leads the better medication use.  Self-medication practices, etc.
 Pharmacoepidemiology can contribute information about o How the community utilize their Ds?
drug safety and effectiveness that is not available from o The perceptions of people about Ds
pre-marketing studies, pharmacovigilance. C. AIMS OF PHARMACOEPIDEMIOLOGY
o Pharmacoepidemiological public health speaking:  World Health Organization (WHO) targets its
Able to identify ADRs through reporting pharmacoepidemiologic efforts to ensure quality, safety,
o Pharmacovigilance: Adverse Drug Reaction and efficacy of drugs.
Report
 Significant # of Ps manifesting ADRs → 1. Global trends in prescribing
Reported Pharmacovigilance centers/manuf 2. Appropriateness of Drug Use

F
companies → investigation → edit drug 3. Medication adherence
literature → include ADRs in package insert → 4. Lifestyle effects on drug therapy
inform prescribers → withdraw D, change D, 5. Special population (elderly, pediatric, etc.) drug therapy
side effects 6. Drug interactions (Combining two or more drugs, drug-
 Not detrimental: side effects (common,
CK food, etc.)
rare) 7. Predictable Adverse Drug Reactions (ADRs)
 Detrimental: withdrawal of D from the 8. Uncommon and unpredictable ADRs.
market
 Conducting pharmacoepidemiological studies D. ROLE PLAYERS IN
through ADR reporting is needed because PHARMACOEPIDEMIOLOGY
during clinical trials, limited number of patients
are taking the drug → limited scope/evidences
O
KEY ROLE PLAYERS IN PHARMACOEPIDEMIOLOGY
of D effects (ADRs and beneficial uses) CONSUMER OF
Patients
 Ex. Propranolol: indicated for CVDs, MEDICINES
hyperthyroidism, stage fright (anti-anxiety) PRESCRIBERS OF
Physicians
BL

 Added indication: infantile hemangioma MEDICINES

(but not assessed during clinical trials) RESERACHERS Pharmacoepidemiologists
 “Off-label” use: Physicians use Ds for a UNIVERSITIES Educational institutions
certain condition but not included in the PAYERS Government/Insurance/Other
package insert/not based on indications (under cost-effectiveness;
 Irrational use of Ds but later on, Propranolol Health Technology
innovator adapted the indication used by Assessment)
physicians off-label → Beneficial use POLICY MAKERS Administrators and regulators
 The net result of increased activity in (Health Technology
Pharmacoepidemiology will be better for the industry and Assessment)
academe but most importantly, for the public’s health.
 Rational drug use protects its obsolescence. Pharmacoeconomics can fall under
o Using drugs rationally will not make the drug Pharmacoepidemiology.
obsolete.
 Ex. Proper use of antimicrobial drugs
o By nature and certain factors/situations, drugs can Handout & Discussion: CPMataRPhMSPharm©2022
be obsolete.
 Discovery and development of more effective
drug than the existing ones (ex. antineoplastic
agents)
 Antimicrobial resistance

Introducing new developed drugs to the market are not

always effective. Clinical trials to identify effectiveness
must still be conducted and its economic side should be
checked (pharmacoeconomics health technology
assessment).

BERNAS, M.A.B. 2