Pharmacoepidemiology,

Pharmacoeconomics
F I F T H CHA PTER
DI MA T UME H
FACULTY OF MEDICINE, AAUP
DIMA.TUMEH@AAUP.EDU
Pharmacoepidemiology
➢is the study of the use, and effects, of drugs /medical devices in large numbers
of people.
➢This field represents the science of postmarketing medical product
surveillance, studies of the effects of medical products (i.e., drugs, biologicals,
devices) performed after a product has been approved for use.

➢• Pharmacoepidemiology originally arose from the union of the fields of clinical

pharmacology and epidemiology.
Pharmacoepidemiology versus clinical
pharmacology

• Pharmacology is the study of the effects of drugs.

• Clinical pharmacology is the study of the effects of drugs in humans
• Clinical pharmacology is traditionally divided into two basic areas:
pharmacokinetics and pharmacodynamics..
Pharmacoepidemiology versus
epidemiology
• Epidemiology: • Is the study of the distribution and determinants of diseases in
populations.
• Epidemiology is also traditionally subdivided into two basic areas:
1. The infectious diseases in large populations, i.e., epidemics.
2. It has since been expanded to encompass the study of chronic diseases.
➢Pharmacoepidemiology : Is the study of the use of and effects of
drugs and other medical devices in large numbers of people, it
obviously falls within epidemiology, as well.

➢Pharmacoepidemiology: Applies the methods of epidemiology to

the content area of clinical pharmacology
The current drug approval process
• Since the mid-1990s, there has been a decline in the number of novel drugs approved per year,
• Also the cost of bringing a drug to market has risen sharply.
✓The cost to discover and develop a drug that successfully reached the market rose from over
$800 million in 2004 to an estimated $1.3 billion to 1.7 billion currently
• The current drug approval process in most developed countries includes preclinical animal
testing followed by three phases of clinical testing.
Pharmacoeconomics
➢ Pharmacoeconomics may be defined as balancing the cost with the consequences (outcomes)
of pharmaceutical therapies and services.
➢ As a type of outcomes evaluation, pharmacoeconomics looks beyond just the direct or
acquisition cost of a pharmaceutical by including its impact on total health resource utilization
and costs
Orphan disease and drugs ,Fixed
dose combination, Principles of
prescription writing and OTC

SIXTH CHAPTER
DIMA TUMEH
FACULTY OF MEDICINE, AAUP
DIMA.TUMEH@AAUP.EDU
Orphan Drugs & Treatment of Rare
Diseases
➢Drugs for rare diseases—so-called orphan drugs—can be difficult to research,
develop, and market.

➢defined as “any disease or condition which

(a) affects less than 200,000 persons in the U.S. or
(b) affects more than 200,000 persons in the U.S. but for which there is no
reasonable expectation that the cost of developing and making available drug for
such disease or condition will be recovered from sales in the U.S. of such drug
What are the origins and characteristics of rare
diseases?

➢While nearly all genetic diseases are rare diseases, not all rare
diseases are genetic diseases. There are also very rare forms of
infectious diseases, such as auto-immune diseases and rare cancers.
To date, the cause remains unknown for many rare diseases.
Examples
❖Today, about 600 orphan drugs are approved by the U.S. Food and Drug Administration (FDA)
to treat these difficult and rare diseases.
❖Examples of orphan drugs include:
❖Ivacaftor: A therapy to treat cystic fibrosis, a genetic disorder that causes problems with
breathing and digestion and affects about 30,000 Americans.
❖Coagulation factor IX: A drug that helps prevent bleeding in people with hemophilia B.
❖Imatinib: An oncology therapy to treat certain types of leukemia.
❖Rucaparib: A treatment for ovarian cancer.
❖Orphan drugs are expensive for patients, since they are created for small populations. The
median annual cost for an orphan drug as of 2016 was over $32,000.
Fixed dose combination
(What is an FDC product?)
➢Combination medicines (or fixed-dose combination [FDC]
medicines) are: medicines containing two or more active
components in fixed proportions in a single dosage form

➢several medications in fixed combination to be taken together,

presented in composite packaging (co-pack).
As a rule:

1.two drugs to be combined should have approximately equal plasma

half life and
2.the ratio of doses of each component should depend on apparent
volume of distribution and plasma concentration.
EXAMPLE
amoxycillin(t ½-1-2hr,Vd-0.21L/kg) clavulanic acid (t ½-1-1.5hr,Vd-0.2 L/kg)
➢hence these can be combined in their standard dose regimen...i.e amoxycillin
500mg+clavulanic acid 125mg can be administered as 1 to 2 tab 8hrly
ADVANTAGES
➢ dose schedule and better patient compliance.
➢ Enhanced effect of the combinations e.g-oestrogen +progesterone.
➢ Minimisation of side effects E.g-levodopa+carbidopa
DISADVANTAGES
➢ The dose of any component cannot be adjusted independently.
➢ Pharmacokinetics must not be widely different.
➢ It becomes difficult to identify one particular drug which is causing harmful/beneficial effects.
➢There will be increase in price if unnecessary drugs are included. -e.g-
ibuprofen+paracetamol+caffeine
➢In FDC there is always a chance that individual medicines may not be present in adequate
amounts e.g-multivitamins
➢ Incompatible pharmacodynamics e.g- combination of antihistaminic and antidiarial is
dangerous as antihistaminic action may mask other symptoms.
 FDC product examples
Two or more medicines in single dosage form Individual dosage forms in a co-pack

•paracetamol 500 mg •esomeprazole 20 mg

•Chlorpheniramine •clarithromycin 500 mg

•Phenylephrine •amoxicillin 500 mg

•Nexium
Cold & Flu tablets
•Treatment of H pylori
Principles of Prescription Writing
Definition:
➢A prescription is a written, verbal, or electronic order from
a practitioner or designated agent to a pharmacist for a
particular medication for a specific patient.
➢Classes of Prescription:
• A. Precompounded : supplied by pharmaceutical company.
• B. Compounded:
Aspirin 6g, Acetaminophen 6g and Amobarbital 1 g: Mix and divide into 20
capsules 1 cap/qd
The “Five Rights” of
Medication Administration

Right drug
Right dose
Right time
Right route
Right patient
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Abbreviations
oTablets - tab
o Capsule – cap
o Syrup – syr
oSuspension – susp
o Injection – Inj
o Metered dose inhaler – as such
o Lotion – as such
•PO: by mouth
• PR: per rectum
• IM: intramuscular
• IV: intravenous
• ID: intradermal
• IN: intranasal
• TP: topical
• SL: sublingual
• BUCC: buccal
• IP: intraperitoneal
Controlled Substances
Narcotic prescription:
• Narcotic drugs (morphine, meperedine, heroin, cocaine). • A special form. • As in usual prescription
order.
• The quantity is written in numbers and in letters, in ink, and is not returned to the patient, kept by the
pharmacist.
• Policy in Prescription Writing:
• a. Never give a ready-written prescription.
• b. Write deliberately and without hesitation.
• c. Avoid re-writing a prescription.
• d. Do not converse with the patient while writing.
• e. Write in clear handwriting.
• f. Avoid erasing, crossing out and tearing up a prescription in the presence
of the patient.
OTC medications
➢are those drugs which are safe and effective for use by the general public
without a doctor’s prescription.
➢ These drugs are the non prescription or over-the-counter drugs.
➢ These have little significant pharmacological activity and therefore the
physician need not to be very much concerned about their use by the patients
themselves.
➢ It is used primarily for symptomatic relief and not as substitutes for
prescription drugs.
SIGNIFACANCE
• Comparatively cheaper
• An increased trend for self-care and increased tendency of patients to
maintain their own health
• Chemist himself may prescribe OTC
• OTC considered as time saving medications. Some patients do not want to
spend much time at physicians clinic.
• Lesser number of side effect compared to prescription medications.
➢ OTC drugs can change the effect of prescription medications.
➢ OTC drugs can mask symptoms of disease.
➢ OTC drugs can lead to overdose.
➢ If misused even common over-the-counter drugs, such as aspirin, vitamins, or
cold remedies can be harmful.
OTC medications
ANALGESICS
ANTIBIOTICS
COUGH SUPPRESSENTS
ANTI ACNE DRUGS
NSAIDS
ANTISEPTICS
DECONGESTANTS
ANTACIDS
ANTIFUNGALS
ANTI HISTAMINES
SMOKING CESSATION DRUGS