Module 1 Pharma

Drugs

Drugs

are chemical substances that affect living organisms

Pharmacology

is the study which is concerned with the sources, physical and chemical properties of drugs as well as ways in which drugs affect living organisms.

Pharmacokinetics

is the process of drug movement throughout the body to achieve drug action

Pharmacodynamics

is the mechanism of action and effects of \n a drug on the body; includes onset, peak and duration of drug

Pharmacogenetics

is the study genetic factors that influence \n an individual’s response to a specific drug

Sources of Drugs

1. Plants

2. Animal products

3. Inorganic compounds

4. Synthetic sources and excipients of drugs

standardization of drugs / Regulation of drugs

• Pharmacopeia around the world- a book of drugs developed by doctors and pharmacists containing description, formulation, analytic compositions, chemical properties, standards for strength, purity and dosage as per government jurisdiction. Interchangeably termed as formulary; started 1820 in US; 2004 in Philippines \n ● Drug Formulary of the Philippines – book published in 2004 and 2008 \n ● FDA – every country have their own FDA and may have varying regulations such as use of marijuana

1988 Generics Act of the Philippines Policy (RA No. 6675)

1. To promote, encourage and require the use of generic \n terminology in the importation, manufacture, distribution, \n marketing, advertising and promotion, prescription and \n dispensing of drugs; \n 2. To ensure the adequate supply of drugs with generic names \n at the lowest possible cost and endeavor to make them \n available for free to indigent patients; \n 3. To encourage the extensive use of drugs with generic names \n through a rational system of procurement and distribution; \n 4. To emphasize the scientific basis for the use of drugs, in \n order that health professionals may become more aware and \n cognizant of their therapeutic effectiveness; and \n 5. To promote drug safety by minimizing duplication in \n medications and/or use of drugs with potentially adverse \n drug interactions

Philippine Food and Drug Administration Act of 2009 (RA No. 9711)

1. protect and promote the right to health of the Filipino people \n 2. help establish and maintain an effective health products \n regulatory system and undertake appropriate health \n manpower development and research, responsive to the \n country’s health needs and problems

Philippine Comprehensive Dangerous Drug Act of 2002 (RA No. 9165)

to safeguard the integrity of its territory and the well-being of its \n citizenry particularly the youth, from the harmful effects of \n dangerous drugs on their physical and mental well-being, and to \n defend the same against acts or omissions detrimental to their \n development and preservation

Phases of Clinical Trial:

1. Drug target

2. Pre-clinical assessment

3. Clinical assessment

   • Phase I

   • Phase II

   • Phase III

4. post marketing strategies

Drug target

basic research, understanding the drug target pathophysiology

Pre-clinical assessment

phase of studying pharmacology and toxicology; animal assays and ADME

Phase I

test in a small group of human volunteers for the 1st \n time to evaluate safety, safe dosage and side effects (20-100 \n samples)

Phase II

given to larger group for further evaluation of effects for safety and efficacy(100 – 300 samples)

Phase III

larger group to confirm effectiveness, monitor side effects, compare with other treatment, get more data on efficacy and side effects for safer use (1000-5000 samples)

Post-marketing surveillance

gather information in various populations and assess side effects associated with long-term use

Pregnancy Categories

1. Category A

2. Category B

3. Category C

4. Category D

5. Category X

Category A

no risks based on human studies (during 1st trimester)

Category B

no risks in animal studies (no adequate studies on humans

Category C

risks cannot be ruled out (animal studies show risks to fetus but no adequate studies on humans

Category D

risk for fetal abnormalities (benefit should outweigh the risks)

Category X

contraindicated (risks outweigh the benefit)

Drugs according to regulation

1. Schedule 1 (S1) drugs

2. Schedule 2 (S2) drugs

3. Schedule 3 (S3) drugs

4. Schedule 4 (S4) drugs

5. Schedule 5 (S5) drugs

Schedule 1 (S1) drugs

no current medical use with high potential for abuse

Schedule 2 (S2) drugs

with acceptable medical use with high potential for abuse; regulated and prescribed by certified S2 doctors only

Schedule 3 (S3) drugs

prescription drugs; with acceptable medical use with low to moderate potential for abuse with some addictive possibility

Schedule 4 (S4) drugs

drugs with low probability of misuse of or abuse

Schedule 5 (S5) drugs

drugs with lower probability of misuse of or abuse than S4; some may be acquired over-the-counter

Therapeutic class

group of drugs with similar pathology or disease being treated. Example: antacids, antibiotics, antihypertensive, diuretics, or laxatives

Pharmacologic class

group of drugs with shared mechanism of action, chemical properties and physiologic effects. Example: Cephalosphorins, MAO inhibitors, Gamma amino- butyric acid, Anti-CMV agents