PHARMACOLOGY  USP-NF

Unit I: Fundamental Concepts of Pharmacology  It is the most comprehensive source for medicine
B. Drug Standards and Drug Information quality standards in the world.
 Quality Standards
Learning Outcomes 1. Monographs articulate the quality
❖Integrate knowledge of physical, social, natural, and health expectations for a medicine. They also
sciences, and humanities in nursing pharmacology describe the tests to validate that a medicine
❖Apply appropriate nursing concepts and actions holistically and its ingredients meet these criteria.
and comprehensively 2. General Chapters
3. Material Reference Standards
I. Drug Standards
II. Drug Information
Ensure that the medicine is safe, effective, and acceptable
Current, critically examined, relevant data about drugs
to the patient.
and drug use in a given patient in a particular situation.
Quality
Classification
 Identity: The correct active ingredient is present.
 Primary Source: Unpublished studies, original
 Purity: The medicine is not contaminated with
articles published in peer-reviewed journals reporting
potentially harmful substances.
original research, ideas or opinions.
 Potency: The correct amount of active ingredient is
 Secondary Source: Indexing and abstracting systems
present.
that organize and provide easy retrieval of primary
 Uniformity: Consistency of, shape, and size of the
resources.
dosage form do not vary.
 Tertiary Source: Summarizes data from primary
 Stability: The activity of the medicine is ensured for
literature and they include reference books, drug
the period of time stated on the product label, that is,
compendia, essential drugs list, treatment guidelines,
until the expiration date.
drug formularies, drug bulletins and pharmacopoeias
Sources of Drug Standards

 Pharmacopoeia
 A legally binding collection, prepared by a
national or regional authority, of standards and
quality specifications for medicines used in that
country or region.

e.g., British Pharmacopoeia (UK)

United States Pharmacopoeia (USA)
Pharmacopoeia of the People’s Republic of
China (China)

⁕ The International Pharmacopoeia

 It is issued by WHO as a recommendation
with the aim to provide international standards
to help achieve a potentially global uniformity
of quality specifications for selected
pharmaceutical products, excipients, and
dosage forms.
 Formulary
 A manual containing clinically oriented
summaries of pharmacological information about
selected drugs. It may also include administrative
and regulatory information pertaining to the
prescribing and dispensing of drugs.

e.g., Philippine National Drug Formulary

⁕ The National Formulary

 It generally concentrates on available and
affordable medicines that are relevant to the
treatment of diseases in a particular country.