Official drug information
The development of the pharmaceuticals brought a revolution in human health.
These pharmaceuticals would serve their intent only if they are free from impurities
and are administered in an appropriate amount. To make drugs serve their purpose
various chemical and instrumental methods were developed at regular intervals
which are involved in the estimation of drugs. These pharmaceuticals may develop
impurities at various stages of their development, transportation and storage
which makes the pharmaceutical risky to be administered thus they must be
detected and quantitated. For this analytical instrumentation and methods play an
important role.
Classification of Information Sources
Drug information sources have been traditionally classified in three different
categories: primary, secondary, and tertiary.
➢ Primary sources
Primary literature consists of clinical research studies and reports, both published
and unpublished. Not all literature published in a journal is classified as primary
literature, for example, review articles or editorials are not primary literature.
➢ Secondary sources
Secondary literature refers to references that either index or abstract the primary
literature, with the goal of directing the user to relevant primary literature.
➢ Tertiary sources
Tertiary sources provide information that has been summarized and distilled by the
author or editor to provide a quick easy summary of a topic. Some examples of
tertiary resources include textbooks, compendia, review articles in journals, and
other general information, such as may be found on the Internet.
Compendium
A compendium is defined “as a comprehensive listing of the Food and Drug
Administration-approved drugs and biologicals (or a comprehensive listing of a
specific subset of drugs and biologicals in a specialty compendium - for example, a
compendium of anti-cancer treatment).”
A compendium is a compilation of knowledge about a particular subject
(“compendia” is plural and “compendial” is an adjective). This collection of
knowledge plays a critical role in protecting public health, especially for medicines
and other aspects of healthcare. Compendia of pharmaceutical knowledge also
may be referred to as “pharmacopeia,” and nearly every country has designated at
least one as the basis for consistent drug manufacturing.
Examples of compendia
1. U.S. Pharmacopeia-National Formulary (USP-NF)
2. Food Chemicals Codex (FCC)
3. Dietary Supplements Compendium (DSC)
4. Herbal Medicines Compendium (HMC)
5. Compounding Compendium
Pharmacopoeia
By dictionary definition
A pharmacopoeia is an official book that lists all the drugs that can be used to treat
people in a particular country and describes how to use them.
WHO definition
A pharmacopoeia is a legally binding collection of standards and quality
specifications for medicines used in a country or region. Within the pharmacopoeia,
a quality specification is a set of appropriate tests that will confirm the identity and
purity of the product, ascertain the strength (or amount) of the active substance
and, when needed, the performance characteristics.
A pharmacopoeia also covers pharmaceutical starting materials, excipients,
intermediates and finished pharmaceutical products (FPPs). General requirements
may also be given on important subjects related to medicines quality, such as
analytical methods, microbiological purity, dissolution testing, or stability.
International pharmacopoeia can be accessed at
https://apps.who.int/phint/en/p/docf/
Role of pharmacopoeia
The role of a modern pharmacopoeia is to furnish quality specifications for active
pharmaceutical ingredients (APIs), FPPs and general requirements. The existence
of such specifications and requirements is necessary for the proper functioning or
regulatory control of medicines production. Pharmacopoeial requirements form a
basis for establishing quality requirements for individual pharmaceutical
preparations.
Monograph
A monograph includes the name of the ingredient or preparation; the definition;
packaging, storage, and labeling requirements; and the specification. The
specification consists of a series of tests, procedures for the tests, and acceptance
criteria.
In a broader sense, pharmacopoeia is a reference work for pharmaceutical drug
specifications. Descriptions of preparations are called monographs. A monograph
is a paper on a single topic.
Formulary
A drug formulary is a list of generic and brand-name prescription drugs for a
particular organization or institute. It is generally created by forming a pharmacy
and therapeutics committee consisting of pharmacists and physicians from various
medical specialties. This committee evaluates and selects new and existing
medications for the formulary. The selections are based on each drug’s therapeutic
class, which is a group of medications known to treat a particular health condition.
