Policy Approaches for the Self-Medication Framework
The first key to developing a drug policy which includes self-medication
is to draw a distinction between products which require more active
involvement by a doctor or other qualified health professional for
safe and effective use - prescription medicines - and those that
are safe and effective for use by consumers on the basis of their
marketing authorizations and labeling (package labels or leaflets)
- nonprescription, or over-the-counter (OTC) medicines. WSMI advocates
this drug classification approach: It is taken by many countries,
including Japan, the US, Canada, and the EU as well as WHO with
two classes of medicines - prescription and nonprescription.
Defining and listing criteria under which a product must be
limited to prescription status, and where a product will have
nonprescription status, is crucial to the two-class system since
it governs legitimate public access and availability to medicines,
and frequently governs information for correct use.
One common criteria approach, such as that used by the EU, Canada,
and the US, has three key elements: (1) It starts with the premise
of nonprescription status, with prescription status specifically
defined. (2) Safety considerations weigh strongly - based on either
side effects, because the ingredient may be habit-forming, or
because of the dosage form a prescription is needed for safe use.
(3) They do not subdivide nonprescription products into categories
such as pharmacist or pharmacy-only, general sale, etc. While
some EU Member States subdivide nonprescription medicines, the
EU legislation does not.
Classification can be seen as part of the market authorization
or registration process, or as a separate process. In either case,
similar safety (including the assessment of risk), efficacy, and
quality considerations will apply. Further, specific product marketing
authorizations need not be seen as the sole method for product
registration. Category or ingredient monographs are alternatives,
if associated with quality controls.