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:
- It starts with the premise of nonprescription status, with prescription status specifically defined.
- 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.
- They do not subdivide nonprescription products into categories such as pharmacist or pharmacy-only, general sale, etc.
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.