Guidelines for the Regulatory Assessment of Medicinal Products for Use in Self-Medication
(2000; 31 pages) View the PDF document
Table of Contents
Close this folder1. Introduction
View the document2.4 Characteristics of self-medication
Open this folder and view contents3. General basis for regulatory assessment
Open this folder and view contents4. Collection and regulatory assessment of evidence for medicinal products intended for self-medication
View the documentAnnex
View the documentAcknowledgements

2.4 Characteristics of self-medication

Self-medication involves the use of medicinal products by the consumer to treat self-recognized disorders or symptoms, or the intermittent or continued use of a medication prescribed by a physician for chronic or recurring diseases or symptoms. In practice, it also includes use of the medication of family members, especially where the treatment of children or the elderly is involved.

In order to use a non-prescription product safely and effectively, the consumer must perform a number of functions normally carried out by a physician treating a patient with a prescription drug. These functions include accurate recognition of the symptoms, setting of therapeutic objectives, selection of a product to be used, determination of an appropriate dosage and dosage schedule, taking into account the person’s medical history, contraindications, concomitant diseases and concurrent medications, and monitoring of the response to the treatment and of possible adverse effects.

In the case of non-prescription medicinal products, all of the information required to permit safe and effective use must come from the labelling material, patient information texts, the individual’s previous personal experience, various sources of information in the media, advertising, and advice given by health care professionals.

Pharmacists in particular can play a key role in giving advice to consumers on the proper and safe use of medicinal products intended for self-medication. It is important, therefore, to take this role into account both in their training and in practice.

The rapid development of new technology, and especially the Internet and related communication systems, has opened up new possibilities for searching for information. This may eventually offer important new channels for the dissemination of knowledge on medicinal products, their characteristics and proper use in self-medication, although the quality of information may vary. It should be emphasized, however, that there are marked differences in opportunities to obtain access to this information between people with different socioeconomic and educational backgrounds and in different countries. Well-tested labelling designed for a particular cultural milieu can help to reduce these differences. However, it should not be used in a way that would limit the availability of the OTC product.

2.4.1 Potential benefits

The social and economic benefits of self-medication reflect the fact that it is voluntarily chosen by consumers for conditions where it seems preferable to them. It will usually be selected for use in symptoms and conditions which the user regards as sufficiently troublesome to need medicinal treatment but not to justify consulting a physician. Only if the condition fails to respond, persists or becomes more severe will professional medical help be sought. Accordingly, good self-medication should offer the individual consumer:

Efficacy: i.e. the product does what it is claimed to do;

Reliability and safety: the individual will often choose a product which experience has shown to be suitable. The scope and duration of self-medication can be kept within safe limits by appropriate selection of approved indications, labelling texts, dosage strengths and forms, and package sizes;

Product safety when used as recommended in the instructions;

Acceptable risk, even when used for a longer duration, at a higher dose, or somewhat differently than recommended in the instructions;

Wider availability of medicines;

Greater choice of treatment;

Direct, rapid access to treatment;

An active role in his or her own health care;

Self-reliance in preventing or relieving minor symptoms or conditions;

Educational opportunities on specific health issues (i.e. stop-smoking aids and products to treat heartburn);


Economy, particularly since medical consultations will be reduced or avoided;

At the community level, good self-medication can also provide benefits such as saving scarce medical resources from being wasted on minor conditions, lowering the costs of community-funded health care programmes (including prescription reimbursement systems), and reducing absenteeism from work due to minor symptoms.

2.4.2 Potential risks

Self-medication has a number of potential risks. In particular, the ordinary user will usually have no specialized knowledge of the principles of pharmacology or therapy, or of the specific characteristics of the medicinal product used. This results in certain potential risks for the individual consumer:

Incorrect self-diagnosis;

Failure to seek appropriate medical advice promptly;

Incorrect choice of therapy;

Failure to recognize special pharmacological risks;

Rare but severe adverse effects;

Failure to recognize or self-diagnose contraindications, interactions, warnings and precautions;

Failure to recognize that the same active substance is already being taken under a different name (products with different trademarks may have the same active ingredient);

Failure to report current self-medication to the prescribing physician (risk of double medication or harmful interaction);

Failure to recognize or report adverse drug reactions;

Incorrect route or manner of administration;

Inadequate or excessive dosage;

Excessively prolonged use;

Risk of dependence and abuse;

Risks at work or in sport;

Food and drug interactions;

Storage in incorrect conditions or beyond the recommended shelf-life;

At the community level, improper self-medication could result in an increase in drug-induced disease and in wasteful public expenditure;

It is important to realize that many of these risks are not unique to self-medication: they can also occur in the prescription situation, particularly, if the patient consults several physicians for the illness or lacks counselling during therapy;

In selecting the types of medicinal products that can be used for self-medication, the aim should be to exploit the benefits listed above and to minimize the risks.


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