Guidelines for the Regulatory Assessment of Medicinal Products for Use in Self-Medication
(2000; 31 pages) View the PDF document
Table of Contents
Open this folder and view contents1. Introduction
Close this folder3. General basis for regulatory assessment
View the document3.1 Established properties
View the document3.2 Approaches to regulatory assessment and supervision
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

3.2 Approaches to regulatory assessment and supervision

In the assessment of a medicinal product’s suitability for use in self-medication, at least the following five complementary aspects need to be considered:

(1) The active substance and the rationality of its indications;

(2) One or more specific routes of administration, dosage forms and formulations;

(3) Other specific safeguards;

(4) Suitability for self-medication status; and

(5) Labelling and package inserts and other information forming a basis for advertising and promotion.

Other aspects may require more specific additional consideration in the light of the pharmacological properties of the medicinal product, the intended indication, type of use, adverse effects or other characteristics, such as those relating to the social and environmental circumstances.

3.2.1 Consideration of the active substance and its indications

This will involve deciding whether the active compound itself is suitable and rational for self-medication. It should include the following aspects:

The purpose for which the product is indicated, i.e. whether the indication can be regarded as appropriate for self-diagnosis, self-medication and self-monitoring. Generally, such indications are widely experienced symptoms or disorders that are readily recognizable by ordinary consumers, or that are initially diagnosed by a doctor and are often self-limiting in nature;

Provision of reliable and consistent relief of symptoms;

Favourable benefit/risk ratio of the product; if the indications are minor, as they generally will be in self-medication, the benefit will be quickly outweighed by potential adverse effects that are other than minor;

The general toxicity, reproduction toxicity, genotoxicity and carcinogenicity of the compound with regard to its use in self-medication. In general, the drug must have a wide margin of safety, even if used incorrectly;

Its potential risks in comparison with prescription drugs that are commonly used in the same patient group;

Its mode of action and pharmacokinetics. In particular, the absorption, metabolism and excretion of the compound should not be affected by other commonly used drugs or display marked fluctuations between individuals because of concomitant diseases, interactions with food, or genetic or environmental factors (working conditions, climate, and so forth);

Low and well-documented risks in specific patient groups, for example in elderly people, during pregnancy and lactation, and in patients with impaired liver or kidney function;

The potential impact of widespread use on the levels of microbial resistance to antimicrobial medicines in the general population;

Low risk of masking symptoms of underlying serious disease, resulting in delays in proper diagnosis and treatment;

Acceptable level of risk from inappropriate use;

Low or well-characterized incidence of adverse effects or side-effects, and contraindications for which advice or counselling is easily available;

Drug dependence and abuse potential of the drug;

The existence of other dosage forms of the same active ingredient that have already been approved for OTC sale.

3.2.2 Consideration of one or more specific routes of administration, dosage forms and formulations

Since no active therapeutic substance is likely to be ideal in every way, it will usually be necessary to consider which specific presentations or formulations might be best suited to self-medication, since these can affect the medicinal product’s safety, efficacy and suitability in such use. For example, only preparations that can be administered in a manner not requiring technical expertise, assistance or patient training can be considered suitable for self-medication; thus, oral or topical preparations will generally be suitable, but injections will usually not. It may be desirable to avoid certain types of excipient, where they are known to affect certain patient groups adversely.

3.2.3 Consideration of other specific safeguards

The suitability of a substance for use in self-medication can be further affected by the feasibility of providing other specific safeguards, e.g. those related to:

(1) Dosage: Restricting the maximum single dose or maximum daily dose may protect against danger when the medicinal product is used either correctly or incorrectly.. However, it is necessary to confirm that the dose retains the necessary efficacy.

(2) Dosage strength: For children, specific dosage strengths suitable for paediatric use are preferable. For the adult population, consideration should be given to the need for several strengths, bearing in mind different uses and characteristics, though this should be balanced against any problem that may be encountered in selecting the proper dose.

(3) Dosage schedule: The recommended duration of treatment should prevent unnecessary prolonged use. If the symptoms fail to respond adequately or persist, medical attention/consultation is necessary.

(4) Package size: The package size should be limited to a reasonable number of doses in relation to the recommended duration of the treatment. This is necessary to safeguard against misuse, particularly overdose or undue delay in seeking medical attention. There may occasionally be a need for larger packages as an option in specific, designated situations or for prolonged use.

(5) Packing material and form: Medicinal products should have a container which as far as possible prevents children gaining access to the medicine if they get hold of the container.

3.2.4 Suitability for self-medication status

The potential benefit/risk characteristics of the medicinal product in self-medication should be set against its benefit/risk characteristics as a prescription product; it cannot be assumed that prescription status necessarily provides a greater guarantee of safety than non-prescription status. Where for example prescription status has been considered preferable because a physician can perform certain diagnostic or sensitivity tests before selecting the product, ensure good patient compliance, or take steps to avoid adverse effects or interactions, it is important to know whether in practice physicians can and do perform these tasks. If commonly they do not, the provision of the medicinal product in self-medication form with appropriate warning instructions may provide at least as great a measure of safety for the user. Similarly, in some countries a large number of medicinal products originally intended primarily for use under medical supervision are in fact widely sold without prescription. In such instances, recognition of the real self-medication situation and the introduction of appropriate safeguards (e.g. adapted package sizes and texts) may be more in the public health interest than the maintenance of a merely theoretical prescription status. The possibility of considering the reclassification of products to non-prescription status on the basis of experience in other countries should be borne in mind.

3.2.5 Consideration of labelling and package inserts

Adequate information on the appropriate use of medicinal products should always accompany the product. Further guidance for self-medication can be provided by health care professionals.

An important consideration is whether the medicinal product and its uses are such that accompanying texts (information, advice and warnings) can be devised that will be sufficiently clear and complete to enable the consumer to use the product safely, effectively and in a rational way.

When package inserts or leaflets are required by governments, manufacturers or distributors should ensure that they reflect only the information that has been approved by the country’s drug regulatory authority. If package inserts or leaflets are used for promotional purposes, they should comply with the WHO Ethical Criteria for Medicinal Drug Promotion set out later in this section.

In addition to approved package inserts and leaflets wherever available, the preparation and distribution of booklets and other informational material for patients and consumers should be encouraged as appropriate. If such material is promotional, it should comply with the WHO Ethical Criteria mentioned above.

Information for the consumer should be easily understandable and in accordance with national legislation; for self-medication products it is particularly important that the written text is comprehensible to the lay person. In general, it is helpful for sufficient information to appear on the outer packaging to allow consumers to make a decision about suitability of the product before purchase. This is of particular importance where advice from health care professionals is not readily accessible. The following aspects of labelling and package inserts should be considered:

The consumer information should be simple and not open to misinterpretation; The fact that the item is a medicinal product should be clearly indicated; The composition of the product (generic name of active substance) should be stated; The uses for which the product is intended should be indicated;

The mode of use should be specified, including the route of administration (systemic or local), maximum single dose, maximum daily dose and duration of the treatment;

It should be clearly indicated whether the product is intended for children or adults;

The most important precautions, contraindications and adverse effects should be clearly presented in lay terms;

Specific warnings and information should be provided for use during pregnancy or lactation, by the elderly, or in patients with renal or hepatic failure, where appropriate;

The circumstances in which medical advice should be sought and the duration of use should be described if appropriate;

Information on storage conditions and shelf-life should be provided;

It may be helpful to describe other measures the patient should take to control symptoms (e.g. for a histamine H2-receptor antagonist, other ways to reduce heartburn);

Inactive ingredients, which may be allergenic, should be listed;

It may be useful to provide information on the expected benefit when the drug is properly used;

The use of pictograms should be considered.

A model list of drug information for a self-medication product is provided in Annex 1. Advertising and promotion

Approval of product information relating to a medicine is an important part of the assessment of suitability for self-medication. Advertising and promotion should always be consistent with this approved information. However, the compliance of advertising with product information can normally be judged only after self-medication status has been approved.

Although these do not constitute guidelines for the classification of medicinal products, the following extracts from the WHO Ethical Criteria are included for reference purposes.

In May 1988, in resolution WHA41.17, the Forty-first World Health Assembly endorsed in 1988, WHO’S Ethical Criteria for Medicinal Drug Promotion. It also appealed to pharmaceutical manufacturers and distributors, the promotion industry, health personnel involved in the prescription, dispensing, supply and distribution of drugs, universities and other teaching institutions, professional associations, patient and consumer groups, the professional and general media (including publishers and editors of medical journals and related publications), and the public:

(1) to use these criteria as appropriate to their spheres of competence, activity and responsibility;

(2) to adopt measures based on these criteria as appropriate, and monitor and enforce their standards. Advertisements in all forms to the general public

14. Advertisements to the general public should help people to make rational decisions on the use of drugs determined to be legally available without a prescription. While they should take account of people’s legitimate desire for information regarding their health, they should not take undue advantage of people’s concern for their health. They should not generally be permitted for prescription drugs or to promote drugs for certain serious conditions that can be treated only by qualified health practitioners, for which certain countries have established lists. To fight drug addiction and dependency, scheduled narcotic and psychotropic drugs should not be advertised to the general public. While health education aimed at children is highly desirable, drug advertisements should not be directed at children. Advertisements may claim that a drug can cure, prevent, or relieve an ailment only if this can be substantiated. They should also indicate, where applicable, appropriate limitations to the use of the drug.

15. When lay language is used, the information should be consistent with the approved scientific data sheet or other legally determined scientific basis for approval. Language which brings about fear or distress should not be used.

16. The following list serves as an illustration of the type of information advertisements to the general public should contain, taking into account the media employed:

• the name(s) of the active ingredient(s) using either international nonproprietary names (INN) or the approved generic name of the drug;

• the brand name;

• major indication(s) for use;

• major precautions, contraindications and warnings;

• name and address of manufacturer or distributor.

Information on price to the consumer should be accurately and honestly portrayed. Free samples of non-prescription drugs to the general public for promotional purposes

21. Countries vary in their practices regarding the provision of free samples of non-prescription drugs to the general public, some countries permitting it, some not. Also, a distinction has to be made between provision of free drugs by health agencies for the care of certain groups and the provision of free samples to the general public for promotional purposes. The provision of free samples of non-prescription drugs to the general public for promotional purposes is difficult to justify from a health perspective. If this practice is legally permitted in any country, it should be handled with great restraint.

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