Adopted by the 53rd WMA General Assembly, Washington, DC, USA, October 2002
and reaffirmed by the 191st WMA Council Session, Prague, Czech Republic, April 2012
The World Medical Association has developed this statement to provide guidance to physicians and their patients regarding responsible self-medication.
- Distinction between Self-Medication and Prescription Medicine
- Medicinal products can generally be divided into two separate categories: prescription and non-prescription medicines. This classification may differ from country to country. The national authorities must assure that medicines, categorized as non-prescription medicines, are sufficiently safe not to be harmful to health.
- Prescription medicines are those which are only available to individuals on prescription from a physician following a consultation. Prescription medicines are not safe for use except under the supervision of a physician because of toxicity, other potential or harmful effects (e.g. addictiveness), the method of use, or the collateral measures necessary for use.
- Responsible self-medication, as used in this document, is the use of a registered or monographed medicine legally available without a physician’s prescription, either on an individual’s own initiative or following advice of a healthcare professional. The use of prescription medicines without a prior medical prescription is not part of responsible self-medication.
- The safety, efficacy and quality of non-prescription medicines must be proved according to the same principles as prescription medicines.
- Use of Self-Medication in conjunction with Prescription Medication A course of treatment may combine self-medication and prescription medication, either concurrently or sequentially. The patient must be informed about possible interactions between prescription medicines and non-prescription medicines. For this reason the patient should be encouraged to inform the physician about his / her self-medication.
- Roles & Responsibilities in Self-Medication
- In self-medication the individual bears primary responsibility for the use of self-medication products. Special caution must be exercised when vulnerable groups such as children, elderly people or pregnant women use self-medication.
- If individuals choose to use self-medication, they should be able:
- to recognize the symptoms they are treating;
- to determine that their condition is suitable for self-medication;
- to choose an appropriate self-medication product;
- to follow the directions for use of the product as provided in the product labelling.
- In order to limit the potential risks involved in self-medication it is important that all health professionals who look after patients should provide:
- Education regarding the non-prescription medicine and its appropriate use, and instructions to seek further advice from a physician if they are unsure. This is particularly important where self-medication is inappropriate for certain conditions the patient may suffer from;
- Encouragement to read carefully a product’s label and leaflet (if provided), to seek further advice if necessary, and to recognize circumstances in which self-medication is not, or is no longer, appropriate.
- All parties involved in self-medication should be aware of the benefits and risks of any self-medication product. The benefit-risk balance should be communicated in a fair, rational manner without overemphasizing either the risks or the benefits.
- Manufacturers in particular are obliged to follow the various codes or regulations already in place to ensure that information provided to consumers is appropriate in style and content. This refers in particular to the labelling, advertising and all notices concerning non-prescription medicines.
- The pharmacist has a professional responsibility to recommend, in appropriate circumstances, that medical advice be sought.
- Role of Governments in Self-Medication Governments should recognize and enforce the distinction between prescription and non-prescription medicines, and ensure that the users of self-medication are well informed and protected from possible harm or negative long-term effects.
- The Promotion and Marketing of Self-Medication Products
- Advertising and marketing of non-prescription medicines should be responsible, provide clear and accurate information and exhibit a fair balance between benefit and risk information. Promotion and marketing should not encourage irresponsible self-medication, purchase of medicines that are inappropriate, or purchases of larger quantities of medicines than are necessary.
- People must be encouraged to treat medicines (prescription and non-prescription) as special products and that standard precautions should be followed in terms of safe storage and usage, in accordance with professional advice.