Adopted by the 53rd WMA General Assembly, Washington, DC, USA, October 2002
Reaffirmed by the 191st WMA Council Session, Prague, Czech Republic, April 2012
and reaffirmed with minor revisions by the 221st WMA Council Session, Berlin, Germany, October 2022
This statement aims to provide guidance on responsible self-medication.
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 or other authorized health professionals following a consultation. Prescription medicines are not safe for use except under the supervision of the health professional 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 referred 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.
- Given the risk of using unprescribed medicine and/or irresponsible self-medication, the WMA recommends the following:
- Patients should inform their physicians or other healthcare professionals concerned whenever they self-medicate in conjunction with other prescribed 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 health professional about his / her 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.
For health professionals
- Physicians and other health professionals concerned must educate patients about the potential risks involved in self-medication and its appropriate use, and instructions them to seek further medical advice if they are unsure. This is particularly important where self-medication is inappropriate for certain conditions the patient may suffer from.
- Information to the patients should include a warning against pseudoscience and pseudo therapies, which have no scientific basis, as stated in the WMA Declaration on Pseudoscience and Pseudotherapies in the field of health.
- Health professionals should encourage patients to carefully read 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.
- Pharmacists have a professional responsibility to recommend that patients seek medical attention, especially when in case of symptoms that warrant them to do so or if patients ask for medication that can be only be given to them after prescription.
- Health professionals should seek to identify potentially relevant self-medication during medical consultations, drug dispensing at the pharmacy and during home-based nursing interventions.
For other stakeholders
- 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.
- Manufacturers 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.
- 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.
- Pharmacovigilance for self-medication should be organized and reinforced by both governments and the industry to control the risks associated with self-medication.
- All parties involved in self-medication should treat medicines (prescription and non-prescription) as special products. Standard precautions should be followed in terms of safe storage and usage, in accordance with professional advice.
- 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.