WHO Ethical Criteria on Drug Promotion PDF

WHO Ethical Criteria on Drug Promotion Presented By Sagar Jung Kunwar  1. Promotion of Drugs In this context, "promotion" refers to all informational and persuasive activities by manufacturers and distributors, the effect of which is to induce the prescript...

WHO Ethical Criteria on Drug Promotion Presented By Sagar Jung Kunwar  1. Promotion of Drugs In this context, "promotion" refers to all informational and persuasive activities by manufacturers and distributors, the effect of which is to induce the prescription, supply, purchase and/or use of medicinal drugs. All promotion-making claims concerning medicinal drugs should be reliable, accurate, truthful, informative, balanced, up-to-date, capable of substantiation and in good taste. They should not contain misleading or unverifiable statements or omissions likely to induce medically unjustifiable drug use or to give rise to undue risks. The word "safe" should only be used if properly qualified. Comparison of products should be factual, fair and capable of substantiation. Promotional material should not be designed so as to disguise its real nature.  Scientific data in the public domain should be made available to prescribers and any other person entitled to receive it, on request, as appropriate to their requirements. Promotion in the form of financial or material benefits should not be offered to or sought by health care practitioners to influence them in the prescription of drugs. Scientific and educational activities should not be deliberately used for promotional purposes.  2. Advertisements in all forms to physicians and health-related professionals The wording and illustrations in advertisements to physicians and related health professionals should be fully consistent with the approved scientific data sheet for the drug concerned or other source of information with similar content. The text should be fully legible. Advertisements that make a promotional claim should at least contain summary scientific information Where advertisements are permitted without claims (reminder advertisements), they ought to include at least the brand name, the international nonproprietary name or approved generic name, the name of each active ingredient, and the name and address of the manufacturer or distributor for the purpose of receiving further information.  3. Advertisements in all forms to the general public 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.  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 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.  4. Medical representatives Medical representatives should have an appropriate educational background. They should be adequately trained. They should possess sufficient medical and technical knowledge and integrity to present information on products and carry out other promotional activities in an accurate and responsible manner. Employers are responsible for the basic and continuing training of their representatives. Medical representatives should not offer inducements to prescribers and dispensers. Prescribers and dispensers should not solicit such inducements. In order to avoid over-promotion, the main part of the remuneration of medical representatives should not be directly related to the volume of sales they generate.  5. Free samples of prescription drugs for promotional purposes Free samples of legally available prescription drugs may be provided in modest quantities to prescribers, generally on request. 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.  6. Symposia and other scientific meetings The fact of sponsorship by a pharmaceutical manufacturer or distributor should be clearly stated in advance, at the meeting and in any proceedings. The latter should accurately reflect the presentations and discussions. Entertainment or other hospitality, arid any gifts offered to members of the medical and allied professions, should be secondary to the main purpose of the meeting and should be kept to a modest level.  7. Post-marketing scientific studies. surveillance and dissemination of information Post-marketing scientific studies and surveillance should not be misused as a disguised form of promotion. Substantiated information on hazards associated with medicinal drugs should be reported to the appropriate national health authority as a priority, and should be disseminated internationally as soon as possible  8. Packaging and labelling Appropriate information being important to ensure the rational use of drugs, all packaging and labelling material should provide information consistent with that approved by the country's drug regulatory authority. Where one does not exist or is rudimentary, such material should provide information consistent with that approved by the drug regulatory authority of the country from which the drug is imported or other reliable sources of information with similar content. Any wording and illustration on the package and label should conform to the principles of ethical criteria enunciated in this document  9. Information for patients : package inserts. leaflets and booklets 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 ethical criteria. The wording of the package inserts or leaflets, if prepared specifically for patients, should be in lay language on condition that the medical and scientific content is properly reflected.  10. Promotion of exported drugs Ethical criteria for the promotion of exported drugs should be identical with those relating to drugs for domestic use. It is desirable that exporting and importing countries that have not already done so should use the WHO Certification Scheme on the Quality of Pharmaceutical Products Moving in International Commerce. Gracias