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Questions and Answers
What should be avoided when advertising drugs?
What should be avoided when advertising drugs?
What is a requirement for medical representatives?
What is a requirement for medical representatives?
Which of the following drugs should not generally be advertised to the public?
Which of the following drugs should not generally be advertised to the public?
Which statement about the provision of free samples of prescription drugs is true?
Which statement about the provision of free samples of prescription drugs is true?
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How should advertisements convey claims about drug effectiveness?
How should advertisements convey claims about drug effectiveness?
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What policy should be in place regarding the remuneration of medical representatives?
What policy should be in place regarding the remuneration of medical representatives?
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Which of the following statements about drug promotion is NOT true?
Which of the following statements about drug promotion is NOT true?
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What is a responsibility of employers regarding medical representatives?
What is a responsibility of employers regarding medical representatives?
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What is a requirement for advertisements directed at physicians?
What is a requirement for advertisements directed at physicians?
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Which of the following practices is discouraged in drug promotion?
Which of the following practices is discouraged in drug promotion?
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What should be clearly stated during symposia sponsored by pharmaceutical companies?
What should be clearly stated during symposia sponsored by pharmaceutical companies?
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What must reminder advertisements include?
What must reminder advertisements include?
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What is the expected outcome of advertisements directed at the general public?
What is the expected outcome of advertisements directed at the general public?
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Scientific and educational activities should be utilized for which purpose in drug promotion?
Scientific and educational activities should be utilized for which purpose in drug promotion?
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What aspect of drug promotion must be capable of substantiation?
What aspect of drug promotion must be capable of substantiation?
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Which statement is essential regarding comparisons of medicinal products in promotions?
Which statement is essential regarding comparisons of medicinal products in promotions?
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What should be the priority when reporting hazards associated with medicinal drugs?
What should be the priority when reporting hazards associated with medicinal drugs?
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How should packaging and labeling information for drugs be aligned?
How should packaging and labeling information for drugs be aligned?
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What is the ethical standard for the promotion of exported drugs?
What is the ethical standard for the promotion of exported drugs?
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What must package inserts or leaflets comply with when used for promotional purposes?
What must package inserts or leaflets comply with when used for promotional purposes?
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Which of the following practices is discouraged in post-marketing scientific studies?
Which of the following practices is discouraged in post-marketing scientific studies?
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What type of language should be used in package inserts aimed at patients?
What type of language should be used in package inserts aimed at patients?
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If a country's drug regulatory authority is rudimentary, how should packaging materials be handled?
If a country's drug regulatory authority is rudimentary, how should packaging materials be handled?
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What role do gifts and entertainment play in meetings with medical professionals?
What role do gifts and entertainment play in meetings with medical professionals?
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Study Notes
WHO Ethical Criteria on Drug Promotion
- Drug promotion encompasses all activities aiming to increase prescription, supply, purchase, or use of medicinal drugs by manufacturers and distributors.
- Promotional claims must be reliable, accurate, truthful, informative, balanced, up-to-date, and justifiable.
- Claims should avoid misleading or unverifiable statements, or omissions that might encourage inappropriate drug use.
- The term "safe" requires qualification.
- Product comparisons should be factual, fair, and justifiable.
- Promotional materials should not hide their true nature.
Advertisements for Physicians and Health Professionals
- Advertisements must adhere to approved scientific data sheets and similar information resources.
- Promotional claims should include summary scientific information.
- Reminder advertisements must include brand name, international nonproprietary name/generic name, active ingredients, and manufacturer/distributor details.
Advertisements for the General Public
- Advertisements should encourage rational decisions regarding legally available drugs.
- They should acknowledge public interest in health information without exploiting it.
- Prescription drugs and those for serious conditions requiring qualified professionals are generally not allowed.
- Scheduled narcotics and psychotropics should not be advertised to the general public for addiction/dependency reduction.
Scientific Data and Information
- Scientific data in the public domain must be accessible to prescribers and others.
- Financial or material incentives to influence prescription decisions are prohibited.
- Scientific and educational activities should not be used for promotion.
Medical Representatives
- Medical representatives require proper training and sufficient medical/technical knowledge.
- They must maintain integrity and present information accurately and responsibly.
- Employers are accountable for basic and continuing training of their representatives.
- Incentives to prescribers or dispensers are disallowed.
- Representative compensation should not be heavily reliant on sales volume.
Free Samples of Prescription Drugs
- Free samples of legally available prescription drugs may be provided to prescribers in modest quantities.
- Free samples of non-prescription drugs for promotion to the public are not easily justifiable health-wise.
Symposia and Scientific Meetings
- Sponsorship of symposia and meetings by pharmaceutical companies must be disclosed.
- Meeting proceedings and presentations should reflect the subject matter accurately.
- Entertainment and hospitality should be modest.
Post-Marketing Studies and Surveillance
- Post-marketing studies and surveillance should not be disguised promotional activities.
- Confirmed information about drug hazards must be promptly reported to the appropriate national health authority and disseminated internationally.
Packaging and Labeling
- Packaging and labeling information should comply with approved country standards.
- When local standards are absent or weak, information should align with the regulations of the drug's origin country or similar credible sources.
- All material must conform to the ethics guidelines.
Information for Patients (Package Inserts, Leaflets, Booklets)
- Package inserts/leaflets must be consistent with the country's drug authority guidelines, reflecting only approved information.
- If used for promotional purposes, package inserts/leaflets must comply with ethical criteria.
- Patient-oriented materials should be in clear, accessible lay language, while maintaining medical accuracy.
Promotion of Exported Drugs
- Ethical criteria for promoting exported drugs should mirror domestic drug promotion standards.
- Use of the WHO Certification Scheme for Pharmaceuticals in international commerce is encouraged.
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Description
This quiz explores the WHO's ethical guidelines for drug promotion, emphasizing the importance of accurate and truthful advertising practices. It covers essential criteria for promotional claims, comparisons, and the responsibilities of advertisers towards health professionals. Test your understanding of these crucial ethical standards.