WHO Ethical Criteria on Drug Promotion
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Questions and Answers

What should be avoided when advertising drugs?

  • Using language that induces fear or distress (correct)
  • Providing clear scientific data
  • Targeting advertisements at adults
  • Indicating limitations of drug use
  • What is a requirement for medical representatives?

  • They should possess sufficient medical and technical knowledge (correct)
  • They should work independently without training
  • They should be sales-oriented primarily
  • They should have a managerial background
  • Which of the following drugs should not generally be advertised to the public?

  • Scheduled narcotic drugs (correct)
  • Homeopathic remedies
  • Over-the-counter medications
  • Vitamins and supplements
  • Which statement about the provision of free samples of prescription drugs is true?

    <p>They can only be provided in modest quantities (B)</p> Signup and view all the answers

    How should advertisements convey claims about drug effectiveness?

    <p>Only if claims can be substantiated (A)</p> Signup and view all the answers

    What policy should be in place regarding the remuneration of medical representatives?

    <p>It should not be directly related to sales (B)</p> Signup and view all the answers

    Which of the following statements about drug promotion is NOT true?

    <p>The term 'safe' can be used without any qualifications. (B)</p> Signup and view all the answers

    What is a responsibility of employers regarding medical representatives?

    <p>To provide basic and continuing training (A)</p> Signup and view all the answers

    What is a requirement for advertisements directed at physicians?

    <p>They must be consistent with approved scientific data sheets. (B)</p> Signup and view all the answers

    Which of the following practices is discouraged in drug promotion?

    <p>Offering financial incentives to health care practitioners. (C)</p> Signup and view all the answers

    What should be clearly stated during symposia sponsored by pharmaceutical companies?

    <p>The fact of sponsorship by the manufacturer (C)</p> Signup and view all the answers

    What must reminder advertisements include?

    <p>The brand and generic names along with manufacturer details. (C)</p> Signup and view all the answers

    What is the expected outcome of advertisements directed at the general public?

    <p>To aid in rational decision-making about legally available drugs. (B)</p> Signup and view all the answers

    Scientific and educational activities should be utilized for which purpose in drug promotion?

    <p>To provide objective information without promotional intent. (D)</p> Signup and view all the answers

    What aspect of drug promotion must be capable of substantiation?

    <p>All promotional claims made about medicinal drugs. (A)</p> Signup and view all the answers

    Which statement is essential regarding comparisons of medicinal products in promotions?

    <p>Product comparisons should be factual and fair. (B)</p> Signup and view all the answers

    What should be the priority when reporting hazards associated with medicinal drugs?

    <p>To report to the appropriate national health authority as a priority (B)</p> Signup and view all the answers

    How should packaging and labeling information for drugs be aligned?

    <p>With the country's drug regulatory authority's approved information (B)</p> Signup and view all the answers

    What is the ethical standard for the promotion of exported drugs?

    <p>Identical to those related to drugs for domestic use (D)</p> Signup and view all the answers

    What must package inserts or leaflets comply with when used for promotional purposes?

    <p>Ethical criteria approved by the regulatory authority (B)</p> Signup and view all the answers

    Which of the following practices is discouraged in post-marketing scientific studies?

    <p>Utilizing studies as a subtle form of promotion (A)</p> Signup and view all the answers

    What type of language should be used in package inserts aimed at patients?

    <p>Lay language with proper medical content reflected (D)</p> Signup and view all the answers

    If a country's drug regulatory authority is rudimentary, how should packaging materials be handled?

    <p>They should follow the importing country’s regulations (A)</p> Signup and view all the answers

    What role do gifts and entertainment play in meetings with medical professionals?

    <p>They should complement the meeting purpose modestly (D)</p> Signup and view all the answers

    Flashcards

    Drug Promotion

    All activities by manufacturers and distributors designed to influence the prescription, supply, purchase, and use of medicines.

    Truthful and Reliable Claims

    Promotional claims about medicines must be accurate, truthful, and supported by reliable evidence.

    Avoiding Deception

    Promotional materials should not be misleading or disguise their true nature.

    Transparency with Data

    Medical professionals should have access to scientific data about the drugs they prescribe.

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    Avoiding Bribery

    Financial or material benefits should not be given to influence doctors to prescribe specific drugs.

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    Accurate Advertisements to Doctors

    Advertisements aimed at doctors must be consistent with approved scientific information about the drug.

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    Informed Public Decisions

    Advertisements to the public should help people make informed choices about over-the-counter medications.

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    Reminder Advertisements

    Advertisements without claims should still include basic drug information, including the brand name, active ingredients, and manufacturer contact.

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    Ethical Drug Advertising

    Drug advertising should not exploit people's health concerns. It should provide accurate information based on scientific evidence and avoid using fear-inducing language.

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    Drug Advertising to Children

    Drug advertising aimed at children is generally discouraged and should not be used to promote prescription drugs.

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    Responsibilities of Medical Representatives

    Medical representatives must have the necessary knowledge and training to promote drugs responsibly. They should avoid offering incentives to healthcare professionals.

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    Free Samples of Prescription Drugs

    Free samples of prescription drugs may be provided to doctors, but in limited quantities and on request.

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    Free Samples of Non-Prescription Drugs

    Free samples of non-prescription drugs are generally not justifiable from a health perspective. If permitted, their distribution should be limited.

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    Transparency in Sponsored Meetings

    When a pharmaceutical company sponsors a scientific meeting, this fact should be clearly disclosed to attendees.

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    Truthful Drug Advertising Claims

    Drug advertisements must be truthful and supported by scientific data. They should clearly indicate any limitations of use.

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    Advertising for Serious Conditions

    Drug advertising should not be used to promote drugs for serious conditions that require treatment by a qualified healthcare professional.

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    Ethical Drug Promotion: Meetings and Gifts

    Promotional activities, like meetings and gifts, should be mainly focused on the purpose of the event and not be excessive.

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    Ethical Drug Promotion: Post-Marketing Studies

    Scientific studies conducted after a drug is on the market should not be used as a way to promote the drug.

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    Ethical Drug Promotion: Packaging and Labelling

    Drug packaging and labels should clearly show information approved by the drug regulatory authority.

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    Ethical Drug Promotion: Patient Information

    Package leaflets and booklets should also follow the approved information and be easily understood by patients.

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    Ethical Drug Promotion: Exporting Drugs

    The ethical guidelines for promoting exported drugs should be the same as those for domestic use.

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    Ethical Drug Promotion: International Trade

    Countries should use the WHO Certification Scheme to ensure the quality of pharmaceutical products traded internationally.

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    Ethical Drug Promotion: Reporting Hazards

    Information about potential dangers of drugs should be shared with the relevant authorities quickly and globally.

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    Ethical Drug Promotion: All Materials

    All promotional materials, even those that are not directly aimed at selling a product, should adhere to the ethical guidelines.

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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.

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