Critical Appraisal of Drug Promotional Literature

Introduction to Critical Appraisal

  • All informational and persuasive activities by manufacturers and distributors , the effect of which is to induce the prescription, supply, purchase /or use of medical drugs is termed as DRUG PROMOTION
  • It is an important bearing on the rational use of drugs, price-control mechanisms, manufacture, availability and the use of essential drugs and the cost of healthcare, thus making it a central public health issue.
  • The clinicians get information about new drugs through various sources.
    • Most important source – Through Promotional literature provide by pharmaceutical companies.
    • The information is in the form of Verbal presentations by medical representatives , as the continuously visit the physicians and update their knowledge.

The information provided by this promotional literature should be (Critical Appraisal)

  1. Factual
  2. Evidence —based
  3. Unambiguous
  4. Balanced
  • Unfortunately most of the times , these literatures are neither factual nor evidenced based.
  • Majority of the advertisements are based on the studies of poor methodological quality.
  • Inacuarate and Incomplete information is usually made palatable when given along with gifts.
  • Every physician should be equipped with the necessary skills and knowledge , in order to critically evaluate the knowledge regarding the drug provided in the promotional literature.

A new drug should be selected on the basis of-

  • Clinical relevance
  • Efficacy
  • Safety
  • Tolerability
  • Cost compared to the already established drug.

What do the regulations say –

  1. Manufacturers / Traders cannot promote their product for indications that are not listed in the approved product information.
  2. They cannot promote their products over telephones and social media messages.
  3. Reprint of journal articles must be consistent with the product information , and the word “Safe” cannot be used unless it is substantiated.
  4. Committes are set up in order to monitor drug
    promotion.
    • The regional committes are located at Chandigarh, Mumbai, New Delhi and Chennai.
  5. The central ethics committee collects information on unethical advertising practices of pharmaceutical manufacturers and forwards complaints to the Drug Control Authority.
  6. The Drug Control Authority is empowered to take necessary legal stepson this unethical promotion (Drugs and Magic Remedies Act [5] for Objectionable Advertisement , 1954, clause 4.

How to Appraise the Drug Promotional Literature –

General Assessment

  1. Promotional material is made attractive , atches the eye due to its design, color , images etc. It makes a link between drug, indication and the images usually establishes in the physician mind bypassing his/her critical appraisal defences.
  2. When a patient presents his/her case, the prescriber will think of the most powerfully promoted drugs first. The physicial must look beyond these distractions for complete information of the drug.
  3. Sometimes key issues like ADRs, contraindications and precautions may be entirely omitted or presented in very fine print
    • DRUG NAME
      • Letters of generic name should be atleast half as large as the proprietary names.
      • Generic name should have same prominences as that of proprietary names in terms of Typography, Layout, Contact and other printing features.
    • PICTURES
      • Type & Relevance of the picturfe should also be assessed.
      • Scientific tables and graphs should be properly interpreted.
    • PSEUDOGRAPH– graphical representation without proper axis, labelling should also be checked if any.

CLAIMS MADE IN PROMOTIONAL LITERATURE-

  • Check the claims made in the promotional literature about Efficacy, Safety, Cost, Conveineince, Pharmacokinetic properties.

SUPPORTING SCIENTIFIC EVIDENCE (Reference) —

  • Sufficient references to substantiate the claims made by new products.
  • Studies of poor methodological quality should be identified
  • Retrievability & Validity of references should be checked as well.

TYPES OF PROMOTIONAL LITERATURE

  • Product monographs
  • Detail Aid
  • Newsletter
  • Booklets
  • Leave behind literatures
  • Training material
  • Speaker slides/slidedecks
  • Patient education Material
  • Advertisements
    • Reminder advertisement
    • Complete advertisements

WHO CRITERIA FOR PROMOTIONAL LITERATURE

  • The names of the active ingredients using either
    international proprietary names (INN) or the
    approved generic name of the drug,
  1. The Brand Name
  2. Pharmacological Data
  3. Breifly describing the PK, PD & MOA of drug.
  4. Clinical Information
  5. Indications- To give in which conditions /diseases.
  6. Adequate Dosing regimen & Relevant PK data.
  7. Average doses and range for adults and children.
  8. Dosing interval
  9. Avg. duration of treatment.
  10. Special Situations – renal, hepatic, cardiac ailments or nutritional insuffiencies that require either increased or reduced dosage.
  11. Precautions & Warnings.
  12. Adverse effects.
  13. Drug interactions.
  14. Over dosage description
  15. Pharmaceutical information
    • Dosage form
    • Strength of dosage form
    • Excipients
    • Storage conditions & Shelf life (Expiry date)
    • Description of product & package
    • Legal category
    • Name & address of manufacturer & importer
    • Reference to scientific literature as appropriate.

Other Pharmacology Notes :-

General Anaesthetics

Hypnotics – Sedative

Depression

Antiparkinsonian Drugs

Alzheimer’s Disease

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