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)
- Evidence —based
- 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
- Cost compared to the already established drug.
What do the regulations say –
- Manufacturers / Traders cannot promote their product for indications that are not listed in the approved product information.
- They cannot promote their products over telephones and social media messages.
- Reprint of journal articles must be consistent with the product information , and the word “Safe” cannot be used unless it is substantiated.
- Committes are set up in order to monitor drug
- The regional committes are located at Chandigarh, Mumbai, New Delhi and Chennai.
- The central ethics committee collects information on unethical advertising practices of pharmaceutical manufacturers and forwards complaints to the Drug Control Authority.
- The Drug Control Authority is empowered to take necessary legal stepson this unethical promotion (Drugs and Magic Remedies Act  for Objectionable Advertisement , 1954, clause 4.
How to Appraise the Drug Promotional Literature –
- 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.
- 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.
- 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.
- 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.
- DRUG NAME –
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
- Leave behind literatures
- Training material
- Speaker slides/slidedecks
- Patient education Material
- 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,
- The Brand Name
- Pharmacological Data
- Breifly describing the PK, PD & MOA of drug.
- Clinical Information
- Indications- To give in which conditions /diseases.
- Adequate Dosing regimen & Relevant PK data.
- Average doses and range for adults and children.
- Dosing interval
- Avg. duration of treatment.
- Special Situations – renal, hepatic, cardiac ailments or nutritional insuffiencies that require either increased or reduced dosage.
- Precautions & Warnings.
- Adverse effects.
- Drug interactions.
- Over dosage description
- Pharmaceutical information
- Dosage form
- Strength of dosage form
- 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 :-
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