A Critical Assessment of Rationality in Drug promotion literature using WHO Guidelines

  • Mohd Ashraf Alam Senior Resident, Department of Pharmacology, J.N. Medical College and Hospital, Aligarh Muslim University, Aligarh, Uttar Pradesh, India.
  • Mohammad Nasiruddin Professor and Chairman, Department of Pharmacology, J.N. Medical College and Hospital, Aligarh Muslim University, Aligarh, Uttar Pradesh, India
  • Gufran Ali Patient Safety Pharmacovigilance Associate. ADR Monitoring Centre, J.N. Medical College and Hospital, Aligarh Muslim University, Aligarh, Uttar Pradesh, India.
Keywords: Ethical drug promotion, promotional literature, WHO criteria for evaluation of drug promotion, drug marketing, medicine promotion.

Abstract

Background Aim: To evaluate the scientific and ethical status of the drug promotional literature available in the Indian market for accuracy, consistency, and validity of information present in it using WHO criteria.
Methods: A cross‐sectional, observational study was carried out in the department of pharmacology for evaluation of 180 drug promotional literature by WHO‐criteria, collected randomly from outpatient departments of JN. Medical College and Hospital, Aligarh, a tertiary care hospital in Northern India. They were also analyzed for different claims, catchy terms, quality of paper and print, and representation of data with statistics/diagram/table and references cited in support of their claims for their source, year of publication, authenticity, and retrievability.

Results: 45% of literature were designed for promotion of fixed dose‐drug combinations (FDCs), and 55% were single-dose formulations. Most of the drug promotional literature collected were from CVS, Endocrinology, GIT & Chemotherapy. Most of them mentioned indication, dosage form, and its strength and description of the product and package. Description of pharmacological effects and mechanism of action was present only in 31% of literature. More than (90%) were lacking information related to indications, correct dosage regimen, and dose adjustments in special situations, as well as the dosage in Paediatrics and elderly. False/tall claims, catchy/broken statements were given in 81% and 58% of literature, respectively. Irrelevant diagrams were depicted in 69%. References were cited in 69% of literature, of which 92% were from indexed‐journals and were retrievable. Conclusion: Critical assessment of drug promotional literature can make drug prescribing more effective. In our study, the majority of DPLs satisfied only half of the WHO criteria, and none of them fulfilled all the specified DPL criteria. Incomplete or embellished information in DPLs may mislead physicians and might lead to an irrational prescribing. Therefore, physicians must critically evaluate DPLs regarding updated scientific evidence required for quality patient care.

 

Author Biographies

Mohd Ashraf Alam, Senior Resident, Department of Pharmacology, J.N. Medical College and Hospital, Aligarh Muslim University, Aligarh, Uttar Pradesh, India.

 

 

Mohammad Nasiruddin, Professor and Chairman, Department of Pharmacology, J.N. Medical College and Hospital, Aligarh Muslim University, Aligarh, Uttar Pradesh, India

 

 

Gufran Ali, Patient Safety Pharmacovigilance Associate. ADR Monitoring Centre, J.N. Medical College and Hospital, Aligarh Muslim University, Aligarh, Uttar Pradesh, India.

 

 

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Published
2020-06-30