Tejas Khakhkhar, Maulin Mehta, Rima Shah, Dineshchandra Sharma

Journal of Pharmaceutical Negative Results 2013 4(1):33-38

Aim: To evaluate the scientific and ethical status of the drug promotional literatures available in Indian market using WHO criteria. Materials and Methods: A cross-sectional observational study was carried out in department of pharmacology for evaluation of 142 drug promotional literatures by WHO-criteria, collected randomly from various regions of Gujarat. They were also analyzed for different claims, catchy terms, quality of paper and print, and representation of data with statistics/diagram/table. The references cited in the literatures were evaluated for their source, year of publication, authenticity, and retrievability. Results: 49% of literatures were designed for promotion of fixed dose-drug combinations (FDCs). Chemotherapeutic agents and cardiovascular drugs were most promoted drug groups (19% each). None of the drug promotional literature fulfilled all the WHO criteria. Description of pharmacological effects and mechanism of action was not given in 54% and 80% of literatures, respectively. Majority (80-90%) were lacking information related to indications, correct dosage regimen, and dose adjustments in special situations. Most neglected aspect of drug promotion was mentioning about adverse drug reactions, drug interactions, precautions, and over dosage (<10%). False/tall claims, catchy/broken statements were given in 86% and 72% of literatures, respectively. Irrelevant diagrams were shown in 69%, statistical data for support in 7%, and tabular presentation in 5% of literatures. References were cited in 67% of literatures, of which 98% were from indexed-journals and were retrievable. Conclusion: Critical review of drug promotional literatures can make drug prescribing more effective. If drug promotional literatures fulfill all WHO guidelines, it can make promotion ethical and rational.