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Objective: To evaluate the rationality of drug promotional literature (DPL) using World Health Organization (WHO) ethical criteria and to evaluate the perception of clinicians regarding DPLs using prevalidated criteria. Methods: The promotional material was collected at a tertiary care teaching hospital over a period of 3 months. The perception of different prescribers has been changed. The data were analyzed using descriptive analysis. Results: 191 DPLs were collected from various outpatient departments at a tertiary care hospital. The information regarding brand name, generic name, and active ingredients was mentioned in 100% of the collected material. Therapeutic uses of the promotional agents were mentioned in only 60.20%; references were cited in only 15.18%. The adverse effects were listed in only 17.80% of the DPLs. The perception regarding DPLs was gathered from 27 physicians at the same institute. The percentage of clinicians who were aware of the WHO criteria used for analyzing DPL was only 37.03%. All healthcare workers have agreed on the necessity of including critical appraisal of the DPLs in the undergraduate curriculum. [ABSTRACT FROM AUTHOR]

Background: Drug promotional literatures (DPLs) are one of the well-known promotional activities of pharmaceutical industries which are sometimes inaccurate as well as of poor educational value. Angiotensin receptor blockers (ARBs) are one of the most commonly used antihypertensives. Therefore, this study was done to estimate the accuracy of DPLs on ARBs as per the World Health Organization (WHO) criteria. Aims and Objectives: The aims of this study were to estimate the accuracy of DPLs on ARBs as per the WHO and to estimate the DPLs for types of claims and appropriateness of claims. Materials and Methods: A cross-sectional observational study was carried out for 1 month. All the required information of selected DPLs on ARBs were recorded in a pro forma and were evaluated according to the WHO criteria. Results: In this study, a total of 20 (twenty) DPLs were evaluated only on ARBs. It was observed that none of the DPLs fulfilled all the WHO criteria. In this study, some DPLs made multiple claims, as much as five per DPL. Claims were, further, analyzed and divided into appropriate and inappropriate. We have observed that 65.96% claims were appropriate and 34.04% claims were inappropriate. Conclusion: This type of study can contribute to make prescribing practices rational as promotional activities influence the prescribing behavior of the health-care provider. [ABSTRACT FROM AUTHOR]

Objectives: Evaluation and comparison of ethical standards of published drug promotional literatures (DPLs) between different Indian and non-Indian scientific medical journals regarding compliance to the World Health Organization (WHO) and International Federation of Pharmaceutical Manufacturers and Associations (IFPMAs) guidelines. Materials and Methods: A cross-sectional, observational study was carried out at pharmacology department. DPLs published in Indian and non-Indian scientific medical journals available at central library of medical college during the period of 6 months were collected according to selection criteria. DPLs were evaluated and compared for compliance to ethical standards of drug promotion laid by the WHO and IFPMA. Data were analyzed using Fisher's exact test. Results: Out of total 178 DPLs, 103 DPLs were from Indian journals and 75 DPLs were from non-Indian journals. When compared regarding compliance to all the 11 ethical criteria of WHO, no significant difference was found between DPLs published in Indian and non-Indian journals. However, DPLs from indian journals contained significantly less information regarding dosage regimen (P = 0.0096), adverse drug reactions (P = 0.0028), warnings (P = 0.0104) and major drug interactions (P < 0.0001) as compared to non-Indian journals. Compliance to all the five IFPMA criteria was significantly higher in DPLs of non-Indian journals (88%) than Indian journals (39%) (P < 0.0001). Conclusion: Noncompliance to ethical standards of WHO and IFPMA guidelines is more common in DPLs of Indian journals as compared to non-Indian journals. Thus strict implementation of regulatory measures regarding DPLs published in Indian medical journals is recommended. [ABSTRACT FROM AUTHOR]

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. [ABSTRACT FROM AUTHOR]

Objectives: The study was aimed to evaluate collected drug promotional brochures for accuracy, consistency, and validity of the information presented in it, using World Health Organization (WHO) criteria for ethical medicinal drug promotion. Drug promotional brochures were evaluated for the type of claims and pictorial content presented in it and for references cited in support of these claims. Material and Methods: This observational, cross-sectional study was conducted in the outpatient department of Government Medical College and Hospital, Nagpur, India. In addition to the fulfillment of "WHO criteria, 1988," we examined 513 promotional brochures for the type of claims and pictorial content presented in it and references quoted in support of claims to check their retrievability, type, and authenticity. Results: None of the promotional literature fulfilled all WHO criteria. Majority (92%) brochures claimed about the efficacy of product, and a few about safety (37.8%). Out of 1003 references given in support of various claims, 84.4% were from journals and only 28.5% were validly presented researches. Brochures presenting irrelevant pictures were 41.3%, whereas brief prescription information (BPI) of the promoted drug was given only by 8.8% brochures. Conclusion: Pharmaceutical industries did not follow the WHO guidelines while promoting their products, thus aiming to satisfying their commercial motive rather than fulfill the educational aspect of promotion. [ABSTRACT FROM AUTHOR]