Evaluation of drug promotional literatures using WHO guidelines

Khakhkhar, Tejas; Mehta, Maulin; Shah, Rima; Sharma, Dineshchandra

doi:10.4103/0976-9234.116770

Cited by 26 publications

(49 citation statements)

References 7 publications

(14 reference statements)

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“…Similar line of findings was reported from various other studies. [10][11][12][13][14] The pharmaceutical industries rather accomplish their own commercial motive and neglected the ethical educational aspect. This carries a marked impact on the overall health delivery system.…”

Section: Discussionmentioning

confidence: 99%

Critical appraisal of drug promotional literature using World Health Organisation guidelines

Gautam¹,

Chugh²,

Sah³

et al. 2017

Int J Basic Clin Pharmacol

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Background: Pharmaceutical marketing using drug promotional literatures is an important strategy adopted by the companies to promote their drugs. The primary objective of the present study is to compare the drug promotional literature of different pharmaceutical companies on the basis of World Health Organization (WHO) guidelines on ethical drug promotion.Methods: This observational, cross sectional study was conducted at a tertiary care hospital, Delhi. The promotional literature was evaluated in accordance with WHO guidelines, nature of claims, pictorial content presented in it and for the cited references.Results: A total of 208 promotional brochures were analysed. Only few (5.8%) of the promotional literature fulfilled all the criteria as mentioned by the guidelines. Nutritional supplements (27.9%) were the most promoted group of drugs. Pharmaceutical companies were most reluctant to provide information regarding contraindications (9.6%), adjuvants (11.5), side effects (10.6%) and drug interactions (9.6%). Generic name, brand name, dosage form, therapeutic indications were outlined in most of the brochures. Exaggerated emotional claims were made in 47.1% brochures, followed by that of efficacy in 39.4% and safety in 25% of brochures. Pictures of medicinal products outnumbered others with 39.9% followed by pictures of women, children and doctors with 20.7%, 17.3% and 13.5% respectively.Conclusions: Majority of the drug promotional literature did not comply with the ethical guidelines and was inadequate in terms of their adequacy, quality and reliability. Hence, it can be concluded that the majority of the promotional advertisements that are given to the prescribers are not able to spread awareness towards rational prescribing.

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Section: Discussionmentioning

confidence: 99%

Critical appraisal of drug promotional literature using World Health Organisation guidelines

Gautam¹,

Chugh²,

Sah³

et al. 2017

Int J Basic Clin Pharmacol

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“…These findings have been also supported by other studies. 2,[18][19][20] From our study observations, they found that majority of literatures had mentioned generic name / INN (98.39%), brand name (100%), amount of active ingredient per dosage (94.07%), approved therapeutic uses (84.91%) and dosage form (91.37%). These components being an essential part of detailed pharmacological information have been supported by Mali et al and other studies.…”

Section: %mentioning

confidence: 99%

“…Similar findings were also consistent with findings of other studies. 2,3,18,19 Printed promotional material is an important source of information. Most health professionals are dependent on commercial sources of drug information from medical representatives, drug advertisement brochures etc., and it has great impact on prescribing behaviour.…”

Section: %mentioning

confidence: 99%

“…21 Another studies carried out in india by Mali et al and others showed similar observations regarding safety information presented in DPLs. [18][19][20] This suggests that unethical drug promotion especially in terms of neglecting the safety aspects of drugs is wide spread in india as well as all over the world, which truly demands utmost concern of health authorities. Moreover, this information was given in fine print which was not readily readable and the same is also supported by other study.…”

Section: %mentioning

confidence: 99%

“…These components being an essential part of detailed pharmacological information have been supported by Mali et al and other studies. [18][19][20] In all of the DPLs, information provided regarding safety parameters like; name of active ingredient known to cause problem (11.59%), dosage regimen (32.88%), side effects and drug reaction (14.56%), major drug interactions (14.02%) and precaution, contraindication and warning (14.29%) seems to be too low and thus grossly neglected. These findings coincide with observations of another study conducted in Russia wherein safety parameters were mentioned in less than 5% of literatures.…”

Section: %mentioning

confidence: 99%

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Critical appraisal of Drug Promotional Literatures (DPLs) as per World Health Organization (WHO) guidelines

Vyas¹,

Bhave²

2018

Int J Basic Clin Pharmacol

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Background: The study was aimed to critically analyse Drug Promotional Literatures (DPLs) using WHO guidelines. This would help to create awareness about DPLs amongst healthcare providers thus encouraging the improvement of healthcare system.Methods: This cross sectional observational study was carried out at Department of Pharmacology, Medical College Baroda. DPLs were collected & critically analysed for consistency, accuracy, validity of the provided information as per WHO guidelines.Results: Out of total 616 DPLs collected, 371 satisfied the inclusion criteria. None of the DPL was fulfilling all criteria according to WHO guidelines. Most of DPLs were having information regarding; generic name / INN (98.39%), brand name (100%), amount of active ingredient per dosage (94.07%), approved therapeutic uses (84.91%), dosage form (91.37%) and name & address of manufacturers (91.91%). Of all the DPLs, information provided for safety parameters like; name of active ingredient known to cause problem (11.59%), dosage regimen (32.88%), side effects & drug reaction (14.56%), major drug interactions (14.02%) and precautions, contraindications and warning (14.29%) seemed to be grossly neglected. Total of 431 claims were evaluated, of which the most common type of claim was efficacy (55.45%). Relevant references to claims were present in (48.74%) DPLs. Total 203 references were evaluated from 371 DPLs, of which maximum reference were from journal article (74.38%).Conclusions: From this study, it was concluded that pharmaceutical companies didn’t follow the WHO guidelines for ethical drug promotion, thus failing to fulfil the rational promotion of drugs. Given the present findings physicians should be cautious about drawing conclusions regarding medicine based on DPLs provided by pharmaceutical companies.

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Adherence to WHO Criteria on Drug Promotion Literature: An Exploratory Study From a Tertiary Healthcare Facility in South-West Nigeria

et al. 2022

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Introduction: In many low and middle-income countries (LMIC), drug promotional literature (DPL) remains one of the main sources of drug information for physicians. Studies conducted in many LMICs showed poor compliance to the WHO guidelines for ethical drug promotion especially in the area of information about excipients, adverse drug reactions, drug-drug interactions and contra-indications. These inadequacies in the information provided may mislead the prescriber with potential adverse consequences among patients using the medicines. Nigeria has a big pharmaceutical sector which is poorly regulated and we hypothesize that such unethical drug promotional practices may exist. This study therefore set out to assess compliance to the WHO ethical drug promotion (using DPL) at the Ekiti State University Teaching Hospital (EKSUTH), Ado-Ekiti, South-West Nigeria. Methodology: This was a descriptive cross-sectional study conducted in several specialist clinics of EKSUTH, Ado-Ekiti. Printed DPLs (brochures and leaflets) were collected from these clinics, collated using a pre-designed data collection form and analyzed using the WHO ethical criteria for medicinal drug promotion. Results:Two hundred seventy-five DPLs were screened A total of out of which 234 DPLs were selected after screening to after removal of duplications. Only 5 (2.1%) DPLs met all the WHO criteria. DPLs promoting antibiotics, cardiovascular drugs, and vitamins/nutritional supplements were in the majority (22.2%, 17.1%, and 11.5% respectively. Most of the DPLs had the generic (223; 95.3%) and brand (234; 100%) names, active ingredients (209; 89.3%), excipients (149; 63.7%), and indications (232; 99.1%). Information about adverse drug reactions (76; 32.5%), contra-indications (73; 31.2%), and drug interactions (46; 19.7%) was less represented. Only 59 (25.2%) DPLs had references. Fixed-dose combination drugs made up 34.6% of drugs being promoted. Conclusion:The DPLs assessed in this study had low adherence to WHO ethical drug promotion criteria especially those related to adverse drug reaction, drug interactions, and contra-indications.

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Evaluation of drug promotional literatures using WHO guidelines

Cited by 26 publications

References 7 publications

Critical appraisal of drug promotional literature using World Health Organisation guidelines

Critical appraisal of drug promotional literature using World Health Organisation guidelines

Critical appraisal of Drug Promotional Literatures (DPLs) as per World Health Organization (WHO) guidelines

Adherence to WHO Criteria on Drug Promotion Literature: An Exploratory Study From a Tertiary Healthcare Facility in South-West Nigeria

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