ABSTRACT
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.
ABSTRACT
There is limited mechanism to monitor the drug promotional campaign by pharmaceutical industries despite the fact that there is enough evidence of irrational pharmacotherapy increasingly encountered even in the developed countries. Unethical pharmaceutical promotional practice is a common cause of irrational pharmacotherapy which is a most common problem worldwide. Main objective of this study was to evaluate the medicinal promotional literatures provided by the pharmaceutical companies for accuracy, consistency and validity of the information presented in it, using World Health Organization (WHO) criteria for ethical medicinal drug promotion. Two hundred & fifty (n=250) literatures were collected randomly from selected doctors chambers in Barisal, Bangladesh. One hundred & thirty (130) of those literatures were excluded for being either duplicates, reminder literatures, promoting medical devices or cosmetics. The remaining (120) literatures were then screened to match their macro-informational contents against same advised in world health organization ethical criteria for medicinal drug promotion. The name of active constituent(s), content of active ingredient(s) per dosage form & brand name, were mentioned in 100% (n = 120) of promotional literatures, whereas dosage form were mentioned in 91.66% (n = 110), therapeutic indications were mentioned in 99.1% (n = 119) of literatures but informations on side effects mentioned in only 55.33% (n = 70), contraindications in 63.33 % (n = 76), precautions in 51.67% (n = 62) & references in 70 % (n = 84) of drug promotional literatures (DPLs). None of them mention anything about adjuvant. None of the promotional literatures fulfilled all the WHO criteria. Screened literatures were found to display poorly reliable and unbalanced medication information. Healthcare providers shall, accordingly, seek independent medicinal information sources, and not solely depend on commercial sources of medicinal information. Official regulators shall strictly define and mandate medication information contents in printed pharmaceutical promotional materials. Healthcare providers should, also, master the skills of appraising such promotional printed materials if rational medication use is to be achieved. Pharmaceutical industries did not follow the WHO guidelines while promoting their products, thus aiming to satisfying their commercial motive rather than fulfilling the educational aspect of promotion.
ABSTRACT
This study was aimed to evaluate the drug promotional literatures (DPLs) as per World Health Organization (WHO) criteria and also to evaluate claims, references and pictures presented in DPLs. It was an observational, cross-sectional study conducted at the outpatient department of Civil Hospital, Ahmedabad, a tertiary care teaching hospital for period of 2 months. Printed drug promotional literatures for modern drugs were collected as per selection criteria and analyzed. WHO guidelines were not fulfilled in any of the 200 DPLs. Out of 299 claims, most commonly presented claim in 192 DPLs was efficacy (45.15%) followed by pharmaceutical properties (26.75%). 130 (65%) DPLs did not provide any references to support claims while only 70 (35%) DPLs provided references. Most commonly used reference was journal articles 66 (88%) followed by websites 5 (6.66%). Most common source of journal article reference was research article 53 (85.48%) followed by review article 7 (11.29%). 125 (78.61%) DPLs presented with irrelevant pictures while only 25 (15.72%) DPLs presented appropriate pictures. Information on adverse drug reactions, contraindications and drug interactions was missing in most of DPLs. None of the promotional literatures contained all of the information as per WHO guidelines for medicinal drug promotion. They were lacking with scientific and critical information.