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

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

A cross-sectional questionnaire-based study of medication adherence in children suffering from epilepsy attending pediatric out-patient department at a tertiary care teaching hospital

Background: Epilepsy is a common chronic disease presenting during childhood that requires long-term treatment. Rates of adherence to antiepileptic drugs are variable in children ranging from 25% to 75%. Non-adherent patients are more likely to experience frequent and recurrent seizures which drastically impact the health of the patient. This study was therefore conducted in order to assess the medication adherence of children suffering from epilepsy to the prescribed anti-epileptic drug therapy. Methods: Children diagnosed with epilepsy aged 6-18 years were enrolled in the present cross-sectional questionnaire-based study after prior written informed consent and written informed assent. Children with co-morbidities were excluded from the study (as diagnosed by the Paediatrician). The case record form was filled after interviewing the patients. A questionnaire based on the Morisky medication adherence scale-8 (MMAS) was used to evaluate the quality of life of children. Results: Total 243 patients got enrolled in the study. GTCS was found to be the most common type of epilepsy. Valproate was the most commonly used agent. Out of the 243 patients in total, 201 patients (83%) showed high adherence, 24 patients (10%) showed medium adherence and 18 patients (7%) showed poor adherence to the treatment prescribed. Patients on monotherapy showed higher adherence rates than patients on polytherapy. Medication adherence was highest with Valproate among monotherapy and valproate + carbamazepine among poly-therapy. Conclusions: We conclude that monotherapy with anti-epileptic agents and patient satisfaction is positive predictors of medication adherence leading to a lesser impact of the disease on the child and improved health

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

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