No abstract

Objectives: Package inserts (PIs) are used by physicians and other health-care providers as ready source of approved prescribing information. In India, they are subject to statutory regulations that specify the information to be provided under various headings. Uniformity of PIs with optimal level of information is desirable, the absence of which may lead to medication errors. This observational study aimed to evaluate the information adequacy and accuracy of PIs available in the Indian market. Materials and Methods: PIs of drugs marketed in India, and approved by United States Food and Drug Administration, were collected from various retail pharmacies through purposive sampling. The adequacy and accuracy of the information in each PI were evaluated with the help of a 25-item checklist prepared as per stipulations mentioned in statutory guidelines. Each required item of information was scored 1 if present and appropriate or 0 if absent or deemed incomplete or inaccurate. A total information adequacy score (IAS), with maximum value 25, was thereby calculated. Results: From the total 135 PIs analyzed, the median IAS was 17 (interquartile range 15–19). Deficiencies were observed under important headings. For example, “references” were mentioned in only 6.67% and “date of last updating” in only 19.26% of PIs. Other notable shortcomings were in “disposal” (not mentioned in 92.59%), “effects on ability to drive and use machines” (76.30%), “pharmaceutical incompatibilities” (66.67%), “shelf life” (62.96%), “excipients” (60.00%), and “overdose” (17.78%) information. Information on “generic name,” “composition,” and “indications” were however provided by all (100%) PIs. Conclusions: The information provided by PIs in India being inadequate, may not be able to serve as a reliable source of information.

Introduction: Self-Medication is a practice common in developing countries, and accepted in society, unlike the western world. NSAIDs are responsible for the delayed diagnosis (due to suppression of clinical features), disease progression and adverse effects. Objective: To determine the factors leading to self-administration of NSAIDs, their usage pattern and possible adverse effects. To compare NSAID's use by prescription and over the counter acquisition. Materials and Methods: The present study investigates the determinants and effects of self-administration of NSAIDs by patients attending a tertiary care hospital during August-October 2019. The patients were interviewed regarding basic socio demographic variables, their rationale behind taking NSAIDs along with adverse effects experienced by them with a validated questionnaire. Their awareness pertaining to the drugs was also assessed. Results: 55.2% of the population were aware about adverse drug reaction due to NSAIDs but only 17% suffered any consequence of such activity. 23% of the patients were not aware about the nature of the disease whereas 44.2% visited physician less than 1 month. Awareness regarding adverse drug reaction is more in elderly and middle aged in compare to youth. The intention to administer the drugs was relief of musculoskeletal pain (62.9%) followed by relief of headache (15.2%) followed by others. The people at the medicine shops are advisors to majority of the people administering drugs without prescription (42.9%) followed by family members (32.4%), colleagues as well as friends. Conclusion:We found large proportion of patients taking self-prescribed NSAIDs for symptomatic relief and advice by overenthusiastic peers.

In this case series, we are going to present you with half a dozen cases of adverse drug reactions affecting skin, which took place recently in a tertiary care hospital in eastern India. They were contributed to the wrong use of over-the-counter medications due to the incorrect prescribing by the medical shop owners or self-medication. The casual behaviour of the government over 'quack' prescribing and unawareness of common people regarding self-medication may guide to adverse events caused by medical management rather than by an underlying disease which remain undetected by pharmacovigilance programmes. That is why we have decided to analyse series of 6 cases presented in our institution due to self-medication within 14 days.