Comparison of drug information in package inserts with standard medical textbook of pharmacology

Abstract

INTRODUCTIONAccurate and reliable drug product information is important for the safe and effective use of medicines. It has been observed that there are variations in the quantity and quality of information mentioned in different drug information sources and a single credible benchmark is lacking. Such variation do not provide the medical fraternity reliable drug information and can also promote off label and irrational drug use leading to increased incidence of adverse reactions and possible treatment failure.1-2 In India, healthcare professionals depend on a variety of sources, including textbooks for information on drugs.3 Standard medical textbooks are convenient and accessible. Out of these Goodman and Gillman's pharmacological basis of therapeutics is considered to be a "gold standard" pharmacology textbook. Drug information contained in this is generally well accepted by one and all and also approved and accepted by Regulatory Agencies.Package Insert is considered to be the another source of drug information. It is a printed leaflet provided by pharmaceutical companies that contains information based on regulatory guidelines for the safe and effective use of a drug. It is also known as prescription drug label. A good PI contains the approved, essential, and accurate information about a drug. It is written in a language that is ABSTRACT Background: Accurate and reliable drug product information is important for the safe and effective use of medicines. But there are variations in the quantity and quality of information mentioned in different drug information sources and a single credible benchmark is lacking. This study was carried out to compare the presentation and completeness of clinical information in package inserts (PIs) marketed by pharmaceutical companies in India with standard medical textbook of pharmacology. Methods: Out of eighty five PIs of different drugs, only 55 were found eligible to be included in this study after applying inclusion and exclusion criteria. These PIs and medical textbook were analysed for quantitative and qualitative drug information and were compared using Chi square test of two proportions. The p value of 0.05 was used as cut off to evaluate statistical significance. Results: Quantitatively medical textbook was significantly better statistically in context of treatment of overdose and references. No statistically significant difference was observed in relation to information related to mechanism of action (MOA) and pharmacokinetics (Pk). After qualitative analysis, medical textbook was significantly better statistically in context of size and readability, references related to adverse drug reactions (ADRs) and indications and pictures. No statistically significant difference was observed in context of dosing interval, frequency of doses and pharmacokinetic parameters. Conclusions: PIs can be used as a reliable source of drug information by health care professionals in addition to other sources like medical textbooks.

Evaluation of Medication Package Inserts in Ethiopia

“…Drug treatment is the most common intervention by healthcare providers [ 1 ]. Patients require accurate and reliable information to help them use their medications safely and effectively [ 1 , 2 ]. However, inadequate information provided by healthcare providers is common because of heavy workloads, many patients unable to retain verbal information they have been told for a long time [ 3 ], and misunderstanding of verbal information [ 4 ].…”

“…MPIs are leaflets that are packed with both over-the-counter and prescription medicines to provide specific information about their indication, administration, precautions during use, dose/dosage, potential side effects, and contraindications [ 5 , 9 ]. MPIs, which are also called patient package inserts or prescription drug labels, are provided by the medicine's manufacturer based on regulatory guidelines [ 2 , 4 ]. It is an important source of medication information to both healthcare providers and patients especially in developing countries where access to contemporary medical information is limited [ 3 , 10 ].…”

Egyptians’ dependency on Medication Pamphlets as a Source of Health Information and its Impact on their Health awareness and Behavior:

“…The MPs The MPs is a written document that accompanies both over-the-counter and prescribed medications and its purpose is to provide patients or their caregivers with all the necessary information about the drug (Sawalha et al 2008;Ramdas et al 2013). MPs is widely recognized as one of the most valuable resources for conveying essential and scientifically accurate information to healthcare professionals provided by the medicine's manufacturer based on regulatory guidelines (Al-aqeel 2012;Joseph et al 2017;Jain et al 2018). It is an important source of medication information to both healthcare providers and patients especially in developing countries where access to contemporary medical information is limited (Qatmosh et al 2017;Gavgani et al 2018).…”