Analysis of package inserts of orally administered drugs available in the Indian market

Abstract

Background:The package insert of a medication forms an important source of information to the patient while taking a drug. The package insert is expected to contain complete information regarding the drug aiding the patient to obtain additional knowledge regarding the drug. Methods: 100 package inserts of orally administered drugs were obtained from local chemists and were analysed according to the Sections 6.2 and 6.3 of Schedule D (II), Drugs and Cosmetics Act (1940) and Rules (1945). Results: The posology and contraindications were mentioned in 98% and 96% of the inserts, respectively, whereas the list of excipients, incompatibilities and shelf life was mentioned in 12%, 19%, 16% of the inserts, respectively. Conclusions: There is a wide variation in the information available on the package inserts of drugs available in the Indian market. The package inserts should be carefully scrutinized for completeness before the respective drug is marketed.

A study on the evaluation of drug package inserts: a prospective observational study

“…Antibacterial class was also found maximum in studies conducted by Deepak et al, Sudhamadhuri et al and Shruti et al 17,1,19 Oral as route of 1,17,[19][20][21] As per the guidelines evaluated according to Drugs and Cosmetic Act 1945 (Table 1) undesirable effects were mentioned in 98% of the evaluated package inserts which is more as compared to studies conducted by Deepak et all where it was mentioned only in 37.69% and Chhaya et al where it was mentioned in 97% of the evaluated package inserts. 17,22 In the present study pregnancy and lactation was mentioned in 98% of the evaluated package inserts which is more in comparison to study conducted by Deepak et al where it was mentioned in 37.69% and Chhaya et al where it was mentioned in 89% and Sudha et al where it was mentioned in 84%. 17,20,22 As per the guidelines mentioning of Method of administration and precautions of use as found out in present study was 80% and 90% which was similar to the study conducted by Sudhamadhuri et al 1 In present study antidote was mentioned in 40% of the evaluated package 100 package inserts which was more compared to studies conducted by Sudhamadhuri et al where only 20% is mentioned, 13% in a study conducted by Chhaya et al and Kalam et al where it is mentioned in only 4%.…”

“…17,22 In the present study pregnancy and lactation was mentioned in 98% of the evaluated package inserts which is more in comparison to study conducted by Deepak et al where it was mentioned in 37.69% and Chhaya et al where it was mentioned in 89% and Sudha et al where it was mentioned in 84%. 17,20,22 As per the guidelines mentioning of Method of administration and precautions of use as found out in present study was 80% and 90% which was similar to the study conducted by Sudhamadhuri et al 1 In present study antidote was mentioned in 40% of the evaluated package 100 package inserts which was more compared to studies conducted by Sudhamadhuri et al where only 20% is mentioned, 13% in a study conducted by Chhaya et al and Kalam et al where it is mentioned in only 4%. 1,21,22 In the present study contraindication was present in 96% of the evaluated package inserts which was similar to a study conducted by Chhaya et al however more than the result as obtained by Shruti et al and Sowmya et al which was 91%.…”

“…17,20,22 As per the guidelines mentioning of Method of administration and precautions of use as found out in present study was 80% and 90% which was similar to the study conducted by Sudhamadhuri et al 1 In present study antidote was mentioned in 40% of the evaluated package 100 package inserts which was more compared to studies conducted by Sudhamadhuri et al where only 20% is mentioned, 13% in a study conducted by Chhaya et al and Kalam et al where it is mentioned in only 4%. 1,21,22 In the present study contraindication was present in 96% of the evaluated package inserts which was similar to a study conducted by Chhaya et al however more than the result as obtained by Shruti et al and Sowmya et al which was 91%. 19,22,23 In the present study special mention about driving was present in 30% of the evaluated package inserts as compared to 2% in a study conducted by Kalam et al,16% in a study conducted by Chhaya et al, 13% in a study conducted by Sudha et al and 17% by Shruti et al [19][20][21][22] Excipicents where mentioned in 60% of the present study as compared to the study conducted by Sudhamadhuri et al 120% and 12% in a study conducted by Chhaya et al 22 Storage information was present in80% of the present study compared to 62% in a study conducted by Sudhamadhuri et al and 58% in a study conducted by Kalam et al 1,21 Interaction with other medications was mentioned in94% of the package inserts evaluated as compared 89% in a study conducted by Chhaya et al and 90% as compared to Sudha et al and only 12% as found in a study conducted by Kalam et al [20][21][22] In the present study shelf life after dilution and after sale was present in 50% and 10% whereas it was absent in a study conducted by Deepak et al 17 Retail price was present in 2% of the evaluated package inserts however absent in Deepak et al and Shruti et al 17,19 In the present study most of the evaluated package inserts belonged to Grade B (Figure 3) which was similar as seen in a study conducted by Deepak et al and Shruti et al 17,19 In the present study most of the evaluated package inserts were written in English as compared to other studies as well…”

A study on awareness about package inserts among postgraduate medical students: an observational questionnaire based study

“…At the same time, for the physicians also package inserts serve as an important source of drug information prescribing effectively and safely as many a times, it is not possible for the doctors to go through the research articles and look for recent advances in relation to a particular drug. 3 Since, a good Package Insert (PI) is evidence-based and is updated time to time as relevant preclinical and clinical data becomes available, therefore, it can prove to be of immense importance to physicians also. 4 In India, the concept of package insert is governed by the 'Drugs and Cosmetics Act (1940) and Rules (1945)'.…”

Information adequacy of medicine package inserts in India

“…Earlier, Shivkar[ 10 ] and Kalam et al .,[ 11 ] in separate studies, reported that most PIs did contain information on therapeutic indications, contraindications, undesirable effects, etc., but there were also important gaps in clinically important information. In a more recently published study on PIs of oral drugs,[ 12 ] the author reported broadly similar findings and concluded that there is wide variation in the information available in PIs circulating in the Indian market.…”