Drug package inserts: how accessible is the information?

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

“…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 (Figure 4).…”

“…16 The present study about package inserts carried out collecting package inserts available in local pharmacy as well as drug store of tertiary care hospital and was analysed, in the 100 package inserts analysed 60% of the package insert belonged to class of antibacterial and 82% of them belonged them had oral route of administration (Figure 1 and 2). 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%.…”

“…17,22 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%.…”

“…In the present study as well 70% was directed to the prescribers ( Figure 5) similar to that found by Sudha et al, Kalam et al and Sudhamadhuri et al in their respective study. 1,20,21 The present study was conducted with the package inserts available local pharmacy and medical store of a tertiary care hospital hence more wide scale study covering different pharmacy as well as hospitals in a region should be done for more better evaluation.…”