Adherence of safety information on over‐the‐counter product labels and leaflets to the regulatory guidelines in Malaysia

Piyush Mittal, Xin Yi Gan, Ai Ying Sim, Jia Qi Yeo, Jia Xin Cheng, Suresh Shanmugham, Syed Shahzad Hasan

Research output: Contribution to journalArticlepeer-review

3 Citations (Scopus)


To evaluate the adherence of medication safety information provided on over‐the‐counter (OTC) product labels and patient information leaflets (PILs) to the Malaysian and international regulatory guidelines.

A total of 133 randomly sampled OTC medications (gastrointestinal = 31, pain = 36, skin = 35, coughs and colds = 31) from 17 community pharmacies located around Klang Valley, Malaysia were evaluated. The adherence of relevant safety information provided on the OTC product labels and PILs from the manufacturing companies to the Malaysian and international regulatory guidelines was evaluated.

The majority of the products (n = 81) were locally manufactured, followed by 34 products from the European region. About 31% (n = 41) of the sampled OTC products were sold without PILs. Overall, 98% of the labels adhered to all the criteria, but none of the PILs adhered to all the parameters. Information on action to be taken in the case of a missed dose (96%), advice on consulting a doctor/pharmacist for further information (92%) and disposal instructions (98%) were generally missing. Surprisingly, none of the PILs included the compulsory statement which is essential for adverse drug reaction reporting. In addition, only 30% of the studied PILs provided information on the date of revision. Overall, imported products had slightly better adherence compared to locally manufactured products.

The safety information stated on the OTC products marketed in Malaysia has room for improvement to ensure safe and effective use of these products. A uniform format and collective effort is needed to ensure consumers receive adequate information about OTC products.
Original languageEnglish
Pages (from-to)204-211
Number of pages8
JournalJournal of Pharmacy Practice and Research
Issue number3
Early online date15 Jun 2018
Publication statusPublished - 15 Jun 2018
Externally publishedYes


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