Unregistered Medical Products Detected by Malaysia’s Pharmacy Enforcement Division During Routine Inspection: A Cross-Sectional Study among Selected Mainstream Medicines’ Retailers in the State of Sarawak
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Globally, substandard and falsified medical products (SFMPs) have been a major public health concern, and can be devastating to patients’ safety. In Malaysia, the detection of unregistered medical products (UMPs) by the Pharmacy Enforcement Division (PED) officers among mainstream medicines’ retailers (MMR), aims to curb the distribution of SFMP to the public.
This study explored the UMP detected by PED officers during routine inspections among the MMR that were sampled for the screening of UMP. The MMR include private medical clinics (PMCs), retail pharmacies (RPs) and non-pharmacy drug stores (NPDS).
This was a retrospective cross-sectional study that gathered the relevant information using a data collection form, from the routine inspection reports (RIRs) of the MMR in Sarawak throughout the year 2016. Of the 361 PMCs, 242 RPs and 894 NPDS that underwent routine inspection during the study period, a total of 20 PMC, 23 RP and 43 NPDS were selected by the senior PED officer in charge of the inspection unit to undergo screening of UMPs and were included for the purpose of this study. The top 10–12 MP, which were commonly used and had high turnover, based on the sales record of every premises, were sampled. The methods used to detect UMP were through the searching of online product registration database “QUEST 3”, the vetting of the Meditag™ Hologram (MH) using its decoder and the vetting of the MH serial numbers through Meditag Online Ordering System. Data analyses were conducted with SPSS V20.0.
From the 86 premises selected for screening of UMPs, a total of 888 MPs were sampled and recorded into RIR. It was found that 4 out of 888 (0.45%) samples were UMP. Each the UMPs were found in NPDS. In term of types of the UMP found, two were traditional medicines, one was a controlled medicine and one was an over-the-counter medicine.
The findings of this study provide preliminary information to relevant authorities on the UMPs detected by PED officers during routine inspections among selected MMRs.
The authors would like to express their gratitude to Director General of Health Malaysia YBhg. Datuk Dr Noor Hisham Bin Abdullah for his approval to publish this manuscript. The authors are obliged to thank the Director of Sarawak State Health Department Dr. Jamilah Hashim for her approval on the data collection of this study and unconditional support in this study. Last but not least, credits to all enumerators from Sarawak Pharmacy Enforcement Branch who devoted their efforts unreservedly in the data collection process to make this study possible.
All authors read and approved the final manuscript.
Compliance with Ethical Standards
The study was reviewed and approved by the Ministry of Health Malaysia Research Ethics Committee (MREC) on December 23, 2016 with registration number NMRR-16-2147-33176. All the data are restricted to the principal investigators and solely used for research purposes. The study was conducted in compliance with ethical principles outlined in the Declaration of Helsinki and Malaysian Good Clinical Practice Guideline.
Consent for publication
No personal information will be disclosed, and subjects will not be identified when the findings of the survey are published. This study had obtained approval from Director General of Health Malaysia for publication’s approval.
Availability of data and materials
The datasets used and/or analyzed during the current study are available from the corresponding author on reasonable request.
Conflicts of interests
Chuo Yew Ting, Shing Chyi Loo, Sui Theng Sim, Eng Chun Tee, Mohamed Azmi Hassali, Abu Hassan Alshaari Abd Jabar, Shahren Ahmad Zaidi Adruce, Benodict Apok Talin declare that they have no conflict of interest.
All the overhead expenses were covered by the operating fund of Pharmaceutical Services Division, Sarawak State Health Department. There are no other funding sources.
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