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

• Published in: Pharmaceutical medicine 2018-04, Vol.32 (2), p.143-148
• Main Authors: Ting, Chuo Yew, Loo, Shing Chyi, Sim, Sui Theng, Tee, Eng Chun, Hassali, Mohamed Azmi, Abd Jabar, Abu Hassan Alshaari, Ahmad Zaidi Adruce, Shahren, Talin, Benodict Apok
• Format: Article
• Language: English
• Subjects: Biomedical and Life Sciences; Biomedicine; Counterfeiting; Cross-sectional studies; Drug stores; Enforcement; Inspections; Original Research Article; Patient safety; Pharmaceutical Sciences/Technology; Pharmaceuticals; Pharmacology/Toxicology; Pharmacotherapy; Public health; Registration; Regulation; Regulatory agencies; Retail stores; Web portals
• ISSN: 1178-2595; 1179-1993
• DOI: 10.1007/s40290-018-0229-7

Background 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. Objective 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). Methods 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. Results 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. Conclusion The findings of this study provide preliminary information to relevant authorities on the UMPs detected by PED officers during routine inspections among selected MMRs.