Article

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

Authors:
  • Sarawak State Health Department
  • Jabatan Kesihatan Negeri Sarawak
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Abstract

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.

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... Notifications include name, occupation, place of business, fine, forfeiture and the nature of offense shall be published in newspapers if the court order to do so. The cost of such publication is charged on an individual who commits offense in contradiction of this act as a civil debt based on section 14 [9]. Licenses Involving in Sales: There are 5 categories of licenses included in sales ( Figure 1) and each license will be considered in the structure endorsed appropriate to the kind of such authorization and it will express the name of the issued individual and the premises on which any sale or use might be affected and the legality of the permit. ...
... In agreement with this act, nobody can import, possess, supply, sell, manufacture or administer any product that is unregistered under section 7 (a). Nobody can supply false or ambiguous info to the authority during the claim of product registration under section 8 (9). The Secretary will keep a register of the product which must contain the name of the enlisted product, the quantity of active ingredients, address and name of a producer, address and the name of the product registration holder, product listing number or item registration number and date of issue or expiry date if present [12]. ...
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