Falsified Medicines

According to The Pharmaceutical Security Institute data, the incidents of counterfeit medicine increased dramatically from 196 incidents in 2002 to 2018 incidents in 2012 (Pharmaceutical Security Institute, 2018). The data are, in part, a reflection of adequate law enforcement and regulatory oversight in countries where these reports came from 10. However, this figure would be even higher if resource-poor countries had adequate surveillance system. Drug regulatory authorities and pharmaceutical companies hold records on counterfeit medicines, yet most are inaccessible (The Institute Medicine, 2013).Counterfeit medicine that now known as Falsified medical products is a medical products that deliberately/fraudulently misrepresent their identity, composition or source. Falsified medicines are often disguised as authentic medicines but my contain ingredients of bad or toxic quality, or in the wrong dosage. As they have not been properly checked for quality, safety dan efficacy, ther can pose a real risk to your health. Those risks should be addressed by strengthening the verification requirements applicable to the manufacturer of the medicinal product.

As discussed above, trade in medical products that are falsified, poorly made or degraded threatens health in every region driven by globalization of trade and the increasing complexity of supply chains, it is likely to increase unless serious, well-resourced efforts are made to tackle the issues. Based on those explanation, what need to be done to:

• Prevent the manufacture, sale and consumption of substandard and falsified medical products
• Implement system to detect any substandard or falsified products that are already in the supply chain;
• Respond quickly and proportionately to any incidents that are detected, in ways that safeguard patients and the supply chain, take appropriate action against those responsible, whilst not causing unnecessary shortages.

Hamilton W, et al. 2016 explain that some public health intervention to protect against falsified medicines are:

• Intervention can target multiple stages of the pharmaceutical supply chain to protect against falsified drugs, which are deliberately fraudulent poor quality medicines.
• At the international scale, a widely used global reporting service would provide up-to-date information on specific poor quality medicine threats and allow global monitoring. Strong supranational leadership and multi-source funding are required.
• Robust National Medicine Regulatory Authorities (NMRA) are essential for pharmacovigilance, ideally with medicine quality testing at entry ports and throughout the pharmaceutical supply chain, national reporting systems, drug certification requirements and interdepartmental cooperation.
• The private sector can be improved through greater pharmacists training on recognizing and reporting poor quality medicine, drug registration checks and increase consumer awareness.
• New drug testing technologies can screen for drug authenticity in low-resource settings, though these require further improvements and field testing.
• Consumer verification strategies are newly emerging, with the potential empower consumer to safeguard the authenticity of their own medicines at point-of-purchase. The huge increase in mobile phone usage across Africa and Asia makes this is very promising strategy.
• A combination of interventions operating at these different levels is likely to be the most effective approach for guaranteeing medicine safety and authenticity. More evidence is needed to evaluate how successfully current medicine quality policies are being implemented and their effectiveness.

The presence of substandard and falsified (SF) medical product at a significant level has become one of the threat to public health in Indonesia. BPOM as National Regulatory Authority in Indonesia has developed and implemented a policies to prevent, detect and act toward SF medical product. Currently SF medicines cases in Indonesia are handled by BPOM. Most of the cases found are cases of falsified medicines. An example is falsified medicines that found in Semarang, Indonesia. This case is carried out by the Bareskrim POLRI with the BPOM, the explanation is given the modus operandi found in Semarang is the existence of illegal facilities that produce falsified medicines by repackaging generic medicine into branded medicine, which have higher selling prices, including repackaging expired medicines.

What the BPOM has done in countering falsified medicine through the National Action for the Eradication of Illegal Drug ang Drug Abuse (POIPO National Action). This National Action is carried out through three strategic approach, there are prevention strategy, detection/supervision and response/enforcement. The strategy used to the WHO Substandard and Falsified Medicine Control Strategy (Prevention, Detection, and Response). BPOM carries out prevention strategy through the comprehensive legal framework by issuing regulations on the implementation of 2D barcode in drug controls. In addition, BPOM carries out multi stakeholder engagement through MoU expedition associations, e-commerce association, market places, and online transportation. Prevention strategy for understanding, awareness and community empowerment against drug abuse is carried out through education and awareness by involving public figures, influencers, and bloggers in educating the public.

The response strategy is a law enforcement effort related to the eradication of illegal drugs and drug abuse, through the intensification of investigation and law enforcement operations with other law enforcement agencies. Cooperation with e-commerce, expedition association and online transportation support the tracing of the production and distribution of falsified medicine to uncover the main actors of drug counterfeiting through the exchange of data and information.

In the detection strategy, BPOM has a good risk-based inspection and surveillance system, which was proven during the 2018 WHO benchmarking which assessed the regulatory capacity of the BPOM in the mature category. BPOM also collaborate with WHO in the pilot project for reporting substandard and falsified medicine by health workers through the smartphone application in 2018.

Falsified medicines are medicines produced by unauthorize persons based on the laws and regulations or medicines production with a label that imitates the identity of another medicine that already has a marketing authorization number. BPOM release tips how to recognize the original medicine as follow:

• Produced by the pharmaceutical industry with a clear address
• Have a marketing authorization number, expired date, bets number and other product identities
• Obtained from official facilities, such as pharmacies, hospital/puskesmas, licensed drug stores

BPOM invites the public to actively participate in reporting SF medicines through the form that available on the BPOM website. Another program related to handling SF medicines is serialization in packaging, namely 2D barcode system. 2D barcode is a graphic representation of digital data in a 2 dimensions format with a high decoding capacity that can be read by optical devices used for identification and tracking. Regarding the application of the used of 2D barcodes according to BPOM Regulation Number 33 of 2018 about the application of 2D barcodes in Drug and Food Control page 5 chapter 3 explains that there are 2 methods, namely:

• Authentication method
• Identification method

The authentication method is a method that traces and verifies the legality batch number, expired date and serial number of drug and food products. The application of 2D Barcode with the authentication method can be issued by the BPOM or private sector. Both the BPOM or private sector use a QR code that can be read by the BPOM track and trace as stated in BPOM regulation No 33 of 2018 chapter 5. The second method is the identification method. The identification method is a method that verifies the legality of drugs and food based on a marketing authorization number. The identification method is issued through an electronic marketing authorization number in the form of a QR code. Currently, the pharmaceutical industry in Indonesia is required to use 2D barcodes, although not all industries have implemented them, they are still concerned about fulfilling the obligations of 2D barcodes.

On the other hand, a qualitative study that conducted by Handayani et al, 2019 conclude that BPOM scope of responsibility is not only specific and focus on medicine control, but also other commodities, such as cosmetics, traditional medicines, and food products. As SF-related policies are only one part of the policy on whole scope of the BPOM, the sustainability of policies and program tend to be inconsistent. The task force involving collaboration with the stakeholders with a defined shared-responsibility would be alternative to develop a continuous and sustainable program in combating SF. It will also able to minimize the BPOM barrier related limitation of authority and insufficient resource for vast coverage area which will not able to be resolved in near future. Moreover, prevention and detection program in combating SF shall be the main agenda in the policy. As it should be involving society to be able to provide an efficient and effective early detection system. Strengthening and empowering the role of private and community shall become a priority.