Supply Chain Security Toolkit for Medical Products

Comprehensive product quality and supply chain security requires a multilayer approach that includes prevention, detection, and response strategies and actions. The Supply Chain Security Toolkit is a resource that addresses areas of vulnerability in the medical product supply chain. The Toolkit is intended to cover the entire supply chain and life cycle of medical products (i.e., raw materials to use by patients) and focuses on developing— and implementing through training programs— processes, procedures, and tools directed at enhancing global medical product quality and supply chain security. The Toolkit contains recommended best practices and tools to prevent and detect S&F medical products before they reach the consumer and to efficiently respond to incidents involving S&F medical products.

While a comprehensive list of resources is not feasible, the workgroup compiled numerous documents illustrative of product quality and supply chain security considerations. For each toolkit, selected economies and regions face different economic, health and pharmaceutical realities, and program designs will reflect those unique and varied conditions. One country or institution is not being favored over other economies or institutions when choosing documents included in the Toolkit.

The documents provided are intended as resources for economies and regions to assist them in developing their own product quality and supply chain security programs that will address the unique circumstances they face.

The Toolkit can be used in conjunction with the World Health Organization’s (WHO) guidance, linked below, in developing a national plan.

Note: The APEC Supply Chain Security Toolkit was developed prior to the endorsement of the WHO S&F definitions and should be viewed as in alignment with the S&F definitions agreed upon by WHO Member State Mechanism.

Appropriate manufacturing is essential for global medical product quality and supply chain security. The materials below identify best practices related to medical product supply chain security, providing current good manufacturing practices (CGMP) recommendations for stakeholders. These recommendations for best practices are intended to minimize divergent practices and opportunities for the introduction of substandard and falsified (S&F) medical products into the global supply chain.

The information and materials below are intended for industry stakeholders and National Medical Regulatory Authorities (NMRAs)-

1. Industry may use this information to adopt best practices;
2. NMRAs may use this information to strengthen laws and regulations; and
3. Industry and government may use for training purposes.

To ensure supply chain security and integrity and maintain product quality, good distribution practices (GDPs) should be followed by all stakeholders as medical products move through the supply chain. The materials provide recommendations for the standardization and convergence of GDPs, focusing on supply chain security across industry, while accounting for evolving regulations.

The information and materials below are intended for industry stakeholders and National Medical Regulatory Authorities (NMRAs)-

1. Industry may use this information to adopt best practices;
2. NMRAs may use this information to strengthen laws and regulations; and
3. Industry and government may use for training purposes.

Trade allows for the global distribution of new medical products, providing health benefits to patients around the world. However, inadequate and ineffective regulatory controls facilitate the movement of S&F medical products and have detrimental public health consequences. Materials and information are being developed with best practices related to good import and export practices.

It is essential that quality control measures are implemented at dispensing sites, (e.g., retail and hospital pharmacies,) because they serve as the last opportunity to prevent patients from getting S&F medical products. Such measures should span from the time of purchase and receipt, to storage, and until the products are dispensed or administered. The information and materials provide overviews of clinical and retail pharmacy practices across APEC economies, identifying best practices and resources required to support implementation.

The materials are intended for industry stakeholders, National Medical Regulatory Authorities (NMRAs), and healthcare practitioners.

1. Industry may use this information to adopt best practices;
2. NMRAs may use this information to strengthen laws and regulations; and
3. Healthcare practitioners may use this information to improve patient care and outcomes
4. All may use for training purposes

Given the continued growth of threats to the global medical product supply chain, including substandard and falsified (S&F) medical products, cargo theft, intentional adulteration, product diversion, substandard products, and product tampering, holistic, end-to-end supply chain solutions are necessary to ensure the security and integrity of the supply chain. The information and materials cover comprehensive supply chain security programs, managing upstream supply chain threats, mitigating the risks of cargo theft, audits of logistics service providers, monitoring marketplace threats to supply chains, responding to supply chain security breaches, and measuring the effectiveness of supply chain security systems.

A good management system aimed at establishing standards through corporate policies, quality procedures, employee training, and the thoughtful selection of suppliers and distributors can assist firms in implementing effective product security measures.

The information and materials are intended for industry stakeholders and National Medical Regulatory Authorities (NMRAs)-

1. Industry may use this information to adopt best practices;
2. NMRAs may use this information to strengthen laws and regulations; and
3. Industry and government may use for training purposes.

Various tools are available for stakeholders to use at different points in the supply chain to assure the quality and authenticity of medical products. Detection of substandard and falsified (S&F) medical products, and authentication of drug product and packaging, requires the use of numerous complementary features and modes of analysis, such as visual, chemical/forensic, and track and trace. The information and materials highlight the capabilities and limitations of these technologies and provide guidance on the appropriate selection and application of detection technologies to help ensure the integrity of medical products along the entire supply chain.

The growing trend of consumers purchasing their medical products on the Internet is worrisome because of the fraudulent pharmacy websites that offer for sale substandard and falsified (S&F) medical products. Often times the consumer is not receiving the drug they purchased, or it may be an incorrect dosage, sub-potent, super-potent, or contain no active ingredient at all. The information and materials define the scope of the internet sales problem, present recommendations for combatting illegal internet medical product sales, and provide publicly available resource materials. The Internet Toolkit offers key definitions that pertain to internet sales of medical products globally to help national medical regulatory authorities distinguish between legally-operating online medical product sellers and illegal entities.

The information and materials are intended for industry stakeholders, National Medical Regulatory Authorities (NMRAs), healthcare practitioners, and consumers

1. Industry may use this information to adopt best practices;
2. NMRAs may use this information to strengthen laws and regulations
3. Healthcare practitioners may use this information to communicate risks to patients; and
4. Consumers may use this information to make more informed healthcare decisions

The ability to track and trace medical products is critical to curtailing counterfeiting and diversion in the legitimate supply chain. Global standards to identify, capture, and share product information that can enable the authentication and traceability of medical products from manufacturer to patient is essential. The information and materials focus on best practices and resource materials for finished pharmaceutical products; however the same principles may be applied to other associated medical product supply chains as well.

Surveillance and monitoring of medical products is a key regulatory function of national/regional regulatory authorities aimed at the prevention, detection, and response to S&F medical products. Products that don’t meet quality specifications should be removed from the market.

In today’s global markets of complex supply chains and porous national borders, S&F products can enter distribution and reach patients and consumers. These products, particularly medicines, may not only fail to achieve the intended efficacy but could pose other health risks, including contributing to drug-resistance, and death.

Post-Market Surveillance (PMS) is an important part of surveillance and monitoring. The SM toolkit includes international guidelines and technical documents focused on PMS. These materials cover a range of topics, including guidelines on quality testing and sampling drug products, tools supporting different stages of PMS program implementation, and information about global evidence-based data on the prevalence of poorquality products. In addition, examples of national and regional PMS programs are provided.

The PMS programs selected were established by regulatory authorities that are included in the World Health Organization’s (WHO) list of Transitional Authorities or developed in collaboration with experts from internationally recognized organizations (e.g., WHO, U.S. Pharmacopeia, and others).

Due to the globalized nature of medical product supply chains, incidents involving substandard and falsified (S&F) medical products often affect more than one country. Therefore, a well-maintained SPOC network allows authorities to implement best practices, promote cooperation and information exchange for health authorities, customs, police, and other competent authorities at the national level, and international cooperation in the risk management of S&F medical products. The toolkit provides recommendations for National Medical Regulatory Authorities implementing a SPOC system. This includes: 1) identifying officials at the national and international level for the purpose of coordinating regulatory, law enforcement, and judicial actions taken proactively and 2) reactively addressing incidents involving substandard and falsified medical products.