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Pharmaceutical Supply Chain: Security Measures and Impact on Patient Safety

The pharmaceutical industry has a muddled history when it comes to quality of critical supplies. In addition to patient safety, a primary focus of both the Federal Drug Administration (FDA) and other global health authorities are the oversight of finished product marketing and movement, which is impossible to achieve without clear planning and control over the supply chain. The ability of industry to provide safe and effective medications to patients and health care facilities hinges on the manufacturers process controls. Several instances of security initiatives have been implemented to minimize impact on accessibility and the risk on patient health, as discussed in the following sections.

Risks to Patient Safety

Ensuring the health and well-being of patients is an imperative not only for health authorities, but the entire industry. Substandard and falsified medicines may cause severe damage to patients leading to untreated diseases, shortages in supply and an overall decrease in public trust. In some cases, poor supply chain practices may cause serious adverse effects including life-threatening situations and/or death. These products suffer from both quality and effectiveness issues by inadequately treating the related condition. One risk associated with this is the public losing their trust in the manufacturer and health care systems.

Global Supply Chain Requirements

The foundational requirement in producing drugs, as well as developing procedures for global supply chain security, is to make sure that pharmaceuticals are safe to use. The quality and efficacy of finished products must remain high through the product's expiry. This requirement is felt amongst all the stakeholders, including manufacturers, distributors, health care providers and other auxiliary industry partners.

With an increased focus on security comes an increased concern on health care costs. When pharmaceutical prices rise, there may also be an impulse to buy medicines from unauthorized or black-market sources, leading to an influx of falsified medicines. A public health emergency like the current COVID-19 pandemic has given the pharmaceutical industry a broad example of the delicate balance in the global supply chain vulnerabilities, which can quickly impact patient safety.

United States Pharmacopeia (USP) Initiatives Against Falsified Medicines

 As defined by USP, vulnerabilities in the global medicine supply chain can also have a direct impact on patients in the U.S., as well as globally. USP has worked in collaboration with global health authorities to ensure trust in the global supply chain and to minimize the impact of poor-quality medications on patient health. The approach of USP standards is simple and holds companies accountable to maintain the quality of the medical product: Define the standards and make them accessible for stakeholders to increase quality and decrease risk.

USP standards provide a benchmark for manufacturers to test medicines and comply with Current Good Manufacturing Practices (cGMP) requirements. These public standards help ensure the right ingredient is utilized in the correct amount by the right personnel during the manufacturing of a drug product.

FDA Approach to Supply Chain Security

In June 2021, FDA finalized a guidance on Identification of Suspect Product and Notification to counteract and support implementation of initiatives based on Drug Supply Chain Security Act (DSCSA) of 2013. The onus for security is placed on manufacturers, repackagers, wholesale distributors, and dispensers for identifying suspect product and notifying health authorities as well as other partners no later than 24 hours after making the determination. The requirement to terminate notifications of illegitimate product and products with a high risk of illegitimacy in consultation with FDA is defined within this guidance.

Additionally, the DSCSA outlines critical steps to build an electronic, interoperable system over a 10-year period that will identify and trace certain prescription drugs as they are distributed within the United States. The intent is to ensure traceability of errant and harmful products as well as ensure accountability and enforcement legally.

FDA provides guidance on strategies for identification of suspect or illegitimate product which reduces risk to manufacturer reputation, legal liability, and patient safety.

Overcome Threats With the Right Partner

The foundation of the excellent relationship between pharmaceutical companies and the public is “trust.” People spend their lives and their savings to receive quality health care in much of the modern world. Communication and proper oversight of the global supply chain are the keys to ensuring continued patient safety and access. While supply chain disruptions, falsified medicines and suspect product pose a threat to patient health and safety, the only way to overcome these threats are to work with global partners in implementing security initiatives.

Contact a Partner today to learn more about how we’re supporting regulatory affairs in the pharmaceutical industry.

The pharmaceutical industry has a muddled history when it comes to quality of critical supplies. In addition to patient safety, a primary focus of both the Federal Drug Administration (FDA) and other global health authorities are the oversight of finished product marketing and movement, which is impossible to achieve without clear planning and control over the supply chain. The ability of industry to provide safe and effective medications to patients and health care facilities hinges on the manufacturers process controls. Several instances of security initiatives have been implemented to minimize impact on accessibility and the risk on patient health, as discussed in the following sections.

Risks to Patient Safety

Ensuring the health and well-being of patients is an imperative not only for health authorities, but the entire industry. Substandard and falsified medicines may cause severe damage to patients leading to untreated diseases, shortages in supply and an overall decrease in public trust. In some cases, poor supply chain practices may cause serious adverse effects including life-threatening situations and/or death. These products suffer from both quality and effectiveness issues by inadequately treating the related condition. One risk associated with this is the public losing their trust in the manufacturer and health care systems.

Global Supply Chain Requirements

The foundational requirement in producing drugs, as well as developing procedures for global supply chain security, is to make sure that pharmaceuticals are safe to use. The quality and efficacy of finished products must remain high through the product's expiry. This requirement is felt amongst all the stakeholders, including manufacturers, distributors, health care providers and other auxiliary industry partners.

With an increased focus on security comes an increased concern on health care costs. When pharmaceutical prices rise, there may also be an impulse to buy medicines from unauthorized or black-market sources, leading to an influx of falsified medicines. A public health emergency like the current COVID-19 pandemic has given the pharmaceutical industry a broad example of the delicate balance in the global supply chain vulnerabilities, which can quickly impact patient safety.

United States Pharmacopeia (USP) Initiatives Against Falsified Medicines

 As defined by USP, vulnerabilities in the global medicine supply chain can also have a direct impact on patients in the U.S., as well as globally. USP has worked in collaboration with global health authorities to ensure trust in the global supply chain and to minimize the impact of poor-quality medications on patient health. The approach of USP standards is simple and holds companies accountable to maintain the quality of the medical product: Define the standards and make them accessible for stakeholders to increase quality and decrease risk.

USP standards provide a benchmark for manufacturers to test medicines and comply with Current Good Manufacturing Practices (cGMP) requirements. These public standards help ensure the right ingredient is utilized in the correct amount by the right personnel during the manufacturing of a drug product.

FDA Approach to Supply Chain Security

In June 2021, FDA finalized a guidance on Identification of Suspect Product and Notification to counteract and support implementation of initiatives based on Drug Supply Chain Security Act (DSCSA) of 2013. The onus for security is placed on manufacturers, repackagers, wholesale distributors, and dispensers for identifying suspect product and notifying health authorities as well as other partners no later than 24 hours after making the determination. The requirement to terminate notifications of illegitimate product and products with a high risk of illegitimacy in consultation with FDA is defined within this guidance.

Additionally, the DSCSA outlines critical steps to build an electronic, interoperable system over a 10-year period that will identify and trace certain prescription drugs as they are distributed within the United States. The intent is to ensure traceability of errant and harmful products as well as ensure accountability and enforcement legally.

FDA provides guidance on strategies for identification of suspect or illegitimate product which reduces risk to manufacturer reputation, legal liability, and patient safety.

Overcome Threats With the Right Partner

The foundation of the excellent relationship between pharmaceutical companies and the public is “trust.” People spend their lives and their savings to receive quality health care in much of the modern world. Communication and proper oversight of the global supply chain are the keys to ensuring continued patient safety and access. While supply chain disruptions, falsified medicines and suspect product pose a threat to patient health and safety, the only way to overcome these threats are to work with global partners in implementing security initiatives.

Contact today to learn more about how we’re supporting regulatory affairs in the pharmaceutical industry.

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