With the pharmaceutical supply chain becoming more global and complex, regulators, industry groups and academics from around the world have developed a new toolkit of resources to increase harmonization across borders to ensure the quality of drugs from manufacture through ingestion.
The new toolkit, born out of a five-year collaborative project that actually took four years to complete, brings expertise from the US Pharmacopeial Convention (USP), US Food and Drug Administration (FDA) and Asia-Pacific Economic Cooperation (APEC) to offer best practices, guidance, training materials and more to better educate regulators, industry and other stakeholders in 10 different areas:
- Good manufacturing practices
- Good distribution practices
- Good import/export practices
- Clinical/retail pharmacy practices
- Product security
- Detection technology
- Internet sales
- Track and trace systems
- Surveillance and monitoring
- Single points of contact
Ilisa Bernstein, deputy director of FDA’s Office of Compliance, told representatives of regulators from more than a dozen countries at a USP gathering on Tuesday that the supply chain needs to be protected from vulnerabilities and threats from the point at which active pharmaceutical ingredients and inactive ingredients are produced all the way until the product gets to the patient.
And as she and other speakers noted, this is not a task that each country can complete individually because there are so many different multi-national players operating within the pharmaceutical supply chain.
In many parts of the world, like the US and western Europe, the quality of medicines can be taken for granted, Ron Piervincenzi, CEO of USP, noted. Although one slip-up can cost lives.
And for some low- and middle-income countries, the quality of medical products is a risky issue, particularly if a drug shortage looms and falsified or substandard products can fill a gap to meet demand.
Michael Deats, group lead on safety and vigilance at the WHO, said that anti-malarial medicines and antibiotics are the most frequently found drugs to be substandard or fake. But more recently, criminals are targeting more expensive medicines to counterfeit.
Gilead’s expensive hepatitis C cures have been targeted more recently, Deats said, noting that in Japan some packages of Harvoni (ledipasvir/sofosbuvir) were found to be filled with vitamins. He also noted reports of Sovaldi (sofosbuvir) stolen from hospitals in Pakistan and re-packaged and sold as Harvoni in Israel.
In addition, in 2016, falsified vaccines for hepatitis B, tuberculosis, polio and tetanus were found in Indonesia, while in Bangladesh, fake yellow fever vaccines were also found. Deats also explained the need for new smartphone applications that can quickly (within 90 seconds) identify falsified medical products.
Interactive APEC Supply Chain Security Toolkit
Supplier and Supply Chain Qualification and Supply Chain Verification: Roadmap for Global Medical Product Integrity and Supply Chain Security; Manufacturing Practices Work Group