Interest in protecting the drug supply chain is becoming top of mind for drug manufacturers, technology providers, and governments as they begin to understand the current and elevated risks to patient safety. Regulations are well-defined for manufacturing of medicines however, this is not the case for drug transport. When products leave the manufacturer’s warehouse on their trek to wholesalers, pharmacies and patients, there are few concrete regulations and no common guidance upon which to build a sound Good Distribution Practice (GDP). The fear of harm to patients is real. Recent warehouse break-ins and truck hijackings that divert needed medicines to waiting patients have resulted in many harmful actions that have been attributed to patient deaths. Some of these actions include counterfeit products that rob patients of treatment regimens they thought valid; compromised products due to temperature excursions that render drugs impotent; and even worse, tampered exipients in the case of heparin and ethylene glycol. The March 2011 Parenteral Drug Association (PDA) Cold Chain conference created a forum for those in the industry who aired their concerns, discussed ideas that could mitigate risks and brainstormed impending guidance documents. While most agree that the solution will be driven by a combination of agency regulations, container, logistic, security and temperature monitoring technologies adopted by suppliers and manufacturers, it is far from certain what path the answer will take. Manufacturers have the burden of responsibility for ensuring that quality drugs meet their intended purpose. It means, in theory, up to the point when drugs are administered to patients, they take it seriously and invest heavily to comply with Good Manufacturing Practice (GMP) regulations. However, detailed guidance for supply chain integrity does not exist. It's a new era for all constituencies. Conference attendees, including large pharmaceutical and logistics providers, had many more questions than answers. While the pharmaceutical industry is in contraction, companies are still willing to invest where there is a clear outcome to mitigate risk. Answers on how to buttress the supply chain are not yet forthcoming. I believe it will happen but only with industry guidance to clarify recently and soon-to-be published GDPs. Regulations have always been subject to interpretation by the industry, but when guidance is too vague, it is difficult to be proactive about correcting deficiencies. Many companies will look to regulators to make the first move. When the U.S. Food and Drug Administration (FDA) begins inspecting stored products downstream, the industry will have some reference from any observations made. As one pharmaceutical manufacturer said at the meeting after inspectors completed an audit of their warehouse: "The next inspection will be at your distribution center." That was two years ago. The stakes are high for the industry and the public. For every new regulation there is a cost of compliance, and companies must weigh the investment in quality against other factors such as the need to be profitable. For big pharma, revenues are in threat of decline as patents for exclusivity run out, resulting in cutbacks for investments in drug discovery. As someone said at the International Society for Pharmaceutical Engineering (ISPE) Spring 2011 conference, only one new medicine is coming into the market for every two that are leaving. Makers of generics are happy about being able to make more types of drugs but cannot charge the price of newly discovered medicines, which also factors into their costs to comply. The transport of drugs takes many routes with untold hand-offs between stationary and mobile storage sites. New regulations and uncharted territories are great incentives for suppliers to fill the void with technology. They will show up to tackle areas such as temperature monitoring, containers temperature uniformity and vibration stability, Standardized Numerical Identification (SNI), logistics tracking and others. Ideas with great promise are out there, but need industry acceptance before they will invest, which means solutions that are cost-effective.Meeting regulations is the goal of all pharmaceutical companies. They cannot do business without being compliant with Good Manufacturing Processes (GMPs). While independent GDP regulations have been drafted by 35 countries, the language in these 1,000 plus pages are taking a common form. That’s good news in the sense that it should be easier for manufacturers to develop a unified approach to meeting most countries' compliance demands. It will also allow suppliers to focus solutions on high risk areas. In 2011, more meetings on supply chain management will take place within North America and Europe. From these meetings, new regulations, guidance and check lists will evolve. Each one exposes a new group of quality, supply chain, security, and regulatory professionals to solve a growing global challenge: How to ensure a drug meets its intended purpose for a patient one mile away from a manufactures distribution center or a clinic on the side of the world.If would like to start a dialog to share experiences, notes from conference meetings, or any perspective on supply chain, please e-mail me at [email protected].
