Turning raw materials into pharmaceutical products and delivering those medicines safely to patients at the right time and place requires an extremely complex and precisely orchestrated network of suppliers, manufacturers, contract organizations, third-party logistics providers, distribution warehouse, retail pharmacies, and health systems. A supply chain for any given therapy or drug may cross multiple international borders and be subject to a wide variety of compliance obligations, business objectives, and distribution challenges before reaching the patient.
With a contribution to global gross domestic product approaching nearly half a trillion U.S. dollars, the pharmaceutical industry is an important part of the world economy. Modern healthcare outcomes would be impossible without a safe and secure supply of medications and drugs, and the pharmaceutical supply chain that delivers these therapies to patients is a crucial component of modern life.
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Pharmaceutical supply chains begin with the sources of commodity chemicals used in the active ingredients, as well as inactive ingredients and packaging. Natural resources such as sand for glass vials; petroleum for plastics and basic chemical building blocks of medicines; and agricultural products that yield important biological compounds comprise some starting points in the pharmaceutical supply chain.
Depending on the resource, these basic components may be further refined at facilities that manufacture goods for a host of uses beyond medicines. Corning™ produces specialized glass for vaccine vials, but also produces glasses for smartphones and fiber optics.
Managing a network of suppliers to ensure the safe and timely production of pharmaceutical products presents a range of challenges for pharma companies, and failing to manage these suppliers effectively can have consequences on the broader pharmaceutical supply chain. For example, quality defects, packaging problems, or production delays can cause disruptions with downstream trading partners and ultimately patients, directly impacting costs, medicine availability, and other business objectives.
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The pharmaceutical industry supply chain incorporates the various raw and refined inputs from other industries into medicines. For medicines that use basic ingredients, the facility where the packaged pharmaceutical is produced may do little more than simply combine the ingredients. Pure active ingredients are mixed with inert carriers according to therapeutically appropriate dosing.
Other pharmaceutical plants are advanced laboratories built to an industrial scale. Insulin is produced in specialized equipment that can culture bacteria that has been genetically modified to produce human insulin. Further refining and purification may take place at the pharmaceutical plant before being formulated into deliverable therapies.
Recent legislation in more than 50 countries has led to pharmaceutical serialization requirements. These laws stipulate that every saleable unit of pharmaceuticals sold must have a unique serial number that can be traced to the point of manufacture. Pharmaceutical serialization track and trace regulations help to ensure the safety and security of pharma supply chains, and helps prevent counterfeiting, diversion, and theft.
Pharmaceutical supplies are ultimately delivered as medical therapies to patients. A traditional logistics network may link the plant where the medicines are produced to the hospitals, clinics, or doctor's offices where they are administered. For example, the BioNTech COVID-19 vaccine is being distributed by Pfizer using UPS and FedEx as cold chain couriers.
The safety and security of the pharmaceutical supply chain must also take into consideration unused pharmaceuticals, especially with substance with high black-market value and abuse potential, like opiates and benzodiazepines, making arrangements for collecting and disposing of leftover medications is a public health concern. Some municipalities have organized drug donation or disposal events where unused medications can be collected and safely disposed of.
FAQs: Which regions produce the most pharmaceuticals?
Which regions produce the most pharmaceuticals?
Asia has the highest output in terms of the value of pharmaceuticals produced. Europe and North America also produce a large amount of pharmaceutical products.
Why is pharmaceutical cold chain management a challenge?
A pharmaceutical cold chain requires consistently low temperatures from the moment of manufacture until the moment of administration to a patient. Some compounds require the maintenance of a cold chain at cryogenic temperatures, meaning at least -150° Celsius. This requires specialized equipment and facilities; should there be an interruption in the cold chain, the pharmaceuticals may lose their effectiveness.
What makes the pharmaceutical supply chain unique?
The pharmaceutical supply chain has unique requirements due to the nature of medical treatments. The consequences of supply chain disruptions in the clothing industry are unlikely to result in increased mortality; however, a shortage of insulin could lead to very real risks to patient safety, including death. Furthermore, counterfeit medicines or medicines that have lost their efficacy due to a break in a cold chain may not appear to be different than potent medicines. A patient may be administered the defective medicine, with possible negative health outcomes.
What are examples of a basic ingredient for a medicine?
Lithium salts are one of the most widely prescribed drugs for a variety of conditions. The most common chemical formulation of lithium is a basic salt composed of lithium hydroxide and citric acid, both of which are commodities.
How do counterfeit drugs affect the pharmaceutical supply chain?
The threat of adulterated medicines makes keeping track of the various links in the pharmaceutical supply chain an issue of public health. To this end, many governments have implemented pharmaceutical serialization requirements which allow the legitimacy of every saleable dose of medicine to be ascertained by checking a unique serial number.