Increasing Transparency in the Global Medical Supply Chain

 Improper use of medical product supply can lead to contamination of medical equipment and supplies. Imitations of original and certified products are also produced by many manufacturers. This situation leads to significant health risks, while posing a huge financial loss to the health care system as well. Imitation products can be extremely dangerous and should be avoided.

The main sources of medical product supply shortages include counterfeit and substandard drugs, medical devices, and supplies. Faulty and unsafe medical devices pose a serious threat to public safety, while failing to meet required standards and leading to the overuse of the product. Examples of these devices are endoscopes, surgical machines, and lasers. Imitations of certified and approved drugs also pose a threat to public health. These include antibiotics, chemotherapy medications, cancer medications, sedatives, and aspirin. Likewise, defective and substandard medical devices contribute to various types of health threats and provide for an enormous financial burden on public health care systems.

There are many instances of medical devices and drugs being supplied to the United States by companies that have no experience or manufacturing license. In addition, there are many cases where medical devices or drugs are distributed by non-licensed manufacturers, which are not subject to the same supply regulations and inspections as licensed suppliers. These practices have resulted in a dramatic increase in the accidental or unneeded deaths of individuals who take vital medicines. To address this problem, the Food and Drug Administration (FDA) has established numerous guidelines for manufacturers to follow to ensure the highest quality of medicine that reaches the public.

There have been a number of reports of supply shortages due to manufacturers ceasing operations, moving production facilities to other countries, and/or closing down their pharmaceutical plants. In response to these supply shortfalls, the FDA has held temporary supply freeze orders. While these steps have helped to mitigate some supply shortfalls, the FDA has warned that drastic cuts to the food and drug supply may be on the horizon. The FDA has repeatedly emphasized that it is monitoring both short-term and long-term trends regarding pharmaceuticals, identifying potential product shortages and outbreaks before they occur.

According to the FDA, the three most common sources of medical supplies that are subject to sporadic shortfalls include wholesalers, retailers, and direct suppliers. Wholesalers are the U.S. distributors of medicines that are not retail-ready. They frequently import raw materials from abroad and must comply with all export requirements. Because wholesalers usually have access to raw materials that are either unavailable or expensive, they frequently experience supply shortfalls. In addition, wholesalers must comply with all foreign laws governing foreign-imported medicines, including import restrictions and fees, which can reduce their profitability and force them to close their operations.

Importers typically obtain bulk quantities of the medicine that they can resell. Importers frequently falsify the quantities of drugs that they sell to achieve higher profits. The majority of importers have not established good documentation or reliable reporting systems to track the movement of goods in large quantities. Importers are a key contributor to the global medical supply chain because they are required to keep detailed records of the items they buy and sell. However, according to the FDA, the majority of importers have not submitted all necessary reports to support their claims that they regularly monitor the health of their customers. 

In response to these high costs and uncertainties inherent in the global medical product supply chain, several organizations have formed partnerships to provide information to prescribers about their stocks of drugs, devices, and medicines. For example, the Blue Cross and Blue Shield pharmaceutical companies jointly distribute data about emergency store inventories to thousands of doctors and hospitals nationwide. Similarly, the American Society of Clinical Oncology and the American Society of Health Quality Assessors require manufacturers to submit data on all pharmaceuticals they produce and ship to pharmacies on a regular basis. PPE Products

To address the issues outlined above, the United States is requiring manufacturers of medical devices and pharmaceuticals to develop and maintain a coordinated strategic national stockpile. According to the strategic national stockpile initiative (TVSI), developed by the National Institute of Health (NIH), the national strategic stockpiling of medications includes at least one of eight core groupings: antibiotics, diagnostic imaging devices, blood supplies, therapeutic supplies, surgical products, antimicrobial medicines and vaccines. According to TVSI, when such a group is reached by a manufacturing manufacturer, that manufacturer should immediately dispatch one of its products to a primary dealer and then contact that dealer within one business day. If the dealer cannot accept the product, it should return the item to the manufacturer for further processing. This process of secondary processing helps reduce the average cost of production and maintains pharmaceutical stability.