The concern with medical suppliers and vendors has grown in significance in recent years. From tainted heparin, to melamine used as an ingredient in pet food and toothpaste, to unknown ingredients introduced into medical supplies through ghost suppliers and vendors, the resulting patient deaths, crippling injuries and acute patient trauma have grown in complexity. We have witnessed extraordinary ignorance and carelessness regarding the nations medical supply chain. In most of these instances, unidentified foreign material has been introduced into the supply chain without manufacturers and consumers being aware of it. Further, incoming inspection often is weak and lacking in sufficient depth to detect alien material in time to stop the product from reaching the market.
Medical Supply Chain
Nutraceuticals – As manufacturers seek supplies, new suppliers have materialized in China, India, Pakistan, Bangladesh, Brazil, etc. often in collaboration with US vendors offering supplies at lower prices. Fifteen years ago a friend of mine who worked for a medical device insurance company told me her company was going to start insuring nutraceutical manufacturers, in particular manufacturers of dietary supplements. For the insurance company nutraceutical manufacturers offered an attractive new market. Today the nutraceutical market is estimated at $86 billion dollars.
She had just visited some foreign suppliers to US manufacturers and was shocked at the crude storage of raw ingredients being readied for shipment to US manufacturers. It was a marked contrast from the sanitary conditions and FDA regulation of US medical device and pharmaceutical manufacturers. As a consumer of dietary supplements, I was more than a little interested in her information and concern.
Compounding Laboratories & Heparin – Pharmaceutical grade heparin is a widely used anticoagulant derived from the mucosal tissues of slaughtered meat animals such as pigs and cows. With its large consumption of pork, China has become a major producer of heparin for the US market. Heparin is widely prescribed by physicians for use as a blood thinner. A few years ago, a US distributer supplying heparin for medical uses was caught up in a controversy when patients using heparin became gravely ill and over 80 persons died.
The American distributer responded that they purchased their supplies from consolidation laboratories in China. At the same time I was reading articles and looking at pictures in the New York Times showing diseased pig intestines draped over concrete sinks in rural China being washed with dirty water. The Chinese farmers wanted to recover losses from diseased pigs and found intestines for heparin offered an avenue to make some money. Clearly, the US supplier went no deeper that the consolidation laboratory in their audit of suppliers and did no research on the origin of intestines for the consolidation laboratory.
It is not an unusual scenario, US suppliers often don’t speak the language or know the culture where they obtain their supplies. They fail to dig deep enough in who is sourcing the consolidation laboratories. Consequently, they are easy victims for foreign vendors who take advantage of their linguistic and cultural ignorance.
It reminded me of being at a reception in Guatemala City when I was on a research project in graduate school. A professor from a US University who did not speak Spanish and attended the reception told me that he always ordered iced tea when he was visiting countries in Central America, because he knew that water would have to be boiled in order to make the tea and was therefore safe. A Costa Rican colleague of mine said in Spanish in front of the same professor that everyone knew his strategy, but in fact the water came from a tap, dehydrated tea was added with ice cubes also from tap water and given him to drink. All the while the same professor who did not understand a word of our conversation happily drank his tea.
Of course deadly medical supplies are far more significant than tea made from questionable water, but I never forgot the lesson on cultural and linguistic ignorance. Over a two-year research project in Costa Rica and Guatemala I saw numerous examples of Americans failing to understand the language and local culture, make flawed assumptions and write articles and books that were inaccurate.
Compounding Pharmacies & Steroid Injections – In October of 2012 a Massachusetts based New England Compounding Center was linked to a contaminated steroid medication for meningitis. When first reported 170 people in 11 states had become sick and 14 had died. By February 2013, 651 illnesses and 45 deaths were linked to the compounding center. An investigation revealed serious safety lapses, unsanitary conditions and questionable supplies.
News reports noted that compounding pharmacies and laboratories supply about 40 percent of all intravenous medications used in hospitals. They make some of the highest risk drugs available yet are not required to follow the safety rules that apply to commercial drug manufacturers. Needless to say, supplier audits are not required, rarely performed and incoming inspection of supplies to determine that a lab received what it ordered is weak at best. Consequently, the safety of supplies used to make compounds often is questionable.
Compounding pharmacies are designed to fill a gap between large pharmaceutical manufacturers and a need to have patient specific products made to order which is known as traditional compounding. The problem appears to have risen in part from a reliance of hospitals on compounding pharmacies to meet their regular supply needs turning these pharmacies into small to medium mass scale production manufacturers of a product rather than patient specific production, and creating what few observers have called non-traditional compounding. Making the role of compounding pharmacies more complex and problematic is the issue that they are not overseen by the FDA but instead by State Pharmacy Boards which vary in the quality of their oversight. I want re-visit this topic in a future blog. For the moment, however, my focus is on manufacturer supplies and supplier audits.
All Medical Device, Pharmaceutical and Biologic Manufacturers are supposed to audit their suppliers to make certain that the Vendors are competent and capable of delivering supplies in the condition stipulated by the purchaser, e.g. Manufacturer. FDA oversight and EU third party notified body oversight greatly help the process. I have worked with a number of medical device companies that were told by FDA to improve their supplier oversight by increasing the number and quality of their supplier audits. In these cases their suppliers were located in the US & Canada.
With the increased number of supplies coming from sources in China, India, Bangladesh, Brazil, etc. and around the world, supplies and suppliers require more in depth scrutiny to make certain that manufacturers, laboratories and pharmacies actually receive what they order. This will require improved incoming inspection. Trusting an intermediate entity such as a Heparin Compounding Laboratory in China isn’t sufficient.
In the cases of melamine entering the US & Canadian supply chain, Chinese suppliers frequently didn’t care what happened to end users, they just wanted to make money. Hopefully, they will be punished by the Chinese Government, but that doesn’t undo the damage to humans and pets in the US, Canada and Panama and improve supplies. If supplies of certain ingredients aren’t reliable, then it will be necessary to choose suppliers from more relaible countries other than China.
Finally, US companies have to conduct in depth analysis of the real source of supplies. These companies also must conduct a rigorous analysis of incoming supplies to assure that the company receives what they ordered. This may require hiring field personnel who are linguistically proficient and culturally aware of potential supplier risks.
My primary focus is on International Regulatory Compliance, which includes both the requirements of regulatory authorities and the legal implications of compliance, non-compliance, documentation and sloppy attention to detail that could result in a lawsuit in a US Federal Court or state courts. I focus on product safety, product liability and the steps necessary to create a safe product and serve as Legal Expert/Expert Witness where safety has been compromised or ignored resulting in damage and/or injury. If you have questions regarding ISO 9001, FDA’s Quality System Regulation or CE Marking lawsuits you can contact me for a free preliminary consultation at my e-mail address firstname.lastname@example.org