More than 100 drugs face supply chain shortages, FDA says

"In shortage" drugs include antidepressants, antibiotics, heart medicines, cancer-fighting drugs, and pain killers.

More than 100 pharmaceutical drugs are facing supply chain shortages, the U.S. Food and Drug Administration (FDA) warned.

Drugs currently listed as "in shortage" by the FDA include antidepressants, antibiotics, heart medicines, cancer-fighting drugs, and pain killers.

"The FDA continues to take steps to monitor the supply chain," the federal agency wrote.

"The Drug Shortage Staff within the FDA’s Center for Drug Evaluation and Research (CDER) has asked manufacturers to evaluate their entire supply chain, including active pharmaceutical ingredients, finished dose forms, and any components that may be impacted in any area of the supply chain due to the COVID-19 outbreak," the FDA wrote in a statement on the shortage.

Products regulated by the FDA account for 14% of imports and 15% of exports in the United States. The agency also reports that "about 80 percent of active pharmaceutical ingredients manufacturers are located outside of the U.S."

The National Community Pharmacists Association's November poll showed that 60% of pharmacies report facing supply chain disruptions. Exacerbating issues, 68% of pharmacies stated they are facing staffing shortages.

At WorstPills.org, they “list the drugs we and our consultants think you should not use. For each of these, we recommend safer alternatives.” This excellent website is worth the small yearly fee. Their simple rule is to wait seven years after drugs go on the market before using them. Lack of efficacy and harmful side effects are usually apparent by then. They describe the “seven deadly sins” of medication use. You can often spot them, even if your physician does not. The following are from their superb article, “Misprescribing and Overprescribing of Drugs.” ✪ Treating side effects of one drug with more drugs. ✪ Prescribing drugs when life-style changes are more effective. ✪ Using drugs that do not work. Virus treatment with antibiotics is an example. ✪ Use of new drugs rather than the simplest and cheapest. ✪ Prescribing multiple drugs that interact with each other. ✪ Multiple drugs are used rather than just one. ✪ Prescribing doses that are too high. If you decide that you need medications, price-shop them. Several websites show the cheapest costs for each insurance plan. You can often find drugs for even less than your copay. See: ✪ HealthWarehouse.com ✪ GoodRx.com ✪ BlinkHealth.com ✪ WeRx.org ✪ Costco and Sam’s Club ✪ Independent and grocery store pharmacies ✪ Shopping outside the US (see below) Watch your retail pharmacy closely to avoid being overcharged. They are not like a grocery store. Price shopping for food is natural, you understand it, and in some stores, prices are nearly wholesale anyway. Since you rarely go to the pharmacy, price comparison is more difficult. You know much less about drugs than the pharmacist, and they will gouge you if you are not careful. For example, the mupirocin antibiotic ointment (oil-based, Bactroban brand), went off patent and now costs $10 a tube. The company later patented a cream (water-based) and priced it at $80. Know the difference, or they will sell you the expensive type. The ointment is better for most things, anyway. Generic vs patented drugs: The flip-side of price shopping is that you may be handed cheaper generics. In theory they are identical, but the quality control on foreign-manufactured generics is inferior to the brand names, and this may translate into problems for you. Since you often get a different generic every time you re-order, you may find some are weaker or problematic in other ways. I have observed this when prescribing calcium channel blocker blood pressure medications. The patented ones seem to work better with fewer side effects. Another example: I prescribed a generic beta blocker drug called metoprolol, which was supposed to work for 24 hours. But after only 12 hours, the patient’s heart rate would go up, and the patient would go into an abnormal heart rhythm called atrial fibrillation. This meant the drug was shorter acting than the manufacturers claimed. I even tried having the patient cut the pill in half and take it every 12 hours, but this worked poorly also. Here is how drug names work: the industry usually creates both a confusing chemical name and also a catchy trade name to use when harassing doctors and patients. Celebrex, for example, has a chemical name of celecoxib—try pronouncing that one. Medical journals traditionally use the chemical name. I have used whatever seems more readable here.

Yoho MD, Robert. Butchered by “Healthcare”: What to Do About Doctors, Big Pharma, and Corrupt Government Ruining Your Health and Medical Care (pp. 133-135). Inverness Press. Kindle Edition.

With India and China, the world’s two major discount drugmakers, you get what you pay for. Each has its own unique issues. India has cheap labor and an English-speaking workforce, both significant advantages. Ramesh Venkataraman recently described the disadvantages in the Indian Express: Ask any international businessman or investor about India, and the word “difficult” is bound to pop up.… India, despite its many obvious attractions, is seen as a tough place to do business in. Red tape and the inconsistent and arbitrary manner in which our governments have administered taxes and investment rules and regulations is, of course, an important reason for this sentiment. But what polite and politically correct international investors will not say openly is that Indians are seen as highly unethical. The 2016 “Global Business Ethics Survey” ranked India in the bottom three of thirteen major countries, along with Russia and Brazil. This measures illegal activity, abuse of ethical principles, and violations of organizational values observed by employees. Ernst and Young’s “Asia-Pacific 2017 Fraud survey” reported that 78 percent of respondents from India said that bribery and corrupt practices are frequent. Transparency International found 69 percent of people surveyed said they had to pay a bribe, the highest rate in Asia. Another article in the HinduBusinessLine.com explains: “Businesses [in India] short-change customers and other businesses. Finally, a breakdown of trust boomerangs on them.” They give examples that range from tourism to financial services to housing. Doctors take inducements as well. These problems are petty thievery compared with ours, however. American healthcare is systemically corrupt on a mammoth scale, but no-one ever acknowledges it. Eban did not understand the irony of being critical of India. Their graft is amateurish. India’s poverty and 25 percent illiteracy rate must contribute to their business style. On the interface between two contrasting cultures, trust becomes tenuous and costs go higher, sometimes in concealed ways such as poor quality. With these obstacles, the only way to get top quality work is the use of overbearing supervision, which is difficult from thousands of miles away. The authors of China Rx (2019) explain the difference between the two countries: “India is different from China because it is not an existential threat to the United States. It does not have a centralized plan, designed and executed at the highest level of government, to drive out global competitors, dominate the world market, instill fear of retribution, or use its leverage to extract economic and political concessions from countries dependent on it.” The Chinese work ethic is almost religious. In theory, their culture is well-suited to the exacting manufacturing standards required for drugs. In theory, they need little supervision after a task is delegated. Just as in India, however, many people in China are out to make a fast buck. A heparin formulation that Chinese firms sold to the US contained a synthetic ingredient, oversulfated chondroitin sulfate. The FDA speculated that the drugmaker added this substance to increase the amount of product to sell. Reactions to it were sometimes life-threatening. By 2008, there were 81 US fatalities. One man lost both his wife and son to the drug within a month. US scientists discovered NDMA, a carcinogen once used in rocket fuel, in Chinese-made Diovan (valsartan), a blood pressure medication. In an unusually frank admission, the manufacturing company explained that this was also used to increase yields. European regulators recalled dozens of products. Melamine is a plastic introduced into the domestic Chinese milk supplies to make them seem to contain more protein. Several hundred thousand babies fell ill, and more than ten died. Twenty-five foreign countries banned Chinese milk. The Chinese executed two leaders of the milk producers in 2009, and others involved in the scandal received lengthy prison sentences. The first head of China’s FDA-type agency took bribes to approve untested medicine. Ten deaths occurred, and China executed him in 2007. There must be more to the story, but we have no idea since it is China. In 2015, Peter Baker, who spoke only rudimentary Mandarin, was the only FDA investigator stationed in China. He was responsible for over 400 facilities, and his experiences were similar to those he had in India. He saw ruined or vanishing audit trails, and the Chinese routinely denied him access to records and even entire facilities. They sometimes transported him to plants that were counterfeit Potemkin-village setups. Solutions: As a stopgap, some US institutions are operating like a mini-FDA. For example, Cleveland Clinic detected reduced efficacy of certain generics after the cardiology patients who took them got sick or even died. Lab testing proved certain ones were inactive, so the doctors substituted brand-name drugs, and many patients improved. Since then, the Clinic developed a program to test generics. Other groups have followed suit. The FDA is ineffectual. Since corporate fees pay 46 percent of their 2019 budget (the low estimate), closing dangerous manufacturing operations affects the FDA’s ability to make its own payroll. And when drugs never get approved, the agency loses revenue. And although the FDA has no directive for speedy drug and device approval, Congress applies pressure to make novel things available sooner and relieve perceived shortages. The corporations leverage these perverse incentives and make the FDA’s enforcement process anemic. The following would fix our system. We know what is ineffective—attempted oversight of thousands of manufacturing facilities around the globe by this US agency. Our well-meaning traditional quality control method involves checking documents and examining processes rather than testing products. Because drug analysis is now cheap, I propose we spend the FDA budget testing drug samples at their point of entry into our system. They have already started limited testing programs, but the budget is only a few million dollars. Since three of the US wholesalers account for 90 percent of the drugs sold, they could enforce such a system. They pay our taxes and could be penalized if they do not cooperate. When we discover weak or harmful drugs, we must fine or ban overseas companies from our marketplace. The money received must go into the general tax revenue. It should never go back to the FDA because, like user fees, this works like a kickback. This system I suggest might substitute for all the rules, checklists, investigative work, and inspectors riding around on bad roads in foreign countries. Why should we care about the manufacturing process if the ultimate results are acceptable?

Yoho MD, Robert. Butchered by “Healthcare”: What to Do About Doctors, Big Pharma, and Corrupt Government Ruining Your Health and Medical Care (pp. 127-131). Inverness Press. Kindle Edition.

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