JustCare

Tag: Drug shortages

  • Prescription drug shortages and quality issues are a growing concern

    Prescription drug shortages and quality issues are a growing concern

    Imagine yourself in the hospital and the hospital being out of the critical chemotherapy drugs you need. That sounds like something more out of the Soviet Union than the United States, but almost every hospital in the US is facing prescription drug shortages. Prescription drug shortages are leading to drug rationing, treatment delays and, sometimes, no treatment possibility, reports Stat News.

    One new survey of 1,100 hospital pharmacists from the American Society of Health-System Pharmacists found that one in three hospitals are rationing drugs or not providing critical treatments. Virtually all hospital pharmacists report inadequate supplies of some prescription drugs. Treatments for syphilis, different cancers, severe pain are hard to come by. More than eight in ten hospital pharmacists say hospitals are rationing care or switching to alternative treatments.

    Pharmacists are forced to buy different drugs or different concentrations of drugs or getting their drugs from pharmacies that manufacture the drugs through compounding. The consequences are not only dire for some patients but causing almost three in four pharmacists to pay more for drugs. And, the situation is getting worse.

    What’s responsible for these shortages? Everything from climate issues and increased demand, to quality issues.

    The Food and Drug Administration’s response is unsatisfying. As of now, the FDA is not acting to ensure patients get treatments that are safe. It is permitting Intas Pharmaceuticals to continue to import chemotherapy treatments notwithstanding its finding of “a cascade of [quality] failures” where its drugs are manufactured. The FDA reported that an Intas analyst poured “acetic acid in a trash bin containing analytical balance strips,” in order to destroy records.

    Quality issues at plants in China and India are particularly concerning. Many generic drugs and chemotherapy ingredients are produced in these plants. What’s pretty clear is that some chemotherapy treatments are of questionable quality.

    Here’s more from Just Care:

  • Congress should overhaul drug patent laws to ensure Americans access to medications

    Congress should overhaul drug patent laws to ensure Americans access to medications

    Anyone who thinks that the pharmaceutical industry should continue to be able to gouge Americans with their near-monopoly pricing power should recognize that this power is preventing people from filling prescriptions and keeping important drugs from both coming into the market and from being manufactured. Mounting evidence suggests the need for the government to intervene to ensure that people get the medications they need.

    A story in The New York Times about a lawsuit against Gilead, a pharmaceutical company, for failure to bring a critical drug to market quickly, speaks volumes about how drug company profits come before patient health. The delay in bringing a new HIV drug to market allowed Gilead to maximize revenue on another drug with possibly more dire side effects.

    The people at Gilead believed the new drug would have less harsh side effects on people’s kidneys and bones. But, the drug likely would bring down revenue on Gilead’s patent-protected drug. So Gilead’s executives  decided to delay bringing the new drug to market until the patent-protected drug lost its protection. Based on a review of Gilead’s internal documents, the New York Times reports that Gilead was “gaming the U.S. patent system to protect lucrative monopolies on best-selling drugs.”

    Stories also abound about drugs that are not available because pharmaceutical companies are not able to make big profits selling them. These drugs are not outliers. They can treat cancer and heart disease and basic infections. And, there are drug shortages of more than 300 of them.

    Geoffrey Joyce, Director of Health Policy at the USC Schaeffer Center, explains in The Express that drug shortages have been around for some time. But, we are seeing shortages of more drugs of late and we are seeing drug shortages for longer time periods. Amoxicillin to treat ear infections, for example, is hard to get, as is lidocaine and albuterol, which many Americans depend on for treating their asthma. Ironically, the problem is that these drugs come with a low price tag, so pharmaceutical companies don’t see the financial value of producing them.

    Because of US patent laws, pharmaceutical companies can pretty much call the shots on what they charge for brand-name drugs for a long period of time. That means big bucks for them. They can charge many times more for these drugs in the US than in any other wealthy country because every other wealthy country negotiates drug prices. And, drug companies generally can charge high prices for at least 20 years or until their patent expires, which could be even longer. Once a drug is off patent, they face generic competition and prices tend to fall, along with profits.

    Even when drug companies outsource generic drugs for manufacture, they do so to cut costs and, in the process, sometimes undermine quality and supplies. Interestingly, though the FDA struggles to inspect foreign drug manufacturing facilities, it allows the sale of these drugs in the US but still does not allow drug importation.

    And, when several companies manufacture a generic, quality and supplies can suffer. The supplier of key ingredients might be the same for all of them. If the supplier stops producing, no generics are produced. Or, the supplier might be responsible for a harmful ingredient in all the generics. Who knows the consequences in any given situation, but people can die.

    Joyce proposes that the US produce more generic drugs, as California has proposed to do.

    Here’s more from Just Care:

  • Large corporate entities drive major generic drug shortages

    Large corporate entities drive major generic drug shortages

    Yes, we are facing drug shortages in the United States, the wealthiest country in the world. The result is that many Americans with cancer and other deadly diseases are not able to receive treatment, reports Christina Jewett for The New York Times. Three large corporate entities likely are responsible for the drug shortages but are not accountable.

    There are literally hundreds of prescription and over-the-counter drugs that Americans cannot get, including drugs that treat strep throat, lung cancer, breast cancer and ovarian cancer. The drugs are generic, meaning that they generally do not command the prices that pharmaceutical companies charge for brand-name drugs. It seems likely that somehow the goal of maximizing profits is behind the generic drug shortage.

    One possible immediate solution to the generic drug shortage would be for the US to open its borders to the importation of these drugs from verified pharmacies abroad. While today these imports are not legal, no one has ever been prosecuted for purchasing them for personal use. But, that solution does not appear on the table.

    Instead, Congress is considering handing pharmaceutical companies more money through lower taxes as a carrot to manufacture the drugs we need. I would imagine that would only induce them to keep making limited supplies of generics so the tax benefits continue. Congress might be better off having government take control of the prescription drug supply-chain to ensure that supplies are adequate.

    The Food and Drug Administration (FDA) wants the White House to focus on the economic challenges facing generic drug manufacturers. Today, almost all generic drug purchases come from just three entities. Those entities, such as Red Oak Sourcing and Clarus ONE, include big retailers such CVS Health and Walmart. You can bet they are doing what they can to maximize their profits.

    One academic expert, Dr. Kevin Schulman, who teaches at Stanford Medicine, argues that these entities use their leverage to demand super low prices from the generic drug manufacturers. When the manufacturers don’t deliver, it’s not their problem. They are not accountable. Rather, they profit off of the brand-name drugs they sell, and it’s the patients who suffer because their generic drugs are not available.

    One big manufacturer of generics, Akorn, closed down. It had made 100 generic drugs, including albuterol and a drug that treated lead poisoning.
    There is at least one promising domestic solution, Civica Rx, a non-profit that manufactures prescription drugs, which you can read about on Just Care here. Civica was started to ensure a robust supply of critical generic drugs.

    Here’s more from Just Care:

  • How should we address drug shortages?

    How should we address drug shortages?

    It’s hard to believe, but some prescription drugs are hard to come by. A new federal report by the Food and Drug Administration (FDA) attributes these drug shortages to a combination of low profitability and a “broken” health care marketplace. The FDA’s market-based recommendations for addressing these drug shortages likely means we can expect them to continue.

    These days, more than 150 prescription drugs are in short supply in the US. Both generic drugs and brand-name drugs can be hard to come by. They include anesthesia drugs such as lidocaine, palliative care drugs such as bleomycin for patients with cancer, drugs for septic shock such as norepinephrine, and vaccines. Medical supplies, such as sterile water, can also be unavailable.

    To be clear, drug shortages mean treatment delays or changes in treatment regimens for patients. This can jeopardize their health. One study found that more than half of hospitals (56 percent) reported they had delayed or changed patient treatment  because of drug shortages. 

    Unfortunately, the problem is not getting better. In fact, it’s getting worse. An increasing number of drugs are in short supply. Moreover, shortages of drugs tend to last longer and longer.

    As unfortunate, no one is keeping good data on the issue. We need good evidence of the number of drugs unavailable at any given time and the consequences of their lack of availability. As the report says, we need to know the frequency, persistence and intensity of drug shortages if we are going to best prevent them.

    Most of the 163 drugs that are hard to get are generic drugs that have been on the market for decades. But, more than 50 are brand-name drugs. The reason that about half of these drugs are so hard to get is quality-control problems where the drugs are manufactured.

    The FDA report recommends that the price of these drugs go up to address the shortages. It suggests that there be quality ratings of these drugs as a possible way to help pharmaceutical companies command higher prices for them.

    Notably, the authors did not recommend government intervention to ensure these drugs are available, even though some of these medications are critical for saving lives. Vincristine, for example, is a cancer drug, that treats a variety of common childhood cancers. Pfizer, which makes the drug, says it is addressing the shortage.

    Here’s more from Just Care: