Is there a cancer drug shortage? If you’ve listened to the news lately, you’ve probably heard that there is indeed a drug shortage. Hospitals and pharmacies across the United States, Canada, Europe and Australia are running short of important drugs used to treat several forms of cancer and serious infections aftera manufacturer decide to temporarily halt production. They are now bracing for possible shortages.
Thesedrugs are often crucial. Doxorubicin hydrochloride liposomefor injection, also know as Doxil?,Caelyx? and Myocet?, for example, is used to treat breast, ovarian and a rare form of skin cancer.The active substance, doxorubicin hydrochloride, has been available since the 1960s. The drug is contained within ?pegylated liposomes,? or tiny fatty spheres that are coated with a chemical called polyethylene glycol. The liposomal formulareduces the rate at which it is broken down, allowing the drugto circulate in the blood for longer. Doxorubicin was first introduced to get rid of the side effects of other types of treatments available in the market. Thereare no generic brands available for this drug, which is usedby hundreds of relapse patients. Because the manufacturer, Janssen-Cilag and Ohio-based contract manufacturer Ben Venue Laboratories, decided to temporarily halt production, thisdrug is now in very short supply.
Cause of shortage: worrisome
A recent survey of pharmacists in Canada showed that virtually all of them, more tha 90%, are dealing with drugs shortages. The explanations why there is a shortage are not just limited to a temporarily halt in production as a result of manufacturing glitches. A number of other causes include scarce raw ingredients, reduced production (or discontinuation) of a particular drug, changing government monitoring and stricter price regulation. In other words, there doesn?t seem to be a single underlying cause of the shortage. There are, however, a number of worrisome trends because thatseem to suggest that drug shortages are here to stay and, if anything, will getworse.
Many reasons
One of the reasons is that our medicines contain a multitude of components, including the active ingredient, binding agents and preservatives. More than ever before, manufacturers buy these raw ingredients from countries such as Chinawhere standards may notalways be up to snuff. A sample was the contamination at a large heparin-manufacturing plant in China in 2008, which immediately led to a worldwide shortage. This incident sparked stricter regulation and slowed production. Some experts see this as one of the root cause of the shortages we see today. Another reason is that- in recent years – amajor consolidation of the pharmaceutical industry has taken place. This means that fewer companies are producing drugs, even commonly used ones, which ismagnified when companies experience manufacturing glitches.
Cheap and not excessively profitable
Interestingly, most of the acute drug shortages involve products that are cheap and not excessively profitable. In an economic climate in which investing in new production facilities is difficult, manufacturers with limited capacity will defend making the switch from a generic drug that sells for pennies a pill to novel drugs that sells for dollars.
Financial repercussions
One little talked-about issue is the fact that when shortages are resolved, there are usually financial repercussions. When the drug prochlorperazine, used to control severe nausea and vomiting, for example,”temporarily” disappeared, pharmacists, physicians and patients made a big fuss. But the drug soon returned with an adjusted price. This price was 56% higher than before the shortage.
Harming patients
Patients being treated with drugs that are in short supply are being inconvenienced and, in some cases, harmed. Doxorubicin, for example, is also used in combination with some other anticancer medicines, their use may be affected by the shortage. Unfortunately, there is no fast or simple solution to the problem. Some hospitals have resorted to gray market purchases of important cancer drugs. This practice often involved third parties, some criminal but in most cases companies without any pharmaceutical background that tried to corner the market on some drugs and resell them at exorbitant mark-ups. Unfortunately, this practice, in turn, hasfueled shortages. In the meantime, patients are, more and more, taking matters into their own hands.
Limited shortage oversees
The question is if this shortage and the negative impact on patients a world wide problem? Who exactly is experiencing this shortage? While there is indeed lower supply of some cancer and other drugs in Canada, Europe and Australia, it may surprise you to find out that the cancer drug shortage is a problem is mainly limited to the United States. How do I know this? I work for IHT World, amedical tourismcompany that specializes in helping people secure American quality health care overseas, without the crushing costs demanded in the United States.
When the drug shortage was first brought my attention, I decided to contact hospitals in other countries to find if they too were experiencing cancer drug shortage. I even sent them a list of drugs that are in short supply or not available in the U.S.A. The hospitals I contacted overseas had ample supply and wanted to know why the United States was experiencing difficulty. This is a question I cannot answer.
Prescription drugs
It?s illegal for anyone to bring prescription drugs into the United States from another country, including importation of unapproved new drugs. Under the law, “unapproved” drugs may includemedicines that have not received the FDA’s approval orforeign-made versions of U.S.-approved drugs.
While it is possible to import a personal supply of any medicinal drug obtained in another country, many prescription drugs are “controlled substances” and are under the jurisdiction of the U.S. Drug Enforcement Administration (DEA).Patients can only import drugs themselves when returning to the United States and need to declare them to U.S. Customs. The caveat is that in all cases a valid prescription from a U.S doctor in the patient’s own name is required, which makes it hard to import them.
However, the patient may be able to utilize IHT World?s medical tourism services and travel overseas to receive needed cancer drug and treatment.
For more information:
– IHT World at IHT World
– Cancer Society Endorses Requiring FDA Notificationof Drug Shortages
– FDA Drug Shortages
– Shortage of Caelyx (doxorubicin hydrochloride)
– Other drugs in short supply (United Kingdom)
– American System of Health-System Pharmacists<
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This post was developed, in part, by Pam Brammann, R.N., President & Managing Director, IHT World,LLC
