The counterfeit drug trade has reached global proportions, and solving the problem needs a global approach.

So says an editorial in this week’s The Lancet.

While the Avastin announcement last week raised lots of concern and media attention, the issue of counterfeit drugs isn’t new. In 2009, the European Union seized 34 million fake pills in just two months, including antibiotics, cancer drugs, and sildenafil (Viagra). Counterfeit medicines are a problem for both low and high income countries and can seriously hurt patients.

In January the FDA warned healthcare providers not to buy injectable cancer medications from “direct-to-clinic” promotions or non-verified sources. Such drugs, says the FDA, put patients at risk. Read the rest of this entry »

ASCO in Action has updated information on the best way to obtain imported leucovorin in solution.

Teva Pharmaceuticals customer service provided them with detailed instructions to help hospitals, pharmacies, and oncology practices obtain imported calcium folinate solution.

Teva has FDA approval to import calcium folinate solution which is the same strength as the powdered leucovorin approved for sale in the United States once water is added.

Please be clear that individual patients cannot obtain the drug themselves.  It must be requested by pharmacists or physicians, and the requests must be approved by Teva. Read the rest of this entry »

President Barack Obama signed an Executive Order yesterday addressing the drug shortage issue.

As we have reported extensively on www.FightColorectalCancer.org, the current drug shortages have impacted colorectal cancer patients who have been unable to get 5-FU, leucovorin or on occasion, irinotecan.

The Executive Order does not change the law, and it will not help patients who cannot get their drugs today, but it does reinforce the powers of the Food and Drug Administration to take steps that would ease the burden by:

• Broader reporting of when a manufacturer has stopped producing a drug that could lead to a shortage.
• Increased effort to review drug suppliers and manufacturing sites and changes. It also directs the FDA to prioritize its resources according to the burden of the shortage to the public health.
• Collaboration with the Department of Justice to address drug stockpiling and price gouging.

A survey of physicians, pharmacists, and nurses working in healthcare facilities found an increasing number of frustrating drug shortages.  Worse:

• One out of three reviewed facilities had a serious error that was caught in time — a near miss.
• One out of four had an actual medication error resulting from the shortages.
• One out of five reported actual adverse outcomes for patients.

This may only be the tip of the iceberg according to the health care professionals surveyed.  Many felt that errors and bad patient outcomes aren’t always shared so there maybe many more. Read the rest of this entry »

Watch our patient webinar
“What to do when your doc is out of 5-FU“  

Frequently Asked Questions

What drugs for colorectal cancer patients are in short supply?

The list of drugs on the short supply list can change week to week, but there are two drugs that have been low for some time: leucovorin and fluorouracil (5-FU).

Leucovorin is a folic acid that has long been used with 5-FU to treat colorectal and other cancers. Leucovorin boosts the effectiveness of 5-FU, by lengthening the time that the very short-acting 5-FU works to kill cancer cells.

Why are there leucovorin and 5-FU shortages?

For several years, manufacturing problems at the US companies that make and distribute generic leucovorin and 5-FU and have limited the amount of the drug that they are able to ship to pharmacies and doctors.  Many oncologists now cannot obtain it at all.  Others can only get limited supplies, so they are reducing doses for patients. Additionally, one of the companies that makes 5-FU has blamed their shortage on manufacturing delays.

Both the FDA and the American Society of Health-System Pharmacists track drug shortages, the reasons for those shortages, and when the shortage for each drug might be resolved. But the national picture does not always reflect day-to-day shortages in specific parts of the country or individual cancer centers.

What choices do I have if my doctor doesn’t have leucovorin?

The National Comprehensive Cancer Network (NCCN), which provides cancer treatment guidelines, has recommended that doctors do one of the following:

• Use a lower dose of leucovorin for all patients. (Several studies have shown equivalent effectiveness at lower doses.)
• Use Fusilev® (levoleucovorin) a brand-name drug with a chemical structure similar to leucovorin. Although the dosage is different, levoleucovorin has the same effectiveness as leucovorin when combined with 5-FU.  It was approved by the FDA in April 2011 to treat advanced colorectal cancer.
• If there are no other options, “treatment without leucovorin would be reasonable.” For patients who can tolerate it without side effects, NCCN suggests increasing the bolus dose of 5-FU in the range of 10 percent.

The FDA has also approved temporarily importing injectable calcium folinate–the form of leucovorin most commonly used in Europe.

What choices do I have if my doctor doesn’t have 5-FU?

The Association of Health System Pharmacists recommends that doctors:

• Evaluate the health-care system’s total supply of fluorouracil before beginning patients on combination chemotherapy regimens containing fluorouracil. If adequate supplies are not available, select an alternative regimen.
• Consult a Hematology/Oncology specialist for patient- and neoplasm-specific recommendations.
• Refer to the ASHP Guidelines on Managing Drug Product Shortages for more guidance on developing a multidisciplinary plan when the supply must be allocated.

What is Fight Colorectal Cancer doing to help patients, and to solve this problem?

• Our Research & Treatment News has been tracking this issue since 2008, and we will continue to keep you informed with frequent updates. Subscribe to receive our updates by email.
• The Answer Line (877-427-2111) has fielded over 100 calls on this topic and has assisted patients and families facing drug shortages.
• Fight Colorectal Cancer supports S. 296 and H.R. 2245, bills that would require manufacturers to report shortages as they arise and also require the FDA to take specific actions to ease drug shortage issues. Please email your Members of Congress in support of this legislation.
• Fight Colorectal Cancer continues to push both manufacturers and the FDA to increase the availability of generic oncology drugs.