Shortages of prescription drugs cost the United States more than $200 million.
In addition, shortages force doctors to delay or cancel treatment. Patient safety is compromised when doctors have to use different or unfamiliar drugs when they can’t get the right ones.
In the six months from July to December of 2010, 240 drugs were either in short supply or completely unavailable. More than 400 generics were back-ordered for more than five days.
Most of the medicines with shortages are necessary for emergency care, sedation, or chemotherapy — including leucovorin which is a backbone of most colorectal cancer treatment regimens.
The Premier healthcare alliance surveyed 311 pharmacy experts in 211 hospitals, surgery and oncology centers, and pharmacies. They discovered that over the course of six months in 2010:
- 89 percent experienced shortages that could have caused a patient safety issue.
- 53 percent had that problem more than 5 times.
- 80 percent experienced a shortage that caused them to delay or cancel patient care
- 34 percent had that happen more than 5 times.
- 98 percent encountered a shortage that caused an increase in costs.
- 88 percent spent more 5 or more times.
- 41 percent spent more 20 0r more times.
Reasons for Drug Shortages
Quality of Raw Materials: Nearly half of shortages were related to quality issues including impurities, microbials contamination, and chemical instability. Eighty percent of raw materials for medications manufactured in the United States come from outside of the US.
Manufacturer Financial Decisions: Nearly 1 in 5 of injectable drug shortages were due to a manufacturer stopping making the drug. Pressures from patent expirations, cost of FDA compliance, and healthcare reform impact profits and financial decisions.
Enforcement of FDA Standards and Regulations: Meeting manufacturing inspections requirements and the high costs of FDA’s Unapproved Drug Initiative, launched in 2006, have led some manufacturers to cease production rather than invest to meet requirements and regulatory user fees inherent in the drug approval process.
Leaner Inventories: In recent years, “just-in-time” inventory management has led to lower quantities of raw materials and finished products.
Gray Market Price Gouging: During shortages distributors may buy up all available supplies and sell them at greatly inflated markups. Premier members reported as much as a 335 percent markup for a drug in shortage.
Stockpiling by Users: Shortages can be worsened when hospitals and doctors try to protect themselves by ordering larger amounts of drugs than they really need.
Changes in Clinical Practice and Emergency Situations: Shortages of one drug can lead to shortages of a replacement medicine.
Leucovorin and Fusilev Shortage Update
The American Society of Health-Systems Pharmacists (ASHP) updated their information on leucovorin and Fusilev® (levoleucovorin) on March 23,2011. At that time all three manufacturers of leucovorin were experiencing delays in shipping it, and Spectrum Pharmaceuticals had a shortage of Fusilev.
ASHP had personal communications with each of the companies and found:
- Bedford could provide no reason for the shortage. They have some dosages on back order and don’t know what the release date will be. For other dosages, they are estimating release late March, 2011.
- Teva says their shortage is due to manufacturing problems. They cannot estimate a release date.
- APP has leucovorin on back order and estimates being able to release it late March or early April 2011.
- Spectrum Pharmaceuticals has Fusilev on back order due to increased demand. They cannot estimate when they will release it. They will have supplies of imported levoleucovorin, but cannot estimate a release date.
The FDA has authorized Spectrum to import levoleucovorin from a Pfizer manufacturing facility in Italy. That facility has been inspected by the FDA, but it is the only approved foreign source of Fusilev.
Preserving Access to Life-Saving Medications Act
On February 7, 2011 Senators Amy Klobuchar (D-Minn.) and Robert Casey (D-Pa.)introduced a bill to address the issue of drug shortages. The legislation, S.296, would require
- manufacturers to notify the FDA if they anticipate changes in supplies or production that may lead to shortages . If a company plans to discontinue making a drug, they have to inform the FDA at least 6 months in advance. The FDA must develop penalties for manufacturers not complying with notifications.
- FDA to publish information about manufacturing problems and actual drug shortages on its website.
- FDA to develop evidence-based criteria for drugs that are vulnerable to shortage and publish that information on their website. Factors that would make drugs vulnerable to shortages include the number of manufacturers, supply of raw materials, characteristics of the supply chain, and availability of other treatments.
Fight Colorectal Cancer is doing all we can to keep pressure on the issue of drug shortages, particularly leucovorin and now Fusilev. We will let you know as the situation changes.