In the Midst of the Oncology Drug Crisis, There Is A Solution

          by Dave Schneider, president of Carmel Pharma, USA

 So many of our customers are struggling with the U.S. drug shortage deemed a national health crisis by leading industry experts. Affecting nearly every hospital in the nation, patients are not getting the drugs they need or receiving alternatives that may not be equal in efficacy.

Let’s dissect the gravity and complexity of the situation.

A record 211 medications became scarce in 2010 – triple the number in 2006 and at least 89 new shortages have been recorded through the end of March, according to reports.1 While the shortage includes a variety of drugs, the FDA reports that about 75% involve chemotherapy sterile injectables2 – life saving drugs for cancer patients. I know that with chemotherapy drugs, there are basically no alternatives and they’re not easy to substitute.3

As we look at the many factors that have fueled the national shortage, it’s understandable how we arrived at this current situation. Late last year, two of the largest injectable manufacturers had to shut down some production lines because of difficulty in meeting required quality control standards. Other manufacturers simply made a business decision to stop making select, older, less profitable drugs.4 Raw materials are harder to attain and the rising worldwide demand for injectable chemotherapeutic drugs is also putting pressure on the distribution system.3

Because it’s difficult to produce sterile injectables, especially cytotoxic drugs such as chemotherapy, it’s not easy to find other manufacturer’s to take on production of these drugs. In response to this crisis, some medical centers have begun stockpiling drugs when they receive them, which can actually exacerbate the shortage, keeping supplies away from other hospitals.

A more effective approach would be to borrow and trade; however, when hospitals do that, medical personnel are spending a lot of valuable time searching for drugs and are probably spending more money buying drugs on the secondary market instead of through lower-priced contracts with primary wholesalers.

Recovery from the national drug shortage will take time and require a committed effort from numerous factions. The use of a closed-system drug transfer device (CSTD), such as the PhaSeal® System, can significantly contribute to the solution. A recent study concludes that drug solutions could be expected to remain sterile for up to 168 hours if the PhaSeal device is applied properly and all additional USP <797> standards are followed.5 Pharmacists who use PhaSeal understand the remaining drug in the vial is sterile after they retrieve the first dose due to the mechanical barrier of PhaSeal’s airtight, leakproof system.  The study also says, ‘using PhaSeal for high-cost unpreserved drugs may provide a way to avoid discarding viable drug product because of sterility concerns and help organizations worldwide to reduce waste and drug costs.’6

More medical facilities are adopting the use of a CSTD as a key component in their best practices of the safe handling of hazardous drugs. We are all facing this drug shortage together and my focus is to educate pharmacists, nurses and administrators on a solution – PhaSeal is a proven and effective device that can preserve these precious, life-saving drugs.

Drug vial optimization (DVO), where drugs that might otherwise be discarded may instead be conserved, is a priority for pharmacists and hospitals. Even ASHP has taken the initiative to survey national pharmacy practices in hospital settings this year on their use of a CSTD as part of a DVO program to reduce cost and minimize waste. DVO will continue to play a major role in helping clinicians deal with drug shortages now and in the future. Ongoing research shows the nation is on track for even more drug shortages. Ultimately the ones who suffer are the patients, with the potential that their life-saving drug is rationed. Using PhaSeal to extend drugs in short supply does not just improve the shortage issue for the hospitals but it improves the quality of care for the patients by making sure the drug they need will be and is available for their care.

●  To see the FDA list of chemotherapy drugs in short supply, click here.

●  To read answers to frequently asked questions about the drug shortage crisis, click here.  

1Stein, R. Shortages of Key Drugs Endanger Patients. The Washington Post. 2011. Accessed July 18, 2011.
2FDA Works to Lessen Drug Shortage Impact. Consumer Health Information. U.S. Food and Drug Administration. 2011. Accessed July 18, 2011.
3Corso, T. Crisis Averted? Oncology & Biotech News. 2011; 5(3): 20-27 .
4Tobin, J. Understanding and Managing Drug Shortages in Oncology. Oncology Nurse Advisor. 2011; 24-29
5,6McMichael D, Jefferson D, Carey E, et al. Utility of the PhaSeal closed system drug transfer device.  The American Journal of Pharmacy Benefits.  2011; 3:9-16


Posted on July 28, 2011, in Uncategorized. Bookmark the permalink. Leave a comment.

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