Brian Williamson, PharmD, president & CEO of JCB Laboratories, a compounding pharmacy that serves ambulatory surgery centers, hospitals and clinics, discusses six things ASC should know about pharmaceuticals and outsourcing pharmaceutical solutions.
1. Regulatory problems and other challenges are going to continue to create shortages for critical drugs. "In 2010, there were over 170 drugs unavailable," Mr. Williamson says. "During the first quarter of 2011, there were over 80 unavailable, with over 50 percent of those being injectables that are critical drugs for chemotherapy, anesthesia and surgery."
There are three primary reasons for today's drug shortages: raw material shortage (powder is not available), regulatory issues (manufacturing plant has an FDA compliance issue) or financial/economic reasons (a company decides to discontinue producing a drug). While there are a few legislators trying to enact laws requiring manufacturers to give advanced notice of drug cancellation, there's currently no such law, he says.
2. When drugs become scarce, outsourcing is an option worth exploring. Most healthcare facilities have primary wholesalers from whom they order the majority of their drugs. In cases where drugs are unavailable or in short supply from primary vendors, secondary or tertiary wholesalers are often contacted. Alternative sources should be qualified and they should be able to provide pedigree information for the products, Mr. Williamson says. When no other option is available, compounded drugs may be a reasonable option. It is very important that proper due diligence is performed on compounding suppliers before procuring drugs from them.
3. Alternative drugs can carry significant costs. While purchasing a non-formulary alternative drug is one means of overcoming the lack of availability of a commonly used formulary drug, ASCs may see a noticeable increase in cost of the alternative over the formulary.
"Markups as high as 3,000-4,000 percent are not uncommon from alternative sources says Mr. Williamson. "Something that used to cost $1 or $2 is now $12-$15 a vial, and sometimes even higher than that. It's a pretty significant issue when it comes to dollars. They have everybody held hostage: Do you want to cancel cases or do you want the drug?"
4. Dosing and concentration differences can create safety problems. The need to switch from a familiar drug to an alternative can do more than just raise costs — it can also create safety problems.
"If you have to use an alternative drug that has different dosing and concentration [from the traditional drug used in your ASC], that can create safety problems," says Mr. Williamson. "There have been instances of overdoses when morphine was unavailable and providers had to switch to hydromorphone instead and the dosing was different."
5. Lack of drug availability can hinder efficiency. "At many ASCs, a staff nurse, clinical nurse manager or director of nursing will do the ordering [of drugs]," says Mr. Williamson. "When they have all of these other things to do, the last thing they want to do at the end of the day is spend 2-3 hours trying to find a drug that's unavailable."
When an alternative drug is found, it often requires retraining of staff to ensure proper dosing and administration. This can create inefficiencies during patient cases, which will inevitably decrease throughput.
6. Outsourcing not always an appropriate option. Outsourcing should not be considered when patient safety is questioned. If forced to look at alternative options for securing drug products, patient safety should be the first priority. "There are a lot of 'gray market' drug providers whose only interest is to make a quick buck," says Mr. Williamson. "If there is any question about the credibility of drug suppliers then the choice should be made to not use them. Partnering with a company that can help locate credible alternatives is important."
Learn more about JCB Laboratories.
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