The unprecedented shortage of critical drugs used by ambulatory surgery centers has severely impacted an ASC's ability to provide services, according to Sheldon S. Sones, RPh, FASCP, president of Sheldon S. Sones and Associates, a pharmacy and accreditation consulting firm based in Newington, Conn. There are several causes for the U.S. drug shortage as identified by the American Society of Health-System Pharmacists (ASHP) and other industry experts:
- Natural disasters that reduce access to raw materials, most of which come from outside the United States
- Product recalls, such as those that have occurred over the past year with some brands of propofol
- Business decisions of manufacturers that curtail or eliminate further production
- FDA enforcement actions limiting further production of specific products
- Volume demands that far exceeded anticipated production projections
- Stockpiling of drugs
While there is pending legislation and other efforts underway to help reduce shortages and assure more timely communications, there is no foreseeable solution to the problem. As such, surgery centers must take action now and identify ways to minimize the negative impact of the shortage on their facility, says Mr. Sones. Here are six strategies he suggests ASCs follow.
1. Regularly visit the ASHP Drug Product Shortages Management Resource Center. Mr. Sones suggests ASCs bookmark the following website: www.ashp.org/drugshortages/current/. It will take you to the ASHP Drug Product Shortages Management Resource Center. On this page you can review drug shortage resources, including the ASHP's "Guidelines on Managing Drug Product Shortages in Hospitals and Health Systems [2009]" and a webinar on "Effective Management of Supply Chain Challenges: Focus on Parenteral Drug Shortages."
This site also provides bulletins on the current drug shortage. "[The website] is one of the best that tells you reasons for shortages and anticipated release dates," Mr. Sones says.
Note: Going one level higher on the website to www.ashp.org/shortages provides additional resources ASCs might find helpful.
2. Multiply your resources. Mr. Sones suggests ASCs develop services with more than one wholesaler. "It's not the wholesaler's 'fault' but we have to broaden our options of supply," he says. "My experience is that shortages or backorders of a particular item with one wholesaler doesn't necessarily mean the secondary wholesaler can't step up for you. In fact, we have had luck with small volume wholesalers when the larger companies have demands that exceed their allotment quotas. Work with your pharmacy consultant to identify alternative resources."
Mr. Sones also advises ASCs to keep their eyes on relative price increases in response to shortages. "Having two or three wholesalers who you regularly work with, will go far to assure consistent pricing rather than opportunistic pricing that any industry in short supply might face," he says.
3. Project needs. ASCs should work to understand clearly what type of drugs and in what amounts they need to adequately support the facility's daily, weekly and monthly services, and have active orders in place to cover these projections.
"One of the things that work well for our facilities is to have inventory control systems that show a historic trend in relation to volume or in relation to time frames (i.e., per month)," Mr. Sones says. "For example, during the ongoing propofol shortage, it was fairly easy to identify weekly or monthly needs. If your system can't currently reveal this, a simple manual tally will work for key items. While wholesalers can give you a historical trend, that is data based on their sales to you and not your overall purchases when multiple sources are used.
"My facilities had little problem, knowing what they needed," he says. "Getting it, was the challenge."
While it's important to have an adequate stock to cover the caseload, he says ASCs should refrain from "stockpiling" drugs (see strategy #6).
4. Consider alternative drugs. Whenever possible and when appropriate, ASCs can consider and purchase alternative drugs. "For some drugs, there simply are no alternative pharmacological choices," Mr. Sones says. "Generally speaking, alternatives are not always 'drugs of choice,' but they can be safe and efficacious options nonetheless," he says.
Before purchasing alternative drugs, make sure the decision to do so has received approval from your ASC's medical executive committee and/or medical director on an interim basis before the MEC next meets, Mr. Sones says.
5. Consider alternative dosage forms. Mr. Sones says ASCs can consider deviating from their currently used products and consider purchasing alterative dosage forms such as premixed antibiotics instead of traditional vials, higher volume vials (such as a 50 ml. vial rather than a 20 ml. vial), different product availabilities such as the less desirable multiple dose vials rather than ampoules and generics rather than stipulating a "trade name" (which might serendipitously bump reasonable options out of the ordering process at the wholesaler level).
"We should minimize the use of multiple-dose vials, but in this climate, sometimes best options are not there for us," Mr. Sones says.
6. Avoid stockpiling. ASCs might be tempted to make a significant purchase of a drug it needs once that drug becomes available in an effort to stockpile it for the future in anticipating of shortages. Informally called "stockpiling," it is practice the ASHP suggests the medical community to refrain from in "good (medical) community spirit", says Mr. Sones.
"While there are isolated anecdotal reports of some hospitals and surgical centers 'stockpiling' drugs in short supply, by and large I find this not the case in ASCs," he says. "By exercising some of the ideas mentioned, we have walked the tightrope between need, supply and ordering restraint. Drug and material shortages for the ASC material manager or drug purchasing person is like playing hopscotch on a moving sidewalk: We can take good steps, but the sidewalk is always moving."
Learn more about Sheldon S. Sones and Associates and www.sheldonsones.com.
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