–Origianal article by Rob Kurtz in Becker’s ASC Review
1. Regulatory problems and other challenges are going to continue to create shortages for critical drugs. Drug shortages are at an all-time high. 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 to help ease the situation, there’s no doubt drug shortages will continue to be an industry problem.
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. When wholesalers can’t meet demand, compounded drugs may be a reasonable option.
3. Alternative drugs and wholesalers can carry significant costs. While purchasing an alternative drug or using an alternative wholesaler are means of overcoming the lack of availability of a commonly used drug, ASCs may see a noticeable increase in cost. Markups as high as 3,000-4,000 percent are not uncommon. It’s a significant issue when it comes to dollars.
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, double check the dosing and communicate any differences to your staff.
5. Lack of drug availability can hinder efficiency. At many ASCs, a staff nurse, clinical nurse manager or director of nursing is responsible for ordering. With all their other responsibilities, the last thing they need is to spend 2-3 hours trying to source unavailable drugs. If 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. Some unscrupulous “gray market” drug providers are more interested in making a quick buck than protecting patient safety. 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.
Reprinted with permission of ASC Review. Copyright ASC Communications. For the original article, please click here.