How to Protect Patients and Profits During Drug Shortages

by Elements magazine |

It might be time to add drug shortages to the list of eternal certainties—alongside death and taxes. According to the American Society of Health-System Pharmacists (ASHP), drug shortages have only grown since 2004, averaging 160 per year and peaking at 267 in 2011.

“It’s safe to say that shortages aren’t going away,” said Erin Fox, PharmD, BCPS, FASHP, senior director of drug information and support services at the University of Utah Health. Most recently, pharmacies have been hampered by a prolific recall of several cardiovascular drugs containing contaminated valsartan, which hasn’t subsided since the initial announcement in July 2018. Additionally, the CDC-preferred shingles vaccine, Shingrix, has suffered from a shortage since May of last year, and providers will continue to experience order limits and shipping delays through 2019 at least.

Shortages pose obvious problems for patients who rely on consistent medication to manage their health. But they also pose serious issues for your business. For starters, “certainly you’re not going to have the business if you don’t have the product,” Fox said. And if you’re fortunate enough to find a substitute, it comes at a high price. Total costs for substitutions reached more than $200 million in 2013, according to an ASHP report. That doesn’t include costs for drugs purchased off contract, therapeutic alternatives, and additional labor required to “manage the multiple pharmacy automation systems and electronic medical record changes that must be adjusted in the face of a drug shortage.”

And patients who can’t get their prescription medication from you may find it at a competitor and not look back. Depending on how you handle the situation, frustration alone may send them away for good.

To make matters worse, most pharmacies don’t find out about a shortage until the day the shipment fails to show up, Fox said. Drug manufacturers aren’t obligated to publish shortages to the public or their clients.

What causes a shortage?

  • Unique market for drug products
  • Manufacturing and quality problems
  • Production delays and lack of capacity
  • Manufacturer business decisions
  • Shortages of API or raw materials
  • Restricted distribution and aollocation of drug products
  • Inventory practices

Source: ASHP Guidelines on Managing Drug Product Shortages, 2018

Responding to a shortage

Despite these frustrating realities, there are several things you can do to minimize the consequences and keep your patients and profits happy.

Because manufacturers won’t warn you of a shortage, you need to always be alert and aware. Take special note of shorted product orders, which is the prime sign of a shortage. Use dedicated staff to consistently monitor the ASHP and FDA websites that list current shortages. And reach out to all your connections, such as your group purchasing organization, social media, and professional networks, Fox said.

Once you recognize a shortage, the first step is to make a list of all the patients who will be affected. Then take inventory of what you have on hand and estimate how long your supply will last. Figure out which patients will be able to safely use therapeutic alternatives and verify that the patient’s insurance will cover it. With that information, you’ll know how to best manage the medication for the greatest benefit of your patients.

Rationing the medication may require convincing patients to switch their automatic refills to take place more frequently, say from a 90-day refill to 30-day. In these cases, explain the issue and inform them that the switch will enable other patients to access necessary medication.

Other actions to take during this process include searching for the medication from alternate suppliers, contacting the manufacturers and wholesalers, and putting together official patient communications.

For all these approaches, the ASHP recommends creating formal processes with dedicated teams for specific items. Fox said having this infrastructure in place beforehand is the most important factor in successful management of a shortage. When the shortage occurs, the whole team will know who’s responsible for what and will follow a consistent process, which will increase efficiency and effectiveness.

Getting the new shipment

No one can predict when the drugs will become available, but the ASHP website lists estimated release dates for individual NDCs for back orders. Even though you can’t control when you’ll receive the new supply, be proactive. “Stay in communication with your wholesaler,” Fox said. “Even providing them with some data about, ‘I have 20 patients that need a refill of this prescription, I have a back order placed, can you tell me when it will release.’” She suggests accepting partial orders if that means getting some drugs sooner.

Don’t let desperate times cause desperate measures. It may be tempting to reach for gray market secondary suppliers to fill the gap, but think twice before you do. Like the valsartan contamination, drugs from these suppliers may be substandard or counterfeit.

And they may come with a heavy financial burden. “One of the frustrating things about using a gray market secondary supplier, it’s usually at a very high cost,” Fox said. “It’s almost never worth it to use one of those distributors. Usually they can’t help you with all of your patients. It’s usually a small supply. Is it worth the expense and trouble?”

Preserving patient relationships

During shortages, patients will understandably be frustrated. But with the right approach, you can minimize the damage and keep them loyal. Fox suggests being straight with patients. Show them it’s a national crisis, not just an inventory mistake. Be transparent about the specific actions you’ve taken and that you’re taking to solve the problem. Assure them that you’ll notify them as soon as their medication is available. Although it’s counterintuitive, consider reaching out to other pharmacies for your patients to see if they still have the medication in stock. Patients will likely try that anyway, and this demonstrates that you truly care and goes a long way toward building loyalty.

Shortage preparation strategies

Before a shortage occurs, the ASHP suggests your pharmacy should institute committees and processes specifically dedicated to addressing shortages. Here’s how you can prepare.

Drug product shortage team

Responsible for data gathering and monitoring; purchasing alternatives; changing storage, preparation, and dispensing procedures; deciding to conserve or ration; implementing technology changes; and communications.

Resource allocation committee

Composed of various stakeholders responsible for deciding how to distribute available drugs among patients.

Process for approving alternative therapies

Procedures to efficiently and effectively identify, approve, and communicate alternative medication options.

Process for addressing ethical considerations

Consistent system for deciding how to ethically handle limited drug availability

From the Magazine

This article was published in our quarterly print magazine, which covers relevant topics in greater depth featuring leading experts in the industry. Subscribe to receive the quarterly print issue in your mailbox. All registered independent pharmacies in the U.S. are eligible to receive a free subscription.

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