Running on Empty

Supply Management

By: Daniel Cook

Published: 8/12/2019

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Don't let the drug shortage leave you hung out to dry. Take these 5 steps to ensure limited supplies of essential medications never impact patient care.


In the early morning hours of Sept. 20, 2017, Hurricane Maria slammed into the southeast coast of Puerto Rico and tracked across the island with maximum sustained winds of 155 mph, leaving a trail of catastrophic destruction in its wake. The Category 4 cyclone knocked out the island’s power grid that ran the manufacturing plants of Baxter International, a major supplier of IV saline bags used by healthcare professionals across the United States to administer intravenous drugs. Baxter’s plants were offline for months, causing a severe shortage of 50 ml and 100 ml IV bags. Production volume of the bags is only now reaching pre-Maria levels.

The historic hurricane was an obvious event that slowed the flow of IV fluid to a trickle, but other causes of drug shortages are more subtle — and more persistent. Pharmaceutical companies hit with FDA warnings for failing to comply with quality medication production standards has led to massive recalls and forced some manufacturing plants to shutter, putting more strain on other drug producers that might not have the capacity or resources to fill the void. In September 2015, Pfizer acquired Hospira in a major merger involving companies that make a vast majority of injectable medications. Pfizer inherited Hospira’s manufacturing plants, which were wrought with quality control problems, and implemented a remediation plan 2 years ago. But production problems, unbelievably and frustratingly, persist.

In general, the generic injectables market remains fragile. There isn’t much of a profit incentive — generics are expensive to make and inexpensive to buy — for companies to produce the medications. Big Pharma is big businesses, first and foremost, and companies are opting to focus their manufacturing resources on more lucrative brand-name therapeutics.

Mother Nature and market forces make drug shortages predictability unpredictable — and extremely difficult to manage. But try telling that to frustrated anesthesiologists and surgeons who don’t give two shots of saline about the underlying causes that limit their access to needed medications. You can look for untapped resources (spoiler alert: none exist) to find the drugs they want or you can accept that managing drug shortages is the new normal and realize that doing it well demands a bit of clinical creativity, constant communication with your surgical team and plenty of hard work.

1. Monitor drug shortages daily. Start by being proactive, not reactive, when managing your facility’s drug inventory. Review the live list of drug shortages that’s posted on the website of the American Society of Health-System Pharmacists (ashp.org/shortages). The list should be your go-to resource. Check it every day and sign up to receive email alerts of new and resolved shortages. Dextrose is on it right now. Bupivacaine, too. And fentanyl and ketorolac. Obtaining various sizes of morphine and hydromorphone has also been problematic in recent months.

2. Stock up on drugs in shortage. If a drug you need is on shortage, scour the online inventories of your medication suppliers and immediately order available supplies, suggests Thomas Durick, MD, a consultant anesthesiologist with Envision Physician Services in Walnut Creek, Calif.

Dr. Durick, the former medical director of a busy multispecialty surgery center in the San Francisco Bay Area, recalls dropping a batch of medications into his online shopping cart and clicking to confirm the order — only to find the inventory he reserved seconds earlier had vanished.

“The market is that volatile,” he says. “If you put off ordering medications that are in short supply, even for a couple hours, you might come up empty.”

Comparing current shortages to your facility’s inventory should sit atop your to-do list. As a consultant, Dr. Durick regularly visits 6 surgery centers and is surprised that even the largest and busiest one has only a single staff member who monitors drug shortages — on a part-time basis, no less.

“You’re at a severe disadvantage if you don’t have a dedicated staff member in charge of constantly ensuring needed medications are on hand,” he says. “Make sure the person understands the critical important of the job. If they don’t, find someone else who does.”

Erin Fox, PharmD, BCPS, FASHP, senior director of drug information and support services at University of Utah Health Care in Salt Lake City, monitors the drug market and updates the list of shortages posted on the ASHP website.

“Keep constant tabs on your own supply in order to determine how much product you have on hand and how long that supply will last,” says Dr. Fox. “It’s important to have a plan in place that you can implement when shortages occur.”

NETWORKING OPPORTUNITY It's a good idea to develop strong working relationships with your medication supply reps, who can let you know if a batch of sought-after medications is about to become available.   |  Pamela Bevelhymer, RN, BSN, CNOR

3. Stretch your current supply. Make the most of medications by investing in prefilled syringes, which limit waste, or split single vials into multiple doses. Keep in mind, however, that vials labeled by the manufacturer as “single dose” or “single use” should only be used for a single patient. And you can’t draw up medication from multi-dose vials in patient treatment areas (the OR, procedure room or patient bedside). You must draw them up in a room remote from the procedure room using sterile technique.

Members of your surgical team might have to alter their preferred practices and find creative ways to achieve desired outcomes. Dr. Durick, for example, recalls when hyperbaric bupivacaine was on backorder at his facility, and he struggled to find a viable alternative for administering spinal anesthesia. Dr. Durick, who generally prefers to place ultrasound-guided regional blocks, combined an adductor canal block and iPACK block with injections of Exparel (liposomal bupivacaine) around the incision site during a medial unicompartmental knee replacement.

“I provided the patient with longer-lasting pain relief with fewer risks and potential side effects,” says Dr. Durick. “The short supply of bupivacaine forced me to find a better alternative.”

4. Buy from multiple suppliers. Dr. Durick suggests diversifying your medication supply options, especially if you work in a smaller surgery center, by working with 2 to 3 wholesalers. That way, you’re not left in the lurch if one of the wholesalers decides to send limited supplies of in-demand medication to larger facilities with more purchasing power.

You might also consider working with Civica Rx (civicarx.org), a fledging non-profit organization in Lehi, Utah, that’s partnering with pharmaceutical manufacturers and healthcare facilities to ensure essential generic medications in short supply are regularly available and affordable. Civica Rx currently has relationships with manufacturers of vancomycin and daptomycin, and recently announced it will soon coordinate the production of 14 injectable medications (the specific agents were not announced by press time).

Dr. Fox, who holds a volunteer position on the company’s board of directors, says facilities pay a one-time membership fee (based on facility size) to the company and provide an estimate of how much of the available medications they’ll need over a 5-year period. The facilities commit to purchasing the agents through Civica, which in turn ensures the medications will be available. It’s a win-win arrangement that could help solve the shortage crisis; pharmaceutical manufacturers have guaranteed business for 5 years, and facilities receive a steady supply of the medications they need.

5. Stock more often-used medications. If your facility employs just-in-time inventory management, you probably keep a 3-day supply on shelves to limit waste and ensure drugs are used before they become outdated. That thinking makes good practical sense, but isn’t the best way to manage medications in short supply.

“We’ve been burned by that before,” says Tricia Meyer, PharmD, MS, FASHP, FTSHP, associate vice president in the department of pharmacy at Baylor Scott and White Health in Temple, Texas. “It might be best to extend inventories to stock 5 to 7 days’ worth of often-used medications.”

To help combat shortages, Dr. Meyer has added back-up to inventory, lowered par levels in automated medication dispensing cabinets, settled for buying needed drugs at various strengths, and purchased more expensive generics and therapeutic alternatives. She’s also found that requiring anesthesia providers or staff members to request drugs on short supply on a case-by-case basis curtails usage and extends reserve supplies. OSM

ADMINISTRATION AUDIBLES
Workarounds for Drugs in Short Supply
MORE WITH LESS When ketorolac is unavailable, acetaminophen is an effective pain-relieving option.   |  Pamela Bevelhymer, RN, BSN, CNOR

The following drugs are in shortage. Thomas Durick, MD, a consultant anesthesiologist with Envision Physician Services in Walnut Creek, Calif., shares how to make do without them.

  • Pain relievers. If morphine, fentanyl and hydromorphone are in short supply, try ultrasound-guided regional anesthesia: interscalene, supraclavicular, infraclavicular and axillary blocks for shoulder and upper extremity surgery; femoral, adductor canal, popliteal and iPACK blocks for lower extremity surgery; rectus sheath and TAP blocks for hernia repairs and abdominoplasties; and PEC 1 and 2 blocks for breast and chest wall surgery. If blocks aren’t options, a multimodal approach that includes long-lasting infiltration of a local anesthetic at the surgical site, NSAIDs and pre-op gabapentin can help control post-op pain.
  • Hydromorphone. Has been intermittently available. Obtainable dosages (0.5mg/ml, 1mg/ml, 2mg/ml, 4mg/ml and 10mg/ml) can vary, making dosing errors more likely.
  • Fentanyl. With sufentanil in short supply, you can switch to remifentanil and alfentanil. Lack of experience with the alternate drugs, especially for conscious sedation administered by non-anesthesia staff, increases risks of improper dosing and potentially serious side effects.
  • Morphine. Poses similar risks to hydromorphone with variations in available dosages (0.5mg/ml, 1 mg/ml, 10 mg/ml, 25 mg/ml, 50mg/ml). Read the label carefully to make sure you know the dose you’re giving, as it might change from day to day.
  • Bupivacaine. If bupivacaine isn’t available, use another local anesthetic such as ropivacaine or add lidocaine with epinephrine to your limited supply of bupivacaine to increase volume and duration with the epinephrine component. Exparel (liposomal bupivacaine) for single injections can eliminate the need for the large volumes of local anesthetic required to fill pain pumps and provide excellent analgesia for a variety of blocks, including those used off-label.
  • Ketorolac. There is no equivalent substitute to give intravenously. Some facilities are resorting to combinations of p.o. NSAIDs and p.o. or IV acetaminophen as part of a multimodal regimen.
  • Dextrose. If 50% dextrose isn’t available, you can use 25% dextrose in its place. Glucagon is also an effective alternative, but at the cost of an increased side-effect profile. You can also administer Lactated Ringer’s and 5% Dextrose Injection, which has a much longer response to increase blood glucose. The other alternative is to give p.o. glucose when the patient is alert enough to swallow it.

— Daniel Cook

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