“Code blue. Medical ICU, bed 14.”
3 AM, halfway through a graveyard shift at the hospital. Adrenaline coursed through my body. The announcement meant a patient was having a medical emergency. Code blue usually referred to a cardiac problem; I needed to prepare.
I hurried to the back of the pharmacy and grabbed my medication kit. I took one last glance at the depleted stock on the pharmacy shelves and hurried upstairs.
30 minutes later our patient still remained unstable. The intensivist continued to call out for medications, especially IV sodium bicarbonate. I watched my stock dwindle.
Normally I would call down to the pharmacy, and they would send up more. But due to a national shortage of the drug, there was no more. The doctor kept ordering sodium bicarbonate, sometimes 2 vials at once. He wiped out the supply in the code cart and my med kit, forcing me to dip into the “emergency supply” stuffed into my jacket pockets.
I gently reminded him about the shortage, always tough to do when someone’s life was at stake, and I have never forgotten his reply. He demanded to know why such a common product was on backorder, and couldn’t pharmacy just make some. “Couldn’t we go lick some rocks and find the stuff?” His joke lightened the tense mood, but it got me thinking.
What factors led to scarcity in medications? And could I use my expertise as a pharmacist to alleviate the situation?
What Causes Drug Shortages?
It’s actually quite mysterious. According to data from the University of Utah Drug Information Service, in 2019 an astonishing 82% of shortages were listed as reason unknown. The other causes include manufacturing, discontinuation, raw materials, and supply and demand.
Manufacturing reasons are varied and encompass plant shutdowns, factories not passing quality assurance inspections, and product recalls.
A few years ago, our hospital experienced a major potassium phosphate shortage. We could not get the stuff, causing last-minute reformulations of the TPN nutritional support IV bags administered to patients who could not eat.
What was the reason cited by the manufacturer? Glass particles discovered in a few batches, prompting a recall, stock-outs, and subsequent shortage of the alternative agent, sodium phosphate.
Eventually, we obtained enough potassium phosphate to replenish our stock, but the problems didn’t end there. The pharmacy staff was instructed to filter every vial of potassium phosphate before adding it to a diluent; no matter which manufacturer we received it from. We also took the extra step of instructing nurses to run the potassium phosphate using tubing with an in-line filter.
This practice was enforced by every hospital I worked at for years after the initial event. One would think the problem would be resolved by now, but we were never given clear guidelines. We kept on filtering, happy to have the product back in stock.
Discontinuation of products is often due to a lack of profitability. Physicians stop prescribing the old generic drugs; who can resist the marketing influence of flashy new ones? Or, sadly, the medication might treat a rare condition. that only affects a small percentage of the population.
Often manufacturers give no advanced notice. We only know when our pharmacy buyers attempt to order a medication, and it doesn’t come in.
One example popular with the OB anesthesiologists was injectable caffeine citrate. They used it for patients with epidural related headaches. I can’t remember the last time I saw it in stock, but I still receive occasional inquisitive calls. There simply isn’t a good alternative.
My introductory story is a frightening example of when a compound used to produce medication is in short supply. Scarcity at the bottom level of production can halt the entire supply chain. The problem worsens when raw materials come from other countries. In fact, the U.S. imports around 80% of bulk or raw materials. Contamination, shipping delays, and devastation of crops of plants used to extract medication can all cause disruption.
Supply and Demand
Lack of supply with increased demand is a big cause of our current coronavirus shortages. Unfortunately, our two biggest drug suppliers are India and China, both countries struggling with their own response to the coronavirus.
The pandemic compounded the problem of drug shortages already on the rise. As of June, the FDA reported over 200 drugs on a shortage, with five classes of drugs being the most critical: CNS, antimicrobials, cardiovascular, ophthalmic, and chemotherapy. The first three groups are especially important for COVID-19 patients. These include medications a critically ill patient in the intensive care unit would need: sedatives and paralytics for intubation, analgesics to combat pain, and vasopressors and cardiac medications to support heart rate and blood pressure.
The sudden influx of COVID-19 patients places an unprecedented strain on an already tenuous system. According to medical technology manufacturer BD’s internal data:
“Hospitals in hot spots see between a 150% and 600% increase in demand for drugs like propofol, fentanyl, hydromorphone, midazolam and neuromuscular blockers.”
Natural disasters can also play a role in supply reduction. In September of 2017, Hurricane Maria decimated Puerto Rico, cutting off our hospital’s main supplier of large volume IV bags. Suddenly bags of normal saline and sterile water were a hot commodity.
What Are the Consequences of Drug Shortages?
Aside from the major cost of delayed or omitted treatments and therapies to patients, there are unseen costs as well.
Pharmacists must have a plan for every back-ordered drug. An alternative, often a less desirable agent, is located, ordered, prepared for use (e.g. hospital barcoding, sterile compounding), stocked, and the hospital staff educated. This takes a tremendous toll on time and cost, not to mention stress and tension between departments.
When we were short on the pain medication Dilaudid, our pharmacy ordered bulk vials and spent hours each day drawing up individual doses. We gave these syringes short expiration dates which meant stocking supply on the units was always a challenge. Certain departments, I’m looking at you ER, would always run out while others wouldn’t use their stock, and it would need to be wasted.
Medication errors would increase as well. Often we could only order a different concentration of a drug, or a vial which always had a light blue cap would now have a green one, leading to mix-ups and incorrect doses given. In fact, a 2017 ISMP survey showed nearly a quarter of respondents were aware of a drug shortage-related med error.
So what can be done about drug shortages? Unfortunately, from a hospital pharmacy perspective, not much. It often seems we extinguish the small fires without ever managing the source. But we do have a few options.
Pharmacists continually research alternatives- second, third, even fourth-line agents. Working with P&T committees, we place restrictions on certain medications even if it means not all patients will receive the drug they need. The FDA has granted extended beyond-use dating for certain medications, and our tireless pharmacy technicians compound from a bulk supply like never before.
Thankfully, the one thing never in short supply is great people. Supportive co-workers assist and never stop caring. It’s our job and we love it.