Health-system pharmacists can play a critical role in managing drug shortages
to prevent medical errors and adverse events.
Maryann Amirshahi, PharmD, MD, MPH, BCPS, DABAM, attending physician in the Department of Emergency Medicine at MedStar Washington Hospital Center and assistant professor of emergency medicine at Georgetown University School of Medicine, told Pharmacy Times
that pharmacists can mitigate drug shortages in a multitude of ways.
“[Pharmacists] can often prevent shortages from impacting their institution by proactively managing inventory,” Dr. Amirshahi said. “When a shortage situation impacts hospital inventory, pharmacists should inform providers early.”
Pharmacists can also develop protocols for emergency department staff on what to do if a drug is not available. These protocols should include information about the best alternative medication, dosing recommendations, proper administration of the drug, and contraindications, Dr. Amirshahi advised.
“The time to learn about how to use an unfamiliar medication is not at the bedside of an unstable patient,” she said. “This also highlights the importance of having clinical pharmacists at the bedside during major resuscitations and conducting real-time order review in the emergency department.”
Pharmacists can also take the following steps:
· To prevent errors, place specific labeling on a medication if a different concentration than what is normally stocked is being used.
· Help develop protocols for the ethical distribution of medications on shortage.
· Minimize waste of medications while compounding.
· Assist emergency medical services providers and directors with out-of-hospital protocols during shortages.
· Monitor and report adverse outcomes and medication errors.
Dr. Amirshahi and her fellow researchers examined data from the University of Utah Drug Information Service (UUDIS), which receives its drug shortage reports from the American Society of Health-System Pharmacists (ASHP) website.
When a shortage is reported, UUDIS contacts the manufacturers to verify that there is a shortage and to find out the cause as well as when the product is scheduled to be resupplied. Both UUDIS and ASHP define drug shortage as “a supply issue that affects how the pharmacy prepares or dispenses a drug product or influences patient care when prescribers must use an alternative agent.”
This clinician-focused definition casts a wider net for drug shortages than the FDA, the researchers noted.
UUDIS and ASHP deﬁne a drug shortage as “a supply issue that affects how the pharmacy prepares or dispenses a drug product or inﬂuences patient care when prescribers must use an alternative agent.”
They tapped 2 emergency physicians to classify drug shortages based on whether they were within the scope of emergency medicine practice, used in life-threatening situations, and had a substitute available for routine use.
The researchers uncovered 1789 drug shortages between 2001 and 2014.
Here are 7 things pharmacists should know about these findings:
1. Of the 1789 drug shortages, about one-third (610) were within the scope of emergency medicine practice.
Around half of those 610 shortages involved drugs used in lifesaving interventions or high-acuity conditions. Of those 321 drugs, 32 had no available substitute.
2. From January 2008 to March 2014, emergency medicine drug shortages rose by 435%, from 23 to 123.
In that same time period, shortages of drugs used in lifesaving interventions or high-acuity conditions increased 393%, from 14 to 69. In addition, shortages of drugs with no substitute grew 125%, from 4 to 9.
3. The reason behind shortages remains unknown for around half of the 1789 cases.
The manufacturer did not provide a specific reason when contacted, the researchers stated.
4. Infectious disease medications were hit hardest.
Infectious disease drugs were the most common emergency medicine treatment on shortage, with a total of 148 shortages during the study period.
Analgesia, toxicology, critical care, and gastrointestinal drug categories were the next most frequent drugs out of supply. More specifically, lidocaine/epinephrine, acyclovir injection, hydromorphone, pantoprazole, dexamethasone, nitroglycerin injection, and phenobarbital elixir were some of the drugs most frequently on shortage.
5. Around 40% of drug shortages affect emergency care, according to a report from the Health and Human Services’ Emergency Care Coordination Center.
When there’s a drug shortage, physicians may have to opt for less effective or more expensive alternatives. Physicians may be less familiar with substitutes, as well.
6. The median shortage time for emergency medicine drugs was 9 months.
Dr. Amirshahi said one of the most surprising things she discovered in her research was the duration of the drug shortages.
The median shortage time for drugs with no substitute was 10.5 months.
7. The most common reasons for a drug shortage were related to manufacturing delays or problems.
Supply and demand, raw materials, and discontinuation were the next-most common reasons given for a drug shortage. An unknown reason was cited in 284 cases (46.6%).
The researchers acknowledged that they were unable to determine a reason why drug shortages fell between 2002 and 2007, and then rose from 2008 on. However, they cited a 2014 Government Accountability Ofﬁce (GAO) report that suggested some of the reasons could be the role of group purchasing organizations, changes in Medicare Part B reimbursement policy, or low-profit margins.
In addition, the increase in FDA oversight of manufacturing may have temporarily or permanently closed some operations.
“Drug shortages are of particular concern in emergency care settings where providers must rapidly treat ill and injured patients,” the researchers concluded. “…For most medications, substitutes exist but may not be as effective and may have more side effects, or providers may not have as much experience using them. This could lead to increases in medication errors, such as issues with dosing or interactions.”
Dr. Amirshahi told Pharmacy Times
that she was struck by how many drugs with similar indications were on shortage at the same time.
“For example, there were multiple injectable benzodiazepines on shortage, and there were also shortages of the 2 most commonly used alternative medications: barbiturates and propofol,” she noted.
The researchers called for more exploration by policymakers, manufacturers, patients, and health care providers into the culprits behind drug shortages. In addition, the they called for the FDA to provide better communication about the availability of medically necessary drugs to hospital pharmacies.