What your agency can do
The healthcare system is experiencing an alarming increase in the number of reported drug shortages for a range of products vital to the treatment of critically ill patients. These drug shortages are already affecting the ability of some EMS responders to provide critical care for patients during life-threatening emergencies.
There are no indications from the Food and Drug Administration (FDA) that the problem will correct itself any time soon. In fact, the federal government expects the shortages to worsen. According to a brief compiled by the Assistant Secretary for Planning and Evaluation, the number of drug shortages in the U.S. nearly tripled between 2005 and 2010.1 Although the government takes pains to note that the vast majority of drugs are readily available, the majority of the drug shortages are found among medications needed for sedation, pre-hospital and in-hospital emergency treatment and chemotherapy.
Aside from the lack of critical care medications, a primary concern among the EMS community is the potential for increased medical errors. In a survey of healthcare practitioners conducted by the Institute for Safe Medication Practices between July and September 2010, 35% of respondents indicated they experienced a “near miss” as a result of a drug shortage in the previous year. Nearly one in four reported a medication error and one in five reported an adverse event.2
Strategies for EMS
Some EMS agencies have begun creating “just in time” protocols for alternative medications or multiple protocols for similar conditions. Still others have been forced to purchase more expensive brand name drugs to replace the ones they can’t get. Unfortunately, due to current reimbursement models, many agencies find that they’re unable to recoup the additional expense. A few fire-based EMS systems report that they have had to pull drugs from ALS engine companies to re-stock ambulances.
There may be those who consider turning to “gray market” pharmaceutical vendors. However, the average markup for the drugs in short supply is 650%, according to one study.3 The highest markups were for drugs needed to treat the most critically ill patients.
Temporary waivers of drug expiration dates are also being explored as a possible avenue of relief. The National Association of State EMS Officials (NASEMSO) Medical Directors Council is at the forefront of this issue. They caution that one of the serious risks for EMS professionals and EMS medical directors is a potential conflict with the DEA over regulations concerning expired scheduled medications and should proceed carefully.
In February, the Ohio Department of Public Safety, Division of EMS, sent a memo to Ohio EMS agencies, EMS medical directors, hospitals, and hospital pharmacists, announcing drug shortages from the FDA. Carol Cunningham, MD, FACEP, FAAEM, Ohio state medical director and member of the JEMS Editorial Board, states that although the council doesn’t have the authority to grant states the ability to waive the expiration dates of medications or create policies for the FDA or DEA, it’s “committed to be a lead partner with EMS organizations and other stakeholders within the emergency care system to definitively address this dilemma, that we believe the incidences of drug shortages will be ongoing for some time.”
James J. Augustine, MD, FACEP, director of clinical operations for Emergency Medicine Physicians in Canton, Ohio, and member of the JEMS Editorial Board, emphasizes that the states have the authority to act on temporary waivers. “It’s certainly something we haven’t had to do before,” he says. “But the science says the manufacturers are very conservative in their estimates of an expiration date.” Numerous studies have shown that many drugs retain their effectiveness long after the expiration date.
“For many of the drugs, when they test them, they don’t find degradation,” Augustine says.
What that means for EMS is that agencies must be exceedingly careful about how medications are stored. “EMS leaders are going to have to store medications in places that are away from fluctuations in temperature, humidity and light, then bring out the medications in small quantities to put in drug boxes where it is not as easy to control the environment,” Augustine says. He points out that the federal government has been doing the same thing with Chempacks for years.
Another strategy is to establish a cooperative relationship with local hospitals to avoid allowing drugs to expire. Medicines that are about to expire get moved to the hospital, where they are used immediately for patient care. Those with later expiration dates are slated for the ambulances and medic units.
“Hospitals are also struggling,” Augustine says. “They are interested in the availability of medicine for emergency care. Sometimes EMS has access to critical drugs the hospital can’t get and vice versa.”
Augustine recommends sharing supplies with other agencies on a regional basis and establishing an incident management team at a regional base. By using an action plan to combine resources, the allied agencies can ensure that appropriate drugs are in the right place at the right time. Instead of negotiating for supplies on its own, they are in a stronger position by negotiating as a region.
Finally, Augustine strongly recommends that EMS leaders stay in contact with state medical boards, pharmacy boards and EMS authorities so actions are consistent. “In some places the state department of health has some authority,” he says. “It’s important in this emergency that EMS be in contact with these bodies.”
Ohio’s alternative drug plan
The memo to Ohio EMS agencies also included a list of suggestions for alternative drugs based upon the Feb. 22, 2012, drug shortage report from the FDA (see Table 1, below).
EMS managers and medical directors were instructed to pay attention to state laws, boards and the Department of the Drug Enforcement Administration when assessing the value of an alternative medication. The highest priority, the memo says, must be given to striking a balance between patient care and obeying state law. “The addition of any alternative medication to an EMS protocol must be paired with training, continuing education, competency assessment and continuous performance improvement measures,” the memo states.
International Association of Fire Chiefs recommendations
On March 8, the International Association of Fire Chiefs (IAFC) released a position statement outlining the following recommendations for EMS managers:
- Stay abreast of the latest shortages by visiting the FDA’s website, www.fda.gov/Drugs/DrugSafety/DrugShortages/default.htm.
- Reevaluate current EMS inventories to ensure we are not contributing to the shortage.
- Actively report drug shortages to commanding officers, your medical director and the appropriate government agencies. Work with local EMS medical directors to implement a medication shortage list with the primary, secondary and tertiary medications within protocols to limit the effect of short notice.
- Develop policies and procedures to build agility into protocol changes and a tracking mechanism to allow for quality assured compliance.
- Examine other medically appropriate and approved solutions, such as using multi-dose vials to pre-draw up medications in syringes, and seal them in tamper-proof bags or containers that are clearly marked with the drug, expiration date and lot number.
- Explore the requirements to provide a fully functional pharmacy internally to lessen dependence on local hospital supply.
- Regionalize pharmaceutical plans to assist in limiting shortages or their effect.
- Develop a more formal memorandum of understanding with local hospital pharmacies that identifies the effects of medication shortages and the expected remedy/actions when they occur. Also incorporate discussions on how to increase on-hand storage, such as shared remote secure storage.
- Enhance paramedic training to include the implications of pharmaceutical shortage s and to improve proficiency in drug calculations and medications.4
Summary
Despite national attention, the drug shortage isn’t going to end quickly. EMS agencies facing shortages will need to find innovative ways to address the issue.
References
- Assistant Secretary for Planning and Evaluation. (Oct. 28, 2011). ASPE Issue Brief: Economic analysis of the causes of drug shortages. In U.S. Department of Health and Human Services Assistant Secretary for Planning and Evaluation. October 2011, Retrieved March 8, 2012, from aspe.hhs.gov/sp/reports/2011/DrugShortages/ib.shtml.
- Institute for Safe Medication Practices. (Sept 23, 2010). Drug Shortages: National survey reveals high level of frustration, low level of safety. In ISMP Medication Safety Alert. Retrieved March 8, 2012, from www.ismp.org/newsletters/acutecare/articles/20100923.asp.
- Institute for Safe Medication Practices. (Aug. 25, 2011). Gray Market, Black Heart: Pharmaceutical gray market finds a disturbing niche during the drug shortage crisis. In ISMP Medication Safety Alert. Retrieved March 7, 2012, from www.ismp.org/Newsletters/acutecare/showarticle.asp?ID=3.
- EMS Section Board of Directors, International Fire Chiefs Association. National Drug Shortage. In International Fire Chiefs Association. Retrieved March 8, 2012, from www.iafc.org.