EMS Legal Experts Discuss Drug Shortage Liabilities

Reduce risk for your agency in how you manage the drug shortage crisis

 

 
 
 

Douglas Wolfberg JD, EMT | Ryan Stark | Steve Wirth, Esq., EMT-P | From the June 2012 Issue | Wednesday, May 23, 2012


Conduct a keyword search for “drug shortage” at JEMS.com for more information. If you haven’t been affected yet, it’s probably just a matter of time until you are. The national drug shortage is really starting to hit home for EMS agencies, and there’s no relief in sight for the foreseeable future. Nearly half of the drugs on a shortage list recently released by the Federal Drug Administration (FDA) are administered by EMS providers, and many of those medications are used to treat seizures, cardiac arrests and other life-threatening conditions that occur in the prehospital setting.

As a result, many EMS agencies have been forced to make hard choices among alternatives that range from bad to worse. Some use alternative medications, or even expired medications, in the face of this crisis. Other agencies are simply waiting for direction from their state or regional EMS agencies and hoping for the best. But this raises an important question: Could an EMS agency incur liability for taking these kinds of actions or for failing to take any action at all?

General Rules
The more prepared you are to weather a drug shortage, the less likely you are to incur liability. Of course, EMS agencies can never completely inoculate themselves from lawsuits. But devising clinical strategies that best promote patient care in the event that critical prehospital drugs become completely unavailable can decrease the likelihood of being sued successfully.

Fortunately, prehospital professionals are protected from liability if they act in good faith and without gross negligence in most states. Some states specifically provide immunity for EMS personnel if they follow applicable protocols or medical direction from an authorized physician, again presuming the EMS provider acts in good faith and without gross negligence. Many states also provide similar liability protection for the EMS agency itself, and for physicians who develop protocols or provide medical direction, if such activities are done in good faith and without gross negligence.

That means that in most states, a plaintiff will likely have to prove that an EMS agency went far beyond “ordinary negligence” if they want to successfully sue the agency. But that may not be the standard in every state, and the immunity statutes and gross negligence standards may not apply to decisions regarding which medications to carry.

Regardless of whether a simple negligence standard or gross negligence standard applies, most courts will ultimately look at things like whether EMS agencies acted in the best interests of their patients, followed applicable rules and protocols, and actually took reasonable and timely action when faced with a potential drug shortage. Generally, courts understand we’re often faced with circumstances beyond our control. There may be circumstances for which there’s simply no viable alternative to a medication that’s unavailable. In such cases, courts are often reluctant to impose liability. But EMS agencies still need to prepare for contingencies so that it’s clear what happens in the event that there are no alternatives.

Protocols
State laws and local protocols may dictate how your agency can address drug shortage concerns. For example, in some states, medical directors are given wide latitude in determining which drugs will be carried on the ambulance and in developing local clinical protocols. In these states, alternative therapies that involve more widely available medications can be more easily implemented. In other states, changing a drug may require going through a bureaucratic process that could take several months.

States that rigidly regulate EMS drug lists, or have statewide protocols that include specific medications, may need to invoke an emergency rule-making process to respond to these challenges and allow their EMS agencies to continue to provide high-quality patient care. Nevertheless, certain strategies can be applied universally, and applying these strategies can help reduce the risk of liability for EMS agencies.

Inventory frequently: EMS agencies should inventory all their drugs and check their expiration dates on a frequent basis. Agencies should assign drugs with more recent expiration dates to be used before those with later expiration dates. It’s a good practice to look at historical usage rates for your organization so the organization knows when it has fallen below a critical level. Also, ensure medications are properly distributed among vehicles and establish benchmark levels for medications on each ambulance in adherence with applicable laws and protocols.

Track shortages: EMS agencies should also assign an individual or committee to track drug shortage information and trends on a local, regional and national level. The American Society of Health-System Pharmacists (ASHP) maintains the most current list of drugs in short supply and anticipated dates of resolution. You may also wish to work with state and regional EMS agencies.

Work cooperatively: Other providers may have what you need. If state law permits, consider implementing purchase agreements with other EMS agencies and facilities. State ambulance or EMS associations may be able to help organize group purchasing options to increase EMS buying power. There are also established purchasing cooperatives that may be able to help. Hospitals may have much better buying power with drug manufacturers and can obtain preference in purchasing drugs that are in short supply. Just make sure these agreements dictate that you’ll pay fair market value for the medications and have the agreement reviewed by your legal counsel for potential Anti-
Kickback Law concerns.

Always follow laws and protocols: When considering and/or using alternative treatments and medications, or when using drugs with lapsed expiration dates, always adhere to applicable laws, protocols and medical direction. If there’s a way to relax those laws and protocols, pursue those avenues. Consider obtaining an emergency exception from the state if one is available.

Consider viable alternatives: EMS agencies, in conjunction with their medical directors, need to be proactive in making protocol recommendations when a drug is in short supply or when a drug will likely be in short supply. Is there an equivalent medication that’s safe? If so, consider any side effects and other contraindications of its use. If there’s a way to have medications approved beyond their expiration date, consider this option. Or the agency may wish to consider using compound medications.

Have a contingency plan: The agency should have a contingency plan in place in the event there’s no drug, or viable alternative, available. Consider other treatments, besides medication, that might assist the patient. Work with medical directors to develop protocols that deal with worst-case scenarios.
 




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Related Topics: Administration and Leadership, Legal and Ethical, EMS drug shortages, drug shortage, Jems Priority Traffic

 
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Douglas Wolfberg JD, EMT Doug Wolfberg is an EMS attorney and founding partner of Page, Wolfberg & Wirth. He has previously worked as an EMS field provider, EMS educator, county EMS director, and EMS administrator at the state and federal levels.

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Ryan Starkis an EMS attorney with Page, Wolfberg & Wirth, a national EMS industry law firm. Visit the firm’s website at www.pwwemslaw.com to sign up for their free EMS Law Bulletins, or like their Facebook page at Facebook.com/pwwemslaw.

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Steve Wirth, Esq., EMT-Pis a founding partner of Page, Wolfberg & Wirth, LLC. Steve is an active EMS provider and firefighter, and a national EMS speaker and a member of the JEMS and EMS Insider editorial board. He can be reached at swirth@pwwemslaw.com.

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