Mixing Your Meds: Working Through the Pharmaceutical Shortage for EMS
James J Augustine // March 1, 2013
A year ago, EMS and emergency care leaders recognized an unprecedented, unexpected and unplanned shortage of emergency medications. After an initial set of actions and two federal hearings, it is apparent that the shortage of pharmaceuticals is now an ongoing problem, and will require EMS agencies to adapt their processes.
The causes of this shortage are still poorly understood. Drug manufacturers, the Federal Drug Administration (FDA), and the Drug Enforcement Administration (DEA) have been at odds for the past few years over safe manufacturing and quality processes.
Several recent high profile drug contamination events are increasing the scrutiny and pressure on medication manufacturers. At this point, it is clear that the issue is:
- Centered on the manufacturing process (and a relatively small number of manufacturers)
- Related to the production of medicines that are given through a needle
- Prices of medications have been and likely will continue to increase significantly
- All classes of medicines used in EMS care are involved
EMS leaders are now faced with an ongoing management challenge of assuring that a supply of safe medications, in a form that EMS personnel can use safely, is available to all patients needing that treatment. Agencies and personnel can develop programs that can address these concerns, using a five part process.
1. Protocol Management
EMS agencies and medical directors must change medical protocols to address supply and shortage of important medications. The protocols should be modified to expand options for therapeutic interventions. The protocol change and medication substitution must be permissible in state law and rule.
The Drug Enforcement Administration has not modified any rules, so controlled substance utilization requires the careful coordination by EMS leaders. It may be necessary to get more medications approved for use by state oversight agencies to use in the event that certain medicines are not available at all.
In some cases, this strategy may require the substitution of oral medicines for intravenous ones, or alternate treatment in case medicines are not available for a clinical problem in any form.
The review of EMS medical protocols is a continuous process. Changes and updates in medical care are asynchronous, even to the timing of AHA updates, which are delivered every five years. Many EMS agencies use the annual "testing and skills checkoffs" as a time to look at the protocols, take input, and consider what areas need change.
In the last two years, the acute shortage of medications is another trigger for looking at protocols. "If we don’t have any atropine in the drug box, is the most effective alternative to use a dopamine drip, apply a pacemaker, or something else?"
Protocol evaluation is, in fact an ongoing event. The challenge is "version control" so that all personnel in the Department know which version of a protocol they are working under.
That is the logistical reason that many Departments do major protocol updates about every five years. It is also why the drug shortage has created some significant challenges in changing drugs and protocols on the fly, and in the middle of a usual cycle.
Working with fellow regional healthcare providers is a strategy to develop alternative supplies for short or potentially short medications. Using the NIMS nomenclature, this is called "mutual aid." Other agencies in the system may have reserve stock on hand that they are willing to share, or may have relationships with out-of-region providers that could possibly help.
However, controlled substances are NOT able to be managed using this strategy, as they are under the jurisdiction of the Drug Enforcement Administration, and supply management is strictly controlled.
3. Active Stock Management
EMS agencies must address supply, utilization, rationing, and storage of each medication. It is critical that a lead person or persons actively manage all stocks, maintain the physical stock so that medicines with short expiration windows are used first, and provide management with reports on use, supply, and strategies for stretching the stocks of important meds.
Where critical medicines are needed at multiple locations on an unpredictable basis, a "medication runner" system will be essential.
Following the active stock management plan, drugs in limited supply must be stored and deployed "just in time" and based on patient need. Key elements are avoiding exposures of medicines to degradation based on the environment they are exposed to, loss due to waste or diversion, and non-use before expiration date.
This strategy contributes heavily to the safe execution of the next strategy, extending the medicine beyond its posted expiration date.
4. Use of Expired Medications
Science says that many drugs maintain their potency past their manufacturer imposed expiration dates. This is variable, drug-specific, and can be influenced by external environmental factors like temperature, light exposure and humidity.
There are companies that will now batch-test product to determine potency (or other related problems like particulate formation, solution stability, degradation, etc.).
This testing is expensive and a determination must be made whether it is cost effective to batch test a supply of medications that is all from the same batch. There is clear concern about the use of this strategy for legal risk reasons.
5. Ongoing Training. This strategy involves the training of personnel on a new process of medication use. EMS personnel must be aware of the drug shortage problem. Rather than using protocols that specify only one type and form of medication, providers may need to select from a choice of medications and/or delivery form.
Effective in-service training with EMS providers should take a POSITIVE focus, not a negative one. Celebrate successes and reward good behaviors. In EMS the team approach needs to be prioritized.
In-service training that focuses on positive elements of service delivery; educational items that come from better medical care delivery; and methods of improved team performance are all elements that are valued by EMTs and paramedics in the programs.
EMS providers may be using drug kits that are more complicated to find the right medicine. A logistics change may have the medicines now in a colored container, or using a colored sticker, to highlight the type of medicine that is available. A typical drug dose for adult or pediatric patients would be printed right on the container or sticker, to provide "just in time" guidance for the paramedic that is going to administer the drug.
Some EMS systems are putting safety cards in their medication boxes, or safety notices on the EMS computers, to give paramedics an additional visual safety prompt. Finally, programs should be instituted that allow all EMS personnel to report all problems, suggestions, and "near misses" in non-punitive fashion, that can improve the medication administration process.
6. Ongoing quality management
There are few evidence-based measures of emergency medical services (EMS) system performance. The Consortium of US and International Major Metropolitan Municipalities EMS Medical Directors (a.k.a. Eagles) have published quality criteria for EMS systems (Myers, JB, et al. Evidence-Based Performance Measures for Emergency Medical Services Systems: A Model for Expanded EMS Benchmarking. A Statement Developed by the 2007 Consortium U.S. Metropolitan Municipalities' EMS Medical Directors (Appendix) Prehospital Emerg Care 12 (2) , 2008. Pp 141-151).
Why the system would look for quality measures, leads to when the system would look. Some elements require continuous observation and action.
Some elements require the system to look across a time interval, to collect enough cases to allow an adequate observation and conclusions. These are important elements of measuring the performance of systems, processes, equipment, individuals, and teams.
The Eagles developed the quality improvement model that encompasses a broader range of clinical situations, including myocardial infarction, pulmonary edema, bronchospasm, status epilepticus, and trauma.
The benefit conferred by EMS interventions is presented in the number needed to treat format. The model serves to improve EMS system design and deployment strategies while enhancing the benchmarking and sharing of best practices among EMS systems.
Quality improvement programs are not effective if only the QI staff know the results and the implications. QI programs need to change behavior in a positive manner. This is done with regular newsletters, posts, or educational sessions that share the results of the QI program.
These focus first on areas of success, then on areas where improvement is needed, and those areas where new initiatives need to be incorporated where new problems have evolved. The drug shortage issue is an example of this last element, where a previously routine operation, like stocking drug boxes with a fixed package of medicines well-incorporated into the medical protocols, has abruptly been disrupted.
In a broader and very positive manner, the medication shortage allows EMS leaders to address another paradigm shift in health care and an element of regulatory compliance.
As the entire health care industry struggles to implement effective information technology strategies at all levels, the use of technology will support efficiency, flexibility, accountability and regulatory compliance in the use, storage and planning for medication use.
For example, the widespread use of electronic dispensing systems in hospitals has dramatically improved accountability, planning capability and staff satisfaction, while reducing medication loss. The use of barcoding as a staff-friendly method of information input and quality management may also have EMS applications.
Related to controlled substances, there are tightening regulatory mandates to manage supplies of controlled substances that ensure these medicines are available for critical patient care, and not diverted for criminal purposes.
All of these elements will allow creative EMS leaders to improve medication inventory management systems and point of care electronic assistance, and extensions of the program can improve the tracking of all important EMS assets.