The following post is co-authored by two special guests:
Jonathan D. Washko, BS-EMSA, NREMT-P, AEMD and Scott Matin, MBA, NREMT-P
In a recent meeting held in Washington DC, sponsored by the Department of Health and Human Services (HHS) and the Assistant Secretary for Preparedness and Response (ASPR), the EMS industry and other key industry players were invited to learn more about why the current drug shortage situation exists. Those that attended the meeting were fortunate to be addressed by a panel of experts from the FDA, HHS, drug manufacturers, drug suppliers and a variety of EMS providers and industry trade Associations.
How did we get into this situation?
It became quickly evident that the problem being experienced by the EMS industry along with other emergency health service providers is due to a variety of unmanaged but tightly integrated series of manufacturing, regulatory, supply chain and end user processes and practices that have come together in a perfect storm to produce the situation we find ourselves in.
In the drug manufacturing industry of today, production capacity is limited due to a variety of reasons including: regulation, the cost associated with developing manufacturing capacity at the levels of quality dictated by the federal government and the fine balancing / wall street like “hedging” of maintaining supply and demand at such a point that prices don’t drop too low while also keeping the supply chain from running out (especially with lower margin generic drugs). The problem with this approach is how fragile this balancing act can be when the bet is wrong or unforeseen circumstances arise (like recent shut downs of manufacturing plants in an already underserved market), as is being currently demonstrated by the drug shortages being felt today.
In short, our problems are due to too many drugs that need to be manufactured on a production capacity incapable of meeting demands. How we got here is up for debate, with the drug companies placing blame on slow and over burdensome regulatory processes and the government blaming private industry for trying to maximize their return on investments by allowing price elasticity of supply and demand to dictate production schedules.
How do we fix the problem both for the short term and long term?
There is no simple solution according to industry insiders and the federal agencies that regulate these businesses. Supply chain coordination along with improved lines of mandatory supply, demand and production reporting are needed to help permanently solve the problem, however due to the competitive nature of the industry, this happening by itself is a long-shot.
There are currently efforts at the federal level to reform legislation to help solve some of these problems and you should watch these initiatives closely so that when the time comes, advocate based lobbying efforts can be focused, as it is not difficult to assume that the drug industry may be opposed to further legislative or regulatory efforts and will fight these efforts on capital hill.
In the near term, EMS agencies must use their innate skill sets of “overcoming and adapting” in order to bridge drug shortfalls. Ideas and best practices shared at the meeting included:
Situational Awareness – You must understand the scope of your agency’s particular problem before you can manage it. This means you need to understand for each effected drug: your current use / burn rate, amount on hand, how long your existing supply will last and when your supplier advises they can get you a shipment (although this date should not be trusted according to many). With this data you can gap analyze shortfalls then use other mitigation strategies below to fill the gap.
- Deployment Strategies – Consolidate limited supply drugs out from ambulances and onto supervisor units or quick response units and dispatch these units if these drugs are presumptively needed (e.g. based on dispatch determinant) or called for by on-scene clinicians. This strategy can be very effective, however this is not a tactic that will work for all agencies (especially rural areas). Additionally, for those agencies utilizing this strategy, immense planning, coordination and communication is a must.
- Compounding Strategies – Work with local or regional compounding pharmacies to create the drugs needed. While this is a valid option for many drugs, there are some downsides. The first is that the average price reported by many EMS agencies that utilize compounding is 8 to 10 times more than they currently pay for drugs. Another, is the limited shelf life which on average is 6 months versus a year or more for drugs manufactured the traditional way. Federal officials were quick to point out that agencies should only use accredited compounding pharmacies to ensure quality.
- Use of Expired Drug Strategies – There is clear concern here from all parties regarding this solution for obvious clinical and legal risk reasons. Often, many drugs maintain their potency past their expiration dates, however this is highly variable, drug specific and can be influenced by external environmental factors like temperature, light exposure and humidity. The best advice offered regarding this strategy was that it is a local decision, and that batch-testing product to determine potency (or other related problems like particulate formation, solution instability, degrading, etc.) may be an option for those considering this solution. One concern, however, is that this type of testing is expensive and a determination must be made whether it is more cost effective to batch test or purchase new drugs from a compounding pharmacy.
- Partnership Strategies – Working with regional EMS and healthcare providers is another strategy to consider as they may have alternative suppliers you do not have access to, may have reserve stock on hand that they are willing to share, or may have relationships with out-of-region providers whom possibly could help.
Additionally, closely monitoring the shortage situation to try and do some hedging on your own is another important tool in your arsenal and there are some great on-line resources available to keep you informed (see below). This is important so that you don’t find out about a drug shortage after your supply drops and you can’t find what you need (be proactive and not reactive).
Lastly, agencies should avoid hoarding as it compounds the problem, especially for smaller rural agencies that do not have the purchasing power or clout that their larger urban counterparts may have with suppliers, purely due to their size. Hoarding creates artificial spikes in demand and can abruptly interrupt supply-chain improvement efforts, as supply becomes available, it will quickly disappear due to these practices and not get fairly distributed based on actual agency needs.
There are three resources worth sharing and mentioning to help you gain better situational awareness and help ensure solution strategy quality:
The first resource is from the American Society of Health-System Pharmacists (ASHP) and is considered by many (including those within the federal government) to be the best resource for reporting and monitoring drug shortages.
The second resource is from the Pharmacy Compounding Accreditation Board (PCAB) whom oversees voluntary quality accreditation designation for the compounding industry. They provide a list of accredited compounding pharmacies that you can check when looking into this option for your agency.
The third resource is from the US Food and Drug Administration. This site’s topics include: what the FDA is doing about drug shortages; Presidential and legislative action to date; current drug shortages; how to report a shortage or supply issue; resolved drug shortages; and drugs scheduled to be discontinued.
This is a complex problem that will not resolve itself anytime soon. While our legislators work to try and find future mitigation and abatement strategies, we as front line providers must take a proactive approach using a variety of strategies that work for your particular agency, region and State.
It is also extremely important to get involved and financially support EMS advocacy groups and associations so that our patient’s voices can be heard by our legislators! Believe it or not, the democratic process does work, but you have to participate, stand up and say something and not let big business get in the way of providing the best patient care we can offer.