There has been an increase in drug shortage reports recently. What does this mean for you and what does that mean for your onboard medical kits? It is not easy to plan for drug shortages; they can take effect at any time.
While recently drug shortage reports have been on the rise, the height of the shortage crisis was in 2010. Shortage causes have not changed in the past eight years and are primarily the result of quality problems during the manufacturing process. When a manufacturing problem identified, companies will halt production until the problem is fixed. Manufacturers have also experienced issues receiving raw materials and components from their suppliers.
In some cases, a drug manufacturer has discontinued older drugs in favour of newer alternatives. The FDA (Food and Drug Administration) cannot require a company to continue producing a drug it wants to discontinue; this can cause a shortage issue for those taking the discontinued medication until new prescriptions are written for the alternatives.
Natural disasters can also impact drug supply chains. Puerto Rico houses significant drug manufacturing infrastructure, when hurricane Maria ravished Puerto Rico in September 2017, production and supply problems created a shortage of saline bags. Saline bags are the foundation of basic I.V. compounding for hundreds of drugs that require further dilution (i.e., antibiotics, electrolytes and chemotherapy drugs). A 500-bed hospital can easily consume 20,000 100ml bags of 0.9% sodium chloride (saline) for injection in a single month. Therefore when a major production hub is compromised, it can have a global impact.
HOW ARE MEDAIRE MEDICAL KIT REFURBISHMENTS IMPACTED BY DRUG SHORTAGES?
MedAire’s onboard medical kits are designed to contain the essential medications needed to respond to an in-flight or at sea medical event. The kits are built with a one year expiration date.
When a drug shortage is announced, MedAire first determines if the shortage will impact a regulatory requirement of the medical kit. If it does, MedAire will work with its global supply chain to source alternatives or re-allocate inventory. If no other options are available, MedAire will then engage all applicable Civil Aviation Authorities the FDA and their International Counterparts to determine how the drug supply shortage impacts adherence to the regulation and then advise clients on the remedy.
If the drug shortage does not impact a regulation, MedAire will replace with an alternative if available. If no alternative can be sourced, MedAire will work with impacted clients to resolve this issue in line with their needs.
MedAire refurbishes over 300,000 medical kits globally every year and maintains extensive relationships with drug manufacturers and medical equipment suppliers to keep clients’ medical kits stocked with the most appropriate medicines and tools to help in the remote environment of an aircraft or maritime vessel.
WHAT ACTIONS ARE BEING TAKEN BY DRUG COMPANIES AND GOVERNMENT AGENCIES TO PREVENT DRUG SHORTAGES?
“The FDA responds to potential drug shortages by taking actions to address their underlying causes and to enhance product availability. FDA determines how best to address each shortage situation based on its cause and the public health risk associated with the shortage.” Source
“When a shortage occurs, and a firm has inventory that is close to expiry or already expired, if the company has data to support extension of the expiration dating for that inventory, FDA is able to review this and approve the extended dating to help increase supplies until new production is available.” Source
“Food and Drug Administration (FDA) officials are working closely with industry, health care providers, and patients to prevent and mitigate shortages of “medically necessary” medicines. Medically necessary drugs are those used to treat or prevent a serious disease or medical condition for which there is no alternative medicine available in adequate supply.” Source
The FDA has been working with other firms who manufacturer the drugs which are in short supply to increase production, if possible, to prevent or reduce the impact of the shortage. Increasing communication between the public and the FDA is an essential component of preventing and mitigating drug shortages. Source
FDA works to find ways to mitigate drugs shortages; however, there are factors that contribute to drug shortages that are outside of the control of FDA. Source
In 2012, legislation was enacted requiring that drug manufacturers notify the FDA “of any change in production that is reasonably likely to lead to a reduction in supply” of a covered drug in the USA. This legislation has played a significant role in reducing the number of drug shortages, but it has not solved the problem.
Several organisations including the American Hospital Association (AHA), Department of Health and Human Services (HHS) and the Office of the Assistant Secretary for Preparedness and Response (ASPR) are reviewing and identifying new opportunities to address the ongoing supply chain and patient care challenges associated with drug shortages.
In 2016, the World Health Organisation (WHO) “also unveiled several options to reduce shortages, notably a new global agreement on actions to diminish specific shortages; expansion of regulatory collaboration on essential medicines susceptible to shortages; centralized negotiation to preserve essential medicines susceptible to shortages including definition of minimum volume and fair price; and work with partners to ensure appropriate demand for medicines for children, including medicines for uncommon diseases.” Source
In 2015, drug manufacturer, McKesson, issued this article of advice for hospitals.
WHAT STEPS SHOULD YOU TAKE?
For yourself or loved ones review the below resources for shortage information and consult with your doctor on concerns or alternatives.
- AMERICAN SOCIETY OF HEALTH-SYSTEM PHARMACISTS | www.ashp.org
- FOOD AND DRUG ADMINISTRATION MOBILE APPS | iOS or Android
- FOOD AND DRUG ADMINISTRATION DRUG SHORTAGE DATABASE | www.fda.gov
- WORLD HEALTH ORGANIZATION | http://www.who.int
If your onboard medical kit is due for refurbishment, consult with your account manager on any concerns you may have about drug shortages. MedAire’s Medical Supply team will already have a plan in place to keep your kit compliant and stocked with the best medicine to assist your crew when medical events occur in flight.
Written by: Deborah Richeal, NRP, MedAire Instructor, USA