Methods to overcome global prescription drug shortages

In its ongoing quest and mandate to provide the highest quality health care to the people of the Cayman Islands, the Health Services Authority is often faced significant external challenges.

One such obstacle that is currently impacting the quality of medical care in the Cayman Islands is the limited supply or unavailability of some widely used and regularly prescribed pharmaceutical agents.

The most recent drug shortage list published by the American Society of Health System Pharmacists includes several drugs currently used by the Cayman Islands Health Services Authority, such as uncommon complex drugs needed for chemotherapy to more commonly used simple drugs like Paracetamol suppositories.

The Cayman Islands does not currently enjoy a preferred relationship with any large country that maintains larger supplies of pharmaceuticals and being at the end of the logistical supply chain, is therefore vulnerable to the problems presented by global drug shortages. Additionally, many vital drugs are now under the control of a new United States law that prohibits their export.

Small international hospitals such as the Cayman Islands Hospital are feeling the effects of these global forces most keenly due to their lack of volume-based buying power.

The HSA is heavily dependent on drugs manufactured for both the US and United Kingdom markets even though a smaller percentage of pharmaceuticals are also obtained from Canada, Central America, the Caribbean, New Zealand and Europe (mainly through the UK). Unfortunately, several of these manufacturing companies outside of the US and UK are owned by the same companies within the US that are themselves experiencing problems keeping up with the heavy demand in the US market.

The global shortages are due to several combined factors, these include manufacturing problems such as the shortage of materials to make medicines, US Food and Drug Administration recalls of key drugs due to the quality, manufacturing or safety issues; the discontinuation of older but still needed drugs by companies after patents expire; increased demand for particular drugs; and mergers of companies leading to the discontinuation of certain branded drugs. This results in procurement and delivery delays for varying periods due to the limited availability or unavailability of certain prescription drugs.

While the issue of prescription drug shortages has become more topical in recent months, this is a long standing issue affecting both the medical and pharmaceutical community and has attracted the attention of the US Food and Drug Administration, as well as other major policy makers in the area of health care worldwide.

In July 2011, a FDA statement said the agency “recognises the significant public health consequences that can result from drug shortages and takes tremendous efforts within its legal authority to address and prevent drug shortages. The FDA is aware that in 2010 there were a record number of shortages and in 2011 the FDA has continued to see an increasing number of shortages, especially those involving older sterile injectable drugs.”

A report by the US Department of Health and Human Services blamed “a substantial expansion in the scope and volume of products produced by the industry that has occurred over a short period of time, without a corresponding expansion in manufacturing capacity”. In many cases, generic manufacturers are unable to fill the void created by the shortages due to costs and volume constraints, or not having a legal right to do so due to pending patents.

Currently, the Cayman Islands Health Services Authority is being affected by ongoing waves of shortages, and the management and staff are working extremely hard to curtail the problem in order to avoid an unsafe situation for patients.

For example, since numerous pharmaceutical items are placed on back order as a result of suppliers being out of stock, HSA pharmacy team have taken extraordinary and time-consuming efforts to secure some of these back-ordered drugs through regular or secondary suppliers from non-traditional places such as New Zealand and Turkey.

However, because of the global shortage, the Cayman Islands is in direct competition with the rest of the world for consistent pharmaceutical supplies and have already begun to experience the inability to obtain certain drugs from US suppliers which are now only available for the US market, such as Adderall and Rebif.

To deal with this potentially dangerous situation, the HSA Pharmacy team has developed a contingency plans to mitigate the pharmaceutical shortages. The HSA has doubled its monthly orders to create sustainable stock levels while taking into consideration expiration dates and stock usage rates. In addition, the HSA is exploring alternate IV fluid manufacturers and securing additional storage space to maintain approximately one year’s supply of these solutions, including hurricane supplies.

One possible solution to be considered could be the formation of a central purchasing unit or local supply unit (similar to a system employed by the Eastern Caribbean states) this would facilitate the purchase and storage of larger quantities of known essential and in-demand drugs, such as anticoagulants, diabetic, hypertensive, asthmatic and epileptic drugs that are guaranteed to be used based on annual national trends and requirements.

While the Ministry of Health is actively exploring the issues and seeking to find a way to effect a permanent solution, the HSA continues to be proactive by putting contingencies in place to avoid negative impacts to patient care. In the face of a potential drug shortage crisis a long-term plan is needed to address drug supply issues, and ensure the day-to-day needs of patients are met and there is preparation for emergency situations including natural disasters such as hurricanes and other mass casualty situations.

The Health Services Authority runs a regular column looking at what’s new in local health services.