Tuesday, 12 April 2016

Why you need to be concerned about Drug Shortages in the USA

The lack of adequate drugs to treat patients is becoming a concern not only for US administration officials but also the general public and clinicians as well. There are several factors that might explain these otherwise inexcusable shortages. First of all the ingredients of certain drugs are so rare that the process of sourcing them disrupts the production process significantly. Secondly some manufacturers like the capacity to meet the growing demand for drugs while others make profit-based decisions that put public health at risk. Thirdly federal regulators have sometimes created such stringent entry requirements that many potential manufacturers have opted to pull out of the process.

Understanding the Full Impact of Drug Shortages

The immediate impact is that the people that need this type of medical treatment are left struggling. Some of them go for untested and sometimes unhealthy alternative medication. At other times important medical procedures have to be delayed in order to ensure that all the right medications are in place before the patient is put in a situation of no-return. The shortages necessarily drive up the costs of medical treatment due to the forces of demand and supply. In general this trend is reducing the health outcomes for people who are living in the most prosperous nation on earth.

Challenges of Developing Coordinated Strategies

The problem of missing drugs could have been mitigated if all the agencies involved were working together. Unfortunately the opposite is true in as far as the definitions of what a shortage really is differ considerably. For example the American Society for Health-System Pharmacists (ASHP) focuses on end-user where alternatives must be found; whereas the FDA focuses on the availability of capable suppliers. Ultimately these two definitions point towards the same problem but require solutions that are divergent. Whereas ASHP might consider the supply chain and affordability; the FDA is more concerned with licensing and safety.

A Statistical and Practical Nightmare in the Making

Understanding the extent of these trends requires a close examination of FDA drug shortage data. This is often gleaned from a combination of private and public resources. A lot of information relating to this issue has been presented by the Drug Information Service at the University of Utah Health Care (UUHC) trust. By 2010 there were no fewer than 211 separate shortages. This turned out to be the highpoint of the dire statistics. The following year the Premier Health Alliance reported that there about 240 separate drug shortages in the country. Another worrying statistic was that about 400 generic medications had back-order averages of at least five days, which is equivalent to a working week. This information complements the FDA drug shortage data which shows that suppliers are failing to meet demand.

Some Practical Solutions

First of all the licensing protocols must be liberalized further in order to bring in more market-oriented participants. This does not mean neglecting safety issues but rather offering new opportunities to meet demand. Secondly generic manufacturers should be encouraged in order to supplement the official supply from the patented companies. Finally early surveillance is of the essence in order to detect the problems before they become crises.

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