Hive Health Media

Speciality Pharmacies Cut Corners with Fatal Consequences

The Food and Drug Administration or FDA has arrived at a crossroads in their efforts to supervise ‘specialty pharmacies’. These are believed to be complicit in a mounting number of sickness’ and fatalities, according to an agency bulletin last week. It was the Washington Post that first exposed the substandard procedures and basic hygiene failures at three large drug producing, speciality pharmacies. The paper linked their products to a number of deaths and quite a few outbreaks of sickness since 2000.


All of this predated the high national profile case of the New England Compounding Center (NECC). This Massachusetts based firm produced the contaminated steroid shots that were at the epicenter of last year’s outbreak of fatal meningitis. The FDA say they need stronger enforcement teeth behind specific legislation to bring speciality pharmacies that are “firms engaged in large-scale distribution” under control. Their speciality products are tailor made pharmaceutical compound and drugs. Many of which were specifically named in the Washington Post expose.

The legislation at present is a bewildering array of federal and state regulations. Even when seen as body it is falling short when it comes protecting patients across the country from technically demanding and therefore potentially risky compounding factories. The FDA feel they have, “reached a critical point on this issue”.

The democratic representative from Massachusetts, Edward Markey, put out a press release, in November last that revealed just how patchy oversight by state level government was on these pharmacies. He further stated last week, that the FDA should be given greater powers to intervene. He is planning to bring back legislation that would give the health watchdog powers to regulate the private compounders that are de facto drug manufacturers. His conclusion is that, “These compounding pharmacies have been operating under the radar for too long”.

Local druggists have always combined ingredients to make the medically specified compounds according to the individual needs of patients as prescribed by their doctors. The profits involved in this specialized function have led to the development of a national oligopoly market. With fifteen large and dominant firms, compounding on a huge scale and distributing across state borders. The mixtures are often anticipating patient needs and produced to maintain stock levels in the system rather than to order.

Three of the big fifteen, besides NECC have had hazardous quality failures that have led to 39 known cases of serious illness. Two of the companies had cut corners in processing and caused at least 6 fatalities. When medication doses are mixed to too great a strength they can become dangerous. When they are too weak they are a waste of time and money. When medication is not produced in sterile conditions they can become contaminated with bacteria and again be potentially fatal and always harmful. The FDA are naming the 3 companies; Central Admixture Pharmacy Services in California, PharMEDium Services in Illinois, and Texas-based ApotheCure. All 3 deny any lapses in standards and say they make only quality products.

Claire Al-Aufi is a contributing author for Hive Health Media who provides updates on health and fitness news.

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