Quality failures in the medical sector are a big cause for concern. Recently there have been two high-profile product recalls, one for prescription drugs and one for a diagnostic device. The first was a recall of a number of drugs by a Woburn pharmaceutical company called â€˜Pallamid Pharmacyâ€™. While the second was a recall of a model of blood glucose level meters, made by the giant Johnson and Johnson company.
Pallamid Pharmacy Recall
Most worryingly of all with the drugs recall was the fact it came only after an inspection by state regulators, of the production facilities. Serious problems were found and more than twelve lines of prescription drugs, manufactured so far this year, are being recalled. The pharmacy is continuing to produce drugs in its non-sterile facility, but is not making any more in the sterile site until further notice. Many of the recalled drugs were meant to be injected by patients. The recall is a voluntary one, but no doubt under duress from the authorities. It is clear that not all pharmacies are to be trusted to maintain the required sterile standards, nor to recognise the times when they fall short in quality terms.
The Pallimed website communicates the situation thus; â€œUntil further notice, Pallimed will not dispense any sterile compound products and will not engage in any sterile compounding activities.â€ The brands that have been subject to recall are generally prescribed to treat erectile dysfunction, hormone replacement therapy, and in optical medications. There have been no reported cases of patient harm from using any of the recalled brands so far.
It is a necessary precaution however since regulators saw 50 fatalities and 668 cases of sickness due to tainted pharmaceuticals from a New England compounding pharmacy in Framingham.
Recall of OneTouch Verio IQ Meters
Meanwhile over at Johnson and Johnson no less than 2 million units are being recalled again as a precaution. These medical devices are used by diabetics to monitor their blood glucose levels. Unfortunately the â€˜OneTouch Verio IQâ€™ meters (there are about 90,000 in use in America alone) fail to warn patients when their glucose level goes catastrophically high. They even shut down when faced with levels above 1024 mg/dl. Clearly the danger is that patients may not react quickly enough; if at all, to such a life threatening condition and thereby do not get the medical help they need.
LifeScan is the Johnson and Johnson subsidiary that make the units and they discovered the problem themselves and are voluntarily making the recall. They also notified the FDA and all relevant health providers. The company is recalling 670 thousand of the OneTouch Verio Pro model in Europe and nearly 5000 units from hospitals in the Middle East, Europe and Asia. All this even though there was only 1 reported case of patient suffering linked to the wrong measurement.
This case was not conclusively linked to the device misreading and there have been no such cases identified in America. Diabetics should be aware of the potential problem but continue to use their monitors until replacements can be provided.