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Food and Drug Administration and Compliance Issues
Sunday, May 19, 2013
Compounding Pharmacies Geared to Be a Public Health Risk Posted by :admin On : May 16, 2013
Normally, when a person goes to fill a prescription at the pharmacy, the pharmacist only has access to standardized doses and medicine formats. However, at places known as compounding pharmacies, employees specialize in fine-tuning pharmaceutical compounds so that they more closely meet individual needs. Compounding pharmacies assert that patients are less likely to fall victim to troublesome side effects by taking these tailored solutions, but some professionals are worried that these types of pharmacies could actually pose a public health risk.
Most States Not Tracking Drugs Closely
An article from the Boston Globe says that in most states, compounding pharmaciesare not regulated to provide reports about how many drugs they produce or where those drugs go. Also, Missouri and Mississippi are the only states that require compounding pharmacies to have a specific license.
Waiting Until Problems Are Reported, Even When Large Batches Are Made
A report that was compiled to be read at a US House hearing goes into detail about how instead of being proactive in regularly performing inspections, most states follow the practice of waiting until people begin complaining about drugs that were mixed incorrectly, rather than monitoring facilities to catch problems before they become serious issues. Although compounding pharmacies are supposed to meet the precise needs of patients and theoretically only make drugs in small batches, some instead make huge quantities, including those that should be produced in environments that are carefully controlled and sterile.
This problem was clearly highlighted last year, when a compounding pharmacy in Framingham Massachusetts came under fire for a batch of contaminated injectable steroids that contained fungal meningitis. In that incident, more than 700 people got sick, and at least 53 of them have died.
A Voluntary Recall
Recently, a pharmacy in Florida called Balanced Solutions voluntarily recalled all lots of its sterile, non-expired drug products after concerns that the products might be tainted with bacteria. The company did not mention how many products could be affected, but mentioned how they are fully cooperating with investigations from officials. So far, inspectors have found gram-negative bacteria in samples of chromium chloride, although coverage of the recall on MedPageToday noted that the bacteria does not usually cause infection in humans. Black particles in seven containers of an injectable steroid were also found, but it’s not yet known if the black particles are dangerous or harmless.
Making Changes Moving Forward
In addition to being concerned conditions in Florida, inspectors conducted investigations between February and April and found problems at 30 other compounding pharmacies around the country. Five of those locations protested and initially did not allow inspectors to either enter the facilities or make copies of records. One even required investigators to get a court-ordered inspection warrant.
A Food and Drug Administration Commissioner named Margaret Hamburg has noted that there are now more than 2,800 compounding pharmacies throughout the United States and said that “regulatory uncertainty” continues to be a risk to the American population. There are also doubts surrounding the type of legal action that FDA officials can take, since any sort of regulation of compound pharmacies currently occurs at the state level. However, in an article published by Yahoo! News, Hamburg that the FDA is pledging to do a better job moving forward, even if it means hiring additional regulatory authorities to reduce health risks.