With an aging population and the rising popularity of products such as bioidentical hormones, an increasing number of Americans are exposed to drugs created in compounding pharmacies.
These pharmacies are not bound by the same FDA rules regarding raw materials as standard drug companies. Nor does the FDA verify the safety, quality, and efficacy of drugs created by compounding pharmacies. Instead, compounding pharmacies are regulated by state pharmacy boards.
Enforcement by these boards is spotty, at best. If this lack of significant regulation, and the absence of an administration to keep them accountable sounds like a potential recipe for disaster, that’s because it is.
Hundreds of people have died, and thousands more experienced severe and/or permanent injury due to inadequate compounding pharmacy conditions. Victims have substantial legal rights against pharmacy negligence or misconduct.
Compounding Pharmacies – Frequent FDA Conflicts
When doctors prescribe a medication, most patients receive a drug from a regular pharmacy made in standard forms by a commercial manufacturer. A compounding pharmacy makes drugs for an individual patient.
Compounding pharmacies serve an important function. For example, a child may require a medication available only in adult doses, and a compounding pharmacy can create an appropriate dosage.
Patients allergic to dyes in certain medications may need a compounded version of the drug. Compounding pharmacies allow patients unable to swallow pills the option of using a liquid form of the medication. Moreover, some of the largest compounding pharmacies mass produce medications, especially intravenous drugs for hospital use, and higher-risk drugs in general.
The downside of compounding pharmacies, which are overseen by licensed pharmacists, is that many of them do not meet basic safety standards, and may use raw materials of questionable origin.
When the FDA has tried to inspect facilities because of public health emergencies traced back to compounding pharmacies, its investigators have been denied access to the pharmacy itself or its records.
One Out of Four Compounding Pharmacy Drugs is Inadequate
Since drugs are compounded for individual patients, there is little testing involved. It generally takes injury to a patient before the testing process is investigated. Just two states – Missouri and Texas – regularly test compound drugs at random, and the results are not pretty.
The Texas State Pharmacy Board has found that as many as 25 percent of compounded drugs tested were either “too weak or too strong,” according to The New York Times. In Missouri, the potency of the same compounded medications varied by as much as 300 percent. In some states, compounding pharmacies are not subject to strict procedures for making transactions and keeping records.
Fungal Meningitis Outbreak from Horrid Pharmacy Lab
A 2012 outbreak of fungal meningitis, linked to a New England compounding pharmacy, led to 732 becoming sick with the brain disease, and 64 deaths. Many of the afflicted still suffer permanent damage and pain.
Although the owner of the compounding pharmacy was acquitted on charges of second-degree murder, he was convicted in March, 2017 on charges of racketeering and mail fraud. A meningitis victim was quoted as saying, “I have a lifetime sentence of pain. Standing hurts, bending over hurts, putting my socks on hurts.”
Investigators found the pharmacy’s laboratory was not sterilizing some products for the right amount of time, and that a room contained a rodent and insect infestation. “Dark debris was floating in some vials of medicine,” according to The New York Times.
Miami Eye Infections from Compounding Pharmacy
In 2011, a Hollywood, Florida compounding pharmacy repackaged the cancer drug Avastin – a chemotherapy drug used for treating various types of cancer – into vials for injection into the vitreous of the eye.
Such injections are considered “off-label” treatments by the FDA for macular degeneration. The compounding pharmacy apparently compromised Avastin’s sterility during the repackaging process.
Not only did numerous patients in the Miami area suffer eye infections as a result, but five patients undergoing treatment at Los Angeles Veteran’s Affairs Medical Center were blinded.
At the time, the FDA issued a warning stating, “Health care professionals should be aware that repackaging sterile drugs without proper aseptic technique can compromise product sterility, potentially putting the patient at risk for microbial infections. Health care professionals should ensure that drug products are obtained from appropriate, reliable sources and properly administered.”
Act Quickly to Preserve Your Rights – There are Time Limits to Compounding Pharmacy Injury Claims
If you or a loved has experienced a compounding or traditional pharmacy error resulting in physical harm, Call or Email John Uustal today for a no-cost case evaluation.