What is a compounding pharmacy?To understand the issues currently surrounding compound pharmacies, it's vital to consider what they are. Put simply, compound pharmacies work to combine, mix, or alter medications to meet patient needs. Some examples of how this can be put into use include:
- Altering a medication for easy consumption
- Changing medication flavors
- Removing inessential allergens
- Customizing strength and dosage
Prescribing the Problem of compound pharmaciesJudging by the fact that compound pharmacies work solely to meet unique patient needs, you'd assume they’re a positive thing, but evidence is emerging to suggest otherwise. The lack of FDA regulation in place within these pharmacies has long been an area of concern. This is an issue that's come up even more since top name celebrities like John Oliver began discussing it on Last Week Tonight. Alongside Oliver, Kristen Bell, Jimmy Kimmel, and more have also warned of the risks these non-regulated ‘designer drugs’ can bring. There are currently 7,500 compound pharmacies across the country, and Oliver has already exposed several of them for fraudulent activities. While experts have accused Oliver of ‘oversimplifying’ this issue, no one can deny that his fears around lacking regulations are relevant. During the compound segment of his show, he claimed, “Even when there isn’t fraud, it is not rare for compounded medications to be ineffective.” This high-profile attention isn’t the first time that compound pharmacies have come under scrutiny in recent years. In 2012, the New England Compounding Center (NECC) was found to be illegally compounding drugs that resulted in an outbreak that killed 64 and caused infections in 793 patients. This was just one in a worryingly long line of serious adverse effects found from mislabeled or poorly compounded drugs. In response to the 2012 outbreak, in particular, Congress passed the Drug Quality and Security Act (DQSA) to toughen regulations with registrations for compound pharmacies. But, as Oliver pointed out, these requirements had a rather large loophole of being voluntary. Despite this growing debate, no one is denying that compound pharmacies fill a much-needed niche in the medication market. Rather than calling for closure, the current discussion is primarily centered around the need for increased regulations and inspections to guarantee patient safety moving forward.
The real risks of lacking regulationsThese lacking regulations are what come most often under scrutiny from our medical lawyers in Las Vegas, and there’s certainly a cause for concern. In an age where FDA-approval is vital, the failure to focus on this growing area seems like a significant oversight. Worse, it leaves patients at risk in a few significant ways. In standard medical facilities, the FDA works to ensure everything from the safety to the effectiveness of drugs. Failure to apply the same checks to compound creations leaves patients at risk from either drug that is compounded in unsafe ways or those which are ineffectual. Both can lead to severe and worsening medical conditions that could otherwise be avoided. This lack of regulation also leaves patients at risk from non-sterile compounding conditions. While compounds should receive regular inspections in keeping with current good manufacturing practice (CGMP) requirements, this regulation seems questionable due to a lack of inspectors on the ground. The 2012 outbreak, for instance, happened due to the contamination of a compounded drug. Other facilities have even been caught storing pills next to the toilet. Overall, Oliver’s references to compound facilities as the ‘Wild West’ of the drug world aren’t entirely unfounded. While many compounding pharmacies do play by the rules, some are sneaking through the gaps. Where health is concerned, that’s worrying indeed.
How lawyers can help with compound drug casesSeeking a Las Vegas lawyer should be a top priority for anyone in the instance of a compound pharmacy misdemeanor. As well as bringing medication issues to the forefront of a judge’s mind, seeking legal representation can lead to much-deserved compensation. Not to mention that holding individual compound facilities to account improves processes moving forward. Sadly, cases against compound pharmacies aren’t always easy to pursue. In large part, that’s because medical liability acts in many states protect facilities like these. Furthermore, state laws are varied and sometimes tricky to pin down. These cases must, therefore, be approached by a trained medical attorney in Las Vegas or elsewhere. To stand any chance at holding up in court, a Las Vegas attorney will need to provide an expert report detailing applicable standards of care and how the facility in question failed to meet them. Cases can also be long-winded given that, as with most dangerous prescription claims, proof must be provided of the lasting implications of patient injuries/suffering. Despite this rather bleak legal outlook, seeking compensation in these cases can go a long way towards rebuilding lives and even affording the best possible health care. Turning to the best personal injury attorneys in Las Vegas can make it happen.
Signs that you have a case to pursueCompound pharmacy misdemeanors can be hard to pin down because they often go unnoticed. If you’re wondering whether you have a viable case against a compound near you, there are a few telltale signs that you could benefit from speaking to lawyers in Las Vegas. Some top things to look out for include:
- Failure to improve after taking compound drugs
- Worsening of symptoms outside of listed side effects
- Strong reactions to typical dosages
- Hospitalizations or worse for seemingly simple illnesses