The Massachusetts Senate voted late last month unanimously to increase regulatory oversight within the state of drug compounding pharmacies, in order to help protect patient safety.
The potential issues regarding the largely unregulated compounding pharmacies such as the one in Massachusetts, which was believed to be the source of a deadly fungal meningitis outbreak, have been discussed at length on this blog.
Following the contamination of compound medications affecting hundreds of patients, which was eventually traced back to a Massachusetts lab, one of the most important regulations of the bill is that it establishes sterile compounding and complex non-sterile compounding specialty licenses, which will be issued by the Board of Registration of Pharmacy.
The bill also requires that inspectors be trained in the sterile compounding and complex non-sterile compounding processes, and that they further conduct both planned and unplanned inspections of licensed pharmacies, in order to ensure compliance with the regulations.
The bill also increases requirements for continuing education hours required of pharmacists, and requires training in the sterile and complex non-sterile requirements. Additionally, in order to expedite the discovery of potentially unsafe conditions, the legislation further requires that stores and pharmacies report any improper dispensing of prescription medications that result in serious injury or death.
In addition, the bill equips the Board of Registration of Pharmacy with new enforcement powers, including the ability to assess fines or suspensions of pharmacists or pharmacies should any reasonable regarding public safety or well being arise.
As previously discussed, until this point, safety concerns have not been adequately addressed by regulators because these compounding pharmacies can fall within a precarious loophole between state pharmacy boards and the FDA. The companies, which supply an estimated 40% of all intravenous medications used in American hospitals alone, are not subject to the same stringent requirements as drug makers, meaning they cannot be compelled to test each lot or batch for sterility and proper potency. Hopefully, once passed, this new law will spur other states to follow suit, and will sharply reduce the potential for contamination within compounding pharmacies located within its own borders.
Although contaminated medication is one way that consumers can be harmed by a prescription medication error, it is not the only way. Other common errors occur when patients are given an incorrect dose, and in some cases an incorrect medication altogether. Errors can occur when a healthcare professional inputs a prescription incorrectly, a pharmacist incorrectly fills a prescription, or even when in the hospital a patient is given the wrong pill. Whatever the case, if you have been harmed by a prescription medication error, you may be entitled to compensation for your injuries, medical bills, pain and suffering, and other related expenses.
If you or a loved one has been harmed as a result of a prescription error, contact the pharmacy error attorneys at Lebowitz & Mzhen,LLC. Our attorneys have extensive experience in representing victims or family members of those who have been injured by medications that were prescribed, dispensed, or administered incorrectly. Contact us today in order schedule your free and confidential consultation through our website, or by calling us at (800) 654-1949.
More Blog Posts:
Four Doctors Potentially Tied to 27 Prescription Medication Related Deaths, Pharmacy Error Injury Lawyer Blog, published November 6, 2013
Widow Awarded $850,000 for Medication Dosage Error of Husband, Pharmacy Error Injury Lawyer Blog, published October 28, 2013