Compounding pharmacies and improving patient safety have been an ongoing topic of conversation and legislative discussion for the past five years now. It is hard to believe that it has actually been 5 years since the tragic deaths associated with the NECC (New England Compounding Center) occurred. Remembered as one of the worst pharmacy related health tragedies in US history, a fungal meningitis outbreak that was traced to tainted steroid injections compounded by the New England Compounding Center (NECC) resulted in 64 deaths and an additional 753 patients becoming severely ill, as reported by the CDC (Centers for Disease Control and Prevention).
The Current Status Of Pharmacy Compounding and Patient Safety
Most can agree that much has changed since 2012 in regards to improvements made in pharmacy compounding legislation and regulation in an attempt to better safeguard the public’s safety. However, the recent “State of the Union” report just released by the Roundtable on Patient Safety and Hospital Compounding does raise some concerns as to the effectiveness of the efforts undertaken so far.
The report was the result of intensive discussions and dialogues between high level pharmacy leaders, major hospital groups, healthcare provider consortiums and patient organizations. The goal of these major “stakeholders” was to define the additional steps and recommendations that are still required to guarantee patient safety when it comes to compounded medications. It is important to note that the following steps and initiatives were all put into place since the 2012 NECC tragedy occurred:
1. The 2013 enactment of the Drug Quality and Security Act by Congress (DQSA)
– This law (also known as H.R. 3204) amended the Federal Food, Drug, and Cosmetic Act and granted the FDA (US Food and Drug Administration) more authority to regulate and monitor the manufacturing of compounded drugs.
2. The FDA’s 2018 Compounding Policy Priorities Plan
– Detailing how sections 503A and 503B of the Federal Food Drug & Cosmetics Act will be better regulated, address manufacturing standards, provide improved guidance to compounders, plus “solidify the FDA’s partnership” with all of the state regulatory agencies in the US.
3. Updating and strengthening of regulations on the individual state levels. USP <795> & <797> have always been the practice standards for both non-sterile and sterile pharmacy compounding, but until the NECC case, many states had never “formally” incorporated them into their legislative regulations. This changed dramatically after 2012 and now almost every state in the nation has done so.
Despite all of these federal and state actions, enhanced regulatory efforts, plus additional industry “self-policing” by compounding pharmacies, the report by the Roundtable on Patient Safety and Hospital Compounding does indicate that perhaps the efforts undertaken so far are not sufficiently addressing the issues involved to ensure the public’s safety and prevent another pharmacy compounding tragedy from happening. The white paper that they released noted that a “State of Pharmacy” survey in 2016 documented that greater than one third (1/3rd) of all US hospitals “have experienced a patient health event stemming from a compounding error since 2012”. The round-table panel placed their concerns around the following issues:
– Training not being uniform and having “gaps”.
– Limitations caused by lack of proper hospital resources.
– A severe lack of uniformity in regards to “accepted and implemented best practices” in both hospitals and compounding pharmacy facilities.
Recommendations By the Roundtable on Patient Safety and Hospital Compounding
The roundtable basically called for 100% participation from all parties involved to follow the following recommendations:
1. Implementation of the most recent technological advances in medicinal compounding to minimize the chances of human error. They noted that currently only two out of ten hospitals in the nation employ the most up-to-date technologies available.
2. Development of a uniform curriculum for all sterile medication compounding practices. The panel noted that numerous Colleges of Pharmacy currently do not include sterile compounding as part of their core curriculum. They additionally pointed out the lack of a standard pharmacy technician curriculum.
3. The use of commercially manufactured products and medications, wherever available and appropriate.
4. Adherence to a “Best Practices Checklist” that the roundtable plans to distribute in the near future.
What This Means To Compounding Pharmacies
As many may already be aware, the FDA just released their 2018 Compounding Policy Priorities Plan. Under the plan both 503A and 503B facilities will face heightened statutory requirements. The key will be to understand all compliance issues and to then include them by updating your Policies and Procedures manual as soon as possible. Then make sure that your staff is properly educated and trained in following all the guidelines and requirements. Lastly, provide documentation that your operation is adhering 100% to all of the updated requirements and regulations for audits and inspectors to see.
If you are a compounding pharmacy, the time to get into compliance is now! Do not let issues with regulatory compliance turn into serious threats to YOUR pharmacy. Be pro-active regarding the requirements to the USP 797 sterile compounding guidelines and any of these new FDA requirements. With over 28 years of experience, Healthcare Consultants has been known as a national leader in regards to pharmacy consulting since 1989. Let us help you ensure that your compounding pharmacy or operation has no issues by contacting us today for a complete Compliance Review. Reach us online or call today at 800-642-1652.