Hospital leadership leading the effort to ensure compounding safety
USP new and revised chapters take effect in less than 6 months
By Gregory S. Burger, MS, RPh, FASHP, Senior Vice President, Visante Inc. and Fred Massoomi, Pharm.D, RPh, FASHP, Senior Director, Visante, Inc.
Too many egregious lapses in medication compounding standards have led to hundreds of patients taking contaminated drugs. One of the worst examples was the New England Compounding Center (NECC) where 76 patients died from a fungal outbreak. Thankfully, positive change came from the tragedy with the approval of the 2013 Drug Quality and Security Act (DQSA) and more recently the introduction of new and revised standards from the U.S. Pharmacopeia.
A number of new or revised USP standards go into effect in merely a matter of months, and it’s imperative that hospital leadership make compliance with USP a top priority for their organizations. While the NECC debacle highlights the problems with outsourcing compounding medications, hospitals are not immune to the impact of the lapses for both outsourced medications and drugs compounded within their own facilities.
USP has developed much more sophisticated and effective standards for ensuring patient, worker and community safety due in part to the increased pressures being applied by accreditation bodies, Centers for Medicare and Medicaid Services, State regulatory bodies and Food and Drug Administration. Familiarity should include the knowledge of required chapters of USP for their specific institutional practice models:
- Pharmaceutical Compounding – Sterile Preparations (<USP> 797)
- Pharmaceutical Compounding – Non-Sterile Preparations (<USP> 795)
- Hazardous Drugs (also primarily known as Oncology drugs) – Handling in Healthcare Settings (<USP> 800) and,
- Radiopharmaceuticals (<USP> 825)
Dedicated personnel a must
Establishing a designated team or person to manage compliance is key. The complexities associated with the standards has prompted USP to state: ‘Each entity must have a designated person who is qualified and trained to be responsible for developing and implementing appropriate procedures; overseeing entity compliance with this chapter and other applicable laws, regulations, and standards; ensuring competency of personnel; and ensuring environmental control of the storage and compounding areas.i ii The didactic programs for pharmacists have not kept pace with the changing standards and in most cases are void of the details necessary for establishing and monitoring a compliant program.
Safety standards require upgraded facilities and operations
Half of all cleanrooms currently in use in hospitals are greater than 5 years in age with no modifications.ii However, the revisions to USP chapters for compounding have been revised and in the case of hazardous drugs (includes oncology drugs), requires potentially significant facilities modifications. The top three potentially expensive facility modifications would include:
- External ventilation of rooms for compounding hazardous drugs for each site including infusion centers;
- Heating, ventilation and air conditioning (HVAC) upgrades for units servicing compounding spaces; and,
- Relocation of the compounding services to larger spaces to accommodate the necessary practice changes and increased storage.
While these changes are clear and obvious, when asked about budgets approved for necessary renovations and equipment, 53% of pharmacy directors reported the process to be ‘very difficult’ and 32% ‘difficult’. With the expected compliance date of revised and new standards of December 1, 2019 looming and difficulties gaining budget approvals. Concerningly, 56% of pharmacy directors reported in the survey they anticipate increases in compounding over the next 3 years.
Modifications to the compounding practices in the United States change frequently and systems should include within budget forecasts the ability to anticipate the changes and plan for them. USP publishes anticipated changes to standards at least a year in advance of the expected compliance date for the public to review the modifications and comment. It is important to note that these USP standards are the “minimum” and are reviewed/revised every 3 years. Hospitals should align themselves with industry experts to assist with facility design with an eye towards anticipated changes in order to maximize their capital investments during renovation(s).
Good news, bad news
Standards and regulations often drive compliance. The Pew Institute monitors published examples where compounding practices have failed, leading to patient harm and death.i Hospitals are not immune from these unfortunate events and thus should continually strive towards excellence when preparing medications for their patients.
There are many hospital leadership teams who have already embraced the new and revised standards as a critical way to ensure patient and worker safety. However, too many hospitals are just beginning – or haven’t even begun – to make the necessary preparations, capital investment and training into achieving compliance with USP standards on drug compounding. The USP effective dates are fast approaching, and more importantly the safety of patients and workers is at stake now. As practitioners in this complex area of healthcare, it is our experience that establishing a task group and conducting an assessment is the most timely and successful first step to providing safe and effective medications.
[i]USP General Chapter <797> Pharmaceutical Compounding – Sterile Preparations, USP 41 proposed revision PF 44 (5) [Sept.-Oct. 2018]. https://www.uspnf.com/notices/general-chapter-797-proposed-revisions Accessed May 16, 2019.
[ii]USP General Chapter <800> Hazardous Drugs—Handling in Healthcare Settings. First Supplement to USP 40–NF 35, Second Supplement (2017). https://www.usp.org/compounding/general-chapter-hazardous-drugs-handling-healthcare. Accessed May 16, 2019