Implementing a Performance Improvement Program In Your 503A Compounding Pharmacy
You’ve done your due diligence and implemented a robust quality control program. You fully understand the difference between quality control and quality assurance, and have also implemented a quality assurance program that meets your compliance and quality needs. You regularly score highly in all key indicators of quality, and you follow industry best practices and all pertinent regulatory guidelines.
So where is the weak link in this system? The answer, as always, is the human element.
The third leg of an excellent program is performance improvement (PI). All the quality control and assurance measures you can research and implement might not address the human element. Figuring out how to measure and incentivize your pharmacists and other staff, and how to properly implement an effective PI program can result in a smoother operation, fewer compliance issues and, ultimately, happier customers.
Why a Performance Improvement Program Complements Quality Control and Quality Assurance
Following the 2012 tragedy at the New England Compounding Center, regulatory compliance has become an increasingly large part of a compound pharmacy operator’s purview. The requirements for accreditation and certification include the United States Pharmacopeia (USP) standards, guidelines established by the Pharmacy Compounding Accreditation Board (PCAB) and various state-level recommendations as well.1
Where a quality control (QC) program focuses on ensuring outcomes and a quality assurance (QA) program focuses on consistency of process, a performance improvement program focuses on actively reducing all elements of human error. Systematically and proactively addressing areas where human error could disrupt QC or QA helps you promote better purity, potency, effectiveness and safety in your sterile and non-sterile preparations.
Specifically, PI programs can benefit compounding pharmacies defined as traditional compounders under section 503A of the Food and Drug Administration’s Compounding Quality Act—generally meaning that your pharmacy compounds preparations for specific patient prescriptions and is in no way categorized as a manufacturer.
PI programs can also benefit compounders classified as manufacturers or outsourcing facilities under section 503B of the Act, but those programs would have additional considerations under the Current Good Manufacturing Practice regulations as well.2
How to Implement a Performance Improvement Program in a 503A Compounding Pharmacy
Putting together a classic healthcare performance improvement plan is so systematic that going through the process can actually help you diagnose a number of quality issues with your system. Broadly, the process moves from assessing root causes for performance issues, forms a plan for addressing said issues, and then measures whether those issues have been reduced or eradicated from your pharmacy operation.
To implement a PI program at your compounding pharmacy, you should focus on:
The Big Picture
This very first stage can seem like a waste of time if you’ve already been thinking about implementing a PI program for some time, but you should take a moment with all your key stakeholders to define your bigger picture goals:
- What are we trying to accomplish with this improvement initiative?
- How will we know whether we have improved?
- What changes can we make?
Having your initial thoughts on these questions defined, written down and agreed to by your entire committee (or even just yourself, if no other stakeholders are involved) can help promote accountability during the process.
These answers can always be adjusted as you discover more specific information. For instance, you might answer that you would like to improve the percentage of misfills, only to discover in the next step that you actually have more issues with hand hygiene or incomplete mixing instructions.
You can also use the answers to these questions as guiding statements as you go through the rest of the process, making sure that everything you decide at each stage works for your compounding pharmacy and isn’t simply being done for the sake of it.3
Identifying Performance Issues
This is a key step: figuring out what performance issues you will be working to improve. Finding issues can be done any number of ways. Most commonly, you’ll be able to assess this through:
- Direct observation of pharmacy processes
- Evaluating lapses from your QA and QC data, such as consistent issues with certain types of errors (percentages off, misfills, dispensing errors, etc.)
- Patient and customer feedback, which should be encouraged as part of the process
- Formal audits
Creating a Baseline for Performance Measurement
Next, you’ll want to define your quality metrics and figure out how you can measure them prior to implementing your formal PI program.
Your indicators will depend on the issues you previously identified. A few common tools for collecting data include staff interview transcripts, QA/QC data, observation summaries, survey results, and more.
Once you’ve established a clear picture of your pharmacy’s current performance in the areas of concern, you can decide where your end goal should be. For instance, if you’re consistently finding a five percent dispensing error margin and would like that reduced to two, formalize that as a goal and identify all the steps that lead to that dispensing error.4
Planning for Addressing Areas of Concern, Including Incentivization
Identifying specific behaviors leading to the human errors you want to eradicate will help you identify ways to fix that issue. For example, could the dispensing errors you’re seeing be caused by poorly trained staff? Do they lack the proper equipment or workspace?
Involving your pharmacists and staff in this part of the process may help lead to breakthroughs regarding the root causes of all your identified issues.
Once you have a grasp on why these errors could be occurring, create a plan to specifically address each root cause.
Incentivization does not necessarily need to be part of your plan, but it’s proven that people respond better to incentives than sanctions. Common incentivization in pharmacy practices can include performance-based bonuses or group-based bonus sharing.
Measuring Performance Improvement Quality Indicators
Using the same quality metrics you identified to measure your baseline performance, you’ll want to re-measure using the same methodology at intervals. This will tell you whether progress is actually being made, and can help you fulfill any incentivization framework you built for your pharmacists and staff.
Pharmacists are increasingly in service-related positions and playing a larger role as clinicians. As such, pharmacists will be held more often to standards of healthcare quality on the level of hospital quality standards. Implementing a performance improvement program will ensure that your pharmacists and your pharmacy are ready to be part of interdisciplinary healthcare teams and provide the best possible patient care.5
Pharmaceutica North America is a leading provider of high-quality active pharmaceutical ingredients and compounding kits for compounding pharmacies and in-office compounders. Contact us to find out how our products can help you create a premier patient and customer experience and compound the highest-quality medications.
- “Customizable toolkit helps hospitals improve quality,” Oct. 1, 2013, http://www.pharmacist.com/customizable-toolkit-helps-hospitals-improve-quality ↩
- “Performance Improvement in 503A Compounding Pharmacies: A Plan for Assessment, Implementation and Sustained Success,” January 2016, http://www.ijpc.com/Abstracts/Abstract.cfm?ABS=4088 ↩
- “Primary Health Care, Inc., Performance Improvement Plan,” Sept. 2003, http://bphc.hrsa.gov/archive/technicalassistance/resourcecenter/services/sampleperformanceimprovementplanprimaryhealthcareinc.pdf ↩
- “Performance Improvement in 503A Compounding Pharmacies: A Plan for Assessment, Implementation and Sustained Success,” ibid. ↩
- “Improving Pharmacy quality: On-site performance measures,” Nov. 15, 2010, http://drugtopics.modernmedicine.com/drug-topics/news/modernmedicine/modern-medicine-feature-articles/improving-pharmacy-quality-site-per ↩