PCAB Accreditation: What is it all About?
By Joe Cabaleiro, RPh, PCAB Executive Director
Many pharmacies have questions about the Pharmacy Compounding Accreditation Board (PCAB) - What is it, what is the process like, and why should the pharmacy consider accreditation?
This article will address those questions and more.
What is PCAB?
The mission of PCAB is to promote high quality in pharmacy compounding through a voluntary accreditation program that recognizes adherence to established principles, policies and standards.
At their core, the PCAB standards are a set of quality assurance, quality control and quality improvement best practices to which every compounding pharmacy should adhere. In fact, most compounding pharmacies probably already comply with PCAB standards to some extent. For example, all pharmacies use a fairly standard system to label their prescriptions - it is required by law. PCAB also has a standard related to labeling. It includes the usual requirements for a patient label with which all pharmacists and technicians are familiar; perhaps the only differences are that the PCAB standards require that all the ingredient names be clearly spelled out, that the beyond use date is clearly indicated, and that the label indicates the preparation is compounded.
In many cases, PCAB standards and requirements help pharmacies "fine tune" their compliance with United States Pharmacopeial Convention (USP) Standards and best practices. The majority of sterile compounding pharmacies use a waterless, alcohol- based hand disinfectant. Often, these are off the shelf "hand sanitizers," which do not have the persistent activity required by USP<797>. In these cases, PCAB asks the pharmacy to upgrade their hand sanitizer to one labeled, "surgical hand scrub." These products have the persistent activity required by USP<797>. Even though the differences may appear to be subtle, there is good clinical rationale for using a surgical hand scrub instead of hand sanitizer.
PCAB has no legal enforcement power; the organization's mission is to promote high quality in pharmacy compounding. Occasionally, quality and regulations do overlap. For example, if a pharmacy is shipping medications into a state in which it is not licensed, and licensure is required, PCAB will not issue accreditation until the pharmacy addresses this issue. PCAB accredits pharmacies, and in the example above, the organization is not legally a "pharmacy" in the state into which it is shipping.
Why Should Pharmacies Consider Accreditation?
PCAB-accredited pharmacies consistently tell PCAB that the preparation and survey process helped improve the quality of their compounding operations and preparations. Improving quality is not only good for patients and business - compliance with the PCAB Standards will help a pharmacy close gaps that may lead to patient safety issues, and in turn, minimize legal/regulatory risks. In some cases, PCAB has helped pharmacies identify and eliminate risks of which they might not have otherwise been aware. Quality and safety are the most important reasons to achieve PCAB accreditation.
Patients, prescribers, and organizations that rely on compounded medications, such as hospitals and surgical centers, are seeking to identify high quality compounding pharmacies. PCAB accreditation provides pharmacies external, independent validation that a pharmacy meets nationally accepted quality standards. Almost universally, healthcare organizations such as hospitals, and surgical centers are accredited by specialized accrediting bodies. For those organizations, accreditation is a requirement for reimbursement; they understand the accreditation process and are looking to work with pharmacies that have gone through a similar external validation.
Various organizations recognize PCAB accreditation. AMA resolution H-120.945 AMA Action on Non-FDA Approved Compounded Medications says, in part:
"recognizes the accreditation program of the Pharmacy Compounding Accreditation Board (PCAB™) and the PCAB™ Seal of Accreditation as a means to identify compounding pharmacies that adhere to quality and practice standards,"
"encourages all state boards of pharmacy to require compounding pharmacies in their states to obtain the PCAB™ Seal of Accreditation or, alternatively, to satisfy comparable standards that have been promulgated by the state in its laws and regulations governing pharmacy practice"
The California Board of Pharmacy accepts PCAB accreditation in lieu of sterile licensure in their state. PCAB maintains an outreach program to various governmental and non-governmental health care groups and the public. These communications share a common theme - if your patients need compounded medications they should be obtained from a pharmacy that has independent, external validation that it meets nationally accepted quality standards.
What Is The Process Like?
The thought of allowing a quality evaluation of their pharmacy understandably makes personnel at some pharmacies nervous - a question PCAB often receives is, "what happens if I fail a PCAB survey?" This question has a simple answer - PCAB surveys are not "Pass/Fail." PCAB surveys identify specific areas where a pharmacy is not fully compliant with PCAB standards; accreditation is a matter of addressing those compliance issues, not a "pass/fail" grade.
There are certain circumstances where a pharmacy may not be eligible for accreditation, including probation or suspension of pharmacy licenses due to quality, compounding or controlled substance issues.
Accreditation involves six distinct steps:
Preparation: The PCAB Standards manual may be downloaded at www.pcab.org. Upon reviewing the PCAB standards, most pharmacies will find that some preparation will be necessary to become fully compliant. PCAB is often asked: "how long will it take to prepare for survey?" On average, pharmacies spend about six months preparing; some pharmacies may require less time, others more.
PCAB's standards are a set of best practices every pharmacy should follow. Whether your pharmacy is interested in applying for accreditation now or in the future, working on implementing compliance with best practices will have an immediate benefit for your organization.
Application: Once the pharmacy is compliant with PCAB standards, the next step is submitting an application. Once your application is completed, PCAB will contact your pharmacy to schedule the onsite survey. The survey occurs on a mutually agreeable date - when the leadership at your pharmacy determines the pharmacy is ready.
Survey: Depending on the volume of the pharmacy, surveys are one to two days onsite. PCAB surveyors are all compounding pharmacists with experience in both sterile and non-sterile compounding. The surveyor will evaluate the pharmacy's compliance with PCAB standards by observing and interviewing personnel; they will also review the facility’s equipment and records. Surveyors do not make accreditation decisions. The surveyor’s mission is to gather data about the pharmacy's compliance with the standards. Though the surveyor does not make accreditation decisions, throughout the course of the survey, they will provide feedback to your pharmacy regarding their findings. This is an opportunity for your pharmacy to clarify those findings so that they may be addressed. PCAB recommends that your pharmacy wait for the official, written report before taking any actions on surveyor findings at your organization.
Survey Report: Within 30 days of the survey, the pharmacy will receive a written report from PCAB which documents the surveyor's findings at your pharmacy. In cases where a pharmacy is not fully compliant with a PCAB standard, the report will also document what actions the pharmacy needs to respond to the findings. Pharmacies are typically given 120 days to address any non-compliant findings. For example, a common finding is that sterile compounding pharmacies are not using an appropriate hand disinfectant. In this case, PCAB will request that the pharmacy submit evidence that it has purchased an appropriate disinfectant, and trained personnel on its use.
Pharmacy Response: Most pharmacies will have one or more survey findings to address. These findings may require the pharmacy to implement certain procedures or systems. PCAB typically requests that the pharmacy submit documentation indicating that the pharmacy has addressed the report findings. The report includes detailed information about what specific documentation must be submitted. In some cases, PCAB may require another onsite visit to verify full compliance.
Accreditation Committee Decision: The PCAB Accreditation Committee consists of five pharmacists; a representative from the USP, a member from the National Association of Boards of Pharmacy (NABP), and three compounding pharmacists. These individuals review the survey results and the pharmacy's response. Approximately 90% of pharmacies fully address all outstanding findings and receive accreditation. The pharmacies that do not receive accreditation are given a time frame in which to come into full compliance, typically six months from the survey date.
How Long Does the Process Take?
As previously noted, the PCAB Standards are a set of best practices every pharmacy should follow; most pharmacies find that implementing these best practices is the most challenging part of the accreditation process. It is difficult to predict a typical preparation time, because every pharmacy is different.
Once a pharmacy submits a completed application and notified PCAB that it is ready for survey, PCAB can schedule a survey within 30 days. Pharmacies receive a completed survey report within 30 days of the survey. Most pharmacies respond to any survey findings within 120 days. The pharmacy will receive an accreditation decision about 30 days from the date the response was submitted.
What Are The Most Common Compliance Findings?
PCAB standards are divided into nine categories. The most common findings by category include:
Regulatory Compliance: Lack of required license(s). If a pharmacy is doing business in a state, and that state requires licensure as a non-resident pharmacy, PCAB requires the pharmacy to be compliant with that state's licensure laws.
Personnel: The standards in this section require the pharmacy to orient, train and verify the competency of their personnel. Findings in this section usually relate to one of these processes, particularly to competency assessment. For example, USP<797> requires sterile compounding pharmacies to perform fingertip testing and media fill test procedures on a regular basis. Non-sterile compounding competency can be assessed through observational checklists and tracking the results of quality control tests performed by each employee such as capsule weight variation tests and potency analysis.
Facilities and Equipment: The most common issue with this standard is the lack of proper powder containment equipment. If the pharmacy is working with hazardous or potent materials, appropriate powder containment must be in place.
There are several common findings related to sterile compounding:
- Failure to comply with the USP<797> requirement that pre-sterilization procedures such as weighing occur in a minimum ISO-8 environment.
- Viable air sampling: USP<797> requires pharmacies to perform viable air sampling at a minimum of every six months. Findings relate to not testing at the appropriate frequency and/or the use of media that can detect bacterial and fungal growth.
- USP<797> requires the use of a waterless surgical hand scrub for disinfecting the hands, and the use of sterile isopropyl alcohol for disinfecting surfaces. Over the counter waterless hand disinfectants are not the same as a “waterless surgical hand scrub.” Isopropyl alcohol cannot be substituted for sterile isopropyl alcohol. If the pharmacy sterilizes its own alcohol, testing should be performed to verify the effectiveness of the sterilization procedure.
- Failure to depyrogenate glassware and other equipment.
- Endotoxin testing: USP<797> specifically requires that certain high risk sterile preparations prepared in batches of 25 or more (consult USP<797> for details) be tested for endotoxins. However, PCAB requires pharmacies to have a program of endotoxin testing that also includes skip lot testing of high risk sterile preparations prepared in quantities of less than 25 dosage units.
Chemicals, Components and Completed Compounded Prescriptions: Failure to store hazardous chemicals separately from other chemical and materials. Complying with this requirement can be as simple as storing these medications on a separate shelf or in separate cabinet.
Compounding Records: Incomplete formula and compounding records. For example, incomplete preparation instructions, missing quality control procedures, and, when applicable, missing the results of quality control tests.
Beyond Use Dating, Potency and Sterility: Findings in this section relate to:
- Failure to document the source of beyond use dating information, or not being able to document how a beyond use date was assigned.
- Lack of sterility, endotoxin and/or potency testing programs that result in an appropriate or adequate sample size. QC testing should be done on the basis of a written program, and testing should be consistent with the written plan. The plan must be consistent with USP<797>, which requires sterility testing of all high risk sterile preparations given beyond use dates beyond the defaults established in the document.
Completed Compounded Prescriptions: Findings in this section relate to:
- Inability to identify the lot numbers of ingredients used to make a particular preparation and/or the inability to identify a particular batch or lot number of a preparation that a patient received - thus not being able to properly perform recalls.
- The use of abbreviations or names on preparation labels that do not clearly identify what active ingredients the preparation contains.
- Failure to provide written information to patients as required by the standards in this section.
- Failure to verify shipping methods to assure that medications maintain appropriate storage temperatures throughout the shipping process.
Prescriber Communication and Patient Education: Findings in this section relate to the failure to notify prescribers and patients that medications are compounded.
Total Quality Management: This chapter requires pharmacies to have active programs for quality assurance (QA), quality control (QC), collecting and reporting quality related events (QREs) and quality improvement (QI). While pharmacies are generally compliant with the first three requirements, the requirement for an active, defined quality improvement program is overlooked because QI is confused with QA/QC.
How Do We Prepare?
Obtaining accreditation will require a commitment of time and pharmacy resources. The first step is to download and review the PCAB Accreditation Manual at www.pcab.org.
The PCAB website also has updated Frequently Asked Questions and resource documents which may be helpful in your preparation.
Continue the process by assessing your pharmacy’s compliance with each standard. You will likely find that your pharmacy is compliant with some standards and must take steps to fully comply with others. To use preparation resources effectively you must identify the areas that need attention and develop a plan of action for achieving full compliance.
Once your pharmacy is comfortable with its level of compliance with the standards it will be time to submit an application. Your organization can open an application at any time. The survey is not scheduled until your organization indicates to PCAB that it is ready for survey.
The PCAB Standards are a set of best practices incorporating quality assurance and quality control activities to which every pharmacy should adhere. To date, 168 pharmacies have now seen the benefit to their patients and practice of demonstrating their commitment to quality by obtaining PCAB Accreditation. Every day, more and more prescribers, patients and healthcare organizations are using PCAB accreditation as a requirement for selecting compounding pharmacies for their compounded medication needs.
As Executive Director, Joe Cabaleiro, RPh, leads accreditation programs and initiatives designed to support compounding pharmacies in their efforts to continuously improve quality practices and enhance patient care. Prior to joining the Pharmacy Compounding Accreditation Board (PCAB), Cabaleiro held management or consultancy positions in the home infusion therapy field. He worked for the Joint Commission on Accreditation of Healthcare Organizations (JCAHO) where he conducted homecare program pharmacy surveys and evaluated home infusion organizations against JCAHO’s standards. Cabaleiro is the author of several publications on compounding accreditation and is the former owner of a compounding pharmacy; Triangle Compounding Pharmacy. He earned his B.S. Pharm degree from the University of Florida.