San Ysidro Approved for Re-Accreditation as “PCAB Compounding RX”
As of last September 2012, San Ysidro Pharmacy was reaccredited by PCAB (Pharmacy Compounding Accreditation Board), located in Washington DC. San Ysidro Pharmacy was first accredited in 2009 and had become the fifth pharmacy in the state of California to be accredited. San Ysidro’s desire to become accredited was fueled by a collective mutual need among other compounding pharmacies nationally. Compounding pharmacies have been questioned and scrutinized by some groups claiming that there has been no qualified oversight for those pharmacies. However, in 2005, PCAB was established by eight of the nation’s leading pharmacy organizations to quell those concerns. The accreditation process was designed to reassure the community that the quality of products being made for patients would be reflected in the policies and procedures that standardize how all compounding pharmacies operate.
While all pharmacies must meet state licensure requirements, PCAB accredited pharmacies must, voluntarily, go the extra distance to demonstrate that they comply with nationally accepted quality control, quality assurance and quality improvement standards.
Compounding medications is an integral part of what we do at San Ysidro Pharmacy, and the demand for these customized medications has been increasing every year. Compounded medications are prescriptions that are written by physicians, veterinarians and other legally authorized prescribers and are prepared for an individual patient by specially trained pharmacists and technicians. Examples of compounded prescriptions are:
- When a child needs a smaller dose of medicine that is only commercially manufactured in adult-size doses.
- When a person cannot tolerate the inactive ingredients (such as gluten or sugar) in manufactured medicines.
- When a manufacturer has discontinued the medicine which is still needed by patients.
Presently, the oversight for compounding pharmacies is by the State Boards of Pharmacy. Even though there is oversight by the state, the compounding profession has seen an increasing need for a more comprehensive system of standards by which each pharmacy can test its quality processes; a mechanism to allow them to know that they are producing a high quality compound for all patients. PCAB accreditation represents this need and has given patients, prescribers and payers a way to select a pharmacy that meets or exceeds USP’s (United States Pharmacopeia) high quality standards.
In order to demonstrate compliance with PCAB standards and earn PCAB Accreditation, pharmacies voluntarily participate in a lengthy evaluation process that includes:
- Verification that the pharmacy is not on probation for issues related to compounding quality, public safety or controlled substances.
- Verification that the pharmacy is properly licensed in each state it does business in.
- An extensive on-site evaluation by a PCAB surveyor, all of whom are compounding pharmacists trained in evaluating compliance with PCAB’s quality standards.
a. An assessment of the pharmacy’s system for assuring and maintaining staff competency.
b. A review of the facilities.
c. Review of records and procedures required to prepare quality compounded medications.
d. Verification that the pharmacy uses ingredients from FDA registered and or licensed sources.
e. Review of the pharmacy’s program for testing compounding preparations.
Only when a pharmacy has met PCAB’s rigorous standards, is accreditation issued.
In short, “PCAB Accreditation” means that the pharmacy has had a PCAB approved, qualified and independent outside surveyor to validate that the pharmacy meets nationally accepted quality assurance, quality control, and quality improvement standards.
We believe, and it is our hope, that more pharmacies will make the voluntary move to become a PCAB accredited pharmacy. The accreditation process brings more credibility to the compounding profession as a whole, and, in a profession where potential errors translate into sometimes fatal situations, we believe that the process of accreditation reduces the possibility of those errors significantly. We, at San Ysidro Pharmacy, encourage other compounding pharmacies to become involved in this process, and have kept our doors open to sharing and supporting this process with other non-accredited pharmacies. Even though a compounding pharmacy may not be accredited it does not mean that they are not providing a quality product. However, if the compounding profession wishes to establish credibility for what we do, then the accreditation process is the way for our profession to achieve this. Our compounding profession is only as strong as the weakest, less skilled pharmacy among us. PCAB accreditation offers us a process by which pharmacies can validate their policies and procedures; that we have done “due diligence” in all aspects of compounding in becoming a fully qualified pharmacy.
By Steve Hoyt RPh