Compounding Pharmacy Accreditation

Transcription

1 Compounding Pharmacy Accreditation The time has come to vigorously support excellence in compounding. One of the most constant criticisms of bio-identical hormone therapy is that there is no mandated standard of excellence for either the components OR the process that results in the creation of your finished compounded medication. For many years, this has been one of the primary issues that we discuss when we create your individualized prescriptions. On numerous occasions, both in the office setting and in various articles that I have written for this website, I have stressed the extraordinary importance of 3 crucial facets that impact your hormonal supplementation. The first is my ability to create your prescription based on your individual needs and evidence-based medicine. The second is taking every step that we can to assure that the compound you are taking is exactly what we have prescribed in both content and quality. The third is that you utilize the compounded hormones in the manner in which we have prescribed them for you. Those of you who are using compounded hormone replacement therapy have come to understand that there are differences in the seemingly "identical" products that are manufactured by different compounding pharmacies. Some of you have personal experience with inferior products and inferior results. With regard to compounding pharmacies, I have diligently educated you regarding the importance of quality control, accurate record keeping and random testing of products. To satisfy non biased requirements the assessments must be performed by a third party : an organization or agency that has

2 no personal or financial interest in the outcome of the evaluation process. As I mentioned, there is no government mandated process to assure your safety or the quality of your hormone therapy. BUT there is voluntary accreditation. In this article I am making certain important web site addresses available to you so that you may better understand and review the process and definitions that are required to hold accreditation. At these sites you will be able to use search functions to find accredited pharmacies in your area. As you may know, I have long recommended that you use pharmacies that follow the guidelines of random testing and quality control. The overwhelming majority of you have honored my concern for your well-being and have used such pharmacies. Based on the growing community concerns, I am taking the recommendation process a step further: From now on, prescriptions for compounded medications will only be sent to accredited pharmacies. The premier accrediting agency is Accreditation Commission for Health Care (ACHC.org) Prior to July 1, 2014, the Pharmacy Compounding Accreditation Board (PCAB) became a service of Accreditation Commission for Health Care (ACHC). Accreditation by ACHC demonstrates a pharmacy's commitment to quality through compliance with national standards and the highest of industry practices.

3 To search for an accredited pharmacy in your area, Go to: Accreditation Commission for Health Care, Inc. Navigate to the Resources tab and click on Accredited Locations from the dropdown list: In the right hand column of the form enter your state, your city and, under the type of program select pharmacy. Click on the Find button. At this point a list of accredited pharmacies will come up. Please note: under the state column, you may select show / hide accreditation

4 details. When you click on this, you may see many different accredited headings. Look for PCAB non sterile compounding, to assure that the pharmacy is accredited to create bioidentical hormone therapy in troche or cream form as opposed to injectable forms. Please do not confuse the Professional Compounding Accreditation Board (PCAB) with the Professional Compounding Centers of America (PCCA) PCCA. PCAB is an arm of ACHC that, through random monitoring, accredits the specific pharmacy that actually creates your hormone therapy or other compounded medication. PCCA has an accredited course to train pharmacists and technical staff with regard to proper compounding techniques. They also sell some or all of the raw material to various pharmacies for compounding. They do not monitor the quality of records, equipment, processes or products that individual compounding pharmacies create.

5 According to one accredited pharmacy: PCAB accreditation involves rigorous review of all compounding processes and procedures, including extensive testing of compounds to ensure purity and potency. Accreditation also includes a vigorous testing process that assesses compounding outcomes such as drug stability, end dose validation, beyond-use dating, drug qualification and drug safety. Ultimately, accreditation by PCAB validates a pharmacy as having met the highest standards of quality and consistency in the industry. PCAB accreditation is voluntary but all pharmacies have a responsibility to their patients and doctors to assure they are continuously striving to meet and exceed industry standards. It is my sincere hope that pharmaceutical accreditation becomes mandatory with all state and federal regulatory bodies within the near future. Be well, Arlene