PCAB Accreditation and Why You Should Care

Martin Avenue Pharmacy, Inc. – PCAB™ Accredited since 2016

How do you, as a consumer, who were prescribed a compounded medication, make an informed decision in selecting a compounding pharmacy that will provide medications that you and your loved ones depend on for health and quality of life?

Do you have the knowledge to go into a pharmacy and understand if that particular pharmacy meets all state laws and United States Pharmacopeia (USP) compounding requirements and confirm the pharmacy meets recognized ethical standards? If not, perhaps you might want to have someone else inspect the pharmacy for you. Someone you can trust. Someone who is independent of the pharmacy so you know the answer doesn’t contain sales hype or the bias of the compounding pharmacist and staff members.

Let us explain and give you information on how you, as the consumer, can know you are getting the highest quality medications that are safe, accurate and made the same way for you and your family.

Who is PCAB?

The Pharmacy Compounding Accreditation Board (PCAB) is a not-for-profit corporation formed by eight national pharmacy organizations:

The American College of Apothecaries
American Pharmacists Association
The International Academy of Compounding Pharmacists
The National Association of Boards of Pharmacy
National Alliance of State Pharmacy Associations
The National Community Pharmacists Association
The National Home Infusion Association
The United States Pharmacopeia

These organizations recognized the need to have a national standard organization for compounding pharmacies. Together, these leading organizations developed the policies and standards of care for the practice of compounding pharmacy, as well as the PCAB Accreditation criteria, processes and seal of approval.

Who is ACHC

Accredited Commission for Health Care (ACHC) is a recognized leader in the area of Pharmacy Accreditation. ACHC Surveyors are licensed Pharmacists who draw upon relevant experience to provide a comprehensive assessment of the organization as well as provide helpful, consultative advice. ACHC accredits pharmacies that dispense medications pursuant to a prescription order for an individually-identified patient. In 2014, PCAB Accreditation became a service of Accreditation Commission for Health Care (ACHC). The alignment of the organizations ensures that safety and compliance needs are met in the most efficient and effective manner.

What does it mean to receive the PCAB™ Seal of Accreditation?

The PCAB™ Seal of Accreditation is a system of standards created by leading experts in the compounding pharmacy field today.
Our status as a PCAB Accredited™ compounding pharmacy lets you know that Martin Avenue Pharmacy, Inc. is dedicated to protecting our patients by practicing safe, accurate, high-quality compounding.

How many pharmacies have this accreditation?

There are only 6 out of 102 counties in Illinois that have a PCAB Accredited compounding pharmacy located within them.
As of February 2016, there are only 414 PCAB Accredited Compounding Pharmacies across the nation

Did You Know?

Less than 1% of Compounded Pharmacies have reached PCAB Accreditation in the US. Of that 1% only a select few have received a perfect score. Fewer have done this on their first time applying. Martin Avenue Pharmacy received a perfect score and reached this incredible honor on their first application to become Accredited!

Why is it important to have PCAB Pharmacy Compounding Accreditation?

Many pharmacies practice a small degree of compounding, while others, like Martin Avenue Pharmacy, specialize in the centuries-old practice of making your medication from “scratch”. That is starting from the pure chemical that you need.

With an estimated 30 million to 40 million prescriptions that are compounded each year, there is a need for an enhanced, profession-wide system of standards by which each compounding pharmacy can test its quality processes. While compounding is regulated by the individual state, PCAB™ Accreditation is a comprehensive way to ensure that a compounding pharmacy has undergone the profession’s strictest review and inspection measures across the nation.

PCAB Pharmacy Compounding Accreditation is a service of ACHC that assesses both the sterile and non-sterile pharmacy compounding process (the making of your medications) as defined by a specific set of standards that concentrate on the quality and consistency of medications produced. As the demand for compounded medications has increased, the pharmaceutical profession recognized a need for a system of standards by which each compounding pharmacy can test its quality processes to ensure they are making a quality medication. Compounding pharmacists also wanted a way to allow them to know they are producing a high quality compound. In doing so, this provides the best quality of medication to their patients. PCAB Accreditation gives patients, prescribers, and insurance companies a way to select a pharmacy that has been evaluated against the highest quality standards, including those published by the United States Pharmacopeia (USP).

Who Benefits from going to a PCAB accredited pharmacy?

Patients are assured of receiving the highest-quality medications that meet regulatory requirements.
Hospitals, the VA, Specialists and Physicians are assured that their patients are receiving what they ordered each and every time.
Sponsors of clinical trials are assured that the products they use in the clinical trials are compounded correctly and consistently so that the results of the studies are reproducible.

Who Requires that a pharmacy have PCAB Accreditation

Hospitals require compounded prescriptions to come from an accredited compounding pharmacy before they are allowed to be dispensed to a patient.
The Veteran Affairs (VA) Hospital require all compounded prescriptions come from an accredited compounding pharmacy before they are allowed to be dispensed to a patient.
Physicians and Specialists: many of the top leading physicians and specialists in the United States require compounded prescriptions to only be filled at Accredited Compounding pharmacies.
Third Party Insurance Companies either require or are more likely to cover compounded prescriptions that come from an Accredited Compounding Pharmacy.

PCAB® Accreditation requires that a pharmacy:

Uses only high quality chemicals and equipment.
Employ compounding pharmacists, nurses and certified pharmacy technicians who receive continuing education and training in compounding
Pass an extensive on-site inspection
Utilize a system of continuous quality improvement

Martin Avenue Pharmacy is inspected and reviewed for re-accreditation every three (3) years. On January 19th, 2016, our pharmacy was accredited. If you would like more information on our PCAB® Accreditation, would like to review our Accreditation Report, or have questions about compounding pharmacy, please call us or visit www.pcab.org.

Who ensures that drugs made by compounding pharmacies are safe?

The FDA traditionally regulates drug manufacturers, but each state regulates their own pharmacies. Even so, three government agencies regulate compounding pharmacies:

State boards of pharmacy ensure that pharmacies follow state regulations for pharmacy practice.
The Food and Drug Administration (FDA) regulates “the integrity of the drugs” and the active pharmaceutical ingredients from which they are made.
The Drug Enforcement Administration (DEA) regulates compounding pharmacies’ handling of controlled substances.

In addition, the United States Pharmacopeial (USP) Convention issues standards that apply to compounding. This quasigovernmental organization defines the chemical composition of drugs and also issues practice standards. Two standards in particular are relevant to compounding pharmacists.

The USP standard is a national standard for the process, testing and verification of any compounded sterile preparations. It provides guidance on preventing microbial contamination and other variances in compounded sterile products regardless of setting (for example, hospitals, community pharmacies) and who is performing the compounding (pharmacists, nurses, pharmacy technicians, or others).

USP provides similar guidance for nonsterile preparations that are compounded in health care settings. It describes categories of compounding (simple, moderate, complex); defines terms such as beyond-use date (do not use after this date) and stability (how long the active ingredient of your medicine remains at 100%); and provides criteria for compounding pharmacists to follow in preparing various drug preparations.

Compliance with these and other USP standards is considered a standard of practice in pharmacy. Compliance carries the force of law in many states based on statutes or regulations passed by legislatures and boards of pharmacy.

Martin Avenue Pharmacy’s Accreditation Process:

To earn the designation “PCAB Accredited™ compounding pharmacy,” Martin Avenue Pharmacy, Inc. completed an in depth application and submission process that was reviewed by the Pharmacy Compounding Accreditation Board. Our compounding policies and procedures were then reviewed by professionals. Next, we opened our doors for an extensive on-site inspection led by compounding experts. Only when these strict and precise evaluations were completed did PCAB™ officially grant us the PCAB™ Seal of Accreditation.

Why Use Compounded Medications?

Compounding medications is an important part of the practice of pharmacy – yet many people may not even be aware of it. Compounded medications are ordered by prescriptions that are written by a physician, veterinarian or other legally authorized prescriber. Compounded medications are prepared for an individual patient by a specially trained pharmacist for situations such as:

When a child needs a smaller dose of a 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 doctor believes a medicine is needed for his or her patient, but a manufacturer has discontinued the medicine for economic reasons.
When a person/pet cannot swallow tablets a cream or liquid/suspension can be made.

The Real Question to Ask:

Do you trust the judgement of the following organizations?

The American College of Apothecaries
American Pharmacists Association
The International Academy of Compounding Pharmacists
The National Association of Boards of Pharmacy
National Alliance of State Pharmacy Association
The National Community Pharmacists Association
The National Home Infusion Association
The United States Pharmacopeia
The Accredited Commission for Health Care (joined PCAB in 2014

These are the Founders of the Pharmacy Compounding Accreditation Board’s (PCAB™). These organizations and others also believe in the need for pharmacies to be independently inspected and certified to meet all appropriate standards. They want the best for YOU, your family and the pharmacy.

If you can place your trust in these Founders you can trust Martin Avenue Pharmacy, Inc. We have been independently inspected to meet national standards and less than 1% of all compounding pharmacies in the United States meet this criteria. If a pharmacy does not meet PCAB requirements you must ask why not? Your life is precious; choose your compounding pharmacy wisely.

When You Know the Difference, it makes a difference!
@
Martin Avenue Pharmacy, Inc.
We Make It Better…”