Posted on Jul 28, 2013 in
COVER STORY
Shannon Maguadog, Pharm. D.
Compounding Specialist/Owner
Photos by Nesossi Studios –
Compounding pharmacy? So, just what exactly is a compounding pharmacy? A compounding pharmacy is a specialty pharmacy that actually makes a medication by weighing, mixing and finalizing a prescription into a capsule, liquid, suspension, ointment, injection, lollipop, eye drop or any other of many available dosage forms.
Defining Compounding
According to Shannon Maguadog, Pharm. D., owner of Compounding Corner Pharmacy, Inc.®, compounding is the time-honored profession of preparing medication utilizing standardized ingredients to make an individualized medication for a patient pursuant to a practitioner’s prescription order. “In the old days, all medications were compounded,” explained Dr. Maguadog. “As the pharmaceutical engine revved up in the mid twentieth century, most medications became available through manufacturing via large scale production. However, to this day, many patients require individualized medication for specific needs that cannot be addressed through traditional pharmaceutical manufacturing.”
From bio-identical hormone replacement to GFCF medications for Autism to topical pain medications to veterinary compounding, all walks of life occasionally see the need for an individualized medication that can only be provided through a compounding pharmacy.
The issue then focuses on one of quality, safety and efficacy, which is paramount to the compounding pharmaceutical industry. “Remember the horrible events that transpired with the New England Compounding Pharmacy (NECC) and all of the people who died? Like restaurants, each compounding pharmacy makes medications differently. They each have their own formulas, methods, training, certifications, sourcing of ingredients, equipment, quality control and quality assurance. Basically, it boils down to what the proverb says: ‘You get what you pay for,’” said Dr. Maguadog.
Marielena Garza and Jason Witzel perform trituration by mixing powder with a morter and pestle in Dr. Maguadog’s pharmacy.
The Compounding Corner Pharmacy, Inc.® Difference
Compounding Corner Pharmacy, Inc.® is accredited by the Pharmacy Compounding Accreditation Board (PCAB) and the Better Business Bureau (BBB). The pharmacy purposefully distinguished itself from all of the other compounding pharmacies in the area as it is the only PCAB-Accredited compounding pharmacy in Fort Bend. To fully understand the accreditation process and distinction, visit www.pcab.org and www.compoundingcornerpharmacy.com for more information. These sites fully explain about the stringent and comprehensive standards which serve as an assurance that Compounding Corner Pharmacy, Inc.® has been tested against the pharmacy profession’s most rigorous standards in the nation.
The PCAB-Accreditation helps ensure that compounding pharmacies are using the highest quality ingredients, has proven potency testing, has a proven safety record and has met or exceeded the highest pharmacy standards in the nation as set by the United States Pharmacopeia, the National Association of Boards of Pharmacy, the American Medical Association, the American Pharmacists Association, the American Veterinary Medical Association and others. “It’s not an easy process,” explained Dr. Maguadog. “But it’s a necessary standard to providing the highest quality compounded medications, and it’s our standard at Compounding Corner Pharmacy, Inc.®.” Not only was Compounding Corner Pharmacy, Inc.® one of first PCAB-Accredited compounding pharmacies in the nation in 2008, but they have already gone through the re-accreditation in 2011.
Compounding Checks and Balance
The Compounding Corner Pharmacy, Inc.® team: Jason Witzel, Ronald Bee, Marielena Garza, Wayne Bilyeu, Dr. Shannon Maguadog and above, Connie Graves.
So, what quality assurance and quality control goes into a compounded medication? Let’s map out a typical prescription process that occurs at Compounding Corner Pharmacy, Inc.®:
A USP or NF-grade active ingredient arrives at the pharmacy.
Active ingredient is quarantined until certificate of analysis is verified and MSDS sheet is on file.
Active ingredient is assigned a bar code.
As the prescription is made, each active ingredient is verified by bar code scan.
A digital scale that is linked to the lab computer triple-verifies and records the weight and percent error of each active ingredient.
The medication is finalized through the appropriate equipment such as an ointment mill, a capsule machine, a homogenizer, a v-blender, an autoclave, a tube sealer, an IsoTech Microsphere, etc.
The finished medication is verified by the pharmacist, and the prescription is labeled with the lot number for quality assurance, quality control and the ability to recall if ever necessary.
Additional quality assurance and quality control:
ACPE Accredited technicians in primary basic training program in compounding techniques.
ACPE Accredited pharmacists in Risk Level I,II and III aseptic compounding.
Regularly sent samples to an outside third-party laboratory (Eagle Analytical) for end-potency product, microbial and endotoxin contamination testing.
A system of continuous quality improvement including incident reports and regularly scheduled employee meetings.
A Standardized Operating Procedures Manual.
Extensive scheduled and unannounced on-site inspections by PCAB surveyors.
Monitoring of temperature and humidity by Fisher Scientific traceable hygrometers.
Use of Professional Compounding Centers of America’s proprietary PK Software dedicated to compounding.
Membership in and utilization of PCCA’s pharmacist consultants and PhD’s.
“Our goal is to build rapport with patients and practitioners to provide the highest quality compounded prescriptions available to assist in optimal outcomes,” said Dr. Maguadog. “Wellness is our primary focus because it’s not just how long you live, it’s also how well you live. Quality of life is vital.”
Compounding Corner Pharmacy, Inc.® offers individual wellness consultations online at www.compoundingcornerpharmacy.com by filling out the necessary information and answering the in-depth questionnaire. They also offer a variety of supplements including outstanding lines such as Thorne Research, Metagenics, Pharmanex and Carlson’s. “It’s hard to filter through all of the supplements on the market and identify what is right for your individual situation. We are happy to discuss and answer any questions consumers may have about supplements.”
Compounding Corner Pharmacy, Inc.® was the first compounding-only pharmacy in Fort Bend back in 2004, and they will be celebrating ten years in business in February 2014. The pharmacy has established itself as the gold standard for compounded prescriptions. “Fort Bend has embraced us and allowed our business to prosper,” said Dr. Maguadog. “Our customers appreciate the quality and care we put into creating their medications, and we appreciate their support.”
Top Five Reasons to Use a PCAB-Accredited Pharmacy
5. Endorsement —PCAB is endorsed by trusted entities in the medical field, including the American Medical Association, American Pharmacists Association and the American Veterinary Medical Association.
4. Ethics — PCAB adopted the Code of Ethics for Pharmacists and encourages the pharmacies it accredits to do the same. This code includes principles such as integrity, compassion, competence and confidentiality.
3. Training —Pharmacies accredited by PCAB are required to be trained in compounding regularly. Each staff member at Compounding Corner Pharmacy is accredited by the Accreditation Council for Pharmacy Education (ACPE) in the primary basic training program in compounding techniques. The pharmacists are ACPE-accredited in Risk Level I, II and III aseptic compounding.
2. Efficacy — This term refers to a drug‘s effectiveness. Through standardized methods of compounding required by PCAB, pharmacies can ensure the medications they compound are effective and meet a patient’s needs on a personalized level.
1. Safety — Dabbling in compounding pharmacy is dangerous, Dr. Shannon Maguadog said, thus pharmacies that are serious about taking on the responsibility must uphold strict safety standards. PCAB-accredited pharmacies go through a rigorous process in which they prove they do everything the right way and have standards for continuous quality improvement.
