Tips For Selecting A Compounding Pharmacy
How the triad of patient/prescriber/pharmacy results in the preparation of patient-specific medications.
Because they recognize that each patient is unique, integrative practitioners often reject mass-produced drugs in favor of specially compounded, fully personalized medications. By providing these esoteric concoctions, compounding pharmacies fulfill an essential role in the health care system.
Steve Bernardi, owner and pharmacist at Massachusetts-based Johnson Compounding and Wellness Center, described compounding as “the preparation, mixing, assembling, packaging or labeling of a drug pursuant to a practitioner’s order. It is distinguished from manufacturing because it’s made for the individual needs of a patient. Instead of [the] one-size-fits-all approach of commercially available drugs; the possibilities with a compounded prescription are endless.”
Noting that his company has more than 25 employees, 2,500 square feet of retail space, 3,500 square feet of office space and two laboratories with a combined total of 1,500 square feet, Bernardi said, “We specialize in bioidentical hormone therapy, customized vitamin mixes, topical pain management, veterinarian compounding, pediatrics, ophthalmic compounding and much more.”
Beyond prescription drugs, some compounding pharmacies roam into other areas as well. For example, New Jersey-based Hopewell Pharmacy and Compounding Center promotes “free nutritional counseling with a certified nutritional consultant.” The consultation can be conducted in person or via telephone.
According to Hopewell’s website, “Our nutritionists have access to Nutrabalance, a state-of-the-art software program used to customize nutritional therapies based on the results of individual blood tests. A report is generated that contains dietary recommendations, lifestyle changes and vitamin/supplement regimens.”
Alex Chervinsky, Rph and president of New York-based HM Compounding, said the compounding process gives prescribers “latitude to address a patient’s needs specifically, and address any sensitivities, allergies or other restrictions if they exist.”
He lists three scenarios in which a patient’s singular requirements may be best served by a compounding pharmacy:
• The patient is a child who cannot take a pill and needs a liquid version of a medication, or a smaller dose than is available through mass manufacturing.
• The patient cannot tolerate one or more of the components of a manufactured drug (such as preservatives, sugar or gluten).
• A manufacturer decides to stop making a medication for economic reasons, [and the prescriber believes that particular medicine is the one needed by his or her patient].
The website of Florida-based AnazaoHealth Corporation (www.anazaohealth.com) also focuses on the reasons certain prescribers rely on compounding pharmacies.
The company excerpted the following from the International Journal of Pharmaceutical Compounding, www.IJPC.com, April 2005, Lloyd V. Allen, Jr., PhD, editor-in-chief:
• Limited dosage strengths— One size does not fit all and it is often necessary to change the strength of a drug for patients through compounding.
• Limited dosage forms— Compounding addresses the needs of children, premature infants, the elderly and special needs patients. Some patients may not be able to swallow pills or capsules; compounding allows for different dosage forms such as liquids, fast-dissolving troches and lollipops. Other methods include compounded medications for oral inhalation, nasal administration, topical/transdermal and rectal use. Some patients may be allergic or sensitive to red dyes or preservatives commonly found in most mass-produced preparations; compounding allows for medications to be compounded without dyes or preservatives.
• Discontinued Drugs—The pharmaceutical industry has discontinued thousands of drug products due to economic considerations. These were very effective and important medications and the only way they are now available is through pharmacy compounding.
• Drug Shortages—Commercially manufactured drugs become unavailable and these can be compounded to help “bridge the gap” until the commercial product comes back on the market.
• Special Patient Populations—These include pain management patients, bioidentical hormone replacement therapy (BHRT) patients, sports injury patients, dental patients, dermatological patients, environmentally and cosmetic-sensitive patients and other patients who are being treated successfully with compounded medications prescribed by their physicians. Many cancer treatments involve compounded “cocktails” or mixtures of cancer drugs that would be unavailable if they could not be compounded.
• New Therapeutic Approaches—If a physician desires to use a medication that is successfully used in other countries but is not commercially available here, that physician can prescribe a compounded formulation of the medication for patients.
• Veterinary Compounding—There are relatively few medications available for animals and those medications that are available are for specific species and diseases. For an animal to be satisfactorily treated, a compounded medication is needed.
• Clinical Studies—Pharmacists compound drugs that are not commercially available that are used in various clinical studies.
• Nuclear Compounding—A radioactive source is “tagged” to a compound that circulates throughout the body and eventually concentrates in the organ under exploration.
The Triad Relationship
In daily practice, compounding pharmacies are one-third of a triad formed by the patient, prescriber and pharmacist. Jim Smith, president of PCCA (Professional Compounding Centers of America) in Texas, said, “The ultimate goal of the triad is a positive outcome for the patient based on all three individuals communicating and working together. This depends on practitioners and pharmacists using their experience and training to determine the best course of action, all the while recognizing that patients, too, must take full responsibility for their treatment course and overall well being.”
Bernardi expressed that Johnson Compounding views itself as a “conduit” or “link” between a patient and his or her prescriber.“So often a patient is unsure of [his or her] medication—we take the time to have conversations discussing the prescription(s). And in all cases, we encourage providers to contact us with questions. Although we do not treat patients, many providers refer to the pharmacists with questions regarding specific patient needs.”
“The three-part relationship enables patients to receive the personalized care they deserve,” added HM Compounding’s Chervinsky.
Regulatory Considerations
Turning to questions about how compounding pharmacies are regulated, Chervinsky said his firm often gets questions asking if its preparations are FDA approved. “The answer is no. Compounding pharmacies are regulated by the state boards of pharmacy, and not the Food and Drug Administration,” he explained, noting, however, that the FDA has released a video on YouTube acknowledging the need for pharmacists to be able to compound.
Testing and Quality Control
This raises issues of testing and accreditation; prescribers and patients must be certain that drugs they administer will be helpful, not harmful. As part of what it calls its “stringent quality control standards,” AnazaoHealth said. “We put our own actual performance to the test by an independent laboratory that checks our testing procedures and quality of processes.”
Florida-based Franck’s Pharmacy relies on the following 13-point quality assurance program:
• Daily refrigerator monitoring and calibration, as well as temperature and humidity documentation
• Daily calibration of analytical balances
• Chemical weight verified by printout
• Calibration of pH meter before each use on compounded products
• Daily random sterility and Pyrogen testing of products
• In-house testing using HPLC (high pressure liquid chromatography) to test potency and stability of products
• Random endotoxin testing of product by independent laboratory
• Scheduled certification of sterile environment
• Independent lab testing of air and surface samples of clean rooms
• Compounding software with backup for continuous record keeping of:
– Formulas
– Procedures/Techniques
– Lot Numbers
– Prescription Numbers
– Expiration Dates
• Regulated storage of raw materials and end products
• Personnel trained and certified in each type of aseptic procedure with continuous education and accountability
• Internal tracking of quality related incidents The company added, “Our clean room exceeds standards set forth by in the USP 797 Guidelines. Continuous education keeps our staff knowledgeable of the latest and most innovative medication administration.”
Founded by the Harbin family in 1922 and dedicated to compounding since 1964,Wellness Pharmacy calls quality control “job No. 1.” On its website, the Alabama-based firm said that not only are ingredients monitored very carefully, but “prescriptions are re-checked after preparation for color and/or clarity, consistency, packaging integrity and readability of label instructions—enabling patients to easily measure required doses accurately. [Also,] a product sample is tested by an independent lab to verify sterility and integrity. Patients living in states requiring extensive end-product testing (before dispensing) must await the results before the product is dis- Pensed.”
Women’s International Pharmacy, with offices in Arizona and Wisconsin, said that its “clean room is an ISO Class 7 room that encloses an ISO Class 5 clean bench. The clean room is independently tested on a biannual basis to ensure sterility standards are maintained. The sterile processes and quality assurance procedures meet or exceed USP Chapter 797 standards specific to high-risk compounded sterile products.”
As evidence of its commitment to quality, the company’s website cites its numerous professional affiliations, including the International Academy of Compounding Pharmacists (IACP), American College of Apothecaries (ACA), United States Pharmacopoeia (USP), the National Association of Community Pharmacists (NACP) and the American Pharmacist’s Association (APhA). On a local level, the firm maintains relationships with faculties and students at the University of Wisconsin School of Pharmacy, Midwestern University College of Pharmacy and various state associations.
The Importance of Accreditation
The Pharmacy Compounding Accreditation Board (PCAB) is the organization that gives approximately 150 compounding pharmacies around the nation a badge of authoritative recognition. Through a voluntary program, the Washington, D.C.-based PCAB sets quality standards and verifies that accredited pharmacies comply with quality assurance, quality control and quality improvement standards through the use of on-site assessments performed by experienced pharmacist-surveyors.
Executive Director Joe Cabaleiro, Rph, said all accredited pharmacies have undergone an on-site evaluation that “includes assessing the pharmacy’s facilities, staff competency, equipment, documentation, finished preparation testing program and other aspects of its compounding operation, all in an effort to assure the pharmacy compounds quality preparations.”
According to Cabaleiro, “PCAB accreditation allows consumers and prescribers of compounded medications to identity those pharmacies that have gone the extra mile to comply with nationally accepted compounding quality standards.” For a list of PCABaccredited Pharmacies, visit www.pcab.org.
How to Select a Compounding Pharmacy
Cabaleiro offers several tips in the form of questions for prescribers and patients seeking a compounding pharmacy:
• Is the pharmacy licensed in your state? Most states require that pharmacies be licensed in each state where they do business. Therefore, a practice may incur liability if it orders or uses medications from a pharmacy that is not licensed in the state where the practice is located.
• Does the pharmacy test finished preparations? For non-sterile medications, such as capsules, this includes potency testing. For sterile preparations, testing should include evaluation of potency, sterility and endotoxins.The pharmacy should be able to provide you with specific reports on how it verifies the quality of each compound you purchase.
• Does the pharmacy have a functioning recall mechanism? Make sure the pharmacy has a process in place to identify which patients and practices received any particular lot number. If your practice has lot numbers of compounded preparations available, ask the pharmacy that provided them to list the lot numbers of the medications your practice has received. The response should match the lot numbers of the medications you have on-site.
• Does the pharmacy’s facility meet USP requirements? The United States Pharmacopeia publishes written standards for medicines and their ingredients. Chapter 795 outlines conditions and practices for non-sterile preparations, and Chapter 797 “covers sterile compounding. Ask every pharmacy you order from if it is compliant with both chapters.
“Finally,” said Cabaleiro, “the International Association of compounding Pharmacists (www.iacprx.org) has published a Compounding Pharmacy Assessment Questionnaire, which is available at http://bit.ly/ye9yWp. This tool has a comprehensive list of questions that will further help you identify top quality compounders.”
Branching Out
Beyond prescription drugs, some compounding pharmacies roam into other areas as well. For example, New Jersey-based Hopewell Pharmacy and Compounding Center promotes “free nutritional counseling with a certified nutritional consultant.” The consultation can be conducted in person or via telephone.
According to Hopewell’s website, “Our nutritionists have access to Nutrabalance, a state-of-the-art software program used to customize nutritional therapies based on the results of individual blood tests. A report is generated that contains dietary recommendations, lifestyle changes and vitamin/supplement regimens.”
