Compounding Pharmacy of America CEO Matthew Poteet has received his board certification for sterile compound pharmacy from the Board of Pharmacy Specialties (BPS). The BPS provides certifications that set the standard for pharmacists who work at advanced levels in this competitive industry. The distinction Mr. Poteet achieved is the highest certification level a pharmacist can earn. There are only eight pharmacists in the state of Tennessee and just over 500 in the whole world, so this achievement makes a strong statement about our company’s commitment to the highest quality products.
This certification demonstrates our company’s commitment to using specially designed equipment and facilities to meet the quality standards and legal requirements necessary to stand out as a leader in the compounding practice. We are a pharmacy that prepares components of drug preparation when specialty needs arise due to a practitioner’s prescription order or a pharmacist, patient, practitioner-based initiative that comes about during treatment.
What Does It Mean When the BPS Certifies Sterile Compounding Pharmacists?
Board certification by the BPS in compounded sterile preparations pharmacy provides pharmacists who take the necessary measures to meet stringent eligibility criteria with credentials. This distinction is recognized across the industry as the benchmark for quality practices and advanced training. They must also be responsible for making certain these sterile preparations fill patients’ clinical needs and satisfy all demands for safety, quality, and environmental needs in their practice. The BPS Board Certification in Compound Sterile Preparations Pharmacy is vital to confirm a pharmacist’s commitment to advanced experience and knowledge because it guarantees:
- Proper supervision, training, and competency of any person who is part of the sterile compounding process
- A focus on safety
- Better therapeutic results
- A goal of quality patient care
How Does a Pharmacist Become Eligible for Certification?
If a pharmacist has the goal of becoming certified in compounded sterile preparations pharmacy, the minimum requirements include:
- Passing the Compounded Sterile Preparations Specialty Certification Examination.
- Having four thousand hours of hands-on training after gaining license/registration, which the pharmacist may earn in various settings related to compounded sterile preparations pharmacy practice experience. Applicants’ employers must attest that the applicant has four thousand hours of practice occurring within the previous seven years to the date they apply.
- Holding registration or active license to practice pharmacy in the United States or another jurisdiction.
- Being a program graduate who has met the criteria of the Accreditation Council for Pharmacy Education, or a program from another country that qualifies the pharmacist to practice.
BPS certification programs base the appropriateness of their requirements on standards such as:
- Passing the BPS pharmacy specialty exam can help ensure pharmacist education that is in line with the validated content outline for the specialty.
- Having experience is essential so that the pharmacist has practical application experience in their field of certification. There are various ways that a pharmacist can meet this practical experience requirement.
- Holding a license or registration. This rationale is meant to increase public protection. BPS further follows this requirement in recognizing licenses the National Association of Boards of Pharmacy (NABP) administers, which focus on public safety and health through its assessment programs for pharmacist competence.
- Having graduated from a college of pharmacy or school that is recognized within the individual’s jurisdiction. The Accreditation Council for Pharmacy Education (ACPE) is the group responsible for recognizing colleges and schools of pharmacy in this country.
What Is Sterile Compounding?
Compound sterile preparations pharmacies work to ensure that their preparations meet the clinical needs of patients. Environmental, safety, and quality control requirements are met in each phase of preparing, storing, transporting, and administering the products in ways that comply with established regulations, standards, and professional practices. There are three different types of sterile compounding: high risk, medium risk, and low risk. Each of these compounders meets various consumer needs, ranging from small-sized medicine vials available from manufacturers in large numbers to specialty products not available from the manufacturer. To meet the varied needs of physicians, all three types of sterile compounding suppliers play a vital role.
In this type of compounding, non-sterile materials are used to make the sterile product, after which it is terminally sterilized. Few sterile compounding pharmacies can produce exclusively high-risk products. These products may include corticosteroids that are preservative-free for epidural use, fortified antibiotic ophthalmic eye drops, and epidural or intrathecal injections made from raw drug powders. The reason that high-risk sterile compounding pharmacies can act quickly when needs such as drug shortages arise is that they can easily access the small amounts of ingredients they need to make the medications.
In medium-risk sterile compounding, many small or individual doses of sterile products are brought together and pooled to create a single sterile compound for one patient, multiple patients, or for one patient who needs multiple doses. This type of sterile compounding can be seen in compounding total parenteral nutrition.
Compounding with aseptic manipulations that use only sterile devices, components, or products is known as low-risk compounding. This may include using sterile syringes and needles for transferring sterile drugs from the original manufacturer’s packaging into another type of vessel. An example of this process is a syringe with a unit of use dose of morphine that would be used in an operating room.
Companies that specialize in medium and low-risk sterile compounding operate around the country, producing products that begin with commercially available sterile materials. Thus, there is a limit to production, based on the amount of available manufactured products that they use. The strengths of these available products are another factor that places limits on production. When the limits on the supply of necessary materials do not meet the specs of physician orders, the order may be sent to a high-risk sterile compounder.
How Long Is BPS Certification Good For?
The Board of Pharmacy Specialties requires that a pharmacist be recertified once every seven years. The BPS has built its reputation on this commitment to ongoing education and a full understanding of the latest techniques and standards. Candidates seeking recertification may do so by taking the BPS Compounded Sterile Preparations Pharmacy Recertification Examination and passing the exam. This is a 100-item test given by the BPS and focused on the outline of content for the Compounded Sterile Preparations Specialty in the seventh year, which ends the cycle.
Another option for recertification is for the individual to take continuing education credits throughout the seven-year BPS certification cycle, totaling at least 100 hours. These educational credits must be earned through a BPS-approved professional development program, such as those offered by the American Society of Health-System Pharmacists (ASHP) or the American Pharmacists Association (APhA). These courses may be taken for credit toward recertification only twice (not in consecutive years) throughout the BPS recertification cycle.
Once sterile compounding pharmacists are board-certified, they must pay a maintenance fee to the BPS of $125 per year for the first six years, and $400 to recertify in the seventh year. Pharmacists who have multiple BPS certifications are only required to pay one annual maintenance fee per year.
Why Become Board of Pharmacy Specialties Certified?
When pharmacists become certified by the Board of Pharmacy Specialties, it not only stands out as an exemplary resume listing in a competitive job market, but it gives them a host of other opportunities. Some of the benefits of BPS certification include:
- An unparalleled level of recognition from their employer and other professionals in the health care field, as well as that of insurers and patients
- The necessary tools to be a part of the evolution of the pharmaceutical industry as part of the multidisciplinary treatment team
- A keen ability to be an integral part of more complex and comprehensive patient care
Medical professionals hold BPS certification in high esteem, as it helps establish which pharmacists are prepared to handle the rigors of advanced practice levels. The Board of Pharmaceutical Specialties utilizes the most demanding standards to ensure that the pharmacists it certifies are fully equipped to meet the ever-evolving expectations of the health care industry and the unique needs of patients from a host of backgrounds. Ensuring that pharmaceutical compounds are prepared in a sterile environment, meeting all safety and quality standards for patients’ needs is the hallmark of the Board of Pharmaceutical Specialties certification, and it sets the bar for the future of the industry.
Learn more about Matthew Poteet, Pharm.D. and our staff.