Addressing Common Challenges: Compounding Medication in the Ambulatory Surgical Center
Anyone who has faced high hospital bills for brief visits or seemingly minor issues understands the need for health care to become more affordable, more accessible, and more efficient. The advent and growth of ambulatory surgical centers (ASCs) is intended to assist healthcare providers with accomplishing all of those goals, reducing overhead, streamlining patient services, and placing more emphasis on outpatient procedures and alternatives to costly surgical services. For ASC operators, physicians, and technicians, compounding medication to help meet patient needs is a natural step—compounding aligns with ASC goals to streamline patient care and meet needs efficiently.
The first ASC was opened in 1970 in Phoenix, Arizona, by two physicians frustrated with the challenges of operating out of a hospital and their inability to provide high-quality patient care while fighting limited operating room availability, hospital budgets, and other limitations. Today, ASCs are part of the healthcare industry’s sweeping trend toward efficiency and provider autonomy, and part of that equation is the ability of ASC operators to provide customized patient care such as custom compounding medication.1
Is Compounding Medication Allowed in the ASC?
Compounding medication can be a vital part of ambulatory surgical centers and many environments providing outpatient services. According to the Ohio Association of Ambulatory Surgical Centers, as of 2013, one in ten prescriptions has the potential to be compounded.2 As with all environments where compounding occurs, the United States Pharmacopeia standard USP <797> should be applied. This standard regulates compounding environments including hospitals, ASCs and clinics, and applies to all healthcare professionals involved in compounding medication, such as doctors, nurses, technicians, pharmacists, and anesthesiologists.
USP <797> has many tenets, but some that ASC operators should be aware of are that all environments must:
- Be certified and recertified on a regular basis by professionals.
- Be cleaned and disinfected with validated procedures, including challenge tests to verify effectiveness of the procedures.
- Use reputable vendors for bulk reagents.
- Use tested and verified “beyond-use dating” to determine risk based on intended storage conditions.
- Utilize a solid quality assurance program for personnel, environment monitoring, and equipment maintenance.
Compliance with these standards can be difficult for some operators and some regulations vary by state. For many ASCs and clinics, it can be advantageous to form relationships with accredited compounding pharmacies and providers of pharmaceutical compounds to ease the burden of compliance with USP <797>.3
Additionally, some compound medications are exempt from USP <797>, including a number that might be used in an ASC. This includes all compound medications that involve fewer than three commercially available, sterile non-hazardous products; those medications that can be created in a continuous compounding procedure lasting less than one hour; and those where administration commences within one hour of preparing the compound.4
What Role Do Compound Pharmaceuticals Play in the ASC?
Compounding medication in an ASC can help providers meet patient needs in ways that might be much more difficult without preparing compounds. For instance, shortages and backorders of pharmaceuticals can adversely affect ASCs, which rely on their ability to provide a higher volume of outpatient care at a high quality. In recent years, shortages have included a number of anesthesia-related drugs crucial to operating an ASC, including critical agents such as morphine, ketamine, lidocaine and epinephrine.
Additionally, when medications go off of patent, pharmaceutical companies often significantly cut production of that medication. Oftentimes, even generic manufacturers have little reason to make drugs that have gone off of patent as their margins are no longer adequate to cover the drug’s creation. In these situations, when a non-patent or low-volume medication is the best treatment for the patient, compounding medications allows ASCs to provide this service for their patients.5
Many ASCs face the same challenges as larger hospitals and providers when it comes to medication storage in order to meet regulatory requirements and minimizing drug waste. Compounding medications can streamline storage, as it is much easier to store active pharmaceutical ingredients, compound reagents and other elements of compound medications, and prepare the medications closer to the time of administration. Again, if meeting storage requirements is a primary concern for an ASC, a relationship with a compounding pharmacy or bulk provider can be extremely advantageous.
Regulation and State-by-State Considerations
Federal and state laws governing compounding medication apply to all environments where compounding may occur, including ASCs, so it’s important for all providers and operators to understand enacted legislation and trends.
For ASCs who compound medication on-site or who have relationships with compounding pharmacies, quite a bit of relevant legislation occurs at the state level, so it’s important not to lose track of state-by-state issues. California is the most stringent while other states have essentially no regulation for sterile compounders. For instance, California legislators have ruled that California compounders are not permitted to supply compounded medication for “orders” to an ASC or hospital, which greatly affects how California ASCs are able to use compounded medication. Additionally, as of 2011, sixteen states only allowed compounding on a patient-by-patient basis.6
Despite the challenges of compliance for compounding medication in and for ASCs, it is hard to imagine these service centers without compounded medicine. The goals of the ASC—high-quality patient care, efficiency in service, lower overhead, more customization, and streamlined healthcare—align so perfectly with the goals of compounding pharmacies and compounding medication that ASCs would do well to continue utilizing compounded medication as they continue to cover more and more of the healthcare landscape.
Pharmaceutica North America is a premier provider of high-quality compounding kits, active pharmaceutical ingredients, and bulk reagents for ambulatory surgical centers and other healthcare providers and pharmacies. Contact us to learn more about how PNA’s ingredients and kits can aid your ASC or pharmacy in compounding key medications for patient care.
- “Ambulatory Surgical Centers: A Positive Trend in Health Care,” Oct. 8, 2011, http://goo.gl/wTbKdn ↩
- “Compounding Pharmacies & ASCs,” 2013, http://associationdatabase.com/aws/OAASC/asset_manager/get_file/68277/cherney_presentation.pdf ↩
- “Compounding: An American Society of Anesthesiologists Article,” Sept. 1, 2012, http://www.asahq.org/resources/publications/newsletter-articles/2012/september2012/compounding ↩
- “Medication Compounding in the ASC,” 2011, http://www.progressivesurgicalsolutions.com/wp-content/uploads/2013/03/8-Medication-Compounding-Summer-2011.pdf ↩
- “Compounding: Anesthesiologists,” ibid.; “Compounding Pharmacies & ASCs,” ibid. ↩
- “Compounding Pharmacies and States,” May 14, 2015, http://www.ncsl.org/research/health/compounding-pharmacies-and-states.aspx; “Compounding Pharmacies & ASCs,” ibid. ↩