OASC | REGULATIONS

How ASCs Have Adjusted to Stricter Compounding Rules

Most order from outside pharmacies, but how to handle emergency cases remains unresolved.

By James Knaub, Contributing Editor

Ophthalmic ASCs have had just over 2 years to adjust to tighter regulation and monitoring of medications compounded for their patients. That adjustment typically focuses in two areas. First, most ASCs and practices now purchase their compounded medications from an outside compounding pharmacy. The added complexity and cost of preparing medications under the guidelines spelled out in Chapter 797 of the US Pharmacopeia (USP 797) — which is required by Medicare and an increasing number of states — makes onsite compounding impractical for most facilities. The USP 797 guidelines have been in place since 2008, but weren’t proactively enforced in ASCs until late 2012.

Second, each compounded drug must be prepared from a prescription for a specific patient. Practices can no longer stock batches of compounded medications to use as the need arises. The single-patient requirement creates lag time between ordering the medication and treating the patient and this may create dangerous delays in emergency care.

“In the past, surgery center staff mixed up a batch of their block solution and drew up doses for each patient under aseptic conditions at the beginning of the day,” says Crissy Benze, RN, BSN, a consultant with Southern California-based Progressive Surgical Solutions. “You can’t prepare doses for the whole day anymore.”

NECC Repercussions

The demarcation point between the past and now — as it pertains to compounding medications — was the tragic incident involving the New England Compounding Center (NECC). In 2012, a few batches of tainted medications triggered a fungal meningitis outbreak that led to 64 deaths. Both the owner and chief pharmacist of the now-bankrupt pharmacy were charged with racketeering and second-degree murder this past December.¹ The NECC incident prompted investigation, legislation, regulation and tighter enforcement of medication compounding on both the federal and state levels. Before the NECC incident, pharmacies tended to be inspected only when complaints were made. Investigations prompted by the NECC case found lax compliance and enforcement of existing regulations was common in the compounding industry. The FDA and state pharmacy boards began increasing proactive inspections. For example, surprise state inspections in Massachusetts, where the NECC was located, found that only four of 40 compounding pharmacies investigated passed the safety inspection; 11 pharmacies were partially or completely shut down.²

Because the problem wasn’t limited to Massachusetts, the investigations resulted in the federal Drug Quality and Security Act of 2013, which granted additional authority for FDA oversight of compounding. Numerous state legislatures added new laws and pharmacy boards have tightened their regulation and enforcement. In 2013, 10 states passed new laws regarding compounding.³ The National Conference of State Legislatures also reported that 30 related bills were under consideration in 14 states in 2014.⁴

“What happened at NECC scared everyone,” says Todd Albertz, Director of Surgical and Pharmacy Services at Cincinnati Eye Institute, which has offices in the tri-state area of Ohio, Kentucky and Indiana. “Everyone wants to make sure that what they’re injecting into the eye is the right medication and was properly prepared. Before, the issue wasn’t on anybody’s radar. Now, at every meeting I attend, this issue is front and center. You can either set up your own compounding pharmacy, as we have, or you can buy everything from an outside compounding pharmacy. Both approaches are expensive, but required.

“We’ve addressed the compounding issue and the patient-specific issue by bringing it in house, but most practices aren’t equipped for that,” Albertz adds. “Because of our large size, we were able to do it.” CEI has the case volume to make setting up its own compounding pharmacy economically feasible, but I believe that many organizations purchase their blocks, drops and other compounded prescriptions from a licensed compounding pharmacy.

“We evaluated all of our options: buying from an outside pharmacy, partnering with a pharmacy and giving that pharmacy all of our business volume or doing it in-house,” Albertz says.

CEI was performing about 9,500 surgical cases per year in 2012 and had been considering its own pharmacy before the NECC incident. Albertz says he calculated that it costs $15 to $18 per case to acquire medications from an outside pharmacy.

CEI decided to contract with a compounding pharmacist to run the new operation. From there, CEI purchased the necessary equipment, set up the pharmacy and pursued licensure from their state pharmacy board. CEI was licensed and began compounding early in 2013. The institute now prepares its own bevacizumab (Avastin, Genentech), blocks, gels, steroids and vancomycin. (CEI still uses an outside pharmacy for mitomycin C, which Albertz says requires additional equipment and procedures to prepare. They’re investigating bringing that in house, too.)

“Every day, we evaluate our operating schedule 2 days in advance to determine what we need for each patient on each day, then we place an order with our pharmacy,” Albertz says. “We produce it, separate it for each location, label it for each individual patient. The next day, we bring it down to the clinic or to the ASC and place it in a secure refrigerator.”

What started as an effort to provide for its own doctors’ compounding needs has grown into a revenue stream for the institute, which now provides compounding services for 19 clients in nine states.

In the fall of 2013, CEI was accredited by the Pharmacy Compounding Accreditation Board (PCAB), becoming one of the few accredited compounding pharmacies in Ohio. The PCAB is the compounding industry’s quality assurance program. The voluntary program is separate from licensure by the Ohio Pharmacy Board. “Becoming PCAB-accredited validated our processes and set us apart from others in the compounding industry,” Albertz said. CEI’s surgery center case volume rose to approximately 11,000 cases in 2014, but their pharmacy compounded about 50,000 injections last year, according to Albertz. The strong growth of CEI’s pharmacy business illustrates that most facilities either can’t or won’t handle compounding on their own.

Benze agrees. “Most organizations just aren’t in the position to perform their own compounding and their option is to purchase their compounded medications from an outside pharmacy,” she says. Benze notes that the compounding pharmacy industry is also adjusting to regulatory changes in the wake of the NECC incident. She offers the following tips for selecting a quality compounding pharmacy:

1. Verify that the pharmacy is licensed in both the state in which it’s located and, if different, the state(s) where your practice is located. Pharmacy laws differ among states. A medication compounded under the regulations in one state might not meet the requirements of another state. Your state pharmacy board can tell you the states with which it maintains reciprocal licensure agreements. Those reciprocal agreements demonstrate compatible standards between states.

2. Request evidence of accreditation by the Pharmacy Compounding Accreditation Board (PCAB) from a potential pharmacy. Participation in this voluntary accreditation process suggests the company is concerned about maintaining quality standards.

3. Ask to see proof of the pharmacy’s malpractice insurance coverage. Benze says it shouldn’t be difficult for a pharmacy to produce its licensure, accreditation and malpractice documents.

4. Obtain references. Ask for references from organizations that order similar medications to those your ASC would use.

5. Check for pharmacy infractions with the appropriate state pharmacy board. State boards maintain records of pharmacy infractions. The FDA also posts inspection results on the drug Guidance, Compliance & Regulatory Information section of the FDA site.⁵

6. Create a business contract with your supplying compounding pharmacy. A contract helps define the level of service expected, Benze says.

Emergency Cases

While ordering compound medications for a specific patient from a licensed pharmacy increases costs and management time for ASC staff, the lag time also raises clinical concerns about how to handle emergency cases. The requirement to order a compounded medication for a specific patient requires time to prepare and deliver it, potentially causing a dangerous delay in treatment.

Richard Mackool, MD, of the Mackool Eye Institute in Astoria, New York, offers the example of a patient who presents with extremely high and uncontrollable intraocular pressure (IOP), requiring an emergency trabeculectomy procedure and administration of mitomycin C (MMC).

“If the procedure is done that day without the use of MMC, it’s much less likely to be successful in lowering IOP,” Dr. Mackool says. “If it’s delayed in order to procure the MMC, the patient may suffer permanent damage to his or her vision as a result of the disease.”

Similar situations arise with intravitreal antibiotics for treating endophthlamitis cases, compounding fortified topical antibiotics for bacterial corneal ulcers, vascular endothelial growth factor (VEGF) inhibitors for macular degeneration and compounded combination dilating drops for pediatric patients.⁶

Under current regulations, ophthalmologists don’t have a clearly defined, compliant way to treat emergency cases. Albertz and CEI took this issue to the Ohio state pharmacy board in reference to bevacizumab injections. CEI asked what they should do if someone comes in on an emergent basis and needs the VEGF inhibitor injection. They asked whether, based on the specific-patient requirement, they were to deny a needed injection to a patient who may have driven a long distance to get to the clinic.

The pharmacy board allowed CEI to keep a small stock of compounded medications as an emergent care reserve, Albertz says. There’s no specific rule about keeping a reserve for emergency cases in the Ohio regulations so it’s not a complete solution, but Albertz believes it’s smart to take a proactive approach and ask your pharmacy board how to handle emergency situations.

“It gives you a resource and a bit of a safety net,” Albertz says, “but you have to police your expiration dates and police yourself to make sure you’re not taking advantage of the situation. Once you have that discussion with your pharmacy board, do what you said you would. They may drop in unannounced to see your inventory. You don’t want them finding that 25% of your syringes aren’t labeled for specific patients.”

Dr. Mackool believes current regulations must be changed to specifically allow an ASC or practice to keep an appropriate medication reserve on hand so ophthalmologists can promptly and appropriately treat emergent cases in compliance with the regulation. He says the Mackool Eye Institute obtains its compounded medications from an outside pharmacy for its planned procedures, but the specific-patient requirement actually puts some patients at risk instead of protecting them as intended. The Outpatient Ophthalmic Surgery Society, American Academy of Ophthalmology and other societies are lobbying for regulation or legislation to specifically address compounding related to emergent care.

Immediate-use Exception

So-called immediate-use compounding is another option ophthalmologists can consider for some low-risk medications, according to Benze. However she cautions that the USP 797’s immediate-use exception has specific guidelines⁷ that require nurses or other appropriately licensed personnel to mix medications in a syringe, use specific labeling requirements and mandate that the preparation be used within 1 hour of preparation. The timing constraints of this approach would likely alter workflow in a facility and only provide a partial solution.

Summary

The tightening regulatory environment has driven most ophthalmic ASCs and practices to order their compounded medications from an outside pharmacy, increasing costs and adding to inventory management issues. Increased enforcement of the single-patient requirements has created legitimate concerns about emergency cases. Ophthalmic practices should carefully evaluate potential pharmacies, stay informed about any changes in their state pharmacy requirements, and consider seeking guidance regarding the unresolved issue of how to handle compounded medications in emergency situations. ■

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