Historically, there have been anesthesiologists who dilute the drugs themselves to create patient-specific doses to administer to patients, a practice that goes against FDA regulations. These anesthesiologists run the risk of human error, cross-contamination, labeling errors and lack of quality when re-mixing medication.
Anesthesiologists may also be tempted to reuse a single-use bag of medication to prepare individual sterile syringes, on multiple patients. This practice is not compliant with most regulatory bodies and accreditors.
Compounding pharmacies, like Lake Forest, Ill.-based PharMEDium, offer an alternative: ready-to-use, compounded sterile preparations. Registered with the FDA as a 503B large-scale compounding “outsourcing facility” under the Drug Quality and Security Act, PharMEDium provides healthcare providers with medications in various doses and diluents. PharMEDium’s sterile compounding process utilizes FDA-approved sterile drugs, containers and diluents.
“I think of [compounding pharmacies] as a way of increasing safety and JCAHO compliance at my center,” says Steve Vitcov, MD, medical director of Presidio Surgery Center in San Francisco. He started using the PharMEDium’s products about a decade ago.
FDA-registered compounding pharmacies help facilitate ASC compliance by selling approved, safe, single-use medications to providers. Key benefits of using a compounding pharmacy include:
1. Liability protection: If a liability issue arises with an ASC, the center can confidently explain its processes and where they purchased the medication. Using compounding pharmacies provides a defense against legal claims, as the medications are prepared in USP797 compliant environments.
2.Organization: When physicians dilute medication themselves, they handwrite the medication label, leaving room for others to misread the name and measurement. Mixing your own medication may also result in inconsistent quality. The compounding pharmacy’s quality process ensures consistent and reliable products every time in clearly labeled containers.
3. Waste management: Compounding pharmacies greatly cut down waste that negatively affects the ASC’s bottom line and can pose an environmental threat. Compounding pharmacies offer drugs in a wide range of doses. This variety of available doses allows anesthesiologists to order the exact amount needed for a single procedure.
“It’s an environmental stewardship problem, the unused containers of drugs,” says Dr. Vitcov. “All the excess medication has to be disposed of properly in pharmaceutical waste containers.” These waste bins are then incinerated into the atmosphere. In contrast, the compounded pharmacy single-use syringes are thrown out in red sharps waste containers, as the medication is fully used.
4. Medication shortage alternative: Compounding pharmacies may also provide an option during a nationwide shortage of medications. “Using compounders can help alleviate that problem for us, because they hold back some stock for bigger customers,” says Dr. Vitcov. These pharmacies step in during shortages, so an ASC won’t face a supply chain disruption.
And from a financial standpoint, since compounding pharmacies allow providers to buy a single-dose syringe, they aren’t wasting a bottle of unusable multiple doses.
Dr. Vitcov sees a great potential market for compounding pharmacies.
“The trend has been slow, but there is a gradual increase in the amount of medication from compounding pharmacies I have seen,” says Dr. Vitcov. “It doesn’t take too many mistakes for surgery centers to look at this [option].”
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