By Thomas Doherty
The passage last year of federal legislation to regulate pharmacy compounding was not only necessary but long overdue. Compounding pharmacies had historically been regulated at the state level, even though some produced drugs that were being sold in other states. Meanwhile, the public remained largely unaware of the compounding industry, confident that their health care providers would never inject them with anything that was not safe.
All that changed in the fall of 2012 when people began falling ill – and dying – from steroid injections produced by the New England Compounding Center (NECC) in Farmingham, Massachusetts. The NECC tragedy not only reaffirmed the risks inherent in manual compounding, but the scale at which the pharmacy operated. The tainted injections it produced were linked to more than 750 cases of illness and 64 deaths across 20 U.S. states.
The federal government responded in two ways. First, FDA enforcement was stepped up substantially, evidenced by product recalls from compounding pharmacies in Georgia, Florida, Texas, Nevada and New Jersey, among others, all related to concerns about product sterility. Second, Congress passed legislation imposing new standards on pharmacy compounding and the interstate sale of compounded products.
Specifically, the Drug Quality and Security Act (DQSA) amends one section (503A) of the existing Food, Drug and Cosmetic Act to clarify compounding standards nationwide. It also adds a new section (503B) that describes how a compounding pharmacy can register with the FDA as an outsourcing facility. FDA’s draft guidance on Section 503A emphasizes compliance with current Good Manufacturing Practices (cGMP), as well as standards and documentation for the admixtures being used.
Although the law addresses weaknesses in the system, we should ask if it goes far enough in regulating an industry whose products continue to be manufactured manually – meaning dose safety depends on people following complex processes. Data documenting compliance with the law will only be as good as the humans that collect it, and as NECC and other recalls have shown, even the best-intentioned humans are prone to error.
The law currently does not apply to hospital pharmacies, though there are several reasons that hospitals should be familiar with it. First, those that purchase medications from an outsourcing facility will want to consider buying from one that is registered with the FDA. In addition, hospital systems that use a central fill model essentially have an outsourcing facility in-house. Although central fill facilities are not currently regulated, hospitals should think about what mandated compliance might mean for them.
The fact is, future pharmacy regulations are only going to be more stringent and regulate more facilities. The facilities that are going to be best equipped to meet increased regulation are those that have implemented automated pharmacy technology, especially automated compounding systems.
Automated compounding technology has been available for more than a decade and has produced millions of doses accurately. The most sophisticated systems already have features that would allow compliance with DQSA mandates. For example, there are systems that photograph every vial, scan their barcodes and match each to a product database to ensure the right products are being used in every step.
And today’s technology can do even more than that. Some systems offer dispensing profiles that include the specific gravity of different fluids, as well as statistical data about the diameter and length of a syringe, telling the pharmacist the volume and weight of the final product with high precision.
Equally important, automated compounding technology provides an electronic audit trail documenting every aspect of compounding needed to comply with existing (or future) regulations. Some systems can store records of every vial used, every dose dispensed, the patient for whom it was made, environmental conditions within the compounding chamber, and much more.
Even though hospital pharmacies are not yet required to comply with these regulations, there are several other benefits to having an electronic audit trail for compounded IV medications. Such data can help hospitals control inventory, document pharmacy throughputs, provide medication records for patient billing and assure compliance with internal quality controls. In short, automated compounding records can help hospital pharmacies document compliance with any number of parameters, whether internal, external or regulatory.
While the DQSA is a step in the right direction, it may also be a foreshadowing of greater regulation to come. Those hospitals that have adopted automated compounding technology will be several steps ahead in meeting compliance standards for any new regulations.
Thomas Doherty is a founder and chief technology officer of Intelligent Hospital Systems in Winnipeg, Manitoba.
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