Roundtable on Patient Safety

Healthcare can do better for improving compounded-pharmaceutical quality

Training, guidelines and enforcement are lagging


It’s been six years since the New England Compounding Center (NECC) scandal broke: poor quality control caused compounded products (distributed nationally) to infect patients with spinal meningitis; 78 deaths were documented with hundreds more suffering serious adverse events. The outbreak led to passage of the Drug Quality and Security Act (DQSA), the shutdown of numerous compounding pharmacies around the country, and a new FDA program to verify the quality standards of some compounding pharmacies who voluntarily register as “503B outsourcing facilities.”

To look at where hospital-based compounding stands today, a stakeholder roundtable was held in Washington DC in late 2017; the group has now issued a white paper, “Roundtable on Patient Safety.” According to the stakeholders, the current state of the art is not good enough:

  • Too many compounding errors [occur] and most [are] due to human error
  • Challenges exist in regulating and enforcing compounding safety guidelines
  • [There is a need for] increased training and support for uniform curriculum of sterile compounding practices.

The roundtable’s gloomy assessment is reinforced by FDA data (however, the roundtable is also critical of FDA’s oversight, saying “FDA’s enforcement of the DQSA has also been more limited than it should be, many stakeholders asserted, as it has yet to finalize many DQSA-triggered guidances”). FDA’s website lists 63 503B facilities, and another page lists dozens of Form 483 warning letters (to 503B and non-503B pharmacies), which have continued to stream out of the agency even through all of last year.

Although compounding is primarily a function of the pharmacy profession, there is a substantial overlap with the pharma industry. Pharma is the source of the bulk ingredients of many compounded products, and there are numerous drugs whose dosage is tailored to the weight or condition of a patient. Beyond that, medication errors caused by improper or inaccurate compounding lead to thousands of adverse drug events (ADEs) in hospitals. According to a 2016 report cited by the roundtable, one third of health systems acknowledge having an ADE in the past five years.

Technology to the rescue?
The roundtable participants cite the value of technology involving IV admixture, gravimetric testing and more comprehensive barcoding; only 20% of hospitals employ this technology. (it’s not clear whether this is based on all US hospitals, as some of them outsource compounding to such providers as PharMedium, now an AmerisourceBergen unit and the country’s largest, handling over 3,000 hospitals). The report does not mention automated compounding systems; coincidentally, one of the leaders in that application, Arxium (Winnipeg, MB), announced a batch of new features for its RIVA 4 unit last month. These features include handling multiple types of closed -system transfer devices, upgraded barcoding capability and software for integrating with ordering and inventory systems. The company claims that employing automated IV equipment can prevent over 3,200 ADEs annually for a 100-bed hospital.