Collaboration Focused on Priority Issues Promotes Safety

October 9, 2008

Between May and August 2008, the California (CA) Board of Pharmacy (BOP) and CA Department of Public Health (CDPH) took action to ensure that CA hospitals had responded to recent life-threatening drug recalls and related threats to patient safety. On April 28, 2008, FDA issued an alert regarding a Class 1 nationwide recall of all strengths of DIGITEK (digoxin) due to concerns about double thickness tablets that may contain twice the approved level of active ingredient. In January 2008, Baxter recalled lots of a specific strength of heparin in vials due to reports, including fatalities, of allergic reactions. The company broadened its recall in February to all lots and doses of heparin in multi- and single-dose vials and flush solutions. In March, American Health Packaging and Covidien also issued heparin recalls, and in May, Medtronic recalled its heparin-coated products. Between January and May, more than 100 deaths potentially associated with allergic reactions to the recalled heparin products had been reported.

After recalled heparin products and Digitek were found in pharmacies during onsite visits, the BOP, CDPH, and the California Society of Health-System Pharmacists (CSHP) issued alerts to all CA hospital pharmacies to ensure all pharmacists were aware of the heparin recall. In April, the BOP announced it would be inspecting licensed facilities to ensure compliance with these drug recalls. Since then, the BOP has inspected all 533 licensed hospital pharmacies in CA. Unfortunately, the inspectors continued to find the recalled products in 94 hospitals. Because the pharmacist-in-charge (PIC) is responsible under CA state licensure for drug distribution within the hospital, PICs where the recalled products were found were fined $2,500 and cited for “unprofessional conduct,” the only charge applicable under these conditions. If the BOP inspectors confirmed that a recalled product had actually been administered to patients, the PIC was fined up to $5,000.

Because the BOP’s scope of influence did not extend beyond hospital pharmacies, CDPH conducted follow-up visits in hospitals where the BOP found and confiscated the recalled drugs. To their surprise, recalled drugs were still found in a significant number of hospitals, which may receive citations and up to a $25,000 fine from CDPH, particularly if the hospital is deemed an “immediate jeopardy” to patients.

ISMP supports compelling the removal of recalled drugs and other threats to patient safety, and we urge hospitals that have not taken these recalls seriously to address the issue immediately. In fact, beginning with potassium chloride injection concentrate and vinCRIStine in 1980-1990, we have called for regulatory agencies to promote patient safety by visiting hospitals to ensure critical safety measures are in place. ISMP also recognizes and upholds the duty of the CDPH and BOP to protect the public from medical harm. Yet, some concerns have emerged as a result of this wave of fines and citations, due in large part to:

Fines and citations in some hospitals where staff have gone to great lengths to remove the recalled products only to find supplies in unlikely places or from uncontrollable sources
Perception that public reprimands of “unprofessional conduct” for individual PICs are unusually harsh in hospitals where recalled products were overlooked due to human error, not intentional disregard of product recalls.

Fines and citations. To be fair, there were many instances in which hospitals and pharmacists who were fined and cited had not diligently attempted to remove recalled products from their facilities, or had not followed their own internal procedures regarding recalls. But there were also instances in which hospital staff followed procedures and truly thought they had removed all recalled products. In these cases, fines and citations for overlooked products seem harsh. Take the following cases, for example, which were recently reported to ISMP.

In one hospital, fines and citations were issued because pharmacy-prepared heparin flushes in NICU had been overlooked. The organization had taken the recall seriously and removed all recalled heparin from pharmacy shelves and bins, refrigerators, patient care unit supplies (including automated dispensing cabinets), treatment carts, ambulances, and other typical distribution sources. But the pharmacy-prepared heparin flush syringes were overlooked because they had been removed from their usual NICU storage area and placed near the isolettes. No other recalled heparin was found in the organization.
In another hospital, heparin vials that had been added to hospital-prepared treatment kits had been overlooked. As in the prior example, staff had followed their policy and removed all heparin from the typical distribution sources and storage locations listed in its policy. Medications packaged within treatment kits had not been considered when developing the policy.
In a third hospital, the pharmacy department made sure there was no recalled heparin in any distribution and storage locations. This included dialysis carts, which initially contained supplies of the recalled heparin from an outside pharmacy. When the BOP inspected a few days later, heparin was again found in the dialysis carts, despite assurances from the contracted dialysis company that this would not occur. The hospital and PIC were cited.
In a fourth hospital, pharmacy staff thought all recalled heparin had been removed from the facility. Heparin 10 units/ mL flush syringes labeled with “Kendall-Tyco” as the manufacturer remained in stock because they were not on the list of recalled products. But Tyco Healthcare was renamed Covidien in 2007, although the syringes still bore the Kendall-Tyco name and purchase records listed Kendall Healthcare as the manufacturer. All recall notices from the FDA, BOP, and CDPH listed Covidien as a manufacturer that was recalling heparin syringes, not Kendall-Tyco. No other recalled heparin was found in the hospital, yet the hospital and two pharmacists, one of which was not the PIC, were cited.

In response to these and other fines and citations, the CDPH and BOP suggest filing an appeal if there is evidence that the hospital fully attempted to comply with the manufacturers’ recalls. However, an appeal should not be necessary. In our opinion the citations should not have been issued if an honest and seemingly thorough attempt to remove the recalled drugs occurred. Appeals use up valuable resources that could be devoted to patient safety activities. Further, in a just culture, human error is consoled—not punished—and learning from the error results in improved systems to prevent similar errors in the future.

We recognize that the CDPH and BOP may be required by current statutes to issue citations and fines to noncompliant hospitals and pharmacists and, therefore, may not have any leeway to handle this issue differently. However, we hope that the conditions under which hospitals and pharmacists are found noncompliant will be re-evaluated to best support patient safety as well as fairness to professionals and hospital leaders who have otherwise demonstrated a sustained commitment to patient safety. This may require changes to regulations.

“Unprofessional conduct” reprimands. Pharmacists who have received citations from the BOP have a permanent record of “unprofessional conduct,” which is publicly available. As previously mentioned, these citations are certainly just if the PIC did not make a reasonable effort to remove the recalled products. However, ISMP and the California Society of Health-System Pharmacists (CSHP) both question whether the reprimand of “unprofessional conduct” is justified when the failure to remove the recalled products is due to the human error of overlooking products that are not within typical distribution avenues. Further, the fact that almost a quarter of CA hospitals were found during the initial inspections to have recalled heparin or Digitek products in their facilities suggests that the problem is larger than an individual pharmacist’s performance and most likely a large-scale systems issue. CSHP has specifically asked the BOP to reconsider the citation of “unprofessional conduct” related to the heparin recall, stating it’s a gross misinterpretation of “unprofessional conduct” and an arbitrary expansion of the scope of the regulation that may cause irreparable harm to the pharmacists’ reputation. The BOP suggests that these actions are not intended to be a personal reprimand on a pharmacist’s individual record, but a reprimand associated with the larger role of the PIC. Nonetheless, some pharmacists have ex-pressed concern with continuing in the role of PIC given the recent fines and citations.

Positive steps forward. We urge the CDPH, BOP, and US hospitals to recognize through this experience that the current processes for removing recalled products need improvement. To that end, we applaud and fully support the BOP and CDPH in their plan to distribute a summary of experiences with the heparin/Digitek recall as a learning opportunity. We hope the BOP will include PICs and other key healthcare providers including nurses in this effort, working collaboratively to design a framework for a more robust system for finding and removing recalled products. When the project is completed, we welcome the opportunity to publish the findings to help all US hospitals improve their urgent drug recall policies.

We also encourage the BOP and CDPH to build upon this effort to address other urgent patient safety issues collaboratively with healthcare providers, in a manner that does not punish human error but rather sets standards to make it more difficult to err. This requires departure from the “gotcha!” approach of some of the inspections—a complaint we received from numerous CA professionals. A climate of collaboration would be a better strategy to achieve common goals regarding patient safety.

Collaborative efforts should also be focused on a reasonable set of well-defined priority initiatives. An increasing number of safety initiatives are being disseminated through quality/safety/regulatory agencies, creating significant challenges for organizations. Additionally, some healthcare professionals have reported that CDPH is now “citing” hospitals for not following guidelines from ISMP, which were never intended as standards or regulations. (CDPH officials told us that the guidelines are used to create a dialog about safe practices, and that no citations or fines have been issued for not following these guidelines.) We have also received reports of “citations” for not developing and implementing written policies and procedures to ensure safe use of drugs with a black box warning—a decidedly important issue, but one which hospitals may not have known they were required to address in a specific manner. A climate of collaboration and eager participation in a reasonable set of well-defined and widely communicated priority patient safety interventions should be the desired goal. To that end, we encourage CDPH and the CA BOP to convene biannual Safety Forums with CA hospitals to help identify the priority safety issues and suggest reasonable and reliable solutions.

In some states, the healthcare professional licensing boards, department of health, and healthcare providers have been working side-by-side to improve patient safety—from transforming the culture to implementing practical interventions that have been prioritized, developed, and rolled out collaboratively. To begin a similar process in CA, we encourage CDPH and the CA BOP to convene a consensus group to review and update Title 22 (CA code of regulations for hospitals) and applicable pharmacy legislation to adopt a Just Culture, which will result in fairness to individuals and healthcare systems without lessening their accountability for behavioral choices, or lessening the health department’s and licensing board’s accountability to protect public safety. If the lessons learned from this drug recall effort are carefully examined and applied, CA regulatory agencies will be perfectly poised to join, if not lead, in this growing, nationwide effort.