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California’s Findings of Gaps in Heparin Recalls Highlighted at FDA Track and Trace Workshop

Evidence of the gaps in the 2008 heparin recall process uncovered by the State of California underscores the need for a track and trace system for prescription drug products, CA State Board of Pharmacy Executive Officer Virginia Herold maintained at an FDA-sponsored public workshop on February 15-16 at its White Oak, MD campus.

Citing the heparin investigation in particular, Herold reported on the work California has done to understand the weaknesses in the current Rx distribution and recall system, and stressed the importance of finding ways of addressing them.  California has been on the forefront in its efforts to push forward with implementing an effective track and trace system to address its concerns.

[Editor’s Note:  FDA has also continued to investigate the events surrounding the 2008 heparin contamination.  A recent warning letter issued to heparin API supplier Scientific Protein Labs stemming from the agency’s investigation sheds light on concerns related to how recalls are being managed at the manufacturer level (IPQ “In the News” Feb. 6)].

FDA held the public forum to draw input from the participants across the supply chain on how an effective track and trace system could be developed.

The intention of the workshop, the agency explained, was to address “the attributes and standards for the identification, authentication, and tracking and tracing of prescription drug packages” and help further the goal of securing the drug supply chain against the introduction of counterfeit and other substandard drugs.

Following opening presentations by agency officials and California’s Herold, breakout sessions were held to discuss three key areas instrumental to a track and trace system:  ● interoperability (data sharing between the subsystems involved) ● product authentication, and ● data management (format, storage, capture and protection of data).

The workshop concluded with summaries and discussions of the inputs received.

[The compelling results of California’s investigation into the heparin recall and how the shortcomings in the current recall/distribution system support the need for a track and trace approach are explored for subscribers only beyond this point.  By special arrangement, IPQ is making the full story available on a complimentary basis to Rx-360 members.]

Security of the Drug Supply Chain at Issue

An introduction by FDA Acting Principle Deputy Commissioner John Taylor providing an overview and a brief history of agency efforts to date in the track and trace area was followed by a background presentation by Acting Deputy Director CDER Office of Compliance Ilisa Bernstein.

“The supply chain has been taking a painstakingly slow – yet deliberate – approach to track and trace.  We are here today to kick it up a gear or two,” Bernstein stressed.

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She explained how a track-and-trace system would improve the security of the drug supply chain and shared the agency’s “overarching” goals for a track and trace system for prescription human drugs and biologics.

These goals, she said, are to:  ● prevent the introduction of counterfeit, diverted, subpotent, substandard, adulterated, misbranded, or expired drugs from getting into the legitimate supply chain ● facilitate the identification of counterfeit, diverted, subpotent, substandard, adulterated, misbranded, or expired drugs ● provide accountability for the movement of drugs by supply chain participants, and ● improve efficiency and effectiveness of recalls.

Agency Senior Policy Advisor for Pharmacy Affairs Connie Jung provided additional background and a set of key principles and terminology to ground workshop participants and prepare them for the breakout discussions.

California Experience Supports FDA Recall Improvement Objective

California’s Herald followed Bernstein with a summary of the track and trace efforts by her state and its investigations into the heparin recalls – the compelling results of which underscore the criticality of the agency’s recall improvement objective.

Herald explained that five separate recalls of heparin from four different manufactures in 2008 meant that hospitals “were constantly getting notices for recalls of heparin.”

The CA State Board of Pharmacy received reports about “price gouging and hoarding” and sent inspectors into selected hospitals to check their heparin supplies. “We figured we would find unlicensed activity.  We could pull some of their products, have them tested, [and] maybe we would find some counterfeit drugs in California,” she commented.

In early April of 2008, inspectors visited about 40 hospitals and found that 40% of them had recalled heparin still in the pharmacy.  “That triggered for us the need to go on and do an in-depth inspection of all hospitals in California,” Herald stressed.

Pharmacy board inspectors visited all 533 licensed hospitals in California, and found that 94 of them had heparin from the recalled lots in patient care areas, outside the control of the pharmacy, where it could be used.  The California Department of Public Health estimates that over 7,000 patients were exposed to recalled heparin in that state after the recalls were supposedly completed.

“This was in spite of repeated notices to the hospitals that were available to the popular media” and those sent our by the CA State Board of Pharmacy and Department of Public Health (that licenses hospitals in California) sent out,” Herold emphasized.

Understanding of the Term “Voluntary” Among Recall Disconnects

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The pharmacy board official highlighted what her agency learned from its investigations of the recalls, referring to the “perfect storm” of circumstances that led to the recall problems (see box at right).

One serious problem it discovered is that manufacturers recall by lot number, but pharmacies and wholesalers do not necessarily track that number in-house.   As such, the recall notices in some cases do not even get the attention of the hospital staff.

Of special import was the use of the word “voluntary” in the recall notices, which was not understood by the hospital staff.  The California finding on this terminology disconnect is a potential red flag across the recall spectrum, with implications for Congress’ current consideration of the need for FDA to have “mandatory recall authority” (IPQ “In the News” Sept. 22, 2010).

In addition, the inspectors found heparin “stashed everywhere in the hospital because people did not want to wait” for an alternative supply.

Also of concern were three occurrences where heparin that had been returned to a wholesaler was resold because the wholesaler did not recognize it as being recalled.

Many of these recall issues, Herald commented, may have been prevented with the institution of pedigree requirements.  That type of system, she stressed, would have allowed hospitals to indentify whether they had purchased any of the recalled heparin and helped avoid the confusion caused by the numerous and staggered recalls.

One of the steps California took after its investigation was to pass legislation providing for fining pharmacies and pharmacists-in-charge for possessing an adulterated drug.

In addition, the state took steps toward changing its law to require all licensed sites to join its subscriber alert list – the list it uses to immediately contact licensees in the event of a recall.  It also worked with hospital pharmacists to develop a document for hospitals titled “Recall Best Practices.”

The increasing number of recalls that the state has been involved with recently further supports the refining of recall practices, Herald commented.  She noted that in the ten-day period before the workshop, the pharmacy board had received seven recall notices – one to the consumer level, the other six to the retail level.

Slides from the FDA Workshop

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