Monday, December 10, 2007

Do Pharmacists want Pedigree?

Do pharmacists want pedigree laws? Who should pay for pedigree implementation in pharmacies?

I thought of these questions while reading the comments of Dave Wilcox, RPh, owner of Northwest Medical Pharmacy in Fresno. Mr. Wilcox testified on behalf of the National Community Pharmacists Association (NCPA) at the California Board of Pharmacy’s Work Group on E-pedigree last Wednesday. You can read his written testimony online.

NCPA argue that the implementation should be extended to January 1, 2011. They also raise two points that anyone concerned with pedigree should consider:
  • “As E-pedigree is implemented, independent pharmacists should be compensated for the costs associated with the purchase of multiple technologies.”
  • Regarding “inference” that a container has the items listed in it: “[A] pharmacist and other recipients of 'inferred' containers should be held harmless for the contents of the container.”
Both points highlight the potential burdens that pedigree activities place on pharmacies. Yet pedigree laws only close the loop in the supply chain if pharmacy buyers authenticate pedigree documents (whether electronic or paper). Validating pedigree based only on wholesaler shipments creates gaping holes in supply chain security.

Alas, I wonder if raising the costs and administrative burdens of pedigree for pharmacies could lead to rampant non-compliance and turn pedigree laws into a meaningless exercise that will not secure the supply chain.

The Return of Unsafe Sourcing?

I also wonder if the burden of pedigree could tempt some pharmacies to engage in unsafe buying practices, especially if any type of importation law gets passed in the next Congress.

A recent Integrichain white paper suggests that $10 billion in prescriptions products in 2006 were either diverted, parallel imported, or outright counterfeit. Their analyses suggest that most secondary wholesalers now buy from non-wholesale sources (including long term care facilities, retailers, and public health services) and then sell directly to pharmacies. (You can download this white paper after registering.) Florida continues to have major diversion problems in the first year of its new pedigree laws.

I hate to be the bearer of bad news, but we should all acknowledge that it will be very difficult for the CA Board of Pharmacy to catch non-compliance. The California Board of Pharmacy has 50 employees and a budget of less than $10 million. There are fewer than 20 field inspectors to cover 5,300 community pharmacies and almost 65,000 community pharmacists – and that’s before we start counting institutional pharmacies in hospitals and clinics!

Given these limited resources, the CA Board ambitiously aims to inspect every licensed facility once in every three year inspection cycle. Pedigree non-compliance will likely to be low on the list of potential frauds.

Who should pay for pedigree?

Last January, I warned that private companies are being forced to shoulder the burden of protecting the drug supply chain with a do-it-yourself (DIY) model. I don’t see much changing in the future.

So far, nearly all of the costs of pedigree are being borne by manufacturers and wholesalers. Independent pharmacists are busy just trying to keep their heads above water - as the comments about AMP made by pharmacists on my blog indicate.

Since many boards of pharmacy are composed of independent pharmacists, I sincerely doubt that these Boards will allow additional burdens or costs to be put on independent pharmacies. Just reread California’s statute, which I view as deliberately vague about whether pharmacies must actively check the pedigree from wholesalers.

Still not convinced? Consider the comments of Bruce Roberts, who recently highlighted NCPA’s intention to “minimize any impact” of Federal pedigree laws on independent pharmacy. In 2006, the American Pharmacists Association (APhA) expressed its mild support for the FDA's attempt to implement the PDMA but worried about any minor disruptions or costs to pharmacists. (Read the APhA statement to the FDA.)

So, what do the pharmacists out there think? Who should pay for pedigree? Am I being a realist or a pessimist?


  1. Allen
    Based on the latest public meeting, it appears that the Enforcement Committee is trying to figure out how to recommend a delay to the board without exposing itself to legal concerns about siding with the industry and putting the public at risk. The Enforcement Committee told industry participants at the conclusion of the 12-5 meeting to submit written statements requesting a delay so that the committee can prepare a submission for the January 23rd full Board meeting. The statements should include:
    - All efforts to comply to date made by the submitting organization
    - Challenges encountered in complying by 2009
    - Planned efforts to comply if there is a delay
    - Timelines for compliance
    - A Statement why delaying until 2011 will be in the best interest of California Citizens

    The committee also encouraged stakeholders to summit detailed comments on both inference and grandfathering.

    With the exceptions of comments from the former Florida DA warning the board that they run the risk of their law becoming a "Sham" just like Floida's and a representative from Siemens claiming that the industry's finanacial forecasts for serialization were over blown, all public comments were in favor of a delay.

  2. FYI, Nick Basta at Pharmaceutical Commerce just posted some comments from the recent NACDS/HDMA meeting. It's a good update on the shifting alliances and perspectives:

    Arguments Rage Over How to Meet California e-Pedigree Deadline

    No clear consensus yet, from what I see.