Pedigree Provisions: A New Responsibility for Pharmacists and Their Organizations
Roger S. Klotz, R.Ph., BCNSP, FASCP, FACA, FCPhA, CDM
The increasing introduction of counterfeit drugs into the United States legal distribution system impacted the development of federal legislation that resulted in the passing of the 1988, Prescription Drug Marketing Act (PDMA), which was to become final in January 2000. This bill included the provision that required proof of the drugs “Pedigree” be tracked and documented. The legal definition of “Pedigree” is that a statement of the origin be identified as well as each prior sale, purchase, or trade of a drug, including the date of those transactions and the names and addresses of all parties involved in these transactions since the drug/product left the original manufacturer’s facility. The implementation was delayed by the FDA to allow more time for the development of a totally electronic tracking system of all sales or trades of drugs/products in order to avoid a paper system.
The FDA in June of 2006 announced that because no electronic system has become available and appears will not be available in the near future that they would implement the “Pedigree provisions of the 1988 PDMA law. The FDA announced at this point that the “Pedigree” provisions will go into effect on December 1, 2006. While, this will required a paper tracking system it is critical that the “Pedigree” rules be implemented at this time, since the United States drug/product distribution system continues to have problems with counterfeit drugs/products. Thus, pharmacists and their organization must implement a paper system beginning December 1, 2006. This provision of the regulations does throw additional responsibilities onto the shoulders of the pharmacists and their organization.
Pharmacists effective December 1, 2006 must begin requesting the proof of “Pedigree” documentation for all drugs/products purchased, the documentation must be provided with each delivery. The pharmacy manager or their designated pharmacist should begin contacting the suppliers/wholesalers immediately to determine if they are an “Authorized Distributor of Record” (ADR) which exempts these suppliers/wholesalers from the “Pedigree” documentation requirement. The 1988 PDMA defines ADR is a wholesaler that has an “ongoing relationship” with a manufacturer to distribute that manufacturer’s drug. The 1999 revision to section 203.3(u) defines “ongoing relationship” to include a written agreement between the manufacturer and the supplier/wholesaler. If the supplier/wholesaler is not an ADR then the pharmacy must obtain a document indicating the “Pedigree” for all drugs/products supplied by that supplier/wholesaler. The non-ADR supplier/wholesaler must provide a proof of “Pedigree” document and to legally sell the drug/product the pharmacy must receive the “Pedigree” documentation. The proof of “Pedigree” document for each drug/product must be provided each time the drug/product is purchased. The pharmacy must develop a filing system and retain/maintain all proof of “Pedigree” documentation. I would recommend that the pharmacy should refuse to purchase from any supplier/wholesaler that is not an ADR and will not provide the appropriate documentation of “Pedigree” of all drugs/products sold to the pharmacy. It is the pharmacy’s responsibility to assure that all suppliers of all medications are either an “Authorized Distributor of Record” (ADR) or that they provide documentation of the medications/products “Pedigree”.
The pharmacy manager (Pharmacist-In-Charge) should document all the contacts of the suppliers/wholesalers made as well as document the individual they contacted in the organization regarding this issue. I would also recommend that you ask for proof that the wholesaler is an ADR. The proof of “Pedigree” documentation must be retained (filed) in a secure environment to allow for easy recall in case of an investigation as well as proving that the pharmacy has implemented the provisions regarding “Pedigree”. Any new vendor should of coarse be requested to follow these regulations.
It is quite obvious that the enforcement of these provisions will have a major impact on small wholesalers in particular, but they obviously will impose a new record keeping requirement on pharmacists and their organization who deal with suppliers/wholesalers that do not have ADR status. The FDA has announced that the enforcement of “Pedigree” requirement will be phased in. The FDA has published a draft Compliance Policy Guide (CPG) that includes factors that will be the initial focus of their enforcement efforts. The draft CPG is available at the FDA Web site at www.fda.gov/ohrms/dockets/98fr/06d-0226-gdl0001.pdf . While, the ultimate goal is to have an electronic “Pedigree” this will probably not occur in the near future so we all will have to deal with the paper trail. The FDA does make the point in the CPG that they “may, under appropriate circumstances, initiate regulatory action, including criminal prosecution, for pedigree violations that involve drugs that don not meet the factors set forth” in the draft document. The FDA in its phased enforcement approach will give higher priority to enforcement efforts regarding the “Pedigree” requirements based on the following descending factors:
- Factor 1: High Value in the US Market
- Drugs that have a high sales volume or price in the US.
- Drugs that are a “high priced/specialty” product used for serious or life-threatening diseases
- Drugs that have high demand
- Drugs that are in short supply
- Factor 2: Prior Indicators as the drug has been counterfeited or diverted previously in the U.S.
- Factor 3: Reasonable Probability (for newly-approved drugs) that these new agents based on historical data that they be at risk.
- Factor 4: Other violations of the law. The FDA regardless of the preceding factors the FDA intends to enforce the requirements against wholesale distributors and others who are engaged in conduct related to the manufacture or distribution of counterfeit drugs, or engaged in the manufacturer or distribution of prescription drugs that other wise violate the Act or other laws.
The federal rule will be used by the majority of states as the legal stance, but a number of states have passed or are in the process of creating their own legislation and rules (i.e. California) which may require additional procedural changes within the pharmacy and the organization.. The pharmacy manger should contact their state pharmacy association and/or Pharmacy Board to determine the status of additional legislation in your state. This legislation was created and enacted so that appropriateness of the proof of “Pedigree” documentation legitimizes all of the drugs/products purchased through legitimate distribution channels, it is designed to assure that the drugs/products are not counterfeits and therefore patients are protected
We all have been hearing since 1988 about the implementation of the proof of “Pedigree” process that would ultimately be implemented. Our professional organizations have been diligently following this process. In order to maintain my policies and procedures I try to keep up on major legal, regulatory, and accreditation regulations and standards. I like many individuals are now surprised that the FDA has made the decision to implement the “Pedigree” process without the electronic tracking component, but we will have to deal with the process which will help assure our patients that they are not getting counterfeit drugs/products. While the time line for pharmacist and their organizations to create policy and procedures and then implement the processes it is doable. Fortunately, pharmacists and their organizations do not have to create the proof of “Pedigree” documentation which is obviously the large administrative burden, but they must develop their process for verifying that their supplier/wholesaler is an approved ADR or they will be able to provide the proof of “Pedigree” documentation for the pharmacist. Developing a paper tracking system that maintains the appropriate documents to allow readily retrieval of the documents will create a burden and the effort required to obtain the documentation with each delivery and make sure the documents are properly handled does add to the pharmacist’s responsibility and the workload of the pharmacy staff. Again we have been given a responsibility, but on the other hand it is opportunity to protect our patients and show everyone that the professional deals well with new responsibility.
My medical friends and mentors long ago taught me that the cornerstone of medicine is “first of all do no harm”. The problem of unknown counterfeit and/or diverted drugs in our system do carry high risk of do harm to our patients. Diverted drugs maybe the original manufacture’s drug, but do to the diversion these drugs may not have been proper handled and stored during the diverted distribution process. Counterfeited and diverted drugs may either contain toxic materials or have decomposed drug which can result in injury to the patient or failure to treat their disease. When I think of the impact of counterfeit and diverted drugs/products can have on our patients I am proud that our professional has been given an additional responsibility to help assure the drug supply chain provides only the purest and safest drugs/products to our patients.
I had planned to do a follow up article to last months article to deal with the methods of documenting pharmacist provided cognitive services such as Medication Therapy Management (MTM), but when I say the news item that the proof of “Pedigree” regulations will be implemented by the FDA on December 1, 2006 I thought that it would be more important to bring this to the attention of our readers so they weren’t totally surprised and at risk of being in violation of federal and state regulations.
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