Electronic Distribution of Prescribing Information For Prescription Drug Products
Docket No. 2007N-0114 (72 Fed. Reg. 15701; April 2, 2007)
April 27, 2007

Good afternoon, I am Anita Ducca the Senior Director for Regulatory Affairs and Healthcare Policy for the Healthcare Distribution Management Association (HDMA).  On behalf of HDMA, I commend the FDA for holding this important public meeting, and I thank you for the opportunity to comment on behalf of HDMA and our members.

HDMA represents the nation’s primary, full-service healthcare distributors. Our approximately 40 members include national, regional and small, family-owned businesses.  Each day, HDMA member companies deliver nine million prescription medicines and healthcare products to more than 144,000 pharmacies, hospitals, nursing homes and clinics across the United States.

HDMA thanks the FDA for seeking information on how to best electronically distribute FDA-approved prescribing information or package inserts (PIs) for prescription medicines and biological products.  In our testimony today, HDMA will provide information on: 

• How distributors use the current, paper PIs.
• The benefits distributors believe will be possible with electronic PIs.
• How electronic PIs could be handled operationally.

HOW DISTRIBUTORS USE THE CURRENT PAPER PIs

In the current system, paper PIs are created by the manufacturer, and are usually affixed to individual products or cases.  While distributors ship these products and their attached PIs safely and efficiently to customers, the PI has no functional role in the distributor’s operations.

Some of the products distributors provide must be stored or handled following specialized requirements to help ensure the product’s safety and potency.  Although these requirements may be specified on the PI, distributors typically receive storage, handling and other product information directly from the manufacturer before the distributor receives the products and their PIs.  Distributors can request the information from manufacturers using the HDMA Standard Product Introduction Form by contacting the manufacturer directly or by visiting the manufacturer’s Web site. Distributors can also find product information they need easily from the following sources:

• On the package label or case container;
• From the product’s Material Safety Data Sheet (MSDS);
• From Internet sources, including the National Institutes of Health Web site or the FDA Web site; and
• Through a medical information service.   

Because distributors do not use the PI, do not reach the prescriber, do not interact with patients, and do not provide counseling services, there is little to no value in having them serve as a conduit for this information, in paper or electronic form.

BENEFITS DISTRIBUTORS BELIEVE WILL BE POSSIBLE WITH ELECTRONIC PIs

An electronic system represents a better approach to ensuring the delivery of PI information to the prescribers and others that serve patients.  In our members’ experience, a paper PI is only as good as the glue holding it to the bottle or package.  An electronic PI will help ensure that those who need the PI to counsel their patients receive it. An electronic system also would enhance patient safety, by speeding the availability of critical new risk information to prescribers and dispensers. 

Second, many distributors use automated systems for picking drug products to fill customer orders, which can be clogged or jammed by paper PIs. An electronic system could enhance operational efficiencies and reduce manual handling efforts needed for paper PIs. 

HOW ELECTRONIC PIs COULD BE HANDLED OPERATIONALLY

While our members support replacing paper PIs with electronic ones, there is no need for the distributor to be part of an electronic PI system. In addition to the other, readily available sources of PI information, distributors usually have little or no interaction with prescribers, a key audience FDA has identified for this information.  Typically, our products are distributed to a pharmacy or dispensing setting, and bypass the prescriber entirely. 
As the FDA is aware, distributors are experienced leaders in implementing new systems that streamline operations, enhance business processes and improve efficiencies in healthcare.  Based on that experience, we offer some suggestions that might be useful in developing an electronic system for delivery of the electronic PI.  In our view, an optimal electronic PI system would have the following characteristics:

• First, we recommend creation of one, uniform system offering information in a single format, managed by a single entity.  An electronic system that runs on multiple systems and formats would waste human, technology and capital resources, and would be too complex for the fast throughput, high volume healthcare product delivery system.  For similar reasons, HDMA also recommends against a combined system that requires both paper and electronic PIs. A paper-electronic hybrid system would be confusing and would erode any possible efficiency gains.  Although testing or a short “phase-in” period could be considered, the ultimate goal should be to have all PIs available electronically as soon as the system is operational. 
• If a single system is not feasible, HDMA recommends a system of compatible, networked sites. 
• Drug packages should be modified to include information on where to obtain the PI, such as a Web site and/or an 800 number.
• The manufacturer currently assumes the costs associated with creating and duplicating the paper PI. HDMA sees no need to significantly alter the current cost structure if and when the PIs are provided electronically. 
• If PIs reside on one or more Web sites, the sites should be managed and updated by manufacturers, as they work with the FDA to gain approval for PIs, have the most up-to-date data and possess the most detailed product knowledge.
• PIs should be transmitted directly from the manufacturers to the prescribers and dispensers. Making the distributor a gatekeeper between the manufacturer and those who counsel patients and dispense medications is not appropriate or efficient.
• Electronic transmission of PIs must be independent of any other electronic product identification and tracking systems that are used or under development in the supply chain.

CONCLUSION

HDMA plans to supplement this testimony with more detailed written comments on the feasibility of electronic PIs.  Also, we currently plan to participate in the upcoming public meeting on Medication Guides, as we believe the two issues are closely related. We plan to offer further comment on this relationship in conjunction with that hearing. 

Thank you very much for the opportunity to discuss this important topic.