On May 8 and 9, 2014, FDA held a public workshop on the development of initial standards for

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1 The Drug Supply Chain Security Act Implementation: FDA s Public Workshop on Developing Standards for the Interoperable Exchange of Information for Tracing of Human, Finished, Prescription Drugs, in Paper and Electronic Format. THIS IS A SUMMARY OF SOME OF THE COMMENTS SHARED BY PUBLIC WORKSHOP PARTICIPANTS. IT IS NOT COMPREHENSIVE BUT REFLECTS THE RECURRING THEMES HEARD. THIS SUMMARY SHOULD NOT BE INTERPRETED AS A FINAL DECISION OR POSITION OF THE FDA. On May 8 and 9, 2014, FDA held a public workshop on the development of initial standards for the interoperable exchange of transaction information, transaction history, and transaction statements in paper or electronic format. The workshop was intended to provide a forum to seek input from stakeholders in the drug supply chain and facilitate the productive exchange of information and ideas. More than 150 participants attended the workshop, representing a broad spectrum of stakeholders, including drug manufacturers, wholesale distributors, pharmacies, standards organizations, and solution providers. The goals of the workshop were to: Obtain input from workshop participants on how trading partners (manufacturers, repackagers, wholesale distributors, dispensers) can best comply with the requirements for the interoperable exchange of transaction information, transaction history, and transaction statements under the Drug Supply Chain Security Act (DSCSA) on January 1, 2015, using currently available standards or practices. Utilize this input to help FDA establish initial standards for the interoperable exchange of transaction information, transaction history, and transaction statements in paper or electronic format that will be issued in the draft guidance required under Sec. 203 (h) of the DSCSA. This is an important aspect of the implementation of the DSCSA that will help safeguard the U.S. drug supply against, counterfeit, stolen, and adulterated drugs. Overview of the Public Workshop The workshop was structured around four breakout discussion sessions, each introduced with a short FDA presentation. Workshop participants were organized into smaller groups to include a diverse mixture of supply chain stakeholders (i.e. manufacturers, wholesale distributors, pharmacies, solution providers, standards organizations, etc.) and each group was facilitated by an FDA moderator. During these sessions the participants discussed several topics, including: issues associated with transaction information, transaction history, and transaction statements as described in the DSCSA; discussion and refinement of supply chain options to meet the 2015 deadlines required by the DSCSA; and 1

2 the transition to full utilization of electronic practices, processes or systems to enable the exchange of transaction information, transaction history, and transaction statements with lot-level information. Each small group provided its summaries to the entire group of workshop participants for consideration and discussion. The public workshop agenda, discussion topics, slides, and recorded webcasting of portions of the workshop may be found at the FDA s public workshop webpage: Stakeholder Responsibilities Beginning in 2015, trading partners will be required to provide and receive specific types of information about drugs moving through the supply chain 1 : 1) Transaction Information (TI) (A) Proprietary or established name of the product; (B) Strength and dosage form of the product; (C) National Drug Code (NDC) number of the product; (D) Container size; (E) Number of containers; (F) Lot number of the product; (G) Date of the transaction; (H) Date of the shipment, if more than 24 hours after the date of the transaction; (I) Business name and address of the person from whom ownership is being transferred; (J) Business name and address of the person to whom ownership is being transferred. 2) Transaction History (TH) - A statement in paper or electronic form, including the transaction information for each prior transaction going back to the manufacturer of the product. 3) Transaction Statements (TS) - A statement, in paper or electronic form that demonstrates that the entity transferring ownership in a transaction: (A) Is authorized to do as required under the DSCSA; (B) Received the product from a person that is authorized as required under the DSCSA; (C) Received transaction information and a transaction statement from the prior owner of the product, as required under the law; (D) Did not knowingly ship a suspect or illegitimate product; (E) Had systems and processes in place to comply with verification requirements under the law; (F) Did not knowingly provide false transaction information; and (G) Did not knowingly alter the product s transaction history. 1 For full definitions of transaction, transaction history, transaction information and transaction statement, please see 21 U.S.C. 360eee of the Federal Food, Drug and Cosmetic Act. 2

3 As of January 1, 2015, drug manufacturers, repackagers, and wholesale distributors, followed by dispensers by July 1, 2015, must provide TI/TH/TS information to the next purchaser in the supply chain with each transaction (i.e. when change of ownership occurs). The transaction information includes lot-level information amongst other information about the product and transaction (except for certain wholesale distribution transactions, as outlined by the law). Highlights of Workshop Discussion I. TRANSACTION INFORMATION, TRANSACTION HISTORY AND TRANSACTION STATEMENT During Sessions 1 and 3, FDA asked participants to discuss issues related to statutory definitions of Transaction Information, Transaction History, and Transaction Statement that may pose challenges to stakeholders in complying with requirements and may need clarification by FDA or others. A. Transaction Information 1. Proprietary or Established Name or Names of the Product Many workshop participants observed that in order for the system to be interoperable throughout the supply chain there should be a naming convention so that all drug products are identified by name in a consistent manner. The established name could match the product label, be a trade name or a chemical name, therefore, it will be important that the standard be clearly identified and consistently used in order to ensure that the system can match and recognize the drug product information. In addition, several stakeholders wanted to know if abbreviated names could be used (i.e. particularly for those products that may have long names because they contain multiple active ingredients). 2. Strength A few stakeholders noted that identifying strength for bio-therapeutic products is an issue because biological drug strength may be presented as nominal or actual potency, and for other products, the strength may be related to the package size. In addition, stakeholders wanted to know if abbreviated units for strength can be used. 3. Dosage Form Some stakeholders also requested clarification in the standards on the use of abbreviations in dosage forms and whether downstream trading partners should use what is on the label of the product or what the previous trading partner provides in its transaction information. 4. National Drug Code (NDC) Some stakeholders would like clarity in what format should be used to represent the National Drug Code (NDC) because different formats may be used for billing and reimbursement purposes. 3

4 5. Container Size While a package is defined by the law as the smallest individual saleable unit of product for distribution, container size may apply to the individual saleable unit or the package level used to ship product. Stakeholders would like FDA to specify what container size should be included in the transaction information when there are multiple package levels for product, including pallet, case, box, and bottle. Some stakeholders have also interpreted the container size to mean the number of dosage units in the container (e.g. the number of tablets in a bottle). 6. Number of Containers Stakeholders discussed the number of containers often when discussing container size because there are multiple package levels for product, including pallet, case, box, and bottle, and what is used for container size will affect how the number of containers would be determined. Some stakeholders noted that the number of containers a distributor purchased from the manufacturer may be proprietary information. 7. Lot Number of the Product A few stakeholders asked for clarity on whether a repackager needs to provide the original lot number from the manufacturer, the repackager s lot number, or both lot numbers with each transaction. 8. Date of Transaction: Several stakeholders wanted clarity about whether the date of transaction is triggered by billing, when the money changes hands, when the money is provided or when the money is received. Alternatively, the date of transaction could be triggered by product movement, when the product is shipped or when the product is received. Because transactions are based on when change of ownership occurs, stakeholders noted the need for clarification on what constitutes a change of ownership and when change of ownership occurs, such as when an order is created by a customer, when an invoice is created by the seller, when an order is shipped to the customer or when an order is received by a customer. 9. Date of Shipment Several stakeholders expressed concern with managing and maintaining two dates: the date of transaction and the date of shipment. While the law states that the date of shipment should be part of the transaction information if more than 24 hours after the date of the transaction, stakeholders expressed a need for flexibility for the date of shipment, depending on how the date of transaction is to be determined (see 8. Date of Transaction for related issues). 10. Business Name and Address of Person from Whom and to Whom Ownership is Being Transferred: Discussions revolved around whether the business name and address should be that of the parent corporation, the compensation/reimbursement part of the company, the manufacturing facility, the shipping part of the company, or the receiving part of the company, citing organizational complexity of corporations. 4

5 Additional stakeholder discussions included the use of a standard identification number (such as DUNS, or DEA registrant number) so that downstream trading partners would be able to more precisely identify the appropriate trading partner and address, particularly for verifying if the trading partner is authorized. For drop shipments, some stakeholders indicated that clarification was needed regarding the contact information for the wholesale distributor that must be provided to the recipient, e.g. should it be a person and direct phone number or address, or should it also include the business address. B. Transaction History We heard that many of the issues stated above concerning elements of the transaction information would also apply to the transaction history. Some stakeholders felt that the transaction history should trace prior transactions about the physical location and not just ownership, but others felt that only changes of ownership should be traced with this information. A few stakeholders recommended that FDA address change of custody in the guidance for trading partners that want to capture this information. Several stakeholders indicated that the number of containers that were originally purchased is considered proprietary information. For prior transactions going back to the manufacturer of the product, some stakeholders indicated that clarification is needed on how trading partners document partial transactions when transferring information at the lot level. Stakeholders expressed challenges with the amount of information that will be provided to the subsequent purchaser, particularly the last purchaser who will receive all the previous transaction information as it is appended to each transaction. C. Transaction Statement 1. Use of an abbreviated transaction statement Many stakeholders opined on the length and the amount of information that constitutes the transaction statement and that, in certain scenarios, not all of the assertions may apply to the trading partner or the transaction. Much of the discussion revolved around what the format should be for the transaction statement. Several workshop participants suggested that FDA consider an abbreviated transaction statement such as DSCSA compliant to satisfy the TS requirement. Some stakeholders felt that a web portal may be a way to provide trading partner access to the transaction statement. 2. Verifying Authorized Trading Partners Some stakeholders wanted more clarification on what would constitute adequate steps to verify that a trading partner is authorized. 3. False Transactions Stakeholders sought clarity on what constitutes a false transaction and how they should avoid false transactions. 4. Not Knowingly Alter the Transaction History 5

6 Stakeholders indicated that there was a need to clarify how to update transaction history for products when exceptions occur, such as damaged product received or shipments in partial increments. Currently, corrections to such scenarios are performed manually by updating the invoice or package slip. II. STAKEHOLDER CHALLENGES WITH COMPLIANCE In session two, challenges with compliance were discussed by workshop participants in addition to those related to the transaction information, transaction history, and transaction statement. Common issues raised include (but are not limited to) clarification of manufacturer responsibilities in regards to the use of contract manufacturers that may be the NDA or ANDA holder, or who is considered an affiliate and a co-licensed partner; verification requirements and what downstream trading partners will need to know from whom to request verification; how to handle transaction history requirements for saleable returns; grandfathering of product tracing requirements as of January 1, 2015; what dispensers should do with transaction information that they may receive from other trading partners prior to July ; and what information related to the transaction is needed for drop shipments. III. SUPPLY CHAIN OPTIONS TO MEET THE 2015 DSCSA DEADLINES Workshop participants expressed the importance for FDA to allow for flexibility in how trading partners exchange transaction information, transaction history, and transaction statements in order to meet the January and July 2015 DSCSA requirements. Many of the participants indicated that they would likely modify existing practices, processes, and systems to accommodate the information required by the DSCSA, particularly lot-level information. With regard to transaction statements, many groups suggested using short, standardized language indicating compliance with the applicable requirements of the DSCSA. To further stimulate discussion, the FDA provided participants with a list of tools to exchange transactional information, although participants were free to consider other approaches as well. The list of tools FDA generated was based on comments received in a public docket established in February 2014 to receive input on standards for the interoperable exchange of information associated with transactions involving human prescription drugs to comply with new requirements in the DSCSA. The most frequently identified tools to exchange information among trading partners were Electronic Data Interchange (EDI)/Advance Ship Notice (ASN), packing slips, web portals, Electronic Product Code Information Services (EPCIS), invoices, and . Workshop participants recognized that paper is still often used to exchange information through the supply chain, and would need to be available as an option to meet the 2015 deadlines; this is especially important for less technologically sophisticated supply chain stakeholders who may not currently transmit information electronically and cannot start doing so by However, participants could not reach agreement on how electronic and paper tools should be defined. 6

7 IV. FULLY ELECTRONIC The final breakout discussion session asked participants to explore how stakeholders can transition to fully utilizing electronic practices, processes or systems to interoperably exchange transaction information, transaction history, and transaction statements with lot-level information. Participants noted that it was important to keep multiple electronic transmission options available for stakeholders to meet DSCSA requirements. Moving to fully electronic practices would be more difficult for smaller stakeholders such as dispensers. Thus, going forward, participants thought it was important to ensure that electronic options are affordable, scalable, and generally accessible to trading partners of all size. However, participants also recognized that, over time, a gradual narrowing of electronic options would likely happen, propelled by a combination of improved or more affordable technologies, industry preference, and FDA regulation. Although moving to fully electronic, interoperable practices is not required by the DSCSA until 2023, participants suggested that FDA provide benchmarks or milestones prior to that date, allowing stakeholders enough time to develop approaches, resolve challenges, and transition smoothly. Additionally, many stakeholders noted pilots as a valuable tool for trading partners of various sizes to help identify and refine electronic options. V. OVERALL THEMES Finally, although the guidance in support of the 2015 DSCSA deadlines is not statutorily required to issue until late November 2014, participants urged the FDA to issue the guidance earlier, allowing trading partners additional time to prepare to meet the 2015 deadlines. In addition, stakeholders requested flexibility with many aspects of the elements of the transaction information, transaction history, and transaction statement, in addition to the standards for the interoperable exchange of tracing information. 7