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What is the AMCP/Dymaxium partnership?
The AMCP/Dymaxium partnership is the basis for the AMCP eDossier System, which is powered by Dymaxium Healthcare Innovations, Ltd.  AMCP and Dymaxium are working together to launch this new system and ensure that it meets the needs of stakeholders. In general, AMCP will be responsible for educational efforts and will provide guidance related to the System and its related processes. Dymaxium will be responsible for all technical, operational, administrative, R&D, and support aspects related to the System.

Does the manufacturer retain full control over who has access to their product eDossiers included on the System?
Yes, the manufacturer always retains full control over who has access to their product eDossiers. Requests for access to a product eDossier MUST originate from a health care decision maker (HCDM) in order to adhere to unsolicited request requirements. Once a request is received, the manufacturer is in control of authorizing access. Manufacturers may update access permissions as they deem appropriate.

What is the process for a decision maker to gain access to a product’s eDossier on the System?
Watch a brief video demo! A HCDM must provide a documented unsolicited request (using the System’s eRequest Tool) for any product eDossier that he/she wishes to access. A product manufacturer will review the request and determine if access to the requested product eDossier is authorized (assuming the product eDossier is available on the System). Decision makers are pre-screened by the AMCP eDossier System to verify that they are working with a health care organization and are directly involved in the formulary and/or benefit design decision making process. Manufacturers, however, follow their own internal processes to determine who will be authorized to access a specific product eDossier that is available on the System, after it is requested by a HCDM.

Does the System conform to FDA provisions governing the release of product information from a manufacturer to a requesting health care decision maker?
Yes. Together, executives from AMCP, FMCP, and Dymaxium have communicated with the FDA and incorporated feedback into the System processes. The same policies and procedures that the FDA has in place which regulate the use of hard copy dossiers prepared using the AMCP Format for Formulary Submissions pertain to eDossiers made available through the AMCP eDossier System. The System has been structured to be in strict compliance with all FDA governing provisions, including those regarding the distribution of information based on an unsolicited request.

Who is responsible for the content of eDossiers posted on the System
The manufacturer has sole responsibility for dossier content. Neither AMCP nor Dymaxium create, endorse, or review dossier content.

Is the System’s web site secure?
Yes. The AMCP eDossier System is secure. The security is comparable to that used in other industries (e.g., banking) that require protection of applications and data. Specific information related to the security of the System can be provided upon request.

What checks and balances are in place to ensure that only authorized users access product eDossiers after receipt of an unsolicited request and direct authorization by the product’s manufacturer?
HCDMs who are directly involved in making formulary and/or benefit design decisions are invited to register on the System. Each registration is individually evaluated. An employer-provided email address must be provided to register. Additionally, HCDMs are asked to provide their state license information (if applicable) during registration, which is verified by the System’s Administrators. HCDMs must also accept the Privacy Policy and Terms of Use associated with the System before they are permitted to register. These Policies and Terms provide privacy protection to the registered user, as well as, legally bind registered users to treat any information provided to them as confidential. Finally, regular checks are performed by the System to ensure that registered users remain employed by the health care company under which they originally registered. If a registered user has changed employers, he or she will not be permitted to access the System until their updated information is verified. This ensures that all HCDMs accessing the System are considered qualified users of the System. Importantly, registered users do not, by default, have access to any product eDossiers. Access to all product eDossiers occurs only after the registered HCDM submits an unsolicited request for that information AND the manufacturer of that product authorizes access to the requesting HCDM for that specific product eDossier. Even if a HCDM is qualified as a registered user on the System, each participating manufacturer follows its own internal processes to determine who will be authorized to access a specific product eDossier that is available on the System, after it is requested by a HCDM.

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