National Pharmacy and Therapeutics Committee - Charter

Refer to:  OCPS

1. Purpose.  The purpose of the National Pharmacy and Therapeutics Committee (NPTC) is to provide a forum for perpetual evaluation and updating of the Indian Health Service (IHS) National Drug Core Formulary (NCF), in order for it to remain current and relevant to medical practice across the Indian health care system.
2. Responsibilities.  The primary responsibility of the NPTC is to ensure that the NCF remains up to date with changes in medical knowledge and practice, and provides IHS, Tribal, and Urban Indian (I/T/U) clinicians with the tools to provide evidence-based and cost-effective pharmaceutical services.  The NPTC also has evaluative and educational roles as detailed below.
   1. The NPTC:
      1. Has sole delegated authority to specify the content of the NCF.
      2. Holds regular meetings to review the NCF and to determine if any additions or deletions of drugs, or other changes need to be made to reflect current best evidence and clinical practice.
      3. Monitors the activities of the Department of Veterans Affairs (DVA) Pharmacy Benefits Management program and the Department of Defense (DoD) Pharmacoeconomic Center, so that actions taken or information provided by these groups may be immediately considered for inclusion in the NCF or for distribution to I/T/U clinicians and pharmacists.  The NPTC will look for opportunities to collaborate with the DVA and DoD, and other governmental partners.
      4. Consults, as appropriate, with IHS clinical and program specialists and other subject matter experts, to ensure that NCF content and other recommendations are consistent with existing IHS policy, best practices, and evidence-based standards of care.
      5. Develops processes to allow for formulary-related input from I/T/U clinicians and pharmacists, and for disseminating reports of NPTC activities and formulary updates to the field.
      6. Monitors the publication of disease management guidelines by expert groups (government or private), evaluates the relevance of these guidelines to I/T/U clinical practice, and distributes appropriate guidelines or commentary to I/T/U clinicians and pharmacists.
      7. Assists IHS Areas and I/T/U facilities by making its members available for training of clinicians and/or presentations to other stakeholders, on subjects such as implementation of the NCF, disease management guidelines, and pharmacy cost management.
      8. Evaluates the implementation, utilization, and effectiveness of the NCF on National, Area, and site-specific levels, and reports this information to sites, Areas, and national leadership as appropriate.
      9. Engages in ongoing self-evaluation to ensure that NPTC remains up to date with current medical practice and responsive to the needs of I/T/U health professionals.
      10. Assists the IHS Principal Pharmacy Consultant and other leaders with policy development and recommendations related to pharmacy practice and pharmaceutical cost management.
      11. Monitors adherence to the NCF by federal IHS facilities which are required to implement the NCF within their facilities.  The NPTC will work to encourage tribally-operated facilities to maximize their use of the NCF.
   2. Funding.  Funding for NPTC, including leadership positons, comes from the IHS Pharmaceutical Procurement Management Function (PPMF) fee.  The PPMF fee is assessed to IHS Pharmaceutical Prime Vendor users/stakeholders and administered by the IHS National Supply Service Center (NSSC).
   3. Membership and Officers.
      1. Officers.  The NPTC is a permanent national committee of the IHS.  Leadership of the NPTC is provided by a physician Chairperson and a pharmacist Vice-Chairperson.  In order to ensure that these individuals are able to devote necessary time to the activities of the NPTC, 25 percent of the Chairperson's salary and 100 percent of the Vice-Chairperson's salary are supported by funds allocated by NSSC from the PPMF fee.  Officers are appointed by the Chief Medical Officer of the IHS, and serve indefinite terms at the pleasure of the IHS Director.
      2. Area Representatives.  In addition to the two officers, NPTC membership includes twelve (12) Federal employees or Officers who are practicing physicians and pharmacists drawn from the ranks of federal IHS and tribally-operated Indian health care facilities.  The Committee consists of six to eight physicians and four to six pharmacists; at no time does the number of pharmacists exceed the number of physicians.  A minimum of three members represent tribally-operated facilities.  Members are nominated by IHS Area Directors and confirmed by agreement of the Chairs of the National Council of Chief Medical Officers (NCCMO) and the National Pharmacy Council (NPC), who ensure geographic and facility type diversity of the group.  Members serve for two (2) years, and may be selected for multiple terms.
      3. Adjunct Members.  Due to the interdependent cooperative relationship that the NPTC has with the IHS National Supply Service Center (NSSC) related to pharmaceutical contracting and procurement, pharmacoeconomic analysis, and pharmacy benefits management, the Director of the NSSC and the supervisor of the NSSC Pharmacy Support Branch will serve as adjunct members of the NPTC.  Adjunct members may provide feedback during NPTC formulary discussions, but will be considered a non-voting member.  Travel for attendance of adjunct members will be subject to budgetary constraints, which may necessitate participation via electronic means of communication.
   4. Partnerships.

      In developing, evaluating, and modifying the NCF, the NPTC communicates with formulary experts at the DVA and the DoD, other governmental partners, subject matter experts within and outside of IHS, and I/T/U clinicians and pharmacists. The NPTC also communicates its activities, formulary decisions, and additional recommendations to the National Council of Clinical Directors, the NPC, the NCCMO, and the National Council of Chief Clinical Consultants.

3. Requests for NCF Review.  Topics for NPTC meetings are identified by NPTC officers based upon:
   1. Requests from the field.  IHS providers may request NPTC review of a drug or drug class via the NPTC Request for Formulary Review document from the NPTC website or via direct email correspondence with NPTC leadership or a committee member.
   2. Other Government Agencies.  The NPTC officers work closely with formulary experts from the DoD, DVA, and other governmental partners and may elect to review a drug or drug class based upon the activities of these agencies.
   3. Evidence-based medicine.  The NPTC officers closely monitor the publication of new evidence, including disease management guidelines, systematic reviews and primary literature.  If the topic meets the NPTC criteria for consideration, it may be included as a NPTC meeting topic.
   4. Committee Members.  The NPTC committee members may request topics to be reviewed based upon experience at the facility or Area level.
4. Conflicts of Interest and Non-disclosure.

   It is critical for members of the NPTC to be free from potential or real conflicts of interest when making formulary decisions for the Agency.  As such, all officers, Area representatives, and adjunct members will be required to annually file a Confidential Financial Disclosure Report (OGE Form 450) and complete appropriate training as required by the Agency.  Any member with a real conflict of interest should take action to resolve the conflict, recuse themselves from decisions for which they are in conflict, or step down from their position.  In addition, members should not engage in direct contact with representatives of the pharmaceutical industry.  Adjunct members that work for the NSSC must have regular contact with pharmaceutical industry personnel in order to perform their assigned duties and, therefore, this policy does not pertain to NSSC.  All members should refrain from accepting any gift from a pharmaceutical company, including meals, books, office supplies, and sample drugs.  It is also important that all information, including pre-decisional procurement sensitive information, discussed by the NPTC be considered confidential until the meeting minutes are completed and the release of information approved by NPTC leadership.  As such, voting members, non-voting (adjunct) members, invited subject matter experts and speakers, and invited guests (other government agency representatives, pharmacy residents, students/interns, etc.) will be asked to sign a non-disclosure agreement which prevents them from releasing information discussed during the NPTC meetings until approved by NPTC leadership.

5. Meetings, Staff Support, and Budget.

   The NPTC meets three times a year, at a time and place determined by the membership.  At least one officer and six members must be present to constitute a quorum; at least half of the attendees must be physicians.  The NPTC conducts additional business between meetings by means of conference calls and electronic mail.  Costs incurred by members and invited guests attending NPTC meetings are reimbursed from funds allocated by NSSC from the PPMF fee.

6. Ad Hoc Committees and Work Groups.

   The Chair of the NPTC may appoint ad hoc committees and/or work groups as needed to achieve the goals of the Committee.  Such committees and work groups are supported as necessary from the NPTC budget.

7. Reporting.

   The Chair of the NPTC is responsible for assigning and coordinating the drafting of reports and position statements, and for representing the NPTC as requested by IHS leadership.

8. Amendments to the Charter.

   Recommendations for amendments to this Charter may be made by a majority vote of members.  Approval of changes is subject to normal approval processes for IHS directives.

9. Supersedure.

   National Pharmacy and Therapeutics Committee - Charter, approved February 20, 2004 as part of the IHS Core Drug Formulary, but not published as an IHS Circular on the Indian Health Manual website.

10. Effective Date.

    This IHS Circular is effective upon the date of signature by the Director, Indian Health Service.