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 ongoing evaluation and updating of the Indian Health Service (IHS) National Core Formulary (NCF). This will ensure that the NCF remains 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 and reflects appropriate changes in medical knowledge and practice to provide clinicians and pharmacists within the IHS, Tribes, Tribal Organizations, and Urban Indian Organizations (I/T/U) with the tools they need 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, from the IHS Director, to specify the content of the NCF.
      2. Convenes regular meetings to review the NCF and determine whether there needs to be additions or deletions of drugs, or other changes made to reflect current best evidence and clinical practice.
      3. Monitors the activities of the United States (U.S.) Department of Veterans Affairs (DVA) Pharmacy Benefits Management program and the Department of Defense (DoD) Formulary Management Branch to ensure that any action taken, or information provided by these groups may be considered for either inclusion in the NCF or distribution to I/T/U clinicians and pharmacists. The NPTC will look for opportunities to collaborate with the DVA, the DoD, and other governmental partners.
      4. Consults as appropriate with I/T/U clinicians and pharmacists, 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 NCF-related input from I/T/U clinicians and pharmacists and reports NPTC activities and formulary updates across the Indian Health Care System.
      6. Monitors the release and 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 pharmacists and/or presentations to other stakeholders, on subjects such as implementation of the NCF, disease management guidelines, and pharmaceutical cost management.
      8. Evaluates the implementation, utilization, and effectiveness of the NCF on national, Area, and site-specific metrics and reports this information to sites, IHS Areas, and national leadership as appropriate.
      9. Conducts ongoing performance evaluations to ensure that the NPTC remains in accordance 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 facilities, operated by Tribes or Tribal Organizations, to maximize their use of the NCF.
      12. Maintains a system of pharmacovigilance with the objective of ensuring sufficient surveillance, signal detection, analysis, and intervention to improve patient clinical outcomes related to prescribing medications throughout the I/T/U.
   2. Funding.  Funding for the NPTC, including leadership positions, comes from fees derived from the IHS Pharmaceutical Procurement Management Function (PPMF). 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. The leadership of the NPTC is provided by a physician Chairperson and a pharmacist Vice-Chairperson. To ensure that these individuals can devote sufficient time to NPTC activities, 50 percent of the Chairperson's salary and 100 percent of the Vice-Chairperson's salary are supported by funds allocated by the NSSC from the PPMF fee. Officers are appointed by the IHS Chief Medical Officer (CMO) and each officer serves an indefinite term at the discretion of the IHS Director.
      2. Area Representatives. In addition to the two officers, NPTC membership includes twelve federal employees or U.S. Public Health Service Commissioned Corps Officers who are practicing physicians and pharmacists drawn from the ranks of Direct Service and tribally operated Indian health care facilities. The membership of the NPTC is comprised of six to eight physicians and four to six pharmacists. At no time will the total number of pharmacists exceed the number of physicians. At a minimum, three members represent tribally operated facilities. Members of the NPTC are nominated by IHS Area Directors and confirmed by the Chairs of the National Council of Chief Medical Officers (NCCMO) and the National Pharmacy Council (NPC). This will ensure sufficient diversity regarding geographic and facility type within the NPTC. Selected members serve for two years and may be selected for multiple terms.
      3. Adjunct Members. Due to the interdependent and cooperative nature of the relationship between the NPTC and the IHS NSSC as it pertains to pharmaceutical contracting and procurement, pharmacoeconomic analysis, and pharmacy benefits management, the NSSC Director and the supervisor of the NSSC Pharmacy Support Branch, or their designees, will serve as adjunct members of the NPTC. The NPTC Director of Pharmacovigilance will also serve as an adjunct member. Adjunct members may provide feedback during NPTC formulary discussions but will be considered non-voting members.
      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 the 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 on the following:
   1. Requests from the field. Indian Health Service clinicians and pharmacists may request a NPTC review of a drug or drug class by submitting a request by e-mail to NPTC leadership.
   2. Other Government Agencies. National Pharmacy and Therapeutics Committee officers work closely with formulary experts from the DVA, DoD, and other governmental partners. NPTC may elect to review a drug or drug class based upon the activities of these agencies.
   3. Evidence-based medicine. National Pharmacy and Therapeutics Committee 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. National Pharmacy and Therapeutics 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 NPTC members to be free from potential or actual conflicts of interest when making formulary decisions for the IHS. As such, all officers, Area representatives, and adjunct members of the NPTC will be required to annually file a Confidential Financial Disclosure Report (U.S. Office of Government Ethics Form 450) and complete appropriate training as required by the IHS. Any NPTC member with an actual conflict of interest should resolve the conflict, recuse themselves from any associated decision(s), or resign from their position. In addition, NPTC members should not have direct engagement with representatives of the pharmaceutical industry. Adjunct NPTC members who work for the NSSC must have regular contact with pharmaceutical industry personnel to perform their assigned duties. Accordingly, this policy does not pertain to NSSC. All NPTC Officers and Area Representatives will refrain from accepting any pharmaceutical company gift, including meals, books, office supplies, and sample drugs. Discussions by the NPTC, including pre decisional and procurement sensitive information, are considered confidential until the meeting minutes are completed and NPTC leadership has approved the release of the information. Accordingly, voting members, non-voting (adjunct) members, invited subject matter experts and speakers, and other invited guests will be required to sign a binding non-disclosure agreement, which prevents the release of information discussed during the NPTC meetings until approved by NPTC leadership.
5. MEETINGS, STAFF SUPPORT, and BUDGET.  
   
   The NPTC meets quarterly at a time and place determined by the membership, subject to funds availability, and approval per IHS and U.S. Department of Health and Human Services (HHS) policy. At least one officer and six members must be present to constitute a quorum and at least half of the meeting attendees must be physicians. The NPTC conducts additional business between meetings by means of conference calls and e-mail. Due to the sensitive nature of procurement information considered, all meetings convened by the NPTC are closed. Except for the IHS Director (or their designee) and the CMO (or their designee), attendance and/or participation is limited to officers, members, adjunct members, and speakers/guests invited by the NPTC officers. Costs incurred by members and invited guests attending NPTC meetings are funded by the NSSC from the PPMF fee.
6. AD HOC COMMITTEES and WORK GROUPS.  
   
   The NPTC Chairperson may appoint ad hoc committees and/or work groups, drawn from NPTC members and officers, as needed, to achieve the NPTC’s goals. Such committees and work groups are supported as necessary from the NPTC budget.
7. REPORTING.  
   
   The NPTC Chairperson is responsible for assigning and coordinating the drafting of reports and position statements, and representing the NPTC as requested by IHS leadership.
8. AMENDMENTS to the CHARTER.  
   
   A majority vote by NPTC members may make recommendations for changes to this Charter. Approval of changes is subject to standard IHS directive approval processes.
9. SUPERSEDURE.  
   
   National Pharmacy and Therapeutics Committee - Charter, approved on March 8, 2017.
10. EFFECTIVE DATE.  
    
    This Charter becomes effective on the date of signature.