UCSF Pharmacy & Therapeutics Committee Charter

UCSF Health and UCSF Benioff Children's Hospital | Pharmacy & Therapeutics Committee Charter 

Committee structure 

The P&T Committee is a medical staff subcommittee of the Executive Medical Board [EMB]. The committee is composed of physicians, pharmacists, nurses, and other healthcare professionals at UCSF Medical Center. 

Mission 

Promote safe, efficacious and high-value medication use across UCSF Health.  

Purpose 

The P&T Committee makes recommendations to EMB on matters related to the therapeutic use of medications and medication-containing pharmaceutical devices. Other responsibilities include, but are not limited to: 

  • Developing, maintaining, and approving changes to the UCSF Health formulary using evidence-based evaluations of efficacy, safety, and cost-effectiveness 
  • Reviewing and approving the use of medications in order sets, order panels and disease management protocols. This function may be delegated to a task force of members with expertise in the relevant clinical areas 
  • Educating the UCSF Health community about the appropriate use of medications and notifying providers about important new concerns related to a medication’s safety or availability 
  • Reviewing UCSF Health policies, protocols, and guidelines related to medication management 
  • Reviewing drug utilization patterns and health outcomes at UCSF Health towards a goal of ensuring safety, effectiveness, and high value care in accordance with formulary criteria.  
  • Reviewing the findings and recommendations from UCSF Health subcommittees 
  • Recommend pharmacy-related utilization management criteria that will promote the safety, effectiveness, and affordability of medications used in clinical settings 
  • Monitoring the results of continuous quality improvement efforts involving pharmaceutical services 

Members 

Members of the Committee are appointed by the EMB to serve two-year terms. The Committee includes 15 voting members. Ongoing membership is reviewed by the Chair in consultation with EMB on an annual basis. Membership is further dictated within the medical staff bylaws.

Responsibilities 

P&T Committee members: 

  • Review agenda and supporting materials in advance of the Committee meetings  
  • Actively participate in Committee discussions 
  • Serve in an advisory capacity to the Committee on other matters, when needed  
  • Attend at least two-thirds of the meetings and participate in any electronic voting topics 
  • Maintain high ethical and professional standards 

Voting 

  • All business of the Committee shall be transacted by a motion, which requires a second.  Discussion and deliberation of each agenda item occurs during the Committee meeting
  • Following the P&T Committee meeting, each voting recommendation as finalized by the Committee will be sent out for an eVote. Members will have a minimum of three days to vote on the recommendation(s)
  • Each member of the Committee shall have one vote on each matter submitted to a vote of the Committee
  • All appointed medical staff members have voting privileges, provided they are in attendance, including the Chair or the Chair’s representative, and the Secretary. Advanced health professionals may have voting rights if appointed by EMB with voting rights
  • Resource members of the Committee are not voting members
  • A quorum (one-third of the Committee) is required for the meeting to adjourn
  • When a member must recuse him or herself from acting on a matter, that person will not be counted for purposes of determining a quorum
  • Member(s) who have recused themselves from acting on a matter and the physician championing that request will not be present during the deliberation and vote
  • Members must be present to vote on each matter submitted for a vote. A member will be considered present if they attend in person, or by telephone via teleconference or similar method of communication
  • A motion requires the approval of one-third of the Committee

Conflict of Interest and Financial Disclosure 

All voting members must disclose any and all, real, potential and perceived material conflicts, including direct family member employment. Conflicts may include but are not limited to, holding stocks (excluding mutual funds), options, and other involvement with a pharmaceutical company, or other organization.   

All voting members are asked to complete a conflict-of-interest disclosure and a financial disclosure form once yearly during their two-year term. Please contact the Formulary Coordinator, [email protected] to obtain the conflict-of-interest disclosure form.

Any voting member with a conflict of interest is asked to abstain from voting; the member may contribute to the discussion provided that they disclose their conflict before discussing the matter before the committee. 

Subcommittees of P&T 

The Chair of the Committee shall appoint subcommittees as required to accomplish the work of the Committee. The subcommittees shall report their recommendations to the full Committee for consideration based on an agreed-upon timeline. 

  • Antimicrobial 
  • Antithrombotic and Hemostasis  
  • Dietary/Nutrition Services (requests are ad hoc)  
  • Medication Safety 
  • Medication Value Analysis Committee  
  • Oncology 
  • Pediatrics Medication Review Committee
  • Pharmacogenomics 

Formulary Principles 

  • Medications are added to the formulary based on the strength of the scientific evidence and current standards of practice 
  • Formulary management is an established methodology that maximizes cost-effective therapy, enhances quality of care, and improves patient safety 
  • Formulary decisions are based on thorough evaluation of the benefits, risks and potential outcomes for patients; risks encompass adverse drug events (adverse drug reactions and medication errors, including those caused by confusing product names or labels) 
  • Generic medication substitution, the use of biosimilars and therapeutic interchange programs are implemented when clinically appropriate and when there is authorization based upon written guidelines or protocols within a formulary system 
  • Medications added to formulary are evaluated for their cost-effectiveness, reimbursement and acquisition costs 
  • UCSF Health has one medication formulary 
  • An adequate supply of formulary medications will be stocked and maintained to meet patient care requirements with consideration of drug cost and frequency of use 
  • Formulary medication orders are properly built within the Electronic Health Record (EHR) so as to minimize medication errors during the ordering, verification, dispensing, administration and monitoring processes 
  • UCSF treatment protocols, pathways, order sets, order panels and guidelines contain only formulary medications 
  • Only formulary medications are stored within automated dispensing cabinets, e.g., Pyxis® or equivalent 
  • Formulary maintenance allows for streamlined medication purchasing by reducing unnecessary inventory and duplication 

Formulary Coordinator Responsibilities 

  • Provides leadership, direction, organization, planning, and implementation of the formulary management program 
  • Determines the P&T committee meeting agenda(s) in collaboration with the Chair 
  • Disseminates scientific, clinical and health economic information and materials for P&T committee member review 
  • Analyzes economic factors, such as drug pricing, and emerging trends 
  • Conducts follow-up research when necessary 
  • Communicates P&T committee decisions to health care professionals as appropriate 
  • Communicates with operations leaders to implement changes to the formulary 
  • Collaborates with pharmacist clinical content champion to submit requests for EPIC builds and ticket submissions as appropriate 
  • Oversees the submission and posting of guidelines/protocols to Carelinks 

Requests for Consideration 

To allow adequate review and budgeting of full agenda items, all requests for consideration by the Committee must be received at least two weeks in advance of the meeting. Any requests that do not meet the timelines outlined below will be considered for discussion at a time that the agenda will allow. 

All requests must include the following: 

1. A brief summary of the proposal and any supportive written documentation 

2. Champion or contact person(s) for follow-up 

3. Name of person(s) who will attend the meeting to present or support the request  

All materials must follow standard templates to be considered for presentation. Items not in the requisite format may not be accepted for presentation.  

Drug Formulary Addition Requests  

New Drug Requests 

Requests for drug formulary consideration must be submitted via completion of a Formulary Addition Request form.

Policies/Procedures/Guidelines/Protocols 

Requests for other agenda items, (policies/procedures, guidelines, protocols) must be submitted directly to the formulary coordinator and Carelinks portal.  

The formulary coordinator in discussion with the Chair will consider the request and will determine the timeline for consideration by the committee. The Committee may decline to review a request at the discretion of the Chair and Secretary (e.g., insufficient clinical evidence, non-FDA approved product). The Committee analyst will notify the clinician requesting the review of the proposal’s status or proposed date of review. 

Any UCSF Health clinician may request a drug be considered for formulary addition. Pharmaceutical representatives are prohibited from requesting a drug be considered for formulary consideration. 

Formulary decisions are made based on the following principles:  

  • Medications are added to the formulary based on the strength of scientific evidence and current standards of practice 
  • Formulary management is an established methodology that maximizes cost-effective therapy, enhances the quality of care, and improves outcomes while maintaining patient safety 
  • Formulary decisions are based on thorough evaluation of the benefits, risks and potential outcomes for patients; risks include adverse drug events (adverse drug reactions and medication errors, including those caused by confusing product names or labels) 
  • Generic medication substitution including the use of biosimilars and therapeutic interchange programs are implemented when clinically appropriate and when there is authorization based upon written guidelines or protocols within a formulary system 
  • Medications added to formulary are evaluated for their cost-effectiveness, reimbursement and acquisition costs and consideration of the total cost of care 
  • Medication procurement and use follow regulatory requirements and established government or private payer requirements 
  • The following formulary categories may be used to meet patient care and regulatory requirements.  
    • Formulary, stocked  
    • Formulary, not stocked (or not consistently stocked)  
    • Formulary, restricted  
      • Confirmation of benefits or coverage prior to use 
      • Site of care 
    • Non-Formulary, not stocked 

Formulary definitions 

Formulary: Medications that can be prescribed by a valid provider without having to designate a special justification.   

Non-formulary: Medications that are not readily available in the hospital and can only be prescribed with a valid reason via the non-formulary procedure.  

Formulary - Not Stocked: Medications that can be prescribed without having to designate a special justification but is only procured pursuant to an order or prescriber request.   

Formulary - Restricted: Formulary medications can be prescribed based on predetermined restrictions (designated providers, specific condition(s)/diagnosis, specific areas of care/services, or as specified by the P&T committee). Restricted formulary medications used outside the approved criteria are considered non-formulary.  

Formulary - Requirement for confirmation of benefits or coverage prior to use: Medications that can be prescribed without having to designate a special justification but coverage of medication by insurer or other payment source must be obtained prior to medication being dispensed.  

Formulary - Site of Care, stocked: Medications that can be prescribed without having to designate a special justification but only in outpatient locations. Inpatient use of medication is considered non-formulary.  

Non-Formulary, Not stocked: Medications that are not on formulary and are prohibited from being ordered or stored in the medical center unless reviewed and approved by the Pharmacy & Therapeutics chairperson or their designee. 

  • Once a given medication or medication-containing device is approved, the Department of Pharmaceutical Services determines which strengths and/or dosage forms to maintain in inventory to reduce unnecessary inventory and waste
  • Formulary medication orders are properly built within the EHR so as to minimize medication errors during the ordering, verification, dispensing, administration and monitoring processes
  • Only formulary medications are contained in UCSF Health treatment protocols, pathways, policies, order sets, order panels, and guidelines
  • Only formulary medications are stored within automated dispensing cabinets (i.e.i.e., Pyxis® or equivalent) 

Formulary Line Extensions 

Formulary line extensions that are cost-neutral with equivalent safety and efficacy. Changes to existing formulary items require approval by the P&T committee via the Consent Agenda. These include pharmacy administrative approval of new formulations of existing formulary medications or conversion between similar products. These determinations will be made at the discretion of the formulary coordinator [or their designee] and the Chair. 

Medication Use Evaluation Considerations  

Medication Use Evaluations (MUEs) are performed to ensure continued medication safety. MUEs are typically performed for new formulary items 6 to 12 months after addition depending on utilization and safety. MUEs may also be performed in response to safety, effectiveness, or utilization concerns and will evaluate: 

  • Safety 
  • Real-world effectiveness and health outcomes associated with therapy, as available 
  • Use relative to formulary approval criteria and anticipated impact  
  • Costs (expected vs. actual) with consideration of the total cost of care, as available  

Policy and Procedure Guideline Considerations 

New or modified medication-related policies, protocols or guidelines shall be presented for approval by the Committee. For inclusion on the agenda, final materials must be submitted two weeks before the Committee meeting and must include notation of any additional approvals, approval dates, and owners. Modified policies, procedures or guidelines should be shared as a final version and one with modifications clearly indicated within. Policies and Procedures are subsequently approved by the Policy Steering Committee.  

Procedures 

Meeting Time and Location 

The Committee meets once monthly, on the second Wednesday of every month from 12:05 pm to 1:30 pm.

Notice of meetings is sent to members of the Committee via electronic mail at least two days prior to the meeting. The notice includes the date, time, location and agenda items along with supporting documents. 

Agenda and Materials 

The Committee agenda will be shared on behalf of the Chair and includes notification of completed voting approvals and meeting minutes, consent agenda items and full agenda items to be presented.  

Consent Agenda 

The consent agenda is determined by the Chair and formulary coordinator and consists of routine approvals, minor updates, or topics that are limited in scope and are not anticipated to require discussion by the full committee. Examples include medication-containing guidelines, policies and protocols, smart pump medication library updates or look-alike-sound-alike lists. Sponsors for consent agenda materials are not required to present these items live during a P&T meeting; they are required to attend the committee meeting at the start of the meeting in the event there are questions about the item in question.   

Electronic Voting Topics 

The Chair and the formulary coordinator review which topics are eligible for electronic voting. Medication-related voting decisions are sent when there is a timely need for approval and when the item(s) do not require committee deliberation.  

Minutes  

The Chair, the formulary coordinator or their designee shall prepare minutes of the proceedings of all Committee meetings, including the date, time, place, members present or absent, and action taken. A copy of the minutes of each meeting of the Committee shall be transmitted to each Committee member for review for approval. The minutes shall not be considered official unless and until approved by the Committee. The Committee meeting minutes are confidential and protected from legal discovery under UCSF Health evidence codes. 

Newsletter 

All P&T-approved medication-related changes are communicated to the campus community in a newsletter format via email listservs. In addition, formulary information is updated in Lexicomp and within the electronic health record on a monthly basis.

Annual Report 

An annual report is prepared to summarize the Committee actions from the prior year and their anticipated budget impact.