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UW Health Pharmacy and Therapeutics Committee Organizational Policy (6.1.4)

UW Health Pharmacy and Therapeutics Committee Organizational Policy (6.1.4) - Policies, Clinical, UW Health Clinical, Medications and Pharmacy

6.1.4


UW HEALTH CLINICAL POLICY 1
Policy Title: UW Health Pharmacy and Therapeutics Committee Organizational Policy
Policy Number: 6.1.4
Category: UW Health
Type: Ambulatory and Inpatient
Effective Date: July 21, 2016

I. PURPOSE

To define the scope, authority, responsibilities, and procedures of the UW Health Pharmacy and
Therapeutics Committee (“Committee”) and its subcommittees.

II. POLICY ELEMENTS

The authority and responsibilities of the Committee are determined by the Medical Board. The Committee
provides oversight of all guidelines, policies, procedures, and delegation protocols involving the medication
use process (i.e. procurement, preparation, dispensing, ordering, administration, and monitoring) at all
UWHC and legacy UWMFDFM sites of care. This policy supplements the Medical Staff Bylaws that govern
the Committee and all other Medical Board Committees.

The Committee’s responsibilities include:
A. Formulary
i. The Committee shall maintain processes for all additions, deletions, modifications, and restrictions
to the drug formulary that maximize safe, efficient, evidence-based, rational drug use.
ii. At a minimum, drug formulary evaluation criteria will include: indication for use, effectiveness, drug
interactions, risks (potential for medication errors, abuse potential, sentinel events) and cost.
iii. The Committee reviews the complete formulary list on an annual basis to ensure continued
relevance and safety.
iv. Formulary medications are approved for all United States Food and Drug Administration-approved
indications and for all uses listed in Centers for Medicare and Medicaid Services-approved
compendia (e.g. American Hospital Formulary Service Drug Information) unless otherwise explicitly
stated.
v. The Committee shall maintain a process for the selection, approval, and procurement of
medications that are not on the formulary.
B. Adverse Drug Events
i. The Committee shall ensure the establishment processes for the reporting of medication errors,
adverse drug reactions, and drug incompatibilities with subsequent evaluation and
recommendations for medication use system improvements and or formulary changes.
C. Medication Safety
i. The Committee shall ensure the establishment of policies and procedures for the storage, ordering,
handling, dispensing, and administration of medications that pose a heighted risk of causing
significant harm or injury to patients or staff (e.g. high-alert/high-risk medications, hazardous
medications, high-risk patient populations)
D. Investigational Drugs
i. The Committee will ensure the establishment of policies and procedures for reviewing, approving,
supervising and monitoring investigational medications.
E. Drug Shortages
i. The Committee will ensure policies and procedures to address medication shortages and outages
that include the following:
a. communicating with appropriate staff and prescribers
b. developing approved substitution protocols
c. educating appropriate licensed independent practitioners, health care professionals and
staff about these protocols
d. obtaining medication in the event of a disaster
F. Medication Use Evaluation
i. The Committee will participate in quality assurance activities related to medication use structure,
processes and outcomes and make recommendations for improvement when appropriate.
G. Drug Recalls
i. The Committee will ensure that policies and processes exist to monitor drug recall or
discontinuation notifications from the Food and Drug Administration and manufactures and retrieve
those medications when recalled or discontinued for safety reasons.



UW HEALTH CLINICAL POLICY 2
Policy Title: UW Health Pharmacy and Therapeutics Committee Organizational Policy
Policy Number: 6.1.4

H. Guidelines, Policies, Procedures, Order Sets, Delegation Protocols
i. Guidelines, Policies, Procedures, Order Sets, Delegation Protocols concerning the evaluation,
selection and therapeutic use of medications used in the diagnosis, treatment and prevention of
disease are formulated by the committee according to the following method:
a. Identification of need
b. Prioritization of tasks
c. Conducting analyses
d. Making recommendations to approving bodies
e. Guiding implementation
f. Maintaining all documents with updating as necessary
g. Measuring outcomes of use
ii. The Committee will ensure the availability of up to date medication information relating to drug
interactions and information of drug therapy, side effects, toxicology, dosage, indications for use,
and routes of administration.
I. Medication Delivery Devices
i. The Committee will ensure that policies and procedure exist for the use of medication delivery
devices
ii. The Committee will provide guidance on the selection of medication delivery devices

III. PROCEDURE

A. Structure of the Committee
i. The committee is composed of actively practicing:
a. Physicians
b. Advanced Practice Providers (i.e. physician assistants, advanced practice registered
nurses)
c. Pharmacists
d. Nurses
e. Respiratory therapists
f. Dieticians
g. Administrators
h. Clinical lab personnel
i. Other health care professionals or staff that participate in the medication use process
ii. Supportive staff prepare necessary materials for the committee to perform its duties:
a. Drug Policy Program
b. Center for Clinical Knowledge Management
iii. Invited guests routinely attend meetings to present:
a. Expert opinion
b. Relevant reports
iv. Members are appointed to the Committee by the Medical Board
v. Committee minutes are taken and submitted to the Medical Board Chair for review and approval of
recommended action items at Medical Board Meetings
vi. Committee leadership is provided by:
a. Chair- physician
b. Secretary- Director of Pharmacy
c. Staff- Manager, Drug Policy Program
B. The Committee meetings are structured to optimize the fulfillment of responsibilities.
i. The Committee meets regularly on the third Thursday of every month from 1200 to 1300.
ii. The meeting is private and includes only committee members and guests that are invited at the
pleasure of the Chairperson, Secretary, or the Manager, Drug Policy Program or their designees.
Non-members may be invited to contribute specialized or unique knowledge or skills to the
evaluation process of policies, procedures, formulary decisions, or other matters addressed by the
committee.
iii. Contingency meetings may be called by the Chairperson or Secretary in emergencies as specified:
a. medication safety breaches
b. drug recalls
c. drug shortages
d. other needs as determined by the Chair



UW HEALTH CLINICAL POLICY 3
Policy Title: UW Health Pharmacy and Therapeutics Committee Organizational Policy
Policy Number: 6.1.4

iv. Meeting format is organized according to parliamentary procedure (Robert's Rules of Order, Newly
Revised) with a goal of standardizing discussion, debate, and voting.
a. Meetings are operated in a manner that ensures objectivity and credibility in decision
making thereby enhancing acceptance of and adherence to policy development.
v. Decisions are finalized by a simple majority vote among a minimal quorum.
a. A quorum, shall consist of one-third of the membership
vi. Detailed and accurate minutes of meeting transactions are transcribed and available to UW Health
staff
a. The minutes routinely specify members in attendance, absent, or excused
b. The minutes, in final format, will be forwarded from the Drug Policy Program to the Chair
and Secretary.
c. The minutes will be verified by the Chair and Secretary and approved for electronic
signature.
d. The minutes will be forwarded by the Drug Policy Program to the Medical Board with
specific notation of items requiring action by the board.
e. The minutes are maintained permanently in an electronic record.
vii. Electronic ballots may be used to facilitate consideration of straight forward, items unlikely to
require discussion.
a. Complex issues that require significant explanation or discussion are not candidates for
electronic vote.
b. Typical items eligible for electronic vote include but are not limited to: meeting minutes,
and standard reports.
c. Members will receive necessary materials for review one week prior to regularly
scheduled meetings.
d. Members will forward approval/ dissent to the Drug Policy Program no later than one day
prior to regularly scheduled meeting.
e. Voters may respond with one of two possible choices, "Approve" or "Not Approve"
f. Voters responding with "Approve" but who wish further discussion at a future meeting may
so indicate.
g. The final decision will be based on general consent (all votes must indicate approval)
h. Voting results will be reported at the next scheduled meeting.
i. Items not receiving a consensual vote will be added to the P&T agenda for discussion and
subsequent vote.
C. Meeting agendas are organized according to a pre-specified structure.
i. Each agenda will include an evaluation of:
a. Minutes from prior Committee meeting
b. Non-formulary drug request report
c. Adverse drug reactions report
d. Drug shortages report
e. Human Subjects Committee approvals
f. Anticoagulation Subcommittees minutes/report
g. Drug Product Selection and Supply Subcommittee minutes/report
h. Antimicrobial Use Subcommittee minutes/report
i. Clinic Administered and Specialty Medications Subcommittee minutes/report
j. Medication Use Evaluation Subcommittee minutes/report
k. Smart Pump Oversight Subcommittee minutes/report
l. Chemotherapy Council minutes/report
m. Medication Safety Subcommittee minutes/report
n. Breakthrough therapies when pertinent
o. Old business items
p. New business items
ii. The agenda and supplementary materials are prepared by staff in the Drug Policy Program and are
distributed to committee members in sufficient time before each meeting for them to review the
materials in a thoughtful manner.
a. Members with questions regarding agenda items are encouraged to contact the Drug
Policy Program prior to the Committee meeting.
iii. The agenda will include information pertaining to:
a. Healthcare professionals consulted in the preparation of documents or medication



UW HEALTH CLINICAL POLICY 4
Policy Title: UW Health Pharmacy and Therapeutics Committee Organizational Policy
Policy Number: 6.1.4

monographs.
b. Reports of conflict of interest by professionals requesting medications for formulary
placement.
D. Any conflict of interest encountered in decision making is systematically addressed by the committee.
i. The committee provides guidelines for reporting any/all activity which may create a potential conflict
of interest.
ii. All committee members are expected to report all activities which might create a potential conflict of
interest for decision making.
iii. Transparent assessment of conflict of interest ensures objectivity and credibility in decision making
and better acceptance or adherence to policy developed by the committee.
iv. Disclosure includes any role in any organization related to the development, production, or
marketing of medications in the previous calendar year.
a. Personal or immediate family ownership
b. Direct ownership
c. Stock holdings independent of mutual funds
d. Employment or contractual
e. Leadership positions
1. Participation on speaker's bureau
2. Board membership
3. Direct consultation
4. Expert witness
v. Principle investigator of clinical trial
vi. The disclosure of potential conflicts must be completed:
a. Annually during the month of January
b. As new interests arise or are terminated
1. Notification of any changes in relationship will be sent to the Chairperson or
Secretary of the Committee by email.
c. The nature of the relationship to the outside organization should be described in sufficient
detail to reasonably determine the extent of the involvement.
vii. Potential conflicts associated with specific agenda items will be identified by the Drug Policy
Program staff.
a. The P&T Chairperson and any affected members are notified of topics scheduled for
discussion on the agenda in question.
b. Members so identified must declare their potential conflict of interest prior to the
commencement of discussion of the agenda item.
c. Members with a conflict of interest may be allowed to participate in discussion of the
agenda item but will not be allowed to vote.
E. When formulating drug use policies for UWHC, the committee is attentive to pertinent items generated by
outside entities which influence the delivery of healthcare. These include but are not limited to the
guidelines, policies and policy changes of:
i. Professional associations
a. Medical
b. Pharmacy
c. Nursing
ii. Standard-setting organizations
a. The Joint Commission
b. National Committee for Quality Assurance (NCQA)
iii. Government agencies
a. Medicare
b. Medicaid
c. Veteran's Administration
iv. Third party payers
a. Unity
b. Blue Cross Blue Shield (BCBS)
c. WPS Health Insurance
d. Group Health Cooperative (GHC)
e. Dean Health
f. UnityPoint Health



UW HEALTH CLINICAL POLICY 5
Policy Title: UW Health Pharmacy and Therapeutics Committee Organizational Policy
Policy Number: 6.1.4

F. The Committee will maintain regular and consistent communication with other organizational committees,
councils and task forces concerned with medication use.
G. Subcommittees and Task Forces
i. The Committee will charter subcommittees in strategic high priority areas to facilitate effectiveness
and efficiency.
a. Anticoagulation Subcommittee (inpatient)
b. Anticoagulation Subcommittee (outpatient)
c. Antimicrobial Use Subcommittee
d. Breakthrough Therapy Subcommittee
e. Clinic Administered and Specialty Medications Policy Subcommittee
f. Chemotherapy Council
g. Drug Product Selection and Supply Subcommittee
h. Medication Use Evaluation Subcommittee
i. Medication Safety Subcommittee
j. Smart Pump Oversight Subcommittee minutes/report
ii. The Committee will receive and act as necessary on reports from subcommittees and task forces.
iii. The Chair may create task forces on an as-needed basis.
a. Task forces may be established permanently at the discretion of the chair
iv. Subcommittees have the authority to approve, not approve, or require full Committee review of
revisions to previously approved clinical practice guidelines, policies, protocols at the discretion of
the Committee Chair
v. Activities and actions of subcommittees are reported to the Committee and actions called out as
part of the Subcommittee report

IV. COORDINATION

Author: Manager, Drug Policy Program
Senior Management Sponsor: Chief Operating Officer
Approval committees: Pharmacy and Therapeutic Committee; UW Health Clinical Policy Committee; Medical
Board
UW Health Clinical Policy Committee Approval: May 16, 2016

UW Health is a cohesive, united and integrated academic medical enterprise comprised of several entities.
This policy applies to facilities and programs operated by the University of Wisconsin Hospital and Clinics
and the University of Wisconsin Medical Foundation, Inc., and to clinical facilities and programs
administered by the University of Wisconsin School of Medicine and Public Health. Each entity is
responsible for enforcement of this policy in relation to the facilities and programs that it operates.

V. APPROVAL

Peter Newcomer, MD
UW Health Chief Medical Officer

J. Scott McMurray, MD
Chair, UW Health Clinical Policy Committee

VI. REFERENCES

Several related policies and procedures have been developed, coordinated and maintained by the utilizing
services.
UWHC Bylaws, Rules and Regulation of the Medical Staff
Hospital Administrative Policy #8.93 Process for Approval of Patient Care Delegation Protocols

VII. REVIEW DETAILS
Version: Original
Next Revision Due: July 2019
Formerly Known as: Pharmacy departmental policy #13.18