/policies/,/policies/clinical/,/policies/clinical/uwhc-clinical/,/policies/clinical/uwhc-clinical/department-specific/,/policies/clinical/uwhc-clinical/department-specific/pharmacy/,/policies/clinical/uwhc-clinical/department-specific/pharmacy/drug-policy/,

/policies/clinical/uwhc-clinical/department-specific/pharmacy/drug-policy/1321.policy

201410290

page

100

UWHC,

Policies,Clinical,UWHC Clinical,Department Specific,Pharmacy,Drug Policy

Admitting a Drug to the Formulary (13.21)

Admitting a Drug to the Formulary (13.21) - Policies, Clinical, UWHC Clinical, Department Specific, Pharmacy, Drug Policy

13.21

POLICY & PROCEDURE





Effective Date:

August 2002
⌧ Pharmacy Policy Manual
Chapter: Drug Policy
Operations Procedure Manual
Chapter:

Policy #: 13. 21

Original
⌧ Revision 4/12
Page 1
of 5
Title: Admitting a Drug to the Formulary

I. PURPOSE: To establish a uniform procedure and selection criteria for admitting a drug to the
UWHC formulary.

II. POLICY: All staff physicians and pharmacists will use the following procedure in requesting
admission of a drug to the UWHC Formulary.

III. FORM USED: UWHC Formulary Addition Request Form

IV. PROCEDURE:
A. Physicians or pharmacists interested in obtaining admission of a drug to the UWHC
formulary will:
1. Formulary Addition Request Forms are available on UConnect and can be
completed online. When completed, the forms are automatically forwarded to the
Drug Policy Program (DPP).
2. The Formulary Addition Request Form will be completed by an attending physician
or a staff pharmacist and returned to the DPP via web link. The request should
include a reasonably accurate estimation of future use and which drug(s) may be
replaced by the new addition.
a. Documentation of requests, their progress through the review process, and
final outcome will be administratively tracked via a database maintained
by the DPP staff.
b. An email acknowledgement of receipt of the formulary request will be sent
to the requestor.
B. The Pharmacy and Therapeutics Committee (P&T) is the entity with decision making
authority for adding medications to the formulary. All formulary requests will be reviewed
by P&T and agents will be added to the formulary only after committee approval,
designated by a simple majority vote. Please refer to policy 13.18 for more details regarding
the P&T Committee and its activities.
C. The hospital develops and approves criteria for selecting medications. Decisions
regarding formulary addition will be made on the basis of minimum standards of drug
efficacy and safety according to currently available evidence. Designating minimum
standards ensures that drugs that are admitted to the formulary are efficacious (evidence is
generated through well designed and executed clinical trials) and effective (positive
outcomes have been demonstrated under routine care which may be reflected in post-
marketing trials). To be considered for admission to the formulary, information from each
of the following categories will be evaluated:
1. Indications for use

POLICY & PROCEDURE





Effective Date:

August 2002
⌧ Pharmacy Policy Manual
Chapter: Drug Policy
Operations Procedure Manual
Chapter:

Policy #: 13. 21

Original
⌧ Revision 4/12
Page 2
of 5
Title: Admitting a Drug to the Formulary

a. Formulary medications are approved for all FDA approved indications and
for all uses listed in CMS-approved compendia (AHFS-DI, Clinical
Pharmacology, Drugdex, NCCN) unless otherwise specifically stated
2. Safety: contraindications, warnings, precautions, adverse reactions, and toxicity,
interactions, potential for errors and abuse, sentinel event advisories, and other risks,
etc.
3. Efficacy: optimally, the results of randomized controlled trials are available with at
least one Phase III trial included in the evaluation.
4. Effectiveness: data from Phase IV trials, or internal investigations should be
included, along with case reports if available.
5. Cost efficiency: may be evaluated through internal analysis prepared by the DPP
with published analysis providing complementary information. All analyses
provided by the pharmaceutical industry should be corroborated by DPP staff.
D. In general, AB-rated generic products will be preferred over brand-name products. Also,
single entity formulations will be preferred to combination products.
E. In general, the P&T committee will consider for formulary addition only medications that
meet the minimum standards of evidence as described above. However, under certain
circumstances, the committee may consider the addition of products that do not meet these
minimum standards. Under these circumstances, other criteria such as the uniqueness of the
product or the risk of serious negative consequences should the agent not be used, may
provide support for formulary addition. Agents that may be considered under these less
rigorous standards include, but are not limited to, dietary supplements, natural / herbal
products, medical foods to be purchased and distributed by Pharmacy, agents that were
commercially available prior to the Kefauver Harris amendment of 1962. The criteria to be
used to consider these products include:
1. The action of the agent must be biologically plausible.
2. The agent is included in standard therapy required to prevent death or substantial
morbidity (e.g., growth or developmental disability, etc).
3. The disorder being treated is sufficiently rare that suitably powered investigations of
safety and efficacy are unlikely.
4. Ethical concerns exist that limit the meaningful study of the disorder to be treated by
the agent under consideration.
5. Alternative treatments are not available.
6. The agent is associated with little risk based on historical experience or case reports.
7. The agent is manufactured by a company licensed in the USA and of good standing.
F. Drug use criteria that will guide utilization, should the medication be added to the
formulary, will also be assessed by the P&T committee when formulary addition is under
consideration. These criteria will include but not be limited to:
1. Accepted indications

POLICY & PROCEDURE





Effective Date:

August 2002
⌧ Pharmacy Policy Manual
Chapter: Drug Policy
Operations Procedure Manual
Chapter:

Policy #: 13. 21

Original
⌧ Revision 4/12
Page 3
of 5
Title: Admitting a Drug to the Formulary

2. Monitoring parameters
3. Potential populations included/excluded:
a. Pediatric
b. Pregnant
c. Breastfeeding
d. Geriatric

4. Potential restrictions:
a. Limited location
b. Limited service
c. Limited prescriber
d. Recommended dose
e. Duration of use
G. A comprehensive review prepared by the DPP staff (or by trainees under the supervision of
DPP staff) will provide the basis for all analyses and will document currently available
evidence of efficacy, safety, effectiveness, cost efficiency, uniqueness, and established need
for the agent as categorized above.
1. This document will include, but not be limited to:
a. Indications
b. Actions
c. Adverse reactions
d. Medication safety
e. Efficacy
f. Cost
2. Comparative evaluations will be conducted whenever possible, particularly when
alternative agents are currently available on the formulary. Information included in
the analysis should be derived from sources that have used sufficiently rigorous
methods and, ideally, with the potential to be graded by evidential strength.
Objective comparisons of sufficient quality but prepared by other entities are
acceptable for editing to meet this objective.
3. All information included in the comprehensive review will be evaluated prior to the
P&T review by relevant professionals. This includes, but is not limited to:
a. Physician or pharmacist requesting the drug
b. Other appropriate physicians
c. Other appropriate pharmacists
d. Nurses
e. Allied health professionals
f. Administrators

POLICY & PROCEDURE





Effective Date:

August 2002
⌧ Pharmacy Policy Manual
Chapter: Drug Policy
Operations Procedure Manual
Chapter:

Policy #: 13. 21

Original
⌧ Revision 4/12
Page 4
of 5
Title: Admitting a Drug to the Formulary

4. Review by pharmacist(s) in the area(s) where the drug will be used is particularly
emphasized. Discussion of issues pertinent to use of the proposed agent are
encouraged and DPP staff will be responsible for highlighting relevant issues,
including potential removal of agent(s) from the formulary should the requested
agent be added.
H. Professionals requesting an addition to the formulary will be invited to participate in the
discussion of the P&T Committee whenever possible. They will be informed of agenda
schedules at two junctures; first a tentative date for review will be provided when the DPP
acknowledges receipt of the request; second a notification will be sent when the review is
confirmed on the P&T agenda. The second notification will be sent no later than one week
prior to the meeting. The P&T Committee will not postpone discussion due to absence of
the requestor, even in circumstances where the DPP recommends against addition of the
medication to the formulary.
I. In collaboration with professionals reviewing the comprehensive materials, the DPP staff
will provide a recommendation to the P&T Committee as to whether the medication should
be admitted to the formulary or declined formulary status. Subsequently decision making
by the Pharmacy and Therapeutics Committee will result in one of three options:
1. Admit the medication to the formulary with no restrictions
2. Admit the medication to the formulary with restrictions as noted above
3. Do not admit the medication to the formulary
J. The decision of the P&T Committee will be publicized in the following manner:
1. Notification of the House Staff Administration Office for distribution to physicians.
2. Notification of pharmacists through the DPP.
K. DPP staff is responsible for providing adequate notification to physicians and pharmacists.
The requesting professional will be notified by email, if not present when the P&T makes its
final decision.
L. Formulary actions will be implemented through the following actions:
1. When medication is added to formulary:
a. Notification of the Purchasing Agent, computer operators, sterile
product pharmacist and ambulatory pharmacy personnel via eForm.
b. Add to the web-based formulary (per policy and procedure #13.06)
c. Add to the food-drug interaction guideline, including web-based version
of the guideline, if the product has a food-drug interaction concern.
d. Add to the hazardous drug list when medication poses increased hazard.
e. Add to the restricted drug list when medication is approved with
restrictions.
f. Medications added to the formulary with restrictions will receive special
attention in order to publicize restrictions.

POLICY & PROCEDURE





Effective Date:

August 2002
⌧ Pharmacy Policy Manual
Chapter: Drug Policy
Operations Procedure Manual
Chapter:

Policy #: 13. 21

Original
⌧ Revision 4/12
Page 5
of 5
Title: Admitting a Drug to the Formulary

2. When medication is denied formulary status, an appeal process is available.
Physicians or pharmacists that wish to appeal the decision of the P&T Committee
may do so by notifying the Secretary of the P&T Committee.
a. Reconsideration of the Committee’s decision will occur no sooner than six
(6) months following the date of the initial vote. The appeal process is not
limited to the requesting professional.
M. Drugs deleted from the UWHC formulary are typically maintained in stock for four (4)
months in order to allow time for appeal and to notify physicians and patients of the change.
N. The Drug Product Selection and Supply Committee (DPSS) may return medications to the
formulary if they have been previously removed due to lack of availability. Such action
may be taken when these agents are subsequently returned to the US market/ production.
(Refer to Pharmacy Policy 13.22 for more information on DPSS and its activities).
O. Information regarding the process for admitting a drug to the UWHC formulary can be
obtained by contacting the staff of the DPP.



Approved By: ____________________________
Director of Pharmacy Services

Date: ____________