Drug Therapy Committee Meeting Highlights
August 2004
Volume XIV, Issue 7

Old Business

Initiation of GP IIb/IIIa Inhibitors on the General Medical Units: Updated
Approved

Discussion
The Committee was presented with the updated version of "Initiation of GP IIb/IIIa Inhibitors on the General Medical Units". The policy describes the indications and recommendations for the use of glycoprotein IIB-IIIA inhibitors in the management of Acute Coronary Syndrome. The Committee approved the guidelines with the following suggested revisions:

The Committee approved the guidelines with the above recommendations and recommends that a Provider Order Entry template be created within POE to assist with ordering and proper administration.


Formulary Product Change Alert

Morphine 100mg/4ml and 250mg/10ml Prefilled Syringes to be Replaced with 10mg/ml (10ml) Vial: Nursing Practice Change regarding 1:1 Morphine
Approved

Discussion
The Committee was informed that the prefilled syringes are indefinitely backordered from the manufacturer. The Nursing Practice Manual states that nurses are able to make 1mg/ml intravenous morphine solutions using the 100mg/4ml or 250mg/10ml prefilled syringes only. Due to the unavailability of the prefilled syringes, pharmacists will prepare all narcotic mixes for patients on general care units. Nurses working in intensive care units or those certified to make IV's are allowed to make intravenous solutions on general care units. Currently, morphine injection in a concentration of 15mg /ml in a 20 (300mg vial) ml vial is stocked on most units. This will be replaced with a 10mg/ml 10 ml vials in order to simplify calculations.

The Committee is in agreement with the above procedural changes.


Formulary Requests

Lansoprazole (Prevacid) Injection
Approved with restrictions


Discussion
The Committee was presented with a request to add intravenous lansoprazole to the Formulary. An open-label, single-center, two-period study was conducted to evaluate the pharmacodynamics of 30 mg of intravenous lansoprazole and 30 mg of oral lansoprazole in 29 healthy subjects. The primary pharmacodynamic endpoints were pentagastrin-stimulated, maximum acid and basal acid output. Subjects received oral lansoprazole for 7 days and were then switched to intravenous lansoprazole for 7 days. Maximal acid and basal acid output were measured at baseline and 21 hours following the last oral and intravenous dose of lansoprazole.
This study demonstrated that these therapies were equivalent. Based on these results and the cost of therapy, oral proton pump inhibitor therapy should be used unless absolutely contraindicated. The use of the intravenous formulation will require approval of the GI Unit. The Pharmacy will provide a lansoprazole daily usage report to the GI Unit for review and further assessment.
The Committee approved intravenous lansoprazole with the following restrictions: treatment of documented erosive esophagitis, endoscopically-proven gastrointestinal bleeding, or documented Zollinger-Ellison Syndrome where esomeprazole cannot be administered nasogastrically or enterally and if intravenous ranitidine is contraindicated or has been documented to be inadequate to control gastric pH.


Nesiritide (Natrecor)
Approved with restrictions

Discussion
The Committee was presented with a request to add nesiritide (Natrecor) to the Formulary. Nesiritide is a recombinant human B-type natriuretic peptide, which is a cardiac hormone that regulates cardiovascular homeostasis and fluid volume during states of volume and pressure overload. Nesiritide reduces pulmonary capillary wedge pressure and improves dyspnea in patients with acute decompensated congestive heart failure. Nesiritide can cause symptomatic hypotension comparable to nitroglycerin. The duration of symptomatic hypotension with nesiritide is longer (2.2 hours versus 0.7 hour) when compared to nitroglycerin. Until more studies are available, use of nesiritide should be limited to those patients who are refractory to standard therapy. A monograph for use by the nursing staff will be provided. The Pharmacy will develop a "criteria for use" evaluation tool for ongoing review of the use of nesiritide.
The Committee approved nesiritide with the following restrictions: Restricted to heart failure patients going to transplant only who are refractory to standard therapy. A member of the Heart Failure group must approve the use of the nesiritide.


Formulary Restriction

Pegfilgrastim (Neulasta) Outpatient Use Only
Approved with restrictions

Discussion
The Committee was presented the past year's inpatient utilization of pegfilgrastim (Neulasta). A Drug Use Review revealed that the drug is being administered within 7 days of discharge 75% of the time. The pharmacoeconomic breakeven point when compared to the daily dosing of filgrastim is 8.5 days, given that pegfilgrastim is administered once per chemotherapy cycle. The Oncology/Hematology Group has endorsed restricting pegfilgrastim to outpatient use only. The pharmacy has estimated a $200,000 savings by this intervention.

The Committee has approved the following restriction to pegfilgrastim - restricted to outpatient use only.

New Business


POE Screenshot Submissions
Approved

Discussion
The Committee was presented with a request from the Pharmacy that submissions for new drugs or policies pertaining to drugs have representative Provider Order Entry (POE) screenshots submitted with the request and approved by the Drug Therapy Committee before implementing within the POE system.

The Committee is in agreement with this process. This will hopefully streamline the process and reduce turnaround time.

The Committee approved this request.


Adult Code Cart IV Medication Reference
Approved

Discussion
The Committee was presented with the 2004 Adult Code Cart Medication Reference Guidelines. The guidelines review all the medications on the code cart and incorporate ACLS Guidelines, Drug Information Handbook, and clinical practice. They will be kept on all adult code carts as a reference.

The Committee approved the guidelines.


Approval of June 2004 Minutes
Approved with modifications

Discussion
The Committee was presented the minutes of the June meeting. A concern was raised regarding the discussion of the hematopoetic growth factors. The minutes reflected limiting access via POE to erythropoetin. A recommendation was proposed that an erythropoetin COE template for myelodysplastic syndrome (MDS) be developed. Given the technological limitation of this type of intervention, a recommendation for an alternative approach was made. A pop-up screen to direct clinicians to use darbepoetin will be investigated, as there is a significant financial incentive for the hospital. Phase One of the Partners ordering process of hematopoetic products collects appropriate laboratory data to support the use of these products. Recommended dosing schemes and algorithms are the next phase of the project. Further work needs to be done to ensure a system of checks and balances to determine if clinicians are compliant with the guidelines and to assess the feasibility of appropriate inpatient and outpatient dosing.

The Committee is in agreement, and more discussion is to follow.


2004 Infectious Disease Stewardship Program Update
Approved

Discussion
The Committee was presented with information discussed at the Semi Annual Infectious Disease Subcommittee meeting of June 9, 2004. The recommendations are:


Representatives from Emergency Services expressed concern during the discussion regarding the approval process through the Emergency Department for first-time doses of certain restricted antibiotics. The Committee recommended that Emergency Service and the ID Department discuss this outside of the meeting and make recommendation at an upcoming meeting.

The Committee approved the recommendations.


NICU Dosing Card
Approved

Discussion
The Committee was presented with the 2004 Mass General Hospital for Children Neonatal (<1 month) Dosing Guidelines. The card has undergone several revisions and was vetted through several pediatric subspecialties. The card will be made available to all pediatric staff.

The Committee approved the 2004 Card.