Drug Therapy Committee Meeting Highlights April 2004
Volume XIV, Issue 5
Formulary Line Extension
Olanzapine (Zyprexa) IM

Approved with restrictions

Discussion

The Committee was presented with the request to add olanzapine (Zyprexa IM) injection to the Formulary. Olanzapine injection is the second injectable atypical antipsychotic on the market. It may offer an advantage over intramuscular haloperidol in the presence of extrapyramidal symptoms. It may offer some benefit in elderly patients with dementia, although it does not carry an FDA indication for dementia. Olanzapine injection may offer some benefit in the management of the acutely psychotic patient in the Acute Psychiatric Service or on the Blake 11 Inpatient Psychiatry Unit. Olanzapine injection is approximately six times the cost of haloperidol per dose.
The Committee approved the addition of olanzapine (Zyprexa IM) injection with the following restrictions: Acute Psychiatric Service and the Blake 11 Inpatient Psychiatry Unit. The Committee recommends criteria for use be developed and that the Psychiatry Department provide educational guidelines to support appropriate use of this agent.
New Business
Critical Care Guidelines Intravenous Nicardipine (Cardene)

Approved

Discussion

The Committee was presented with the intravenous nicardipine Critical Care guidelines. The Committee commented that the statement of reassessment every 15 minutes under Special Considerations needs to specify what is to be monitored and to what goal.
The Committee approved the guidelines with the above-suggested revision.
Guidelines Prophylactic Chlorhexidine 0.12% (Peridex) for Ventilator-associated Nosocomial Pneumonia (VAP)

Approved

Discussion

The Committee was presented with the Oral Care of the Acutely Ill policy for mouth care in ventilated patients. The policy includes chlorhexidine 0.12% (Peridex) 5cc twice daily in intubated patients for the prevention of VAP. A study in the American Journal of Critical Care from September 1995 discussed the use of a foam brush and elevation of the head of the bed by 30-35 degrees. Their conclusion is that oral care is needed, elevation of the head of the bed is essential and that a cleansing solution such as saline or chlorhexidine 0.12% may be beneficial. There are several ongoing randomized controlled clinical trials evaluating the efficacy of this intervention. Members of the nursing department stated that there are also some benchmarking data being collected by VHA. The Critical Care Committee has reviewed the data and signed off on the policy. Physicians are writing orders separately and would like the drug added to the ICU admission template. Although chlorhexidine has had some patterns of resistance, the ID Unit is not concerned at this point in time about the use of this drug in ventilated patients.
The Committee approved the policy with the use of chlorhexidine and will await the results of the trials and other benchmarking statistics. Should the data suggest that the intervention offers no benefit, chlorhexidine will be removed from the policy.

Pharmaceutical Representatives in Patient Care Areas

Discussion

The Committee was presented with information regarding the recent activities of representatives of a pharmaceutical company. It was identified that representatives of the company were observed in a patient care area on the day that a specific drug became available on the market. Pharmaceutical representatives are not allowed in any patient care areas. Additionally, they are not allowed to promote drugs that are not on the Formulary or in a restricted category. They have also been directly paging clinical staff, which is also not allowed. Appointments with individuals are to be made through the administrative offices of that person's service. Please refer to the following link.
The Committee asked the Pharmacy Department to address this with representatives from the company in question.
Farewell and Thank You to Katharine Treadway, MD, Chair

Approved

Discussion

The Committee was informed that Dr. Katharine Treadway will be leaving the Committee to pursue other activities. She will be working at Harvard Medical School to help with the Curriculum Committee. The Committee acknowledged Dr. Treadway's work on the Committee with a Revere Bowl and wishes her the best in the future.
The Committee accepted Dr. Treadway's resignation.
Interim DTC Chair Leadership-Theodore Stern, MD
Approved

Discussion
The Committee asked Dr. Theodore Stern to act as Interim Chair of the Drug Therapy Committee. During this time, a group coordinated by Margaret Clapp and Dr. Britain Nicholson will review candidates and make a recommendation to the Committee for a new chair. Dr. Stern accepted this responsibility.
The Committee approved Dr. Stern as the Interim Chair of the Drug Therapy Committee
Ondansetron vs. Haloperidol in PONV
Discussion

The Committee was presented with the results of a study conducted by members of the Anesthesia Department comparing the efficacy of haloperidol 1 mg versus ondansetron 4 mg intravenously in the management of post-operative nausea and vomiting (PONV). This randomized, parallel group, third-party blind design evaluated 244 adult elective surgical patients scheduled to receive general or general-regional combined anesthesia with planned PONV prophylaxis. Nausea, emesis, retching, need of rescue, amount of time in the PACU, changes in QTc intervals and sedation were evaluated. Efficacy of haloperidol 1 mg was equal to ondansetron 4 mg with respect to complete responders, nausea, emesis, and the need of rescue medication. Adverse reactions and side effects were the same in both groups. Sedation, time in the PACU, and changes in the QTc were equal in both groups.
Preliminary results suggest that haloperidol is a reasonable and less expensive alternative to ondansetron 4 mg with equivalent safety. This information will be presented at an upcoming Anesthesia Department meeting for review and proposed practice changes.
A discussion continued about the management of prolonged PONV (<24hours) with haloperidol. The use of haloperidol 1 mg as a reasonable alternative to ondansetron in these patients was discussed. Representatives of the Psychiatry Department commented on the use of haloperidol in particular age groups. Provided the patient does not have any contraindications to the drug, haloperidol 1mg IV every 6 hours as needed for PONV in patients less the 60 years of age is safe. Elderly patients, 60 - 80 years of age, could receive dosing at intervals of every 8 to 12 hours. Single doses in patients greater than 80 would be appropriate. Before pursuing changes to the post-operative templates, the Committee will await feedback from the Anesthesia Department for recommendations.
Revised Approval Procedures for IV Levofloxacin
Discussion

The Committee was presented with a recommendation to remove the requirement of the ID staff individually calling in approval for the use of intravenous levofloxacin directly to the Pharmacy. When levofloxacin was introduced to the formulary, the intravenous formulation was placed on restriction. This was a result of the fact the oral formulation has almost 100% bioavailability and the intravenous formulation is approximately five times more expensive. Based on the historical tracking of the IV to PO ratio, the Hospital has kept this ratio rather low. Intravenous levofloxacin will still require approval by the ID Service and the ID physician's name must be placed within the order entered in POE by the prescribing physician after receiving approval.
The Committee reviewed the ID approval process. The process is that the ordering physician, after speaking with the ID service, enters the name of the approving physician in the order. The Pharmacy places the name in the pharmacy computer system. Daily, a report is sent to the ID unit with all current orders and the approving ID physicians' names for review. These lists are reviewed internally with the ID Unit. A current list of the ID-restricted antifungal and antibacterial agents can be found here. The Committee approved the change in the approval process for IV levofloxacin.