Formulary Requests
Aripiprazole (Abilify): APPROVED WITH RESTRICTIONS
APPROVED FOR RED-TIER PCHI GRID
The Committee reviewed the request for the addition of aripiprazole (Abilify) to the Formulary. It was studied against haloperidol and appeared to be equally efficacious, with fewer side effects. It also has been suggested that aripiprazole is associated with less weight gain and fewer Parkinsonian effects than other medications used to treat schizophrenia and schizoaffective disorders. The drug will be made available on a per-patient basis for patients maintained on aripiprazole therapy at home. The Committee approved the addition of aripiprazole to the Formulary with the following restrictions: Inpatient Psychiatry approval for patients failing first-line therapies, patients currently maintained on this agent at home, patients experiencing prolonged QTc, or patients with increased prolactin levels on other antipsychotic medications. The Committee approved aripiprazole to be added to the red tier on the PCHI grid.
Lansoprazole granules (Prevacid) "Pediatric Only": APPROVED WITH RESTRICTIONS
The Committee reviewed the request for the addition of lansoprazole granules (Prevacid) to the Formulary. The Pedi GI group has observed that children dislike the salty, non-palatable taste of omeprazole suspension mixed in sodium bicarbonate. The pediatric pharmacy group has agreed to measure out the granules, which can effectively pass through bottle nipples for infant feeds. The Committee approved the addition of lansoprazole granules (Prevacid) with the following restrictions: for pediatric use only. The Committee also approved the deletion of omeprazole from Formulary.
Paroxetine (Paxil CR): APPROVED
APPROVED FOR YELLOW-TIER PCHI GRID
The Committee reviewed the request for paroxetine CR to be added to the Formulary. Paroxetine CR is a controlled-release product designed to dissolve further down the GI tract, thereby decreasing nausea. It is comparable to paroxetine immediate-release (IR), but contains 20% more active ingredient. In a recent study, both the IR and CR formulations exhibited equal efficacy; however, a slightly higher discontinuation rate was observed with the IR. Less nausea was exhibited with the controlled-release form during the first few weeks of therapy, but, by the second week, the rates of nausea declined in both the IR and CR groups. The Committee approved the addition of controlled-release paroxetine to the Formulary. The Committee recommends possible removal of paroxetine IR from Formulary pending SSRI utilization review in 6 months. The Committee approved paroxetine CR to be added to the yellow tier on the PCHI grid. The Committee awaits input within the next 6 months from the Department of Psychiatry regarding all SSRI usage as well as to determine whether or not to remove paroxetine IR from Formulary.
DTC Old Business
Adverse Drug Reaction (ADR) Review of Quarter 4 (July - Sept.) 2002
The Adverse Drug Reaction Review of Quarter 4 (July - Sept.) 2002 was presented to the Committee. Of note, there was an increase in the number of adverse events associated with chemotherapeutic agents. The Committee agreed that the increase in numbers is due more to diligence in reporting ADRs rather than an increased occurrence. The ADR assessment report "Possibly Avoidable Reactions" was presented to the Committee. There were two avoidable adverse events: first, a patient was given morphine with a documented codeine allergy resulting in facial swelling. Second, a patient had silver sulfadiazine (Silvadene) applied while having a documented sulfa allergy. Silvadene was not entered into the Provider Order Entry (POE) system, but was used from the floor stock supply. The patient subsequently developed a rash. The Committee thoroughly discussed and reviewed each of the possible avoidable reactions. The Committee suggests that, to increase compliance of ADR reporting, it may be beneficial to add a button on the POE system to report ADRs immediately. The Committee recommends possibly incorporating the ADR forms within the primary care physicians' offices to aid with reporting. The Adverse Drug Reaction Hotline (x6-1575) is another method of reporting.
New Medication Inhalation Policy
Antibiotics administered by aerosolization may be inadvertently inhaled by health care workers during treatment. The risk of exposure to these agents is unproven. The Committee has been informed of the draft "Antibiotics Administered by Aerosol" policy targeting the following medications: amphotericin B, colistin, and tobramycin. This policy was devised to support concerns of exposure raised by the respiratory therapy group. The literature suggests that respiratory therapists tend to have an increased incidence of respiratory issues and health problems. In-hospital data revealed an increased use of aerosolized colistin, amphotericin B, and tobramycin by cystic fibrosis patients (60% of all inhaled antimicrobials). The remaining 40% are utilized by a variety of other patients.
The hospital has performed room air sampling studies and evaluated the effect of inhaled antimicrobials in the environment. The results of the studies indicated that the exposure can be controlled. The study recommends the use of the N95 respirator for all health care providers, who should be fitted for individual size. Other recommendations include closing the room door during therapy and for 10 minutes afterwards. The Committee approved the policy with the following recommendations:
-all non-cystic fibrosis patients require ID approval
-education and cost information be provided to housestaff.
Formulary Drug Shortages
Ampicillin/sulbactam I.V. (Unasyn)
The Committee was advised that ampicillin/sulbactam (Unasyn) is now in short supply. This medication will require ID approval with a follow-up call.
Meropenem I.V. (Merrem)
The Committee was advised that meropenem is currently on national backorder. The Infectious Disease Subcommittee recommends that imipenem/cilastatin be the carbapenem of choice. The limited meropenem supplies will be reserved for documented CNS infections. The Committee approved the switch to imipenem/cilastatin for these situations.
Methylprednisolone Injection/Steroids
The Committee was advised of the nationwide shortage of methylprednisolone injection due to the lack of raw material. The drug has been removed from all Omnicell machines and pharmacy will be manufacturing syringes available in 40mg, 60mg, and 120 mg dosage strengths. The Committee recommends that any dose less than 40mg be administered orally. An exception to this will be for bone marrow transplant patients with severe esophagitis and stomatitis. Pediatrics will have individual doses prepared.
Morphine 5mg/ml x 1ml and 10mg/ml x 1 ml
The Committee was advised of the national morphine shortage. Due to the shortage of morphine 5mg/ml and 10mg/ml prefilled syringes, the hospital will convert to the 4mg/ml and 8mg/ml pre-filled syringes for all inpatient care units. The 10mg/ml x 1ml vials will be available in operating suites through the OR pharmacy. Provider order entry (POE) has been changed to include the available dosage forms. The duration of the shortage is unknown due to manufacturing problems as well as discontinuation by another manufacturer.
Formulary Deletions
Casanthranol
The Committee was informed of the FDA decision to remove all casanthranol-containing products from the market due to lack of efficacy and poor safety data. The Pharmacy has requested all template orders containing Peri-Colace be removed and replaced with senna. The Committee approved deleting all products from the Formulary after the current supply is depleted and suggests using senna in place of casanthranol.
Omeprazole
The Committee approved the deletion of omeprazole from Formulary.