February, 2003 Vol. 9

Description: Angiomax® (bivalirudin) is a direct thrombin inhibitor. This drug has been used in patients with unstable angina undergoing coronary angioplasty.

Decision: Add Angiomax® to the formulary only for use in patients with HIT or AT3 deficiency.

Rationale: The results of the REPLACE-2 study were reviewed by the committee. Angiomax® is intended to reduce the incidence of major bleeds during and following coronary angioplasty. The rate of major bleeds locally is already low and comparable with the results obtained in the study using bivalirudin. Although not statistically significant at this point, the early data shows a trend of increasing cardiovascular events at 30 days with Angiomax®. The drug is a good alternative for use for patients with HIT or AT3 deficiency and warranted approval for that restricted use.

Description: Zelnorm® (tegaserod maleate) is a Serotonin-4 (5HT4) receptor partial agonist. This is the only drug in its class and the only drug available for the short-term treatment of women with constipation predominant irritable bowel syndrome.

Decision: Add Zelnorm® to the formulary.

Description: Zetia® (ezetimibe) is an antihyperlipidemic agent and the only one of its type. It is a selective cholesterol absorption inhibitor indicated for the treatment of high cholesterol as monotherapy or in combination with a statin as an adjunct to diet for the reduction of elevated total cholesterol, LDL cholesterol, and apolipoprotein B.

Decision: Add Zetia® to the formulary.

Rationale: Literature reviewed by the committee showed Zetia® may reduce cholesterol by 25% when added to statin therapy. This may result in lower doses of statins and possibly a reduction in side effects.

Description: Abilify® (aripiprazole) is an atypical antipsychotic with an unknown mechanism of action. Other atypical antipsychotics on the formulary include: Clozaril® (clozapine), Zyprexa® (olanzapine), Seroquel® (quetiapine), Risperal® (riperidone), and Geodon® (ziprasidone).

Decision: Add Abilify® to the formulary.

Rationale: Patients admitted to the hospital who are stabilized on this medication could experience a loss of symptom control if the drug is not continued. In trials the drug was compared to placebo and either haloperidol or risperidone. All three drugs were found to be significantly more effective than placebo in the PANSS and CGI scales.

Request: The gastroenterologists presented a protocol for continuing use of droperidol in endoscopy. Droperidol in this setting is used as a neuroleptic analgesic to potentiate the action of meperidine or midazolam in difficult patients and is not used for its antiemetic properties.

Decision: Retain droperidol on formulary only for use under the endoscopy protocol.

Rationale: Although the risk of using droperidol still exists, the committee agreed that the risk of the alternative agent, propofol is greater. The protocol meets the requirements of the FDA guidelines given in the black box warning for droperidol. A low dose of 1.25 mg will be used, droperidol will not be given if other QT interval prolonging drugs are on board, and an ECG will be done.

The joint hospital Institutional Review Board (IRB) recently gave approval for participation in a research study called Addressing the value of primary angioplasty after combination therapy of eptifibatide (Integrilin®) monotherapy in acute myocardial infarction (Advance MI). A non-formulary drug, tenecteplase (TNKase®) will be used in randomized patients. The Joint P&T committee gave approval for use of TNKase only for patients enrolled in the study.

Pharmacies across the country continue to deal with an increasing number and severity of drug shortages. Virtually no notice is given that a drug will be put on restricted allocation or not be available at all. Every effort is made by the hospital pharmacies to find a suitable replacement. PLEASE note all pharmacy bulletins that are issued relating to drug shortages and comply with any associated requests to limit use. Conservation requests for Protonix IV® have not been successful enough and we have had several occasions of near and total outage. Therefore, effective immediately, orders for IV Protonix® will only be filled for patients with active GI bleeding who are unable to take any medications orally. Orders for all other patients will be called to the physician, requesting switch to oral Protonix® or an alternative agent.

A multidisciplinary team, including a high use physician, reviewed and revised the order form for adult TPN. Changes are intended to make the form easier to use and more informational. Changes include:

Calories contained in a standard TPN are noted, with more helpful information on the back of the form.

Allowing certain orders to be automatic rather than requiring a phone call to the physician (eg. multivitamin and trace minerals will be added daily unless the physician orders otherwise).

Infuvite® will be used instead of M.V.I-12® for the multivitamin product. Infuvite® includes 150 mcg vitamin K per dose so weekly dosing of vitamin K on Friday will be discontinued. Additional vitamin K can be ordered by physician request.

A policy, procedure, or protocol that includes any medication and that will be used by more than one physician should be reviewed by the Joint P&T Committee. The intent of this review is not to limit such practices but to assure that the medications are therapeutically appropriate, cost effective, and do not conflict with the existing formulary. Physicians and nursing staff are asked to keep this in mind when working on new or changed orders, pathways, etc. In many cases, these requests may be approved by the P&T Committee co-chairs, without full committee review. Please contact the pharmacy director at either hospital to request a review.

Clear, legible, and unambiguous orders are of paramount importance in preventing errors, particularly relating to medications. JCAHO has mandated that hospitals review the way orders are written and specifically identify dangerous abbreviation practices. A policy was written, in line with the JCAHO requirement and following the recommendations of the Institute for Safe Medical Practice (ISMP), that lists which abbreviations should not be used. The committee directed the pharmacies at both hospitals to work together to develop a notification form to send to physicians alerting them when an unapproved abbreviation is used. Six specific ordering practices will be targeted for elimination in the initial phase of this safety initiative:

A leading zero must be used in front of a decimal point (use 0.1 instead of .1).

A trailing zero must not be used following a decimal point (use 2 instead of 2.0).

Write out "units" instead of using U.

Handwritten orders must be legible.

Medication orders must be complete including name, dose, frequency/rate, and route.

A sub-committee with interdisciplinary membership from both hospitals has been working persistently on a communitywide project to improve the process of obtaining an accurate list of current patient medications. A "Medication Matters" history card inside a clear plastic sleeve has been designed for patients to record all pertinent medical history and to list all their medications, along with dose, frequency, and reason for taking. A colorful brochure explaining the importance of taking charge of your own medication record has been written and printed. Both wall posters and table displays are available announcing the project and encouraging patients to take a card, fill it out, keep it with them, and present it to every health care provider. Education plans have been devised for hospital staff as well as community pharmacies and physician office staff. The final product of over a year’s work by this team will roll into the community in April. Funding for this project was provided by Mercy Medical Center and St. Luke’s Health Care Foundation.

Physicians who want to preserve their ability to write "meds as at home" on the patient chart need to get behind this project and encourage all their patients to diligently maintain their "Medication Matters" cards.