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Volume II, Issue 2
April 2005
A Publication of the Department of Pharmacy
Saint Francis Hospital and Medical Center
Pharmacy Information
In this edition of
Pharmacy Information, the Formulary
changes include
revisions to the formulary which were
approved at the
DTM meetings in
January and March
2005. Additional
topics include the
approval of a policy for the use of
fentanyl infusions
outside the intensive
care unit, an update
on the Cox-2 inhibitors, and information concerning
“look-alike, soundalike” medications.
Inside this issue:
Formulary Changes
2
Drug Use Policy and
Therapeutics
3
Drug Information
Corner
3
Adverse Effects and
Medication Safety
4
Formulary Changes
DTM Meetings
January, March 2005
Additions to Formulary
Duloxetine (Cymbalta®): is a serotonin and norepinephrine reuptake inhibitor (SSNRI) approved for
the treatment of major depressive disorders and diabetic peripheral neuropathic pain. The dosage for
diabetic peripheral neuropathic pain is 60 mg daily (may start at a lower dose if 60 mg is not tolerated). The dosage for depression is 20 mg twice a day and may be titrated to the target dose of 60
mg/day (or 30 mg twice a day). It should not be prescribed for patients with severe renal impairment
(CCr < 30 ml/min) or substantial alcohol use. There are potential drug interactions with CYP1A2
inhibitors and CYP2D6 inhibitors.
Atomoxetine (Strattera®): is a selective norepinephrine reuptake inhibitor approved for the treatment
of attention deficit hyperactivity disorder (ADHD). It is approved for use in children > 6 yrs of age
and adults. In children and adolescents (6-18 yrs) and up to 70 kg body weight, the initial dose is 0.5
mg/kg/day. After at least 3 days, the dose can be increased to a target total daily dose of 1.2 mg/kg,
administered as a single daily dose in the morning or divided evenly in the morning and late afternoon/early evening. In children and adolescents > 70 kg body weight and adults, the initial dose is 40
mg/day. After a minimum of three days, the dose may be increased to a target dose of 80 mg/day administered either as a single daily dose in the morning or divided doses in the morning and late afternoon/early evening. After 2 to 4 weeks, the dose may be increased to a maximum of 100 mg/day in
patients who have not achieved an optimal response. Potential adverse effects include: decreased appetite, dizziness, headache, mood swings, tachycardia, and hypertension. Use is restricted to patients
receiving this drug prior to admission, or for new patients with documented failure to stimulant therapy.
Risperidone Long Acting Injection (Risperdal
Consta®): a long acting injectable formulation of
risperidone, indicated for the treatment of schizophrenia. It is administered every 2 weeks by
deep IM gluteal injection. The recommended
dose is 25 mg IM every 2 weeks. Use is restricted to continuation of therapy for inpatients
on the Mount Sinai Campus. Therapy may not be
initiated as an inpatient.
Papain/Urea Debriding Spray (Accuzyme®):
is indicated for debridement of necrotic tissue in
acute and chronic such as pressure ulcers, varicose and diabetic ulcers, burns, postoperative
wounds, pilonidal cyst wounds, carbuncles and
miscellaneous traumatic or infected wounds.
The spray formulation will replace the ointment
formulation, since the spray is easier to administer.
Hyaluronidase for Injection: hyaluronidase is an enzyme which hydrolyzes intercellular ground
substance. It is used in: ophthalmic surgical procedures to increase absorption of local anesthetics and
enhance sensory anesthesia, for the management of extravasations of cytotoxic medications, for hypodermoclysis to facilitate the administration of fluids or other drugs subcutaneously, and in the subcutaneous administration of urographic contrast media.
Volume II, Issue 2
A Publication of the Department of Pharmacy
Saint Francis Hospital and Medical Center
Additions to Formulary (cont’d)
Tiotropium (Spiriva®): is an orally inhaled dry powder formulation of a long-acting anticholinergic agent derived from the
chemical structure of ipratropium bromide. It is approved for the long-term, once daily maintenance treatment of bronchospasm associated with chronic obstructive pulmonary disease (COPD) including chronic bronchitis and emphysema. The recommended dose is the inhalation of the contents of one capsule (18micrograms) once daily with the HandiHaler® inhalation
device. The capsules are for inhalation only and should not be swallowed. Adverse effects may include: dry mouth, tachycardia, blurred vision and urinary retention. Tiotropium is intended for use as a maintenance therapy only, and should not be used
for an acute exacerbation.
Premetrexed (Alimta®): is an anti-folate neoplastic agent. It is indicated for use in combination with cisplatin for the treatment
of patients with malignant pleural mesothelioma whose disease is either unresectable or who are otherwise not candidates for
curative surgery. Premetrexed is also approved for use as a single agent in the treatment of locally advanced or metastatic nonsmall-cell lung cancer after one prior chemotherapy failure. Use is restricted to Medical Oncologists in the outpatient cancer
center.
Granisetron (Kytril®): is a 5-HT3 receptor antagonist indicated for the prevention of nausea and vomiting associated with chemotherapy and for prevention and treatment of post-operative nausea and vomiting. The use of granisetron is restricted to prevention of chemotherapy-induced nausea and vomiting, in the inpatient and outpatient settings. The dose is 1 mg orally for low
emetogenic potential chemotherapy or 2 mg orally for moderate-high emetogenic potential chemotherapy given one hour before
chemotherapy, or 30 mcg/kg IV push 30 minutes prior to chemotherapy. Breakthrough nausea/vomiting may be treated with
traditional anti-emetics and/or ondanseteron 4-8 mg IV every 8 hrs as needed.
Deletions from Formulary
Kaopectate® (bismuth subsalicylate): the original formulation of Kaopectate® contained kaolin and pectin. It was then reformulated and contained the adsorbent, attapulgite. It has been re-formulated once again and now contains bismuth subsalicylate.
Kaopectate® has been deleted from the formulary, however, generic bismuth subsalicylate ( Pepto-Bismol®) is still available on
formulary.
Papain/Urea Debriding Ointment (Accuzyme®): ointment
formulation deleted from formulary and replaced with spray
formulation.
Beractant (Survanta®): a lung surfactant for prevention and/
or treatment of neonatal respiratory distress syndrome.
Infasurf® (calfactant) is currently the lung surfactant available
on formulary.
Glutamine Powder (Glutasolve®): this agent is being deleted secondary to lack of use. Glutapak® (glutamine and Lactobacillus
reuteri) is currently on formulary as a nutraceutical for use in ICU patients experiencing diarrhea or known or suspected C. difficile colitis.
Page 2
Volume II, Issue 2
A Publication of the Department of Pharmacy
Saint Francis Hospital and Medical Center
Drug Use Policy and Therapeutics
Guidelines for the Use of Fentanyl Infusion Outside of the Intensive
Care Units for Adult Patients
In March 2005, the Drug Therapy Management (DTM) Committee approved guidelines for the use of fentanyl outside of the Intensive Care Unit. Fentanyl is a synthetic narcotic analgesic, in which: fentanyl 0.1 mg is approximately equivalent in analgesic activity to morphine 10 mg, hydromorphone 1.5 mg or meperidine 75 mg. Fentanyl may be prescribed in all adult inpatient areas at
Saint Francis Hospital. However, when prescribed outside of the intensive care units, it may only be prescribed by: Anesthesia Attendings, Palliative Care Attendings and Fellows, Palliative Care APRN, Critical Care Attendings, Critical Care PA, Oncology Attendings and their PA’s, Gynecology/Oncology Attendings and extenders, Emergency Department Attendings and Saint Francis
Care Hospitalists. A copy of the policy may be obtained on the Infonet.
Drug Information Corner
QUESTION: UPDATE ON COX-2 INHIBITORS
On April 7, 2005, the FDA announced several changes concerning both selective and non-selective non-steroidal anti-inflammatory
drugs (NSAID).
Selective NSAID’S:
• Valdexocib (Bextra®) – withdrawal from market as overall risks outweigh benefits. There is a lack of adequate data concerning
cardiovascular safety with the long-term use of valdecoxib, and an increased risk of adverse cardiovascular events when used
short-term following coronary bypass surgery (CABG). In addition, valdexocib was required to add a “black box warning” in
December 2004, as the product may cause life-threatening skin reactions.
• Celecoxib (Celebrex®) – addition of boxed warning required which highlights the potential for increased risk of cardiovascular
events and gastrointestinal bleeding. Also, to provide a Medication Guide for patients to increase their awareness of the potential adverse effects. When prescribing celecoxib it is important to use the lowest effective dose for the shortest duration possible.
• Rofecoxib (Vioxx®) - voluntarily withdrawn from market September 2004.
Non-Selective NSAID’s:
• All manufacturers of prescription non-selective NSAID’s, are revising their labeling to include a boxed warning concerning the
potential increased risk of cardiovascular events and gastrointestinal bleeding.
• In addition, there will be a contraindication for use in patients who have recently undergone CABG. A Medication Guide will
be provided for patients to increase their awareness of the potential for cardiovascular and gastrointestinal adverse events associated with the use of NSAID’s.
• All manufacturers of non-prescription (OTC) NSAID’s are to revise their labels to include more specific information concerning the potential cardiovascular and gastrointestinal risks. In addition, the FDA has requested the inclusion of a warning concerning potential for skin reactions.
• These warnings do not apply to aspirin, as it has clearly been shown to reduce the risk of serious adverse cardiovascular events
in certain patient populations.
Overall, patients who are at higher risk for adverse events when using NSAID’s include: patients immediately post-operative from
CABG, patients with known coronary artery disease, patients who have cerebrovascular disease (stroke, TIA’s) and patients with a
history of gastric ulcers. For more information, please refer to http://www.fda.gov/cder/drug/advisory/cox2.htm
Page 3
A Publication of the Department of Pharmacy
Saint Francis Hospital and Medical Center
Adverse Effects and Medication Safety
Look-Alike, Sound-Alike Medications
Historically, look-alike, sound-alike drug names have resulted in many serious adverse drug events. Miscommunication between
physicians, nurses, pharmacists and heath care staff can naturally occur, and the existence of look-alike, sound-alike drug names increases the likelihood of a communication breakdown which may result in a potentially disastrous consequence.
During the past decade, the Institute for Safe Medication Practices (ISMP) has regularly warned health care practitioners of specific
medication misadventures due to confusion with drug names. Also, the JCAHO has received sentinel event reports from health care
organizations describing serious adverse events related to drug name confusion.
In view of the significant patient safety concerns related to look-alike, sound-alike drug names, the JCAHO has included a new National Patient Safety Goal for 2005 which states that each hospital must, “Identify and, at a minimum, annually review a list of lookalike/sound-alike drugs used in the organization, and take action to prevent errors involving the interchange of these drugs.” Saint
Francis Hospital’s list of look-alike, sound-alike drugs, includes seventeen pairs or sets of drugs. A reference chart listing the problematic drug names, the potential errors and consequences, and specific medication safety strategies to reduce errors with these
drugs, is included as a separate handout with this edition of Pharmacy Information. The Saint Francis Hospital list of look-alike,
sound-alike drug names was reviewed and approved by the Medication Safety Committee and the Drug Therapy Management
(DTM) Committee in January 2005.
We encourage all healthcare professionals to review the list, become familiar with the drug names and to proceed with particular
caution when prescribing, dispensing, and administering any of the medications listed.
Some examples of more problematic drug names include:
Epinephrine and Ephedrine: there have been reports of serious adverse drug events when these two medications have been confused. A verbal order which is misunderstood during an operative procedure is the most frequently sited occurrence. In addition,
since these products are often stocked alphabetically in the pharmacy and in patient care areas, their close proximity can increase the
likelihood of an error.
Insulin Products: the large quantity of insulin products available with many similar sounding names, (ie., Novolog® and Novolin®,
Lantus® and lispro, Humulin® and Humalog®), may result in confusion and errors associated with the insulin products. Incorrect
prescribing, dispensing or administration of any of the insulin products could have serious consequences for the patient.
Amaryl® and Reminyl®: recently both the FDA and JCAHO have issued notices to health professionals because of adverse drug
events, including death, associated with Amaryl® and Reminyl® being confused with each other. Amaryl® (glimepiride) is an oral
antidiabetic agent, while Reminyl® (galantamine) is a medication used to treat mild to moderate dementia of Alzheimer’s disease.
Therefore, if a patient with mild to moderate dementia received Amaryl® instead of Reminyl®, the signs of severe hypoglycemia
could be misinterpreted as progressive dementia and therefore go untreated. In addition, the low dose Reminyl® tablet is 4 mg, which
is the same tablet strength as the higher dose Amaryl® tablet. It is easy to see that all of these factors can contribute to a serious
situation, with a few deaths reported in the literature.
Hespan® and heparin: these products are supplied in similar size and appearing IV bags. In addition the lettering on both products
is in red print and if located near each other they could be easily confused. This is compounded by the fact that Hespan® is usually
infused at a very rapid rate while heparin is usually infused at a slower more controlled rate. A patient receiving heparin instead of
Hespan® could have a serious bleeding episode, especially if the error occurs during or immediately following a surgical procedure.
These are a few examples of specific misadventures associated with look-alike, sound-alike medications. Please take the time to review the insert to this month’s Pharmacy Information and share the information with colleagues and staff in your area. If you identify other look-alike, sound alike medications, or have additional questions, please contact the Department of Pharmacy.
Please address all inquiries to:
Saint Francis Hospital and Medical Center
Department of Pharmacy
114 Woodland Street, Hartford, CT 06105
Phone: 860-714-4710 [email protected]