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PHARMAGRAM January, 2010 ..an educational memo from your Pharmacy and Therapeutics Committee Switch to Iron Sucrose (Venofer®) on January 12th : Due to safety concerns, cost and formulary consistency across the OSF System, parenteral iron sucrose (Venofer®) will replace iron dextran (Imferon®) and ferric gluconate (Ferrlicit®) on the Formulary. This will become fully effective on Tuesday, January 12th . ‘Banana Bag’: Content Change and Prescribing Considerations: ‘Banana Bags’ consist of MVI, thiamine 100mg, folic acid 1mg, and magnesium in 1 liter lactated ringers. For consistency across the OSF System, the 1 gram of magnesium sulfate will change to 2 grams starting Tuesday, January 12th . Other considerations when ordering Banana Bags are: No evidence to support use for acute alcoholic intoxication. IV bags should be limited to 1000 mls per day Limit to one bag and use oral vitamins for maintenance Formulary Additions: Rufinamide (Banzel®), a new antiepileptic drug, was added to the Formulary and offers an alternative to patients refractory to other therapies. Cetirizine with pseudoephedrine (Zyrtec D®) for allergy symptoms. Saliva substitute (Entertainer’s Secret®) will replace Salivart® Formulary Deletions: Removed from the Formulary due to discontinuation or low use: Ipecac Syrup Dipivefrin (Propine®) ophthalmic Procyclidine (Kemadrin®) Starch (Anusol®) suppositories Codeine Phosphate injection Substitutions Approved: Normal saline will replace sodium bicarbonate solution used for mouth wash. Omeprazole (Prilosec®) substitution for dexlansoprazole (Kapidex®) Fluconazole 200mg single dose substitution for 150mg dose. Nitric Oxide Guidelines Approved: Guidelines were approved for the use of nitric oxide, an inhaled pulmonary vasodilator, for non-FDA approved indications. Limited use of this agent is encouraged and only when other therapies have failed. Full guidelines are available through the Respiratory Therapy Department. New Adult Neuromuscular Blockade Infusion Order Set: Developed by a critical care workgroup, a new order set for continuous neuromuscular blockade in adults was approved by the P&T Committee. Providing continuous sedation (i.e. midazolam, propofol, lorazepam) and analgesia (i.e. fentanyl, morphine, dexmedetomidine) is required as part of this protocol. Diet Drugs Prohibited from Use within the Hospital: Due to significant cardiovascular and other side effects, the following drugs are banned from use within the hospital: phentermine (Ionamin®), sibutramine (Meridia®) and orlistat (Xenical®). Unavailability of 80mg Acetaminophen: Dose Rounding Required: Since 80mg acetaminophen suppositories are no longer available, the P&T Committee approved a dose substitution of rounding doses to 40mg and 60mg and using the 120mg suppositories. PHARMAGRAM February, 2010 Educational memo from your Pharmacy and Therapeutics Committee WARNING: HYDROmorphone (Dilaudid®) Dosing: HYDROmorphone 1mg IV equals about 7mg of IV morphine! Despite a similar notice in a previous PharmaGram, the Pharmacy continues to see new orders for IV hydromorphone such as 1-2 mg every 3-4 hours prn for patients not currently receiving opioid analgesics. It is suggested that for opiate-naïve patients starting with 0.3mg of IV hydromorphone is a safe and effective dose. Doses can be adjusted based on the patient’s response to this initial dose. Also be aware that oral hydromorphone 7.5mg is approximately equivalent to 30mg of oral morphine. Drug Shortages: Our standard heparin infusion of 25,000 units in 500ml D5W is currently in short supply and unavailable. This will cause a change in the base solution from 5% dextrose to 500ml ½ Normal Saline in the same concentration. Certain propofol (Diprivan®) products were recalled due to contamination and microbial growth which created a nationwide shortage. Frensenius Propoven®, which is available on the international market, was emergently approved by the FDA for use in the US. Various neuromuscular blockers have become in short supply over the past few months. Currently there is a severe shortage of cisatracurium (Nimbex®). Supplies of rocuronium (Zemuron®) are low but adequate. Previously unavailable, vecuronium (Norcuron®) is back in stock with adequate quantities to meet current orders. Name Confusion: MucoMYST® and MuciNEX®): N-acetylcysteine (MucoMYST®) is available as: a mucolytic in nebulized form an antidote for treating acetaminophen overdoses. Acetadote® is the intravenous form N-acetylcysteine (Cerefolin NAC®) is available orally as a 600mg tablet to prevent contrast-induced renal dysfunction. Guaifenesin (MuciNEX®) 600mg tablet is an oral expectorant. In order to avoid confusion between MucoMYST® and MuciNEX® be sure to use the correct trade names or consider using the generic names. Propylthiouracil-Induced Liver Failure: Reports to the FDA indicate there are increased risks of hepatotoxicity with propylthiouracil as compared to methimazole (Tapazole®). Both drugs are indicated for the treatment of hyperthyroidism due to Graves’ disease. Healthcare providers should carefully consider which drug to initiate in a patient recently diagnosed with Graves’ disease. Drug Information Service – 655-2382 (Mon-Fri; 7 am – 3 pm) PHARMAGRAM March, 2010 Educational memo from your Pharmacy and Therapeutics Committee Two New Diet Menus Approved: St Jude Low Bacteria Diet was approved for patients with highly compromised immune systems needing to be protected from bacteria that are potentially harmful. Cystic Fibrosis Related Diabetes (CFRD) Diet provides higher energy by removing restrictions on carbohydrate and fat intake. Questions about these diets should be directed to Nutrition Services. Formulary Addition: Perflutren lipid microspheres (Definity®) was added to the Formulary for use as a contrast agent in endocardiography. A Black Box warning recommends monitoring vital signs, EKG and oxygen saturation during and at least 30 minutes after contrast administration to patients with pulmonary hypertension or unstable cardiopulmonary conditions. Perflutren is contraindicated in patients with right-to-left bi-directional or transient right-to-left cardiac shunts. Autosubstitutions Approved: Due to the unavailability of desiccated thyroid extract tablets, levothyroxine (Synthroid®) may be substituted by the pharmacist using the following dose conversion: Desiccated Thyroid 15mg Levothyroxine 25mcg 30mg 50mcg 60mg 100mcg 90mg 150mcg Orders for magnesium gluconate tablets, which are no longer available, will be substituted to the liquid dosage form. Formulary Deletion: Neomycin/polymixin GU irrigation (Neosporin GU®) was deleted from the Formulary due to low use. Dose Rounding Policy for Adults: To reduce errors and unnecessary increase in workload and drug costs resulting from unusual dose orders, the P&T Committee approved guidelines for dose rounding by a pharmacist to within 10% of the ordered dose. Revised Procedure for Cephalosporin Orders on Penicillin-Allergic Patients: A procedure change was approved for situations in which a cephalosporin antibiotic is ordered for a patient with a penicillin ‘allergy’ and the reaction is unknown. The pharmacist will now contact the prescriber for clarification. . Drug Information Service – 655-2382 (Mon-Fri; 7 am – 3 pm) PHARMAGRAM April, 2010 Educational memo from your Pharmacy and Therapeutics Committee Ordering Non-Formulary Drugs in Epic: When ordering a non-formulary medication with an auto-substitution, prescribers using Epic are encouraged to ‘Accept the Alternative’ drug therapy. Choosing to ‘continue with original order’ will necessitate following established procedures, which includes contacting the P&T Committee Chairman. Autosubstitution will still take place if the following reasons for not accepting the alternative drug therapy are chosen: v Currently taking formulary alternative v Dosage/strength form v Private pay Review of Non-Formulary Antimicrobial Drug Requests: The Chairman of the Pharmacy and Therapeutics Committee will now be assisted by the infectious disease pharmacist, Julie Giddens, in reviewing requests for non-formulary antibiotics. New Drugs Added to the Formulary: Romiplostim (NPlate®) is a once weekly injection used to treat refractory idiosyncratic thrombocytopenia (ITP). Eltrombopag (Promacta®) is an oral, once daily medication used to treat ITP. Triamcinolone acetonide ophthalmic injection (Triesence®) is a preservative-free corticosteroid used during ophthalmologic procedures. Sodium Chloride 3% Infusions: Guidelines for use of Sodium Chloride 3% were revised. This product is not intended for maintenance therapy and will have a 24-hour automatic stop, unless reordered by the physician. Use is limited to the ICU and intermediate/progressive care areas. Besides severe hyponatremia, this revised policy also addresses the use to include emergent reduction of increased (or refractory) intracranial pressure. Drugs Denied Formulary Addition: The following were not approved for Formulary addition: Polyethylene glycol (MoviPrep®) used for bowel cleansing Tolvaptan (Samsca®) used for hyponatremia Perflutren (Optison®) used for contrast in cardiology. New Policy for Subcutaneous Insulin Pumps: A new policy has been approved which addresses situations in which patients come into the hospital with an insulin pump. A physician order and signed permission are required to continue the infusion pump, which may include patient adjusted dosing. Drug Information Service – 655-2382 (Mon-Fri; 7 am – 3 pm) PHARMAGRAM May, 2010 Educational memo from your Pharmacy and Therapeutics Committee Formulary Additions: Trimethoprim, an antibiotic typically used to treat urinary tract infections, such as E. coli, and offers an alternative to patients with a sulfonamide allergy, was added to the Formulary. Rizatriptan (Maxalt®), used to treat migraine headaches, was added to the Formulary to offer a secondary alternative to sumatriptan (Imitrex®). New Therapeutic Drug Substitutions: Armodafinil (Nuvigil®) was approved as substitution for modafinil (Provigil®) in the treatment of patients with excessive sleepiness. Orders for the ophthalmic antihistamines emedastine (Emadine®), epinastine (Elestat®), olopataday (Pataday®), and azelastine (Optiva®) will be substituted to ketotifen (Refresh®, Claritin Eyes®, and others). Substitution of ceftazidime to cefepime (Maxipime®) has now been extended to all patients. Epic Reminder: ‘Accept the Alternative’ Avoids Delays: When ordering a non-formulary medication with a P&T Committee approved therapeutic alternative, prescribers using Epic are encouraged to ‘Accept the Alternative’ drug therapy. Choosing to ‘continue with original order’ will necessitate following established non-formulary procedures, which may cause delays in therapy. Substitutions will still take place if the following reasons for not accepting the alternative drug therapy are chosen: v Currently taking formulary alternative v Dosage/strength form v Private pay New Vaccine Contract Approved: Starting May 1st all of OSF will begin switching vaccine supplies to those manufactured by Sanofi® and Merck®. In addition, Gardasil® will be retained on Formulary, however Adacel® will replace Boostrix® and Rotateq® will replace Rotarix®. More detailed prescriber information will be provided in the coming weeks. Drug Information Service – 655-2382 (Mon-Fri; 7 am – 3 pm) PHARMAGRAM June, 2010 Educational memo from your Pharmacy and Therapeutics Committee Formulary Changes: IVIG and Pancreatic Enzyme Supplements: Intravenous immune gamma globulin (IVIG) (Privigen®) was added to the Formulary and will replace the lypholized Carimune® product which is being discontinued by the manufacturer. Lower IgA content and 10% stock solution are advantages with the new product. ZenPep®, Pancreaze® and Creon® are newly FDA approved oral, pancreatic enzyme supplements. These products will gradually replace the older pancrealipase agents. Because of product content similarity, Epic order entry will include the trade names to avoid inaccurate prescribing. Formulary Deletions: Dimenhydrinate (Dramamine®), senna/sucrose (X-Prep®), and gold sodium thiomalate (Myochrysine®) will be deleted from the Formulary due to low prescribing. Formulary Addition: Sitagliptin (Januvia®), which will be added to the Formulary, is indicated for the management of type 2 diabetes mellitus as an adjunct to diet and exercise as monotherapy or in combination therapy with other antidiabetic agents. Therapeutic Substitutions Approved: The following therapeutic substitutions were approved and recommended by the P&T Committee: Silodosin (Rapaflo®) substituted to tamsulosin (Flomax®) Miglitol (Glyset®) substituted to acarbose (Precose®) Furosemide Intravenous Infusions Added to Drug Matrix: The Drug Matrix, which details restrictions of parenteral drug use on each patient care unit in the medical center, now includes continuous infusions of furosemide (Lasix®). If indicated, these infusions may be administered on all patient care units. Order Set Required for Drotrecogin (Xigris®): Prescribing drotrecogin (Xigris®), which is used in severe sepsis, will require the use of an Epic order set and cannot be ordered as only the drug. This requirement is the same as prior to Epic implementation. In addition, a review of drotrecogin orders by an attending physician is required within 24 hours of the drug order. Drug Information Service – 655-2382 (Mon-Fri; 7 am – 3 pm) P H A R M A G R A M July, 2010 Educational memo from your Pharmacy and Therapeutics Committee Editor: Ed Rainville, PharmMS (655-7331) Formulary Additions: Magnesium hydroxide (Pedia-Lax®) is a laxative that comes as a watermelon flavored, chewable tablet containing 400mg of magnesium hydroxide or 170mg of elemental magnesium. Senna (Pedia-Lax Quick Dissolving Strips®) is another laxative that is available as a fast dissolving strip containing 8.6mg of sennosides with a grape flavor. Rifaximin (Xifaxan®) was approved to the Formulary for treatment of hepatic encephalopathy not responding to usual therapy. The dose for this indication is 550mg orally twice a day. Nitroglycerin Spray Restriction: Nitroglycerin spray costs over $100 more than a bottle of sublingual tablets and the only advantage may be in patients who are vomiting and cannot use the tablets. In order to control unnecessary use and expense, the spray will be limited to the Emergency Department or dispensed from the Pharmacy. Generic Drug Substitution Policy: The Medication Management policy on selecting Formulary drugs was revised to reflect the FDA’s definition of generic equivalency. Generic equivalent products have the same active ingredients, dosage forms and route(s) of administration as the brand name drugs. The FDA further states ‘…that products classified as therapeutically equivalent can be substituted with the full expectation that the substituted product will produce the same clinical effect and safety profile as the prescribed product.’ P&T Approved Drug Indications for Use is Criteria for Formulary Status per Joint Commission: Prescribing drugs for non-FDA approved indications will come under closer scrutiny based on a new Joint Commission standard. To address this, a revised Medication Management policy requires off-label drug prescribing without supportive clinical evidence of efficacy will be handled as a non-formulary drug request. Approval of the P&T Committee chairman is part of this requirement. Enalaprilat IV (Vasotec IV ®) Added to the Drug Matrix: Intravenous enalaprilat, which is the parenteral form of the ACE inhibitor enalapril and is used for blood pressure control and heart failure, may now be used on all patient care units. Information about this and other parenteral drugs and where they may be used in the Medical Center is contained in Guide to Medication Use for SFMC Clinicians (aka ‘Drug Matrix’) is located as a link on the SFMC Home Page. Drug Information Service – 655-2382 (Mon-Fri; 7 am – 3 pm) PHARMAGRAM August, 2010 Educational memo from your Pharmacy and Therapeutics Committee Formulary Additions: Letrozole (Femara®), an aromatase inhibitor used for adjunctive therapy in breast cancer treatment, was added to the Formulary. Formulary Deletions: Injectable Bicillin CR® was removed from the Formulary due to low use and product confusion with Bicillin LA®. Both Bicillin products are available in pre-filled syringes with a white-colored injectable solution. Cromolyn (Intal®) inhaler is no longer available from the manufacturer. Denied Formulary Addition: Two prothrombin complex concentrates, Profilnine® and Bebulin®, were denied addition to the Formulary due adverse prothrombotic reports and high cost. Factor VII (NovoSeven®) and various antihemophilic factor VIII products are currently available on formulary. The capsule formulation of hydrocodone and chlorpheniramine (Tussicaps®) was not added to the Formulary due to cost and current availability of an equivalent liquid Tussionex. An autosubstitution is available in Epic for this product conversion. Substitution of Immune Globulin (Gammagard 10% Liquid®) Orders: The intravenous immune globulin Privigen® was recently added to the Formulary to replace the older Carimune® product. Because Privigen 10% solution has a low IgA content, this product will now be the autosubstitution for Gammagard 10%®. The IgA content of Privigen is about one-tenth of the Gammagard 10% liquid. Note: Gammagard S/D (low IgA) ®, which is not the same as Gammagard 10% Liquid, is FDA approved for patients with antibodies to IgA. This product is currently being evaluated and is currently available by formal request only. Adverse Drug Events (ADEs) and Medication Errors Policy Revisions Approved: The Medication Management policy that addresses ADEs and medication errors has been updated to reflect current practices. Healthcare providers are encouraged to document these events in Peminic® to assist in improving product selection and future processes. Drug Information Service – 655-2382 (Mon-Fri; 7 am – 3 pm) PHARMAGRAM September, 2010 Educational memo from your Pharmacy and Therapeutics Committee Formulary Additions: Escallantide (Kalbitor®), a C-1 esterase inhibitor used for rescue treatment in patients with hereditary angioedema, was added to the Formulary. This is a recombinant product which has a black box warning regarding potential anaphylaxis. A human-derived, esterase inhibitor, (Berinert®), was denied addition to the Formulary. Formulary Deletions: Choline magnesium trisalicylate (Trilisate®) was removed from the Formulary due to low use and discontinuation by the manufacturer. Denied Formulary Addition: The following drugs were denied addition to the Formulary due a low therapeutic use for hospitalized patients: Abatacept (Orencia®) – used for adult rheumatoid or juvenile arthritis Ibandronate (Boniva®) – used for osteoporosis prevention. Zoledronic acid (Reclast®) – used for osteoporosis prevention. Changing Concentration of Liquid Ferrous Sulfate: Various manufacturers have started changing the liquid concentration of ferrous sulfate from 15mg of elemental iron per 0.6ml to 15mg per 1ml. This new concentration has been activated in Epic and is available from the Pharmacy. New Autosubstitution: Autosubstitution of ADEK® to AquADEK® was approved. The AquADEK® vitamin supplement is used by patients with cystic fibrosis and contains a higher vitamin concentration and is available in a liquid formulation. Tyramine Free Diet Restriction Removed for Linezolid (Zyvox®: Linezolid (Zyvox®) is an antibiotic effective against drug resistant gram positive bacteria and has weak MAO inhibitor properties. Due to the low tyramine content on patient menus, the diet restrictions requirement has been eliminated for linezolid, but will remain for other MAO inhibitor drugs. Mandatory Order Set: Ordering therapeutic infusions of heparin now requires the use of an order set within Epic. This requirement addresses safety concerns and meets regulatory standards. Drug Information Service – 655-2382 (Mon-Fri; 7 am – 3 pm) P H A R M A G R A M October, 2010 Educational memo from your Pharmacy and Therapeutics Committee Editor: Ed Rainville, PharmMS (655-7331) Correction to Ecallantide (Kalbitor®) Information: In the September PharmaGram, ecallantide (Kalbitor®) was described as a C-1 esterase inhibitor. Ecallantide is a recombinant protein which inhibits the conversion of high molecular weight kininogen to bradykinin by selectively and reversibly inhibiting plasma kallikrein. Unregulated bradykinin production is thought to contribute to the increased vascular permeability and angioedema observed in hereditary angioedema. Formulary Addition: Terbinafine (Lamisil®), which is an oral antifungal agent used to treat onychomycosis of the toenail or fingernail due to susceptible dermatophytes, was added to the Formulary. Dose Requirement for Titratable IV Infusions: The ‘Ordering and Transcribing’ Medication Management policy was revised. This policy now requires a minimum and maximum dose range to be specified for all continuous IV infusions. Renal Dosing of Enoxaparin by Pharmacy: Dosing guidelines for enoxaparin (Lovenox®) in patients with renal impairment were approved and will be used by the pharmacist, if needed, to adjust doses upon new order verification and upon request of the patient care provider. Oral Mucositis Treatment – Different Names, Same Ingredients: A mixture of 12.5ml diphenhydramine (Benadryl®) elixir, 90ml aluminum and magnesium hydroxide (Maalox®) and 20ml lidocaine 2% (Xylocaine®) viscous has been used as a treatment for oral mucositis. The P&T Committee has decided that whenever BMX, Magic Mouthwash or Miracle Mouthwash is ordered that this will be the approved, standardized formula to be dispensed. Autosubstitution Changes: Because of dose conversion problems in Epic, the following non-formulary autosubstitution changes will be made: Dalteparin (Fragmin®) – order as non-formulary drug Darbepoetin (Aranesp®), arformoterol (Brovana®), pirbuterol (Maxair®), albuterol sustained-release (Volmax®) – pharmacist will autosubstitute with note of the change placed in drug entry Mometasone (Nasonex®), ipratropium (Atrovent 0.3%) nasal inhalers – autosub dose will be 1 puff. Newly Revised Hazardous Drug Policy: A newly revised policy on how to handle potentially hazardous drugs has been approved. Education and in-services for nurses and other healthcare providers who administer or handle medications are currently underway. Drug Information Service – 655-2382 (Mon-Fri; 7 am – 3 pm) P H A R M A G R A M November, 2010 Educational memo from your Pharmacy and Therapeutics Committee Editor: Ed Rainville, PharmMS (655-7331) Formulary Changes: Polyvinyl alcohol 1.4% (Liquitears®, Akwa Tear®) will replace all other artificial liquid tear products. Magic Bullet® brand of bisacodyl suppositories has been removed from the Formulary. Docusate sodium for rectal administration (Enemeez Mini Enema®), sometimes used for neurogenic bowel dysfunction, was added to the Formulary. Prune supplement (Way2Go®), a laxative which is useful in St. Jude pediatric patients, was approved to the Dietary Formulary. Autosubstitution Approved: A substitution for cyclosporine ophthalmic emulsion (Restasis®), which increases tear production, to artificial tears polyvinyl alcohol (Liquitears®) was approved. Help Reduce Costs From Wasting Drugs: Cost is important when considering drug therapy. Needless drug wastage can also result in increasing the Medical Center’s drug expenses. The following are examples of some costly drugs: Dexmedetomidine (Precedex®) $129 per IV bag Immune Globulin (Privigen® $70 per gram Factor VII (NovoSeven®) $1258 per 1mg Chlorothiazide IV (Diuril IV®) $419 per 500mg Albumin 5% $36 for 5% 250ml or 25% 100ml Sound Alike / Look Alike Drugs (SALAD): Errors have been reported with the following Sound Alike / Look Alike Drugs. Pay close attention when ordering, receiving orders, and when handling these drug products. HYDROmorphone HydrOXYzine Novolin R or Novolin N Heparin 10 unit/ml HEParin SulfaSALAzine ClonIDINE Diuril Isosorbide MONOnitrate VinCRIStine ValGANCIclovir (ValCYTE) MorPHINE HydrALAzine NovoLOG Heparin 10,000 unit/ml HESpan SulfaDIAzine KlonOPIN Diamox Isosorbide DInitrate VinBLAStine ValACYclovir (ValTREX) Vaccines can cause SALAD confusion. Match middle 4 digits of NDC code in the Epic Admin Instructions with product label!. Drug Information Service – 655-2382 (Mon-Fri; 7 am – 3 pm) P H A R M A G R A M November, 2010 Educational memo from your Pharmacy and Therapeutics Committee Editor: Ed Rainville, PharmMS (655-7331) STATGRAM–PHARMAGRAM …an educational memo from your Pharmacy and Therapeutics Committee November 24, 2010 PROPOXYPHENE-CONTAINING PRODUCTS (ex. Darvocet N-100®) WITHDRAWAL FROM MARKET S: Removal of propoxyphene from the market. B: The FDA is advising health care professionals to stop prescribing propoxyphene to their patients, and patients who are currently taking the drug should contact their health care professional as soon as possible to discuss switching to another pain management therapy. Propoxyphene is an opioid used to treat mild to moderate pain. First approved by the FDA in 1957, propoxyphene is sold by prescription under various names both alone (e.g., Darvon) or in combination with acetaminophen (e.g., Darvocet). Studies have shown that, even when taken at recommended doses, propoxyphene causes significant changes to the electrical activity of the heart. These changes, which can be seen on an electrocardiogram (ECG), can increase the risk for serious abnormal heart rhythms that have been linked to serious adverse effects, including sudden death. The available data also indicate that the risk of adverse events for any particular patient (even patients who have taken the drug for many years) is subject to change based on small changes in the health status of the patient, such as dehydration, a change in medications, or decreased kidney function. A: Propoxyphene and propoxyphene containing products are being withdrawn from the market.. R: As of today, we are asking physicians to no long order and to discontinue orders for propoxyphene containing products. Pharmacists will call the prescribers of any new orders of these drugs for an alternative analgesic. Tim Miller, MD, Medical Director Jerry Storm, RPh, Pharmacy Director Ed Rainville, Pharm MS, Pharmacy Clinical Coordinator Drug Information Service – 655-2382 (Mon-Fri; 7 am – 3 pm) P H A R M A G R A M December, 2010 Educational memo from your Pharmacy and Therapeutics Committee Editor: Ed Rainville, PharmMS (655-7331) Formulary Changes: Amiloride (Midamor®) and amiloride with hydrochlorthiazide (Moduretic® were removed from the Formulary due to low use. Ketoconazole (Nizoral®) was added to the Formulary due to occasional use in treating prostatic cancer. Formulary Denial: Diclofenac potassium (Zipsor®), which comes as a liquid-filled capsule, was denied approval to the Formulary and an autosubstitution to naproxen was approved. Autosubstitution Approved: Galantamine (Razadyne®) regular-release tablets have been approved for substitution to the extended-release capsules. Ordering a Non-Formulary Drug for One-Time Use: When a non-formulary medication is needed for a patient, the prescriber needs to complete a Non-Formulary Request form and personally contact the P&T Committee Chairman. The Non-Formulary One-Time Use Request Form can be accessed by clicking on Guide to Medication Use for SFMC Clinicians located on the Right side of the SFMC Homepage. PALS can be used to reach the P&T Chairman for SFMC. High Risk Medications that Require a Double Check: The following medications are considered ‘High Risk’ and require double checking prior to administration. Ø Heparin (IV and subcutaneous) Ø Insulin (IV and subcutaneous) Ø Narcotics (IV and subcutaneous) Ø Medications that need conversion from one unit of measure to another Ø Medication infusions that need to be calculated (including PCA and Epidural) Ø Chemotherapy Ø Paralytics Ø Contrast Agents FDA Risk Evaluation and Mitigation Strategy (REMS) Requirements: The FDA, through its REMS program, mandates risk management and patient safety strategies for selected therapies. REMS has three general components that impact hospitals; medication guides, elements to assure safe use, and implementation systems. Any or all of these components may apply for a given drug, depending on the potential severity of the risks. Through the REMS program the following drugs require prescriber registration and/or providing specific information to patients: dofetilide (Tikosyn®) Atrial fibrillation/flutter fingolimod (Gilenya®) Multiple Sclerosis epoetin alpha (Epogen®, Procrit®) Anemia due to chemotherapy ecallantide (Kalbitor®) Hereditary Angioedema Drug Information Service – 655-2382 (Mon-Fri; 7 am – 3 pm)