|Guideline Watch | GENERAL MEDICINE, INFECTIOUS DISEASES |
January 11, 2018
|David J. Amrol, MD reviewing Greenhawt M et al. Ann Allergy Asthma Immunol 2018 Jan . |
All available flu vaccines are safe in all egg-allergic patients.
Sponsoring Organizations: American Academy of Allergy, Asthma, and Immunology (AAAAI); American College of Allergy, Asthma, and Immunology (ACAAI)
Target Audience: All providers who administer influenza vaccines
Historically, patients with egg allergy have been told to avoid flu vaccines, because most flu vaccines are produced in embryonated chicken eggs; the concern was that a vaccine might contain residual egg protein, which could lead to anaphylaxis. Many studies have shown that flu vaccines are safe for egg-allergic patients, but many physicians still have been hesitant to vaccinate such patients. This updated practice parameter incorporates recent data on flu vaccine safety in egg-allergic patients, including children.
|Editor Disclosures at Time of Publication |
Disclosures for David J. Amrol, MD at time of publication
There is a nationwide shortage on DOBUTamine 500 mg/250 mL IVPB. At present consumption, we expect CHS has about a 12 day supply. We may continue to receive backordered quantity, but we cannot rely on this. Please be aware of this shortage and consider alternatives as our supply depletes.
Alan Mader, PharmD, BCPS
Department of Pharmacy Services
Centegra Health System
Morphine Injection Shortage 10.18.2017
There is a nationwide shortage of morphine injection that expected to last until early to mid-November. The Pharmacy Department is running very low on supply and expects that the drug will become unavailable. Please consider ordering an alternate injection product for pain management. An opioid dose conversion chart is included below for your convenience.
Oral: Parenteral Ratio
Oral Morphine: Analgesic Ratio
|Morphine||30 mg||10 mg||3 : 1||1 : 1||4 – 6 hrs||3 hrs|
|Oxycodone||20 mg||—||—||1.5 : 1||3 – 5 hrs||4 – 5 hrs|
|Hydromorphone||7.5 mg||2 mg||4: 1||4: 1||3 – 4 hrs||2 – 3 hrs|
|Fentanyl||—||100 mcg||—||See Table B on page 2||1 hr||3 – 12 hrs|
|Methadone||20 mg||10 mg||2 : 1||See Table C on page 2||4 – 12 hrs||15 – 50 hrs|
|Codeine||200 mg||130 mg||1.5 : 1||1 : 7||4 – 6 hrs||3 hrs|
|Hydrocodone||30 mg||—||—||1 : 1||3 – 6 hrs||3 – 4 hrs|
|Meperidine||300 mg||75 mg||4 : 1||1 : 10||2 – 4 hrs||2 – 3 hrs|
|Nalbuphine||—||10 mg||—||1 : 1||3 – 6 hrs||5 hrs|
Starting at 00:00 on Monday, October 2, 2017, the PTT Goal Range for patients at all Centegra hospital campuses will be 45 to 70, with alerts being triggered for values greater than 100.
All “Per Pharmacy Heparin” will be adjusted to the new range with PTT draws after this time.
From: Dima Awad, PharmD, MS, System Director of Pharmacy Services
Date: August 31, 2017
Re: D5W/0.45% NS Shortage
We are experiencing a shortage in D5W/0.45% NS.
Medications including IV fluid shortages keep occurring at great frequency, this situation has been worsening over the past several years due to multiple factors such as fewer suppliers, inability to acquire active ingredients, issues with packaging and more.
Currently, Pharmacy services has a 1 day supply of D5W/0.45% NS. When the current supply of D5W/0.45% NS becomes depleted, a plan for automatic substitution needs to be implemented. This is not a new workflow nor is it a change in practice in case of shortages.
When supply becomes depleted, Pharmacy services will initiate substitution with D5W/0.225% NS, to be administered at same infusion rate that was ordered. Pharmacy services will place “Substituted for D5W/0.45% NS” in the comment section of the Paragon order so that nursing is aware of the change. This substitution has been approved by The Pharmacy and Therapeutics Committee. Pharmacy will also maintain vigil on availability of D5W/0.225%, as we anticipate that increased use will decrease supply.
Keytruda (pembrolizumab) in Patients with Multiple Myeloma: FDA Statement – Two Clinical Trials on Hold
ISSUE: Based on data from two recently halted clinical trials, the U.S. Food and Drug Administration today is issuing this statement to inform the public, health care professionals, and oncology clinical investigators about the risks associated with the use of Keytruda (pembrolizumab) in combination with dexamethasone and an immunomodulatory agent (lenalidomide or pomalidomide) for the treatment of patients with multiple myeloma. Keytruda (pembrolizumab) is not approved for treatment of multiple myeloma.
The FDA statement is based on review of data from two clinical trials (KEYNOTE-183 and KEYNOTE-185) evaluating the use of Keytruda (pembrolizumab) combined with other treatments in patients with multiple myeloma. On July 3, 2017, the FDA required that all patients in these trials be discontinued from further investigation with this drug, because interim results from both trials demonstrated an increased risk of death for patients receiving Keytruda (pembrolizumab) when it was combined with an immunomodulatory agent as compared to the control group (see statistical analysis section below). Merck & Co., Inc. was made aware of the issue through an external data monitoring committee recommendation and suspended the trials to enrollment on June 12, 2017. Continue reading
Pharmacy Services has subscribed to Johns Hopkins ABX Guide for use by all associates at Centegra Health System to support our multidisciplinary approach to the Antimicrobial Stewardship Program Clinical Decision Support Tools and Education
Johns Hopkins ABX Guide is a comprehensive web source that provides regularly updated, evidence-based decision resources regarding antibiotics, diagnosis, pathogens, management of infections and vaccines.
Prior to the Guide, CHS did not have a specific detailed resource for antibiotics clinical decision support.
Johns Hopkins ABX Guide may be accessed through Unbound Medicine’s uCentral as follows:
- Click link https://www.unboundmedicine.com/ucentral
- This link allows both mobile and desktop access
- Creation of a username and password are necessary
The following will no longer be available for use at CHS:
- QUAD Strength NorEPINEPHrine
- QUAD Strength Phenylephrine
Alan Mader, PharmD, BCPS, Pharmacy Clinical Coordinator 815-759-4407
[4-20-2017] The Food and Drug Administration (FDA) is restricting the use of codeine and tramadol medicines in children. Codeine is approved to treat pain and cough, and tramadol is approved to treat pain. These medicines carry serious risks, including slowed or difficult breathing and death, which appear to be a greater risk in children younger than 12 years, and should not be used in these children. These medicines should also be limited in some older children. Single-ingredient codeine and all tramadol-containing products are FDA-approved only for use in adults. We are also recommending against the use of codeine and tramadol medicines in breastfeeding mothers due to possible harm to their infants. Continue reading
MedWatch – The FDA Safety Information and Adverse Event Reporting Program
Canagliflozin (Invokana, Invokamet): Drug Safety Communication – Increased Risk of Leg and Foot Amputations
AUDIENCE: Internal Medicine, Family Practice, Pharmacy, Patient
ISSUE: Based on new data from two large clinical trials, the FDA has concluded that the type 2 diabetes medicine canagliflozin (Invokana, Invokamet, Invokamet XR) causes an increased risk of leg and foot amputations. FDA is requiring new warnings, including the most prominent Boxed Warning, to be added to the canagliflozin drug labels to describe this risk.
Final results from two clinical trials – the CANVAS (Canagliflozin Cardiovascular Assessment Study) and CANVAS-R (A Study of the Effects of Canagliflozin on Renal Endpoints in Adult Participants With Type 2 Diabetes Mellitus) – showed that leg and foot amputations occurred about twice as often in patients treated with canagliflozin compared to patients treated with placebo, which is an inactive treatment. Amputations of the toe and middle of the foot were the most common; however, amputations involving the leg, below and above the knee, also occurred. Some patients had more than one amputation, some involving both limbs. See the FDA Drug Safety Communication for additional information, including a data summary.
BACKGROUND: This information is an update to the May 18, 2016 MedWatch safety alert. Canagliflozin is a prescription medicine used with diet and exercise to lower blood sugar in adults with type 2 diabetes. It belongs to a class of drugs called sodium-glucose cotransporter-2 (SGLT2) inhibitors. Canagliflozin lowers blood sugar by causing the kidneys to remove sugar from the body through the urine. It is available as a single-ingredient product under the brand name Invokana and also in combination with the diabetes medicine metformin under the brand name Invokamet.
RECOMMENDATION: Patients taking canagliflozin should notify your health care professionals right away if you develop new pain or tenderness, sores or ulcers, or infections in your legs or feet. Talk to your health care professional if you have questions or concerns. Do not stop taking your diabetes medicine without first talking to your health care professional.
Health care professionals should, before starting canagliflozin, consider factors that may predispose patients to the need for amputations. These factors include a history of prior amputation, peripheral vascular disease, neuropathy, and diabetic foot ulcers. Monitor patients receiving canagliflozin for the signs and symptoms described above and discontinue canagliflozin if these complications occur.
Healthcare professionals and patients are encouraged to report adverse events or side effects related to the use of these products to the FDA’s MedWatch Safety Information and Adverse Event Reporting Program:
• Complete and submit the report Online: www.fda.gov/MedWatch/report
• Download form or call 1-800-332-1088 to request a reporting form, then complete and return to the address on the pre-addressed form, or submit by fax to 1-800-FDA-0178
Read the MedWatch safety alert, including a link to the FDA Drug Safety Communication, at:
You are encouraged to report all serious adverse events and product quality problems to FDA MedWatch at www.fda.gov/medwatch/report.htm
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