Author Archives: Caryn Beck

Johns Hopkins ABX Guides

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:

QUAD Strength Vasopressors

The following will no longer be available for use at CHS:

  • QUAD Strength NorEPINEPHrine
  • QUAD Strength Phenylephrine

Thank you,

Alan Mader, PharmD, BCPS, Pharmacy Clinical Coordinator  815-759-4407

FDA DRUG SAFETY COMMUNICATION: FDA restricts use of prescription codeine pain and cough medicines and tramadol pain medicines in children; recommends against use in breastfeeding women

Safety Announcement
[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

FDA MedWatch – Canagliflozin (INVOKANA, INVOKAMET)

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:
https://www.fda.gov/Safety/MedWatch/SafetyInformation/SafetyAlertsforHumanMedicalProducts/ucm558605.htm
________________________________________
You are encouraged to report all serious adverse events and product quality problems to FDA MedWatch at www.fda.gov/medwatch/report.htm
Follow MedWatch on Twitter
Update your subscriptions, modify your e-mail address, or stop subscriptions at any time on your Subscriber Preferences Page. You will need to use your email address to log in. If you have questions or problems with the subscription service, please visit subscriberhelp.govdelivery.com.
This service is provided to you at no charge by U.S. Food & Drug Administration (FDA).

FDA MedWatch: Pioglitazone-containing Medicines

 

MedWatch – The FDA Safety Information and Adverse Event Reporting Program

Pioglitazone-containing Medicines: Drug Safety Communication – Updated FDA Review, Increased Risk of Bladder Cancer

Includes Actos, Actoplus Met, Actoplus Met XR, Duetact, and Oseni

AUDIENCE: Internal Medicine, Endocrinology, Urology

ISSUE: As a result of an updated review, the FDA has concluded that use of the type 2 diabetes medicine pioglitazone (Actos, Actoplus Met, Actoplus Met XR, Duetact, Oseni) may be linked to an increased risk of bladder cancer. The labels of pioglitazone-containing medicines already contain warnings about this risk, and FDA has approved label updates to describe the additional studies reviewed. See the FDA Drug Safety Communication for more details, including a data summary.

BACKGROUND: FDA alerted the public about the possible risk of bladder cancer in September 2010 and June 2011 based on interim results from a 10-year epidemiologic study. FDA changed the labels of pioglitazone-containing medicines in August 2011 to include warnings about this risk, and required the manufacturer to modify and continue the 10-year study.

Pioglitazone is approved to improve blood sugar control, along with diet and exercise, in adults with type 2 diabetes. Pioglitazone works by increasing the body’s sensitivity to insulin, a natural hormone that helps control blood sugar levels. Untreated, type 2 diabetes can lead to serious problems, including blindness, nerve and kidney damage, and heart disease.

RECOMMENDATION: Health care professionals should not use pioglitazone in patients with active bladder cancer, and should carefully consider the benefits and risks before using pioglitazone in patients with a history of bladder cancer.

Patients should contact their health care professionals if they experience any of the following signs or symptoms after starting pioglitazone, as these may be due to bladder cancer:

  • Blood or a red color in the urine
  • New or worsening urge to urinate
  • Pain when urinating

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 Drug Safety Communication, at:

http://www.fda.gov/Safety/MedWatch/SafetyInformation/SafetyAlertsforHumanMedicalProducts/ucm532772.htm

You are encouraged to report all serious adverse events and product quality problems to FDA MedWatch at www.fda.gov/medwatch/report.htm

Follow MedWatch on Twitter

Update your subscriptions, modify your e-mail address, or stop subscriptions at any time on your Subscriber Preferences Page. You will need to use your email address to log in. If you have questions or problems with the subscription service, please visit subscriberhelp.govdelivery.com.

This service is provided to you at no charge by U.S. Food & Drug Administration (FDA).

Pharmacy & Therapeutics Newsletter 16.1

Headlines from the February issue of the P&T newsletter.

  • VTE Recurrence
  • Neonatal Preparation and Administration
  • Anti-Infective Medications Limited to the Order by an ID Specialist
  • Amphotericin B Deoxycholate added to the automatic substitution list
  • Injectable Iron Products for Use in the Ambulatory Clinic
  • IdaruCIZUMAB (PRDXBIND) added to the formulary
  • Reduction in Lidocaine Products

PT Newsletter 16.1 11.19.15PT

Pharmacy & Therapeutics Newsletter

PT Newsletter 15.6 091715PT

Pharmacy & Therapeutics Newsletter 15.5

PT Newsletter 15.5 062515PT

Pharmacy & Therapeutics Newsletter 15.2

PT Newsletter 15.2 112014PT

Discontinuation of Anticoagulants Prior to Surgery

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