Category Archives: Medicine

Updated Guidelines for Prevention of Perinatal Hepatitis B

Advisory Committee on Immunization Practices (ACIP) and the Centers for Disease Control and Prevention (CDC) published a summary of existing recommendations and provided updated and new recommendations on the prevention of hepatitis B virus infection in the United States.

The new and updated recommendations are:

General Recommendations:

  • For all medically stable infants weighing ≥2,000 grams at birth and born to HBsAg-negative mothers, the first dose of hepatitis B vaccine should be administered within 24 hours of birth.
  • Permissive language for delaying the birth dose that was previously used in the recommendations has been removed.

Identification and Management of HBV-Infected Pregnant Women:

  • All hepatitis B surface antigen (HBsAg) positive pregnant women should be tested for hepatitis B DNA to guide the use of maternal antiviral therapy during pregnancy for the prevention of hepatitis B virus transmission.
    • A brief summary of the American Association for the Study of Liver Diseases (AASLD) guidelines for the use of maternal antiviral therapy to reduce perinatal Hepatitis B virus transmission is also included in the MMWR.

Management of Infants Born to Women Who Are HBsAg-Positive:

  • Infants born to women for whom HBsAg testing results during pregnancy are not available but have other evidence suggestive of maternal hepatitis B virus infection (presence of maternal HBV DNA, maternal HBeAg is positive, or the mother is known to be chronically infected with hepatitis B) should be managed as if born to an HBsAg-positive mother.
  • For infants who are transferred to a different facility after birth, staff at the transferring and receiving facilities should communicate with each other regarding the infant’s HepB vaccination and receipt of hepatitis B immune globulin (HBIG) to ensure prophylaxis is administered in a timely manner.

Management of Infants Born to Women with Unknown HBsAg Status

  • If it is not possible to determine the mother’s HBsAg status (e.g., where confidential safe surrender of infant occurs shortly after birth), the vaccine series should be completed according to the recommended schedule for infants born to HBsAg-positive mothers. Post-vaccination serologic testing and revaccination, if needed, is recommended for these infants.
  • For HBsAg-negative infants born to HBsAg-positive women who show no serologic immune response after receiving the initial HepB vaccine series, revaccinate the infant with a single challenge dose of HepB vaccine and repeat serologic testing (HBsAg and anti-HBs) one to two months later. If the infant remains HBsAg negative and has an anti-HBs of <10 mIU/mL following single dose revaccination, complete the second series on schedule with the two additional Hep B vaccine doses followed by post-vaccination serologic testing one to two months after the final dose.
    • Alternatively,basedonclinicalcircumstancesorparentpreference,HBsAg-negative infants born to HBsAg-positive women who show no serologic immune response after receiving the initial HepB vaccine series may instead be revaccinated with a second 3- dose series and retested one to two months after the final dose of vaccine.
    • As a reminder, post vaccination serologic testing of the infant should include HBsAg and anti-HBs. Anti-HBs testing should be performed using a method that allows detection of the protective concentration of anti-HBs (> 10mIU/mL).

Influenza Vaccination in Patients with Egg Allergy

Guideline Watch | GENERAL MEDICINE, INFECTIOUS DISEASES

January 11, 2018

Influenza Vaccination in Patients with Egg Allergy

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

Background

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.

Key Recommendations

  • Flu vaccines should be administered annually to patients with egg allergy of any severity, with no need to ask recipients about egg-allergy status and no special precautions beyond those recommended for administering any vaccine to any patient. This recommendation applies to both injected and intranasal formulations (although the latter should not be used in the 2017−2018 flu season).
  • Non−egg-containing vaccines can be used but are not necessary or preferred over standard vaccines.
  • The intranasal live attenuated flu vaccine also might be used, if it’s shown to be efficacious and is approved for use.
Comment

Egg-allergic patients can be vaccinated safely with any available age-appropriate flu vaccine, with no special precautions, regardless of egg-reaction history (including anaphylaxis). Concern for egg allergy only adds another barrier to universal flu vaccination, and this practice parameter concludes by stating the following: “Vaccine providers and screening questionnaires do not need to ask about the egg allergy status of recipients of influenza vaccine.”

Editor Disclosures at Time of Publication

Disclosures for David J. Amrol, MD at time of publication

Consultant / Advisory board CSL Behring; Horizon Pharmaceuticals
Citation(s):

Greenhawt M et al. Administration of influenza vaccines to egg allergic recipients: A practice parameter update 2017. Ann Allergy Asthma Immunol 2018 Jan; 120:49. (http://dx.doi.org/10.1016/j.anai.2017.10.020)

Did you know you can get ABIM MOC credits with Uptodate.com?

ABIM MOC completion can be done through Uptodate.com 

Please see here for more information on the program.

Centegra offers access to uptodate.com for all providers in the health system. Just login from any network computer in the system.

Instructions on remote or mobile access can be found here.

Morphine Injection Shortage

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.

A

Analgesic

B

Oral

C

Parenteral

D

Oral: Parenteral Ratio

E

Oral Morphine: Analgesic Ratio

F

Analgesic Duration

G

Half Life

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

pembrolizumab (KEYTRUDA) in Patients with Multiple Myeloma: FDA Statement – Two Clinical Trials On Hold

Keytruda (pembrolizumab) in Patients with Multiple Myeloma: FDA Statement – Two Clinical Trials on Hold
AUDIENCE: Oncology
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

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
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Pre-Surgical Clearance Clinic Day of Week Change

From: Anthony Brown, Director of Clinical Effectiveness & Orthopedics

Effective the week of May 8th 2017 the Total Joint Pre-Surgical Clearance Clinic will be at the McHenry campus Wednesdays and Fridays and at the Huntley Campus Tuesdays and Thursdays. I apologize for the confusion the change o f location may have caused . Below is the contact information for the clinic. Please contact me with any questions .

McHenry Campus

Location: ATS (across from CDU 2)

Phone: 815-759-4902

Hours: 8:00am – 4:30pm

Days: Wednesdays and Fridays

Huntley Campus

Location: MOB 2, Suite 202

Phone: 815-759-4902

Hours: 8:00am – 4:30pm

Days: Tuesdays and Thursdays

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).

Opioid Abuse and Chronic Pain – NEJM

Opioid Abuse in Chronic Pain — Misconceptions and Mitigation Strategies — NEJM March 2016