Category Archives: Pharmacy

D5W / 0.45% NS Shortage 9.1.17

To:      Company-Wide

From: Dima Awad, PharmD, MS, System Director of Pharmacy Services

Date:  August 31, 2017

Re:      D5W/0.45% NS Shortage

SITUATION

We are experiencing a shortage in D5W/0.45% NS.

BACKGROUND

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.

ASSESSMENT

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.

RECOMMENDATION

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.

 

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.

BACKGROUND: This does not apply to patients taking Keytruda (pembrolizumab) for an approved indication. Patients on Keytruda (pembrolizumab) for an approved use should continue to take their medication as directed by their health care professional.
Keytruda (pembrolizumab) is currently approved by the FDA for treatment of: Melanoma, Lung Cancer, Head and Neck Cancer, Classical Hodgkin Lymphoma, Urothelial Carcinoma, Microsatellite Instability-High (MSI-H) Cancer.
For a summary of the statistical analysis and findings, please refer to the FDA Statement.
RECOMMENDATION: Other multiple myeloma clinical trials of Keytruda (pembrolizumab), other PD-1/PD-L1 cancer drugs and other combinations are currently undergoing clinical evaluation. The FDA will be working directly with sponsors of Keytruda and other PD-1/PD-L1 cancer drugs, as well as clinical investigators conducting clinical trials in patients with multiple myeloma, to determine the extent of the safety issue. The agency will communicate any new information to the public as soon as it is able.
Health care professionals and consumers are encouraged to report any adverse events or side effects related to the use of these products and other similar products to FDA’s MedWatch 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 at:
https://www.fda.gov/Safety/MedWatch/SafetyInformation/SafetyAlertsforHumanMedicalProducts/ucm574347.htm
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You are encouraged to report all serious adverse events and product quality problems to FDA MedWatch at www.fda.gov/medwatch/report.htm

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.

As a result, we are requiring several changes to the labels of all prescription medicines containing these drugs. These new actions further limit the use of these medicines beyond our 2013 restriction of codeine use in children younger than 18 years to treat pain after surgery to remove the tonsils and/or adenoids. We are now adding:

FDA’s strongest warning, called a Contraindication, to the drug labels of codeine and tramadol alerting that codeine should not be used to treat pain or cough and tramadol should not be used to treat pain in children younger than 12 years.
A new Contraindication to the tramadol label warning against its use in children younger than 18 years to treat pain after surgery to remove the tonsils and/or adenoids.
A new Warning to the drug labels of codeine and tramadol to recommend against their use in adolescents between 12 and 18 years who are obese or have conditions such as obstructive sleep apnea or severe lung disease, which may increase the risk of serious breathing problems.
A strengthened Warning to mothers that breastfeeding is not recommended when taking codeine or tramadol medicines due to the risk of serious adverse reactions in breastfed infants. These can include excess sleepiness, difficulty breastfeeding, or serious breathing problems that could result in death.
Caregivers and patients should always read the label on prescription bottles to find out if a medicine contains codeine or tramadol. You can also ask your child’s health care provider or a pharmacist. Watch closely for signs of breathing problems in a child of any age who is taking these medicines or in infants exposed to codeine or tramadol through breastmilk. These signs include slow or shallow breathing, difficulty or noisy breathing, confusion, more than usual sleepiness, trouble breastfeeding, or limpness. If you notice any of these signs, stop giving the medicine and seek medical attention immediately by going to an emergency room or calling 911.

Health care professionals should be aware that tramadol and single-ingredient codeine medicines are FDA-approved only for use in adults. Consider recommending over-the-counter (OTC) or other FDA-approved prescription medicines for cough and pain management in children younger than 12 years and in adolescents younger than 18 years, especially those with certain genetic factors, obesity, or obstructive sleep apnea and other breathing problems. Cough is often secondary to infection, not serious, and usually will get better on its own so treatment may not be necessary.

Codeine and tramadol are a type of narcotic medicine called an opioid. Codeine is used to treat mild to moderate pain and also to reduce coughing. It is usually combined with other medicines, such as acetaminophen, in prescription pain medicines. It is frequently combined with other drugs in prescription and over-the-counter (OTC) cough and cold medicines. Tramadol is a prescription medicine approved only for use in adults to treat moderate to moderately severe pain. However, data show it is being used in children and adolescents despite the fact that it is not approved for use in these patients.

In early 2013, FDA added a Boxed Warning to the codeine drug label cautioning against prescribing codeine to children of any age to treat pain after surgery to remove tonsils or adenoids. We also issued Drug Safety Communications in July 2015 and September 2015 warning about the risk of serious breathing problems in some children who metabolized codeine and tramadol much faster to their active form than usual (called ultra-rapid metabolism), causing potentially dangerously high levels in their bodies too quickly. At that time, we said we would continue to evaluate this safety issue. As part of that safety review, the codeine-related safety issues were discussed at an FDA Advisory Committee meeting in December 2015.

Our review of several decades of adverse event reports submitted to FDA* from January 1969 to May 2015 identified 64 cases of serious breathing problems, including 24 deaths, with codeine-containing medicines in children younger than 18 years. This includes only reports submitted to FDA, so there may be additional cases about which we are unaware. We also identified nine cases of serious breathing problems, including three deaths, with the use of tramadol in children younger than 18 years from January 1969 to March 2016 (see Data Summary). The majority of serious side effects with both codeine and tramadol occurred in children younger than 12 years, and some cases occurred after a single dose of the medicine.

In our review of the medical literature1-19 for data regarding codeine use during breastfeeding, we found numerous cases of excess sleepiness and serious breathing problems in breastfed infants, including one death. A review of the available medical literature4,5,23,24 for data regarding tramadol use during breastfeeding did not reveal any cases of adverse events. However, tramadol and its active form are also present in breast milk, and tramadol has the same risks associated with ultra-rapid metabolism as codeine.

We will continue to monitor this safety issue. We are considering additional regulatory action for the OTC codeine products that are available in some states. OTC codeine products are available in combination with other medicines for cough and cold symptoms. We are also considering an FDA Advisory Committee meeting to discuss the role of prescription opioid cough-and-cold medicines, including codeine, to treat cough in children.

We urge patients and health care professionals to report side effects involving codeine-and tramadol- containing medicines to the FDA MedWatch program, using the information in the “Contact FDA” box at the bottom of the page.

*The cases were reported to the FDA Adverse Event Reporting System (FAERS).

Full Safety announcement can be found at https://www.fda.gov/Drugs/DrugSafety/ucm549679.htm

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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What is a true penicillin allergy?

Did you know that most patients who give a history of “penicillin allergy” do not have a true allergy? Most of them will tolerate more effective and less expensive agents without issues.

For more information see the recently updated policy.

How to request non-formulary medication

Please note that CHS is instituting a new policy regarding the order of Non-Formulary medications.  The ordering of Non-Formulary medications will include completion of the Non-Formulary Use Request.  When requests have been completed, they are to be sent to the Pharmacy Department.  The Pharmacy Director, Dima Awad, will be reviewing all requests for approval to use.  This pertains to all Inpatient and all Outpatient (SAGE, ATC/ATS) requests.  Pharmacy will be collecting data on requests which will assist in determining the need of products for Formulary Addition.  Also included is the most recent approved Therapeutic Interchange List for your review.

Thank you very much for your consideration.

Alan Mader

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 and Therapeutics Newsletter Sept 2016

September 22, 2016 issue
Volume 16, Number 5

Table of contents

Enoxaparin Injection Sites

As we know, administration of subcutaneous enoxaparin (LOVENOX) should be alternated between
the left and right anterolateral and left and right posterolateral abdominal wall. Pharmacy has
received requests for administration to be made in areas such as the thigh. Research into alternate
site administration is limited. Only one study was found which compared enoxaparin administration
into the thigh versus the standard injection site. This study was conducted in obese patients and found
that when enoxaparin was injected into the thigh, anti Xa levels were found to be significantly lower.
Based on this limited information and the inability to monitor in-house anti Xa levels at CHS,
administration at the sites outlined by the manufacturer should be followed.

Formulary Additions

Loxapine Inhalation (ADASUVE) Read more here … pt-newsletter-16-5-092216pt

Formulary Additions for Lurie Pediatric Patients

  1. Ampicillin sulbactam (UNASYN) 1.5 GM for injection – added with pediatric restriction
  2. Cefotaxime (CLAFORAN) 500 mg, 1 GM, 2 GM for injection – added with pediatric restriction
  3. Ibuprofen chewable tablet 50 mg and 100 mg – added for pediatrics
  4. Montelukast (SINGULAR) 5 mg tablet – added for pediatrics
  5. Ranitidine (ZANTAC) 15 mg/mL Syrup – added for pediatrics
  6. Sodium Chloride 3% Nebs – added for pediatrics
    1. Vitamin A & D Ointment – added for pediatrics
  7. Sacchromyces boulardi (FLORASTOR) 250 mg capsule and packet – add for pediatric and adult patients

Formulary Deletions

  1. Alvimopan (ENTEREG) – Pharmacy will maintain supply until current stock expires. If this product has little or no use, it will be removed from formulary.
  2. Lidocaine 5%/D7.5W (PF) 100 mg/2 mL injection
  3. Bupivacaine-dextrose-water (PF) 15 mg/2 mL injection
  4. Heparin 1000 units/mL 30 mL MDV
  5. Tromethamine 36 mg/mL 500 mL solution for injection (THAM) – off market
  6. Sodium polystyrene sulfonate powder 454 GM

Therapeutic Substitutions

Drug Ordered Dispensed With
Acetaminophen IV(OFIRMEV) 650 mg for nonpediatric patients Acetaminophen IV (OFIRMEV) 1000 mg
Zolpidem CR (AMBIEN CR) 12.5 mg or 6.25 mg Zolpidem (AMBIEN) 5 mg
Brinzolamide (AZOPT) Ophthalmic Solution 1 drop tid affected eye(s). Dorzolamide (TRUSOPT) Ophthalmic Solution 1 drop tid affected eye(s).

Policy/Protocol Revision

7300–531PT Medication Order Duration Policy
This policy, which specifies medication order duration based on individual medication or medication class type, had previously been deleted. At the February, 2016 Pharmacy and Therapeutics Committee meeting, it was resurrected so that appropriate durations could be placed in Paragon.
The revision that was made at this time was reorganization to make incorporation into Paragon easier.

7300–621PT Argatroban Dosing and Monitoring per Pharmacy Protocol
This protocol has been used for many years without substantial change. It details Argatroban dosing and dose adjustment when the drug is used for heparin induced thrombocytopenia or heparin induced thrombocytopenia with thrombotic syndrome. The only change that was made at this time regards removal of wording for a paper order.

7300–690PT Pediatric Medication Preparation and Administration
This policy, recognizing that the pediatric population has significant specific needs, an interdisciplinary process is designed to ensure that pediatric medication therapy is prepared and dispensed in a safe, effective, and timely manner and that all medications administered to pediatric patients are given accurately, safely, and with proper technique for each method of administration. The change that was made to this policy was the removal of the 0.1 mL overfill on IM and subcutaneous medications drawn up by Pharmacy.