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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:


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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Adding Patients to your Census in Paragon 13

Did you know that in Paragon 13 physicians can search for any patient in the organization and add that patient to their census. Then they can start documenting or CPOE.

How to add patient to your census

  1. Search for the patient
  2. Click on “assignments” under the patient name
  3. Then adding yourself to the census

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.

When is it appropriate to document “history of…”?

As physicians we frequently document past medical conditions with the phrase “history of…”. An example of this would be:

John Doe is a 54 yr old man with history of congestive heart failure who presents with worsening shortness of breath and increased leg swelling.

Though this documentation makes sense to any physician reading this it is not correct by CMS coding guidelines.

According to CMS coding guidelines “history of…” is referring to a condition that is no longer receiving any treatment.

For example 38 yr old man with a history of right tibial fracture in 1995 now presents with fever cough and expectoration. The history of tibia fracture indicates that the patient is no longer receiving treatment for the tibial fracture and is therefore appropriate documentation.

Another example: Jane Doe is a 67 yr old female with a history of hypertension presents with chest pain and is on metoprolol would not be correct as the hypertension is still being treated with the metoprolol even if it is controlled. This distinction is very important to correctly attribute the severity of illness for your patient.

A common mistake is to use the term “history of CHF…” This should be documented as “known CHF currently compensated..” or uncompensated as the case may be.

How to document in the correct encounter using Paragon 13.x

Documenting using physdocs on the wrong patient encounter will result in inaccurate documentation. Please make sure you document in the correct encounter.

Find the patient

Find your patient using the earch function in the upper right hand corner

Include all patients in the search

If the patient is discharged then make sure the “include active only” is unchecked.

Look for additional encounters

If your patient has additional encounters they will show up as “additional visits” in the lower right hand corner of the card.

Open list of encounters

Clicking on the “additional encounters” link will open all the additional encounters for that patient. Individual encounters can be opened by clicking on the patient name in the encounter.

Current drug shortages now added to this website

Current drug shortages will be available under Clinical-> Pharmacy-> Drug shortages.

The link is also available under quicklinks in the right sidebar for desktop users.