Heparin - Decreased Potency as a Result of New United States Pharmacopeia (USP) Standards - Notice to Hospitals

Starting date:

November 25, 2009

Posting date:

November 26, 2009

Type of communication:

Notice to Hospitals

Subcategory:

Biologic/vaccine

Source of recall:

Health Canada

Audience:

Healthcare Professionals

Identification number:

RA-170002033

Notice about Health Canada advisories

Notice to Hospitals - Health Canada Issued Important Safety Information on UNFRACTIONATED HEPARIN

November 25, 2009

To: Hospital Chief of Medical Staff

Please distribute to the relevant Departments of Surgery, Emergency Medicine, Pharmacy, Pediatrics, Anesthesia, Internal Medicine, Cardiology, Nephrology, Neurology, Nursing, Intensive Care and/or other Departments as required and other involved professional staff and post this notice in your institution.

Subject: Decreased Potency of some Unfractionated Heparin Products as a Result of New United States Pharmacopeia (USP) Standards

Heparin products are widely used in the treatment of thrombotic conditions and to prevent the extension of clots and thromboembolic phenomena. They are also used prophylactically to prevent clotting during various procedures.

• New manufacturing and testing requirements for unfractionated heparin manufactured according to USP standards will result in a decrease in potency of approximately 10%.
• There will be a transition period over the next 2 years where heparin products of both the old and new potency will be on the market simultaneously.
• Physicians should consider the possibility of decreased potency when administrating unfractionated heparin and the potential need for dosage adjustments, especially in circumstances where achievement of a rapid or aggressive anticoagulated state is required.
• Patients may require closer monitoring of their coagulation parameters during this transition period.
• Lots of unfractionated heparin with the new USP standard will be shipped by as early as December, 2009 (please refer to table below).

The United States Pharmacopeia (USP), an American organisation which develops standards for the quality of therapeutic products, has revised its monograph for unfractionated heparin, as part of ongoing efforts to reduce the risk of heparin contamination. At the same time, the USP took this opportunity to calibrate their new Unfractionated Heparin potency reference standard to the International Standard for Unfractionated Heparin issued by the World Health Organization, so that potency results of all heparin products would be the same regardless of which standard is used. This will result in approximately a 10% reduction in potency for unfractionated heparin products relative to previous USP standards. Low molecular weight heparins will not be affected by this change.

At this time, dosage recommendations are not expected to change. However, some patients may require closer monitoring of their level of anticoagulation to ensure adequate heparinization. In circumstances where rapid or aggressive anticoagulation is desired, the difference in potency should be considered when determining the dose to be administered.

The manufacturers impacted by the change in the USP reference standard will be implementing measures to distinguish lots with the new standard from lots with the old standard. The following table provides the name of the manufacturer, the date when heparin lots with the new standard will be shipped, and the measures implemented to distinguish the lots:

Managing marketed health product-related adverse reactions depends on health care professionals and consumers reporting them. Reporting rates determined on the basis of spontaneously reported post-marketing adverse reactions are generally presumed to underestimate the risks associated with health product treatments. Any cases of serious adverse reaction suspected to be related to the change in potency or other serious or unexpected adverse reactions in patients receiving unfractionated heparin should be reported to the relevant market authorization holder or Health Canada at the following addresses:

B.Braun Medical, Inc.
Clinical and Technical Support
Tel: 1-800-854-6851

Baxter Corporation (Canada)
Pharmacovigilance Department
4 Robert Speck Parkway Suite 700
Mississauga, Ontario
L4Z 3Y4
Email: canada_pharmacovigilance@baxter.com
Tel: 1-800-387-8399 ext.6626, 6622, 6526 (or state to receptionist that you are reporting an adverse event)

Hospira Healthcare Corporation
Complaint & Safety Department
1111 Dr. Frederik-Phillips, Suite 600
Saint-Laurent (Quebec) H4M 2X6
ProductcomplaintsCA@hospira.com
Tel: 866-488-6088 Option 7
Fax: 877-906-0208

Pharmaceutical Partners of Canada, Inc
Medical Information
45 Vogell Road, Suite 200
Richmond Hill, Ontario L4B 3P6
Tel: 877-821-7724 or 905-770-3711
Fax: 905-770-4811

Sandoz Canada, Inc.
Pharmacovigilance General Contact
Fax: 1-450-641-6408
Email: drugsafety.canada@sandoz.com

Any suspected adverse reaction can also be reported to:
Canada Vigilance Program
Marketed Health Products Directorate
Health Canada
Address Locator: 0701D
Ottawa, Ontario, K1A 0K9
Telephone: 613-957-0337 or Fax: 613-957-0335
To report an Adverse Reaction, consumers and health professionals may call toll free:
Telephone: 866-234-2345
Fax: 866-678-6789
CanadaVigilance@hc-sc.gc.ca

The Adverse Reaction Reporting Form and the Adverse Reaction Guidelines can be found on the Health Canada web site or in The Canadian Compendium of Pharmaceuticals and Specialties.

For other inquiries related to this communication, please contact Health Canada at:
Marketed Health Products Directorate (MHPD)
E-mail: mhpd.dpsc@hc-sc.gc.ca
Telephone: 613-954-6522
Fax: 613-952-7738