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CADTH » Search All Products » Environmental Scanning » Health Technology Update » Issue 11- August 2009 » Eastern Health’s Commitment to ...

Eastern Health’s Commitment to Implementing Evidence for the Use of Off-Label and Non-Formulary Medication

Eastern Health is the largest integrated regional health authority in Newfoundland and Labrador, serving a population of more than 290,000. Of growing concern to Eastern Health is the need for health care delivery to respond to the increasing use of medications outside their original mandate.

Eastern Health operates more than 80 hospitals, health care centers, long-term care facilities, and community health offices. As a single harmonized organization, this regional health authority provides a complete succession of health services, including community, acute, and long-term care. It is responsible for tertiary or high-level care for the entire jurisdiction.

The use of medications for off-label and non-formulary indications is a fairly common practice, occurring in an estimated 40% of adult and 90% of pediatric prescriptions. Off- label medications are considered to be medications that have not been approved by Health Canada for a particular condition or patient group, but have demonstrated success in treating another condition or group. Non-formulary medications are drugs that have been approved by Health Canada for use in specific diseases, but may not be approved yet, or have not been approved at all, by jurisdictional drug lists.

At Eastern Health, requests for the use of off-label and non-formulary medication were traditionally directed to the Vice-President of Medical Services or the Program Director for approval. Neither of these senior health care professionals felt equipped with the necessary knowledge to make decisions about potentially life-saving treatment decisions. Many of these medications are for last resort requests to treat illnesses that were unresponsive to conventional therapy.

Questions were raised over who should make these important decisions and whether or not these decisions were being informed by evidence. An action plan was developed to guide the decision-making process and a Rapid Response Committee was established in the summer of 2008 to respond to the growing requests for funding and support of off-label and non-formulary medication use in patient treatments.

The Rapid Response Committee is an interdisciplinary collaboration and partnership that connects clinical and administrative committees from within Eastern Health. The committee’s membership consists of a broad spectrum of senior health care representatives from allied health professional practices, clinical programs, affiliated local university health care professional schools, and research centres. 

The committee’s first steps included developing a supporting decision process map and identifying resources to support decision-making. CADTH’s Health Technology Inquiry Service (HTIS) was identified as a first port of call for all new requests received by the committee. Additional resources to support decision-making included conducting literature reviews, tapping into clinical expertise, and considering ethical issues. By utilizing resources within the organization and supported by evidence from CADTH, a framework was developed.

The framework was based on issues relating to patient safety, current threats to disease progression, informed consent for treatment, evidence to support the decision to treat, the risks and benefits of off-label treatment with the drug to the patient, and the appropriate use of resources. The guiding principles of the framework were applied to the decision-making process.

The committee then focused on developing a decision process map that would provide direction to the decision-making process. Committee members were required to respond to a series of questions that would help them assess and implement the use of appropriate technologies for each new request for non-formulary or off-label medication.

The questions included:

  • Is this the approved use of the medication in Canada and for this disease process?
  • What evidence is available to support the request for off-label use of this drug?
  • Is this an exceptional case?
  • What are the immediate and future financial costs?

The committee now ensures that each new request consistently adheres to the decision process map. Commitment to the map guarantees that evidence is being used to support decision-making. 

Funding non-formulary/off-label medications: do we or don’t we? Evidence, decisions, outcomes. Optimizing the use of drugs and health technologies. Templeton, J. Eastern Health. CADTH Syposium, April 2009: http://www.cadth.ca/media/symp-2009/presentations/CS-12/Janet%20Templeton%20-%20Funding%20Non-formulary_Off-label%20Mediations%20-%20Do%20We%20or%20Don_t%20We.pdf.