Drug appropriateness criteria: potential for indications creep

1
Drug appropriateness criteria potential for
indications creep

• Amy Lodolce, PharmD, BCPS
• Mike Koronkowski, PharmD

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Learning Objectives

• Describe off-label drug use and populations where
  it is most prevalent
• Explain the key components of appropriate use
  criteria for drugs
• Judge the appropriateness of a given drug for an
  off-label use
• Justify whether or not the formulary should
  restrict drugs based on indications

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Issues surrounding off-label prescribing

• Legality
• Prevalence
• Level of evidence
• Potential risks to patients
• Cost to healthcare system

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How common is this?

• 21 (150 million) of 725 million prescriptions
• 73 (109 million) little or no scientific support
• 27 (41 million) strong scientific evidence
• Ann Intern Med 20061661021-6.

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Which patients?

• Children
• Patients with HIV
• Patients with psychiatric disorders
• Pregnant women
• Ann Intern Med 20061661021-6.

6
Which drugs?

• Anticonvulsants (notably gabapentin)
• Antiasthmatic medications
• Cardiac drugs
• Antibiotics
• Ann Intern Med 20061661021-6.

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Examples

• Gabapentin
• Botulinum toxin type A (Botox)

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Level of evidence

• Tertiary
• Drugdex on Micromedex
• AHFS (the formulary service)
• Secondary
• Medline
• Primary
• Critically evaluate a trial

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Potential harms

• Adverse drug reactions
• Potential for polypharmacy
• Cost to healthcare system

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Role of the pharmacist

• As defined by ASHP
• Patient advocate, drug info specialist
• Evaluate orders (policies and procedures)
• Proactive approaches to promote informed
  decisions by third-party payers
• (http//www.ashp.org/s_ashp/bin.asp?CID1276DID5
  393DOCFILE.PDF)

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Medication use policy

• Evaluate medications (MUE) formally and report to
  PT committee
• PT can restrict or limit use, but this is
  difficult for certain classes of drugs
• State of Illinois Department of Healthcare and
  Family Services criteria

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Medication Use Evaluation

• MUE Goal provide pts. with safe and effective
  drug therapy
• Accomplished through assessment and improvement
  of medication use process
• Focus can be single drug or therapeutic class OR
  component of medication use process/outcomes

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Medication Use Evaluation

• Objectives of MUE
• Improve medication use process
• Reduce medication-related problems
• Reduce cost through appropriate use criteria
• Provide education to staff

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Medication Use Evaluation

• Step 1
• Form the committee
• Multidisciplinary
• Can be a sub-committee of PT
• Assign responsibility

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Medication Use Evaluation

• Step 2
• Choose a topic
• Focus on high volume, high risk, problem-prone
  medications
• Can also focus on aspect of medication use
  process
• Overall, topics should be selected to cover the
  scope of the institution

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Medication Use Evaluation

• Step 3
• Develop criteria (methods)
• Standards that define performance expectations
• Phrase explicitly (yes/no)
• Evidence based
• Define outcomes
• Indicators

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Medication Use Evaluation

• Steps 4 and 5
• Develop data collection form
• User friendly
• Many boxes to check vs. free response
• Collect data
• Prospective
• Concurrent
• Retrospective

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Medication Use Evaluation

• Step 6
• Data analysis
• Step 7
• Corrective action
• Education
• Guidelines/clinical pathway
• Restrictive approach