International Conference on Patient Safety

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International Conference on Patient Safety
Medication activities in the USA Role of the
Institute for Safe Medication Practices November
16, 2006

• Michael R. Cohen, RPh, MS, ScD
• Institute for Safe Medication Practices
• mcohen_at_ismp.org

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USP-ISMP Medication Errors Reporting Program
Operated by theUnited States Pharmacopeia in
cooperationwith the Institute for Safe
Medication Practices www.ismp.org
Pennsylvania Patient Safety Reporting Program

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PhRMA industry

• FDA-ISMP-PhRMA Workshop on Drug Name Risk
  Management Strategies
• Still lacks system-based thinking in addressing
  errors
• Lack of standards for package labeling hampers
  improvement
• No contact number for problem reporting
• No Recalls not made for known problems, even
  after changes made

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United States Pharmacopeia

• Center for Patient Safety
• MedMarx Program and USP-ISMP MERP
• Safe Medication Use Expert Committee
• Safety considered in drug standards
• National Coordinating Committee on Medication
  Error Reporting and Prevention

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Joint Commission on Accreditation of Healthcare
Organizations (JCAHO)National Patient Safety
Goals

• Sentinel event advisory group
• Sentinel event reporting
• Sentinel event newsletter
• Other sources including ISMP

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You can get much farther with a kind word and a
gun than you can with a kind word alone.
Al Capone
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JCAHO
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Preventing Medication Errors
Institute of Medicine Committee on Quality of
Health Care in America
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Error reporting

• Improved error reporting
• Report suggests that all stakeholders, including
  accreditation agencies, state professional
  boards, and relevant state and federal agencies,
  should promote medication error reporting more
  aggressively.

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Oversight of community pharmacy practice

• Community pharmacy safety initiatives that should
  be required by licensing boards are suggested,
  including quality improvement activities.

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Oversight of community pharmacy practice

• The Committee recognized that, with few
  exceptions, there is currently little medication
  safety oversight of community pharmacies.
• The report notes, "State boards do send surveyors
  out, but they may or may not be pharmacists. What
  they look for are issues related to state
  practice acts there is no focus on the types of
  issues that parallel the requirements hospital
  pharmacies must meet under the National Patient
  Safety Goals"

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Role of FDA, Industry and Safety Organizations

• Important to medication safety is recognition of
  the role of FDA and the pharmaceutical industry
  in eliminating medical product errors.
• The report specifically calls upon "industry,
  AHRQ, FDA, and others as appropriate (e.g., USP,
  ISMP)" to work together to undertake actions to
  address medical product issues such as labeling
  and packaging and drug naming.

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Role of professional schools

• Noting that safety education is lacking in
  professional schools, the Committee also called
  upon academic accreditation agencies to set new
  standards for this training.  

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Role of FDA, Industry and Safety Organizations

• The FDA should develop two guidance documents for
  industry one for drug naming and another for
  labeling and packaging. The FDA and industry
  should collaborate to develop (1) a common drug
  nomenclature that standardizes abbreviations,
  acronyms, and terms to the extent possible, and
  (2) methods of applying failure modes and effects
  analysis to labeling and packaging.

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Action Agenda for Health Care Organizations

• Specific recommendations for prescribers,
  pharmacists, nurses to improve safety
• Importance of safety culture
• Discusses importance of oversight from JCAHO
  (NPSGs) and NQF Safe Practices

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Action Agendas for Oversight, Regulation, and
Payment

• Oversight and regulatory organizations and payers
  should use legislation, regulation,
  accreditation, and payment mechanisms and the
  media to motivate the adoption of practices and
  technologies that can reduce medication errors,
  and to ensure that that professionals have the
  competencies required to deliver medications
  safely.

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Action Agendas for Oversight, Regulation, and
Payment

• Payers and purchasers should continue to motivate
  improvement in the medication-use process through
  explicit financial incentives.

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Action Agendas for Oversight, Regulation, and
Payment

• CMS should evaluate a variety of strategies for
  delivering medication therapy management.
• Regulators, accreditors, and legislators should
  set minimum functionality standards for error
  prevention technologies.
• States should enact legislation consistent with
  and complementary to the Medicare Modernization
  Acts e-prescribing provisions and remove
  existing barriers to e-prescribing.

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Action Agenda for Health Care Organizations

• By 2008, all prescribers should have plans in
  place to write prescriptions electronically, and
  by 2010, all prescribers should write
  prescriptions and all pharmacies should be able
  to receive them electronically.
• Subject prescriptions to evidence-based, current
  clinical decision support.
• Have the appropriate competencies for each step
  of the medication use process.

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Action Agenda for Health Care Organizations

• Make effective use of well-designed technologies,
  which will vary by setting.
• Use of bar coding, smart pumps, etc.