Management of Benzodiazepines in Medication-Assisted Treatment College of Physicians, Philadelphia, PA Thursday, February 09, 2012 Risk Management and Benzodiazepine Use Trusandra Taylor, MD, FASAM, MPH
Risk Management?
Objectives Focus upon risk management from the MAT perspective Common risks identifiers Standard of Care Regulatory Medical Legal Role of Practice Guidelines Outline strategies to minimize and prevent liability
Risk Management Opening remarks Prevalence, morbidity and mortality data Multiple clinical settings and coordination of care Pharmacology and drug-drug interactions
Risk Management Definition for health care organizations: an organized effort to identify, assess, and reduce, where appropriate, risks to patients, visitors, staff and organizational assets a program designed to reduce the incidence of preventable accidents and injuries to minimize the financial loss to the institution should an injury or accident occur * Kavalier F, Spiegel AD, Risk Management in Health Care Institutions A Strategic Approach, 1997 Jones and Bartlett Publishers * Smith DG, Wheller JRC. (1992) Strategies and structures for hospital risk management programs. Health Care Management Review 17(3):9-17
Patient Safety Patients Rights Risks in Healthcare Quality of Care Adverse Events
Medication-Assisted Treatment Perspective Patient population unique characteristics Unique pharmacological properties of opioid agonist medications Medication management adherence, challenges
Standard of Care for Medication--Assisted Treatment Medication Medical Regulatory Legal
Standard of Care Medical: is a medical or psychological treatment guideline, and can be general or specific. It specifies appropriate treatment based on scientific evidence and collaboration between medical and/or psychological professionals involved in the treatment of a given condition the watchfulness, attention, caution and prudence that a reasonable person in the circumstances would exercise
Standard of Care Medical: A physician also has a "duty to inform" a patient of any material risks or fiduciary interests of the physician that might cause the patient to reconsider a procedure, and may be liable if injury occurs due to the undisclosed risk, and the patient can prove that if he had been informed he would not have gone through with the procedure, without benefit of hindsight.
Standard of Care Legal: In tort law, is the degree of prudence and caution required of an individual who is under a duty of care the level at which an ordinary, prudent professional having the same training and experience in good standing in a same or similar community would practice under the same or similar circumstances
Standard of Care Watchfulness, attention, caution and prudence that a reasonable person in the circumstances would exercise If a person's actions do not meet this standard of care, then his/her acts fail to meet the duty of care which all people (supposedly) have toward others Failure to meet the standard is negligence, and any damages resulting there from may be claimed in a lawsuit by the injured party The "standard" is often a subjective issue upon which reasonable people can differ
Negligence Conduct that falls below the standards of behavior established by law for the protection of others against unreasonable risk of harm. A person has acted negligently if he or she has departed from the conduct expected of a reasonably prudent person acting under similar circumstances.
Negligence Although there have been important developments in negligence law, the basic concepts have remained the same since the eighteenth century. Today negligence is by far the widest-ranging tort, encompassing virtually all unintentional, wrongful conduct that injures others. One of the most important concepts in negligence law is the "reasonable person," which provides the standard by which a person's conduct is judged.
Standard of Care for Medication-Assisted Treatment Regulatory Methadone: Federal Opioid Treatment Program standards 42 CFR, part 8 Accreditation and certification-based system for Opioid Treatment Programs (OTPs), overseen by SAMHSA. CSAT/DPT Guidelines for the Accreditation of OTPs (2007) Buprenorphine: Office-Based Opioid Treatment (OBOT): Drug Addiction Treatment Act of 2000, (DATA 2000) Physician waiver DEA registration
Practice Guidelines Empiric: Relying on or derived from observation or experiment Guided by practical experience and not theory Evidence-based*: Physician-centric centric 3 critical integrated processes : 1. ongoing systematic review of the "science" 2. the integration of the science with the clinician's training and practice experience 3. consumers comprehend their diagnosis and engage in reasoned assessment of available treatment options *Mechanic D. Bringing science to medicine: the origins of evidence-based medicine. Health Aff. 1998;17:250-251. Muir Gray JA. Evidence-Based Medicine: How to Make Health Policy and Management Decisions. London: Churchill Press; 1997.
Risk Management in Practice Risk Management Program Components Risk identification and analysis Establishing priorities Implementing risk prevention strategies Choosing risk management strategies
Common Risks Identifiers for Benzodiazepine Use Patient incidents Overdose and adverse drug reaction Impairment Drug testing results Other observation, complaints, concerns Pharmacy and therapeutic reports Prescription records Pharmacy audits / PDMP records Hospital and inpatient records
Benzodiazepines and Impairment Patients who are impaired secondary to benzodiazepine use alone or in combination with methadone present potential danger to themselves and others. Operating heavy equipment, machinery Driving motor vehicles, automobiles, motorcycles, motorbikes, boats
Identifying Impaired Patients Support Staff Medical and Nursing Staff Family and Other Patients Clinical Staff
Effective Risk Management Strategy Inform of policy and procedures Educate all patients Total OTP community effort Climate of Impairment Awareness
Climate of Awareness for Benzodiazepine Use Red flags, evidence ignored, MATP should have known Observation and assessment for impairment, foreseeable risk Drug testing results followed up and acted upon Methadone dose monitored, prepared to adjust or defer No Tolerance policy for impairment, with communication to patients Report potentially dangerous situations to authorities
RM Prevention and Management Strategies / Actions Phased informed consents, release of information Discuss concerns privately, maintain confidentiality Diagnostic instruments / tools for assessment Methadone dosing decisions Staff training, competency Document adequately, revise treatment plan appropriately
Summary of the Legal Standard MATPs must take all precautions and reasonable action to : Duty to warn Assure a patient is not impaired prior to dosing Inform the patient of the side effects of benzodiazepines and methadone Prevent the impaired patient from driving MATPs have a legal duty to take action once impairment is identified. MATPs cannot claim protection from a lack of knowledge
Thank you!