Transcript 2015 Pain and Medical Legal Issues

Daniel Wermeling, Pharm.D.
Professor, College of Pharmacy
Is Pain a Symptom or a Disease or
Both?
Is There a Moral/Ethical Obligation
to Treat Pain?
Is Pain Treatment a Basic Human
Right?
Is There a Legal Obligation to Treat
Pain?
An Unusual Legal Standard
 Dual duties
 Typically only to patient
 Given opioid problems, also duty to society
 Legal Principle of Balance
 Yet if pain management was optimized would harms
be reduced?
2009 Rx Opioid Poisoning Data
 2012 - ~ 40,000 deaths from DAWN reports
from prescription drug overdose
 16,000 were opioid related
 Underestimate – why?
 In Ky – 2012 - about 1000 deaths
4
Drug Abuse and Overdose is Directly Tied to Access
KY Opioid Mortality Rate
15.3/ 100K
KY is about 70,000
gms/100K in Sales
Reactions to Overdose
Epidemic
New Laws and Regulations
Creating Potential
Professional Jeopardy
 Federal
 State
 Criminal Prosecution
 Local
 Administrative Action
 Professional Licensing Boards
 Civil Malpractice
 Professional Societies
 Pseudo-government agencies
Federal Initiatives
 FDA – Food Drug and Cosmetic Act
 Drug approval process – determine if product is safe and
effective
 REMS – Risk Evaluation and Mitigation Strategies
 DEA- Controlled Substance Act
 Issue/rescind licenses to authorized prescribers,
pharmacies and pharmacists
 With FDA assess drug abuse liability and schedule
 Issue national quota for industrial production or
importation of each CS
 Control returns and destruction of CS
Federal Initiatives
 Center for Medicare Services – Insurability
 EPA – Environmental Protection Act
 Drugs as waste – water, air, and land
State Initiatives
 New laws and regulations
 KY HB 1 – see handout
 Facilities and ownership
 Prescribing and dispensing
 KASPER
 Medicaid – reimbursement pressures
 Pharmacists and dispensing
 Substance abuse treatment and harm reduction
Other Initiatives
 Licensing Boards – Professional Standard of Care
 Professional Societies – Guidelines, Best Practices
 Local government
 Ordinances to ban pain clinics
 Zoning restrictions on locations
 Law enforcement drug take-back days
 Public Health – Substance abuse treatment and harm
reduction
Professional Duty
 Prescribe and Dispense Legally Authorized
and Therapeutically Appropriate Analgesics
 Consistent with getting the right drug to the
right patient
 Denial of opioid to a legitimate patient can
be a liability
 Giving access to an inappropriate patient
can be a liability
Controlled Substance Duty Grid
Valid?
Yes
 Is Rx legally valid?
No
Ther.
App.?
Yes
Prescribe
Dispense
Error
No
Error
Error
 Is Rx therapeutically
appropriate?
 How do you decide?
 What is the balance of
harms when you err?
Duty Expanded
 Knowledge-based standards apply
 You have the background to know the
benefits and harms
 Professional standards apply
 Meaning that you have to exercise good
judgment
 Patient and societal expectations apply
Biases that lead to under-treatment of pain
 Just “Say No” is not appropriate
 Play it safe, no harm if drug retained or “ not
stocked”
 Prejudice/ bias against minorities and poor
 Fear of regulation or liability
 Reimbursement problems
 Off label use
Areas Where Care/Caution is Necessary
 Obvious Fraud – bulk Rx writing
 Ambiguous Rx
 Over-zealous screening – conservatism and alienating
patients
 What else is required?
 Preserving patient care relationship
 Go beyond processing and make sure patient’s pain
therapy goals are being met
Challenges to Duty
Palliative Care
 Pain Relief Promotion Act
 Oregon law permitted physician assisted suicide,
including use of Controlled Substances, “in violation of
the Controlled Substance Act”
 It is/was illegal to use a drug to hasten death
 Tension between the spectrum of



improved pain management (analgesia at what cost in SE)
palliative care, and
physician assisted suicide
 Recent Supreme Court Ruling Against U.S. DOJ
What Are Additional Resources &
Requirements to Manage Pain
Therapy and Abuse/Overdose
Risks?
 Industry has developed abuse-resistant
formulations
 Industry-based educational programs
 KASPER and similar databases to query
 Doctor shopping
 Pharmacy shopping
 Over-use
 Enhanced law-enforcement
Food and Drug Administration
Responses
 Risk Evaluation and Mitigation Strategies (REMS)
Required for New Drug Approval – long-acting or
extended release products
 Also materials and practices are required for generic
drugs of originally approved drugs
 Clinical trials to assess risk
 Post-marketing trials to assess signals of risks or new
unexpected risks
Medication Guides and Patient
Package Inserts
 Communication tools
 Medication Guides
 Follow FDA approved labeling
 Based on additional professional labeling
 Required to be dispensed with the drug
 Actiq example

www.actiq.com/pdf/actiq_med_guide_4_5_07.pdf
Communication Plans
 Industry must inform key audiences
 Letters to providers
 Information about REMS and safety protocols
 Information through relevant professional societies
Elements to Assure Safe Use
 Prescriber training, certification and demonstrate that:
 Understand risk-benefit and read materials
 Can diagnose product for the condition
 Can diagnose and treat adverse events associate with the
risks of the drug product
 Pharmacies, practitioners and healthcare settings must the
certified
 Drugs dispensed only in certain settings
 Patients are in a registry, subject to monitoring and subject
to testing
Dispenser Assurances for Safe Use
 Only certified pharmacists enrolled in the REMS
 Only certain providers and settings
 Enrollment requires forms, and,
 Systems and protocols for safe use
 Training for dispensers and drug administrators
 Provide information on program adverse events to
FDA
Patient Assurances For Safe Use
 Document understanding and consent
 Pregnancy, drugs or abuse and LFTs
 Subject to monitoring at least every 6 months
 Must be enrolled in a registry
Implementation Systems and
Assessment Programs
 Industry to work with healthcare providers to assess
compliance, adverse events, etc.
 Develop and maintain databases
 Providers, patients, dispensers, etc.
 Provide reports and assessment of activity, adverse
events, known risks and potentially new and unknown
risks
Patient Risk Assessment and
Safe Use
 Group I – no past or present personal or family
substance abuse issues or addiction
 Group II – past or family history but no current active
addiction
 Group III – Patients with active substance abuse
disorder or significant psychopathology
 Screening tools are available
How to Avoid Professional
Jeopardy
 Are you operating
 “inside the box”, or
 “outside the box”, which can be OK for some patients,
 in relation to the legal standard of care?
 What is in the box?
 Typical pain indication (cancer, surgery, etc.)
 Daily dose of < 180 mg morphine equivalent
 Older patient
 Limited contact with non medical users
 No active psychiatric or substance abuse disorders
 Documentation, monitoring as appropriate
Pharmacists are Being Sued for
Dispensing Opioids
 Kentucky, Ohio, Nevada and others
 Remember your duties
 Ask questions
 Get help
 Board of Pharmacy
 Drug Control Board
 DEA
5 Steps Pharmacists Must Take
to Ensure Validity of CS Rx
 Ensure state authorized prescribers write/order
 Prescription is written in the usual course of treatment
 Verify DEA registration
 Access prescriber and patient within prescription
monitoring program
 Review the entire prescription order
 Changes or alterations in Rx
 Description of or access to treatment plan
 Date of issuance
 State specific versus federal requirements
 Documentation of your actions
Options When There is a
Concern Regarding
Inappropriate Prescribing
 Examine state law options regarding retention, return
with note on back, or simple return to patient
 Contact the pharmacy PIC and or management about
concerns
 Or contact Board of Pharmacy, Board of Medicine,
DEA to investigate
 A KY pharmacist may seize a prescription thought to
be inappropriate. Must turn over to law enforcement
within 24 hours.