Risk Management and the Controlled Substances Act: The FDA Perspective

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Risk Management and the Controlled Substances
Act The FDA Perspective

• Deborah B. Leiderman, M.D., M.A.
• Director
• Controlled Substance Staff
• Center for Drug Evaluation and Research
• Food and Drug Administration

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Controlled Substances Act (CSA) 1970

• Enacted to comply with international treaties and
  efforts to combat drug trafficking and to assure
  drug availability for legitimate medical use
• Established five schedules and levels of control,
  CI-V
• Drug classes opioids, depressants, stimulants,
  hallucinogens

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CSA 1970

• Schedule I (CI)
• Most restrictive
• Reserved for drugs with high abuse potential and
  no recognized medical use
• Examples heroin, LSD
• Schedule II-V (CII-V)
• Descending abuse potential and restrictions
• Drugs have medical use in U.S.

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Schedule II Opioid Analgesics

• Highest level of control for drugs with
  recognized medical use
• Highest potential for abuse abuse potential
  comparable to CI drugs
• Pose the greatest risk to the public health

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Schedule II Opioid Analgesics

• Health care system, medical practice, and
  prescribing patterns significant change since
  1970
• CII drugs in past operating room and inpatient
  settings
• Advances in science, medicine, and
  pharmacotherapy have transformed much disease and
  trauma into chronic illness
• Care moved to outpatient setting

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Schedule II Opioid Analgesics

• Oxycodone, morphine, fentanyl, hydromorphone
  classified as CII under the CSA
• Schedule II designation applies to all strengths
  and dosage forms of the drug
• No differentiation between 5 mg oxycodone and 160
  mg OxyContin, fentanyl injectable 20 µg, 2 mg
  patch, morphine 5 mg tablet
• CII encompasses broad range of drug classes,
  potencies, and dosages. Comparable to range
  CIII-CV

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Range of Schedule II Drugs
OPIATES
BARBITURATES
STIMULANTS
Fentanyl 100-250 µg/2mL 2.5-10 mg/patches
Cocaine Topical Solution 4, 10
Morphine 10mg/mL inj. 15-30 mg tabs
Methamphetamine Amphetamine 5-30 mg caps tabs
Secobarbital Amobarbital Pentobarbital
MS Contin 15-200 mg tabs
Hydrocodone Substance
OxyContin 10-160 mg tabs
Hydromorphone 2-8 mg tabs
Oxycodone comb. 5-10 mg tabs
Oxymorphone 1-1.5mg/mL inj.
Methylphenidate 5-54 mg caps tabs
Methadone 5-40 mg tabs
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Range of Schedule III-V Drugs
Schedule IV
Schedule V
Schedule III
Codeine Hydrocodone (comb.) Dihydrocodeine Bupre
norphine
Codeine (comb.) Dihydrocodeine Diphenoxylate
Dextropropoxyphene Pentazocine Butorphanol
Zaleplon Zolpidem
Gamma hydroxybutyrate (GHB)
Sibutramine Modafinil
OPIATES
Dronabinol
DEPRESSANTS
Alprazolam Diazepam Midazolam Quazepam
STIMULANTS
Anabolic Steroids
BENZODIAZEPINES
OTHER
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What does Schedule II require?

• Manufacturing quotas set by DEA (input on medical
  need from FDA)
• Distribution tracking
• Import and export controls
• Registration of prescribers and dispensers
• No refills

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Schedule II does not require

• Physician/practitioner education
• Limits on drug quantity prescribed or dispensed
• Prescription monitoring

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Regulation of Controlled Substances
State Regulatory Authorities
Approval Labeling
Patients Community
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DEA Role

• CSA requires DEA to
• - Register drug manufacturers
• - Establish quotas
• - Register dispensers and prescribers
• CSA does not provide for
• - Prescriber education
• - Knowledge assessment
• - Active surveillance

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FDA Role

• Regulates drug manufacturers
• Reviews and approves drug products - -safe and
  effective
• Drug label primary method for communicating
  information to prescribers and dispensers
• Post-marketing Safety/Pharmacovigilance
• FDC Act does not distinguish between controlled
  and other drug products

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State Role

• Boards of Pharmacy and Medicine primary
  regulators of physicians and pharmacy practice
• States may impose additional drug controls
• Authority, regulations, practices, and resources
  vary across states

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Prescription Drug Monitoring Programs (PDMPs)

• State purview
• Goal to reduce illicit use of prescription drugs
• Deter and identify doctor shopping, illicit
  sales of prescriptions and drugs, forged
  prescriptions
• Collect, review, analyze prescription data from
  pharmacies
• Variable structure, resources
• Database query some electronic
• Active surveillance
• 15 States active PDMPs 2002

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Regulation of Controlled Substances
State Regulatory Authorities
Approval Labeling
Patients Community
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Risk Management and Drug Scheduling

• High-dose, extended-release Schedule II opioid
  analgesic products not distinguished from other
  Schedule II drugs in CSA
• Scheduling under the CSA does not manage all
  risks of misuse, abuse, and overdose of
  prescription drugs
• Drug scheduling alone cannot address challenges
  posed by high-dose opioid analgesics in context
  of the modern health care system with the current
  patterns of medical practice and ease of access
  to information and drugs