Legal and Professional Issues in Prescribing Flashcards
Federal Food and Drug Act of 1906
Enacted due to children dying from tainted food products
1938 Amendment to the Federal Food and Drug Act
Made after more than 100 children died after taking sulfanilamide
1962 Harris-Kefauver Amendment
Mandated preclinical animal trials before testing drugs in children
Orphan Drug Act of 1983
Fosters drug development for rare diseases
Drug Price Competition and Patent Term Restoration Act of 1984
Expanded the number of generic drugs suitable for an abbreviated new drug application (ANDA)
Pediatric Research Equity Act 2003
Required pediatric studies of safety and efficacy
Drug Quality Safety and Security Act in 2013
Enhanced security provisions within the drug supply chain
Increased ability to trace drug distribution and recall in the event of a harmful product
U.S. Food and Drug Administration
FDA
Regulates
- The approval process for new drugs or new indications
- Official labeling
- Surveillance of adverse drug events
- Methods of manufacture and distribution
- Medical devices
- Advertising of prescription drugs
Does not regulate prescribing
New Drug Approval Process
Preclinical Research
Phases of drug testing before approval
- Phase I
- Phase II
- Phase III
New Drug Application
Post marketing research
Expedited New Drug Approval
Priority review
Breakthrough therapy
Accelerated approval
Fast track
Official Labeling
FDA regulates what goes on a label
- Labeling on OTC drugs
- Insert in prescription drugs
Off-label prescribing
- Prescribing for use not indicated on the official FDA label
- Legal
- Decision is based on:
- Understanding of the medication being prescribed
- Rational scientific principles
- Expert medical opinion (the literature)
- Controlled clinical trials
Controlled Substance Laws
Regulate the manufacture and dispensing of drugs identified as “controlled” drugs
U.S. Drug Enforcement Administration (DEA)
- DEA number: registration with the DEA
- Manufacture, prescribing, dispensing
DEA rules
- Record keeping
- DEA registration needed to prescribe controlled substances
- DEA number not used as the insurance billing number
Schedule I
No accepted medical use
No legal use permitted
For registered research facilities only
Heroin, lysergic acid diethylamide (LSD), mescaline, peyote, marijuana
Schedule II
No refills permitted
Written prescriptions only (no telephone orders)
Prescription expires in 72 hours if not filled
Narcotics (morphine, codeine, meperidine, opium, hydromorphone, oxyodone, oxymorphonem methadone)
Stimulants (cocaine, amphetamine, methylphenidate)
Depressants (pentobarbital, secobarbital)
Schedule III
Prescription must be rewritten after 6 months or 5 refills
Telephone prescription accepted
Narcotics (codeine in combination with non-narcotic ingredients not to exceed 90mg/tab; hydrocodone not to exceed 50mg/tab)
Stimulants (benzphetamine, chlorpheniramine, diethylopropion)
Depressants (butabarbital)
Schedule IV
Same as schedule III
Penalties for illegal possesion are different
Pentazocine, propoxyphene, phentermine, benzodiazepines, meprobamate
Schedule V
Same as all prescription drugs
May be dispensed without a prescription unless regulated by the state
Loperamide, diphenoxylate
Controlled Substance Prescribing Precautions
Prescription pad should be stored in locked area
Tamper proof paper
Name, national provider identifier (NPI), address, and telephone number on pad
DEA number if controlled substance
Date
Refills
Spell out quantity
Fax or electronically transmit any prescription except for schedule II drugs
Opioid Prescribing
Legitimate for pain control Accurate assessment and diagnosis -Pain is subjective -Use a valid tool -The screener and opioid assessment for patients in pain -Pain treatment plan -Referral to pain specialist -Pain contract
Prescription Drug Misuse
Principles for Prescribers
- Use of chemical dependence screening skills
- Limit-setting regarding controlled drug prescribing
- Documentation of confirmed diagnosis and the ruling out of chemical dependence before initiating a controlled prescription
- Practice just saying “no”
Drug Scams
Dealing with scams consists of the following steps:
- Learning to recognize the common ones
- Refusing to give in to them
- Practicing the skill of turning the tables on the scammer
Be aware of forging and altering of prescriptions
Prescriber Issues
Pressure to prescribe
Enabling
Dealing with patients who misuse medications
- Communication
- Confrontation
Systemtic solutions to misuse by patients
- Careful documentation
- Electronic medical record
Use of prescription drug monitoring program
Medication Agreements
“Pain Contract”
Universal standards for all patients without cancer
Urine drug screens
Example of pain contract
State Law
Federal government decides what a prescription drug is
States decide who can prescribe
- Prescriptive authority varies from state to state
- States determine how independent an NP is in prescribing
DEA number is obtained from the DEA, but states determine scope of controlled substance prescribing
