Chapter 4: Legal and Professional Issues in Prescribing Flashcards
Food, Drug and Cosmetic Act of 1906 (FDCA):
Established to oversee drug safety and labeling.
Created the Bureau of Chemistry, later the FDA.
Food, Drug and Cosmetic Act of 1938:
Implemented stricter drug safety regulations post-sulfanilamide tragedy.
Introduced pre-market safety testing and quality standards.
Kefauver-Harris Amendments of 1962:
Raised drug approval standards post-thalidomide tragedy.
Demanded proof of safety and efficacy, introduced informed consent.
Established GMP regulations and DESI program for drug evaluation.
Orphan Drug Act of 1983:
Addressed rare disease treatment scarcity via incentives for orphan drug development: tax credits, grants, market exclusivity.
Drug Price Competition and Patent Term Restoration Act of 1984:
Simplified generic drug approval for affordability, balancing innovation. Introduced patent extensions to compensate for regulatory review delays.
Pediatric Research Equity Act of 2003 (Pediatric Rule):
Tackled the absence of pediatric data on drug labels by mandating drug manufacturers to conduct pediatric studies for certain drugs, ensuring their safety and efficacy in children.
Drug Quality Safety and Security Act of 2013:
Enhanced oversight post-fungal meningitis outbreak. Bolstered supervision of compounding facilities, supply chain. Implemented drug tracking system to deter counterfeiting, diversion.
Scope of Authority:
FDA regulates drugs from premarket to post-market. It controls manufacturing, labeling, advertising, and distribution. Covers prescription and over-the-counter drugs, and medical devices.
Classification of Drugs:
Prescription drugs need a healthcare provider’s prescription. Over-the-counter drugs don’t need one but must meet FDA standards. FDA also regulates biologics like vaccines, blood products, and cellular therapies.
Preclinical Research:
Developing a new drug costs roughly $985.3 million, covering lab studies for pharmacological properties, toxicity, and therapeutic effects. Preclinical research pinpoints candidates for human testing.
Medical Devices Regulation:
FDA ensures safety and effectiveness of medical devices. Classified into three categories (Class I, II, and III) based on risk. Higher-risk devices face stricter regulations.
Investigational New Drug (IND) application
contains all known info about the drug compound.
Phase I trials:
Evaluate safety and pharmacokinetics in a small group of healthy volunteers.
Phase II trials:
Assess efficacy and side effects in a larger group of patients with the target disease.
Phase III trials:
Confirm efficacy, safety, and optimal dosage in a diverse patient population.
Phase IV trials:
Post-marketing studies monitor safety and effectiveness in real-world settings.
Bioavailability Studies:
Conducted on healthy volunteers to document the rate of absorption and excretion of a compound’s active ingredients from the body.
New Drug Application (NDA):
FDA approval: Submission includes preclinical/clinical data, manufacturing, labeling, risk plans. Expedited review for critical needs.
Expedited Processes for Drug Approval:
Priority Review
Breakthrough therapy
Accelerated approval
Fast track
Breakthrough therapy:
“Accelerates drug development for severe conditions, showing significant improvement over existing treatments, with evidence of reduced irreversible harm or death.”
Priority Review:
Directs the FDA to review the application within 6 months based on potential “significant improvement” in safety or effectiveness over current treatment.
Accelerated approval:
Allows drugs to be approved for a serious illness based on surrogate or intermediate endpoints which measure laboratory results or clinical effects.
Fast track
Development and review of drugs to treat serious conditions and that fill an unmet medical need.
Phase IV studies:
“Assessment conducted post-approval to evaluate long-term safety, effectiveness, and rare adverse events. Utilizes large-scale observational studies, registries, or post-marketing surveillance programs.”
MedWatch:
FDA’s system for voluntary reporting of adverse events, medication errors, and product quality issues. Open to reports from healthcare professionals, patients, and manufacturers.
Official Labeling:
FDA-approved prescribing information offers crucial details on a drug’s safety, dosage, and more. Healthcare providers depend on drug labeling to guide prescribing decisions and educate patients on medication usage.”
FDA-approved drug labeling
Offers guidance on approved uses, dosages, and administration. The FDA doesn’t regulate medical practice or dictate prescribing. Healthcare providers can prescribe off-label based on clinical judgment and evidence.”
Legend Drug/OTC
Requires a written prescription
Doesn’t require written prescription
Off-label use
When a drug is used for purposes not FDA-approved. This practice relies on clinical judgment, scientific evidence, or medical necessity. Healthcare providers assess risks and benefits, informing patients about alternative treatments when considering off-label use.”
Documentation and Risk Management:
Document reasoning for off-label prescribing in patient records.
Obtain informed consent, discussing risks and benefits.
Stay updated on new evidence and regulations regarding off-label drug use.
Controlled substances act of 1970:
Federal law governing controlled substances: Regulates manufacturing, distribution, and dispensing.
Classifies drugs into five schedules based on abuse potential and medical use.
Practitioners handling controlled substances must register and follow strict regulations.
Schedule I
No accepted medical use
No legal use permitted
For registered research facilities only
Schedule I Drug Examples
Heroin, LSD, Mescaline, Peyote, Cannabis, Fentanyl carbamate and other illicit fentanyl products
Schedule II
No Refills permitted
No telephone orders unless true emergency and followed up by written prescription within y days
Electronic prescription permitted as of 2011
Schedule II Drug examples
Narcotic (morphine, codeine, opium, hydromorphone, methadone)
Stimulants (Cocaine, amphetamine, methylphenidate)
Depressants (Pentobarbital, Secobarbital)
Schedule III
Prescription must be rewritten after 6 months or five refills
Telephone or fax prescription allowed
Schedule III Drug examples
Narcotics (Codeine in with a nonnarcotic ingredients > 90mg/tab)
Stimulants (benzophetamine, chlorpheniramine, diethylpropion)
Depressants (butabarbital, anabolic steroids, testosterone)
Schedule IV
Same as Schedule III
Penalties for illegal possession are different
Schedule IV Drug examples
Pentazocine, phentermine, benzodiazepines, meprobamate
Schedule V
Same as prescription drugs that are not controlled
May be dispensed without prescription unless regulated by the state
Schedule V Drug Examples
Loperamide, diphenoxylate, cough medications with less than 200mg/100mL
Pregabalin
Approved cannabidiol drugs
State Regulations
States have their own controlled substance laws, which can be stricter than federal regulations.
Nurse practitioners must adhere to both federal and state laws when prescribing controlled substances, including obtaining necessary licenses and DEA registration.
Cannabis regulation:
Cannabis is classified as a Schedule I drug with no recognized medical use under federal law.
Some states have enacted laws permitting cannabis use and possession for both medical and non-medical purposes.
Storage and handling of prescription pads/paper:
Store controlled substance prescription pads in a locked area.
Do not sign prescriptions in advance or use them as notepads.
Required information on controlled substance prescriptions:
Prescriber’s name, NPI number, address, and phone number.
Some states may require NP’s license number and supervising practitioner’s.
DEA registration number.
Date of prescription (day written), authorized refills, and clinically appropriate quantity (spelled out with Arabic numerals).
Prescription transmission:
Faxing to the pharmacy is generally acceptable for controlled substances except Schedule II drugs.
Exceptions for Schedule II drugs include nursing homes, hospices, or parenteral medications for home IV administration.
Electronic transmission is allowed per DEA regulations, with many states mandating e-prescribing via secure software.
Tamper-proof prescription pads:
Required for Medicaid prescriptions since 2009.
Recommended for all written prescriptions, especially for drugs with abuse potential not federally controlled.
High abuse potential:
methadone, amphetamines, scheduled appetite suppressants.
Medications with problematic adverse-effect profiles:
meperidine, butalbital.
Medications with narrow safety margins:
secobarbital, pentobarbital, meprobamate, methadone, ethchlorvynol.
Medications with little established efficacy:
carisoprodol, butalbital, scheduled appetite suppressants.
Opioid Prescribing:
Acute pain: Legitimate clinical usefulness.
Chronic pain: Ongoing use questionable.
Buprenorphine and methadone: Prescribed for pain and opioid use disorder treatment.
Comprehensive Addiction and Recovery Act (CARA)
NPs and physician assistants authorized to prescribe buprenorphine under
Management of Patients with History of Substance Abuse:
Special attention and consideration for titration to noncontrolled options.
Genuine symptomatic need established by adequate diagnostic confirmation and evaluation.
Withdrawal/Tapering:
Caution required for withdrawal or tapering of opioids and benzodiazepines.
Quick taper (< 4 weeks) of benzodiazepines rarely warranted or achievable.
Patient education:
Advise patients on the dangers of combining drugs with alcohol.
Avoid prescribing benzodiazepines to those with substance use disorders or on methadone.
Importance of prescriber education to prevent controlled substance misuse.
Principles for Prescribers/Prescription drug misuse assessment:
Acquisition of chemical dependence screening skills.
Establishment of firm parameters for controlled drug prescribing.
Documentation of confirmed diagnosis and ruling out of chemical dependence.
Practice in providing alternatives without escalating into arguments.
Behavioral Red Flags:
Predictors of addiction: Forging prescriptions, selling drugs, illicit drug use, unapproved dose increases, and repeated prescription losses.
Common diversion techniques: Prescription alteration and forgery
Communication Skills:
Red flags identification and defusing (“Just say NO”).
Empathetic conversations using SBIRT for substance use.
Implementation of medication agreements for chronic pain management.
Document clearly in a progress note
Physical evaluation of the patient
The diagnosis
The clinical indications for treatment
The written treatment plan
The expected symptom outcomes
Informed consent and agreement for treatment from the patient
Consultations and/or collaborations necessary to meet treatment goals and objectives.
Prescription Drug Monitoring Programs (PDMP):
Active in all states.
Allows practitioners to access a confidential statewide database of controlled substances.
Some states permit sharing information across states to prevent multiple prescriptions from multiple providers.
Additional Tips for Prescribing:
Conduct a thorough history and exam before prescribing controlled substances.
Limit initial prescriptions without refills to allow for patient assessment.
Educate staff on clinic policies.
Calculate and document morphine equivalent dose.
Discuss naloxone prescription for harm reduction, required by some state laws.
Four “As” for initial and ongoing assessment of medication efficacy
analgesia, activities of daily living (ADLs), adverse effects, and abuse issues.
Additional Considerations for Prescriber Education:
Keep updated on guidelines and regulations.
Attend courses on pain management and safe prescribing.
Collaborate with colleagues and specialists.
Watch for substance misuse signs and intervene when necessary.
Advocate for systemic changes promoting safe prescribing.
State Law and Prescriptive Authority Jurisdiction:
Federal law determines if a drug needs a prescription.
State laws dictate who can prescribe.
Prescriptive authority varies among states.
States license healthcare professionals and may allow cross-state practice.
Regulation of NP Practice:
NP regulation began in the 1960s as an extension of RN roles.
The National Council of State
Boards of Nursing supports licensure as the standard for NP regulation.
State boards can take regulatory actions, like emergency suspension, to safeguard public health.
Prescriptive Authority:
States specify NP titles and prescription clarity.
Prescriptive authority can be independent or dependent.
Some states impose prescribing restrictions.
State-Specific Elements:
State practice acts set licensing and scope of practice.
Some states mandate collaborative agreements for prescribing.
Electronic prescribing follows DEA and state regulations.
Informed Consent:
Informed consent is essential for patient autonomy.
Competence includes legal and clinical aspects.
Providers must ensure patients understand risks, benefits, and their right to refuse treatment.
Prescribing for Self, Family, or Friends:
Prescribing for oneself or close relations raises ethical concerns.
Referral to another provider ensures impartiality and ethical standards.
State laws vary on the permissibility of prescribing for family or friends.
Sale of Pharmaceuticals and Supplements:
Selling pharmaceutical samples is illegal as they’re for free distribution.
Limited sale of meds in practice may be legal, but ethics should be considered.
NPs should be transparent and fair in pricing and distribution.
Canada:
NPs have prescribing authority supported by a national pharmacy system.
Provincial formularies guide prescribing for consistency.
The Canadian Nurse Practitioner Core Competency Framework standardizes NP education and practice.
United Kingdom:
NPs and pharmacists can prescribe based on national guidelines, promoting collaborative care and efficient medication management.
Australia and New Zealand:
NPs gained prescribing authority in Australia and New Zealand, improving primary care access and interdisciplinary collaboration.
The International Council of Nurses facilitates global APN collaboration and knowledge exchange.
