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Pharmacology > Legal and Professional Issues in Prescribing > Flashcards

Legal and Professional Issues in Prescribing Flashcards

1
Q

Federal Food and Drug Act of 1906

A

Enacted due to children dying from tainted food products

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2
Q

1938 Amendment to the Federal Food and Drug Act

A

Made after more than 100 children died after taking sulfanilamide

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3
Q

1962 Harris-Kefauver Amendment

A

Mandated preclinical animal trials before testing drugs in children

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4
Q

Orphan Drug Act of 1983

A

Fosters drug development for rare diseases

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5
Q

Drug Price Competition and Patent Term Restoration Act of 1984

A

Expanded the number of generic drugs suitable for an abbreviated new drug application (ANDA)

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6
Q

Pediatric Research Equity Act 2003

A

Required pediatric studies of safety and efficacy

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7
Q

Drug Quality Safety and Security Act in 2013

A

Enhanced security provisions within the drug supply chain

Increased ability to trace drug distribution and recall in the event of a harmful product

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8
Q

U.S. Food and Drug Administration

A

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

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9
Q

New Drug Approval Process

A

Preclinical Research

Phases of drug testing before approval

  • Phase I
  • Phase II
  • Phase III

New Drug Application

Post marketing research

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10
Q

Expedited New Drug Approval

A

Priority review

Breakthrough therapy

Accelerated approval

Fast track

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11
Q

Official Labeling

A

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
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12
Q

Controlled Substance Laws

A

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
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13
Q

Schedule I

A

No accepted medical use
No legal use permitted
For registered research facilities only

Heroin, lysergic acid diethylamide (LSD), mescaline, peyote, marijuana

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14
Q

Schedule II

A

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)

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15
Q

Schedule III

A

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)

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16
Q

Schedule IV

A

Same as schedule III
Penalties for illegal possesion are different
Pentazocine, propoxyphene, phentermine, benzodiazepines, meprobamate

17
Q

Schedule V

A

Same as all prescription drugs
May be dispensed without a prescription unless regulated by the state

Loperamide, diphenoxylate

18
Q

Controlled Substance Prescribing Precautions

A

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

19
Q

Opioid Prescribing

A 
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
20
Q

Prescription Drug Misuse

Principles for Prescribers

A
  1. Use of chemical dependence screening skills
  2. Limit-setting regarding controlled drug prescribing
  3. Documentation of confirmed diagnosis and the ruling out of chemical dependence before initiating a controlled prescription
  4. Practice just saying “no”
21
Q

Drug Scams

A

Dealing with scams consists of the following steps:

  1. Learning to recognize the common ones
  2. Refusing to give in to them
  3. Practicing the skill of turning the tables on the scammer

Be aware of forging and altering of prescriptions

22
Q

Prescriber Issues

A

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

23
Q

Medication Agreements

A

“Pain Contract”
Universal standards for all patients without cancer
Urine drug screens
Example of pain contract

24
Q

State Law

A

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

25
Q

Writing a Prescription

A
  1. Use preprinted prescription pads or electronic templates that contain the name, address, telephone number, and NPI number of the prescriber
  2. Write the complete drug name, strength, dosage, and form.
  3. Write the date of the prescription
  4. Use metric units of measure, such as mg and mL; avoid apothecary units of measure.
  5. Avoid abbreviations
  6. Avoid the use of “as directed” or “as needed”
  7. Include the general indication, such as “for infection”
  8. Write “dispense as written” if generic substitution is not desired
  9. Include the patients weight, especially if pediatric of older adult patients.
  10. Indicate if a safety cap is not required because medications will be dispensed with them by default.
26
Q

Issues in Writing Prescriptions

A

What may be prescribed

  • Legend drugs
  • Controlled drugs
  • Medical devices
  • Home health products
  • Home testing equipment, needles, syringes
  • OTC medications

State specific
-Each state can regulate prescribing details

Electronic health record

27
Q

Ethical Issues

A

Informed consent
Prescribing for family/friends
Sale of pharmaceuticals and supplements

Pharmacology (14 decks)

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