Controlled Substances: Prescribing

slides 43-68

Who may issue prescriptions for controlled substances?

an individual practitioner that is authorized by their state and is registered with the DEA (unless exempt)

who does proper prescribing and dispensing ultimately fall on?

practitioner

T or F:

A person knowingly filling an invalid script, as well as the person issuing it, are in violation of the CSA

T

What is the key legal principle from U.S. v. Hughes?

Pharmacists have a corresponding responsibility to ensure controlled substance prescriptions are legitimate and can face criminal liability for improper dispensing

What happened in U.S. v. Hughes and why was it illegal?

Pharmacist filled 20,000 T3 tablets/month Ignored obvious red flags

Result: 3 years in prison

What legal principle is demonstrated in U.S. v. Harold Donald Henry?

Pharmacists are still criminally liable if they fill prescriptions knowing or having reason to know they are not for a legitimate medical purpose (even if they verify with the prescriber)

What happened in U.S. v. Henry and why was it illegal?

Patients presented multiple controlled substance prescriptions One admitted intent to share medications Pharmacist still filled them

Result: 11 counts of illegal dispensing

What legal principle is demonstrated in Arkansas State Board of Pharmacy v. Fenwick?

BackPharmacists can face disciplinary action (license suspension/fines) for dispensing excessive or inappropriate quantities of controlled substances, even without criminal charges

What happened in Fenwick and what was the punishment?

Father/son pharmacists dispensed large amounts of anabolic steroids

Result: 60 day license suspension and $6k fine

Can a physician self prescribe?

yeah if it is in the usual course of practice

most states say a physical exam is needed

What does the AMA say about self-prescribing?

Should only be done in unusual/emergency circumstances

What are the required elements of a valid prescription for controlled substances?

• Date (actual date written)

• Prescriber signature

• Patient name & address

• Drug name, strength, dosage form

• Quantity

• Directions for use

• Prescriber name, address, DEA number

• Written in ink or non-changeable format

What are the requirements for the date and signature on a prescription?

Must be dated and signed on the actual date written (no postdating/backdating)

Can a non-DEA registered practitioner use a DEA number on a prescription?

yes they can use a DEA number that is assigned or associated with them (like an institutional DEA number with a suffix)

What is the difference between active and passive euthanasia?

Active: Direct action to cause death

Passive: Withholding/withdrawing life-sustaining treatment

What is active euthanasia and how is it legally viewed?

If patient does it → suicide

If another person does/assists → murder

What are examples of passive euthanasia?

• Removing ventilator

• Stopping life-saving medications

• “Letting nature take its course”

What is the difference between voluntary and involuntary euthanasia?

voluntary: pt chooses to end life

involuntary: pt does not consent

What characterizes voluntary euthanasia?

Patient makes the decision

Often part of end-of-life care

Patient may refuse treatment

What characterizes involuntary euthanasia?

No patient consent

Not always classified as murder (depends on context)

What is the key legal takeaway from the Kevorkian assisted suicide case?

Physician-assisted suicide can lead to criminal liability, including murder charges, depending on state law

What happened in the Kevorkian case?

dude assisted in over 100 pt deaths

michigan created laws to ban assisted suicide

dude was convicted of murder and served 8 yrs

What does the Oregon Death with Dignity Act allow?

A physician may prescribe a lethal dose of medication (usually a barbiturate), which the patient self-administers

What is the pharmacist’s role under the Oregon Death with Dignity Act?

The pharmacist may dispense the medication, but the patient must take it themselves

What does California’s End of Life Option Act allow?

Allows a patient to obtain a lethal medication through a physician, which is dispensed by a pharmacy and self-administered

What are the requirements under California’s End of Life Option Act?

3 total requests (2 oral and 1 written)

must be 15 days apart

What are key legal protections under California’s End of Life Option Act?

providers are not punished if acting in good faith

not legally called suicide

no coercion allowed

What does Louisiana law (RS 14:32.12) say about assisting suicide?

Any assistance (verbal or physical) in suicide is illegal

What are the penalties for assisting suicide in Louisiana?

up to 10 yrs in prison

up to 10k fine

What types of actions count as assisting suicide under Louisiana law?

verbal assistance and physical assistance

What is Louisiana’s policy on end-of-life care (RS 40:1299.58.10)?

The state values human life through natural death and opposes assisted suicide

Is physician-assisted suicide allowed in Louisiana?

NO

Are electronic prescriptions required for controlled substances?

no

What are required components of electronic prescribing for controlled substances?

certification and identity proofing

must keep a copy that is labeled

Can a provider sign multiple electronic prescriptions at the same time?

yes but only for the same pt

Do electronic prescriptions have to be sent immediately after signing?

no

What happens if an electronic prescription for a C-II fails transmission?

cannot be printed

must be physically written and signed

Can an electronic prescription be altered during transmission?

no

Are electronic prescription backups required?

no (recommended to keep them off site though)

Can an electronic prescription be converted back to paper?

no!

What must a pharmacist do when handling duplicate (printed) prescriptions?

Must ensure the prescription has not already been filled

What can a registered physician do for detoxification/maintenance therapy?

admin and dispensing

What can a registered physician NOT do for detoxification/maintenance therapy?

prescribe

What can a non-registered physician do for detoxification?

admin and dispense

limited to 1 day supply at a time for 3 days total

What is the key difference between registered and non-registered physicians in detoxification?

Registered: Administer & dispense (no prescribing)

Non-registered: 1-day supply only, up to 3 days total

What is the status of e-prescribing in Louisiana?

allowed but depends on DEA guidelines

What did SB 223 (2011) do in Louisiana?

allowed e-prescribing under controlled substance law

enabled reimbursement for e-prescriptions

What is the role of Louisiana administrative rules (2745 F) in e-prescribing?

Allows e-prescribing once DEA guidelines are met

Subject to future updates/revisions

Is e-prescribing required for controlled substances in Louisiana?

no (nothing is required to be e-prescribed)

Can Schedule II–V medications be e-prescribed in Louisiana?

yeah

What is the role of LABP and LABME in e-prescribing?

ensure system is compatible