Drug Reimportation & Professional Negligence

A pt asks you for advice on purchasing drugs from Canada. What information should you provide?

Inform the pt that they are only allowed to purchase medications in the US, and assist them in finding alternative ways to save money

Can pts import medications from Canada?

Yes -> As long as they physically do it themselves (not CS or biologics)

**Must be FDA approved meds

Can pts import controlled substances from Canada?

What about "personal use exemptions" for importation of CS (regardless of country)?

Pts can import CS, up to 50 dosage units (must be in fully labeled bottle)

Is there ever a situation where non-FDA approved drugs may be imported into the US? (2)

Pt must fill out a form stating that the drug is necessary (no US equivalent or failed options), and there is no US equivalent.

Physician must sign form

May anyone re-import FDA approved drugs?

Only the manufacturer - but only for emergencies

(i.e., Eli Lilly sends meds to India -> US has a shortage of those meds -> India ships meds back to us)

What is criminal law? (2) Example?

Defined the limitations of a relationship b/w an individual and society

(Intent to cause harm/knowledge that the law is being violated)

EX: Dispensing a drug w/out a Rx

Criminal law can be charged with...

A crime (if a statue is broken)

What is civil law?

Pertains to the relationship among individuals

(person v. person; i.e., lawsuits)

What party is the government in a civil suit?

The government is NOT a party!!

-> Only a party in criminal law

What are the 2 major subdivisions of civil law? (2)

Contract law

Tort law

What is contract law?

Duties that individuals have b/c they entered into a contract

What is tort law?

Duties created by law, NOT the parties themselves

What is the purpose of civil law? (2)

To compensate the inured party for damages caused by the wrongdoer

To determine an undesirable activity

What is administration law? Example?

Pertains to the relationship b/w government and a regulated trade, profession, or industry

-> (Cannot go to jail if broken a admin law)

EX: Ohio BoP Disciplinary actions

What is the purpose of administrative law? (2)

To determine an undesirable activity

Punish and/or rehabilitate the wrong-doer

Possible sanctions of administrative law? (4)

Warnings

Fines

License suspension/revocation

Probation

What is tort? What does it include? (2)

A civil wrong/wrongful act, whether intentional or accidental, from which injury occurs to another

Includes all negligence cases as well as intentional wrongs which result in harm

-> Person must prove injury/harm occurred!!

What is malpractice?

Negligence by a professional

What is the purpose of malpractice law? (2)

Deterrence

Compensation

What are the 4 elements of a Malpractice action?

Duty owed

Breach of Duty

Causation

Damages

In a malpractice action, the plaintiff must prove...

A 4 elements of a malpractice action

What is duty?

To act as a reasonable prudent pharmacist would in a particular situation or to meet a general standard of care

-> (i.e., the pharmacist must counsel)

What is breach of duty?

Failure to meet the standard of care or fulfill duties owed to pts

What is cause? (3)

Both actual and proximate (legal)

-> Generally to be proximate

-> Defendants action's are linked to plaintiffs harm

What is proximate cause?

If a defendant is to be liable for harm, each of the links must be foreseeable to the defendant

A pt continuously refills early refills of amitriptyline. Pt is stock piling and not taking QD as prescribed. Pt decides to take ~60 tabs and commit suicide. Is the dispensing pharmacist liable? (2)

The pt is stockpiling the medication, and taking it all at once would not be foreseeable by a prudent pharmacist

Therefore, this is a superseding case of the harm and breaks the chain of forgeability from the defendant's actions and the plaintiff's harm

What are damages? Examples?

Normally harm or damage cannot be undone, but courts will try to make the aggrieved party " whole" (put them in a comparable situation to the harm had not occurred)

EX: Loss of work and/or earning potential, pain/suffering, medical expenses

What are punitive damages?

Damages exceeding simple compensation and awarded to punish the defendant

What is vicarious liability? (2)

Pharmacists are generally liable for mistakes made by supervised techs

Employers are generally liable for mistakes made by employees, including RPh

What is malpractice insurance?

Often NOT covered if you WILLFULLY violate and statute

An intern compounds 46% cream instead of 0.46% cream. Pharmacist doesn't check it and assumes it's fine. It causes the pt 3rd degree burns.

How is the pharmacy liable?

Vicarious liability

A pharmacist is busy and accidentally switched the labels on a pts digoxin and erythromycin... The pt experiences digitalis toxicity and worsening of infection.

Would punitive damages be warranted?

No - wasn't "careless or reckless"

A pharmacist is busy and accidentally switched the labels on a pts digoxin and erythromycin... The pt experiences digitalis toxicity and worsening of infection.

How can the defense of comparative negligence be used in this case? Would it be good defense?