(Pharm Law) M1 - Terms and Concepts

all federal laws/treaties are the highest order (supreme law)

if there’s a conflict btwn a federal or state law, the federal law will overrule and apply (“preempts”)

1. Bill (proposal for new law) is introduced
2. A committee will research, discuss, and edit bill
3. Bill is put before a Congress chamber for voting
4. Bill passes to another Congress body to vote and work together to agree on a version of the bill
5. Bill passes onto the president to approve or veto
6. Congress can vote to override the veto

- Government/state vs person
- Usually has: violation of a statute
- Punishment: jail and fines
- Burden of proof: beyond reasonable doubt

- Person vs person
- Usually has: injury and compensation
- Punishment: fines
- Burden of proof: with evidence

- Agency (Board) vs licensee (pharmacist)
- Usually has investigation and discipline
- Punishment is fines and license at stake
- Burden of proof: with evidence

medical error/neglect that results in harm, injury, or death to a person

- You directly broke a rule/law/statute
- So no need to prove your negligence with the 4 legal elements

employer/leader (pharmacist) is responsible for acts of employees under their supervision

plaintiff/pt could’ve avoided the consequences of negligence so they must share blame/damage compensation

- Time limit on when a malpractice claim must be filed
- Oregon = 2 yrs from injury discovery and 5 yrs from negligence

1. Duty owed to patient
2. Breach of duty
3. Injury caused by breach
4. Resulting damages

dollar value of actual damage (ex: medical bills, attorney fees)

excess compensation as punishment for inhumaneeckless disregard

- Meds directly caused the injury
- ex: dispensed pt wrong dose, giving them heart failure

- Meds physically led to the injury, whether or not foreseeable
- ex: failed to warn pt on side effect, drowsiness from meds caused pt to crash truck

- drug for treating, preventing, or diagnosing a rare disease/condition
- disease <200k ppl in US or expected unprofitable for 7 yrs after FDA approval

- Risk Evaluation and Mitigation Strategy
- drug safety programs for meds with serious risks that require special monitoring

- Large scale compounders
- Don’t need to compound for individual pt’s
- Subject to cCMP and FDA inspections

- Small trad. compounders
- Can only compound for individual pt’s
- Exempt from cCMP and FDA drug approval

- Supplements diet or increases dietary intake of something
- FDA cannot require pre-market approval for safety or efficacy
- May use broad or general claims, but not specific ones

- *Made* wrong or badly
- Prepared/packed under unsanitary conditions
- Drug’s strength, quality, purity is different than label

- *Labeled* wrong or badly
- False or misleading labeled
- Label missing required info
- Imitates another drug

- lists and rates bioequivalence of drugs (A = good, B = not really)

- AA: no problems (in conventional dosage forms)
- AB: confirmed thru studies
- AT, AO, AP, AN: specific to dosage forms
- BC, BD, BE, BP, BX: some concern or lack of data confirming bioequivalence
- B*: new concerns requiring further investigation

- abuse potential: high
- dependence: high
- medical use: none or lack of supporting info

- abuse potential: high
- dependence: severe dependence
- medical use: yes

- abuse potential: less than C1-2
- dependence: mid-low dependence
- medical use: yes

- abuse potential: less than C3
- dependence: limited dependence
- medical use: yes

- abuse potential: low
- dependence: limited dependence
- medical use: yes

- paper form used to order C1-2 substances
- can only order 10 or less items

used for reporting loss of controlled substances

- Controlled Substance Ordering System
- electronic form used to order C1-4 substances
- can order more than 10 items
- uses digital certificates on specifically identified computers

Emergency C2 Rx:
- Prescriber can call in a Rx
- Pharmacist must immediately write down or record
- Rx must be given to pharmacy in 7 days

Partial filling of C2: only in special cases–
- If pharmacy out of stock (fill within 3 days)
- If pt/prescriber requests partial fill (fill within 30 days)
- If pt is terminally ill or LTCF (fill within 60 days)

must keep distribution records for C3-4 drugs for 2 yrs

- must do Form 222 (to pharm) and Form 41 (to DEA) after destroying meds
- must keep all records

- Must recount and check inventory of controlled substances every 2 yrs
- If in Oregon, must check every yr
- If there’s a new PIC, must do inventory within 15 days

- licensed company that can safely dispose controlled and uncontrolled substances
- needs to be DEA registered (not required for deliverer company)
- ex: expired, unused, recalled, damaged, overstocked, controlled prescriptions and substances

- anyone who works with controlled substances must register

- Business registration: manufacturer, distributor, dispenser, researcher, lab analyzer, compounders
- Prescriber registration: physicians (MD/DO), DDS, DVM, NP, ND
- Exemptions: employee of registrant (pharmacist), common carrier (USP, USPS), employee of wholesaler, patient

Opioid Treatment Programs

- Registration: required
- Receiving records: DEA Form 222
- Rx's: written (oral Rx's only allowed in emergencies)
- Refills: no
- Maintenance of Rx: separate files
- Distribution btwn registrants: DEA Form 222
- Security: locked cabinet / dispersed among non-controlled pharmaceuticals
- Theft: report to DEA and complete Form 106

- Registration: required
- Receiving records: invoices, readily retrievable
- Rx's: written, oral, fax
- Refills: 5 or less within 6mo
- Maintenance of Rx: separate files or readily retrievable
- Distribution btwn registrants: invoices
- Security: locked cabinet / dispersed among non-controlled pharmaceuticals
- Theft: report to DEA and complete Form 106

- Registration: required
- Receiving records: invoices, readily retrievable
- Rx's: written, oral, fax
- Refills: as authorized during Rx issueenewal by provider
- Maintenance of Rx: separate files or readily retrievable
- Distribution btwn registrants: invoices
- Security: locked cabinet / dispersed among non-controlled pharmaceuticals
- Theft: report to DEA and complete Form 106