Acts & Regulations

Question 1

FDA

Answer 1

• Evaluates applications for new drugs, biologics, medical devices & food
• regulate pkg insert
• regulate advertising of drugs
• approve new drugs to be sold in US
• issue recalls
• advisory committees

Question 2

DEA

Answer 2

• federal agency (dept of Justice)
• enforce controlled substance act (CSA)
• track controlled substances manufactured & sold
• investigate violations re controlled substances

Question 3

Pure Food & Drug Act 1906

Answer 3

• First law to restrict drugs
• purpose was to stop sale of inaccurately labeled food & drugs
• label must have truthful info before marketing
• manufacturer not required to stop claims or have inspections

Question 4

Harrison Narcotic Act 1914

Answer 4

• registration required for anyone involved with opiates (production, distribution, importation, etc)
• increased record keeping for dr, RPH dispensing narcotics
• dr allowed to dispense narcotics in course of professional practice

Question 5

Food Drug & Cosmetic Act 1938

Answer 5

• strengthened earlier food & drug act
• demonstrate safety before marketing
• directions for safe use required and pkg inserts
• cosmetics and medical devices
• adulteration/misbranding defined & prohibited; prohibit false therapeutic claims
• narcotics require a warning label

Question 6

Durham Humphrey Amendment 1951

Answer 6

• legend vs otc
• rx drugs were those that demonstrated lack of safety if used without medical supervision
• required label warning: “fed law prohibits dispensing w/out rx.”

Question 7

Kefauver-Harris Amendment 1962

Answer 7

• required proof of safety & effectiveness for new drugs before marketing
• stricter control over drug trials (application required); informed consent for clinical trials
• reporting adverse affects to FDA
• disclose side effects & benefits
• GMP =Good Manufacturing Practice regulates manufacturing; inspections every 2 years

Question 8

Comprehensive Drug Abuse Prevention and Control Act 1970 (aka Controlled Substance Act)

Answer 8

• requires security and strict record keeping for CS
• schedules created based on potential for abuse, medical use & safety
• DEA established to enforce laws concerning narcotics/distribution

Question 9

Narcotic Addiction Treatment Act 1974

Answer 9

• legalized use of methadone to treat opioid use disorder

* limited methadone dispensing to certain clinics (opioid tx programs OTP, registered)

Question 10

Orphan Drug Act 1983

Answer 10

• bypass certain restrictions to produce meds for rare diseases
• these drugs may lack statistical info due to lack of subjects
• still required to be safe, effective, stable, dosing, etc
• help motivate drug manufacturers to make these specialty drugs

Question 11

Prescription Drug Marketing Act 1987

Answer 11

• prevents sale of substandard or counterfeit drugs; diversion, reimportation from other countries
• drug samples need to be accounted for, not sold to consumers
• requires licensing of wholesale distributors, safe storage of drugs, maintenance of distribution records
• hospitals can’t resale

Question 12

Omnibus budget reconciliation act (OBRA) 1990

Answer 12

• enacted to reduce health care costs, improve quality of drug therapy -as safe and effective as possible
• RPH required to counsel all new meds for Medicaid (some states have adopted this for all rx’s), DUR/DUE required including interactions, duplications, dosage, allergies, evidence of abuse/misuse; maintain pt records with allergies, disease states, other meds being used.
• maintain proper pt records

Question 13

Health Insurance Portability & Accountability Act 1996 (HIPAA)

Answer 13

• enacted to improve portability & continuity of health insurance coverage
• address use and disclosure of protected health information
• Ensures pt info is properly secured while still allowing flow of information to provide healthcare.
• national standards to protect pt sensitive health info
• requires pt consent to disclose info

Question 14

Drug addiction act of 2000

Answer 14

• dr may now prescribe CS I’m schedule 3-5 in outpatient setting
• Dr must be certified and get special DEA #

Question 15

Combat methamphetamine epidemic act 2005

Answer 15

• under patriot act
• limits sale of pseudoephedrine, ephedrine, and phenylpropanolamine
• 3.6/day, 9g/month, 7.5g by mail
• must store behind the counter or locked cabinet
• requires written log of purchases
• requires sellers to submit certification they’re in compliance and that employees selling have been trained

Question 16

Anti-tampering act 1982

Answer 16

• otc and cosmetic

* pkg must have seal or tab to let consumers know if product has been opened

Question 17

Poison prevention act 1979

Answer 17

• pkg cannot be opened by 80% of kids under 5, but can be opened by 90% of adults
• req for aspirin, acetaminophen, ibuprofen, iron with more than 250mg per pkg, all oral rx drugs, oral CS, drugs switched from rx to otc, lidocaine, dibucaine, minoxidil
• exempt: drugs used in nursing homes, sublingual nitroglycerin and others that need quick access

Question 18

DEA form 106

Answer 18

SIGNIFICANT LOSS or theft:

• based on which CS is lost
• notify w/in 1 business day of discovery

Question 19

DEA form 222 or CSOS (controlled substance ordering system)

Answer 19

Used to order CI and CII

Question 20

DEA # verification

Answer 20

• add digits 1,3, and 5
• add digits 2,4, and 6; multiply by 2
• add first amount and second total
• last digit of this sun should match the last digit of the DEA #

Question 21

DEA lettering

Answer 21

First letter represents type of practitioner (a,b,f,g-hospital,clinic, practitioner,teaching institution or pharmacy; m=mid level practitioner such as nurse practitioner; p, r is manufacturer, distributor, researcher, narcotic treatment program
Second letter should be first letter of practitioner’s last name

Question 22

DEA form 224

Answer 22

All pharmacies dispensing controlled substances must register with DEA using form 224

Question 23

DEA form 41

Answer 23

Required to submit prior to destruction of a controlled substance

Question 24

Parts of HIPAA

Answer 24

• HIPAA privacy rule: refers to pt PHI
• HIPAA electronic healthcare transactions & code sets standards: requires every provider using electronic to use the same healthcare transactions, code sets & identifiers
• HIPAA security rule: compels admin,?technical & physical safeguards to protect PHI

Question 25

FDA recalls

Answer 25

Class I: may cause serious adverse health consequences or death
Class II: may cause temp. or medically reversible adverse consequences
Class III: not likely to have adverse consequences
Market w/drawal: product has minor violation; removed from market & corrected
Medical device safety alert: device may present unreasonable risk of substantial harm

Question 26

DEA schedules and examples

Answer 26

Schedule I: heroin, ecstasy
Schedule II: codeine, morphine, oxycodone, OxyContin, fentanyl, methadone, hydrocodone, ADHD meds
Schedule III: codeine combos, androgel, testosterone, suboxone
Schedule IV: benzo’s, phenobarbital, carisoprodol, tramadol, zolpidem
Schedule V: codeine cough syrup, liquid lomotil, lyrica

Question 27

Restricted drug programs

Answer 27

iPledge: isotretinoin

CArES: clozaril administration registry enrollment; Clozapine USP orally disintegrating patient registry

StEpS: system for thalomide education and prescribing safety

Pseudoephedrine

Question 28

Misbranding

Answer 28

• false or misleading labeling
• can’t exclude name, place of manufacturer, packed, distributor
• label must be understood by ordinary people
• must include directions for use & warnings
• must have poison prevention pkg’ing
• must have “fed law prohibits dispensing w/out rx”

Question 29

Adulteration

Answer 29

• composition of product
• unsanitary, decomposed substances
• strength, quality, or purity below standard

Question 30

PDMP prescription drug monitoring programs

Answer 30

Statewide electronic databases that collect designated data on controlled substances dispensed in the state