Lec 1: Law Review Flashcards
How many total continuing pharmacy education hours are required to be completed upon the second renewal of a pharmacist’s license in this jurisdiction?
A. 15
B. 20
C. 25
D. 30
E. 40
D.
NOTE: all 30 hrs must be CEU!
-this can vary from different states
Food and Drug Administration (FDA): who is the FDA
The government agency responsible for regulating food, dietary supplements, drugs, cosmetics, medical devices, biologics and blood products in the United States.
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In the case of food supplements , the F.D.A. does almost nothing to ensure that dietary supplements work as advertised. It is only when supplements are proved to be unsafe or to contain regulated substances can the agency take action.
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NOTE: FDA hardly do anything to reg the supplements on the market! Look at USP lable on supplements - verify and confimring what you are taking is whats in bottle but does not go on level of FDA b/c it does not talk about efficiacy of the product! weather it works or not? weather it is safre or not? we dont knbow via USC?
FDA and Drugs
Basic Functions of FDA Drug Regulation
- Approval of drugs on the basis of purity, safety and effectiveness.
- Regulation of all labeling for prescription and nonprescription drugs.
- Regulation of advertising for prescription drugs (The Federal Trade
Commission [FTC] regulates nonprescription advertising). - Regulation of manufacturing processes of drugs and institution of recalls.
- Regulation of bioequivalence for generics and biosimilars.
- Monitoring of drugs post-approval to detect any problems with the use of
drugs, such as unanticipated adverse reactions (a.k.a.- postmarketing
surveillance) - Monitoring of the safety of the nation’s blood supply.
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Once the FDA has determined a drug is safe and effective to be sold in the US,
it has little direct control over how the drug is used or prescribed. - so FDA have nothing to do with off lable use of drug
Drug Enforcement Agency (DEA)
- Drug Enforcement Administration (DEA) is a US federal law enforcement agency under the US Department of Justice.
- Responsible for the enforcement of the provisions of the Controlled Substances Act as they pertain to the manufacture, distribution, and dispensing of legally produced controlled substances.
Where can you find the Federal Laws pertaining to drugs?
The Code of Federal Regulations (CFR) is the codification of the general and permanent rules (law)
published in the Federal Register by the departments and agencies of the Federal Government. It is
divided into 50 titles that represent broad areas subject to Federal regulation.
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NOTE: you will see CFR followed by a number - this pretains to a specific law (fed law) that you have to follow
Beginnings of Law-Food Drug and Cosmetic Act
1.) Pure Food and Drug Act of 1906
2.) Pure Food and Drug Act of 1912
1.) Pure Food and Drug Act of 1906- prohibited the adulteration (added impurity/ add bad things- can cause hard can be intentional or unintentional) and misbranding (labeled as something it’s not) in interstate commerce…but it failed.
- It lacked protection against false efficacy claims (they can say whatever they want!/ make false claim and promises)
- It didn’t regulate cosmetics or devices (this reg comes later)
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2.) Pure Food and Drug Act of 1912-prohibited the use of false efficacy claims- proved to be difficult to enforce.
- Difficult to prove fraudulent claims or intent
Food Drug And Cosmetic Act of 1938
- All marketed drugs must be proven safe and approved by the FDA! yay safety’s finally here… Example: sulfonamides issue! it was not the drug itself that was the issue, it was how it was made/ compounded! so this law looked at the safety of that.
- Labels on marketed drugs must contain “adequate directions for use” and habit forming warnings if applicable (NOTE: now we have to provide lay person instructions for patient to follow!)
- Cosmetics and Devices were now included as part of act
- Drugs that were marketed before 1938 excluded from law
Durham-Humphrey Amendment of 1951
- Prescription Drug Amendment
- Legalization of the verbal transmission of drug orders (first time! this law allowed for that!)
- Allowing pharmacists and interns to recognize refills if authorized on initial prescription
- Established two distinct classes of drugs: Prescription and Non-prescription-Over the Counter (OTC)
- “Caution-Federal law prohibits dispensing without a prescription” - law that you can not dispenses without prescription!!!
- Without this amendment pharmacists would be required to label prescriptions with same content as manufacturers.
Kefauver-Harris Amendment of 1962
- Drug Efficacy Amendment
- Thalidomide marketed in 1950’s as a popular drug used to treat morning sickness…Drug was distributed to the US in 1960s but the approval was withheld by FDA due to lack safety information (not approved by the FDA)..NOTE: preg women who took this had babies w/ birth defects/ malformation! arm or leg were not fully grown! Thalidomide lead to . . . Functions to strengthen the new drug approval process, requiring the medication to be SAFE and EFFECTIVE.
Historical Overview of the Act (cont.) - general
- Medical Device Amendments (1976)
- Orphan Drug Act (1983) - Incentives to produce drugs for “rare diseases or conditions
- Drug Price Competition Act (1984)- To make generic drugs more accessible to the public
- Prescription Drug Marketing Act (1987)
- Safe Medical Devices Act (1990)
- Generic Drug Enforcement Act (1992)
- Prescription Drug User Fee Act (1992)
- Nutrition Labeling and Education Act (1990)
- Dietary Supplement Health and Education Act (1994) - Regulate supplements more as food; not drugs
- Food and Drug Administration Modernization Act (1997)
- Food and Drug Administration Amendments Act (2007)
- Patient Protection and Affordable Care Act (2010)
- FDA Safety and Innovation Act (2012)
- Drug Quality and Security Act (2013)
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MAIN IDEA: new laws will continue to be pass to help improve eff safety, pt use/ education and overall healthcare sys modifications.
Statutes: what are they?
- A statute is a written law passed by a legislature on the state or federal level. Statutes set forth general propositions of law that courts apply to specific situations. A statute may forbid a certain act, direct a certain act, make a declaration, or set forth governmental mechanisms to aid society.
- Changes to statute require amendment by the legislative body
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NOTE: we can go to Santa Fe and try to get something what we want passed
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The Statutes for New Mexico can be in the New Mexico Statutory Authority (NMSA)-
found here:
https://nmonesource.com/nmos/nmsa/en/nav_date.do
Federal vs. State Law
- General rule: state has authority to set statute that does not conflict with federal statute. States may be more restrictive, but never less restrictive. (important) NOTE: you can have a more restrictive state law as long as it does not conflict with federal statue but NEVER anything less restrictive than fed statute.
- The 10th amendment grants the state government the authority to regulate pharmacy practice not granted to the federal government by the constitution. Statutes are passed by the state legislature and enforced by state agencies.
- Laws relating to the health, safety and welfare of its people belong (mostly) to the state.
- The Interstate Commerce Law gives federal authority to regulate drug distribution.
NM Drug, Device and Cosmetic Act
NOTE: promulgate means they can make or create law as long as it does not conflict with that statutes
NM Drug Product Selection Act
1.) Major purpose: save patients money-generic and alternate source substitution (NOTE: main goal is to help patient save money!)
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2.) Permits pharmacists to dispense:
- Lower cost “therapeutically equivalent drug” if appears in Orange Book (NOTE: therapeutically equivalent per orange book? then you can make that sub!)
- Substitution always permitted unless prescriber writes with his hand “no substitution” or “no sub” on face of Rx!
NM Pharmacy Act
NM Pharmacy Act - part 2
- Empowers BOP to require by regulation minimum pharmacy equipment and references
- Requires licenses to be displayed
- Grounds for disciplinary actions —withholding, suspending, revoking licenses
- Prohibits (with exceptions):
—– any person except RPh from selling, compounding any dangerous drug
—– Possession of any dangerous drug without Rx
—– Conducting pharmacy business w/o license
Impaired Pharmacists Act
- Major purpose: to create a program to rehabilitate pharmacists unable to practice safely because of the substance abuse, mental illness, aging, loss of motor skills
- Empowers BOP to appoint committee to administer program
- Establishes functions of committee
- Referral of impaired pharmacist by the BOP
- Voluntary participation by impaired pharmacist (confidential unless noncompliant)
Regulations: talk about it/ general information regarding regulation
- State law gives authority to executive agencies to develop, enact and enforce regulations that support the statutes.
- Regulations are designed to increase flexibility and efficiency in the operation of laws. Many of the actual working provisions of statutes are embodied in regulations.
- Regulations are indirectly enforceable laws.
- Most regulations are developed and enacted through a rule-making process, which includes public input.
Pharmacy Regulations
NM Pharmacy Regulations NMAC 16.19.regulation: Part 4: Pharmacist
NOTE: renewing license requirement may change
NM Pharmacy Regulations NMAC 16.19.regulation: Part:5 Intern
NM Pharmacy Regulations NMAC 16.19.regulation: Part 6: pharmacies (part 1)
NM Pharmacy Regulations NMAC 16.19.regulation: Part 6: pharmacies (part 2)
NM Pharmacy Regulations NMAC 16.19.regulation: Part 10 Limited Drug Clinics… the different classes
