Law #1

Law

Sets forth the minimal expectations of conduct demanded by a governing society

The rules are embodied in legislative codes, statutes or declarations from the courts

Professional Ethics

Function to provide behavioral guidelines

Professional ethics are most often found in the code of ethics or standards of conduct

Overview of Pharmacy law

Basic requirements of day to day practice

Explain the relationship pharmacist have with the public they serve

A slight mistake can cost a life

Why study law

Tells us the minimal competency and actions that are acceptable

If Pharmacist do not meet what is acceptable, they are held accountable

If you dont know the law

Do what is best for the patient

Knowlege of law does not substitute for good professional judgment.

Statutes

Law enacted by congress (if federal) and state legislature (if state)

Regulations

Administrative enactments authorized by statues

Regulatory bodies

DEA, FDA , Ohio Board of Pharmacy

Common Law

Body of principles based on customs and usage (basis for American law)

Case Law

Derived from judicial decisions and interpretations of statutes

The practice of Pharmacy

Protecting public welfare through safe medication delivery

Federal Gov Role

Regulates most aspects regarding the manufacturing, packaging, storage, labeling (including advertising) and labels, distribution (including import) and authorized use (investigational & therapeutic) of pharmaceuticals

Why regulate drugs

contiune new drug development and the creation fo drugs that are for public good

Safe production and use of drugs

mitigate information asymmetry

Food, Drug and Cosmetic Act: Section 503(b)2: Label requirements

*Auxiliary labels & definitions:*

•Used to clarify, provide additional instructions or reinforce primary label

•Some required:  “refrigerate; shake well; discard date; keep out of reach of children (if packaged without safety closure)”

•Some advisory:  “external use only”

Controlled Substances Act of 1970

•Defines agents, authorized possession and acquisition, storage and inventory, and limitations on distribution

•Enforced by the DEA; section of FBI/Dept of Justice

•Pharmacies, not pharmacists, must be registered with the DEA

•Title 21 of US Code (21 CFR-1300+)

State gov role

•Defines the personnel & conditions for the storage and distribution of pharmaceutics on an individual basis

State gov examples

•Definition of a pharmacist, pharmacy practice, pharmacy, pharmacy technician, and pharmacy intern

•State Rules & Regulations:  The Legal Practice of Pharmacy and the Ohio Administrative Code

•Differences between FDA & \n Boards of Pharmacy views

State gov may

further define and be restrictive but not contradict federal law

rule of thumb

follow the most stringent regulation available

USP - Nongov

Initial goal: standardize names and formulations of medications

Mission: promote public health by disseminating standers of quality and authoritative information

Standers of Quailty

*Strength, Quality, Purity, Packaging & Labeling* of “drug products” Inclusive of drug entity, dosage form, medical devices, diagnostic products

information disseminated

Drug entities and pharmaceutical excipients

good compounding practice

Authorative information

Model guidelines for medicare

Prescription Drug Act (MPD)

Focus: establishing and monitoring outcomes in disease states where intervention and prevention can make a differnce

Bases of USP authority

Vested in Federal law


1. Federal food Drug and Cos 1938
2. Medicare prescription drug 2003

Adopted in individual state pharmacy practice acts

Pure Food and Drug act of 1906

Prohibited foods and drugs that were distributed through interstate commerce to be adulterated or misbranded

Did not require manufacturers to list ingredients, label directions for use, regulate cosmetic products, or medical devices

Food, Drug and Cosmetic Act of 1938

triggered by 107 deaths from liquid sulfanilamide (solvent diethylene glycol) in 1937

Required that any new drug could not be marketed unless it had first been proven safe when used according to directions on the label, required labels include adequate directions for use and warnings about habit-forming drugs in products

First law that applied to cosmetic products, drugs, and medical devices

Drugs produced prior to 1938

grandfathered in

Levothyroxine, digoxin, nitroglycerin, phenobarital

Durham-Humphrey Amendment of 1951

Amendment of FDCA

Established two classes of drugs: **Legend drugs** that required medical supervision, did not require adequate directions for use, required to include “Caution: Federal law prohibits dispensing without a prescription”

**OTC** does not require medical supervision, required to be labeled with adequate directions for use

KeFauver-Harris Amendment of 1962

Amendment of FDCA

This resulted from public concern about birth defects from thalidomide

(AKA Drug Efficacy Amendment)

**All drugs must be Safe and Effective (**including drugs produced from 1938 to 1962)

FHA Requirments

 Regulation of prescription drug advertising under the authority of the FDA

 Required “informed consent” by research subjects in clinical investigations

 Required reporting of adverse drug reactions

 Creation of Good Manufacturing Practices (GMP) requirements

Defined conditions for drug manufacture in the U.S.

Medical Device Amendment of 1976

Amendment for FDCA

Provided classification of medical devices by function, performance standers, premarket approval requirements, conforms with GMP, requirements from adherence to record and reporting

Orphan Drug Act 1983

Used to treat diseases that affect relatively few people

limited room for profit

provides tax and licensing incentives to manufacture to make it appealing

Drug Price Competition and Patent-Term Restoration Act of 1984

Amendment to FDCA

AKA Waxman-Hatch

Resolve dispute between generic and brand manufacturers

streamlined drug approval for generic

proved drug manufacters to develop new drugs

Prescription Drug Marketing Act of 1987

Controlled distribution of prescription drug samples

Prevent hospitals and health care entities from reselling pharmaceuticals to other buisnesses

FDA modernization Act of 1997

Far-reaching

Touches virtually every part of FDA activites

Provision for the fast-track review of some new drug applications (HIV,AIDS, COVID)

Clarifications of compounding

Changed “Caution: Federal law prohibits dispensing without a prescription” to “RX ONLY”

Warning may be habit forming removed

Encouraged research of new uses for current drugs

Medicare Prescription Drug Improvement and Modernization act of 2003

created medicare part D

Patient protection and affordable care act of 2010

Requires all to have health ins

Required standards for finaical and administrative transactions

stop agreenments between brand name and generic drugs manufactures that limit competition from generic drugs

Phase elminiation of castarophic caps

Cosmentic Definition

◦Article intended to be rubbed, poured, sprinkled, sprayed on, introduced into or otherwise applied to the human body for the purpose of cleansing, beautifying, promoting attractiveness, or altering the appearance.  Also, any component of the above articles is considered to be a cosmetic

◦Soap is NOT considered to be a cosmetic

Device

◦Any instrument, apparatus, implement, machine, contrivance, implant, ***in vitro*** reagent or related article which is

◦Recognized in the USP/NF or HP or any supplement

◦Intended for use in the diagnosis, cure, mitigation, treatment, or prevention of disease in man or other animals

◦Intended to affect the structure or any function of the body of humans or animals but are not foods

Food

◦An article used for food or drink in humans or animals, chewing gum, and substances used as components of food or drink

Generic name

◦A name that is assigned to a specific drug structure.  It is a simplified name as compared to the chemical name.  Drug products may be marketed under the “generic name” or a brand name (trade name).  Overall implication is that a drug marketed under the generic name only is less expensive than the brand name product

Hospice

◦A facility or program that provides palliative and supportive care for terminally ill patients

Medicare

Federal program

Medicaid

Federal and State program

Vairies by state

Medicare Sections

Part A: Hospitalization

Part B: Physicians and services

Part C: Advantage (managed care)

Part D: Prescription Drugs

Prescription Drug Plans

Voluntary enrollment

Medicare contracts with private insurance

Premiums and deductibles can change yearly and vary among private companies that provide the plans

Spouces have to have own plan

PDP tiers

Tier 1: Least expensive generic

Tier 2: preferred brand drug

Tier 3: non preferred brand drig

Tier 4: high-cost drug

PDP notes

Once enrolled, premium and deductible cant change between the 1st and Decmber 31

Co-pays can change if drugs move teirs

People can change plans once a year unless a beneficiary moves or the plan is discontiuned

PDP Providers

Any willing providers

Cannot require mail order

90 days can come from local pharms

if brand is required, inform paitent

Pharm can get paid for MTM

Plan spons must have mtm programs

PDP Vaccines

covers the cost of vaccines and their administration that was formally covered by part B

Formulary requirments

–All standard plans must include drugs within all therapeutic categories  and classes developed by the USP

–Insurers with their own formularies must have a P&T committee

–Six drug classes require that most drugs are on the formulary: Anticonvulsants, antidepressants, antineoplastics, antipsychotics, antiretrovirals, immunosuppressants

PDP Generally not covered

•Barbiturates

•Benzodiazepines

•Weight loss or weight gain drugs

•Hair growth drugs

•Drugs that increase fertility

•Prescription vitamins except prenatal and fluoride products

•Outpatient drugs for which the manufacturer required monitoring

FPD notice requirments

60 days notce to CMS for plans to remove drugs or change to a different tier

60 day notice to state prescriotion plans, pharmacies, and enrolled beneficiaries

\*black block warning can be removed at any time

FPD out of Network

Paitent pays for U and C and submits a form for reimbursement

FPD enrollment

–Initial enrollment period begins the first day of the third month before eligibility begins and lasts seven months (3 months before and 4 months after the month of their birthday)

–After enrollment, patients are locked into their plans until next open enrollment

MTM Requirments

Two or More diease states

multiple medications (2-8)

predicted annual cost $4696 and above

MTM recent changes

•The final rule expands the definition of beneficiaries targeted for MTM to include at-risk beneficiaries (ARBs) under a Drug Management Program (DMP), regardless of whether those individuals meet other MTM targeting criteria.

•Required to provide MTM enrollees with information on the safe disposal of opioids

MTM requirments of company

Cannot require more than 3 chronic illnesses and must target five of none core disease states:


1. Alzheimers
2. hypertension
3. CHF
4. Diabetes
5. Dylipidemia
6. End stage renal disease
7. Respitatory diease
8. Bone diease
9. Mental Helath

MTM minimum intervension

Annual comprehensive med review

targeted med review (quarterly)

inform about safe disposals

interventions can be passive or interactive

\`Investigational New Drug Application

Extensive testing to ensure it is safe and effective

First application form submitted

Completed before drug is marketed

Completed by sponser before drug is given to humans

intended to protect the rights and saftey of test subjects

Who submits IND

Most sponsers are pharmaceuticals manufacturing companies

Medical researches, Academic personel, public org, and private orgs

IND includes

all preclinical data on safety and use

clinical protocols for human testing

gives FDA 30 days to decide if IND is suitable for human trials

Clinical Trials Phases

1: 20-100 people for several months (testing safty)

2: Up to several hundred, several months to 2 years (short term safety, mainly effectiveness)

3: Several hundred to several thousands for 1 to 4 years (saftey, effectivness, and dosage)

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Rule from 1998 for use in children to prevent

Deaths of newborns from choramphenicol

jaundice in newborns from sulfa

seizures from local anestheic bupivacaine

wtithdrawal from fentanyl

staining of teeth from tetracycline

Phase one Participants

Small groups of healthy subjects, under the direct supervison of sponser

allows for evaulation of toxicology, pharmacokinetics, pharmacological properies, and assessment of safety

Phase two Participants

larger group, patients have disease or condition, under direct supervison of sponse

determines effectiveness, dosage, realtive saftey, adverse effects

Phase three particpants

Large group, varries loctations, double blind, preformed by independent investigators, COSTLY, LONGEST STEP,

obtaints data on effectiveness compared to placebo

Treament IND

Allows use of IND to paitnets not in the clinical trial

Must be in life threatening stage of diease

Drug must be in phase 2 or 3

Treament protocol must be approved by FDA

New drug application process

consits of thousands of pages of data and info (from clinical trials, information about stability, packaging, and production methods)

very costly and time consuing

review takes 6 months

once approved, the drug can be marketed

Phase Four trial

Post marketing surveillance

health profess report adverse effects

Drug Manuf. submits annual reports

Data is used to determine if drug should remain for sale

Expedited Review

Special consideration to therapy that treat serious or life-threatening dieases

Gives: priority review, fast track, breakthrough therapy, and accelerated approval

Supplemental New Drug Application

Abbreviated application

After marketing a drug product

used when changes in drug synthesis, production procedures, manufacturing location, packaging, labeling, ect

Orphan Drugs

Cost of NDA would exceed the anticipated market sales, used for treating small populations

FDA provides incentives like tax relief, exclusive marketing rights, faster NDA approval, ect

Vaccine for Children PRogram

Federally funded program

provides vaccinces to children who would otherwise be unable to pay

distributed through public health departments and agencies to VFC provideers like doctors offices and clinics

Naming new drugs

Durring research phase product are identified by a code name

Names are established once the drug nears it final approval: the generic name and the brand name (to encourage prescriber recognition of that company specific product)

Patent Protection until 1984

Innovator companies had a 17 year period of exclusive rights, included development period and NDA process

Patent Protection after 1984

Waxman-Hatch Admendment/Drug Price competition and Patent-term Restoration Act provided longer patent protection (up to 5 years to allow for more time to gain revenue) while manufactures of the generic versions were given easier access to approval

National Drug Code

Number system that aids in identifying drug products

Used by ins for reiumbursment

Contains 10 or 11 digits

\

NDC Parts

XXXX-XXXX-XX

First four are manufacturer

Second four are ID of drug

Last Two are package size

ID of specific drugs are established by manufacturers

NDC Notes

IF there are 11 digits the manufacturer number is 5 digits long

NDC requirmetns

Required for all prescription drugs marketed in the US

Not necessary to have on package labeling

Not required on prescription labels

Good Manufacturing Practice

Minimum requirments required to maufacture products

Maufactures must be registered with FDA and must provided descriptions of manufacturing and productions as a part of NDA

FDA inspects drug facilities every one to two years

Bad Adverstising

To educate health care providers about misleading adverstising about prescription drugs

Adulterated Drug products

contains any filthy, putrid, or decomposed substance

been prepeared, packaged, of held under unsanitary conditions where it might have been contaminated

has been manufactured under conditions that do not meet GMP

Contains unapproved color additives

Misbranded

Lableing:

–False or misleading

–Missing information (name or location of the manufacturer, packer, or distributor)

–Word, statement, or information required by law is missing, not readable, or not prominent

–Missing established name of active drug

–Does not have each active drug ingredient identified

–Missing quantity

–Inadequate directions (OTC)

–Missing appropriate warnings

–Packaging is not USP/NF

–Offers sale of a drug under the name of another drug

Label

•refers to written, printed, or graphic matter appearing on the immediate container of a drug product.

•If there is an outside package, any word, statement, or other information present on the immediate container must also appear on the outside package.

Package inserts

•Manufacturers are required to provide package inserts in prescription drug packages.

•The information in the package insert must be approved by the FDA and is for informational use only, not for promotional use.

Required: Description of drug, clinical pharmacology, indication and use, contraindications, warning, and precautions, adverse reactions, protential for abuse, symptoms of overdose, dosage and administration, availble forms, dates of revison, and recommended dosage

Identification of Soild Dosing forms

Required to imprint solid dosage forms for both prescription and otc

imprint must ID the manufacture and the specific drug

Prescription Drug Marketing Act 1987

Dingle Bill

Enacted to correct problem of drug diversion from normal distribution channels

Requires proper storage of drugs and the maintenance of distribution records

Restrict the sale, purchase, or trade of prescription drug samples and bars retail pharmacies from receiving samples

Drug samples can’t be delivered to a retail pharmacy, even if they are dispenced to that practitioners paitent

possession of sample would be condidered drug diversion

Pharmact Drug Marketing Act of 1987 in hospital

Health care facilites can handle samples, but records must be kept, and be stored separetly from regular stock

Risk Evaluation Mitigation strategies

Created by manufactures for drugs with potentially harmful side efffects where benefits could outweigh the risk

Five levels of Risk Mitigation

1. Professional label and package insert
2. REMS - Medication Guide
3. REMS- Communication Plan
4. Elements to assure safe use
5. implementation system

REM program for Thailidomide

Females must undergo pregnacy testing and birth control while being treated

Males must wear condoms

All prescribers and pharmacies must be registered in order to prescribe or dispense the drug

use of drug is monitored by paitent surveyes

Prescriptions are limited to 28 days, no refills, and must be filled within 7 days of being written

iPLEADGE

Isotretinoin

Only dispensed if prescrption has gone through the process and recived RMA number

Limited to 30 day supply, no refilles, and must be filled within 7 days for females

Off-Label use of Drugs

Not considered illegal to proscribe unapproved uses or dosages

Federal law prohibits anyone from distribution from suggesting to a patient or precriber that an approved drug may be used for unapproved purposes. Drug manufactuer cannot promote a drug for a prupose it is not indicatied

Ozempic → Diabetes, can’t adverstise for weight loss (even though its happening lol)

Unit Dose Packaging

–Generic name and trade name, if appropriate

–Amount of active drug or drugs present (and number of dosage units if more than one )

–Name of the manufacturer, packer, or distributor

–The re-packager's lot number

–Expiration date

–Any other appropriate information concerning the specific drug (e.g. special storage requirements.)

Unit dose expriation date

Should not exceed 25% of the remaining time between the date of repackaging and the oringal expiration date or a six month date from when the drug was repackaged (GO WITH SMALLEST)

Bar Coding

Product bar code standers are from Uniform Code Council

Bar code is considered part of the label and subject to GMP

Required for manufactueres

Aimed to reduce medication errors

Code contains NDC

Med Paks

Directions that specifically indicate the dat and time that the containers are to be taken

Unit dose packaging is needed plus a serial muber for the patient

beyond use date of 60 days from preperation

MedWatch

Reporting program

Educting all health pro. about the importance of being aware of, monitoring, and reporting adverse events and problems to FDA and manufactuer

ensure that new safety info is rapidly communicated to improve paitent care