Fipp Law exam

Pure food and drug act of 1906

prohibited interstate sale of adulterated or misbranded foods and drugs

• labels cannot be false or misleading about ingredients

Federal food, drug, and cosmetic act of 1938

Gave the FDA authority to oversee the safety of food, drugs, and cosmetics

• drug labels must include directions for safe use

• required pre market approval for new drugs to ensure safety

Created due to the sulfanilamide tragedy of 1937

Adulteration

poisonous or deleterious substance which may render it injurious to users, when used as directed

• expired drugs

• unsanitary conditions

Misbranded

false or misleading in any particular way

• if label contains incorrect: drug, patient name, prescriber name, or directions

• missing poison prevention or tamper-resistant packaging

• packaging without adequate information for use

• doesn’t meet standard of identity, quanitity or fill

1951 Durham-Humphrey amendment

Categorized medications into:

• OTC

• prescription

Defined which drugs are:

• habit forming

• not safe under a practitioners care

• required caution on manufacturer’s label

• requires pharmacists to label prescription products prior to dispensing

• refill process

• process of receiving, recording, and dispensing oral telephone prescriptions

1962 kefauver-harris amendment

drug efficacy amendment

• requires drug manufactures to provide proof of effectiveness and safety of their drug before approval

1967 fair packaging and labeling act

Regulate and ensure all consumer commodity labels include:

• Description/ingredients of products

• name and place of business of the manufacturer, packager, or distributor

• quantity of contents in metric and US units

Controlled substance act of 1970

Created 5 different categories for controlled substances

• labels often include C I-V

The lower the schedule number, the greater the abuse/addiction potential

Drug enforcement administration

• federal agency created to enforce the federal drug laws as wells as drug control activities

1970 poison prevention packaging act

• created child proof caps requirement

• only applies to houshold/retail/to be used at home items

• Does NOT include hospital/nursing homes

• Prescriber or patient must request nonspecial packaging (prescriber requests easy open)

1982 anti tampering amendment

• tamper-evident packaging or properly labeled are considered adulterated or misbranded

1983 orphan drug act

new drugs for rare diseases:

• gave the market exclusivity and tax breaks to make these drugs

• typically are patent protected

1984 drug price competition and patent term restoration act

hatch-waxman act

• created a path for generic companies through abbreviated new drug applications (ANDAs)

• gave patent extensions for brand name medications and some pediatric medications

• protected retail pricing from special pricing programs

1987 prescription drug marketing act

ensures safety and effectiveness of drugs

• protects consumers from counterfeit, adulterated, misbranded, sub potent, or expired drugs

• regulation focused on drug wholesale sub market

• banned samples

• resales from hospitals

OBRA 90

federal legislation for medicaid patients:

• discounted the drug costs paid to manufacturers

• has three main areas: prospective DUR, patient counseling standards, maintaining patient records

• used not just for medicaid patients, applies to ALL

Prospective DUR

is the Rx necessary or appropriate

• over/under utilization

• therapeutic duplications

• drug disease interactions

• drug drug. interactions

• incorrect dose or duration of treatment

• drug allergy interactions

• clinical abuse/misuse

Patient counseling standards

must always offer to counsel

Maintaining patient records

keeping up to date patient profiles:

• patients name

• address and phone #

• date of birth

• gender

• drug profile

• pharmacist comments

• chronic conditions, allergies, and drug reactions

Health information portability and accountability act of 1996 (HIPPA)

reduces disruptions in treatment when a patient’s change in health insurance occurs

• streamlines the flow of health information

• set up standards for electronic data transfers

• info can only be released on a need-to-know basis (minimum necessary to accomplish task)

Exemptions to HIPPA:

• treatment

• payment

• healthcare operations

The pharmacy must post a notice of its privacy policy

• must obtain written acknowledgement of receipt

Privacy officer

responsible for developing policies and procedures regarding HIPPA and ensuring that they are regularly updated

Consequences to violating HIPPA

• loss of employment

• civil law suit

• board of pharmacy can take action

Pharmacy records

include:

• prescriptions

• dispensing records

• patient specific prescription labels

• counseling records

• drug regimen reviews with patient

• drug utilization records

• consult agreement

• immunization administration records

these are confidential

Who can access pharmacy records

• patient

• prescriber who gave prescription

• certified/licensed health care personnel responsible for the patient

• anyone given written consent

• law enforcement (who enforce drug laws)

• BPH

• medical board

• nursing boards

• insurance (access audit claim records)

Who can remove original pharmacy records

• BPH investigators

• federal, state, county, or municipal officer who enforces drug law

only give if they have proof of who they are

they must furnish a receipt for the original records

1997 food and drug administration modernization act

• created a process for disseminating off label information

• shortened federal law prohibits dispensing without prescription to Rx only

• created a fast rack FDA review for manufacturers

  • life threatening conditions

  • unmet medical needs

• distinguished compounding from manufacturing

Combat methamphetamine epidemic act

• regulates retail OTC sales of the following products

  • ephedrine

  • pseudoephedrine

  • phenylpropanolamine

• sales limits and 30 day purchase limits, customer ID verification, sales logbooks, and placing products out of direct customer access

Ryan Haight online pharmacy consumer protection act of 2008

• created to regulate online internet prescriptions for controlled substances

issued that to prescribe a controlled substance:

• conduct an in person medical evaluation

• life interactive videoconferencing (this doesn’t prohibit telemedicine to prescribe controlled substances)

Secure and responsible drug disposal act of 2010

options to collect controlled substances:

• take back even (law enforcement only)

• mail back programs

• use of collection receptacle locations

2013 drug quality and security act (drug supply chain and securities act)

title 1:

• outlines steps for an electric and interoperable system to identify and trace certain prescriptions throughout the US

• Reformed compounding types and requirements for each: traditional pharmacy compounding, outsourcing pharmacy compounders

Title 2:

• Created track and trace regulations for the drug supply chain

• tracks drug transfer of ownership to the end pharmacy

Comprehensive addiction and recovery act of 2016

addresses the prescription opioid abuse and heroin use crisis, and other purposes

• increased both prevention programs and the availability of treatment programs

Support for patients and communities act of 2018

made medical treatment for opioid addiction more widely available

• set up a system to support E-prescriptions for controlled substances

Prep act of 2020

• enabled the RPh to order and administer, FDA approval nasal and serum COVID 19 tests

• also to administer the vaccine

Consolidated appropriations act of 2023

• repealed the drug addiction treatment act of 2000

• retired the X waiver and replaced it with an 8 hour training requirement for OUD

FDA class recalls

class I recall:

• use or exposure to will cause serious adverse health consequences or death

class II recall:

• the use of or exposure to may cause temporary or medically reversible adverse health consequences, or the probability of serious adverse health consequences to remote

Class III recall:

• the use or exposure is not likely to cause adverse health consequences

market withdrawal

• issued by the FDA to manufacturers if risks are minor, as compared to a full blown manufacturer recall

FDA observation letter

483 letter:

• inspection finding violations (minor)

• policy, quality, record keeping

• must respond within 15 days

FDA warning letter

• issued to licensee’s

• must respond in 15 days

• public documents

New FDA pregnancy labeling

pregnancy (labor & delivery)

• pregnancy exposure registry

• risk summary

• clinical considerations/data

lactation (nursing mothers)

• risk summary

• clinical considerations/data

females and males of reproductive potential

• pregnancy testing

• contraception

• infertility

national drug code

• labeler code (first 5 numbers)

  • labeler code

• drug product code (middle 4 or 3 numbers)

  • formulation, dosage form, physical form

• package code (last number or last two numbers)

  • size and type of package

MED watch programs

• database of information from voluntary reporting by patients and health care practitioners

• may report drug safety events or ADRs

adverse event vaccine reporting (VAERs)

• warning system to detect possible safety problems in US licensed vaccines

• analyzes and report adverse events due to vaccination

• anyone can report

Goals of VAERS

• detect new, unusual, or rare vaccine adverse events

• monitor increases in known adverse events

• identify potential patient risk factors

• assess the safety of newly licensed vaccines

the risk evaluation and mitigation strategies program (REMS)

• monitors medications with high potential for serious adverse effects

• 76 medications subject to REMs monitoring

  • ex) accutane, clozapine, thalidomide

• assure safe use

• require a medication guide be in place

• communication plan must be in place

Track and trace

requires the trading partners to provide:

• transaction information: pedigree information on where product has been since manufacturing

• transaction history: lot level info, drug name, strength, dosage form, lot#, container size

• transaction statement: statement from the shipper stating handled and obtained legally

also known as T3

What do track and trace require on mark packages

• product identifier

• serial #

• lot #

• expiration date

What should pharmacists do for T3

• validate authenticity of trading partners and ensure they have proper license for the product

• keep T3 info/records for 6 years

Serialization

every package and homogenous case must have a product identifier in both human readable form and on a machine readable data carrier (barcode)

• takes lot level identification down to the unit level

occupational safety and health administration (OSHA)

• ensures a safe working environment

• universal precautions: where all human blood and other potentially infectious material are considered infectious

Needle stick safety and prevention act

• requires entities to use safer needle devices and maintain a log of injuries from contaminated sharps

clinical laboratory improvement amendments (CLIA)

• goal is to ensure the safety and quality of laboratory measurements

Drug shortage list

a period of time when the demand or projected demand for the drug within the US exceeds the supply of the drug

• one of the biggest problems pharmacies face

• pharmacists can compound these manufactured drugs to assist in the shortage

FDA boxed warning

• located in the manufacturers package insert, and additional info located on manufacturer’s label to inform about potential serious ADR

Orange book

brand to generically substitute drug products, to ensure no clinical issues with the substitution

generic substitutions

• contains identical amounts of the active ingredient, but different inactive ingredients

• identical in identity, strength, quality, and purity

Pharmacist can dispense generically equivalent drug:

• physician has not written DAW or dispense as written

• purchaser is informed that substitution will occur

• purchaser is informed that they may refuse

Biosimilars

composed of living material

• highly similar to the existing biologic brand name reference product (same safety, purity, potency)

interchangeable

• expected to produce the same clinical results as brand name product in any patient

• if not deemed biosimilar than it is not interchangeable

• requires switching studies

• must notify prescriber 5 business days about using interchangeable biologic product

Purple book

interchangeable biosimilar products

schedule I controlled substnaces

not given

illegal/illicit drug/lacks medical use

Schedule II controlled substance

no refills

mostly opiates

Schedule III controlled substances

may be filled or refilled no more than 6 months after the written date or more than 5 times

testosterone, or no more than 90 mg of codeine per dosage unit

Schedule IV controlled substances

may be filled or refilled no more than 6 months after the written date or more than 5 timessleeping/anxiety agents (benzodiazepines), tramadol

Schedule V controlled substances

may refill for life of Rx (up to 12 months from date written)

cough medications containing no more than 200 mg of codeine per 100 ml or g

Mid level practitioner

a practitioner, other than a doctor, dentist, veterinarian, or podiatrist, who can dispense controlled substances in their profession

• Ex) nurse practitioner, PA, RPh

DEA #

must be included on all controlled substances either handwritten or stamped

• the suffix at the end of the DEA # is the hospitals #

Verifying DEA #:

• starts with A, B, F, G

• if med-level practitioner starts with M

• Second letter is first letter of the individuals last name

• (1+3+5)+2(2+4+6)= 47

  • so 7 would be the last number in the DEA #

DEA form 222

order form for CI or CII

• changing to electronic ordering known as CSOS

• must be signed/dated on day order submitted by power of attorney

• keep copy for 2 years

DEA form 224

order form if opening a new pharmacy or attempting to get your personal DEA #

• renew DEA license every 3 years

DEA form 41

reports destruction of controlled substances

• Ex) fire, flood, expired

DEA form 106

reports lost or stolen controlled substances, mail back packages, or inner liners for controlled substance containers

controlled substance ordering system (CSOS)

electronic system to order controlled substances

• digital equivalent to DEA form 222

• allows timely/accurate validation

• reduces ordering errors

• no line item limit on single order

• reduces amount of paper

• faster transaction times

• lower cost per transaction

When a purchaser receives a shipment must create a record of the quanity and the date received. electronically linked to original order

CSOS administrative certificates

• not valid for electronic ordering

CSOS signing certificates

most common

• used for digital signing of controlled substance orders

ARCOS

monitors the flow of DEA-controlled substances from manufacturer to pharmacy

• accumulates all transactions and summarizes them into a report

  • helps identify diversion of controlled substances into illicit channels

  • strengthens crimial cases

HHS OIG exclusion list

database of individuals and organizations that are prohibited from participating in federal health care programs

Loss or stollen controlled substances

notify DEA within 1 business day and local police

complete DEA 106 form, ad the board of pharmacy

Signs of significant loss

• quantity of controlled substances lost in relation to the type of business

• associated with access to those controlled substances by specific individuals

• a pattern of losses over a specific time period

• likely candidates for diversion

• local trends and other indicators of diversion

Controlled substance inventory

DEA= occurs biennial (every 2 years)

ohio = every year

Prescriber requirements for ordering CS

• authorized to prescribe CS by jurisdication

• register with DEA or exempted from registration

• an agent or employee of a hospital or other institution

Valid prescription requirements

• legitimate medical purpose in that doctors profesisonal practice

• pharmacist have a corresponding responsibility to ensure this requirement is met

• if we will we also get a felony

support act

mandates all schedule II-V substances be done electronically

• medicare part D prescription drug plan

• medicare advantage prescription dru gplans

CII substances

• has no expiration or quantity limitations federally

• Ohio you must fill within timeframes or expiration of CII prescriptions and many opiates have quantity limits

• no refills

• No faxes except for:

  • hospice

  • long term care

  • direct administration to patient (IV, IM, subcutaneous)

PRN

cannot be used for amount of refills for controlled substance prescriptions

Refill documentation for CS

• pharmacists intials

• date the prescription was refilled

• amount of drug (if not labeled then assumed the dispension of the full prescription)

How to transfer CS

• allows initial transfer of an unfilled CS received at a pharmacy to send to anther pharmacy only 1 time

requirements for this:

• must be 2 RPh

• no alterations to the Rx

• must keep e records for 2 years

• must be allowed by state regulations

Two ways drugs can be destroyed or disposed of

non-retrievable:

• expired or adulterated controlled drugs

• permanently unusable (can not be chemically changed back)

• incinerated or chemically digested

Unusable or unavailable:

• intended for wasting of partial doses of drugs in clinical settings (makes 10 mg morphine, dose is only 5 mg, so 5mg wasted)

• use of sink in hospitals by nurses to dispose of waste

• or patient wasting drugs at home placed in kitty litter/coffee grounds

controlled and non-controlled substances can be collected by

1) mail back programs

2) collection receptacles

3) drug take back day

(do not take drugs from patients they must go through the following processes)

Central fill pharmacy

fills prescriptions for CS on behalf of retail pharmacies with which it has a contractual agreement to provide such services or with pharmacies who share a common owner

• records must be obtained by both the central fill and retail pharmacy (keep for 2 years from date prescription was last filled)

• no separate DEA registration

• can both initial and refill prescriptions

Current good manufacturing practice (CGMPs)

licensing, manufacture and sale standards for food, beverages, and pharmaceutical products

Requirements include:

• highest quality products

• end products contains no contaminants

• consistent in manufacture

• personnel are well trained

• product checked for quality more than at the end phase

USP 795

non-sterile compounding

(topical products powders, creams, lotions)

USP 797

sterile compounding

(IVs, injectables, opthalmic, otic)

USP 800

hazardous drugs

• protects personnel and the environment (minimize exposure to toxic drugs)

• either non-sterile or sterile

• standards apply to all places when HD are prepared, stored, transported, and administered

3 categories of USP 800

1) antineoplastic drug

2) non-antineoplastic hazardous drug

3) drugs with toxic reproductive effects

NIOSH identifies if a drug is hazardous or potentially hazardous if it includes at least one:

• carcinogenicity

• teratogenicity or development toxicity

• reproductive toxicity in humans

• organ toxicity at low doses in humans or animals

• genotoxicity

• new drugs that mimic existing hazardous drugs in structure or toxicity

9 total board members

8 RPh and 1 public member (60 years or older)

4 years term max of 2 terms

Boards responsibility

• licensure

• OARRS (operate and monitor the prescription drug monitoring program)

• enforce ohio and federal drug laws

• update and review rules

• conduct compliance inspections

• conduct disciplinary hearings

• regulate and enforce medical marijuana regulations

Board

approx 100 employees

What can the board do to license

• revoke (perminent)

• suspend

• limit

• place on probation

• refuse to grant or renew license

• impose fine or forfeiture

What can you be charged of doing

• felony or gross immorality

• guilty of dishonesty or unprofessional conduct in the practice

• addicted to drugs or alcohol, so impaired physically

• been convicted of a misdemeanor or committed in the practice

• guilty of willfully violating, considering to violate, attempting to violate, or aiding in the violations of the rules

• guilty of permitting anyone other than an RPh or intern to practice pharmacy

• guilty of knowingly leading a name to an illegal practitioner or pharmacy

• guilty of dividing or agreeing to divide remuneration made in the practice with any other individual

• has violated the terms of the consult agreement

• has committed fraud, misrepresentation, deception when applying or securing a license

unprofessional conduct

• false advertising (displaying or promoting dangerous drugs that are false or misleading)

• selling prescription drugs without a prescription

• knowingly dispensing medication that is false or forged

• Failing to maintain complete and accurate records of all dangerous drugs

• Obtaining payment by fraud, misrepresentation, or deception

• coercion

• intimidation

• harassment/sexual assault

• improper use of PHI

• threats

• degradation of character

• Indecent or obscene conduct

• theft

summary suspension

occurs if the situation if the public is at immediate risk

• addiction

• immediate threat to the public

• physically or mentally impaired

Pharmacist care

• interpreting prescriptions

• dispensing drugs and drug therapy related devices

• compounding drugs

• counseling patients

• performing DUR

• performing drug regimen

• advising an individual in helath profession in drug therapy

• acting pursuant to consult agreement

• administering immunizations

Dangerous drugs

• bears a label containing caution, Rx only, or the drug may only be dispensed upon prescription

• schedule V CS that can be purchased OTC

• administered via injection other than through a natural orifice of the human body (insulin)

keep thse drugs out of self-service areas