RESOURCES/LIBRARY

PHARMACY LAW

Federal Food and Drug Act  (FFDA)

– Series of consumer protection laws 
– led to creation of the FDA
– banned foreign and interstate traffic in adulterated or mislabeled food and drug products
– Products had to be inspected and offenders where prosecuted
– Active Ingredients had to be placed on labels of packaging
– drugs can not fall below purity levels set by United states pharmacopoeia or national formulary

Health Insurance Portability and Accountability Act (HIPAA)

– reduces health care fraud and abuse
– mandatory industry wide standards for health care information and electronic billing processes
– requires the protections and confidential handling of protected health information

Omnibus Budget Reconciliation Act

OBRA
– Allowed workers and families to keep their group coverage in cases of voluntary or involuntary job loss
– in case of reduced hours worked
– job transitions
– give workers who lost their health benefits right to choose to continue plans under certain circumstances
– required under businesses with 20+ employees
– applies to both government and private sector
– set period of time, maybe influenced by circumstances

OBRA 90

– placed regulations on how to interact with patients
– record keeping mandates, prospective drug reviews
– counseling obligations
– must review medicaid participants entire drug profile before prescribing medications

Medicaid

– Social Health care program for families and individuals with low income + resources
– government insurance for people of all ages who cannot afford sufficient health care
– varies from state to state –> joint funded between state and federal
– must be US citizens or legal permanent residents

Medicare

– National Social Insurance Program
– administered by US government
– provides insurance for Americans aged +65
– members must have worked and payed for the system
– provides insurance for younger people with disabilities

Disability

– Form of insurance that ensures the beneficiaries income against the risk that disability creates a barrier for a worker to complete the core functions of their work
– encompasses paid sick leave, short term disability benefits, and long term disability benefits

U.S. Social Security Act

– Social Welfare Legislation Act
– provides federal assistance to those who cannot work
–

Combat Methamphetamine Epidemic Act

– enacted to curb the growing problem of underground manufacture of illegal drugs
– regulates over the counter products that can be used to make illicit drugs
– include daily sales limits and 30 day purchase limits 
– places products out of easy reach
– sale logbooks
– customer ID verification
– training of employees and sellers

Sale of Ephedrin

– sale is limited to behind the counter
– must present photo ID
– stores require to keep personal information on buyers for at least 2 years
– sales allowed in drive through lanes

U.S. Merck + co

– An American pharmaceutical company
– one of the largest in the world
– publishes Merck Manuals –> a series of reference books for medical professionals
– Merck Index –>list of chemical compounds –> lost

Poison prevention Packaging Act (PPPA)
– requires use of child resistant packaging for prescription drugs, OTC, household chemicals, and hazardous materials
– some drugs are exempt from child proof packaging –> OTC drugs with the proper labeling not for children and in big enough packages

Kefauver – Harris Act

– requires drug manufacturers to provide proof of their effectivness and safety before approval
– requires drug advertisements to disclose side effects
– stopped cheap generic drugs from being marketed as more expensive drugs and taking credit as breakthrough medications

Controlled Substances Act (CSA)
– federal US drug Policy
– manufacture, importation, possession, use and distribution of certain substances is regulated
– created 5 classifications of schedules
– all controlled substances need to be inventoried Biannually

Schedule I Drugs

– High Potential for abuse
– no potential medical use or treatment in US
– lack of accepted safety for use of drug under medical supervision
– No prescriptions may be written for drugs 
– Crimes involving drugs can be quite serious
– “Street” Drugs
– Heroin, methamphetamine, cocaine, etc.

Schedule II Drugs

– Drugs have high potential for abuse
– Drugs have currently accepted medical uses, although there may be serious restrictions
– Abuse of drug may lead to severe psychological or physical dependence
– may not be used unless directly dispensed by a practitioner
– refills not allowed
– must be stored in a safe, while other schedules can be stored throughout pharmacy

Schedule III Drugs

– has potential for abuse, but to a lesser degree than schedules I + II
– drug has an accepted medical treatment 
– abuse of drug may lead to moderate or low physical dependency or high psychological dependence
– may not be dispensed without a prescription
– may not be dispensed six months after prescription written
– may not be refilled more than 5 times
– may be prescribed orally or over phone

Schedule IV Drugs

– low potential for abuse 
– has currently accepted medical use
– abuse may lead to limited physical or psychological dependence
– can be refilled up to five times after 6 months written or orally

Schedule V Drugs

– low potential for abuse
– currently accepted medical use
– limited dependence
– may be dispensed without medical reason
– orally or written

DEA form 222 1 + 2 order form

– Order Forms for Schedule 1 and 2 drugs 
– used to order from another registrant retail and hospital pharmacies
– wholesaler or retailers use this form
– forms need to be maintained for 2 years

DEA Form 41 form of controlled substances
inventory and destruction

– registers inventory of controlled substances
– used to return drugs to DEA or acceptable recipients
– documents surrender or destruction of controlled substances
– forwarded to DEA for disposal

DEA 82 form of inspection

– Notice of Inspections of controlled premises
– informs registrant an inspection will be made

DEA form 104 surrender and close

– Voluntary surrender of controlled substance privileges
– used to surrender permit to the DEA on a voluntary basis
– used to close pharmacies

DEA 106/666 (loss or theft)

– report loss or theft of controlled substances
– Report discovered shortage of controlled substances

DEA 222a

– used to obtain DEA 222 form from DEA

DEA 224 license form – institutions

– new application for registration of controlled substances act 
– Form used by retail pharmacies, clinics, hospitals, practitioners, and teaching institutions, 
– to get license to obtain or dispense controlled substances

DEA 225 license form sellers

New application for registration used by manufacturers, distributors , wholesalers, importers, exporters, researchers
– to obtain and use controlled substances

DEA 226

application for re-registration of controlled substances
– privileged by retail pharmacies, hospitals, practitioners or teachers to obtain or dispense controlled meds

DEA 363 narcotics for pharmacy programs

– Registration for narcotic rx programs
– used to obtain approval narcotic rx program using controlled substances

Ordering and recipt of samples

Only a practicioner who has been issued individual DEA numbers are authroized to recieve any controlled substances in a sample, starter pack, or any container
– Only those with industrial prescribing authority are allowed to order / receive any dangerous drug sample/starter pack

Insulin Storage

– recommended temperature is 36 – 46 F
– unopened lasts until expiration date
– Vials and cartridges can be 59-86 F up to 28 days
– if altered only two weeks
– loses effectiveness when exposed to extreme temperatures or sunlight

Capsule sizes

– size 5 is the smallest (bigger numbers are smaller)
– su07 is the largest
– length and diameter increases as number 
decreases

Capsule Information

– both types of capsules made from aqueous gelling agents –> mainly gelatin but sometimes cellulose

Hard Shelled Capsules

– made of gelatin 
– contain dry powdered ingredients
– made in two halves –> lowered body is filled 
– then sealed by higher diameter cap

Soft Shelled Capsules

– primarily used for oils and active ingredients that are dissolved or suspended in oil
– Single piece encapsulating method
– sealed with a single drop of gelatin

DEA numbers

– assigned to health care providers by the DEA allowing them to write prescriptions for controlled substances
– legally used solely to track controlled substances
– Also used by the Industry as general prescriber numbers –>unique identifier for anyone who can prescribe medications

DEA sections

– Contains 2 letters, 6 numbers, and 1 check digit
– First Letter is code identifying type of registrant 
–> letters A – X depending on job type
– 2nd Letter is the first letter of the registrants last name
– Seventh number is the checksum

Seventh Number

– sum of digits 1, 3, 5 
– then sum the digits of 2, 4, 6 and multiply by 2
– add the two sums together = CHECK
– Right most digit of the CHECK number is the 7th digit

Material Safety Data Sheet (MSDS)
– component of product stewardship, occupational safety and health, and spill handling procedures
– catalog information on chemicals, compounds, and mixtures
– info on safe use and potential hazards
– should be available for reference where chemicals are being stores
– for work settings

Drug-Drug interactions

– whenever two or more drugs are taken, there is a chance that there will be interactions 
– may increase or decrease the effects of intended uses and side effects 
– more drugs taken more likely interactions will occur

Ways drug drug interactions occur

– absorption rate into the body
– distribution of drug throughout the body
– alteration made to drug in body –> metabolism
– elimination of drug from the body

Contraindicated

– Never take these drugs together
– high risk for dangerous interaction
– contra bad

Serious

– Potential for serious interaction
– regular monitoring by doctor is required
– alternate medicine may be necessary
– monitoring by serious black

Significant

– Potential for significant interaction
– monitoring by doctor likely required

Minor

– Interaction is unlikely, minor, or insignificant

FDA Class I Recall

– Dangerous products that could cause serious health problems or death
– contain toxins, allergens, label mix ups, defects

FDA Class II Recall

– for products that might cause a temporary health problem
– pose slight threat of serious nature

FDA Class III Recall

– For products unlikely to cause any adverse health reactions
– still violate FDA labeling and manufacturing laws
– container defects, lack of proper labeling, wrong color/taste

FDA Class Recalls

– company can call a recall on their own after discovering flaw
– FDA can call a recall 
– if recall is not done FDA can call a seizure of product
– must quickly remove products that are potentially dangerous from the market
– Firms must take full responsibility for removal of dangerous products
–

Drug Expiration Guidelines

– Final day the manufacturer guarantees the drug to perform at full potency and safety
– exist on medication labels –> required by law
– no recommendation about drug given after expiration
– drugs typically last 12 – 60 months
– after container is opened, expiration no longer reliable
– shelf life may actually be longer than expiration date
– If just the month and year are indicated –> drug can be used or dispensed until the last day of that month

Strenght of solutions

– need to be calculated in grams/ml

Business days

– do not include weekends 
– day an order arrives does not count as a business day 
– do not include federal holidays

AMA

– American Medical Association
– largest associations of physicians and medical students in US
– promote art and science of medicine to better public health
– advance interests of physicians and patients and lobby for favorable legistlation 
– raise money for medical education 
– Publishes JAMA, Largest circulation of any weekly medical journal

PFC

– Pharmacy Formulary commitee
– lists all mediciens
– annualy updates drugs and ingredients
– standards must be met for strength, quality, and purity

HPhA

– Hospital Pharmacist Association
– Professional organization that represents the interests of pharmacists who practice in hospitals, health maintanence, long term care facilities, home care

P&T

– Pharmacy and Therapeutics commitee
– comittee at a hospital or insurance plan that meets to decide what drugs will appear at that entities drug formulary
– consists of physicians and pharmacists
– weigh cost benifits of each drug and decide which to use

NDC

– National Drug Code
– unique product identifier for drugs intended for human use
– registered drug establishments must provide FDA with a current list of all drugs manufactured
– 10 digit, 3 segment numeric identifier assigned to each medication
– once an NDC is assigned to a product, it may not be reused
– sometimes referred to as the drug listing act of 1972 – for coding

NDC segment 1

– first segment is the labelor code
– 4 or 5 digits
– assigned by FDA upon submission of a labelers code request
– labeler is any form that manufactures, repacks, or distributes a drug product

Second segment

– Product Code
– 3 or 4 digits long
– identifies a specific strength, dosage form, and formulation for a particular firm
– assigned by the labeler

third segment

– Package code
– 1 or 2 digits long
– identifies package forms and sizes
– assigned by the labeler

Orange Book

– Approved drug products with therapeutics equivalence evaluations
– identifies drugs approved on basis of safety and effectiveness by FDA
– lists patents

Red Book

– Multi volume treatise outlined fiscal law 
– pricing and product information for drugs
– answers commonly asked question

Therapeutic Equivalence Index

– for generic drugs

PDR

Physicians Desk Reference
– commercially published compilation of manufacturers prescribing information, package inserts on prescription drugs
– provides physicians with list of fully mandated information for writing prescriptions
– widely available in libraries and bookstores

Auxiliary labels

For the X
– easily identifiable stickers –> bright colors with easily identifiable graphics
– available in Spanish and french 
– contains warnings, Instructions for route of admission, Dietary information
– short to the point phrases

PTCB Certification

– every 2 years a minimum of 20 hours of continued education is neceassary
– 1 hour must be on patient safety

Min/Max inventory size

– the min is the numerator –> once point is reached a new order is needed to be placed
– max is denominator –> what the new order would reach up to

PPPA exception

– nitroglycerin SL
– aspirin or acetaminophen — powder or tablets
isosorbid dinitrate
– erythromycin ethyl succinate
– potassium supplements
– sodium flouride
– betamethasone 
– oral contraceptives
– pancrelipase
– anhydrous cholestyramine
– hormone replacement therapy
– sucrase
– estrogen tablets

Medicare Part A

– Hospital Insurance covers most medically necessary hospital care, skilled nursing facilities, home health and hospice care
– Free if you have worked and paid social security for more than 10 years (40 calender quarters)
– if less than montly premium will be paid

Medicare Part B

– Medical Insurance covers most medically necessary doctor, preventative care, medical equipment, hospital outpatient services, lab tests, mental health care, and home + ambulance
– always pay monthly premium

Medicare Part C

– Part of policy that allows private insurance companies to provide Medicare benifits
– not a seperate benifit
– include HMOs and PPOs
– known as Medicare Advantage plans

Medicare Part D

– outpatient prescription drug insurance
– provided only through private insurance companies that have contacts with the government
– never directly provided by the government
– must choose coverage that works with Medicare benefits

Durham – Humphrey Amendment

Defined two specific kinds of medications
– Legend drugs ( Prescriptions)
– Over the counter Drugs
– legend drugs include drugs with habit forming or harmful side effects

Tall Man lettering

Practice of writing part of a drugs name in upper case letters to help distinguish drugs that sound and look alike
– to avoid errors
– only for portion of drug name that are similar

PPI (prescription package inserts)

– leaflet for provided along with prescription and OTC drugs
first section contains information such as generic name, 
second –> pharacology, indications, warnings, administration, dependence, overdose
– how medicine works in the body, absorned + eliminated, effects –> included in pharmacology section

Medicaid tamper resistant prescription act

– requires physicians to use electronic or tamper proof pads for their patients

Prescription Drug Marketing Act of 1987

USP <797> hand hygiene

– gives advice to practitioners for procedures and practices
– must wash hands and forearms to elbow for 30 seconds
– remove debris from under fingernails with nail cleaner and warm water
– do not use antimicrobial scrub brushes on the skin because they can cause skin shedding
– dry hands and forearms completely using lint free disposable wipes of electronic dryer

Class a balance

– has sensitivity of 6mg with no load –> 6 mg will move the counter of the balance 1 point
– 10 g on each pan
– required to be in pharmacy 
– should be used for all weighing operations for prescription compounding
– do not weigh less than 120mg –> less is require mix with diluent –> to avoid unmeasured error
– do not weigh more than 120 g

iPLEDGE Program

mandatory distribution program for isotretinoin
– intended to prevent use of the drug during pregnancy
– required by law for patients and their doctors to  use a website to in order to receive this medication

BIN number

– leading 6 digits on the bank card numbers
– can be used by pharmacies to process claims

SIGS and Directions

PRN- As needed

C- With UD As Directed

SS – Half

AA – Of Each

QS – Qty. Sufficient

DC – Discontinue

Pure Food and Drug Act *** 1906

1st law dealing with pharmacy
Prohibits interstate transportation or sale of aldulterated or misbranded drugs

The Harrison Narcotic Act of 1914

Created to regulate opium, coca leaves, etc
Deemed unlawful for importation and distribution of opiates & required a prescription for opioids

Food, Drug and Cosmetic Act (FDCA)  1938

Created FDA
Compelled manufacturers to demonstrate safety of new drugs- all new drug pplications must go through FDA
Allowed inspection by the FDA at manufacturers
Clearly defined adulteration and misbranding
and defined -drug/ device/ cosmetic /what is necessary to label product

Durham-Humphrey Amendments to FDCA  1951

Differentiated Legend “RX” and Non-legend “OTC”
Allowed phone in prescriptions by MD to Pharmacist
All Legend drugs must have “Caution: Federal Law prohibits dispensing without a Prescription”

Kefauver-Harris Amendment to FDCA  1962

Must have GMP (Good Manufacturing Practices)
Added more controls on clinical investigations
Requires all medications in US to be pure, safe and effective

Comprehensive Drug Abuse Prevention and Control Act  1970

Created DEA
Classified into 5 scheduled classes
C-I / C-II/ C-III / C-IV / C-V

Poison Prevention Packaging Act 1970

enacted to reduce poisoning
Required most OTC and Legend drugs to be packaged in Child proof containers
Exempt products: Inhalers/ Nitroglycerin (SL)/ cholestyramine

Occupational Safety and Health Act of  1970

Created OSHA
ensure a safe and healthful workplace for employees
Requires SDS to be at locations

Drug Listing Act 1972

Required -NDC-National Drug Code numbers to be assigned to every marketed drug

Federal Privacy Act of 1974

Regulates what personal information the Federal government can collect about private individuals

Medical Device Amendment Act of 1976

Classification of medical device according to function
Establish performance standards

Drug Price Competition and Patent Term Restoration Act 1984 AKA Hatch-Waxman Act

Encouraged the creation of both generic and new meds
Streamlined the generic approval process

Prescription Drug and Marketing Act 1987

Prevents re-importation of a drug into US
Prohibited hospital and healthcare entities from reselling their pharamaceuticals

Omnibus Budget Reconciliation Act (OBRA)  1987

Established revisions to Medicare & Medicaid
Put more requirements in place at long-term care facilities
required services of a consultant pharmacist

Anabolic Steroid Act 1990

Enacted harsher penalties for abuse of anabolic steroids

Omnibus Budget Reconciliation Act (OBRA)  1990

Established 3 esssential components:
Prospective DUR
Retrospective drug use review
Educational programs
Counseling by Pharmacist

Food and Drug Administration safe Medical Devices Act of 1990

All medical devices are to be tracked and records maintained

Dietary Supplement Health and Education Act (DSHEA) 1994

Herbal products are dietary supplements rather than drugs
Manufacturers are NOT allowed to make claims of cure for diseases

Health Insurance Portability Act (HIPAA)  1996

Improve portability and continuity of health coverage
Establish conditions on disclosure of PHI
Patients are entitled to a complete discussion of health care options
Training must be given to employees

Food and Drug Modernization Act of 1997

Required all manufacturers & repackagers to register with FDA for products deemed “misbranded”
Label for Legend shortened to “RX Only”

Medicare Modernization Act 2003

Introduced an entitlement benefit for prescriptions
(Medicare part D)
Created Tax free savings accounts for pharmaceutical purposes

Combat Methamphetamine Epidemic Act  2005

Placed Pseudoephedrine, ephedrine, and phenylpropanolamine to the category “schedule listed chemical products” product must be sold behind RX counter
Requires Picture ID/ must be 18 yoa/ provide information
Patients allowed only 3.6 g per Day & 9g in a 30 day period

Patient Protection and Affordable Care Act 2010

Required all people to sign up for insurance coverage
Patients could not be denied coverage because of a pre-existing conditions
Many other regulations put into place dealing with insurance coverage.