Transcript Lesson 3 Pharmacy Law - LaGuardia Community College Pharmacy

 US Law falls under several categories:
 Criminal law: involves a crime against an individual
specifically and to society in general. Examples are murder,
rape, sexual assault, burglary, grand larceny.
 Civil law (tort law): deals with dispute resolution between
individuals and/or organizations. Emphasis is on
compensation and not on punishment. Most cases of
medical malpractice fall under this category.
 Family Law
 Penalties
 Misdemeanor is a crime punishable by a jail term of 1 year or
less and/or a monetary fine
 Felony is a crime punishable by a jail term of greater than 1
year up to life or death.
Important Milestones in Pharmacy
law
 Pure Food and Drug Act of 1906: forbade the manufacture,
sale and distribution of adulterated medications as well as
meat and poultry products.
 Food, Drug, and Cosmetic Act of 1938 established the Food
and Drug Administration which oversees the production of
drugs, cosmetics and food products in terms of certain
standards. Standards are:
 Manufacturers of drugs are required to submitted safety data
before they can market any drug.
 Requirements for label and labeling of drugs
 FDA is charged with protecting the public by enforcing FDCA
 Label and Labeling requirements made by the FDCA.
 Labels are on the immediate container of the drug
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Must include:
 established name of drug and quantity of each active
ingredient.
 Statement of quantity
 Statement of usual dosage
 Route of administration
 If habit forming, federal disclaimer
 Name of all inactive ingredients if not for oral use
 Name and address of manufacturer, packer or distributor
 Lot number and expiration date
 Additional label elements added through later
amendments
 National drug code
 FD&C yellow #5 (Tartazine) or yellow #6 if present
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(human allergens)
If aspartame is present must declare phenylalanine and
PKU warning
If sulfites are present, must declare it
If methysalicylate is present in concentration of over 5%
must state toxicity warning
Barcode label
 OTC label requirements
 Drug Manufacturer’s name and address
 Active ingredient(s)
 Inactive ingredients
 “Purposes” sections
 “Don’t use” section
 “Directions”
 “Questions” section provides an toll free number of questions
 These requirements were added through amendments to the
FDCA over the years
 National Drug Code, NDC
Labeling requirements by the FDCA
 Labeling is the printed material that accompanies the medication
container. This is called the Package Insert and is required by the FDA
and is intended for use by healthcare clinicians
 Description of the chemical nature of the drug including its generic
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name and chemical properties
Pharmacology
Indications for use
Contraindications-situation where the drug should not be used
Dose
Warnings
Side effect warnings
Adverse reactions
Drug Abuse potential, if applicable
How drug is supplied
Date of most recent revision to labeling
FDCA defines a drug
 FDCA defined a drug as: “article intended for use in the
diagnosis, cure, mitigation, treatment, or prevention of
disease in man or animal”
 FDCA defines adulteration as:
 A product that is combined with an ingredient that reduces
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its potency or quality, any putrid or decomposing substances
A product that is kept in unsanitary conditions
A product that contains unapproved colorants
Manufactured under conditions that are less than GMP’s
Claims to be a drug of USP standards but is differing in
quality
 FDCA defines misbranding as “false and misleading labeling” or
dispensing or distributing a product in violation of its labeling
 Does not include the established name of the drug
 The name and/or address of the manufacturer is missing
 Failure to include Federal disclaimer or “Rx only” on legend drugs
labels (see Durham Humphrey) or dispensing a legend drug
without a prescription
 Sale of a drug under the name of another
 Failure to include “Warning –May be habit forming” if required on
its label
 Products that are “dangerous to health when used in the dosage
prescribed”
 In general, adulteration involves the composition of the drug
products and misbranding involves misleading labeling
Amendments to the FDCA
 Durham Humphrey Amendment of 1951
 called the prescription drug amendment
 Established two classes of drugs: legend drugs that require a
prescription and OTC with does not
 required that legend drugs must have the federal legend: “Caution:
Federal law prohibits dispensing without a prescription”. Later in 1997,
legend was shorten to “Rx only”
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Legend drugs not label with such are misbranded
 Allows prescribers to phone in Rx’s to pharmacies
 Kefauver Harris Amendment of 1962: established that drugs be proven
safe and effective before they are marketed to the public.
 Act came about because of the thalidomide tragedy.
 Also called the “Drug efficacy amendment”. Drug needed to be safe and
effective.
 Established marketing protocols for NDA’s
 GMPs for drug manufacturers
The Comprehensive Drug Abuse Prevention
and Control Act of 1970
 Established five schedules of drugs that have high potential for abuse. Listed
with symbol “C” followed by a number from I to V. I having the highest
potential for abuse and V the lowest.
 Established the Drug Enforcement Agency (DEA) under the US Dept of Justice
 Standards are set in each class that helps law enforcement prevent diversion
and to protect the public.
 Schedule I: have no accepted medical use in the US. Includes Heroin (smack),
LSD, marijuana (weed), methaqualone (Luddes)
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“Crack” cocaine
Crystal Methamphetamine
Hashish
Heroin
Phencyclidine palmitate (PCP) (angel dust)
Rohypnol (Roofies)
Peyote
Schedule II Drugs
BRAND NAME
GENERIC NAME
Codeine ®
Codeine
Dolophine®
Methadone
Duragesic ®
Fentanyl
Astramorph, Duramorph ®
Morphine
Oxycontin ®, Roxicodone ®
Oxycodone
Adderall®
Amphetamine/dextroamphetamine
Amytal ®
Amobarbital
Cocaine 4% ®
Cocaine
Demerol ®
Meperidine
Percocet ®
Oxycodone/Acetaminophen
Dilaudid
Hydromorphone
Vicodin®
Acetaminophen/Hydrocodone
Schedule III Drugs
BRAND NAME
GENERIC NAME
Bontril ®
Phendimetrazine
Soma®
Carisoprodol
Tylenol#3®
Acetaminophen/Codeine
Androgel®
Testosterone gel
Soma with Codeine®
Carisoprolol/Codeine
Schedule IV Drugs
BRAND NAME
GENERIC NAME
Benzodiazepines (Ativan ®, Valium ®,
Tranxene ®, Librium ®, Restoril®)
Lorazepam, Diazepam, Chlorazepate,
Chlordiazepoxide, Temazepam
Fastin ®
Phenermine
Fioricet ® with Codeine
Butalbital, APAP, Caffeine, Codeine
Talwin ®
Pentazocine
Stadol ®
Butorphanol
Xanax ®
Alprazolam
Cylert ®
Pemoline
Schedule V Drugs
BRAND NAME
GENERIC NAME
Acetaminophen/Codeine Elixir
N/A
Lomotil ®
Diphenoxylate 2.5 mg/Atropine 0.025
mg
Lyrica ®
Pregabalin
Phenergan with Codeine ®
Promethazine with Codeine
Exception to the CSA Drug
Schedules
 Some drugs are typical narcotics but because they are combined
with noxious drugs with more side effects they are de-scheduled
from the CSA
 Additive are meant to discouraged abuse
 Examples
 Librax ®
 Donnatal ®
(Chlordiazepoxide/Clidinium Bromide)
(Phenobarbital, atropine, hyoscyamine,
scopolamine)
 Remember Fiorinal ® (Butalbital/Caffeine/ASA) is a scheduled
drug but Fioricet (Butalbital/Caffeine/APAP) is not
 Remember: BDZ are CIV federal, in NY they are CII
 Remember: Barbiturates are CIV except: Secobarbital (Seconal
®) and Amobarbital (Amytal ®)
 Schedule II Drugs- General Guidelines
 prescriptions may be written for a maximum of thirty day supply
>>no refills.
 Have strong potential for abuse and have a medical purpose
 Must use DEA 222 to order
 Must use DEA 106 form to report loss or theft
 Can be written, or electronic
 Can’t be faxed
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Exception(s):
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for a terminal hospice patient in a Medicare XVIII certified hospice
For a patient in a long term care facility
For direct compounding into a parenteral dosage form
Pharmacist must note this on fax copy
 Can’t be called in (except for: Emergency Verbal)
 Can’t be transferred between pharmacies
 Scheduled III & IV Drugs
 Prescriptions can be written, phone in, faxed, or sent
electronically
 Can be filled for up to 5 refills within a 6 months
whichever is first
 DEA 106 to report loss or theft
 Can be transferred to other pharmacy
Schedule drugs continued
 Schedule V: includes cough preparation with codeine not more than 2
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mg/ml.
Can be phone in, written, faxed or electronically sent to a pharmacy
Five refills within a 6 month period, whichever comes first
DEA 106 is filed for theft or loss
Can be filled with out a prescription only under the following
conditions:
 Allowed by state law (NY does not do this)
 Sold by a pharmacist
 Log book must be kept with the following information:
 Name, address of patient
 Drug, quantity and price of the transaction
 Date purchased
 Signature of the pharmacist
 No more than 4 ounces or 24 solid dose forms in a 48 hour period to a
single patient
 Patient must be 18 years old minimum
Other provision of the CSA
 All individuals handling controlled substance are required to register with the
DEA (Drug Enforcement Agency which is a branch of the US Dept. of Justice).
This includes MD’s, drug companies, distributors, pharmacies (not individual
pharmacists).
 A prescription for a controlled substance must have the following to be
dispensed:
 The full name and address of both prescriber and patient.
 DEA of the prescriber
 Date prescription was written
 Signature of the prescriber.
 Drug name, dose, directions for use
 Quantity
 Refills (if not a CII)
 A pharmacist can’t alter the name of the patient, drug, dose, quantity and the
prescriber’s signature. Under Federal law, other information can be altered
with prescriber’s permission
Fraudulent Prescriptions
 A huge problem in the United States
 Types of fake controlled substance prescriptions
 Stolen prescription blanks
 Altered quantity to obtain high amounts of drug
 Stolen prescription blanks with altered phone numbers
 Characteristics of a forged or manufactured
prescription
 Prescription is “too neat” or too clean
 Quantities are higher than normal
 Directions written with no abbreviations
Prescriptions issued for Illegitimate purposes
 Indicators
 Doctor may be running “prescription mills”
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A large number of people coming in with prescriptions from
the same prescriber for the same drug in unusual doses
Prescriptions seems scripted with the same directions just
different patients
Patients coming in that are not from the community
Patients presenting prescriptions for other people (relatives)
Patients returning for refills too early
Security Requirements
 As per Federal Law, CII-CV drugs can be either locked
up or dispersed.
 CII must be locked (key or combination)
 If CIII-CV are grouped together, they must be locked up
in a cabinet
 If CIII-CV are not locked up, they must be scattered
among the pharmacy’s entire inventory
 Record Keeping of Controlled Substances
 All invoices of controlled substances must be kept for two years
 DEA 222 must be attached to the corresponding invoice
 CII invoice must separate from other pharmacy invoices
 CIII-CV may be kept with other invoices but must have a red “C”
stamped
 Biennial Inventory
 All scheduled controlled substances in house must be inventoried
every two years
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Exact physically count of CII is required
Estimated count of CIII-CV is ok if products are container s with less than 1,000
count
 Controlled Substance Prescriptions
 Maintained on file for 2 years
 Options for filing
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1. Three files- CII, CIII-CV, other legend drugs
2. Two files- CII, CIII-CV + other drugs (CIII-CV must have red “C” in corner)
 All records must be made available to law enforcement while 72 hours
 To destroy controlled substances
 Must notify DEA office and state narcotic office (NYS DOH Bureau of
Narcotic Enforcement) of Day and time of destruction
 DEA 41 is used to surrender drugs to the DEA directly or to destroy on
premises. Retail pharmacy..only once a year. Institutions may have
blanket authorization
 To report theft of controlled substances
 Notify local police
 Notify DEA office
 State narcotic office
 Fill out DEA 106 form
 To order CII drugs complete
 DEA 222 form
 To apply for a DEA registration
 DEA 224
DEA FORM 222
 Required to order CII drugs from wholesalers
 Come in a triplicate form
 No alterations, erasures, changes permitted
 Can be used to transfer drugs between DEA registrants
 Must be keep for two years (even voided ones)
 Attached to invoice
DEA numbers
 DEA numbers are issued by the US Dept of Justice to
entities that prescriber, dispense, manufacturer, distribute
or export scheduled controlled substances
 Contains 2 letters with a 7 digit number
 1 st letter signifies the type of DEA registrant
 A/B/F are doctors, dentists, hospitals, clinics, pharmacies
 M are midlevel practitioners (PA, NP, etc)
 P/R are manufacturers, exporters, wholesalers, etc
 2 nd letter is part of the entity’s name (most often the first
initial of the last name)
 Six digits are the serial number
 Seventh digit is a checksum digit
DEA Number
 To verify if a DEA number is valid perform the
checksum algorithm
 First Add the 1st,3rd,5th digits together
 Second add 2nd,4th and 6th digits together and
multiply by two
 Third add the results of the two together and if it
match the check digit the DEA is valid. If not, the
DEA number is fraudulent
Penalties involving violations of the
CSA of 1970
Simple Posession of Controlled Substances (21 USC
844)
Drug or Class
Fine
Imprisonment
C II –C V(First
offense)
Not less than
$1,000
Up to 1 year
C II- CV
(Second Offense)
Not less than
$2,500
15 days to 2 Years
Any Offense
(Flunitrazepam
$250,000
Upto 3 years
Marihuana
(possession of a
small amount)
Not Less than
$1,000
Up to 1 year
Penalties for Violations of CSA of
1970
Drug Trafficking (Possession with intent to distribute) 21 USC 841,960,962
Drug or Drug
Class
Amount
Fine
Imprisonment
Heroin
1 kilo or more
$10,000,000 or
more
10 years to life
Cocaine or Coca
leaves, Ecgonine
5 kilos or more
>=$10,000,000
10 years to life
PCP
(Phencyclidine)
100 grams or more
>=$10,000,000
10 years to life
LSD (lysergic acid
Diethylamide)
10 grams or more
>=$10,000,000
10 years to life
Methamphetamine
50 grams or more
>=$10,000,000
10 years to life
Fentanyl
400 grams or more >=$10,000,000
10 years to life
Drug or Class
Amount
Fine
Imprisonment
C III
Any weight
$500,000 or more
Up to 15 years
C IV
Any weight
$250,000 or more
Up to 5 years
CV
Any weight
$100,000 or more
Up to 1 year
The Orphan Drug Act of 1983
 Passed by congress to provide incentives for drug
companies to create drugs for rare diseases in which the
profit motivation is not there.
 50% tax credit in the cost of conducting clinical trials.
 Research grants
 Waive the costs of submitting fees to the FDA.
 Example is a drug called Aldurazyme® made by BioMarin
Pharmaceuticals . It is an enzyme that is lacking in a genetic
disease called Hurler’s syndrome. People with Hurler’s are
often disfigured with gargoyle like features. They also have
failing organs in particular the liver.
The Drug Price Competition and Patent
Term Restoration Act of 1984
 Result of a decade long dispute between generic drug
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manufacturers and brand drug manufacturers
Allowed manufacturers of generic drugs to file an Abbreviated
New Drug Applications (ANDA) with the FDA.
Allowed these companies to show that their generic drugs where
therapeutically equivalent to their brand competitors without the
necessity of going through extensive efficacy and safety testing.
Did not sit well with large brand drug companies. To help these
drug manufacturers recoup their costs the term of brand drug
patents were extended by an additional five years
Also called the Hatch Waxman act
Anabolic Steroid Control Act of
2004
 Placed anabolic steroids in the CIII category.
 Hormones that are pharmacological similar to
testosterone
 Example of such drugs: Anadrol® (oxymetholone) and
Winstrol ® (stanozolol).
Omnibus Budget Reconciliation act
of 1990 (OBRA 90)
 Passed by congress to address the rising cost of the
medicaid and medicare programs
 Required states to establish prospective drug utilization
review ProDUR, retrospective DUR and educational
programs
 States require the pharmacist to perform a proDUR,
prospective drug utilization review to screen for:
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Drug interactions
Therapeutic duplicates
Drug disease interactions
Wrong dosing
Abuse of medications (earlier refills)
 States require the pharmacist to offer counseling to the
patient with regards to medications
Omnibus Budget Reconciliation act
of 1990 (OBRA 90)
 Key counseling points
 Use of the medication
 Description of the dosage and how it is to be administered
 Common severe side effects or adverse effects
 Self monitoring of side effects and what to do if they occur
 Proper storage
 What to do if dose is missed
 Act also requires that pharmacies maintain patient profiles to
include
 Patient’s name, address, DOB and other demographics
 History of illnesses
 Patient profile to include subprofile for medications (Med profile)
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Medication profile to include all medications current and past, OTC and
information on patient allergies
The Health Insurance Portability
and Accountability Act of 1996
 Known as “HIPAA”
 Requires that protected health information (PHI)be safeguarded by the
healthcare industry.
 Medical records need to be safeguarded electronically which may
involve encryption coding and password protection.
 Patient’s rights under HIPAA include:
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Access to their own health information
Ability to amended information
Ability to control to whom PHI is disclosed
Receive written notification of how PHI may be used by the health
provider , also know as “notice of privacy practices”
 When PHI is used by a provider for any reason other than treatment or
payment, explicit authorization must be obtained from the patient.
 Requires pharmacy to appoint a HIPAA compliance officer
The Health Insurance Portability
and Accountability Act of 1996
 In addition to the security requirement of HIPPA,
there are other area effected by the law including:
 Portability of insurance coverage to those changing jobs
 Address the use of HSA’s (Health Savings Accounts)
 Rules to combat waste, fraud and misuse of medicare
and medicaid and health care delivery
 Administration rule of the act established rules for the
electronic health record and electronic transactions
involving PHI
Ancillary Laws
 Poison Prevention Packaging Act of 1970
 Required childproof dispensing containers for all Rx drugs
 Elderly people who desire non child resistant container must sign a waiver.
 A prescriber can waive the requirement for one prescription for a single dose(no
blanket authorization)
 Drug exceptions to the PPPA are sublingual nitroglycerin, oral contraceptives in the
memory package dial, erythromycin ethylsuccinate tablets, Mebendazole Tablets,
Pancrelipase preparations, among others see text on page 52
 Conditional Exceptions
 patients in hospitals
 For OTC products with more than one strength, one strength can be marketed
with out this package if the following is on the package: “Not for households
with young children”
 Upon dispensing a refill, the pharmacist must used a new plastic vial and cap to refill
the prescription due to the high wear and tear of Rx vials
 Prescription Drug Marketing Act of 1987
 Passed to stop the passage of counterfeit drugs into the
marketplace and to stop unfair monetary gain from illegally
procured drugs
 Made it illegal for retail pharmacies to have in its possession
Rx drug samples from the manufacturer
 Prevents distribution of drug samples except to licensed
prescribers
 Prevents the reimportation of drug into the US except by the
drug manufacturer
 Requires that medications produced for animals have the
following: “Federal Law restricts this drug to be used under
the order of a licensed veterinarian”
 Medical Device Amendment of 1976
 Life saving medical devices were required to have
premarket approval by the FDA
 Example is a cardiac pacemaker and defibrillators
 The Drug Listing Act of 1972
 Amendment to FDCA
 Required all drugs to have an NDC code
 NDC’s have three parts
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First set of five numbers-Manufacturer
Second set of four numbers-drug product
Third set of two numbers-package size
 Medicare Prescription Drug, Improvement, and
Modernization act of 2003
 Provides prescription drug coverage for medicare participants
 Provides for medication therapy management (MTM) where
pharmacist can receive compensation for this
 Reduces medicare reimbursement for durable medical
equipment
 Medicaid Tamper Resistant Prescription Act of 2007
 Due to high federal cost of funding medicare and medicaid,
the government mandated that doctors implement
counterfeit proofing strategies of their prescription pads
 Does not apply if an Rx is faxed, phoned or electronically sent
directly to the pharmacy
 Combat Methamphetamine epidemic act of 2005
 Federal government placed the following drugs under the CSA of
1970 under the “scheduled listed chemicals”
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Ephedrine, pseudoephedrine , and phenylpropanolamine
 This chemicals have been used by “meth kitchens” to make
methamphetamine
 Requires the removal of all products that contain these chemical
from the OTC area
 Sales for products with these chemicals must be documented as
follows:
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Logbook kept with name, address, date and time, drug and quantity
Pharmacist signature
 Sale limits include:
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No more than 3.6 grams of drug per day to any one person
No more than 9 grams of drug per 30 days to any one person
 Occupational Safety and Health Act of 1970
 Created OSHA agency
 Addresses workplace safety from hazardous substances
 Addresses air quality, flammable and explosive chemicals, and
hazardous drugs
 Requires a reporting system for job related injuries
 Requires the use of SDS-Safety Data Sheets (also called MSDS
M=Material)
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SDS are required to be distributed by manufacturers of hazardous chemicals or
drugs to the purchaser
SDS provides users of such with data on Hazards, first aid measures if exposed,
fire fighting methods, handling and storage, Physical and chemical properties,
stability and reactivity
There are a total of 16 sections to the SDS
 Pharmacy that handle hazardous substances must have a “spill kit”
 Kit has disposal bags, eye goggle, latex gloves, absorbable spill sponges
 Resource Conservation and Recovery Act of 1976
 Known as the RCRA
 Established the EPA
 Established different classes of hazardous waste materials
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F listed
K listed
P listed (finished commercial drug products that are acutely toxic)
Examples: Warfarin, arsenic trioxide, Nicotine, Epinephrine and
Nitroglycerin
U listed (finished commercial drug products that are subacutely
toxic). Most chemotherapy drugs like Mitomycin, Chlorambucil,
cyclophosphamide and some chemicals like lindane, phenol and
mercury
 Most Pharmacies use a vendor that handles and disposes
hazardous drugs for them in compliance with the RCRA
 FDA Modernization act of 1997
 Changed the disclaimer of “caution-Federal law prohibits
dispensing without a prescription” first established with the
Durham Humphrey Act to simply “Rx only”
 Drug Addiction Treatment Act of 2000
 Referred to as DATA2000
 Before this law, only MDs licensed to prescribe methadone for
opioid/heroin addiction can write for methadone for this purpose
and only in setting of a clinic licensed by the state and federal
government as a detoxification maintenance provider
 With this law, MD’s can be licensed to prescribe Buprenorphine
based products for office based treatment of addiction
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Suboxone (Buprenorphine/Naloxone) and Subutex ( (Buprenorphine)
This MD have the DEA number of X+ 7 digits
State Boards of Pharmacy
 SBOP makes most of the laws pertaining to the practice of
pharmacy in a given state. Federal laws pertain to drugs that
cross state borders (Interstate commerce clause of constitution)
 Most SBOPs in the US have the following mandates in their
state:
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A licensed pharmacist is on duty whenever the pharmacy is open
An alarm is operational when pharmacy is closed
All pharmacies must have a Class A balance with metric weights
All pharmacies must have a sink with hot/cold water
Minimum amount of counterspace
A safe for CII drugs
 Required references that all pharmacies must have:
 A copy of the CSA of 1970
 A copy of the USP/NF
United States Pharmacopeia
 USP was established during the 19th century and was
later combined with the National Formulary into the
USP/NF
 Provides standards for purity, quality and consistency
to all manufacturer drug and OTC products
 USP/NF standards are used by drug manufacturers
across the globe in the manufacture of drug products
 If a product is in compliance with the USP/NF
standard it will state it on the label
 Lisinopril 10 mg tablet, USP