US Law falls under several categories: Criminal law: involves a crime against an individual...
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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. It is brought to trial by a district attorney or prosecutor who seeks an indictment or a conviction of a crime by a jury to the offender. 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. Medical cases that result in death can be heard here as “wrongful death” cases. 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.
US Law falls under several categories: Criminal law: involves a crime against an individual specifically and to society in general. Examples are murder,
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.
It is brought to trial by a district attorney or prosecutor who
seeks an indictment or a conviction of a crime by a jury to the
offender. 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. Medical cases that result in
death can be heard here as wrongful death cases. 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.
Slide 2
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
Slide 3
Label and Labeling requirements made by the FDCA. Labels are on
the immediate container of the drug 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 Specific container to be
used by the pharmacist to dispense medication (i.e. dispense in an
amber vial for light sensitive drugs)
Slide 4
Additional label elements added through later amendments
National drug code FD&C yellow #5 (Tartazine) or yellow #6 if
present (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
Slide 5
OTC label requirements Drug Manufacturers name and address
Active ingredient(s) Inactive ingredients Purposes sections Dont
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
Slide 6
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 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
Slide 7
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 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 GMPs Claims to be a drug of USP standards but is differing in
quality See text for additional information
Slide 8
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 See text for other provisions In
general, adulteration involves the composition of the drug products
and misbranding involves misleading labeling
Slide 9
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 Legend drugs not label with
such are misbranded Allows prescribers to phone in Rxs 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 NDAs Also regulate
prescription drug advertising
Slide 10
Thalidomide Scare of 1950s and 1960s First used in Europe as a
wonder drug for pain, and insomnia. It was reported to be effective
for treating nausea and as a result it was used to treat morning
sickness in pregnant women. The US FDA never allowed the drug to be
marketed in the US. Pregnant women obtained the drug from other
sources like across border trade and their husbands returning from
WWII active duty in Europe Birth defects have been linked to the
drug even after only one dose. This was proven by 1961. The defect
involved an absence/malformation of limbs in the fetus called
phocomelia.
Slide 11
Thalidomide syndrome
Slide 12
Thalidomide Today Thalidomide was removed from the worldwide
market in 1962-1963. Today however the drug is market in the US
under the brand name Thalomid under very strict conditions and
requires registration with the STEPS program (system for
thalidomide education and prescribing safety). The program is
monitored by the FDA and requires registration by doctors, patients
and pharmacists for dispensing. Drug has approval from the FDA for
use in Erythema Nodosum Leprosum and in multiple myeloma.
Slide 13
Other lesser known pharmacy laws 1914: Harrison Narcotic Act :
The possession of narcotics and coca became illegal. 1924: Heroin
Act: The manufacture and the possession of heroin became illegal.
1927: Bureau of Prohibition: enforces the 18 th amendment to the US
constitution. 1937: Marijuana Tax Act: requires payment of a tax to
buy cannabis. Illegal to do so without payment.
Slide 14
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 1 to 5. 1
having the highest potential for abuse and 5 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) Crack cocaine Crystal
Methamphetamine Hashish Heroin Phencyclidine palmitate (PCP) (angel
dust) Rohypnol (Roofies)
Schedule III Drugs BRAND NAMEGENERIC NAME Bontril
Phendimetrazine Vicodin , Loricet , Anexsia Hydrocodone/APAP
VicoprofenHydrocodone/ibuprofen
TussionexHydrocodone/Chlorpheniramine Soma with
CodeineCarisoprolol/Codeine
Slide 17
Schedule IV Drugs BRAND NAMEGENERIC NAME Benzodiazepines
(Ativan , Valium , Tranxene , Librium , Restoril) Lorazepam,
Diazepam, Chlorazepate, Chlordiazepoxide, Temazepam Fastin
Phenermine Fioricet with CodeineButalbital, APAP, Caffeine, Codeine
Talwin Pentazocine Stadol Butorphanol Xanax Alprazolam Cylert
Pemoline Robitussin AC Guaifensin and Codeine
Slide 18
Schedule V Drugs BRAND NAMEGENERIC NAME Acetaminophen/Codeine
ElixirN/A Lomotil Diphenoxylate 2.5 mg/Atropine 0.025 mg Lyrica
Pregabalin Phenergan with Codeine Promethazine with Codeine
Slide 19
Exception to the CSA Drug Schedules Some drugs are typical
narcotics but because they are combined with other less potent
drugs with more side effects they are de-scheduled from the CSA
Additive are meant to discouraged abuse Examples Pyridium Plus
(Butabarbital) Librax (Chlordiazepoxide/Clidinium Bromide) Donnatal
(Phenobarbital, atropine, hyoscyamine, scopolamine) Anaspaz
PB(Hyoscyamine/Phenobarbital) 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 )
Slide 20
Schedule II Drugs- General Guidelines prescriptions may be
written for a one month supply maximum with 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 Cant be faxed Exception(s): for a terminal hospice
patient in a Medicare XVIII certified hospice A patient in long
term care facility Pharmacist must note this on fax copy Cant be
called in (except for: Emergency Verbal)
Slide 21
Scheduled III & IV Drugs Prescriptions can be written,
phone in, faxed, or sent electronically Can be filled for up to 5
refills or up to 6 months DEA 106 to report loss or theft Can be
transferred to other pharmacy
Slide 22
Schedule drugs continued Schedule V: includes cough preparation
with codeine. Example is Tussin C (Guaifenesin with Codeine). Up to
11 refills are allowed like a regular prescription and is valid for
one year. Can be phone in, written, faxed or electronically sent to
a pharmacy DEA 106 is filed for theft or loss Can be filled with
out a prescription only under the following conditions: Sold by a
pharmacist Log book must be keep 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
Slide 23
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
MDs, 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 cant alter the
name of the patient, drug, or the prescribers signature. Under
Federal law, other information can be altered with prescribers
permission
Slide 24
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
Slide 25
Prescriptions issued for Illegitimate purposes Indicators
Doctor may be running prescription mills 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
Slide 26
Security Requirements As per Federal Law, prescriptions for
CII-CV can be either locked up or dispersed. If CII are grouped
together, they must be locked up in a cabinet If CIII-CV are
grouped together, they must be locked up in a cabinet If controlled
substances are not locked up, they must be scattered among the
pharmacys entire inventory Either group and lock or separate and
scatter
Slide 27
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 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 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) 3. Two files- CII-CV and other legend drugs
(CIII-CV must have red C in corner) All records must be made
available to law enforcement while 72 hours
Slide 28
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 To report theft of controlled substances Notify local
police Notify DEA office State narcotic office Fill out DEA 106
form To order c2 drugs complete DEA 222 form To apply for a DEA
registration DEA 224
Slide 29
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
Slide 30
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 entitys name
(most often the first initial of the last name) Six digits are the
serial number Seventh digit is a checksum digit
Slide 31
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
Slide 32
Penalties involving violations of the CSA of 1970 Simple
Posession of Controlled Substances (21 USC 844) Drug or
ClassFineImprisonment 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 $250,000Upto 3 years
Marihuana (possession of a small amount) Not Less than $1,000 Up to
1 year
Slide 33
Penalties for Violations of CSA of 1970 Drug Trafficking
(Possession with intent to distribute) 21 USC 841,960,962 Drug or
Drug Class AmountFineImprisonment Heroin1 kilo or more$10,000,000
or more 10 years to life Cocaine or Coca leaves, Ecgonine 5 kilos
or more>=$10,000,00010 years to life PCP (Phencyclidine) 100
grams or more>=$10,000,00010 years to life LSD (lysergic acid
Diethylamide) 10 grams or more>=$10,000,00010 years to life
Methamphetamine 50 grams or more>=$10,000,00010 years to life
Fentanyl400 grams or more>=$10,000,00010 years to life
Slide 34
Drug or ClassAmountFineImprisonment Flunitrazepam and GHB (see
below) 1 gram or more GHB (any amount) $1,000,000Up to 20 years Any
other C1 or CIIAny weight$1,000,000 or more Up to 20 years C IIIAny
weight$500,000 or moreUp to 15 years C IVAny weight$250,000 or
moreUp to 5 years CVAny weight$100,000 or moreUp to 1 year The
above table contains that maximum penalty for jail time or amounts
that are less than the one above the fine and penalties are less.
These listed offenses are for first time offenses Flunitrazepam
(Rohypnol or street name of Roofies is a benzodiazepine that
produces powerful sedation and anterograde amnesia. It is a date
rape drug and has been used in committing sexual assault in the US
and other countries. GHB (gamma hydroxybutyrate) is similar to
flunitrazepam and is a date rape drug also known as Georgia Home
Boy","Lollipops"
Slide 35
Rockefeller Drug Laws In 1973, NYS governor Nelson Rockefeller
signed in law one of the most draconian state drug laws in the US.
Anyone with illegal possession with intent to sell 57 grams or more
of heroin, cocaine, marihuana, morphine would sentenced to a
minimum of 15 years Anyone with illegal possession of 113 grams or
more of the above drugs would serve 15 years to life. Due to
political pressures, governors George Pataki and David Patterson
greatly reduced these minimum sentences to class D felonies and for
marihuana a misdemeanor Criminal possession of prescription
narcotics is still a felony in most cases in NY
Slide 36
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 (California based company with the
ticker symbol: Nasdaq: BMRN). It is an enzyme that is lacking in a
genetic disease called Hurlers syndrome. People with Hurlers are
often disfigured with gargoyle like features. They are often
mentally retarded with other neurological features. They also have
failing organs in particular the liver. They often will die by
about 10 years of age because of liver disease.
Slide 37
The Drug Price Competition and Patent Term Restoration Act of
1984 Result of a decade long dispute between generic drug
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 Called
generic drug act Also called the Hatch Waxman act
Slide 38
Anabolic Steroid Control Act of 1990 Placed anabolic steroids
in the CIII category in 2004. Hormones that are pharmacological
similar to testosterone Responded to high rate of steroid abuse in
young teens and athletes (Mark McGuire and Barry Bonds). Example of
such drugs: Anadrol (oxymetholone) and Winstrol (stanozolol).
Slide 39
Omnibus Budget Reconciliation act of 1990 (OBRA 90) Passed by
congress to address the rising cost of the medicaid and medicare
programs Required pharmacist to counsel all medicaid patients. This
requirement later extended to all patients depending on the state
of residency. Required the pharmacist to perform a proDUR,
prospective drug utilization review to screen for: Drug
interactions Therapeutic duplicates Drug disease interactions Wrong
dosing Abuse of medications (earlier refills) Created a need for
pharmacy technicians to assist pharmacists in the technical aspects
of pharmacy to allow them to devoted more time to the clinical
aspects of pharmacy practice.
Slide 40
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. Patients rights under HIPAA include: 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. Portability refers to the ability to
transfer insurance provision from one employer to another Requires
pharmacy to appoint a HIPAA compliance officer
Slide 41
Penalties for HIPAA violations Civil Penalties: up to $25,000
fine Criminal Penalties are incurred if the entity knowingly using
PHI unlawfully $50,000 and 1 year in prison $100,000 and 5 years in
prison if entity obtains PHI under false pretenses $250,000 and 10
years in prison if entity sells PHI for personal gain or for
malicious harm to patients reputation
Slide 42
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 by only for one prescription
at a time (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
Slide 43
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 Hospital Pharmacies were not allowed to
resale drug obtained through discounted pricing. Prevents the
reimportation of drug into the US except by the drug manufacturer
Think of it has the prescription drug samples act
Slide 44
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 NDCs have
three parts First set of five numbers-Manufacturer Second set of
four numbers-drug product Third set of two numbers-package
size
Slide 45
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 Also called the
Medicare Modernization act (MMA) 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
Slide 46
Online Pharmacy Consumer Protection Act of 2007 Also called the
Ryan Haight Act Ryan Haight was a 17 year old teen who died from an
overdose of vicodin obtained from an internet based pharmacy. Ryan
posed as a adult male with severe back pain Established guidelines
for online pharmacies Must display compliance with this law on the
sites homepage Defined that a Rx for a controlled substance must be
for a legit medical reason AND involves at least one in person
medical evaluation
Slide 47
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) 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, fire aid measures of exposed, fire fighting methods,
handling and storage, Physical and chemical properties, stability
and reactivity Pharmacy that handle hazardous substances must have
a spill kit Kit has disposal bags, eye google, latex gloves,
absorbable spill sponges
Slide 48
Resource Conservation and Recovery Act of 1976 Known as the
RCRA Established different classes of hazardous waste materials F
listed (industrial solvents that arise from manufacturing) K listed
(specific industrial wastes) P listed (finished commercial drug
products that are acutely toxic) includes warfarin, nicotine,
physostigmine, epinephrine (Adrenalin) U listed (finished
commercial drug products that are subacutely toxic). Most
chemotherapy drugs Most Pharmacies use a vendor that handles and
disposes hazardous drugs for them in compliance with the RCRA
Slide 49
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
opiate/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,
MDs can be licensed to prescribe Buprenorphine based products for
office based treatment of addiction Suboxone (Buprenorphine) and
Subutex (Buprenorphine/Naloxone) This MD have the DEA number of X+
7 digits