Pharmacy 101
Week I I
Pharmacy Law, Drug Regulation and Control
OTC medications
• Review week I homework assignment
• What did important labeling did you find on the OTC packaging?
OTC Label for Loratadine
Claritin (OTC example)
OTC Label
• Product name
• Name and address of manufacturer or distributor
• List of all active ingredients and inactive ingredients
• Amt of contents (strength and quantity)
• Adequate warnings
• Adequate directions for use
Over the counter medications
• Do not require a prescription
• May be written as a prescription for insurance or other reasons.
• Patients often ask pharmacy technicians about OTC items.
• Any questions or recommendations about an over the counter
medication should be referred to the pharmacist.
• There may be significant drug interactions between OTC meds and
prescription meds.
Motrin, Advil and Ibuprofen
• Many OTC products that have the same active ingredient have
different brand names.
• For example Motrin and Advil both contain Ibuprofen as the
active ingredient
• Learning to look for the active ingredient in OTC products will
help you differentiate between the products.
• Many retail stores carry their own generic version of products at
a cheaper price
1906 – Pure food and drug act
• Prior to this act products were often made in unsanitary
conditions (Adulterated drugs)
• No regulations about safe and effective use
• Traveling drug salesman went from town to town selling high
alcohol content drugs that provided only temporary relief.
• Pure food and drug act passed to regulate strength, quality and
purity. Proved ineffective.
Food, Drug and Cosmetic act of 1938.
• Sulfanilamide had been used to treat strep successfully.
• In elixir form it was combined with poison diethylene glycol
(now used as antifreeze) Caused 107 deaths.
• Read letter from physician about incident
• This act required a pre-marketing approval process for new
drug.
NDA – New drug application
• After food, drug and cosmetic act of 1938, the FDA required an
NDA to be filed.
• The FDA (The Food and Drug Administration) was formed to
administer these laws.
INDA – Investigational New Drug Application
• In 1962 the Kefauver Harris Amendment passed. This
amendment states that prior to a NDA an INDA must be filed to
prove the safety and effectiveness of the new drug.
• The Thalidomide lesson of 1962. This sleeping pill caused
severe birth defects when used by pregnant women.
New Drug Approval Process
• All new drugs require approval by the FDA
• Any drug proposed for marketing after 1938 is considered new
• New drugs must prove to be safe and effective. Benefits must
substantially outweigh the risk.
• New drugs must go through a testing process. The FDA
estimates this process takes about 8.5 years to complete.
Testing
• After Lab testing is complete animal testing begins.
• Generally more than one species is tested on since different
species may react differently
• Less than one percent of drugs tested on animals are then
tested on humans
• Children are only tested on after adults are fully tested.
Placebos
• An inactive substance given in place of a medication.
• In testing, participants are informed they may receive either a
placebo or a potentially effective medication
• Participants must be informed of an effective treatment if one is
available
Three phases of human testing
• Phase one tests 20-100 patients mainly for safety. Testing is
for several months
• Phase two tests several hundreds of patients. Testing is from
several months to 2 years. Short term safety and
effectiveness.
• Phase three-several hundred to several thousand patients. Test
1-4 years. Purpose: Safety, dosage and effectiveness.
IND – Investigational new drug
• During the trial process a new drug is called an IND.
Treatment and Control groups
• Patients with similar conditions and characteristics are placed in
either treatment or control groups.
• Treatment groups receive the new drug
• Control groups receive a placebo, no drug at all, a drug known
to be effective or a different dose of the treatment drug.
All studies are blind
• Patients in the trial do not know whether they are in the control
or treatment group.
• Double Blind study – Neither the patient or the physicians
knows if the patient is receiving a placebo or the treatment
drug
• This keeps the study purely objective and prevents imagining
effects from the drug.
• Results are to be based only on medical results
Patent Protection
• Manufacturer has exclusive rights for 17 years from the date of the drugs
discovery. Patent protection may not exceed 14 years after the drug is
approved.
• The Hatch-Waxman act of 1984 provided a patent protection extension
of up to 5 years for time lost in the FDA approval process.
• Testing process may take up as much as half of the patent time
SNDA Supplemental New Drug Application
• Used when a manufacturer decides to make minor changes in
the procedure for making the drug.
• A SNDA is much shorter than an NDA (New drug application)
Generic drugs
• After the Brand name drug expires other manufactures can release the
drug as a generic.
• Generics must be pharmaceutically equivalent to the brand name drug. It
must have the same active ingredients, strength, dosage form and route
of administration.
• Generics must also be therapeutically equivalent, meaning the bodies use
of the drug must be the same. It must be absorbed into the bloodstream
to the same extent and at the same rate as the brand name.
ANDA (Abbreviated New Drug Application)
• Application filed by a generic company before marketing their
equivalent of a brand name drug.
• This allows for lower costs of a generic drug
GMP -Good Manufacturing Practices
• Regulations that set minimum requirements to be followed in
the manufacturing of human and veterinarian drugs.
The Durham-Humphrey Amendment of 1951
• Mandates that certain drugs are safe only under the supervision
of a pharmacist.
• These drugs must be requested orally, electronically or in
writing to a pharmacist.
• A written prescriptions must contain certain verifying
information about the Patient, the Doctor and the drug.
Federal and State Laws
• The stricter of a state or federal law is the law to be followed.
• If the state law is stricter, the requirement of the federal law is
also met.
Written Prescriptions
• Should contain- The prescriber’s name, address and phone
number.
• The Drug name and strength
• Dispense Quantity
• Sig or directions for the patient
• Signature lines- dispense as written or may substitute. May
also be a checkbox
• Date
• Patients name and address
Prescription Labels (contain)
• Manufacturer’s name
• Generic Name
• Total volume after reconstitution or quantity
• NDC number (National drug code)
• Legend Drug- Rx only designation (Any drug that requires a
prescription
NDC number (National drug code)
• NDC is a 10 or 11 digit number identifying the drug
• NDC is made up of 3 sets of numbers
• The first set indicates the manufacturer
• The second set indicates the medication, strength and dosage
form.
• Third set indicates package size
Controlled substance act (CSA) of 1970
• Classified drugs into 5 schedules based on potential for abuse
• Dispensing, handling and storage vary according to the
schedule #
• Controlled drug labels must denote the schedule #
• Controlled substance- a drug with potential for abuse that is
classified in one of the 5 schedules
DEA (Drug Enforcement Administration)
• Controls the distribution of drugs that have the potential for
abuse. i.e. controlled substances.
Schedule I drugs
• Are considered to have a high potential for abuse and no
accepted medical use in the U.S.
• Examples of schedule I drugs are heroin, various opium
derivatives and hallucinogenic substances such as peyote or
LSD.
Schedule II drugs
• May lead to physical or psychological dependence
• High potential for abuse
• Currently accepted for medical use in the United States
• Examples are amphetamines, opium, morphine, methadone and
various opiates
Schedule III drugs
• Potential for abuse is less than schedule I and II drugs
• Moderate to low physical dependence
• May lead to high psychological dependence
• Examples are anabolic steroids, various compounds containing
limited amounts of narcotic substances such as codeine. Vicodin
is schedule III
Schedule IV Drugs
• Abuse may lead to limited physical or psychological dependence
• Alprazolam, diazepam, phenobarbital, zolpidem are examples of
schedule IV drugs
Schedule V Drugs
• Low potential of abuse compared to schedule I-IV drugs
• May lead to limited physical or psychological dependence
• Compounds containing limited amounts of narcotic are included
in this group
• Example is Robitussin AC (Guaifenesin with codiene)
DEA form 222
• U.S. order form for C-I and C-II substances
• This is form is filled out by the pharmacists
• All forms must be kept for 7 years
• C-III to C-V substances do not require a federal form for
ordering
DEA number
• Assigned number that all prescribers of controlled substances
must have
• DEA number has 2 letters followed by 7 numbers
DEA formula
• The formula to verify a DEA number
• Required by Federal Law
• Example DEA AB1234563
• Add the 1st, 3rd and 5th digits to twice the sum of the 2nd, 4th
and 6th digit
• Last number of the total should be the same as last number of
the DEA
DEA Formula cont.
• AB1234563
• (1+3+5) +2(2+4+6) = 33
• Last digit is 3 validates the DEA
• DEA numbers issued before Oct. 1985 begin with an A.
Numbers issued After that begin with a B.
• The second letter is the first letter of the registrants last name.
Drug Recalls
• Three classes of drug recalls
• Class I. May cause serious health problems or death. Patients who have
received this drug must be notified immediately.
• Class II. No serious effects. Effects may be temporary or reversible.
• Class III. Possibly a labeling problem. Most likely won’t cause any
health problems.
PPI
• PPI – Patient information sheet
• Required to be given to patients for certain drugs prior to initial
administration.
• Examples of drugs that require PPI are accutane,
antidepressants, NSAIDS, oral cancer meds, estrogen or
progesterone containing products and statin drugs.
Package Inserts
• Written for the health professional.
• Black box warning –warning listed at beginning of a label
concerning a serious adverse effect.
• Label also includes, chemical structure, min and max doses,
adverse effects and contraindications of the drug.
Behind the counter OTC meds
• Some OTC meds by law must be kept behind the pharmacy
counter due to restrictions.
The combat methamphetamine act
• Restricts the sale of psuedoephedrine and ephedrine.
• Law limits sale to 3.6 grams per day and 7.5 grams per month.
• Purchaser must present valid photo identification.
• All sale records must be kept for 2 years.
Example of Products containing psuedoephedrine.
• Claritin-D
• Zyrtec-D
• Sudafed
• Advil Cold and Sinus
• Advil allergy sinus
• Mucinex-D
• The “D” stands for decongestant and refers to psuedoephedrine in the
product.
Emergency Contraceptives (EC)
• Plan B has dual marketing status. It has both prescription and
OTC status. For patients under 17 it must prescribed. 17 and
older may purchase it OTC.
• Product label states, “Rx only for women younger than age 17.”
• Next Choice is another example of EC with dual marketing
status.
Exempt Narcotics
• Medications with habit forming ingredients be sold by a
pharmacists to people 18 years or older without a prescription
• Some cough syrups containing small amounts of codeine don’t
require a prescription and can be purchased from the pharmacy
with proof of identification.
• A record book must be maintained.
Technician Liability
• Technicians can be prosecuted for misconduct even if directed
by pharmacist in charge (pic), physician or patient.
• Negligence is the most common form of misconduct and means
failure to do something you should have done.
• Pharmacy technicians may purchase liability insurance.
Negligence examples
• Incorrect labeling of a prescription
• Failure to maintain patient confidentiality
• Calculation errors
• Dispensing the wrong medication
• Incorrect handling of controlled substance
• Other forms of non-compliance
• Compliance means doing what is required and following
protocol or standards of practice.
OBRA (Omnibus budget reduction act of 1990
• Mandate initially stated that all Medicaid patients were to be offered
patient counseling.
• It was quickly realized that this created two standards of practice.
• Law was changed so all patients must be offered counseling by the
pharmacist on new prescriptions.
• Technicians may offer pharmacist counsel. Then call the pharmacist over
to do so.
OBRA cont.
• OBRA also mandates that pharmacists perform a drug utilization
review, checking for drug or disease interactions or therapy
duplication.
HIPPA and PHI
• HIPPA-Health Insurance Portability and Accountability act of
1996- developed to maintain Protected Health Information or
PHI.
• PHI – any health information that can be used to identify an
individual.
1970 Poison Prevention Packaging Act.
• Requires child-proof packaging on most prescription drugs.
• Non-child proof caps or easy open caps may only be used if the
patient or prescriber requests them.
Assignment #2
1. List 3 things you can do to make your life less stressful.
Do one of those 3 things this week and write briefly about
your experience. One or two paragraphs.
2. Create and answer three questions from your notes this week.