Download pharm tech 2016-2017 class 2 ch 7 thru 13

Ch 7: Requirements of the
Pharmacy Area
O State Laws Require Adequate Equipment and a
Proper Environment for a Pharmacy to be Licensed
O Proper location
O Proper size
O Must meet ADA requirements
O Environmental conditions
O Storage
O Sterile compounding (if desired)
O Hazardous waste storage/disposal
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Requirements of the Pharmacy
Area (cont’d)
O Security
O Reference materials
O Proper equipment
O licensure
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Ch 8: How do we get a new drug?
O Research
O Investigation
O Marketing
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The New Drug Approval
Process
O Put in place to protect the public
O Steps insure that requirements of drug laws
are met
O Safety
O Effectiveness
O FDA is responsible for approval
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Mechanisms Involved
O The New Drug Application (NDA)
O The Investigational New Drug Review (INDA)
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The New Drug Application
(NDA)
O Used since the 1938 FDCA
O Must prove both safety & effectiveness
O Includes screening by several committees
O Medical
O Pharmacology
O Chemistry
O Statistical
O Contains 4 Phases
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Phase 1
O Tests the maximum tolerated dose
O Not designed to test efficacy
O Uses a small subject group
O Usually takes place at a single
research facility
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Phase 2
O Determines the Effectiveness vs.
Disease
O Uses volunteers from the affected drug
group
O Usually several hundred subjects
involved
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Phase 3
O Uses several thousand subjects
O Multiple testing centers across the U.S.
O “Double-Blind” Testing used
O Neither the subject or the investigator
know which is the active drug and which is
placebo
O Last phase before FDA consideration
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Phase 4
O Occurs AFTER FDA Approval and the
drug is marketed
O It is the responsibility of the
practitioners using the drug to report
adverse effects to the FDA
O Many drugs have been removed from
the market after negative Phase 4
reports.
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The Approval Process
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Drug Approval Facts
O Average time to market runs 12 to 16 years
O For every 5,000 drugs entering pre-clinical trials:
O 5 will enter Phase 1 trials
O 1 will gain FDA Approval
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Investigational New Drug
Review (IND)
O NOT an application for drug approval
O IS an application for an exemption to the
federal law prohibiting the interstate
shipment of unapproved drug products
O Usually occurs before NDA trials occur
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Drug Patents
O Authority for patents comes from the U.S.
Constitution
O NOT the right to make a product
O IS the right to forbid another from manufacturing
the same product or importing it from another
country
O Period of 20 years, but begins from the time of
application – Way before approval
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Ch 9: The Chemical Name
O A description of the physical structure of the drug
molecule
O Gives information on:
O How the molecule can be synthesized
O How the molecule will react with other chemical compounds
O How a drug will be metabolized
O What actions the drug may have in the body
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The Generic Name
O The name used for FDA approval on the NDA
O Assigned by the manufacturer
O Can give a clue as to the drugs actions
O ie.) Suffixes -olol, -opril, -itidine, etc.
O Used in communication between practitioners, in
professional journals, and in research
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The Trade name
O Used to build brand loyalty
O Trademark
O May also give a clue as to the advantages of a
product
O ie.) Lithobid - twice daily dosing
O May have more than one trade name for a
generic entity
O ie.) Zestril vs. Prinivil
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The NDC Number
O Used to identify the manufacturer, drug
entity, and package size
00000-0000-00
00000-xxxx-xx
Manufacturer
xxxxx-0000-xx
xxxxx-xxxx-00
Drug Entity
Package
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Other Methods
O Abbreviations
- STUDY YOUR LIST
O Mnemonic
O Used in computer systems
O No dependable commonality between systems
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Ch 10: Legal Classifications of
Medicinal Products
O Over the Counter
O Legend
O Controlled Substances
O Schedule Listed Chemical Products
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Over the Counter
O Determined to be safe for use without direct
medical supervision
O Must have complete instructions for use and
warnings about misuse on every package
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Legend
O Deemed too dangerous to use without direct
medical supervision
O Requires a prescription
O Stock bottles must bear the legend warning
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Legend Warning
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Controlled Substances
O Legend drugs which have a high potential for
abuse – even with medical supervision
O Special limitations on the prescription
O Regulated by the 1970 Controlled
Substances Act
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The “Closed System” of the
Controlled Substances Act
O Every facet of a drug’s manufacture, distribution,
and use is tracked
O A clear paper trail is generated
O Requires licensing of practitioners who will handle
controlled substances
O The DEA Number
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The DEA Number
O Unique identifying number for each person or
entity who will have control over controlled
substances
O Issued by the Federal DEA
O Who needs a DEA number?
O Any practitioner who is registered by the State to prescribe,
manufacture, or have possession of controlled substances
O The State determines who needs, or can receive, a
DEA number
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The DEA Number is
“Self Verifying”
O All the information needed to check the validity of
the number, is contained within the number itself
O All DEA numbers start with a letter
O All DEA numbers have the first initial of the
practitioner’s last name as their 2nd digit
O Then Seven Numbers
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To Verify a DEA Number
Example: AA0242622
O Add the 1st, 3rd, and 5th numbers
0 + 4 + 6 = 10
O Add the 2nd, 4th, and 6th numbers then double the
sum
2 + 2 + 2 = 6 x 2 = 12
O Add the two answers together
10 + 12 = 22
O The resulting sum should have a digit that matches
the last digit of the DEA number
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The “Schedules”
O Schedule I
O Schedule II
O Schedule III
O Schedule IV
O Schedule V
Know common drugs in each schedule!
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Bottle Labeling for Controls
A large letter “C” and the
number of the schedule to
which the product belongs
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The Warning
“Caution: Federal law prohibits the transfer of
this drug to any person other than the patient
for whom it was prescribed”
**Must appear on every controlled substance prescription
dispensed
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SLCP Classification
O Schedule Listed Chemical Products (SLCP)
O Created by The Combat Methamphetamine Epidemic
Act of 2005 (CMEA)
O Pseudoephedrine
O Requirements for keeping SLCP’s behind the
pharmacy counter
O MUST be dispensed by a licensed pharmacist
O Quantity limits
O Must be at least 18 years old
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Ch 11: Routes of Administration
O Route of Administration = How a Drug Enters the Body
O Parenteral vs. Enteral
O Common Routes of Administration
O Know what each route is, and
its abbreviation!
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Parenteral vs. Enteral
O Enteral Administration occurs any time the drug
is introduced at any point along the “tube” which
runs from the mouth to the anus
O Parenteral Administration covers any other entry
besides topical.
O Topical Administration occurs when the drug is
applied to the outside surface of the body.
Absorption into the body may, or may not take
place.
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Common Routes of
Administration
O PO - By mouth
O NG - Naso-Gastic
O SL - Sublingual
O BUCCAL - between the cheek & gum
O IV bolus – volume of fluid delivered over a short
period of time
O IV drip – volume of fluid delivered over a long period
of time
O IV piggyback - small volume of fluid delivered thru the
tubing of another IV
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Routes (cont’d)
O IM - Intra-muscular
O SC (SQ, subcut) - Subcutaneous
O IC - Intracardiac
O Transdermal - Through the skin
O Topical - Applied externally
Memorize these abbreviations!
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Dosage Forms
O Solids
O Liquids
O Semi-Solids
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Solid Dosage Forms
O Tablets
O
O
O
O
Compressed
Enteric Coated
Sustained Release
Sublingual / Buccal
O Capsules
O May also be sustained release
O Good choice for bad tasting medications
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Liquid Dosage Forms
O Solution
O drug is dissolved in diluent
O Suspension
O small particles are suspended in a liquid
O Syrup
O sweetened vehicle
O Elixir
O vehicle contains a high percentage of alcohol
O Extract
O drug is the oil or active portion of a plant
O Tincture
O alcohol based dosage form used externally
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Semi-Solid Dosage Forms
O Cream
O Actually an Emulsion. Active ingredients are dissolved in oil
droplets and suspended in water.
O May be “broken” excess heat or cold
O Lotion
O A thinner emulsion than a cream
O Ointment
O generally petrolatum based
O won’t absorb into skin like emulsions
O more potent on a gram per gram basis
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Ch 12: Patient
Confidentiality
O Every patient has the right to expect
confidentiality
O We must protect patient information and be
aware of any unintended transfer of
information
O Elevators
O Corridors
O Lunch Room
O Telephone Conversations
O Never allow yourself to be overheard when
speaking about patient specific information
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The HIPAA Law
O Health Insurance Portability and
Accountability Act of 1996
O Took effect in 2003
O Formalized confidentiality policies
O Affects health care providers, health
insurance companies, and health care
payment companies
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The HIPAA Law
O Administered by the US Department of Health
and Human Services
O Enforced by the Office of Civil Rights
O Controls access to a patient’s Protected
Health Information (PHI)
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The Notice of Privacy Practices
O Must be given to every patient or their guardian
O Explains how the pharmacy will use their PHI
O Explains the patient’s rights regarding their own PHI
O Best to have the patient sign a log to prove they
received the Notice
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Release of PHI
Under the HIPAA Law:
O We MUST release PHI when:
O the patient requests their own information
O the HHS Office of Civil Rights requests PHI
O We MAY release PHI when it involves:
O the patient’s treatment
O the payment for treatment
O the day to day operation of the pharmacy
O These reasons MUST be listed on the Notice of
Privacy Practices
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HIPAA Exemptions
O The HIPAA Law specifically exempts three
organizations from its restrictions:
O law enforcement agencies
O Food & Drug Administration
O worker’s compensation claims
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Patient Rights on PHI
O Patients have the right to:
O restrict the release of their PHI
O amend their PHI
O request an accounting of who has viewed their PHI
O request confidential communications
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Management of HIPAA
O Each pharmacy organization must appoint a HIPAA
Compliance Officer who is the final judge on all
HIPAA decisions
O All HIPAA documentation must be retained for 6
years
O HIPPA affects various practice settings
O Technicians may encounter problems
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The HITECH Act
O Updates HIPPA
O Takes into account the increase use of computers
and transmission of electronic devices
O Greatly increases punishment for unauthorized
release of PHI
O Important provisions:
O Strengthens electronic security of PHI
O Allows online access to PHI by patient
O Allows online submission of PHI forms
O Regulates the patient notification of PHI breaches
O Clarifies the definitions of who may access PHI and
under what circumstances
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The HITECH Act (cont.)
O Understand that:
O Penalties, including criminal and financial, may now
be leveled against any individual member of the
pharmacy team that is held responsible!
O Updated HIPPA requirements are contained in a
table in Chapter 12
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Reasons Not to Use a Drug
O Any lack of confidence in the product
O Inappropriate storage conditions
O Questionable source
O Different appearance than normal
O Many counterfeit drugs
O Verify any changes in product labeling or appearance
O Questionable equivalence
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Reasons to Contact a Prescriber
O Any time there is a question about clarity, intent, or
safety
O Contact the prescriber BEFORE you fill the order!
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Reasons to Refuse a Prescription
O When a legitimate medical reason for the
prescription does not exist
O When the pharmacist determines the filling of the
order will be harmful to the patient and the problem
can not be resolved with the prescriber
O When the sole reason for the prescription is to
support a drug addiction
O The DEA has stated that this is not a valid reason for a
prescription
O Except a licensed drug addiction treatment center
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Illegitimate and Fraudulent
Prescriptions
O It is important that we are aware of attempts to
illegally obtain prescription drugs
O Always bring questionable prescriptions to the
pharmacist’s attention
O A prescription may not be legitimate if:
O Being prescribed for an indication that is not approved
O One particular provider writing abnormally high
numbers of prescriptions or quantities
O Large number of individuals dropping off prescriptions
in someone else’s name
O Large increases in controlled substance orders being
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generated by your pharmacy
Illegitimate and Fraudulent
Prescriptions
O Indications that a prescription may be forged:
O Looks too good
O Quantities, directions, or dosages that vary from the
norms
O Photocopied prescription blanks
O Different colored ink used on the same prescription
blank
O Erasures or changes on the prescriptions
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Drug Use in Pregnancy
O Know the categories that are safe, and unsafe, for
use in pregnancy
O The FDA assigns pregnancy categories to
medications according to their known risks
O Study Chart in Chapter 12
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Ch 13: The OBRA Law
O Omnibus Budget Reconciliation Act (1990)
O The purpose of OBRA was to capture potential cost
savings in the Medicaid drug program
How?
Get pharmacists involved in drug
therapy
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How OBRA Saves Money
O Retrospective Drug Utilization Review
O Education of Practitioners
O Prospective Drug Utilization Review
O Patient Counseling
O Rebates from Manufacturers
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Retrospective DUR
O Happens AFTER the drug is dispensed
O Identify inappropriate use of drugs
O Watches prescribing habits of practitioners
O Generates FUTURE savings
O Solves FUTURE problems
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Education of Practitioners
O OBRA makes the State Board of Pharmacy
responsible for educating practitioners about the
findings of the retrospective DURs
O Keeps practitioners current with recommended
prescribing method
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Prospective DUR
O Occurs BEFORE the drug is dispensed
O Done by the pharmacist who dispenses the
medication
O Only step which catches problems BEFORE they
occur
O Phases of the prospective DUR
O The error can be corrected BEFORE the patient
receives the medication
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Prospective DUR Review
O Drug duplication?
O Drug / Disease contraindication?
O Drug / Drug interaction?
O Incorrect dosing or duration?
O Drug allergies?
O Clinical abuse or misuse?
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Patient Counseling
O OBRA mandates we offer to counsel EVERY Medicaid
patient
O Most states have expanded OBRA to include every
patient
O Notice, we offer, but the patient can refuse
O If the patient accepts counseling, the PHARMACIST
must provide it
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Patient Counseling Should
Include
O
O
O
O
O
O
O
O
O
Medication name & description
Dosage route & duration
Special directions or precautions
Common side effects
Therapeutic contraindications
Required self monitoring
Proper storage
Refill information
Missed dose information
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Questions?
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Assignments Due Next Week
O Class Two Homework Worksheet
O Study Drug Flash Cards # 21 – 40
NEXT WEEK IS OUR FIRST SECTION TEST!
Covers Chapters 1 thru 13
NO MATH QUESTIONS
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