Download Pharm Tech Class 1 Ch 1 thru 6 PPt

Certified
Pharmacy Technician
Course
“Education is not only a ladder of
opportunity, but also an
investment in our future.”
- Ed Markey
© 2013-2015
Agenda
O Twelve Class Sessions
O Four Section Tests
O Three Math Tests
O Final Examination
© 2013-2015
Ch 1: The Certification Process
O Pharmacy Technician Certification Board
O Oldest & most recognized
O Known as the PTCB Examination
O National Healthcare Association
O Limited (but growing) recognition by State Boards
O Known as the ExCPT Examination
Which certification does YOUR state accept?
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Prerequisites to Take Examinations
O Eighteen years old
O High school diploma/GED
O No felony convictions
O Pay the testing fee
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The Pharmacy Technician
Certification Board (PTCB)
O ONLY certifies pharmacy technicians
O Over 555,700 technicians have earned their
certification since 1995
O Open testing dates at computer centers
O States vary in their recognition
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PTCB Test Components
O Question material revamped in Fall 2013
O Usually more hospital oriented questions
O Traditionally about 1/3 math questions
O 90 questions plus 10 trial questions
O Given at Pearson Vue Centers across the US
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National Healthcareer Association
(NHA)
O Certifies MANY allied healthcare professionals - NOT
just pharmacy technicians
O Newer and growing in popularity among state boards
of pharmacy
O Works closely with educators and employers
O Known as The Exam for the Certification of Pharmacy
Technicians (ExCPT)
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ExCPT Test Components
O Traditionally more oriented to retail pharmacy
O 90 questions plus 10 trial questions
O 35% Regulations and Duties
O 11% Drugs and Drug Therapy
O 54% The Dispensing Process
O Exams given at computer testing centers that
have contracted with NHA
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Enrollment and Continuing Ed
O Enrollment- PTCB or ExCPT
O Online registration
O Choose date and location
O Pay testing fee online
O Continuing Education Requirement
O 20 hours of continuing education during each 2 year
period
O State laws may vary on CE requirements
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What Does a Technician Do?
O Knowledgeable in MANY subject areas
O NOT just “count & pour”!
O Protect the patient’s health information
O Protect public health
O Protect the business
Math
Name
Pharma
-cology
O Assist the pharmacist
Compounding
Successful technicians
have many skills
Law
Clerical
Inven
-tory
Kinetics
Customer
Service© 2013-2015
Ch 2: The Role of the
Technician
Judgmental vs. Non-Judgmental Tasks
Where is the “Line in the Sand”?
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Pharmacy Practice Environments
O Community/Retail
O Institutional/Hospital
O Manufacturing
O Nuclear
O Nutritional
O Disease State Management
O Mail Order
O Insurance
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The Role of The Technician
with an Employer
O “Mission Statement” of an organization
O Guiding principle/reason that the business exists
O “Job Description”
O What you should strive to achieve
O Expected job duties
O Communication within the organization
O “Open Door Policy”
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Ch 3: The Patient is Our
Customer
O The challenge for the technician is determining what
factor is the most important to the customer at that
moment and satisfying their needs to the best of their
ability
O Post-surgical?
O Sick child?
O Dental patient?
O Cost conscious?
O Wait time limitations
O etc…….
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The Importance of the Customer
O The customer pays your wages
O The customer keeps the pharmacy’s doors open
O High customer satisfaction (shown by increasing
sales) leads to professional growth and opportunity
within a pharmacy
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Customer Service Methods
O Make the customer your number one concern
O Greet them properly
O 10 foot rule
O Look them in the eye
O Use their name
O Know where your products are located
O Go “the extra mile”
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The Cost of Losing a Customer
O It is always harder to regain a customer than it
was to get them the first time
O Very few will complain verbally to the pharmacy
before they get mad enough to change
pharmacies
O Almost all who leave will tell members of the
community about their bad experience
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Methods to Attract New Customers
O Advertising
O Coupons
O New Baby/New Resident Promotions
O Brown Bag Days
O Doctor Detailing
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Ch 4: Pharmacy as a Regulated
Profession
O Federal Agencies
O Food & Drug Administration
O Drug Enforcement Administration
O Center for Medicare and Medicaid
Services
O Other Agencies
O Board of Pharmacy
O National Association of Boards of Pharmacy
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The Food & Drug
Administration
O Approves new drug entities
O Regulates Package Inserts
O Regulates Drug Advertising
O Issues recalls on affected products
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Drug Enforcement
Administration (DEA)
O Regulates the manufacturing, distribution,
and dispensing of legal controlled
substances
O Federal DEA is involved when state lines
are crossed at any point in the process
O States can have their own DEA agency
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Board of Pharmacy
O State agency
O Licenses pharmacies, pharmacists, and in
some cases, technicians
O Pharmacy Practice Act
O Administrative Code
O State Controlled Substances Act
O State specific questions will NOT be on the
certification test, but will be taught here
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Board of Pharmacy
O Always Remember,
THE BOARD OF PHARMACY IS IN PLACE
TO PROTECT THE PUBLIC,
NOT THE PHARMACY OR ITS
WORKERS!
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Centers for Medicare and
Medicaid Services (CMS)
O An oversight of patients enrolled in:
O Medicare
O Medicaid
O Children’s Hospital Insurance Program (CHIP)
O Also involved in the marketplace provisions of
the Affordable Care Act
O Provides education and information to health
care providers and consumers
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National Association of Boards
of Pharmacy (NABP)
O Provides Standards of Care and licensing services
O Goal is to research, develop, and help implement
better ways of regulating the practice of pharmacy
O Also provides:
O Assistance in the transfer process of pharmacist
licenses between states
O Provide examinations to access competency of
pharmacists
O Accreditation efforts to provide uniform standards
throughout its member states
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Ch 5: What is the “Law”
O The “Act”
O Always comes first through action by
government
O The “Amendments”
O Modifies an Act
O “Interpretation”
O Judicial opinion about the “meaning & intent”
of the law
O “Precedent”
O The outcome of previous court cases
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Federal Food & Drug Act
(1906)
O First Law to demand PURITY OF PRODUCT
O Was originally directed to the meat packing
plants of the time
O Adulterated vs. Misbranded
O 1912 Amendment- mandated specific
evidence be available for the proof of claims
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Federal Food, Drug, & Cosmetic
Act (FDCA – 1938)
O REPLACED the 1906 Food and Drug Act
O Two major improvements on prior law:
O Clarified the definition of adulteration and
misbranding
O DEMANDED SAFETY OF PURPOSE
O Now the drug product had to be safe!
O Specified the Food & Drug Administration as
the responsible agency
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Amendments to the FDCA
O Durham-Humphrey Amendment – 1951
O Kefauver-Harris Amendment – 1962
O Drug Listing Act - 1972
O Medical Device Amendment- 1976
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The Durham – Humphrey
Amendment (1951)
O Recognized that drugs could not be used
safely without complete instructions for their
use
O Even then, some must be used only with
direct medical supervision
O CREATED THE “LEGEND” CLASS OF DRUGS
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Durham – Humphrey (cont’d)
O OTC drugs must have complete instructions
for use
O Legend drugs did not require complete
instructions because they were to be used
under the supervision of a doctor
O Stock bottles of legend drugs are to be
labeled with either “Rx only” or the old
“Caution statement”
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Legend Drug Markings
O The new marking is
simply an
“Rx Only”
On the label of the
product
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Legend Drug Markings
O The old regulations
required the
statement:
“Caution: Federal law
prohibits dispensing
without a
prescription”
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Kefauver – Harris Amendment
(1962)
O Placed regulation of drug advertising under
FDA responsibility
O Began regulation of drug manufacturing
processes
O Demanded PROOF OF EFFECTIVENESS
before a new drug could be marketed
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Poison Prevention Packaging Act
(1970)
O Intended to decrease accidental poisonings from
prescription medications
O REQUIRES THE USE OF LOCKING LIDS on all
prescription bottles, with 3 exceptions:
- The patient requests a non-locking lid
- The doctor requests a non-locking lid
- The drug is an exempted drug
(NTG SL or ISDN SL)
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Drug Listing Act (1972)
O Registered all manufacturers with FDA and
collected information on all the products they
produce
O CREATED THE NATIONAL DRUG CODE (NDC
number) to identify drug products
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Medical Device Amendment
(1976)
O Manufacturers of certain medical devices
must get pre-marketing approval from the FDA
O Does NOT affect drug products
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Prescription Drug Marketing
Act (PDMA - 1987)
O CREATED THE DRUG “PEDIGREE”
O Helped eliminate re-importation of illicit drugs
O Regulated drug samples
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Omnibus Budget Reconciliation
Act (OBRA-1990)
O Concerned about COST REDUCTION in
prescription drug usage
O Objective was to save tax payers money
through more efficient use of taxpayer dollars
used to fund prescriptions
O Will be covered in a separate chapter of the
book and another meeting
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Dietary Supplement Health and
Education Act (DSHEA-1994)
O Concerns standards for dietary supplements
O Amino acids
O Vitamins
O Herbs
O Minerals
O STANDARDIZED LABELING
O Made PROOF OF SAFETY mandatory
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Health Insurance Portability and
Accountability Act (HIPPA-1996)
O Concerned with PATIENT PRIVACY
O Defines what Personal Health Information is
and how it may be handled
O Created a new identifying number for
healthcare entities (National Provider
Identifier-NPI)
O Will be covered in a separate chapter
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FDA Modernization Act (1997)
O Streamlined the drug
approval process
O Regulated drug
compounding in
pharmacies
O Changed the legend
marking on stock
bottles to “Rx Only”
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Medicare Prescription Drug,
Improvement, and
Modernization Act (MMA - 2003)
O Largest overhaul of Medicare since its inception
O Created an entitlement to prescription drugs for
Medicare patients (Medicare Part D)
O Created Medicare Advantage Plans and
Healthcare Savings Accounts
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Medicaid Tamper Resistant
Prescription Act (2008)
O Required all Medicaid prescriptions be written
on tamper resistant blanks
O Most states have expanded this requirement
to include all controlled substance
prescriptions
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Patient Protection and
Affordable Care Act (PPACA - 2010)
O Aka, “The Affordable Care Act”
O Largest overhaul of the US medical system
since the passage of Medicare & Medicaid
O Created insurance mandates, exchanges, and
subsidies to purchase coverage
O Guaranteed insurance inclusion to people
with pre-existing conditions
O Expanded the number of people on Medicaid
© 2013-2015
Drug Quality and Security Act
(DQSA - 2013)
O Regulates large compounding facilities known
as “outsourcing facilities”
O Covers everyone from the compounder down
to the individual who administers or
dispenses the product
O Section concerning pharmacies is Title II of
the Act (“Drug Supply Chain Security Act”)
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Drug Supply Chain Security
Act (DSCSA - 2013)
O Title II of the DQSA
O Creates a system to identify and trace drug
products through the healthcare system
O Allows for the identification and removal of
potentially dangerous, counterfeit, or
unapproved products BEFORE they reach the
patient
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Quick Review
O Food & Drug Act
- Demanded purity
O Food, Drug, & Cosmetic Act
- Demanded safety
O Durham – Humphrey Amendment
- Created legend class
O Kefauver – Harris Amendment
- Demanded proof of effectiveness
- Regulated drug advertising
© 2013-2015
Quick Review (cont’d)
O Poison Prevention Packaging Act
- Locking caps
O Drug Listing Act
- Created registry of all drugs made
O Prescription Drug Marketing Act
- Created drug pedigree
O Omnibus Budget Reconciliation Act
- Cost reduction through greater pharmacy
involvement
© 2013-2015
Quick Review (cont’d)
O Dietary Supplement Health and Education Act
- Proof of safety and standardized labeling
O Health Insurance Portability & Accountability Act
- Patient privacy
O Medicare Prescription Drug, Improvement, and
Modernization Act
- Created Medicare Part D entitlement
O Medicaid Tamper Resistant Prescription Act
- Mandated tamper resistant prescription blanks
© 2013-2015
Quick Review (cont’d)
O Patient Protection & Affordable Care Act
- Created insurance mandates, exchanges, and
subsidies
O Drug Quality and Security Act
- Regulated “outsourcing facilities” and created
tracking requirements
O Drug Supply Chain Security Act
- Created a system of identifying and tracking and
allows the intercept of affected product BEFORE it
reaches the patient
© 2013-2015
Laws Affecting Controlled
Substances
O The Harrison Narcotic Act
O The Drug Abuse Control Amendment
O The Comprehensive Drug Abuse Prevention
and Control Act
O Anabolic Steroid Act
O Combat Methamphetamine Epidemic Act
O Ryan Haight Online Pharmacy Consumer
Protection Act
© 2013-2015
Harrison Narcotic Act (1916)
O Covered narcotics alone
O Used taxation as a control method
O Tax stamps were placed on all controlled
substances
O Any product without tax stamps were subject
to seizure
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Drug Abuse Control Amendment
(1965)
O Changed basis of enforcement from tax levy to
regulation of interstate commerce. (No more
tax stamps)
O Relied on Congress’ ability to control interstate
commerce
O Expanded coverage to barbiturates and
stimulants
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Bureau of Narcotics and
Dangerous Drugs (1968)
O Newly formed agency responsible for
enforcing controlled substance laws
O Changed name to the Drug
Enforcement Administration in 1973
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Comprehensive Drug Abuse
Prevention and Control Act (1970)
O AKA, The Controlled Substance Act
O Repealed and replaced Harrison and DACA
O Introduced the DEA Number
O Relies on registration and record keeping to
track controlled substance transactions
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Anabolic Steroid Control Act (1990)
O Made anabolic
steroids controlled
substances
O Enhanced in 2004 to
include prohormones
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Combat Methamphetamine
Epidemic Act (CMEA-2005)
O All pharmacies are required to have training and be
O
O
O
O
O
O
certified in CMEA
Intended to curb the illegal manufacturing of
Methamphetamine
CREATED “SCHEDULED LISTED CHEMICAL
PRODUCT” CLASS OF DRUGS
SCLP’s must be kept behind pharmacy counter
Log of purchases must be kept for at least 2 years
Limits quantities that may be purchased
Requirements vary by state
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Ryan Haight Online Pharmacy
Consumer Protection Act (2008)
O Intended to insure protection for customers
who purchase medications online
O Covers only controlled substances
O ALLOWS DEA TO TAKE ACTION AGAINST
ONLINE PHARMACIES
O Amendment to the Controlled Substances Act
© 2013-2015
Quick Review
O Harrison Narcotic Act
- Used tax stamps
O Drug Abuse Control Amendment
- Used interstate commerce laws
O Comprehensive Drug Abuse Prevention and
Control Act
- aka, Controlled Substances Act and
introduced the DEA Number
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Quick Review (cont’d)
O Anabolic Steroid Control Act
- regulates steroid products
O Combat Methamphetamine Epidemic Act
- Created SLCP Class
O Ryan Haight Online Pharmacy Consumer
Protection Act
- Regulates online pharmacies
© 2013-2015
Ch 6: Non-Governmental
Regulation
O The “Standard of Practice”
O The Joint Commission (TJC)
O Institute for Safe Medication Practices
(ISMP)
O Third Party Audits
O Employer Audits
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Standard of Practice
What would the typical practitioner, armed with the
knowledge typical of the profession, do in response
to the situation at hand?
O Define “standard of practice”
O Define “typical practitioner”
O “legal” vs. “ethical” standard of practice
O Implications of not performing to the standard of
practice (negligence)
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The Joint Commission (TJC)
O Non-Governmental Organization
O Conducts voluntary certification inspections
- Chart reviews
- Equipment reviews
- Facility inspections
O Some insurance companies require
certification before they will admit or pay for
patient stays
O Formerly known as “JCAHO”
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Institute for Safe Medication
Practices (ISMP)
O Dedicated to educating the health care community
and consumers about preventing medication errors
O Types of errors include:
- Incomplete patient info
- Miscommunication
- Look-a-like, sound-a-like drugs
- Confusing drug labeling
- Similar packaging for different strengths of drugs
- Misinterpreted abbreviations
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Third Party Audits
O Insurance company auditors come to the pharmacy,
or send requests for documentation to the pharmacy,
to check compliance
O If problems are found, they want their money back
O What do they look for?
O Did the pharmacy have a hard copy of Rx?
O Did the patient pick up the Rx? (signature in log book)
O Did the pharmacy bill for the correct package size of
the drug?
O Did the pharmacy use the correct drug item? (correct
stock bottle size)
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Employer Audits
O Conforming to company policies?
O Following pricing guidelines?
O Proper inventory control?
O Is paperwork handled correctly?
O Loss prevention
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Questions?
© 2013-2015