1. Certified Pharmacy Technician Course
“Education is not only a ladder of opportunity, but also an investment in our future.” - Ed Markey ©

2. Pharmacy Technician Certification©

3. Ch 1: The Certification Process
Pharmacy Technician Certification Board
Oldest & most recognized
Known as the PTCB Examination (PTCE)
Introducing specialty certification in the future
certified sterile compounding pharmacy technician (CSPT)
National Healthcare Association
Limited recognition by State Boards
Known as the ExCPT Examination
Which certification does YOUR state accept? ©

4. Common Prerequisites to Take the Examinations
Eighteen years old
High school diploma/GED
No felony convictions
Pay the testing fee ©

5. The Pharmacy Technician Certification Board (PTCB)
Class 1 Slides
The Pharmacy Technician Certification Board (PTCB)
ONLY certifies pharmacy technicians
Over 555,700 technicians have earned their certification since 1995
Open testing dates at computer centers
States vary in their recognition ©
© Mark Greenwald - all rights reserved

6. PTCB Test Components Question material revamped in Fall 2013
Usually more hospital orientated questions
Traditionally about 1/3 math questions
90 questions plus 10 trial questions
Given at Pearson Vue Centers across the US ©

7. National Healthcareer Association (NHA)
Certifies MANY allied healthcare professionals - NOT just pharmacy technicians
Newer and growing in popularity among state boards of pharmacy
Works closely with educators and employers
Known as The Exam for the Certification of Pharmacy Technicians (ExCPT) ©

8. ExCPT Test Components Traditionally more oriented to retail pharmacy
90 questions plus 10 trial questions
35% Regulations and Duties
11% Drugs and Drug Therapy
54% The Dispensing Process
Exams given at computer testing centers that have contracted with NHA ©

9. Enrollment and Continuing Ed
Enrollment- PTCB or ExCPT
Online registration
Choose date and location
Pay testing fee online
ExCPT NOW REQUIRES WORK HOURS (1 year or a class)
Continuing Education Requirement
20 hours of continuing education during each 2 year period
State laws may vary on CE requirements ©

10. Ch 2: The Role of the Technician
Judgmental vs. Non-Judgmental Tasks
Where is the “Line in the Sand”? ©

11. What Does a Technician Do?©

12. What Does a Technician Do?
Knowledgeable in MANY subject areas
NOT just “count & pour”!
Protect the patient’s health information
Protect public health
Protect the business
Assist the pharmacist
Math
Pharma-cology
Name
Comp-
ounding
Law
Kinetics
Clerical
Custo-mer Service
Successful technicians have many skills
Inven-tory ©

13. Pharmacy Practice Environments
Community/Retail
Institutional/Hospital
Manufacturing
Nuclear
Nutritional
Disease State Management
Mail Order
Insurance ©

14. The Role of The Technician with an Employer
“Mission Statement” of an organization
Guiding principle/reason that the business exists
“Job Description”
What you should strive to achieve
Expected job duties
Communication within the organization
“Open Door Policy” ©

15. Sample Mission Statement
PharmacyTrainer Schools, LLC.
“The student is the most important part of our business, and we will do everything in our power to provide them with the best educational experience at a price they can afford” ©

16. Sample Job Description©

17. Who Pays Your Salary? ©

18. Ch 3: The Patient is Our Customer
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
Post-surgical?
Sick child?
Dental patient?
Cost conscious?
Wait time limitations
etc……. ©

19. The Importance of the Customer
The customer pays your wages
The customer keeps the pharmacy’s doors open
High customer satisfaction (shown by increasing sales) leads to professional growth and opportunity within a pharmacy ©

20. Customer Service Methods
Make the customer your number one concern
Greet them properly
10 foot rule
Look them in the eye
Use their name
Know where your products are located
Go “the extra mile” ©

21. The Cost of Losing a Customer
It is always harder to regain a customer than it was to get them the first time
Very few will complain verbally to the pharmacy before they get mad enough to change pharmacies
Almost all who leave will tell members of the community about their bad experience ©

22. Methods to Attract New Customers
Advertising
Coupons
New Baby/New Resident Promotions
Brown Bag Days
Doctor Detailing ©

23. Regulation of Pharmacy©

24. Ch 4: Pharmacy as a Regulated Profession
Federal Agencies
Food & Drug Administration
Drug Enforcement Administration
Center for Medicare and Medicaid Services
Other Agencies
Board of Pharmacy
National Association of Boards of Pharmacy ©

25. The Food & Drug Administration
Approves new drug entities
Regulates Package Inserts
Regulates Drug Advertising
Issues recalls on affected products ©

26. Drug Enforcement Administration (DEA)
Regulates the manufacturing, distribution, and dispensing of legal controlled substances
Federal DEA is involved when state lines are crossed at any point in the process
States can have their own DEA agency ©

27. Board of Pharmacy State agency
Licenses pharmacies, pharmacists, and in some cases, technicians
Pharmacy Practice Act
Administrative Code
State Controlled Substances Act
State specific questions will NOT be on the certification test, but will be taught here ©

28. Board of Pharmacy Always Remember, THE BOARD OF PHARMACY IS IN PLACE
TO PROTECT THE PUBLIC,
NOT THE PHARMACY OR ITS
WORKERS! ©

29. Centers for Medicare and Medicaid Services (CMS)
An oversight of patients enrolled in:
Medicare
Medicaid
Children’s Hospital Insurance Program (CHIP)
Also involved in the marketplace provisions of the Affordable Care Act
Provides education and information to health care providers and consumers ©

30. National Association of Boards of Pharmacy (NABP)
Provides Standards of Care and licensing services
Goal is to research, develop, and help implement better ways of regulating the practice of pharmacy
Also provides:
Assistance in the transfer process of pharmacist licenses between states
Provide examinations to access competency of pharmacists
Accreditation efforts to provide uniform standards throughout its member states ©

31. Ch 5: What is the “Law” The “Act”
Always comes first through action by government
The “Amendments”
Modifies an Act
“Interpretation”
Judicial opinion about the “meaning & intent” of the law
“Precedent”
The outcome of previous court cases ©

32. Federal Food & Drug Act (1906)
First Law to demand PURITY OF PRODUCT
Was originally directed to the meat packing plants of the time
Adulterated vs. Misbranded
1912 Amendment- mandated specific evidence be available for the proof of claims ©

33. Federal Food, Drug, & Cosmetic Act (FDCA – 1938)
REPLACED the 1906 Food and Drug Act
Two major improvements on prior law:
Clarified the definition of adulteration and misbranding
DEMANDED SAFETY OF PURPOSE
Now the drug product had to be safe!
Specified the Food & Drug Administration as the responsible agency ©

34. Amendments to the FDCA Durham-Humphrey Amendment – 1951
Kefauver-Harris Amendment – 1962
Drug Listing Act
Medical Device Amendment- 1976 ©

35. The Durham – Humphrey Amendment (1951)
Recognized that drugs could not be used safely without complete instructions for their use
Even then, some must be used only with direct medical supervision
CREATED THE “LEGEND” CLASS OF DRUGS ©

36. Durham – Humphrey (cont’d)
OTC drugs must have complete instructions for use
Legend drugs did not require complete instructions because they were to be used under the supervision of a doctor
Stock bottles of legend drugs are to be labeled with either “Rx only” or the old “Caution statement” ©

37. Legend Drug Markings The new marking is simply an “Rx Only”
On the label of the product ©

38. Legend Drug Markings The old regulations required the statement:
“Caution: Federal law prohibits dispensing without a prescription” ©

39. Kefauver – Harris Amendment (1962)
Placed regulation of drug advertising under FDA responsibility
Began regulation of drug manufacturing processes
Demanded PROOF OF EFFECTIVENESS before a new drug could be marketed ©

40. Poison Prevention Packaging Act (1970)
Intended to decrease accidental poisonings from prescription medications
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) ©

41. Drug Listing Act (1972)
Registered all manufacturers with FDA and collected information on all the products they produce
CREATED THE NATIONAL DRUG CODE (NDC number) to identify drug products ©

42. Medical Device Amendment (1976)
Manufacturers of certain medical devices must get pre-marketing approval from the FDA
Does NOT affect drug products ©

43. Prescription Drug Marketing Act (PDMA - 1987)
CREATED THE DRUG “PEDIGREE”
Helped eliminate re-importation of illicit drugs
Regulated drug samples ©

44. Omnibus Budget Reconciliation Act (OBRA-1990)
Concerned about COST REDUCTION in prescription drug usage
Objective was to save tax payers money through more efficient use of taxpayer dollars used to fund prescriptions
Will be covered in a separate chapter of the book and another meeting ©

45. Dietary Supplement Health and Education Act (DSHEA-1994)
Concerns standards for dietary supplements
Amino acids
Vitamins
Herbs
Minerals
STANDARDIZED LABELING
Made PROOF OF SAFETY mandatory ©

46. Health Insurance Portability and Accountability Act (HIPPA-1996)
Concerned with PATIENT PRIVACY
Defines what Personal Health Information is and how it may be handled
Created a new identifying number for healthcare entities (National Provider Identifier-NPI)
Will be covered in a separate chapter ©

47. FDA Modernization Act (1997)
Streamlined the drug approval process
Regulated drug compounding in pharmacies
Changed the legend marking on stock bottles to “Rx Only” ©

48. Medicare Prescription Drug, Improvement, and Modernization Act (MMA - 2003)
Largest overhaul of Medicare since its inception
Created an entitlement to prescription drugs for Medicare patients (Medicare Part D)
Created Medicare Advantage Plans and Healthcare Savings Accounts ©

49. Medicaid Tamper Resistant Prescription Act (2008)
Required all Medicaid prescriptions be written on tamper resistant blanks
Most states have expanded this requirement to include all controlled substance prescriptions ©

50. Patient Protection and Affordable Care Act (PPACA - 2010)
Aka, “The Affordable Care Act”
Largest overhaul of the US medical system since the passage of Medicare & Medicaid
Created insurance mandates, exchanges, and subsidies to purchase coverage
Guaranteed insurance inclusion to people with pre-existing conditions
Expanded the number of people on Medicaid ©

51. Drug Quality and Security Act (DQSA - 2013)
Regulates large compounding facilities known as “outsourcing facilities”
Covers everyone from the compounder down to the individual who administers or dispenses the product
Section concerning pharmacies is Title II of the Act (“Drug Supply Chain Security Act”) ©

52. Drug Supply Chain Security Act (DSCSA - 2013)
Title II of the DQSA
Creates a system to identify and trace drug products through the healthcare system
Allows for the identification and removal of potentially dangerous, counterfeit, or unapproved products BEFORE they reach the patient ©

53. Quick Review Food & Drug Act - Demanded purity
Food, Drug, & Cosmetic Act
- Demanded safety
Durham – Humphrey Amendment
- Created legend class
Kefauver – Harris Amendment
- Demanded proof of effectiveness
- Regulated drug advertising ©

54. Quick Review (cont’d) Poison Prevention Packaging Act - Locking caps
Drug Listing Act
- Created registry of all drugs made
Prescription Drug Marketing Act
- Created drug pedigree
Omnibus Budget Reconciliation Act
- Cost reduction through greater pharmacy involvement ©

55. Quick Review (cont’d) Dietary Supplement Health and Education Act
- Proof of safety and standardized labeling
Health Insurance Portability & Accountability Act
- Patient privacy
Medicare Prescription Drug, Improvement, and Modernization Act
- Created Medicare Part D entitlement
Medicaid Tamper Resistant Prescription Act
- Mandated tamper resistant prescription blanks ©

56. Quick Review (cont’d) Patient Protection & Affordable Care Act
- Created insurance mandates, exchanges, and subsidies
Drug Quality and Security Act
- Regulated “outsourcing facilities” and created tracking requirements
Drug Supply Chain Security Act
- Created a system of identifying and tracking and allows the intercept of affected product BEFORE it reaches the patient ©

57. Laws Affecting Controlled Substances
The Harrison Narcotic Act
The Drug Abuse Control Amendment
The Comprehensive Drug Abuse Prevention and Control Act
Anabolic Steroid Act
Combat Methamphetamine Epidemic Act
Ryan Haight Online Pharmacy Consumer Protection Act ©

58. Harrison Narcotic Act (1916)
Covered narcotics alone
Used taxation as a control method
Tax stamps were placed on all controlled substances
Any product without tax stamps were subject to seizure ©

59. Drug Abuse Control Amendment (1965)
Changed basis of enforcement from tax levy to regulation of interstate commerce. (No more tax stamps)
Relied on Congress’ ability to control interstate commerce
Expanded coverage to barbiturates and stimulants ©

60. Bureau of Narcotics and Dangerous Drugs (1968)
Newly formed agency responsible for enforcing controlled substance laws
Changed name to the Drug Enforcement Administration in 1973 ©

61. Comprehensive Drug Abuse Prevention and Control Act (1970)
AKA, The Controlled Substance Act
Repealed and replaced Harrison and DACA
Introduced the DEA Number
Relies on registration and record keeping to track controlled substance transactions ©

62. Anabolic Steroid Control Act (1990)
Made anabolic steroids controlled substances
Enhanced in 2004 to include pro-hormones ©

63. Combat Methamphetamine Epidemic Act (CMEA-2005)
Class 1 Slides
Combat Methamphetamine Epidemic Act (CMEA-2005)
All pharmacies are required to have training and be 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 ©
© Mark Greenwald - all rights reserved

64. Ryan Haight Online Pharmacy Consumer Protection Act (2008)
Intended to insure protection for customers who purchase medications online
Covers only controlled substances
ALLOWS DEA TO TAKE ACTION AGAINST ONLINE PHARMACIES
Amendment to the Controlled Substances Act ©

65. Quick Review Harrison Narcotic Act - Used tax stamps
Drug Abuse Control Amendment
- Used interstate commerce laws
Comprehensive Drug Abuse Prevention and Control Act
- aka, Controlled Substances Act and introduced the DEA Number ©

66. Quick Review (cont’d) Anabolic Steroid Control Act
- regulates steroid products
Combat Methamphetamine Epidemic Act
- Created SLCP Class
Ryan Haight Online Pharmacy Consumer Protection Act
- Regulates online pharmacies ©

67. Ch 6: Non-Governmental Regulation
Class 1 Slides
Ch 6: Non-Governmental Regulation
The “Standard of Practice”
The Joint Commission (TJC)
Institute for Safe Medication Practices (ISMP)
Third Party Audits
Employer Audits ©
© Mark Greenwald - all rights reserved

68. Standard of Practice
What would the typical practitioner, armed with the knowledge typical of the profession, do in response to the situation at hand?
Define “standard of practice”
Define “typical practitioner”
“legal” vs. “ethical” standard of practice
Implications of not performing to the standard of practice (negligence) ©

69. The Joint Commission (TJC)
Non-Governmental Organization
Conducts voluntary certification inspections
Chart reviews
Equipment reviews
Facility inspections
Some insurance companies require certification before they will admit or pay for patient stays
Formerly known as “JCAHO” ©

70. Institute for Safe Medication Practices (ISMP)
Dedicated to educating the health care community and consumers about preventing medication errors
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 ©

71. Third Party Audits
Insurance company auditors come to the pharmacy, or send requests for documentation to the pharmacy, to check compliance
If problems are found, they want their money back
What do they look for?
Did the pharmacy have a hard copy of Rx?
Did the patient pick up the Rx? (signature in log book)
Did the pharmacy bill for the correct package size of the drug?
Did the pharmacy use the correct drug item? (correct stock bottle size) ©

72. Employer Audits Conforming to company policies?
Following pricing guidelines?
Proper inventory control?
Is paperwork handled correctly?
Loss prevention ©

73. Questions? ©