Certified Pharmacy Technician Course “Education is not only a ladder of opportunity, but also an investment in our future.” - Ed Markey © 2013-2018

Pharmacy Technician Certification © 2013-2018

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? © 2013-2018

Common Prerequisites to Take the Examinations Eighteen years old High school diploma/GED No felony convictions Pay the testing fee © 2013-2018

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 © 2013-2018 © 2013-2018 Mark Greenwald - all rights reserved

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 © 2013-2018

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) © 2013-2018

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 © 2013-2018

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 © 2013-2018

Ch 2: The Role of the Technician Judgmental vs. Non-Judgmental Tasks Where is the “Line in the Sand”? © 2013-2018

What Does a Technician Do? © 2013-2018

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 © 2013-2018

Pharmacy Practice Environments Community/Retail Institutional/Hospital Manufacturing Nuclear Nutritional Disease State Management Mail Order Insurance © 2013-2018

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” © 2013-2018

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” © 2013-2018

Sample Job Description © 2013-2018

Who Pays Your Salary? © 2013-2018

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……. © 2013-2018

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 © 2013-2018

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” © 2013-2018

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 © 2013-2018

Methods to Attract New Customers Advertising Coupons New Baby/New Resident Promotions Brown Bag Days Doctor Detailing © 2013-2018

Regulation of Pharmacy © 2013-2018

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 © 2013-2018

The Food & Drug Administration Approves new drug entities Regulates Package Inserts Regulates Drug Advertising Issues recalls on affected products © 2013-2018

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 © 2013-2018

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 © 2013-2018

Board of Pharmacy Always Remember, THE BOARD OF PHARMACY IS IN PLACE TO PROTECT THE PUBLIC, NOT THE PHARMACY OR ITS WORKERS! © 2013-2018

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 © 2013-2018

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 © 2013-2018

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 © 2013-2018

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 © 2013-2018

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 © 2013-2018

Amendments to the FDCA Durham-Humphrey Amendment – 1951 Kefauver-Harris Amendment – 1962 Drug Listing Act - 1972 Medical Device Amendment- 1976 © 2013-2018

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 © 2013-2018

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” © 2013-2018

Legend Drug Markings The new marking is simply an “Rx Only” On the label of the product © 2013-2018

Legend Drug Markings The old regulations required the statement: “Caution: Federal law prohibits dispensing without a prescription” © 2013-2018

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 © 2013-2018

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) © 2013-2018

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 © 2013-2018

Medical Device Amendment (1976) Manufacturers of certain medical devices must get pre-marketing approval from the FDA Does NOT affect drug products © 2013-2018

Prescription Drug Marketing Act (PDMA - 1987) CREATED THE DRUG “PEDIGREE” Helped eliminate re-importation of illicit drugs Regulated drug samples © 2013-2018

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 © 2013-2018

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 © 2013-2018

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 © 2013-2018

FDA Modernization Act (1997) Streamlined the drug approval process Regulated drug compounding in pharmacies Changed the legend marking on stock bottles to “Rx Only” © 2013-2018

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 © 2013-2018

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 © 2013-2018

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 © 2013-2018

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”) © 2013-2018

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 © 2013-2018

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 © 2013-2018

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 © 2013-2018

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 © 2013-2018

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 © 2013-2018

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 © 2013-2018

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 © 2013-2018

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 © 2013-2018

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 © 2013-2018

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 © 2013-2018

Anabolic Steroid Control Act (1990) Made anabolic steroids controlled substances Enhanced in 2004 to include pro-hormones © 2013-2018

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 © 2013-2018 © 2013-2018 Mark Greenwald - all rights reserved

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 © 2013-2018

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 © 2013-2018

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 © 2013-2018

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 © 2013-2018 © 2013-2018 Mark Greenwald - all rights reserved

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) © 2013-2018

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” © 2013-2018

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 © 2013-2018

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) © 2013-2018

Employer Audits Conforming to company policies? Following pricing guidelines? Proper inventory control? Is paperwork handled correctly? Loss prevention © 2013-2018

Questions? © 2013-2018