Pharmacy technician training- Unit 2, lessons 1-5

Echelon

Ancient Egyptian pharmacy technician

Chiefs of fabrication

Ancient Egyptian pharmacist advising patients and compounding

Papyrus Ebers

An ancient Egyptian medical text that includes numerous prescriptions and remedies

Hippocrates

Established scientific practice in medicine, proposed 4 humors, blood, phlegm, yellow bile, and black bile

Blood (humor)

Happiness

Phlegm (humor)

Lethargy

Yellow bile (humor)

Irritability

Black bile (humor)

Anger

Galenicals

Pharmaceuticals compounded by mechanical means

Pharmacopoeia

Official list of drugs and their chemical and generic names, sets quality standards

American Council on Pharmaceutical Education (APCE)

Set standards for pharmacy education and accredits pharmacy programs across the United States

Traditional Era

1900-1930s, formulated and dispensed naturally sourced drugs

Scientific Era

1930s-1960s, new drugs, testing, mass production of synthetic drugs

Clinical Era

1960-1990, dispense drug information, warnings, and advice

Pharmaceutical care Era

1990-current day, focus on patient positive outcome for drug related therapy

Biotechnology

Drugs produced through living organisms with recombinant DNA, mostly injectable drugs and cancer treatment

Pharmacogenomics

May be able to predict patient reactions to medications, hope to be able to make specific medications for individuals with specific illnesses

Medication therapy management (MTM)

Medication review, pharmacotherapy consultation to providers and patients, immunization, disease state management, operate health and wellness programs

PharmD

2 years pre pharmacy, 4 years at college of pharmacy

Ambulatory/Retail pharmacy

Businesses within community, including online and mail order, counsels patients, recommend over the counter, vaccination

Institutional/Health system pharmacy

Hospital/medical facility caring for its residents, dispenses medication to individuals, advices medical staff, manages drug regimens, determines drug use and outcome patterns

Pharmacy technician role ambulatory

Maintain patient profile, insurance billing, manage inventory, prepare prescription for pharmacist sometimes compounding and bulk repackaging

Pharmacy technician role institutional

Review patient chart, prepares and delivers medications to nursing stations, unit dose packaging sometimes IV antibiotics or chemotherapy

Five Patient Rights

Right patient, medication, strength, route, time

When should pharmacist be called

New medication counsel, change in prescription, flagged drug utilization review (DUR), patient request to speak to pharmacist/asked question

Federal statute

Passed by congress, must be signed by president to become law

Regulations

Law that clarifies statues, must be consistent with enacted statue

Legislative intent

Justices and judges create case law based on what legislators wanted the law to mean

Criminal law

Regulates social conduct, includes punishment for perpetrators

Civil law

Core principles in a referable system serving as primary source of law

Administrative law

Regulates operation and procedure of government agencies

Misdemenor

More minor, punishable by less than 1 year in prison and/or minor fine

Felony

Major crime, at least 1 year in prison, large fines

Centers for Medicaid and Medicare Services (CMS)

Regulates administration of federal healthcare programs and laws, conducts inspections to ensure compliance with its laws, includes HIPAA

Drug Enforcement Agency

Regulates trade of dangerous and narcotic drugs, prevents illegal drug trade, works and answers to FBI

Food and Drug Administration (FDA)

Safety, efficacy, and security of drugs (OTC and Rx), biological product (grafts, transplants), medical supplies (oxygen, diabetic supplies), food, cosmetics, reviews new drugs for sale and overviews generics

The Joint Commission (The Joint Commission on the Accreditation of Healthcare Organization)

Sets quality and safety standards of healthcare organizations, including hospitals, hospice, nursing homes, long term care facilities, rehab

Occupational Safety and Health Administration (OSHA)

Overseen by US Department of Labor, sets and enforces standard of worker safety, offers education, technical assistance, advisement, and training programs to workers and employers

State Boards of Pharmacy (SBOP)

Regulates, pharmacy facilities, pharmacists, and pharmacy technicians, monitors their activity, issues punishments, including revoked license

Pure Food and Drug Act of 1906

Regulates manufacturing, sale and transport of medications and food, but could not ban drugs, could not prevent false claims, did not require naming contents

Sherly Amendment of 1912

Amended 1906 Food and Drug Act, prohibited labeling medications with false therapeutic claims

The Food, Drug, and Cosmetic Act of 1938 (FDCA)

Only safe, effective drugs could be sold across in interstate trade, determined who could prescribe and administer drugs, required evidence of safety + efficacy, clinical trials

Pharmacy name+address

Rx number (prescription serial number)

Date of prescription filling

Name of patient and prescriber

Usage instruction

FDCA Prescription label requirements

Patient address

Initials or name of dispensing pharmacist

Pharmacy telephone number

Drug name, strength, and manufacture's lot number

Manufacturer name

Amount dispensed

Refill information

Additional state prescription label laws

Legend drugs

Drugs requiring prescription, must be labeled with:

Name and quantity of active ingredients

Drug amount

Usual dosage

Federal legend

Route of administration

Federal warning for habit forming drugs

Name of inactive ingredients

Lot or control number

Container type

Manufacturer+packer+distributer name and location

Expiration date

FDA Package insert requirement for legend drugs

Chemical structure, clinical pharmacology, indications and usage

Contraindications

Side effects

Adverse reactions

Abuse/dependance risk

Usual dose

Most recent label revision

How drug is supplied

Auxiliary labels

Provide supplementary info about safe administration, use, or storage, located on medication bottles

Contraceptive auxiliary label

Take as directed

NSAIDS auxiliary label

May cause dizziness or drowsiness

Narcotics auxiliary label

Drug alone or with alcohol may impair driving

Antibiotics auxiliary label

Take until gone

Sulfa auxiliary label

May cause light sensitivity, take with water and empty stomach

Warafin auxiliary label

Do not take aspirin

OTC labels

Made user friendly for consumer, requires:

Product name

Name and address of manufacturer, distributer, repacker and others

Active ingredients and quantities of some other ingredients

Total contents

Cautions and warnings

Name of any habit forming drug

Directions for use

Durham-Humphry Amendment of 1951/Prescription Drug Amendment

Established the distinction between prescription and over-the-counter (OTC) medications, federal law prohibits dispensing without a prescription

Kefauver-Harris Amendment of 1962/Drug Efficacy Amendment

Show proof of efficacy by manufacturer, inserts in prescriptions to show efficacy test results, established GMP, FDA oversees prescription advertising, new drug applications and investigative drugs must follow guidelines before distribution

Good Manufacturing Practice (GMP)

Minimize risks during manufacturing by addressing aspects like starting materials, premises, equipment, staff training, and written procedures

Comprehensive Drug Abuse Prevention and Control Act of 1970

Narcotic assigned rating of addiction potential, assigned letter C (controlled) and roman numeral decreasing with increasing addictive potential

Schedule I (C-I)

No accredited medical use or safety standard, high abuse potential includes heroin, LSD, Marijuana

Schedule II (C-II)

Accepted medical use, high potential for abuse, can only be dispensed under certain regulations, morphine, codeine, hydrocodone, hydromorphone, methadone

Schedule III (C-III)

Accepted medical use, moderate risk for abuse or dependance, Vicodin, Lortab, Tylenol #3, anabolic steroids

Schedule IV (C-IV)

Accepted medical use, limited potential for dependance or addiction, includes Valium, Xanax

Schedule V (C-V)

Accepted medical use, low risk of dependance, includes Robitussin AC, Phenergan with codeine

Rules for dispensing C-II medication

Prescription must be type or in ink

Contain patient’s full name and address

Date of issue and medicine information

Faxed prescriptions to long term care, hospice, home infusion pharmacy allowed federally, not by all states

Often limited stock, limited refill to 1 month

Rules for dispensing C-II medication

Partially filled prescriptions must note quantity dispensed on prescription face and filled within 72 hours or a new prescription must be made

Emergency prescriptions can be phoned in from prescriber to pharmacy and require written consent within 72 hours to 7 days, depending on regulation

No refills can be made, new prescription required

State requirement to have constant inventory, DEA requires every 2 years

Storage to prevent theft

Ordering C-II medication

DEA form 222 ordered and supplied with pharmacy name and address printed

Invoices and inventory kept separate

Schedule II medical supply form must be filled by pharmacist

Pharmacist must check order after arrival

Bottom copy and invoice retained in pharmacy records for 7 years

DEA Code

Given by prescribers to write prescription for controlled substances

9 letters, start with A or B, then prescriber’s last initial, 7 numbers added together matching a number

Add 1st, 3rd, 5th, and 2nd, 4th, 6th and multiply evens by 2 and add, number matches last number if valid

Poison Prevention Act of 1970

All legend and controlled drugs, with some exceptions, must be dispensed in childproof containers

Poison Prevention Act of 1970 Exceptions

Elderly/disabled with signed, written request for nonchild proof containers, nitroglycerin, contraceptives, inpatient hospital drugs, some emergency drugs

NIOSH

Researches occupational safety and implement findings into OSHA practices, established by Occupational Safety and Health Act of 1970

Drug Listing Act of 1972

Amended Food, Drug, and Cosmetic Act of 1938, required drug establishments, including manufacturing, preparation, repacking, or compounding facilities, to list drug with FDA

National Drug Code

Unique code given to medications under Drug Listing Act identifying drug establishment, formulation, and packaging type and size, first number set identifies manufacturer, second set the drug, third set the package size

Medical Device Amendment of 1976

Requires life sustaining and supporting devices to have FDA premarketing approval, 3 categories set by FDCA

Class 1 devices

Low potential to cause harm (scissors, needles)

Class 2 devices

Subject to specific performance review standards set by experts, includes thermometers, catheters, hearing aids

Class 3 devices

Devices who are life sustaining whose failure is likely to be lethal or very serious, includes ventilators

Orphan Drug Act of 1983

Stimulate development of medicine for rare diseases (200,000 or less affected)

Exclusive market rights for 7 years to companies producing approved orphan drug

Tax credit of 50% of the cost of conducting trials for companies conducting human trials for potential orphan drugs

In 1997, Congress grants exception from FDA application and user fees to companies developing orphan drug

Drug Price Competition and Patient Term Restoration Act of 1984 (Hatch-Waxman Act)

Manufacturers of generic drugs can seek FDA approval for generic version of drugs with expiring patents

Prescription Drug Marketing Act of 1987

Addressed distribution of free samples, coupons for drugs at very low or no cost, sale of deeply discounted drugs to healthcare facilities, all of which create gray market

Anabolic Steroid Control Act of 1990

Placed anabolic steroids in Schedule III

Anabolic Steroid

Drugs related to testosterone, stimulates muscle growth and promote secondary male sex characteristic, temporary effect with high risk for long term organ damage, side effects of high blood pressure, changes in cholesterol levels, liver and heart damage

Omnibus Budget Reconciliation Act of 1990 (OBRA ‘90)

Focused on federal funding of Medicare and Medicaid, mandated pharmacists preform drug utilization reviews and offer counsel to patients, creating a greater need for pharmacy technicians

Dietary Supplement Health and Education Act of 1994

Amended FDCA to establish standards for supplements

Defined dietary supplements and ingredients

Created safety assurance process

Guidelines for literature at supplement selling locations, making claims of nutritional support

Required GMP

Required ingredients and nutritional facts to be listed on labels

Health Insurance Portability and Accountability Act (HIPAA)

Protect patient confidentiality and privacy, patient right to review medical records, required patient consent to transfer records before transfer

Protected health information (PHI)

Defined by HIPAA, can only be shared for treatment, payment, or operation or with written consent includes

Information related to receiving prescriptions created by or received by pharmacy

Information about patient mental and physical health for past present and future

Identifying information of patient

Food and Drug Administration Modernization Act of 1997

Simplifies FDA regulations and procedures, greater ease and speed of drug approval and of granting access to investigational medications, abbreviated federal legend to ‘Rx only’

Drug Addiction Treatment Act of 2000

Permits physicians who take a course and register with DEA to prescribe C-III,C-IV, and C-V medications to maintain or detoxify patients with opioid addiction, rules limit how many patients of this type that one physician can treat per year

Medication Modernization Act of 2003

Allowed Medicare beneficiaries to enroll in Medicare Advantage/Medicare Part D, a voluntary prescription drug benefit plan for seniors

USP Chapter <797>

US Pharmacopeia’s enforceable standards for sterile compounding, outlines required procedures and practices

Combat Methamphetamine Epidemic Act (CMEA) of 2005

Regulates OTC sale of ephedrine, pseudoephedrine, and phenolpropylamine products due to being precursors of methamphetamine

3.6 g daily sales limit, 9g 30 day purchase limits

Products out of direct customer access

Sales logbooks

Customer ID verification

Employee training

Exclusions: Single dose+less than 60mg does not need to be recorded, but kept behind counter

Medicaid Tamper Resistant Prescription Pad Law of 2008

All written prescriptions for covered outpatient drugs to be written on tamper resistant pad to prevent:

Unauthorized copying of filled or blank prescription form

Prevent erasure or modification of written information

Use of counterfeit forms

Affordable Care Act of 2010 (ACA)

Ability to choose insurance through open market exchange, pooling buying power and give more affordable choices of private insurance

Once required individuals to have insurance or pay a shared responsibility fine

Drug Approval Process

Drugs submitted to FDA for approval before clinical testing, benefits must far outweigh risk, first chemical testing, then animal, then clinical testing, takes 6-7 years in nonemergency situations

Clinical Trial Phase I

Very small number of healthy volunteers, in one facility over several months testing maximum safe dosage

Determines safe limit, not efficacy

Takes 1-2 years

Clinical Trial Phase II

Several hundred of target treatment population tested

Tests drug effectiveness

2-3 years

Clinical Trial Phase III

Final phase before submission to FDA before NDA

Double blind

Careful documentation to determine efficacy and safety

3-4 years

New Drug Application (NDA)

Submitted to FDA, requires approval to market drug

Clinical Trial Phase IV

FDA reviews all previous documentation, follows drug to ensure no unexpected danger

Continues throughout drug’s lifetime

Drug Monographs

FDA required package inserts with description, clinical pharmacology, indications, contraindications, usage, warnings, precautions, drug abuse and dependance, adverse reaction, dose, how it is supplied

Consequentialism

Value of action derived solely from its consequences