Pharmacy Technician

What are pharmacy Technicians?

They’re assistants to licensed pharmacists in providing customer service and preparing prescriptions.

Is receiving prescription requests one of the responsibilities for a pharmacy technician?

Yes, pharmacy technicians are to receive a prescription and process it.

Is processing prescriptions within our scope of practice?

Yes! it’s expected of us to process prescriptions after receiving prescription requests.

Do Pharm. Tech’s need to count tablets and label the tablets?

Yes! We need to, in order to ensure everything is correct

Is maintaining patient profiles one of the responsibilities for a pharmacy technician?

Yes!

Is creating and selling drugs on the side allowed?

NO! Don’t do that!

Are pharmacy technicians allowed to prepare insurance claim forms?

Yes, pharmacy technicians can prepare insurance claim forms as part of their duties.

Are pharmacy technicians expected to perform administrative tasks?

Yes, pharmacy technicians are expected to perform administrative tasks in order to help the pharmacist.

How do you become eligible to become a pharmacy technician?

• You must complete a PTCB recognized education -OR- training program (within 60 days)

• Have equivalent work experience as a pharmacy tech (minimum of 500h)

How do you maintain your certification?

For every 2 years, you must have a minimum of 20 hours of continuing education.

• 1 hour is dedicated to a subject in pharmacy law

• 1 hours is dedicated to be involved in subject to patient safety.

Define certification

A non-governmental association or agency that grants recognition to an individual who was meet their requirements & qualifications.

Define licensure

Being granted a license by a GOVERNMENTAL AGENCY to an individual to practice within their specified profession.

The Durham-Humphrey Amendment did what?

It separated medication into 2 classifications:

• Legend/ Rx

• Over The Counter (OTC)

Define legend

A prescription needed, essentially a Rx medication. It is dangerous for dependency.

Define Over the Counter (OTC)

No prescription needed

What did the DEA create in the 1970’s regarding drug classification?

They created a scheduled list, going from 1-5.

What is a community pharmacy?

A retail pharmacy, that is accessible to the public.

What is a hospital pharmacy?

A pharmacy within a department or inpatient setting to serve patients.

What is a mail order?

It is medication that’s sent via mail, HOWEVER, it MUST be prescribed and send to a pharmacy to refill the prescription.

• ONLY USED TO REFILL!!!

Define long-term care

Patients who need a place to stay and receive care 24 hours a day.

Define managed care

Provides their own pharmacies to those enrolled. Ex) HMO

What is a home infusion?

Providing intravenous medication but specifically at the pt’s home.

Which one does a prescription label contain?

A. Pharmacy info

B. DOB of pharm tech

C. Lightings

D. None of the above

A. Pharmacy info

Which one does a prescription label contain?

A. Prescription number

B. Date Filled

C. Pateint’s name

D. All of the above

D. All of the above

Which one does a prescription label contain?

A. DOB of organization

B. Manufacturer

C. Both B & D

D. Directions of use

C. Both B & D

Which one does a prescription label contain?

A. All of the above

B. Quantity dispensed

C. Amt. of refills allowed

D. Exp. date

A. All of the above

When does a non-controlled drug expire?

1 year

When does a controlled drug expire?

6 months

Pure Food & Drug Act (1906)

All foods and drugs had to meet a standard of strength and purity.

Harrison Narcotic Act (1914)

• Regulated drugs w/ a physical or psychological dependence

• Regulated the importation, sale manufacturer, & use of certain drugs

What drugs were regulated in the Harrison Narcotic Act 1914?

Opium, Marijuana, Synthetic agents.

The Federal Food, Drug, & Cosmetic Act (1938) ______ & _____ adulteration & misbranding

Identified, labeled

The FFDCA 1938 requires?

• Manufacturers MUST prove that their products are safe

• Medical devices are effective

T/F the FFDCA gave the FDA authority to remove products if they were found ineffective/unsafe.

True

What did the Federal Hazardous Substance Act (1960) reuqire?

It required hazardous household materials to be labeled w/ a warning sign and how consumers can protect themselves.

Who did the Federal Hazardous Substances Act give authority to enforce the requirements?

The Consumer Product Safety Commission

The Kefauver-Harris Amendments to the FFDCA (1962) required what?

They required drug manufactures to prove the safety and efficiency of their products prior to FDA approval.

Poison Prevention Packaging Act (1970)

• Required child proof packaging

• Required medications to be dispensed in new and clean containers

The Controlled Substances Act classified drugs based on the potential for?

abuse

OSHA (1972) provides _____ information, education & _____ in the field of occupational safety & health

research, training

The Drug Listing Act (1972) required?

• registered drug establishments to provide the FDA w/ a current list of all drugs manufactured, prepared, propagated, compounded, or processed by it for commercial distributions

• Each drug had to be issued a National Drug Code (NDC) that identities the manufacturers, drug strength, form, and packaging size.

The Medical Device Amendment (1976) regulated the safety & efficacy of _____ _____

medical devices

The Federal Anti-tampering Act (1982) required what?

Medications & devices to be placed in a tamper-proof packaging.

The Orphan Drug Act (1983) passed to expedite development of _____ drugs for ____ diseases.

orphan, rare

The Prescription Drug Marketing Act (1987) enacted to address what?

prescription drug-marketing practices

The Omnibus Budget Reconciliation Act (1990) required what?

• Pharmacists must give medication counseling

• Required a drug use review every time a prescription is processed

• Required manufacturers to provide medication at its lowest price to Medicaid Pt’s.

The Anabolic Steroid Control Act acknowledged steroids as Schedule _ drugs

3

Steroid became known for?

Building muscle and acts similar to testosterone.

HIPPA must protect ____ & ____ privacy

patients, worker’s

T/F HIPPA protects health insurance coverages when someone loses their job

True

The FDA Modernization Act (1997) required legends to become?

They required legends to become Rx only/prescription

T/F The Drug Addiction Treatment Act (2000) allowed prescribers to obtain a waiver to prescribe controlled substance to WORSEN opioid addiction.

False

What law created Medicare part D?

Medicare Prescription Drug, Improvement, & Modernization Act (2003).

What did the Combat Methamphetamine Epidemic Act (2005) do?

Regulated OTC sales for":

• Ephedrine

• Pseudoephedrine —> 3.6g per day

• Phenylpropanolamine products

How long do the records must be kept for in the Combat Methamphetamine Epidemic Act?

2 years

What did the Family Smoking Prevention & Tobacco Control Act (2009) require?

warning labels on smokeless tobacco

What law restricted tobacco marketing & sales use, while enforcing the regulation that the ingredients must be listed?

The Family Smoking Prevention & Tobacco Control Act (2009).

Which law outlined the steps to build electornic, interoperoble systems to identify and trace prescribed drugs?

Drug Supply Chain Security Act (2013)

T/F joint commissions works to improve healthcare for the public

True

The FDA protects?

The public health from foods and drugs that could be potentially harmful.

How many classes are there in the FDA recall?

3

Class 1

can cause serious harm or death

Class 2

temporary or small harm

Class 3

Not harmful, but shouldn’t be sold

Drug Enforcement Administration (DEA) brings and enforces criminal & ___ Justice to enforce the ____ substance law & _____.

civil, controlled, regulations

What does the Federal Trade Commission (FTC) protect?

They protect the public from deceptive or unfair business practice, & from unfair methods of competition through how enforcement, advocacy, research, and education.

State board of pharmacy

creates a uniform education & licensure standards, helps support patient & medication safety through testing of pharmacy tech’s for competence.

How does the National Association of Boards of Pharmacy promote, preserve, and protect health?

They do this by regulating the practice of pharmacy by establishing state-specific regulations regarding the practice of pharmacy.

T/F the United States Pharmacopoeia (USP) is a scientific organization for profit?

F

What is the United States Pharmacopoeia (USP) fouced on?

Building trust in medicine and to strengthen the global chain supply so everyone can get the necessary medication needed.

Prescription Drug Monitoring Program

An electronic database that tracks controlled substance prescriptions within its state.

Schedule I

NOT accepted for medical us, high drug addiction

ex) heroin, LSD

Schedule II

Accepted, but has a high risk for drug dependency

Ex) oxycodone

Schedule III

Low to moderate risk for dependency

Ex) ketamine, benzphetamine, anabolic steroids

Schedule IV

Low potential & low risk of dependency

Ex) zaleplon, zolpiden, mizasolam, tramdol

Schedule V

Even lower risk than IV, typically used for antidiarrheal, antitussive, and analgesic purposes.

Ex) lomtil, pregabalin

Do Schedule II drugs have refills?

NO! if needed a new prescription is ordered

What schedules have refills?

3 and 4

How many refills does Schedule V get?

Unlimited unless specified.

Sales limit for Pseudopephedrine

3.6g per purchaser

T/F it is unlawful to purchase more than 9g of pseudoephedrine during a 30 day period. As for mail orders, it’s limited to 7.5g per customer during a 30-day period.

T

According to the pseudoephedrine regulations the product must be placed where?

Somewhere the customer cannot have direct contact, that is if they’re not OTC

The log book must contain, which of the following?

Both are correct

Should a log book contain the name & address of the purchaser as well as the date & time of the sale?

Yes!

DEA form 41 is used to report?

The destruction of controlled substances

DEA form 222

orders and records schedule II drugs

DEA form 106

reports loss or theft

T/F Before a drug becomes available to the public they SHOULDN’T SUBMIT to an Investigational New Drug Application to the FDA for approval.

F

What are the 2 INDA cateogries?

• Comerical

• Research

How many types of investigational new drugs does the FDA have?

3

Investigator IND:

Submitted by a doctor who initiates and conducts an investigation. Mainly for proposing a study on an unapproved drug, OR an approved product but for a new indication.

Emergency Use IND:

The FDA approves an experimental drug in an emergency situation, that doesn’t have enough time to sumbit an INDA.

Treatment IND:

An experimental drug that shows promise in clinical testing for helping those in serious or life-threatenting conditions

How many phases are there that goes along with the clinical trials?

4

Phase 1:

Initial introduction to human use, so it’s a small study of about 20-100 volunteers. Here they establish saftey & a dose.

Phase 2:

Lasts several months to 2 years & establishes effectiveness and montiors adverse side effects.

Phase 3:

Lasts 1-4 years & better establishes effectiveness and adverse reactions

Phase 4:

approved by the FDA, but is still being watched.

HIPAA Regulation Title I:

Protects health insurance coverage for workers who lose or change their job

HIPAA Regulation Title II:

Simplifies health-care administrated by standardizing health-care transactions.