PTCB

Health Care system

According to the World Health Organization (WHO), a health care system is defined as a system that consists of organizations, institutions, and resources of people whose primary purpose is to improve public health

Medicare

Provides service for the elderly and disabled individuals (must meet a certain criteria)

Medicaid

Provides service for lower income individuals. Federally and state funded

Tricare

AKA military insurance; provides service to veterans and soldiers

NIH

National Institute of Health

Employer Insurance

Most employers provide health insurance to full time employees

Private Insurance

Individuals can apply and pay for health insurance. Smaller businesses offer group rates to their employees.

Copay

The remaining amount an individual must pay for their medication after insurance. This form of payment is collected at the point of sale (ie the pharmacy)

Medicare A

Covers inpatient hospital stays

Medicare B

Covers outpatient hospital stays and diabetic supplies, DME (durable medical equipment), patients on long term disabilities, X-rays, dialysis, vaccines, and respiratory nebulizers

Medicare C

Additional coverage not covered under A or B. Often called the advantage plan or choice plan.

Medicare Part D

Covers prescription medications; usually processed by private insurance but funding is provided by CMS (government)

Medicare Part E

Supplemental coverage; covers A, B, and D (Different than just Medicare C)

Medicare C only covers A and B

HMO

Health Maintenance organization

Health Maintenance Organization (HMO)

With an HMO plan, you must select a primary care physician (PCP) from .a network of local healthcare providers who will refer you to in-network specialists or hospitals when necessary.

All of your care is coordinated through your PCP

Lost cost to the insurance and the patient

PPO

preferred provider organization

Perferred Provider Organization (PPO)

Recommended list of in-network providers and hospitals

-If you choose a provider outside of your network, your copay may be higher

-More flexibility= pay more money per month

EPO

Exclusive Provider Organization

Exclusive Provider Organization (EPO)

Sort of like a combination between HMO's and PPO's

-There is a recommended list of providers and specialists but cannot pick a provider outside of network

-You can pick any primary care physician but they must be in-network

Workers Compensation

When a patient has been hurt at work and his/her company has agreed to pay for the cost of his/her medication

out of pocket

Individuals without health care coverage and have to pay out of pocket expenses

Pharmacy Benefit Managers

PBM

-Primarily responsible for developing and maintaining the formulary, contracting with pharmacies, negotiating discounts and rebates with drug manufacturers, and processing and paying prescription drug claims.

-Working with self-insured companies and government programs; trying to reduce pharmacy expenditures of the plan and trying to improve health outcomes

Drug Development

Complex and time consuming; on average it takes 8-15 years for a drug to be developed and approved by the Food and Drug Administration

3 Basic Steps of Drug Development

1. Research

2. Testing

3. Approval

Research

Can be done be pharmacologists, toxicologists, clinical pharmacologists, pharmacists, and physicians

-The objective of research is to find a new active ingredient or to modify the structure of existing drugs

FDA Regulation

The food and drug administration was established in 1906

-Charged with the regulation of medications ensuring their safety and effectiveness before medications are brought to market

Where does testing begin?

In the laboratory

-Stability

-Structure

-Dosage forms of the drug

Tests are done in animals to assess _______

Toxicity

- A new drug must be deemed safe before used in humans

How many steps is the approval process for testing in humans regulated by the FDA?

4

Human Test Phase 1

Objective: To assess the initial dose and to determine if humans can tolerate the drug (toxicology)

-A new drug is tested on a few healthy individuals at the lowest dose and is slowly increased

Pharmacokinetics

absorption, distribution, metabolism, biotransformation, and excretion

Most drugs do not make it past phase _______

2

Human Test Phase 2

When the drug passes the first phase

-The drug is tested on a few hundred volunteers who have the disease the drug is intended for

-Extensive data on pharmacokinetic and toxicology profile of the drug are collected in this phase

-The optimal dose of the drug is determined in this phase

Human Test Phase 3

-Must pass phase 2

- Drug is tested on thousands of patients in a health care setting

-Must be randomized, double blind (drug or placebo) controlled study

-Test the efficacy of the drug

Human Test Phase 4

AKA Post market surveillance phase

-The drug has reached an approval by the FDA

-Drug interactions, use in pregnancy, and long term side effects are examined

-Pharmacists and patients are encouraged to report side effects to the FDA through medwatch

Pharmacists/Patients are encouraged to report side effects to the FDA through ________

Medwatch

Steps to Drug Use Process:

1. Storage

2. Distribution

3. Prescribing

4. Dispensing

5. Moniotring

Practitioners with Prescriptive Authority:

- Physicians (MD)

- Doctor of Osteopathy (DO)

- Veterinarian (DVM)

- Opthamologist (OD)

- Podiatrist (DPM)

- Nurse Practitioner (NP)

- Physician's Assistant (PA)

MD

Physician

DO

doctor of osteopathy

DVM

Doctor of Veterinary Medicine

OD

Ophthalmologist

DPM

podiatrist

NP

nurse practitioner

PA

physician's assistant

Pharmacy

A site licensed by the board of pharmacy to dispense or compound prescriptions

Drug Store

A place where drugs are sold that do not require a prescription (OTC)

Who is the only person unable to handle medications in a Pharmacy

The clerk/cashier

Some things a technician cannot do:

- Accept new orders over the phone

- Counsel patients/recommend OTC items

CEU's

continuing education units; 20 units of CEU must be completed every 2 years upon passing technician certification

3 Classes of Medication Recalls

- Class I recall

- Class II recall

- Class III recall

Class I recall

A situation in which there is a reasonable probability that the use/exposure to a violative product will cause serious adverse health consequences or death

Class II recall

A situation in which use/exposure to a violative product may cause temporarily/medically reversible adverse health consequences or where the probability of serious adverse health consequences is remote

Class III recall

A situation in which use of or exposure to a violative product is not likely to cause adverse health consequences

More common types of recalls:

- Market withdrawal

- Medical Device safety alert

Market Withdrawal

When a product has a minor violation that is not subject to FDA legal action. The firm removes the product from the market or corrects the violation.

Ex: Tampering without evidence of manufacturing/distribution problems

Medical Device Safety Alert

Issued in situations where a medical device may present an unreasonable risk of substantial harm

What to do when notified about a recall?

- Immediately pull the medication (see if you have the specified lot)

-Expose of/return the medication

- Notify patients

Do not dispose of/give medication to patients! (Return to supplier)

Tablets

Leave a chalky film on the countering tray

- Monitor and clean when necessary

- Can be scored to give fractional dosing

When must you clean a counting tray?

After counting medication containing:

-Penicillin (or a derivative)

-Sulfa (or a derivative)

Buccal Tablets

Placed in area between cheek and gums

Sublingual Tablets

Placed under the tongue

Chewable Tablets

Chewed

Enteric Coated Tablets

-Dissolve in the small intestine rather than the stomach due to digestive issues

Ex: Enteric Coated Aspirin

Troches and Lozenges

Held in mouth and absorbed over time

Capsules

Attract dusty powder from the tray

Effervescent Tablet

Dissolved in water than drank

ER

Extended release (for chronic pain)

IR

Immediate release (acute pain)

The following describe dosage forms over a period of time:

- CR = controlled release

- ER/XR = extended release

- LA = Long acting

- DR = delayed release

- SA = sustained action

Solutions

Medication is equally distributed within the liquid

Suspensions

-Medication "suspended" in the liquid, settles to the bottom

-Shake well

Reconstitutables

- Provided from the manufacturer in a powdered form and a certain amount of distilled water must be added

-Typically these must be reconstituted when the patient arrives to pick up

(They have a short shelf life and often need to be refrigerated)

Elixirs

Mixture of alcohol, water, and active ingredient

Spirits

Much like an elixir, but with a higher concentration of alcohol

Syrups

- mix of sugar, water, and active ingredient

- Do not sweeten

Emulsions

-Mixture of oil, water, and active ingredient

-Shake well

Suspensions and emulsions must always contain an ___________ __________, indicating to the patient to shake well

Auxiliary label

1 fl oz = ???? mL

30 mL

Cream

Absorbs quickly, used for small areas, provides little protection

Lotion

Absorbs quickly, used for larger areas

Ointment

Greasy, absorption, provides greater protection than lotions and creams

Colloidon

Syrup like liquid that dries clear to close small wounds, abrasions, and cuts

Liniment

Typically used for pain, these heat larger areas to provide temporary relief from muscle pain

Matrix

Gel like substance that locks medication into a cube and slowly releases the active ingredient over time

Otic

Preparations intended for the ear

-Can never be used in the eye

Opthalamic

Preparations intended for the eye

-Sterile

-Can be used in both the eye and the ear

Oral

taken by mouth

External

Apply

suppository

insert

Drops

Instill

Nebulizer

Use X vial

Inhaler/Nasal Spray

Inhale

Requirements for all prescriptions

- Doctor's name and contact info

- Doctor's signature

- Date

- Patients name

- Medication name

- Medication strength

- Medication dosage form

- Medication route of administration

- Directions

- Quantity

- Refills

- DAW

DAW Codes

Dispense as written codes

Three main DAW codes

0

1

2

0 DAW code

Unchecked box; dispense generic when available

-When a prescription is written for a brand name medication it is both legal and commonplace to dispense generic when available

1 DAW code

Checked box; "brand name medically necessary"

- Doctor mandates that the pharmacy dispense brand name

2 DAW code

Unchecked box; patient wants brand name

-Pharmacy should dispense brand name

CSA

Controlled substances act

-enacted in 1970

-Regulated use/distribution of substances with potential abuse

-Created the DEA (drug enforcement agency)

- Set up drug schedules

-Requires DEA 222 form for ordering CII medication