PTCB

PHARMACY LAW:

Adulterered: product that differs from quality standards in drug strength, quality , or purity (when drugs get contaminated w other drugs or chemicals)

Misbranded: product whose label includes false statements about the identity or ingredients of the container’s contents

Compromised: damaged packaging, or medication such as tablets or capsules

Drug Listing Act: gave the FDA the authority to compile a list of currently marketed drugs and assign them each a numbered code

• known as the National Drug Code (NDC) Number

Omnibus Budget Reconciliation Act: In order to receive Medicaid funding, each state had to establish a Drug Utilization Review (DUR) board

• set standards for pharmacist to patient education and counseling

• Required that pharmacy personnel review the drugs that the patient takes before each prescription is filled

• made DUR and MTM (medication management therapy) a necessity for Medicaid patients

DRUG REFERENCES:

USP (US Pharmacopeia):

• Sets quality standards for medicines, dietary supplements and healthcare products in the US

• Developed standards for the practice of pharmacists and pharmacy technicians

• USP standards are used to provide accreditation

FDA Orange Book:

• legal source for drug equivalency information in the US(generic drugs)

FDA Purple Book:

• reference for interchangeable biological drug products

FDA Red Book:

• Includes information about drug pricing and product details for both OTC and prescription drugs

Remington: comprehensive textbook that is a reference for pharmacists; it cover info on pharmacy practice, drug info, formulation, and therapeutics

Hospital Accreditation Regulations

Joint Commission:

• sets. high standards of care for hospitals and healthcare institutions

• Many insurance carriers and governmental agencies require it for hospitals to receive reimbursement

• Once a hospital is affiliated with the joint commission, site visits are conducted every 18-36 months

INSURANCE:

• HMOs: require members to get services and products only through their staff or contracted providers and facilities

• PPOs: some elements of the HMO model but with more choices as it allows for some out of network providers

Medicare: for people >65 , people with kidney disease, or those who have received social security disability insurance for 24 months

• Medicare A: covers 80% of the cost of hospital stays, any person who reaches age 65 and submits an application automatically qualifies for this health coverage

• Medicare B: covers 80% of the cost of doctor visits to diagnose and treat an illness after a low deductible is met

• Medicare C(Combo of A and B): complete package of hospital, doctor visits, and prescription drug insurance

• Medicare D : prescription drug insurance targeted at helping patients pay for medication cost

Medicaid: Decreases the cost of health care, including drugs, for eligible disabled, low income, part time, and unemployable state citizens of any age

*NPI(national provider Identifier) is required for the prescriptions from each physician, physician’s assistant, nurse practitioner, dentist, and pharmacist to be legitimate and processed*

*Coordination of Benefits - when the patient is covered by more than one health insurance, normally the primary insurer pays but if they cant then the secondary insurer will pay*

DAW Codes:

• DAW 0: no product selection is indicated

• DAW 1: Substitution is NOT allowed by prescriber

• DAW 2: Substitution is NOT allowed by patient

• DAW 3: Substitution is NOT allowed by pharmacist

Sterile & Non-Sterile Compounding:

• USP <797> is for sterile compounding

• USP <795> is for non-sterile compounding

• Excipients: ingredients other than the active ingredient in a formulation (diluents, flavoring, etc.)

• Occlusive ointment: has the ability to hold moisture in the skin

• Emollient base: ability to soften skin

• Geometric Dilution Method: add ingredients a little at the time and slowly add more so that all of the ingredients are spread out evenly in the solution/mixture

• 95% Ethyl Alcohol: it is used as a solvent as it is able to be consumed orally

• 75% Ethyl Alcohol: is used as a topical antiseptic

• LAFW: Laminar Airflow Workstation, specialized hood that provides clean air (ISO 5)

  • Vertical Hood: hazardous drugs are prepared here - the air goes vertically down

  • Horizontal Hood: non hazardous drugs can be prepared here

• DCA (designated compounding area): ISO should be 5 here and this is basically where the compounding should be taking place

*Only the gown from the PPE can be reused*

Anteroom: transition area from the pharmacy to the clean/sterile room; there would be PPE, changing area, and just prep materials for the technicians to transition into the clean room

Clean Room: clean space for compounding; specialized equipment and strict procedures for cleanliness would be here

Direct Purchase: buying medication directly from the manufacturer

*HEPA filters remove particles of 0.3 micron size*

*Buffer Area: ISO 7 ; PEC Area: ISO 5*

Inventory Management

• Database files should be backed up every day

• JIT (just in time): inventory management system where medications and supplies are ordered only when needed, minimizing the amount of stock on hand and reducing waste of overstocking

• PO (Purchase Order): document that the pharmacy sends to a supplier for a quantity of medication or supplies

• Omnicell: automated medication dispensing cabinet system that utilizes medication tech to streamline medication dispensing, track inventory, and reduce medication errors

• Reorder point: the level of inventory at which a business should place a new order to avoid running out of stock

Medication/Patient Safety

• Root Cause Analysis: process of identifying what the underlying cause was for the medication error

• MTR(medication therapy review): pharmacists assist the patient medication list to see if there is any problems(basically a consultation)

• DAR (Data, Action, and response): basically a documentation method to track medication safety, patient monitoring, and clinical pharmacy practice

• DRUG RECALLS:

  • Class I (most severe): dangerous or defective that poses serious health risk or death to consumer

  • Class II (temporary health risk): causes temporary health problems and have a slightly adverse reaction on health

  • Class III (least risk): unlikely to cause any adverse health effects

PHARMACOLOGY

• Side effects of Anticholinergic drugs: Blurred vision, urinary retention, and dry mouth

• Protease inhibitors treat: HIV/AIDS, Covid-19, and Hepatitis C

• Potassium Sparing diuretics(does not deplete the body of potassium): Spironolactone, Eplerenone, and Amiloride

• Parkinson’s Disease: This affects movement, balance, and coordination( and Dopamine is involved with this disease (dementia and sleep disorders are caused by this)

• MAOI: Monoamine Oxidase Inhibitor; antidepressant

  • Body can’t break down tyramine if MAOIs are present, so it could lead to a dangerous spike in blood pressure

• Z-Drugs: These are prescribed short term and include Zolpidem, Zoplicone, Zaleplon and treat insomnia

• BUD (beyond use dates): Date/time when the compounded sterile prep may not be stored or transported anymore

• Long Acting Insulin: Insulin Detemir (Levemir) and Insulin Glargine (Lantus)

• Both albuterol and salmeterol are bronchodilators that relaxes airway muscles and opens the lungs

• Nitrofurantoin turns the urine Dark yellow or brown.