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Sunday, March 29, 2020

PTCB - Chapter 18 - Common Drugs and Their Uses - Key Concepts

Drug Names and Classes
- A drug's name begins with a chemical name
- Marketed drugs under patent protection have one nonproprietary or generic name and one proprietary or brand name
- The United States Adopted Names Council (USAN) designates the official nonproprietary names for drugs

Classification Schemes
- There are various systems for classifying drugs: by disorder, body system affected, type of receptor acted on, type of action, etc

Analgesics
- Analgesic drugs create a state in which the pain from a painful medical condition is reduced or not felt
- Common types of analgesics include salicylates, acetaminophen, nonsteroidal anti-inflammatory, and opiate type

Anesthetic Agents
- Anesthetics cause an absence of sensation or pain
- Anesthetics are classified as local or general
- Local anesthetics block pain conduction without causing a loss of consciousness
- General anesthetics are administered by inhalation or intravenously by an anesthesiologist and depress the central nervous system to the level of unconsciousness

Anti-infectives
- Anti-infectives treat diseases produced by microorganisms such as bacteria, viruses, fungi, protozoa, and parasitic worms

Antineoplastics
- Antineoplastics inhibit new growth of cancer cells
- Side effects caused by many antineoplastic agents are often uncomfortable and serious
- Pharmacists and pharmacy technicians must be very careful with all calculations associated with drugs that are used to treat cancer

Cardiovascular Agents
- Cardiovascular agents include antianginals, antiarrhythmics, antihypertensives, vasopressors, antihyperlipidemics, thrombolytics, and anticoagulants

Dermatologicals
- The skin is the body's protective barrier and is the largest organ of the body
- Dermatologicals are drugs used to treat diseases or conditions related to the skin

Electrolytic Agents
- Electrolytes are water soluble substances that are contained in our body fluids as salts
- Electrolyte balance is important for healthy body function

Gastrointestinal and Urinary Tract Agents
- Gastrointestinal agents are used to treat disorders of the stomach and/or intestines
- Urinary agents are used to treat conditions affecting the flow of urine

Hematological Agents
- Each stage in the formation of blood clots can be affected by intrinsic clotting factors and drugs
- Hematopoietics are drugs that treat various forms of anemias
- Hemostatic drugs are used to treat or prevent excessive bleeding

Hormones and Modifiers
- Hormones are secreted by glands of the endocrine system
- The pancreas secretes the hormones insulin and glucagon. Insulin and glucagon are involved in regulating serum glucose.

Immunobiologic Agents and Vaccines
- Immune globulins provide passive immunity
- Vaccines provide active immunity
- Immune globulins provide a shorter period of protection than vaccines

Musculoskeletal Agents
- Musculoskeletal agents are used to treat rheumatoid arthritis, osteoarthritis, gout, osteoporosis, and muscle spams

Neurological Agents
- Several common disorders are affected by abnormalities in neurotransmitter release and/or response and include Parkinson's disease, Alzheimer's disease, epilepsy, migraine headaches, multiple sclerosis, and attention deficit hyperactivity disorder

Ophthalmic and Otic Agents
- Ophthalmic agents are used to treat conditions such as glaucoma, eye infection, eye pain, and inflammation. They are also used for eye examinations and in preparation for surgery.
- Otic agents are used to treat conditions including accumulation of earwax and infections of the outer ear

Psychotropic Agents
- Psychotropic agents are used to treat conditions such as bipolar disorder, anxiety, depression, schizophrenia, and drug abuse

Respiratory Agents
- Common respiratory disorders include asthma, allergy, emphysema, croup, bronchitis, chronic obstructive pulmonary disease, and pneumonia

PTCB - Chapter 18 - Common Drugs and Their Uses - Definitions

STEM ------- DRUG CLASS
-alol               combined alpha and beta blockers (used for high BP)
-andr-             androgens
-anserin          serotonin 5-HT2 receptor antagonist
-arabine          antineoplastics (anticancer drugs)
-ase                 enzymes
-azepam          antianxiety agents (diazepam type)
-azosin            antihypertensive (prazosin type)
-bactam           beta-lactamase inhibitors (penicillin and antibiotic)
-bamate           tranquilizers/antiepileptic
-barb                barbituric acid derivatives
-butazone         anti-inflammatory analgesics (phenylbutazone type)
-caine               local anesthetic
-cef                  cephalosporins (antibiotic)
-cillin               penicillins
-conazole         antifungals (miconazole type)
-cort-               cortisone derivatives (anti inflammatory)
-curium           neuromuscular blocking agent
-cycline           antibiotics (tetracycline)
-dralazine        antihypertensives (hydrazinephthalazines)
-erg-                 ergot alkaloid derivatives
estr-                  estrogens
-fibrate             antihyperlipidemics
-flurane            inhalation anesthetics
-gest-                progestins
-irudin              anticoagulants (hirudin tyoe)
-leukin             interleukin-2 derivative
-lukast             leukotriene antagonist
-mab                monoclonal antibodies
-mantadine      antivirals
-monam           monobactam antibiotics
-mustine          antineoplastics
-mycin             antibiotic
-olol                 beta-blockers
-olone               steroids
-oxacin             antibiotics (quinolone derivatives)
-pamide            diuretics (sulfamoylbenzoic acid derivative)
-pamil               coronary vasodilators
-parin                heparin derivative
-peridol             antipsychotics (haloperidol type)
-poetin              erythropoietins
-pramine           antidepressants (imipramine type)
-pred                 prednisone derivatives
-pril                   antihypertensives (ACE inhibitors)
-profen              anti-inflammatory/analgesic agents (ibuprofen type)
-rubicin             antineoplastic antibiotics (daunorubiein type)
-sartan               angiotensin II receptor antagonist
-sertron             serotonin 5-HT3 receptor antagonist
-sulfa                 antibiotics (sulfonamide derivatives)
-terol                 bronchodilators
-thiazide            diuretics (thiazide diuretics)
-tiazem              calcium channel blockers (diltiazem derivatives)
-tocin                 oxytocin derivatives
-trexate              antimetabolites (folic acid derivatives)
-triptyline          antidepressants
-vastatin             antihyperlipidemics (HMG-CoA inhibitors)

Homeostasis
- the state of equilibrium of the body

Neurotransmitter
- chemical released by nerves that interact with receptors to cause an effect

Blocker
- another term for antagonist drug, because antagonist block the action of neurotransmitters

Mimetic
- another term for an agonist, because agonists imitate, or "mimic", the action of the neurotransmitter

Type of Analgesics
- salicylates
- NSAIDs
- non-aspirin, non-NSAID
- opiates

Type of Anesthetic Agents
- local and general

Type of Anti-infectives
- antibiotics, antivirals, antifungals
- antimycobacterials, antiprotozoals, anthelmintics

Analgesic drugs create a state called analgesia.

Analgesia
- a state in which pain is not felt even though a painful condition exist.

Antipyretic
- reduces fever

Common Analgesic Drugs
TYPE ----------------------------- BRAND ------------------- GENERIC
Salicylates                                  Bayer                                acetylsalicylic acid (aspirin)
Non-aspirin, non-NSAID           Tylenol, Ofirmev              acetaminophen
NSAID                                        Motrin, Advil                   ibuprofen
NSAID                                        Naprosyn                          naproxen
Opiates                                        MS Contin                        morphine
Opiates                                        Demerol                           meperidine

Salicylates
- relieves mild to moderate pain
- anti-inflammatory
- antipyretic

Acetaminophen (non-aspirin, non-NSAID)
- relieves mild to moderate pain
- antipyretic

NSAID (nonsteroidal anti-inflammatory drug)
- more potent than salicylates
- relieve mild to moderate pain
- anti-inflammatory
- antipyretic

Opiate-type
- for severe pain
- addicting

Anesthetics cause an absence of sensation or pain.
Local anesthetics block pain conduction from peripheral nerves to the central nervous system (brain and stem) without causing a loss of consciousness.
General anesthetics depress the central nervous system to the level of unconsciousness

Common Local Anesthetic
TYPE ----------- BRAND ----------- GENERIC
Ester                  Novocain                procaine
Ester                  n/a                           tetracaine
Amide               Xylocaine                lidocaine
Amide               Marcaine                 bupivacaine
Other                 Sucrets                     dyclonine
* Cocaine first recognized local anesthetic. Schedule II.

Common General Anesthetics
TYPE ----------- BRAND ---------- GENERIC
inhalation           Forane                  isoflurane
inhalation           Ultane                   sevoflurane
inhalation           Suprane                 desflurane
IV                       Diprivan                propofol
IV                       Valium                   diazepam
IV                       Amidate                 etomidate

Four Stages of General Anesthesia
Stage 1 - Analgesia
-- euphoria with loss of pain and consciousness
Stage 2 - Excitement
-- increase in sympathetic nervous system effects such as blood pressure, heart and respiratory rate
Stage 3 - Surgical Anesthesia
-- the stage of anesthesia in which surgery can be safely conducted
Stage 4 - Medullary Paralysis
-- an overdose of anesthesia that paralyzes the respiratory and heart centers of the medulla, leading to death

Anti-infectives treat disease produced by microorganisms such as bacteria, viruses, fungi, protozoa, and parasitic worms.

Other forms of anti-infectives include:
- antimycobacterials (agents that treat tuberculosis, leprosy, and the MAC complex in AIDS)
- antiprotozoals (agents that treat malaria, vaginitis, and sleeping sickness)
- anthelmintics (agents that treat parasitic worms in the GI tract)

Types of antibiotic action
- damage bacterial cell wall (penicillins and cephalosporins)
- modify protein synthesis (erythromycin and tetracycline)
- modify energy metabolism (sulfonamides)
- modify DNA synthesis (ofloxacin and ciprofloxacin)

Classes of Anti-infectives
- antibiotics (antimicrobials)
   >>> suppress growth of other microorganisms
   >>> Alexander Fleming, penicillin
   >>> can either be bacteriostatic (inhibit bacterial growth or bactericidal (bacteria killing)
- antivirals
   >>> inhibit the replication of viruses
   >>> protease inhibitors - an antiviral used for HIV and hepatitis C that blocks the enzyme responsible for viral replication
- antifungals
   >>> treat fungal infections
   >>> fungal cell is destroyed as the drug prevents cell permeability and nutrition

Antineoplastics inhibit the new growth of cancer cells or neoplasms.

Neoplasm
- a new and abnormal tissue growth, often referring to cancer cells

Malignancy means a life threatening, cancerous group of cells or tumor is present.
Metastasis - when cancer cells spread beyond their original site.
Remission - a state in which cancer cells are inactive

Lymphocyte
- a type of white blood cells that helps the body defend against bacteria and diseased cells

Class of Antineoplastics
- Antimetabolites
  >>> inhibit cell growth and replication by mimicking natural metabolites and taking their place within the cells. Fake metabolites inhibit the synthesis of important cellular enzymes, including DNA
- Alkylating agents
  >>> interfere with mitosis or cell division by binding with DNA and preventing cellular replication
- Plant Alkaloids
  >>> derived from natural products or semisynthetically produced using natural products, some of these drugs inhibit the enzyme topoisomerase
  >>> Topoisomerase is required for molecular cell growth or mitosis and therefore certain plants alkaloids interfere with cellular DNA replication
- Hormones
   >>> hormone therapy can be used to treat certain cancers that require hormones to grow. Hormone therapy works by preventing cancer cells from using the hormones they need to grow
- Antitumor Antibiotics
  >>> drugs that interact directly with cancer cells to prevent the DNA from functioning normally
- Radioactive Isotopes
   >>> used to kill cancer cells in a targeted area

Same Common Antineoplastics
TYPE ------------------------------------------ BRAND ---------------- GENERIC
Antimetabolite                                            n/a                                 fluorouracil
Antimetabolite                                            Rheumatrex                  methotrexate
Alkylating agent/nitrogen mustard             Mustargen                     mechlorethamine
Alkylating agent/nitrosurea                        BiCNU                          carmustine
Plant alkaloid                                              n/a                                  vincristine
Plant alkaloid                                              n/a                                  vinblastine

Cardiovascular agents include antianginals, antiarrhythmics, antihypertensives, vasopressors, antihyperlipidemics, thrombolytics, and anticoagulants

Arrhythmia
- an abnormal heart rhythm

Electrocardiogram (EKG or ECG)
- a graph of the heart's rhythms

Cardiac cycle
- the contraction and relaxation of the heart that pumps blood through the cardiovascular system

Myocardium
- heart muscle

Thrombus
- a blood clot

Embolism, Embolus
- a clot that has traveled in the bloodstream to a point where it obstructs flow; blood clot

Systolic Pressure
- the maximum blood pressure when the heart contracts; the first number in a blood pressure reading

Diastolic Pressure
- the minimum blood pressure when the heart relaxes; the second number in a blood pressure reading

Classes of Cardiovascular Agents by mechanism of action
- beta blockers
   >>> reduce the oxygen demands of the heart muscle
   >>> used to treat high blood pressure or arrhythmias
- calcium channel blockers
   >>> relax the heart by reducing heart conduction
   >>> used to treat high blood pressure or arrhythmias
- diuretics
   >>> decrease blood pressure by decreasing blood volume
   >>> decrease volume by increasing the elimination of salts and water through urination
- ACE inhibitors
   >>> "-pril" drugs, ace inhibitors relax the blood vessels
- vasodilators
   >>> relax and expand the blood vessels

Some Common Cardiovascular Drugs by Mechanism of Action
TYPE ------------------------------ BRAND ------------------- GENERIC
beta blocker                                 n/a                                    propranolol
beta blocker                                 tenormin                          atenolol
beta blocker                                 corgard                             nadolol
beta blocker                                 Lopressor                         metoprolol
calcium channel blocker              calan                                verapamil
calcium channel blocker              Norvasc                            amlodipine
calcium channel blocker              Procardia                          nifedipine
calcium channel blocker              Cardizem                          diltiazem
diuretics                                        Lasix                                furosemide
diuretics                                        microzide                         hydrochlorothiazide
diuretics                                        Aldactone                         spironolactone
ACE inhibitor                               capoten                             captopril
ACE inhibitor                               Vasotec                             enalapril
ACE inhibitor                                Zestril                              lisinopril
vasodilator                                     n/a                                    hydralazine

Dermatologicals refers to a drug used to treat a condition or disease related to the skin

Integumentary system
- the body covering, ie, skin, hair, and nails

Electrolytes are water soluble substances that conduct an electric current as salts

Immune Globulins
- Pathogens for which animal antibodies may be used for immune globulins:
   >>> Diphtheria (using Antitoxin, USP)
   >>> Rabies (using Antirabies serum)
   >>> Botulism
   >>> Black Widow Spider Venom
- Human antibodies are used in immune globulins in the treat of:
   >>> measles
   >>> pertussis
   >>> mumps
   >>> tetanus
   >>> hepatitis A and B

Rheumatoid arthritis
- a disease in which the body's immune system attacks joint tissue

Gout
- a painful inflammatory condition in which excess uric acid accumulates in the joints

Uricosuric drugs
- drugs used to treat gout that increase the elimination of uric acid

Osteoarthritis
- a disorder characterized by weight bearing bone deterioration, decreasing rate of motion and causing pain and deformity

PTCB - Chapter 17 - Other Environments - Key Concepts

Mail Order Pharmacy
- Mail order pharmacy is used for maintenance therapy for such chronic conditions as depression, gastrointestinal disorders, heart disease, hypertension, and diabetes.
- Mail order pharmacies must follow federal and state requirements in processing prescriptions, but are not necessarily licensed in each state to which they send medications.
- Mail order pharmacies are generally large scale operations that are highly automated.
- Pharmacists review mail order prescriptions before and after filling.

Long Term Care
- Because of limited resources, most long term care facilities contract out dispensing and clinical pharmacy services.

Home Infusion
- Home care is supervised by a registered nurse who works with a physician, pharmacist, and others to administer a care plan that involves the patient or another caregiver.
- The fastest growing area of home health care is home infusion.
- Infusion pumps are available for specific therapies or multiple therapies, and include ambulatory pumps that can be worn by patients.
- In home infusion, the patient or caregiver is educated about the therapy: how to self administer, monitor, report problems, and so on.
- The primary therapies provided by home infusion services are: antibiotic therapy, parenteral nutrition, pain management, and chemotherapy.
- The same rules apply to preparing parenteral admixtures in the home setting as in the hospital.

Nuclear Pharmacy
- Nuclear pharmacies prepare radiopharmaceuticals that are used for diagnosis and treatment of disease.
- Nuclear pharmacies are typically located for easy access to hospitals and clinics where diagnostic testing is performed.
- Radiation safety is regulated on the federal level by the Nuclear Regulatory Commission (NRC) and the Department of Transportation (DOT).

PTCB - Chapter 17 - Other Environments - Definitions

Chronic condition
- a continuing condition that requires ongoing treatment for a prolonged period

Maintenance medication
- a medication that is required on a continuing basis for the treatment of a chronic condition

Acute condition
- a sudden condition requiring immediate treatment

Distributive pharmacist
- make sure long term care patients receive the correct medications order

Consultant pharmacist
- develops and maintains an individual pharmaceutical plan for each long term care patient

Automated dispensing system
- a system in which medications are dispensed from an automated unit at the point of use upon confirmation of an order communicated by computer from a central system

Home care agencies
- home nursing care business that provide a range of health care services, including infusion


Saturday, March 28, 2020

PTCB - Chapter 16 - Hospital Pharmacy - Key Concepts

Hospital Pharmacy
- Patient rooms are divided into groups called nursing units or patient care units; patients with similar problems are often located on the same unit.

Hospital Technician Roles
- Hospital pharmacy technicians have many roles and responsibilities and are often cross trained to work in different areas of the pharmacy.

Hospital Pharmacy Areas
- The inpatient pharmacy is responsible for medication preparation and distribution.

Hospital Formulary
- Since hospitals cannot stock every medication available, most have a hospital formulary, which is a list of medications the pharmacy keeps on its shelves and from which doctors can order.

Communications and Computer Systems
- There are several ways the pharmacy communicates with other areas of the hospital, including telephones, fax machines, computerized printouts, pneumatic tubes, and in person.

Medical Records
- Medical records are detailed chronological accounts of a patient's medical history and care received. The medical record may be in the form of a paper chart or electronic system.

Medication Orders
- In the hospital, all drugs ordered for a patient are written on a medication order form or are electronically entered through a computerized physician order entry (CPOE) system.

Order Processing
- When preparing a medication, the technician must pay close attention to the drug name, dosage form, concentration or strength, quantity, and expiration date; and for IV's, solution and volume.

Inventory Control
- To assist in the process of ordering inventory, par levels are assigned to each drug. Par is the quantity of drug that should be kept on the pharmacy shelf or in automated dispensing systems.

Organization of Medications
- In hospital pharmacies, medications are organized in alphabetical order using generic names.

Unit Dose System
- In the hospital, medications are often packed in individual packets that contain the amount of medication needed for each individual dose, unit dose.

Sterile Products
- Technicians may be responsible for preparing small and large volume parenteral, parenteral nutrition therapy, and chemotherapy.

General Hospital Issues
- Needles or other items that may cut or puncture the skin should always be thrown away in designated sharps containers.

Hospital Pharmacy Calculations
- Hospital pharmacy technicians perform many calculations on a daily basis, all of which are critically important to a patient's health and safety. Some examples include calculations for preparing small volume parenterals, calculations for timing medications, and flow rate calculation.


PTCB - Chapter 16 - Hospital Pharmacy - Definitions

Nurses' station
- work station for medical personnel located on a nursing unit

Inpatient pharmacy
- a pharmacy located in a hospital that services only those patients in the hospital and its ancillary areas

Pharmacy satellite
- a branch of the inpatient pharmacy responsible for preparing, dispensing, and monitoring medication for specific patient areas

Central Pharmacy
- the main inpatient pharmacy in a hospital that has pharmacy satellites
- it is the place where most of the hospital's medications are prepared and stored

Batching
- preparation of large quantities of unit dose oral solutions/suspensions or small volume parenteral for future use

Clean room
- area designed for the preparation of sterile products

Unit inspection
- a review of a nursing unit to ensure compliance with hospital medication policies

Outpatient Pharmacy
- a pharmacy attached to a hospital that services patients who have left the hospital or who are visiting doctors in a hospital outpatient clinic

Formulary
- a list of drugs stocked at the hospital that have been selected based on therapeutic factors as well as cost

Closed Formulary
- a type of formulary that requires physicians to order only those medications on the formulary list

Non-Formulary
- drugs not on the formulary list and not regularly stocked in the pharmacy

Therapeutic interchange
- a policy approved by the hospital P&T Committee that allows the pharmacist to change a medication order to a therapeutically equivalent formulary medication

Pneumatic tube
- a system that shuttles objects through a tube using compressed air as the force; commonly used in hospitals for delivery of medication

Electronic medical record (EMR) or electronic health record (EHR)
- a computerized patient medical record

CPOE
- a system in which the physician or agent of the physician enters directly into the hospitals computer system

Standing order
- a standard medication order for patients to receive medication at schedule intervals

PRN order
- an order for medication to be administered only on an as needed basis

STAT order
- an order for medication to be administered immediately

Medication administration record (MAR)
- a form that tracks the medications administered to a patient

Final filter
- a device used to remove particulate matter
- the filter should be placed at the end point of an IV line just before it enters a patient's vein

Drip rounds
- a process in which the pharmacy technician goes to specific nursing units to find out what IV drips will be needed later that day

Drug recall
- the voluntary or involuntary removal of a drug product by the manufacturer
- it usually only pertains to a particular shipment or lot number

Par
- the amount of drug product that should be kept on the pharmacy shelf
- each drug product may have a different par value
- par levels may also be assigned to drug products in automated dispensing cabinets

Emergency drug procurement
- to quickly obtain a medication not currently in stock in the pharmacy in situations where the drug is urgently needed

Extemporaneous compounds
- medications that must be prepared following a specific recipe or formula, usually because they are not available commercially

Bulk compounding log
- a record of medications that are compounded in the pharmacy for nonspecific patients
- information must include a list of all the ingredients, amounts used, manufacturer, lot numbers and expiration dates of each specific ingredient

Reconstitute
- addition of water or other diluent to commercially made drug bottles or vials in order to make a solution or suspension from a premade powder form of the drug
- include oral or parenteral drug

Unit dose
- a package containing the amount of a drug required for one dose

Automated dispensing system
- a system in which medications are dispensed from an automated unit at the point of use

IVPB (intravenous piggyback)
- a small volume parenteral that will be added into or "piggyback" into a large volume parenteral (LVP)

Total Parenteral Nutrition (TPN)
- protein, carbohydrates and essential nutrients to be given to the patient through an IV line

Epidural
- s sterile, preservative free medication administered into a patient's epidural space (located near the spinal cord and backbone)

Short stability
- medication that will expire soon after preparation (ie. within 1-6 hours after preparation)

Code Cart
- a locked cart of medications and other medical equipment designed for emergency use only


PTCB - Chapter 15 - Community Pharmacy - Key Concepts

Community Pharmacy
- In addition to prescription drugs, community pharmacies sell over the counter medications as well as other health and beauty products.
- The community pharmacist's role in counseling and educating patients has been steadily increasing.

Regulations
- Pharmacists and pharmacy technicians must be knowledgeable regarding the many federal and state regulations that affect the practice of pharmacy.

Organizations
- Pharmacies have basic space and equipment requirements that may vary slightly from state to state but generally include a prescription counter to work on, proper storage areas for drugs, designated refrigerators for drugs, equipment for compounding, a sink, computer system, and areas for dispensing prescriptions.

Customer Service
- Technicians should always response to customers in a positive and courteous way.

Processing Prescriptions
- In the case of a patient requesting an early refill of a controlled substance, involve the pharmacist right away.
- Processing new prescriptions involves entering patient information and prescription drug information, as well as billing information.

Preparing the Prescription
- Whenever the prescription system flags drug interactions and allergy conflicts, alert the pharmacist so that he or she can evaluate the significance of the flag.
- Every drug product has a unique, 11-digit national drug code (NDC) number that can used when filling a prescription to verify the correct product has been retrieved from stock.
- All dispensed prescription vials and bottles must have a safety cap or child resistant cap, unless the patient requests an easy open or non child resistant cap.
- Auxiliary labels identify important usage information, including specific warnings or alerts on: administration, proper storage, possible side effects, and potential food and drug interactions.
- As a final step of the preparation process, the final product and all paperwork, including the original prescription, is organized for the pharmacist's final check.

Customer Pick Up
- Customer signatures in a log are required for Medicaid and most third party insurers or HMO prescriptions, along with Schedule V controlled substances, poisons, and certain other prescriptions (depending upon the state).

Other Duties
- With the exception of behind the counter OTC medications, OTC products may be bought freely by customers, but they are not without risks. The technician may direct customers to a product but should involve the pharmacist when making recommendations.
- Ordering stock is often a responsibility of the pharmacy technicians.
- The pharmacy technician is generally responsible for keeping the pharmacy clean, neat, and in proper working order.

PTCB - Chapter 15 - Community Pharmacy - Definitions

Interpersonal skills
- skills involving relationships between people

Omnibus Budget Reconciliation Act (OBRA)
- federal legislation requiring pharmacists to provide counseling to Medicare patients receiving new prescriptions

Health Insurance Portability and Accountability Act (HIPAA)
- federal legislation designed to protect patients' personal and medical information and also to encourage use of electronic data interchange in the US

Medicare Prescription Drug Improvement and Modernization Act
- federal legislation that created Medicare Part D and made allowance for Medicare recipients to receive Medicare medical coverage through private health insurance plans

Combat Methamphetamine Act (CMEA)
- federal legislation enacted to regulate over the counter sales of ephedrine and pseudoephedrine

Red Flag Rule
- a set of provisions created by the Federal Trade Commission (FTC) to help prevent identity theft from patient billing accounts maintained by medical and financial institutions

Transaction windows
- counter areas designated for taking prescriptions and for dispensing them to patients

Safety cap
- a child resistant cap

Counting Tray
- a tray designed for counting pills from a stock bottle into a prescription vial

Kirby Lester
Automatic pill counting devices are frequently used to help a technician count medications.

Parata Max
Automated filling and dispensing machines
- automated machines that fill and label pill bottles with correct quantities of ordered drugs

Auxiliary labels
- labels regarding specific warnings, food or medications to avoid, potential side effects, and other cautionary interaction

Signature log
- a book which patients sign for the prescriptions they receive, for legal and insurance purposes; may be electronic

Markup
- the difference between the retailer's purchase price and their sale price

Shelf stickers
- stickers with bar codes that can be scanned for inventory identification

Unit price
- the price of a unit of medication, such as one ounce of a liquid cold remedy

Friday, March 27, 2020

PTCB - Chapter 14 - Financial Issues - Key Concepts

Financial Issues
- Third party programs are simply another party besides the patient or the pharmacy that pays for some or all of the cost of medication: essentially, an insurer.
- A pharmacy benefit manager (PBM) is a company that administers drug benefit programs for insurance companies, HMOs, and self-insured employers.
- Co-insurance is essentially an agreement between the insurer and the insured to share costs. One aspect of it is the requirement for patients to co-pay a portion of the cost of prescriptions.
- The amount paid by insurers for prescriptions is not equal to the retail price normally charged, but is determined by a formula described in a contract between the insurer and the pharmacy.

Third Party Programs
- Prescription drug benefit cards contain necessary billing information for pharmacies, including the patient's identification number, group number, and co-pay amount.
- HMOs usually will not cover expenses incurred outside their participating network and often require generic substitution.
- POSs often partially reimburse expenses incurred outside of their network and usually require generic substitution.
- PPOs usually require generic substitution.
- Workers' compensation is compensation for employees accidentally injured on the job.
- Medicare covers people age 65 and over, disabled people under age 65, and people with kidney failure.
- Medicaid is a federal-state program for the needy.

Online Adjudication
- In online adjudication, the technician uses the computer to determine the exact coverage for each prescription with the appropriate third party.
- When brand name drugs are dispensed, numbers corresponding to the reason for submitting the claim with brand name drugs are entered in a DAW (dispense as written) indicator field in the prescription system.

Rejected Claims
- Many prescription drugs plan have age limitations for children or dependents of the cardholder.
- Most third party plans require that most of the medication has been taken before the plan will cover a refill of the same medication.
- Many managed care health programs require mail order pharmacies to fill prescriptions for maintenance medications.

Other Billing Procedures
- When a claim is rejected, the pharmacy technician can telephone the insurance plan's pharmacy help desk to determine if the patient is eligible for coverage.
- Claims for disease state management services can be submitted using a paper system and often require follow up.


PTCB - Chapter 14 - Financial Issues - Definitions

Pharmacy benefit managers
- companies that administer drug benefit programs

Online adjudication
- the resolution of prescription coverage through  the communication of the pharmacy computer with the third party computer

Co-insurance
- an agreement for cost sharing between the insurer and the insured

Co-pay
- the portion of the price of medication that the patient is required to pay

Maximum allowable cost (MAC)
- the maximum price per tablet (or other dispensing unit) an insurer or PBM will pay for a given product

Usual and customary (U&C) or (UCR) usual, customary, reason
- the maximum amount of payment for a given prescription, determined by the insurer to be a usual and customary (and reasonable) price

Dual co-pay
- co-pays that have two prices: one for generic and one for brand medications

Deductible
- a set amount that must be paid by the patient for each benefit period before the insurer will cover additional expenses

Prescription drug benefit cards
- cards that contain third party billing information for prescription drug purchases

Formulary
- a list of medications covered by third party plans

Tier
- categories of medications that are covered by third party plan

HMO
-  a network of providers for which costs are covered inside but not outside of the network

POS
- a network of providers where the patient's primary care physician must be a member and costs outside the network may be partially reimbursed

PPO
- a network of providers where costs outside the network may be partially reimbursed and the patient's primary care physician need not be a member

Medicare
- a federal program providing health care to people with certain disabilities or who are over age 65; it includes basic hospital insurance, voluntary medical insurance, and voluntary prescription drug insurance

Medicaid
- a federal-state program, administered by the states, providing  health care for the needy

Workers' compensation
- an employer compensation program for employees accidentally injured on the job

Patient assistance program
- manufacturer sponsored prescription drug programs for the needy

Online Claim Information
1) cardholder identification number; group number
2) patient name; birth date; sex (M or F)
3) relationship to cardholder
4) date Rx written; date Rx dispensed; new/refill prescription
5) national drug code (NDC) of drug;  DAW indicator
6) amount/quantity dispensed; days supply
7) identification number of prescribing physician
8) identification of pharmacy/National Provider Identification (NPI)
9) ingredient cost; dispensing fee; total price
10) deductible or co-pay amount; balance due

DAW Indicators
-- typical
       0 = No DAW (No Dispense As Written)
       1 = DAW handwritten on prescription by prescriber
       2 = Patient requested brand
-- not typical
       3 = Pharmacist selected brand
       4 = Generic not in stock
       5 = Brand name dispensed but priced as generic
       6 = n/a
       7 = Substitution not allowed; brand mandated by law
       8 = Generic not available
       9 = Other

Universal Claim Form (UCF)
- a standard claim form accepted by many insurers

CMS-1500 form
- the standard form used by health care providers to bill for services, including disease state management services

Medication Therapy Management (MTM) services
- services provided to some Medicare beneficiaries who are enrolled in Medicare Part D and who are taking multiple medications or have certain disease

Prescription Drug Plans (PDPs)
- third party programs for Medicare Part D

National Provider Identifier (NPI)
- the code assigned to recognized health care providers; needed to bill MTM services

CMS-10114 form
- the standard six page form used by health care providers to apply for a national provider identifier (NPI)

Current Procedural Terminology codes (CPT codes)
- identifiers used for billing pharmacist-provided MTM services

PTCB - Chapter 13 - Inventory Management - Key Concepts

Inventory Management
- Good inventory management ensures that drugs that are likely to be needed are both on hand and usable - that is, not expired, damaged, contaminated, or otherwise unfit for use.
- An open formulary is one that allows purchase of any medication that is prescribed. A closed formulary is a limited list of approved medications.
- Formularies must be routinely reviewed to evaluate newer products as well as safety profiles for current medications.
- More than three quarters of pharmaceutical manufacturers' sales are directly to drug wholesalers, which in turn resell their inventory to hospitals, pharmacies, and other pharmaceutical dispensers.

Inventory Systems
- A perpetual inventory system maintains a continuous record of every item in inventory so that it always shows the stock on hand.
- Turnover is the rate at which inventory is used.
- Pharmacy operations generally use a point of sale system in which the item is deducted from inventory as it is sold or dispensed.
- Drug reorder points are maximum and minimum inventory levels of each drug.
- Important reports (especially purchase orders) should be regularly printed out and filed as hard copy both for convenience and as a backup record keeping system.

Computers and Inventory
- Pharmacy computer files must be regularly backed up or copied to an appropriate storage media.
- In a computerized inventory system, orders can be generated using an order entry device or automatically generated by the system based on stock levels and reorder points.

Ordering
- In an online ordering system, if an order can be filled as ordered a message from the supplier will automatically confirm the order to the ordering system. The system automatically assigns to each order a purchase order number for identification.
- Schedule II substances require a special order form for reordering.
- Controlled substances are shipped separately and should be checked in by a pharmacist.
- Material Safety Data Sheet (MSDS) for hazardous substances such as chemotherapeutic agents indicate when special handling and shipping is required.
- Good ordering practices assign separate personnel for ordering and receiving steps or processes.

Stocking and Storing
- Most medications are received from the supplier in bulk stock bottles.
- Drugs must be stored according to manufacturer's specifications.
- Most drugs are kept in a fairly constant room temperature of 59-86 degree F. The temperature of refrigeration should generally be 36-46 degree F.
- Schedule II substances may be stocked separately or with regular stock; their stock must be continually monitored and documented.
- Medications should be organized in a way that will dispense the oldest items first.
- In hospitals and other settings, medications are stocked in dispensing units throughout the facility that may be called supply stations or automated dispensing machines.

PTCB - Chapter 13 - Inventory Management - Definitions

Closed Formulary
- a limited list of approved medications

Formulary
- a list of medications approved for use

Inventory
- a list of goods or items a business uses in its normal operations

Open Formulary
- a system that allows a pharmacy to use any prescribed medication

Therapeutic Equivalent
- pharmaceutical equivalents that produce the same effects in patients

Perpetual Inventory
- a system that maintains a continuous record of every item in inventory so that it always shows the current amount of stock on hand

Turnover
- the rate at which inventory is used, generally expressed in number of days

Point of Sale (POS) System
- an inventory system in which the item is deducted from inventory as it is sold or dispensed

Reorder Points
- minimum and maximum stock levels that determine when a reorder is placed and for how much

Database
- a collection of information structured so that specific information within it can easily be retrieved and used

Automated Dispensing Machine
- a device that dispenses medications at point-of-use upon confirmation of an order that has been communicated from a centralized computer system

Material Safety Data Sheet (MSDS)
- OSHA required notices on hazardous substances that provide hazard, handling, clean up, and first aid information

Purchase order number
- the number assigned to each order for identification

Unit-dose packaging
- a package containing a single dose of a medication

Most drugs are kept in a fairly constant room temperature of 59-86 degree F. For most medications, the bar code includes the products NDC number, which in turn identifies the product and package size.

Refrigeration
Some drugs must be stored at a constant temperature in a controlled commercial refrigerator or freezer designed for medications. These units have internal gauges mounted on the outside for monitoring.
Refrigeration temperatures should be generally 36-46 degree F.

Thursday, March 26, 2020

PTCB - Chapter 12 - Information - Key Concepts

Information
- Primary literature provides direct access to the most current contemporary research. Secondary literature primarily consists of general reference works based upon primary literature sources. Tertiary literature sources contain condensed information based on primary literature.
- OSHA requires pharmacies to have Material Safety Data Sheets (MSDS) for all their hazardous chemicals.
- The USP-NF Chapters < 1 > through < 999 > are enforced by the FDA.
- State laws and State Board of Pharmacy rules and regulations require pharmacies to maintain specific professional literature references.

Common References
- Drug Facts and Comparisons (DFC) is a preferred reference for comprehensive and timely drug information, containing information about prescription and OTC products.
- Martindale, The Complete Drug Reference provides the best source of information about drugs in clinical use internationally.
- AHFS is accepted as the authority for drug information questions. It groups drug monographs by therapeutic use and provides off label medication uses.
- The "Orange Book" is the common name for the FDA publication titled "Approved Drug Products with Therapeutic Equivalence Evaluations".
- The Handbook on Injectable Drugs is a collection of monographs on commercially available parenteral drugs that include concentration, stability, dosage, and compatibility information.
- The Red Book: Pharmacy's Fundamental Reference is the pharmacist's guide to products and prices and provides annual price lists of drug products, as well as manufacturer, package size, strength, and wholesale and retail prices.
- PDR provides FDA regulation information about prescription drugs similar to the manufacturer's drug package inserts.

Other References
- Today's Technician, a professional practice journal, is the official publication of the NPTA.
- The Pharmacist's Letter provides recommendations on new developments in drug therapy.

Technician References
- The Pharmacy Technician Certification Board (PTCB) administers the National Pharmacy Technician Certification Exam (PTCE). The PTCB website at www.ptcb.org provides information regarding exam application and preparation.
- Once certified as a pharmacy technician, the PTCB requires you to obtain 20 hours of continuing education credit every two years to maintain your certification. At least one of the 20 hours must be in pharmacy law.

The Internet
- The Internet is a super network, with many networks from around the world all connected to each other and all using a common language.
- A search engine such as Google will search the web for specific information you enter.
- A browser such as Internet Explorer, allows you to view websites.

PTCB - Chapter 12 - Information - Definitions

Primary Literature
- original reports of clinical trials, research, and case studies; use for the most up to date information

Secondary Literature
- general reference works based upon primary literature sources; use to find primary literature

Tertiary Literature
- condensed works based on primary literature (e.g. textbooks); use to find background information or a summary of information

Abstracting Services
- services that summarize information from various primary sources for quick reference

Health Insurance Portability and Accountability Act (HIPAA)
- a federal law created to protect the privacy of patient health records

Off label indication
- a use of a medication for an indication not approved by the FDA

Orange Book
- the common name for the FDA's Approved Drug Products with Therapeutic Equivalence

Common References
1) AHFS Drug Information (www.ahfsdruginformation.com)
----- use AHFS when investigating off label medication indications (ie. an indication not approved by the FDA)
2) Martindale, The Complete Drug Reference
----- use Martindale to research foreign drugs
3) The Merck Index (www.merckmanuals.com)
----- use The Merck Index when information on chemical attributes of drug is needed
4) Physicians' Desk Reference (PDR) (www.pdr.net)
----- the information is similar to pharmaceutical manufacturers' drug package inserts since manufacturers prepare the essential drug information found in the PDR
5) Drug Facts and Comparison (DFC) (www.factsandcomparisons.com)
----- it is used to compare medications in the same therapeutic class
6) American Drug Index
----- use this reference to find trade and generic names
7) Handbook on Injectable Drugs (www.ashp.org)
----- it includes information on preparation, storage, administration, compatibility and stability of injectable drugs
8) King's Guide to Parenteral Admixtures (www.kingguide.com)
----- this reference provides information on injectable drug compatibility and stability, updated quarterly
9) Red Book: Pharmacy's Fundamental Reference (www.redbook.com)
----- it provides the latest pricing information, including nationally recognized AWP's and suggested retail prices for OTC products
10) Orange Book (www.accessdata.fda.gov/scripts/cder/ob/default.cfm)
----- Orange Book is the common name for the FDA's Approved Drug Products with Therapeutic Equivalence Evaluations. Use the Orange Book to determine the therapeutic equivalence of a brand and generic drug
11) Purple Book
----- biosimilar products of Biotech products

PTCB - Chapter 11 - Factors Affecting Drug Activitiy - Key Concepts

Human Variability
- Differences in age, weight, genetics, and genders are among the significant factors that influence the differences in medication responses among people.
- Drug distribution, metabolism, and excretion are quite different in the neonate and infant than in adults because their organ systems are not fully developed
- Children metabolize certain drugs more rapidly than adults
- The elderly typically consume more drugs and have a higher incidence of drug interactions than other age groups. They also experience more physiological changes that significantly affect drug action.
- Genetics can cause differences in the types and amounts of proteins produced in the body, which can result in different responses to the same drug at the same dose.

Disease States
- The disposition and effect of some drugs may be altered in one patient but not another by the presence of disease. Such changes are well documented in cardiovascular, hepatic, renal, and thyroid disease.

Adverse Drug Reactions
- Almost any drug, in almost any dose, can produce an allergic or hypersensitive reaction in a patient. Anaphylactic shock is a potentially fatal hypersensitivity reaction.
- Anorexia, nausea, vomiting, constipation, and diarrhea are among the most common adverse reactions to drugs in the GI tract.

Drug-Drug Interactions
- Many drug-drug interactions affect the disposition of one drug and result in either an increased or decreased effect.
- Decreased intestinal absorption of oral drugs occurs when drugs complex to produce nonabsorbable compounds.
- Displacement of one drug from protein binding sites by a second drug increases the effects of the displaced drug.
- Drugs that induce liver metabolism may also increase metabolism of other drugs that use the same metabolizing enzymes.
- Some drugs increase excretion by altering urinary pH and lessening renal reabsorption.
- Some drug-drug interactions do not alter a drug's disposition but interact at the site of action.
- Additive effect occur when two drugs with similar pharmacological actions result in an effect equal to the sum of the individual effects.
- Synergism occurs when two drugs with similar pharmacological actions produce greater effects than the sum of the individual effects.
- Potentiation occurs when one drug with no inherent activity of its own increases the activity of another drug that produces an effect.

Drug-Diet Interactions
- Dietary intake can influence drug action by altering one or all of the ADME processes.
- Some foods contain substances that react with certain drugs, e.g., foods containing tyramine can react with monoamine oxidase (MAO) inhibitors.


PTCB - Chapter 11 - Factors Affecting Drug Activity - Definitions

Pharmacogenomics
- a field of study that defines the hereditary basis of individual differences in absorption, distribution, metabolism, and excretion (the ADME processes)

Cirrhosis
- a chronic liver disease causing loss of function

Obstructive jaundice
- an obstruction of the bile duct that causes hepatic waste products and bile to accumulate in the liver

Acute Viral Hepatitis
- an inflammatory condition of the liver caused by viruses

Hypothyroidism
- a condition in which thyroid hormone secretions are below normal, often referred to as an underactive thyroid

Hyperthyroidism
- a condition in which thyroid hormone secretions are above normal, often referred to as an overactive thyroid

Adverse Drug Reaction
- an unintended side effect of a medication that is negative or in some way injurious to a patient's health

Carcinogenicity
- the ability of a substance to cause cancer

Idiosyncrasy
- an unexpected reaction the first time a drug is taken, generally due to genetic causes

Hypersensitivity
- an abnormal sensitivity generally resulting in an allergic reaction

Anaphylactic shock
- a potentially fatal hypersensitivity reaction producing severe respiratory distress and cardiovascular collapse

Complexation
- when two different molecules associate or attach to each other

Displacement
- a drug that is bound to a plasma protein is removed when another drug of greater binding potential binds to the same protein

Enzyme Induction
- the increase in hepatic enzyme activity that results in greater metabolism of drugs

Enzyme Inhibition
- the decrease in hepatic enzyme activity that results in reduced metabolism of drugs

Additive Effects
- the summation in effect when two drugs with similar pharmacological actions are taken

Synergism
- when two drugs with similar pharmacological actions produce greater effects than the sum of individual effects

Potentiation
- when one drug with no inherent activity of its own increases the activity of another drug that produced an effect

Antidote
- a drug that antagonizes the toxic effect of another

Drug-Drug Interactions examples
- Additive effects
      trimethoprim + sulfamethoxazole for antibiotic effect
      amiodarone + dofetilide for prolongation of hearts QT interval
- Synergism
      aspirin + warfarin = increased anticoagulation (bleeding)
      vancomycin + gentamicin = increased antibacterial effects of gentamicin
- Potentiation
      amoxicillin + clavulanic acid = increased duration of amoxicillin's antibiotic effect
      penicillin + probenecid = increased duration of penicillin's antibiotic effect
- Antidote
      naloxone + morphine = relief of morphine induced respiratory depression
      vitamin K + warfarin = opposition of the anticoagulant effect of warfarin and a return to normal blood clotting time

Drug-diet Interactions
- when elements of ingested nutrients interact with a drug and this affects the disposition of the drug


Saturday, March 14, 2020

PTCB - Chapter 10 - Basic Bio Pharmaceuticals - Key Concepts

How Drugs Work
- The objective of drug therapy is to deliver the right drug, in the right concentration, to the right site of action, and at the right time to produce the desired effect
- Only those drugs able to interact with the receptors in a particular site of action can produce effects in that site. This is why specific cells respond only to certain drugs

Concentration and Effect
- To produce an effect, a drug must achieve a minimum effective concentration (MEC). This is when there is enough drug at the site of action to produce a response
- The range between the minimum effective concentration and the minimum toxic concentration is called the therapeutic window. When concentrations are in this range, most patients receive the maximum benefit from their drug therapy with a minimum of risk
- Therapeutic drug monitoring can be useful when the blood concentration of the drug reflects the concentration at the site of action

ADME Processes and Diffusion
- Blood concentrations are the result of four simultaneously occurring processes: absorption, distribution, metabolism, and excretion (the ADME processes)
- Besides the four ADME processes, a critical factor in drug concentration and effect is how drugs move through biological membranes. Most drugs penetrate biological membranes by passive diffusion

Absorption
- One of the primary factors affecting oral drug absorption is the gastric emptying time

Distribution
- Many drugs bind to proteins in blood plasma to form a complex that is too large to penetrate biological membranes, essentially making the drug inactive

Metabolism
- Enzymes catalyze the transformation of drugs to metabolites. Most metabolites are inactive molecules that are excreted

Excretion
- The kidneys filter blood and remove wastes, drugs, and metabolites from the body
- Urinary excretion = glomerular filtration + renal secretion - urinary reabsorption

Bioavailability
- The amount of a drug that is delivered to the site of action and the rate of which it becomes available is called the bioavailability of the drug

Bioequivalence
- Bioequivalent drug products are pharmaceutical equivalents or alternatives that have essentially the same bioavailabilities (ie. rate and extent of absorption) when administered in the same dose of the active ingredient under similar conditions
- Pharmaceutical equivalents  are drug products that contain identical amounts of the same active ingredient in the same dosage form, but may contain different inactive ingredients
- Pharmaceutical alternatives are drug products that contain the identical active ingredient, but not necessarily in the same salt form, same amount, or dosage form

PTCB - Chapter 10 - Basic Bio Pharmaceuticals - Definitions

Agonist
- drugs that activate receptors to accelerate or slow normal cellular function

Antagonist
- drugs that bind with receptors but do not activate them
- they block receptor action by preventing other drugs or substances from activating them

Receptor
- the cellular material located at the site of action that interacts with the drug

Selective (action)
- the characteristic of a drug that makes its action specific to certain receptors and tissues

Site of action
- the location where an administered drug produces an effort

Duration of action
- the time drug concentration is above the MEC

Minimum Effective Concentration (MEC)
- the blood concentration needed for a drug to produce a response

Minimum Toxic Concentration (MTC)
- the upper limit of the therapeutic windows
- drug concentrations above the MTC increase the risk of undesired effects

Onset of action
- the time MEC is reached and the response occurs

Therapeutic window
- a drug's blood concentration range between its MEC and MTC

Active transport
- the movement of drugs from an area of lower concentration to an area of higher concentration; cellular energy is required

Disposition
- a term sometimes used to refer to all of the ADME processes together

Elimination
- the processes of metabolism and excretion

Hydrophilic
- capable of associating with or absorbing water

Hydrophobic
- water repelling; cannot associate with water

Lipoidal
- fat like substance

Passive diffusion
- the movement of drugs from an area of higher concentration to lower concentration

ADME
- blood concentrations are the result of four simultaneously occurring processes
- absorption, distribution, metabolism, excretion

Absorption
- the movement of a drug from the dosage formulation to the blood

Gastric emptying time
- the time a drug will stay in the stomach before it is emptied into the small intestine

Complexation
- when different molecules associate or attach to each other

Protein binding
- the attachment of a drug molecule to a plasma or tissue protein, effectively making the drug inactive, but also keeping it within the body

Enterohepatic cycling
- the transfer of drugs and their metabolites from the liver to the bile in the gallbladder, then into the intestine, and then back into circulation

Enzyme
- a complex protein that catalyzes chemical reactions

Enzyme induction
- the increase in hepatic enzyme activity that results in reduced metabolism of drugs

First pass metabolism
- the substantial degradation of an orally administered drug caused by enzyme metabolism in the liver before the drug reaches the systemic circulation

Metabolite
- the substance resulting from the body's transformation of an administered drugs

Glomerular filtration
- the blood filtering process of the nephron

Nephron
- the functional unit of the kidney

Absolute bioavailability
- the bioavailability of a drug product compared to the same drug in a rapidly administered IV solution

Bioavailability
- the amount of an administered dose that reaches the general circulation and the rate at which this occurs

Relative bioavailability
- the bioavailability of a drug product compared to the same drug in any other dosage form than a rapidly administered IV solution

Bioequivalency
- the comparison of bioavailability between two dosage forms

Pharmaceutical alternative
- drug products that contain the same active ingredient, but not necessarily in the same salt form, amount, or dosage form

Pharmaceutical equivalent
- drug products that contain identical amounts of the same active ingredient in the same dosage form

Therapeutic equivalent
- pharmaceutical equivalents that produce the same effects in patients

Thursday, March 12, 2020

PTCB - Chapter 9 - Parenterals: Compounding Sterile Formulations - Key Concepts

Compounding Sterile Formulations
- Parenteral solutions must be sterile, free of all visible particulate material, pyrogen free, stable for their intended time of use, be isotonic, and in most cases (but not all) have a pH around 7.4

LVP Solutions
- Large volume parenteral (LVP) are 100mL or more and come in plastic bags or glass bottles

SVP Solutions
- when a drug is added to a parenteral solution, the drug is referred to as the additive, and the final mixture is referred to as the admixture

Special Solutions
- Parenteral nutrition solutions are complex admixtures composed of dextrose, fat, protein, electrolytes, vitamins, and trace elements used to meet a patient's nutritional needs

Administration Devices
- LVP solutions are usually administered with an administration set. In addition to the basic components (tubing, spikes, clamps, needle adapters), administration sets may have drip chambers, volume control chambers, and Flashballs
- Parenteral administration devices use either gravity or a pump to push the solution into the patient

Laminar Flow Hoods
- A laminar flow hood establishes and maintains an ultraclean work area for preparing parenteral solutions

Biological Safety Cabinets and Clean Rooms
- Chemotherapy agents are to be made in a biological safety cabinet, not a laminar flow hood
- Clean rooms are isolated rooms that house laminar flow hoods and biological safety cabinet; however, clean rooms that meet ISO Class 5 standards do not need a hood or cabinet

Aseptic Techniques for Hoods and Cabinets
- Aseptic techniques maintain the sterility of all sterile items and are used in preparing admixtures

Working with Vials
- There is the potential of coring the rubber stopper of a vial when inserting a needle

Working with Ampules
- Ampules may be pre-scored by the manufacturer or need to be scored with a file

Syringes and Needles
- Syringes come in sizes ranging from 1 to 60 mL
- Needle sizes are indicated by length and gauge. Large needle lumens may be needed for highly viscous solutions but are more likely to cause coring

Filters
- Syringe filters are used to remove particular materials or microorganisms from parenteral solutions

Quality Assurance and Infection Control
- A significant part of preparing parenteral solutions is to have and follow environmental quality and infection control plan
- Drugs and supplies used in making parenteral solutions should be disposed of properly. This may involve using a sharps container, or following procedures prescribed by the EPA and local landfill requirements

Parenteral Incompatibilities
- An incompatibility can exist between the drugs in an admixture or between a drug and the base IV solution

Units of Measurement
- Equivalent (Eq/L) or milliequivalent (mEq/L) concentrations are commonly used to describe concentrations of electrolytes in parenteral solutions
- Percentage concentrations refer to the drug's weight per 100 mL if the drug is a solid, or the drug's volume per 100 mL if the drug is a liquid


PTCB - Chapter 9 - Parenterals: Compounding Sterile Formulation - Definitions

Aseptic techniques
- technique or methods that maintain the sterile condition of products

Hypertonic
- when a solution has a greater osmolarity than that of blood

Hypotonic
- when a solution has a lesser osmolarity than that of blood

Isotonic
- when a solution has an osmolarity equivalent to that of blood

Osmotic Pressure
- a characteristic of a solution determined by the number of dissolved particles in it

Pyrogens
- chemicals produced by microorganisms that can cause pyretic reactions (fever) in patients

Special requirements for Parenteral Dosage Form
1. solutions must be sterile - i.e. free from bacteria and other microorganism
2. solutions must be free of all visible particulate material
3. solutions must be pyrogen free
4. the solution must be stable for its intended use
5. the pH of an IV solution should not vary significantly from physiological pH, about 7.4
6. IV solutions should be formulated to have an osmotic pressure similar to that of blood

Compounded Sterile Preparation (CSP)
- a compounded sterile parenteral dosage form that will be parenterally administered

Additive
- a drug that is added to a parenteral solution

Admixture
- the resulting solution when a drug is added to a parenteral solution

Diluent
- a solvent that dissolves a lyophilized powder or dilutes a solution

Lyophilized
- freeze dried

Ready to mix
- a specially designed minibag by which a drug is put into the SVP just prior to administration

Total Parenteral Nutrition (TPN) solution
- complex solutions with two base solutions (amino acids and dextrose) and additional micronutrients
- they are hypertonic solutions

Total Nutrient Admixture (TNA) solution
- a TPN solution that contains IV fat emulsion.
- when IV fat emulsion is admixed with a TPN solution, the resulting solution is referred to as a TNA
- hypertonic solutions

Dialysis
- movement of particles in a solution through permeable membranes

Osmosis
- the action in which a drug in a higher concentration solution passes through a permeable membrane to a lower concentration solution

Peritoneal Dialysis Solution
- a solution placed in and emptied from the peritoneal cavity to remove toxic substances

Irrigation solution
- large volume splash solutions used during surgical or urologic procedures to bathe and moisten tissues
- washing out wounds

Flow rate
- the rate (in mL/hour or mL/minute) at which solution is administered to the patient

Flashball
- flexible rubber bulb near the needle adapter on an administration set; used to determine if the needle is properly placed in the vein

Piggybacks
- small volume solutions connected to an LVP

Heparin Lock
- an administration device used when a primary LVP solution is not available
- heparin lock is a short piece of tubing attached to a needle or IV catheter
when the tubing is not being used for the minibag, heparin is used to fill the tubing
- heparin prevents blood from clotting in the tubing

HEPA filter
- a high efficiency particulate air filter

Laminar flow
- continuous movement at a uniform rate in one direction

Horizontal flow head
- a laminar flow hood with horizontal air flow across the work area

Zone of turbulence
- an area of blocked air flow in a laminar flow hood

Vertical flow hood
- a laminar flow hood with vertical air flow across the work area

Coring
- when a needle damages the rubber closure of a parenteral container, causing fragments of the closure to fall into the container and contaminate its contents

Ampules
- sealed glass containers with an elongated neck that must be snapped off

Bevel
- an angled surface at the tip of a needle

Gauge
- a measurement with needles; the higher the gauge, the smaller the lumen

Hub
- the part of the needle that attaches to the syringe

Lumen
- the hollow center of a needle

Shaft
- the stem of the needle that provides the overall length of the needle

Slip-Tip, Luer-Lok, eccentric, oral
- different types of syringe tips

Depth filter
- a filter that can filter solutions being drawn into or expelled from a syringe, but not both ways in the same procedure

Membrane filter
- a filter that filters solution as the solution is expelled from the syringe

Final filter
- a filter placed immediately before a solution enters a patient's vein

Sharps
- needles, jagged glass or metal objects, or any items that might puncture or cut the skin

Anhydrous
- without water molecules

Equivalent weight
- a drug's molecular weight divided by its valence, a common measure of electrolyte concentration

Ions
- molecular particles that carry electric charges

Molecular weight
- the sum of the atomic weights of a molecular

Valence
- the number of positive or negative charges on an ion

Waters of hydration
- water molecules that attach to drug molecules