medical review

HEPA

High Efficiency Particulate Air

Local Hormones

Histamine • Local hormone found in all tissues of the body • Causes bronchial constriction, stomach acid secretion, blood vessel dilation, and local edema (swelling), pain, and itching Prostaglandins • A group of local hormones that cause a variety of local reactions • These hormones cause uterine and bronchial contractions and relaxation, decreased gastric secretions, pain, and inflammation

Military Time / International Time

Hospitals and institutional settings use military time. It is based on the full twenty-four hours of the day. The day starts at midnight as 0:00. This is especially important on BUD labels

NIOSH Requirements

In addition to facilities and equipment changes, one of the keys to assuring compliance with USP 800 is for pharmacies to conduct an in-depth assessment of all the HDs they deliver to patients. That assessment begins with reviewing the NIOSH alert that lists the HDs found in health care settings. The NIOSH list encompasses three groups of drugs: • Group 1: Antineoplastic (anticancer) drugs that may also pose a reproductive risk for susceptible populations. • Group 2: Nonantineoplastic drugs that meet one or more NIOSH criteria for an HD. Some of these may also pose a reproductive risk for susceptible populations. • Group 3: Drugs that primarily pose a reproductive risk to men and women who are actively trying to conceive and women who are pregnant or breast feeding

Added substances:

Ingredients that are necessary to compound a preparation but are not intended or expected to cause a pharmacologic response.

Injections

Injections go through one or more layers of the skin. It bypasses alimentary canal (digestive system). Uses • Correct electrolyte and fluid imbalances • Provide basic nutrition (TPN) • Vehicles for drugs

ISO

International Organization for Standardization

Total Parenteral Nutrition (TPN)

Intravenous Nutritional Solutions, containing • Amino acids (protein source) o Branched-chain (BCAA) o Essential o Non-essential o Mixed essential • High concentrations of dextrose (carbohydrate source) • Occasionally lipid emulsions (fat source) • Electrolytes • Vitamins • Trace elements • Sometimes insulin (Regular) Administration Time • Usually administered over 8-24 hours • Provides adequate caloric intake for those patients who are unable to receive proper nutrition orally due to their disease state. Route of Administration • Peripherally • Centrally Incompatibilities • Many additives increase potential for incompatibilities • Calcium and phosphorous precipitate are a major concern Compounding • If the pharmacy compounds more than 30 TPN orders daily, an Automix System will assist in preparation. Note: Considerations for TPNs go beyond the scope of this review!

IPA

Isopropyl Alcohol

Medication Errors

It is important to follow established policies and procedures because they formally establish a system to prevent the occurrence of medication errors.

Working in a Laminar Air Flow Hood

It is recommended by most policies and procedures that the laminar flow hood should be running for at least 30 minutes prior to use.

Maintaining Sterility, Purity, and Stability of Dispensed and Distributed CSPs

It is the responsibility of the compounding facility to maintain quality and control of CSPs that are dispensed and administered within their organization. There should be SOPs established by the compounding facility covering the following: • Packaging, handling, and transport • Use and storage • Readying for administration • Re-dispensed CSPs • Education and training • Storage in locations outside compounding facilities

Integumentary System/ Exocrine System

It protects the body from loss of water, abrasions, chemicals, and UV light. It consists of the skin, hair, nails, and sebaceous glands.

Refrigeration

- between 2 to 8 degrees C or 36 to 46 degrees F. o Temperatures must be checked and logged for refrigerators and freezers twice a day.

Stat

- emergency medication to be dispensed immediately

Syringe Sizes

-1 ml to 100 ml =General Rule: Always use a syringe closest to the amount of fluid that needs to be measured. This method produces a more accurate measurement. Example: If 8.5 ml is to be measured, use a 10 ml syringe instead of a 20 ml syringe

controlled release products

-Are medications which warrant more restrictive regulation because of their potential for addiction and abuse. -release a constant dose of medication over an extended period of time. -allows for consistent blood level over a longer duration and reduces the # of doses that must be taken.

Cleaning process

1. Deactivation: Render compound inert /inactive o Agent used: EPA registered oxidizers (peroxide formulations, sodium hypochlorite (Bleach) 2. Decontamination: Remove HD residue o Agent used: Alcohol, water, peroxide, sodium hypochlorite 3. Cleaning: Remove organic and inorganic material o Agent used: Germicidal detergent 4. Disinfection: Destroy Microorganisms o Agent used: EPA registered disinfectant, sterile alcohol Note: Agents for deactivating, decontaminating, cleaning, and disinfecting agents must be applied through the use of wipes not by a spray bottle to avoid spreading HD residue

Prior to Compounding

1. Remove rings, watches, and bracelets (ideal for bacteria) 2. Wash hands and forearms to the elbows with appropriate germicidal agent. This must be done for 30 seconds.

drugs are broken down into 4 groups:

1. non-presription drugs(otc drugs)- These are medications that the FDA has determined to be safe and effective for consumers to self-medicate when used as directed by the product labeling. An OTC (over the counter) drug is a drug that does not require any form of prescription. Often times, OTC drugs are prescribed by a physician. 2. prescription, or legend drugs- is a drug that requires a prescription. Prescription or legend drugs must be taken with the supervision of a physician and may be harmful if not monitored. These drugs also require a physician's drug order. 3. controlled substances/scheduled drugs- medications that warrant more restricted regulation because of their potential for addiction and abuse. ex: morphine 4. dietary supplements- not regulated by the fda because their suppliers do not make therapeutic claims. products are not reviewed for content, and have not been proven effective. ex: st johns wort

Component:

: Any ingredient used in the compounding of drug preparation, including any active ingredient or added substance that is used in its preparation.

Manufacturing

: the production, preparation, propagation, conversion, and/or processing of a drug or device, either directly or indirectly, through extraction from substances of natural origin or independently through means of chemical or biological synthesis; the term includes any packaging or repackaging of the substance(s) or labeling or relabeling of its container and the promotion and marketing of such drugs or devices.

Vehicle

A component for internal or external use that is used as a carrier or diluent in which liquids, semisolids, or solids are dissolved or suspended.

Bactericidal

Kills the microorganisms

Gout

A disease characterized by overproduction or insufficient elimination of uric acid within the body that will crystallize in the joints and cause pain and inflammation.

Drug - Food Interaction

A drug-food interaction may prevent a medicine from working properly, it may cause a side effect from a medicine to become worse, or it can cause a new side effect. • Grapefruit Juice o Grapefruit juice increases the absorption of certain drugs such as statins. • Green leafy vegetables o Green leafy vegetables eaten in excess can decrease the ability of blood-thinners to prevent clotting. • Salt Substitutes o Salt substitutes often replace sodium with potassium. This can be dangerous for people taking ACE inhibitors because with increased potassium consumption, the ACE inhibitor's effectiveness will be decreased causing heart failure.

Lot numbers

A lot number is an identification number assigned to a batch of medication. The lot number assists with drug manufacturing inventory control and if there is an adverse incident the lot number is used to trace the contaminated batch of medication.

Addiction

A pattern of compulsive use characterized by overwhelming involvement with drug use and abuse Example • Opiates • Alcohol • Nicotine

Compounder:

A professional authorized by the appropriate jurisdiction to perform compounding pursuant a prescription or medication order by a licensed prescriber.

Incompatibility

A reaction that occurs when one drug is mixed with one or more drugs and produces an unsuitable product. The new product becomes unsuitable for administration because the active ingredient has been modified or because a physical change has occurred. Example: Drug change could increase toxicity or change the solubility of the product

LAFW

Laminar Airflow Workbench

Risk-to-Benefit Ratio

A theoretical ratio that weighs risks vs. benefits Must be done on an individual basis Example: • Asthma patient should not be on a Beta blocker • Inderal

Arrhythmia

Abnormal heart rhythm or heartbeats occur and vary from the normal order sequence. This can reduce the heart's ability to pump blood.

ACPH

Air Changes Per Hour

Cross Sensitivity

Allergy to drugs that are chemically similar Example: Penicillin & Cephalosporin

Bacteriostatic

Allows the body's natural defense mechanisms to have time to destroy the microorganisms by inhibiting bacterial growth

Alzheimer's Disease

Alzheimer's disease is a form of dementia, a term used to describe a group of brain disorders that cause memory loss and a decline in mental function over time. Uses • Treat Alzheimer's disease Mechanism of Action • NMDA Receptor antagonists • Cholinesterase inhibitors Side Effects • Dizziness • Confusion • Insomnia • Nausea • Agitation • Coughing • Fatigue • Abnormal thinking Example: NMDA Receptor antagonists: • Memantine (Namenda), Legend Drug • Cholinesterase inhibitors: • Tacrine (Cognex), Legend Drug The use of Tacrine is limited by poor oral bioavailability, the necessity for four-times daily dosing and considerable adverse drug reactions (including nausea, diarrhea, urinary incontinence and hepatotoxicity) such that few patients could tolerate therapeutic doses. Newer cholinesterase inhibitors: • Donepezil (Aricept), Legend Drug • Rivastigmine (Exelon), Legend Drug • Galantamine (Razadyne), Legend Drug

ASHP

American Society of Health-System Pharmacists

Adverse Drug Event (ADE)

An adverse drug event, or ADE, is an unwanted result in taking a medication as directed. There are two types of reactions - Type A and Type B. Type A reactions usually depend on the dose taken and can range from mild to severe. Type B reactions have more to do with the individual patient, such as medicinal allergies or intolerances. These reactions cannot be predicted and are not related to the type or amount of medication give

Adverse Drug Reaction (ADE)

An adverse drug reaction is an undesired, unanticipated, or hazardous reaction to a drug

Dependence

An altered state where continued administration of the drug is necessary to prevent physical and psychological withdrawal systems

Active pharmaceutical ingredient (API):

Any substance or mixture of substances intended to be used in the compounding of a drug preparation,

Cardiac Glycosides

Are obtained from the digitalis plant and exert powerful action on the heart, they also increase the muscle's contraction and improve irregular heartbeats. Use • Congestive heart failure (CHF) • Some arrhythmias Mechanism of Action • Unknown, but cardiac glycosides increase the contraction of the heart Side Effects • Nausea/vomiting • Confusion • Arrhythmias Yellow/green halos • Low therapeutic index Examples: • Digoxin (Lanoxin® Digitek) - Legend Drug

ACD

Automated Compounding

Automatic stop orders

Automatic stop orders, also called automatic end times, auto stops, automatic stops, or automated stop orders, decrease unnecessary continued use of medication. They prevent unplanned consequences due to lack of suitable therapeutic review. An automatic stop order is a way of ensuring the prescribing physician reviews the patient's medications and determines if there is a need to continue treatment. No medication will be dispensed from the pharmacy until it is reordered by the physician

Bar Code Medication Administration (BCMA)

BCMA - barcode system designed to prevent medication errors in healthcare settings and improve the quality and safety of medication administration. The overall goals of BCMA are: • to improve accuracy • prevent errors • generate records of medication administration

Expiration Dates

Based on shelf-life Medication considered effective before the expiration date • Exp. 06/23 - Drug expires last day of June 2023 • Exp. 06/04/23 - Drug expires on June 4, 2023 Never dispense an expired product!

BUD

Beyond-Use Dating

BI

Biological Indicator

BSC

Biological Safety Cabinet

Parenteral Product Reference Materials

Books • Handbook on Injectable Drugs - Trissel • Guide to Parenteral Admixtures - King Information in References • Drug solution • Drug compatibility • Drug dosage • Drug dilution information

Compounding Documentation

Can be kept electronically or in a written log book

CDC

Centers for Disease Control and Prevention

Aseptic Technique

Certain procedures are carried out during the preparation of a sterile product in order to minimize contamination. Important characteristics when preparing an IV admixture in a laminar flow hood: • Sterility • Solubility • Stability Student note: Nosocomial simply means "taking place in a hospital". Nosocomial infection is "hospital borne" infection

Angina

Chest pain is caused by an insufficient amount of oxygenated blood reaching the heart muscle.

CSTD

Closed System Drug-Transfer Device

CSP

Compounded Sterile Preparation

USP 800 Risk Assessments

Consider the following during an assessment of risk: • Type of HD (e.g. antineoplastic, non-antineoplastic, reproductive risk only) • Dosage form • Risk of exposure • Packaging • Manipulation • If an assessment of risk approach is taken, must document what alternative containment strategies and/or work practices are being employed to minimize occupational exposure

Spirits and Essences

Contain substances that evaporate quickly in ambient conditions Keeping in airtight containers can prevent losses due to evaporation

C-PEC

Containment Primary Engineering Control

OSHA Regulations for Sharps

Contaminated sharps should be immediately disposed of in a designated sharps disposal container that is puncture-resistant. Sharps containers are usually red and have a biohazard symbol. The containers must be leak-proof on the sides and bottom. Containers should not be overfilled, they must be closable, and they must be replaced regularly. To prevent spilling the contents, sharps containers must be kept upright. Sharps disposal containers must be readily available and positioned as close as possible to the area where sharps will be used. Contaminated sharps must never be clipped or broken. Needles should not be recapped, bent or removed unless there is absolutely no other alternative. If recapping, bending, or removing of a needle must happen, the one-handed scoop technique should be used.

Coronary Artery Disease

Develops when the major blood vessels that supply the heart with blood, oxygen and nutrients become damaged or diseased. Cholesterol-containing deposits (plaque) in the arteries and inflammation are usually to blame for coronary artery disease.

Vaccination Schedule

Diphtheria, Tetanus, Pertussis (DTaP) Vaccination Age 6 weeks to 7 years Brand Names Daptacel, Infanrix Haemophilus Influenzae Type B (Hib) Vaccination Age 6 weeks to 19 years Brand Names ActHIB, PedvaxHIB Hepatitis A Vaccination Age 12 months and older Brand Names Havrix, VAQTA Hepatitis B Vaccination Age All ages Brand Names Engerix-B Recombivax HB, Twinrix Herpes Zoster (Shingles) Vaccination Age Older than 59 years Brand Name Zostavax Human Papilloma Virus (HPV) Vaccination Age 9 to 27 years Brand Names Cervarix, Gardasil Inactivated Poliovirus (IPV) Vaccination Age 6 weeks to 18 years Brand Name Ipol Influenza, Trivalent Inactivated Vaccination Age 6 months and older Brand Names Afluria, Fluarix, FluLaval, Fluvirin, Fluzone Measles, Mumps, Rubella (MMR) Vaccination Age 12 months to 60 years Brand Names M-M-Vax, M-M-R II, ProQuad Meningococcal, Conjugated (Meningitis) Vaccination Age 6 weeks and older Brand Names Menomune, Menactra Pneumococcal Conjugate (PCV13) Vaccination Age Older than 6 weeks Brand Name Prevnar Pneumococcal polysaccharide Vaccination Age 2 years and older Brand Name Pneumovax 23 Rotavirus (RV) Vaccination Age Older than 1 month Brand Name Rotarix, RotaTeq Tetanus Vaccination Age 10 years and older Brand Names Adacel, Boostrix Varicella (Chicken Pox) Vaccination Age 12 months and older Brand Name Varivax

DCA

Direct Compounding Area

Metabolism

Disappearance or transformation of a drug, when it changes chemically into another compound Takes place in many body organs - primarily in the liver Usually enhances excretion and inactivation of a drug

Cardiomyopathy

Disease of the heart muscle that makes it harder for your heart to pump blood to the rest of your body

Toxicities

Effects that are harmful and destructive to the body. Causes: • Drug dosage exceeds recommended dosage • Drug is used for longer periods of time than is recommended • Drug is not properly monitored Example: • Chemotherapy kills good cells

side effects

Effects that are predictable and widely reported Undesired pharmacological effects of a drug seen when therapeutic doses of the drug are used Often unavoidable, part of the drug's action. Example: • Nausea • Drowsiness • Upset stomach • Addiction

Processing Prescriptions and Medication Orders:

Entering prescription/medication information in the patient profile - computerized with help of database program • Verify information • Compare new order to profile • Enter required information • Pharmacist initials • Reimbursement • Pharmacy policy and procedures followed

EPA

Environmental Protection Agency

Other Cancers

Example: • Medroxyprogesterone Acetate (Depo-Provera) - Legend Drug • Diethylstilbestrol (DES) (Stilphostrol) - Legend Drug

Combination Diuretics

Examples: • Amiloride + HCTZ - Legend Drug • Triamterene + HCTZ (Maxzide, Dyazide®) - Legend Drug • Spironolactone + HCTZ (Aldactazide®) - Legend Drug

Labeling Requirements

Examples: • Patient name • Patient location • Drug name, strength, and amount • Diluent and volume • Route of administration • Beyond use date and time (expiration) • Infusion rate (when applicable) • Compounder's initials • Pharmacist's initials • Auxiliary label(s) • Storage requirements

Two Types of Compounding

Extemporaneous: on the sport compounding for one specific patient • Bulk: Preparing and packaging for more than one patient o Must include lot numbers and expiration dates of ingredients o Documentation of procedure on prescription/medication order

FDA

Food and Drug Administration

Reconstituting a Sterile Powder in a Vial

For drugs in a vial in powder form, it is necessary to reconstitute with a suitable diluent, which will be specified in the vial or package insert. Examples: • Sterile Water • D5W • NS (normal saline 0.9% NaCl) Follow the steps described previously for entering a vial. Inject diluent and tilt or roll until the drug is dissolved. Do Not Shake.

Disease states of the digestive system:

GERD - Gastroesophageal Reflux Disease o Signs and Symptoms: frequent heartburn, sore throat, nausea, vomiting, chest pain • Crohn's disease- Chronic inflammatory disease of the digestive system o Signs and Symptoms: diarrhea, fever, fatigue, abdominal pain and cramping, inflammation, weight loss • Irritable Bowel Syndrome - Disorder that includes recurring abdominal pain, bloating, diarrhea or constipation, and cramping o Signs and Symptoms: abdominal pain, cramping, diarrhea, constipation, bloating, nausea • Diverticulitis - Inflammation of the diverticula which causes abdominal pain and bowel movement changes o Signs and Symptoms: pain in lower left abdomen, nausea, vomiting, fever, constipation

Syringe Types

Glass or Plastic Plastic is most commonly used, but compatibility and cost are both factors that are considered when deciding what type will be used.

USP 800 Facility and Engineering Controls

HDs must be handled under conditions that promote patient and worker safety, and environmental protection. Hazard signs must be prominently displayed before the entrance to the HD handling areas. Access to HD areas must be restricted to authorized personnel to protect persons not involved in HD handling. HD handling areas should be located away from breakrooms for personnel, patients or visitors to reduce risk of exposure. Designated areas must be available for: • Receipt and unpacking of HDs • Storage of HDs • Nonsterile HD compounding (if performed by the entity) • Sterile HD compounding (if performed by the entity)

HD

Hazardous Drug

Patient Confidentiality

Health Insurance Portability and Accountability Act of 1996 (HIPAA) became effective in 2003 and is an important law that gives federal protection for patient health information. • All of the information maintained in the patient profile is considered confidential. • Tech should sign confidentiality statement. Patient information may only be released to the following parties: • Patient or patient representative • Prescriber or other licensed practitioner caring for the patient • Another licensed pharmacist • The Board or representative of the Board • Others, only with a written release from the patient (example: reimbursement companies)

Dispensing Containers

Hermetically sealed containers are impervious to air.

Colloids

Liquid preparations which dry to form a flexible film that can be removed from the skin Example: • DuoFilm - for treatment of warts.

Filtration in Admixture Preparation

Liquid product is forced through a filter device attached to the tip of a syringe with the needle attached at the other end of the filter Size of filter depends on its intended use: • Filtration of particulate matter: o 5 micron • Sterilization of a liquid: o 0.22 micron filter removes most microorganisms

Breast Cancer Treatment

Mechanism of Action • Blocks effect of estrogen in target tissues such as breasts Side Effects • Hot flashes Examples • Tamoxifen (Soltamox) - Legend Drug • Toremifene (Fareston) - Legend Drug • Fulvestrant (Faslodex) - Legend Drug • Megestrol Acetate - Legend Drug, also used to treat endometrial cancer • Testosterone (Depo-testosterone) - Schedule III, Legend Drug • Anastrozole (Arimidex) - Legend Drug • Exemestane (Aromasin) Legend Drug • Letrozole (Femara) Legend Drug • Sacituzumab (Trodelvy) Legend Drug

Antibiotics 2

Mechanism of Action • Inhibits nucleic acid synthesis Side Effects • Bleomycin- Legend Drug - pulmonary fibrosis, fever, chills, nausea/vomiting • Doxorubicin - Legend Drug - myelosuppression, cardiotoxicity, nausea/vomiting • Mitomycin - bone marrow toxicity, nausea/vomiting Examples: • Bleomycin - Legend Drug • Doxorubicin (Adriamycin) - Legend Drug • Mitomycin (Mutamycin) - Legend Drug • Dactinomycin (Cosmegen) - Legend Drug • Idarubicin (Idamycin PFS) - Legend Drug • Mitoxantrone (Novantrone) - Legend Drug • Topotecan (Hycamtin) - Legend Drug • Plicamycin (Mithracin) - Legend Drug • Daunorubicin - Legend Drug • Epirubicin (Ellence) - Legend Drug NOTE: The above antibiotics are bio-hazardous and if spilled, must be cleaned with a spill kit.

Antimetabolites

Mechanism of Action • Mimics a necessary nutrient or blocks a reaction, which synthesizes a necessary nutrient. • Cancer cells utilize these agents faster than normal cells and; therefore, are killed more quickly than normal cells. Side Effects • Bone marrow depression • Hepatotoxicity • Immunosuppression • Anorexia • Nausea/vomiting • Oral and anal ulcers • Fever • Rash • Hair loss Examples: • Fluorouracil (5-FU, Efudex, Adrucil) - Legend Drug - **Gloves should be worn to prevent application to areas not intended to use. This compound can be an irritant to the skin. • Mercaptopurine (6-MP) - Legend Drug • Methotrexate (Trexall) - Legend Drug - Utilizes Leucovorin as an antidote (rescue therapy) • Cytarabine (Ara-C, Cytosar) - Legend Drug • Thioguanine (6-TG, 6-Thioguanine) - Legend Drug • Fludarabine - Legend Drug • Pemetrexed (Alimta) - Legend Drug • Capecitabine (Xeloda) - Legend Drug • Gemcitabine (Gemzar) - Legend Drug • Pemetrexed (Alimta) Legend Drug • Gemcitabine (Gemzar) Legend Drug

Medication Adherence

Medication adherence refers to whether the patient takes their medication as prescribed by their health care provider.

MDV

Multiple Use Vial

Codes Used in Pharmacy

National Drug Code (NDC) - can be found in Red Book Assigned by Federal Drug Administration Pharmacy use: • Filling prescriptions • Ordering medications • Submitting claims • Checking medications • Identification • Can be found in the Red Book, Blue Book Example: NDC 02108-0453-33 • 1st five numbers identify manufacturer or distributor • 2nd four numbers identify name, strength, and dosage form • Last two numbers identify package size Uniform Product Code (UPC) • Bar Code Mnemonic Code - Short Entry/Abbreviation Example: • Pb 30mg (Phenobarbital 30mg)

NIOSH

National Institute for Occupational Safety and Health

Afferent Nerves

Nerves that send messages back to the CNS

Efferent Nerves

Nerves that transmit messages from the CNS to the rest of the body

Smoking Deterrents

Nicotine is a potent parasympathomimetic alkaloid. As nicotine enters the body, it is distributed quickly through the bloodstream and crosses the blood- brain barrier reaching the brain within 10-20 seconds after inhalation. The elimination half-life of nicotine in the body is around two hours. Use • It is an aid in nicotine replacement therapy (NRT), a process for smoking cessation Mechanism of Action • Release nicotine into the body Side Effects • Dizziness • Drowsiness • Headache • Irritability • Sleep disturbances • Vivid dreams • Mild Hallucinations • Depression Examples: • Nicotine patch (NicoDerm CQ) • Nicotine gum (Nicorette Gum) • Nicotine MD (Nicotrol Inhaler) • Nicotine Nasal Spray (Nicotrol NS) Alternative to NRTs Use • Varenicline is indicated for smoking cessation • Bupropion aid to smoking cessation Mechanism of Action • Varenicline tartrate (Chantix) mimics the actions of nicotine on the brain and can help both in easing nicotine withdrawal symptoms and blocking the reinforcing effects of nicotine if smoking is resumed. • Bupropion (Zyban) (an antidepressant medication) is used to help people stop smoking by reducing cravings and other withdrawal effects Side Effects • Nausea was the most common side effect • Headache • Vomiting • Flatulence (gas) • Insomnia • Abnormal dreams • Changes in taste perception

OSHA

Occupational Health and Safety Administration

Semi-Solid Dosage Forms

Ointments Intended for applying medication to the skin or mucous membrane Good for dry skin or areas that need protection Greasy and difficult to remove Example: • Bactroban Ointment Creams Moisturize the skin without being greasy Easily rinsed off Referred to as "vanishing creams" because they are translucent and leave the skin surface dry and non tacky Example: • Bactroban Cream Lotions Similar to creams Typically, thinner in consistency to aid in covering a greater body area and areas heavily covered with hair Example: • Hytone Lotion Gels & Jellies Semi-solid system which contains very small particles of liquid medication Application of gel results in dry surface Easy to apply to body areas covered with hair Example: • Retin-A Gel Pastes Ointments to which a large quantity of insoluble solids have been added to make an ointment stiff Relatively impermeable to water and create a good protective barrier for the skin Ideal for diaper rash and similar conditions Example: • Nitro-paste Liniments Contain various substances that give a heat-producing effect used for relief of pain of muscle aches Example: • Bengay

Patient Med Pak

Patient Med Pak is a package prepared by a pharmacy for a specific patient comprising a series of containers and containing two or more prescribed solid oral dosage forms. These packs are labeled as to indicate the date and time or period of time that the contents within each container are to be taken. Each label must contain: • Serial number identifying each prescription order • Pharmacy name and address • Patient name • Name of prescribing practitioner • Medication name, strength and quantity • Physical description of each medication • Directions to medication use and precautions • Date of preparation • Date of expiration

Manic-depressive Disorder

Periods of elation, followed by periods of depression Drugs used to moderate mood swings Example: • Lithium Carbonate (Lithobid), Legend Drug

PPE

Personnel Protective Equipment

Types of Incompatibility

Physical Incompatibility - A visible change when two or more substances are combined • Cloudiness • Color • Precipitate Chemical Incompatibility - Chemical interactions that occur between ingredients of a prescription that could create a contaminated or inactive product Osmolarity - The concentration of osmotically active particles in a solution expressed in osmoles of solute per liter of solution.

Inhalation Solutions

Placed in a nebulizer to provide topical application of medication to the respiratory tract Example: • Albuterol Inhalation Solution

Solutions

Prepared by the complete dissolution of medication(s) in a suitable liquid; can be taken internally. Examples: • Internal: Pedialyte • External: A.T.S. Topical Solution

PEC

Primary Engineering Controls

Excretion

Process by which the drug is eliminated from the body - primarily by the kidney Drugs can be excreted via the urine, feces, lungs, skin, etc.

Absorption

Process where a drug is taken up from the site of administration and is transported to the blood stream Examples: • ASA goes to stomach - absorbed in stomach • Enteric Coated ASA goes to intestine • SQ Insulin absorbed under skin • IV goes directly into blood stream

Distribution

Process where a drug, once in the bloodstream, is delivered to specific organs and tissues in the body to exert its pharmacological effects Example: • Aspirin goes to the stomach, then to the blood, then to the area that needs relief

Liquid Dosage Forms

Provide a route for medication to those patients who cannot swallow solid dosage forms. • Young • Elderly • After oral surgery The physical properties usually differ from solid dosage forms • Can have shorter shelf life • May need to be refrigerated • May need to mask taste

Mouthwash/Rinse

Provide medication to the oral cavity Patients are usually directed to swish and swallow or swish and spit Example: • Peridex Oral Rinse, Listerine Mouth Wash

QA

Quality Assurance

Collecting and Organizing Information:

Refers patient to the pharmacist with any issue regarding RX or OTC: • Side effects • Drug to Drug Interaction (The Facts and Comparisons book contains information on drug to drug interactions.) • Explanation of therapeutic substitutions • Misuse of medications • Allergies

refill Information

Refill request information from the patient: • Patient name • Telephone number • Prescription number • Drug name, strength • Quantity • Prescriber's information • Doctor's name • Insurance reimbursement information , if applicable Refill authorizations: • Electronically • Phone Information given to prescriber when calling for a refill authorization: • Pharmacy name and number • Patient's name and date of birth • Drug name, strength and quantity • Original prescription date and last refill date • Prescription directions

Reconstituted Liquids

Require the addition of distilled water within the dispensing pharmacy. Stored as a powder due to the rapid deterioration of the medication when stored in the liquid form. Needs to be shaken after reconstitution and before use. Most (not all) need to be refrigerated. "Shake well" and when necessary "refrigerate" auxiliary labels should be placed on the prescription bottle Example: • Amoxicillin Oral Suspension

Beyond Use Dating and Storage Requirements

Risk Category Room Temperature Refrigeration Frozen (≤10°C) Immediate Use 1Hour 1 Hour N/A Low Risk 48 Hours 14 Days 45 Days Low- Risk with 12 Hour BUD 12 Hours 12 Hours N/A Medium Risk 30 Hours 9 Days 45 Days High Risk 24 Hours 3 Days 45 Days

Disease Prevention and Health Promotion

Risk factors for disease • Alcohol o Cirrhosis of the liver o Brain damage o Alcoholic pancreatitis and cancer o Cardiovascular disease • Illicit drug use o Heart disease o HIV o Viral hepatitis • Smoking o Lung cancer o COPD o Emphysema Page | 62 ©Pass Assured, LLC | Version 21.c • Obesity o Diabetes o Heart disease o Stroke • Sedentary lifestyle o Cardiovascular disease o Diabetes o Obesity

Hazardous Drug Preparation

Several hazardous drugs are intended for parenteral administration, needing aseptic reconstitution or dilution to produce a final sterile preparation The federal Hazard Communication Standard (HCS) defines a hazardous chemical as any chemical that is a physical or health hazard.

Sharps Containers

Sharps are any object with a sharp edge that can puncture skin After a single use, needles should be placed immediately into a sharps container. When placing needles into a container, the needles should not touch the outside of the container and should not be forced into the container

Penicillins

Side Effects • Allergy • Nausea/vomiting/diarrhea Examples: • Penicillin - Legend Drug • Amoxicillin - Legend Drug • Ampicillin (Amcill®) - Legend Drug • Dicloxacillin - Legend Drug • Nafcillin - Legend Drug • Ticarcillin (Ticar®) - Legend Drug • Amoxicillin and Clavulanate (Augmentin) - Legend Drug

Macrolides

Side Effects • GI upset • Diarrhea Examples: • Erythromycin (EES®, Erythrocin, Ery-Tab) - Legend Drug • Azithromycin (Zithromax®, Zithromax Z-Pak) - Legend Drug • Clarithromycin - Legend Drug • Fidaxomicin (Dificid®) - Legend Drug • Daptomycin (Cubicin)- Legend Drug

Tetracyclines

Side Effects • Photosensitivity • May cause discoloration of children's teeth CAUTION: Binds to Ca products (do not eat/drink dairy products), binds to aluminum and magnesium. Use protection in sunlight. Examples: • Tetracycline (Viabecline) - Legend Drug • Doxycycline (Vibramycin) - Legend Drug • Minocycline (Minocin®, Solodyn) - Legend Drug • Demeclocycline - Legend Drug • Eravacycline (Xerava) Legend Drug • Omadacycline (Nuzyra) Legend Drug

Forged or Altered Prescriptions

Signs of forged prescriptions: • Different color inks are used • Looks like a photo copy • Sig is suspicious • Quantity prescribed is beyond usual recommendation • When a handwritten prescription is copied, a watermark will appear on the copy. o Example: If you suspect a prescription is forged or altered: • Alert the pharmacist • Verify the written prescription with the prescriber. • If the prescription is called in, use the prescriber's phone number from the phone book and verify prescription. • Obtain the patient's identification • Call the police and if you believe you have a forged or altered prescription

Administration Devices

Some dosage forms require the use of a specific device to aid in proper use. Proper use of these devices can be a challenge for patients to learn; therefore, it is important for the pharmacist to be sure that the patient knows how to use them correctly.

SOP

Standard Operating Procedure

SVI

Sterile Vial for Injection

Media Fill Challenge Testing

Sterile bacterial culture medium transfer via a sterile syringe and needle

Parenteral Medications

Sterile products administered by injection or infusion in order to bypass the gastrointestinal tract Administration involves the use of a needle to penetrate the skin Bypassing the skin disrupts the body's major defense against Infection; therefore, parenteral medications are prepared using aseptic technique to reduce contamination

Foams

Systems in which gas have been incorporated into a liquid and when released the entrapped gas gives the product a very light consistency Example: • Proctofoam

Congenital Heart Disease

Term for birth defects that affect the normal workings of the heart. The defects can involve the walls of the heart, the valves of the heart, and the arteries and veins near the heart.

Physiology

The CNS is composed of the brain and spinal cord Example • Burn your finger, goes to spinal cord to brain, brain says "move finger" • Involved in integrating and deciphering all incoming messages and sending responses to the organs and tissues of the body • Coordinates muscle movements, visualization, temperature regulation, pain and sensation

Equipment calibration and documentation requirements

The FDA guidelines must be followed for the calibration of equipment used in the pharmacy. The frequency of how often equipment is calibrated varies. Intervals between calibrations can be a week, a month, three months, six months, or a year depending on the equipment calibration guidelines. Some equipment requires a calibration certificate. This certificate has a unique serial number associated with one calibration with one piece of equipment. Calibration records must be displayed near each piece of equipment that include: • Equipment identification • Calibration dates • Name of the individual performing each calibration • The date the next calibration should be performed

Right to Know

The Right-to-Know refers to workers' rights to information about chemicals in their workplaces. The federal law that provides these rights is the OSHA Hazard Communication Standard (29 CFR 1910.1200). Private-sector employers must provide chemical information to their workers under the OSHA standard.

USP 797 Definition

The United States Pharmacopeia (USP) is a non-government, non-profit organization designed to create standards on patient safety, healthcare information, and verification of products. The purpose of USP 797 is to set the standard for the compounding of sterile products to prevent harm and death to patients

Cardiovascular / Circulatory system

The cardiovascular system supplies oxygen and delivers nutrients to the cells of the body, transports blood, helps to maintain body temperature, and carries waste products to the organs responsible for elimination. It is made up of the heart, arteries, veins, and capillaries.

BEYOND-USE Date (BUD):

The date after which a compounded preparation should not to be used; determined from the date the preparation is compounded. o For Nonaqueous Formulations - The BUD is not later than the time remaining until the earliest expiration date of any API or 6 months, whichever is earlier o Water-Containing Oral Formulations-BUD is not later than 14 days when stored at controlled cold temperatures. o Water-Containing Topical/Dermal and Mucosal Liquid and Semisolid Formulations the BUD is not later than 30 days

Digestive System/ Excretory System

The digestive system is responsible for breaking down food so the body can absorb the nutrients and dispose of the waste. It includes the salivary glands, mouth, esophagus, stomach, liver, gallbladder, pancreas, small intestine, colon, and rectum.

Endocrine System

The endocrine system produces hormones that control growth, development, metabolism, mood, and sexual function. It includes the adrenal glands, parathyroid gland, pituitary gland, thyroid gland, hypothalamus, pancreas, ovaries, and testes

Stability:

The extent to which a preparation retains, within specified limits and throughout its period of storage and use, the same properties and characteristics that it possessed at the time of compounding.

Standard Operating Procedure (SOP)

The facility must maintain SOPs for the safe handling of HDs for all situations in which HDs are used in a pharmacy. The SOPs should be reviewed every 12 months and the review must be documented. The SOPs for handling of HDs should include: • Hazard communication program • Occupational safety program • Designation of HD areas • Receipt of drugs • Storage of drugs • Compounding • Use and maintenance of proper engineering controls

Reproductive System

The function of the reproductive system is sexual reproduction. The male reproductive system is responsible to produce and transport sperm. The male system includes the penis, testes, prostate, seminal vesicles, and urethra. The female reproductive system is responsible for producing eggs and to supports and nourishes the offspring until birth. The female reproductive system includes the vagina, vulva, ovaries, fallopian tubes, cervix, and uterus.

Respiratory System

The function of the respiratory system is to deliver oxygen to the cells in the body and remove carbon dioxide. It includes the mouth, nasal passages, pharynx, larynx, trachea, bronchial tubes, and lungs.

Lymphatic System / Immune System

The lymphatic system is the body's defense system to fight infection and disease. It creates, stores and carries white blood cells Includes the bone marrow, spleen, thymus, lymph nodes and lymphatic vessels.

Muscular System

The muscular system is responsible for movement of the body, maintaining posture, and stabilizing joints. It includes skeletal, smooth, and cardiac muscles.

Tolerance

The need for larger doses or an increase in the number of doses to achieve the desired response May develop after repeated or chronic administration of the drugs Example • Some with chronic pain will increase dose of analgesics

Nervous System

The nervous system coordinates the control of the body and communication among its parts. It is made up of the central nervous system which is the brain and spinal cord, and the peripheral nervous system which is the nerves

Sanitization Processes

The pharmacy work area must be cleaned at the beginning of the work day, throughout the day, and at the end of the day. Counting trays should be cleaned several times a day with 70% isopropyl alcohol. Trays will need to be cleaned when tablets leave excess residue on the tray. Also, counting trays should be cleaned after Penicillin or Sulfa drugs are counted to prevent cross-contamination.

Skeletal System

The skeletal system protects the vital organs and brain, works together with the muscular system to enable movement, gives the body shape, and produces red and white blood cells in the marrow. It includes the bones.

Therapeutic Duplication

Therapeutic Duplication When two drugs from the same class are given together Example: • Cephalexin and Cefaclor are both Cephalosporins. This is an example of therapeutic duplication.

Refrigerated Prescriptions

There should be a designated person assigned to recording the temperature log and monitoring the receipt and storage of medication that is stored in the refrigerator. Duties of this designated person include: • Checking condition of medication upon receipt • Signing to acknowledge correct medication was received • Properly storing medication immediately • If it is a vaccine that was received completing the vaccine log • Rotating stock and pulling out of date medications • Maintaining an accurate temperature log • If the reading on the thermometer is out of range, they must report immediately to supervisor

Bioavailability

This is a percentage or fraction of the administered dose of a drug that actually reaches systemic circulation. Factors affecting oral route of administration include age, body weight and time of administration.

The importance of immunization:

To prevent diseases that are potentially deadly and dangerous. These diseases can cause significant difficulties on the individual, their family, and healthcare resources.

Closures

Two Types 1. Child resistant 2. Easy-open or non-safety Child-resistant vial caps may not be reused.

Prescription

Two common methods of prescribing medication: • Prescriptions • Medication Orders Utilized in an ambulatory care setting: • Walk-in Patients

Antiviral Agents

Use • To treat viral infections

Contraindicated

When a drug used for one indication cause an increase in severity of another indication. Example: • Pseudoephedrine contraindicated in hypertension

Therapeutic Classes of Local Hormones

antihistamines (Histamine Antagonists) Uses • Treatment of allergies, rashes, and hay fever • Motion sickness, nausea, and dizziness • H2 antagonist is used to treat ulcers and reflux disease Mechanism of Action • Inhibits the action of histamine Side Effects • Drowsiness • CNC depression • Anticholinergic effects Sedating Antihistamines - Type I: competitively antagonize histamine at the H1 receptor (block histamine). They cross the blood brain barrier making them a CNS drug. Examples: • Diphenhydramine (Benadryl) - 25mg OTC/ 50 mg Legend Drug Use: treatment of allergies, rashes, and hay fever • Chlorpheniramine (Chlor-Trimeton) - OTC Drug Use: treatment of allergies, rashes, and hay fever • Hydroxyzine (Vistaril) - Legend Drug Use: treatment of itching, allergies, motion sickness-induced nausea, insomnia, and treatment of mild anxiety • Brompheniramine (Dimetane) -OTC Drug Use: treatment of allergies, rashes, and hay fever • Dimenhydrinate (Dramamine) -OTC Drug Use: to prevent nausea and motion sickness • Meclizine (Bonine, Dramamine Less Drowsy) - Bonine & Dramamine OTC Drugs Use: treat vertigo • Clemastine-OTC Drug Use: treatment of allergies, rashes, and hay fever • Levocetirizine (Xyzal) -OTC Drug Use: treatment of allergies, watery eyes, runny nose • Cyclizine (Marezine) -OTC Drug Use: treat nausea, vomiting and dizziness associated with motion sickness, vertigo and postoperatively following administration of general anesthesia and opioids • Cyproheptadine-Legend Drug Use: treat allergy symptoms, it can help stop runny nose, watery eyes, and itchy rash. (Also used for appetite stimulation) • Dexchlorpheniramine- OTC Drug Use: treat allergic conditions such as hay fever and hives • Promethazine (Phenergan) - Legend Drug Use: treat nausea (antiemetic) • Prochlorperazine (Compazine) - Legend Drug Use: treat nausea (antiemetic) Non-Sedating Antihistamines - Type I: do not cross blood brain barrier, no sedation Examples: • Loratadine (Claritin) - OTC Drug Use: treatment of allergies, rashes • Fexofenadine - OTC Drug Use: treatment of allergies, rashes • Cetirizine (Zyrtec) - OTC Drug Use: treatment of allergies, rashes • Desloratadine (Clarinex) - Legend Drug Use: treatment of allergies, rashes • Azelastine - Legend Drug Use: nasal spray used for seasonal allergic • Claritin-D - OTC Drug • Allegra-D - Legend Drug *The "D" is for decongestant (Pseudoephedrine) - may cause heart palpitations, tends to increase blood pressure. Pseudoephedrine is generic for Sudafed. • Olopatadine (Patanol) - Legend Drug Use: Treatment of pink eye Leukotriene Receptor Agonists Mechanism of Action • Blocks chemicals produced by the body called leukotrienes (hormone-like substances that cause allergy symptoms). Leukotrienes cause the lining of the breathing passages of the lung to swell. Side Effects • Diarrhea • Nausea • Vomiting • Mild rashes Example • Montelukast (Singulair) Antihistamine - Type II: competitive blockers of histamine at the H2 receptors, those in the stomach used to treat ulcers and reflux disease and heartburn. Examples: • Cimetidine (Tagamet HB) - OTC Drug • Ranitidine (Zantac) - OTC Drug • Famotidine (Pepcid) - OTC Drug • Nizatidine- OTC Drug Proton Pump Inhibitors (PPIs) • This group of drugs is not a H2 receptor antagonist and is not antihistamines. • Proton Pump Inhibitors (PPIs) are a group of drugs whose main action is a long-lasting reduction of gastric acid production. They are the most potent inhibitors of acid secretion available today. Uses: • Inhibits the action of histamine • Dyspepsia • Peptic ulcer disease (PUD) • Gastroesophageal reflux disease (GORD/GERD) • Prevention of stress gastritis Mechanism of Action • Proton pump inhibitors act by blocking the enzyme system of the gastric cells that secrete gastric acid. The proton pump is the terminal stage in gastric acid secretion. Side Effects • Headache • Nausea • Diarrhea • Abdominal pain • Dizziness Examples: • Omeprazole (Prilosec) - 40 mg Legend Drug/ 20mg OTC Drug • Lansoprazole (Prevacid) - OTC Drug • Dexlansoprazole (Dexilant) - Legend Drug • Esomeprazole (Nexium) - Legend Drug/ 20mg OTC Drug • Pantoprazole (Protonix) - Legend Drug • Rabeprazole (Aciphex) - Legend Drug Dopamine Blockers Use • Nausea/vomiting • GERD Mechanism of Action • Improves stomach emptying Side Effects • Restlessness Example • Metoclopramide (Reglan), Legend Drug Prostaglandin Antagonists Uses • Arthritis • Minor pain • Fever • Inflammation Mechanism of Action • Inhibit or reverse the actions of prostaglandins by blocking Cox-1 and Cox-2 enzymes Side Effects • Ulcers • Kidney damage Examples: **Non-steroidal anti-inflammatory drugs (NSAIDs): • Aspirin (Anacin, Bayer, Bufferin, Ecotrin) - OTC Drugs • Ibuprofen (Advil) - OTC Drug 200mg tabs and Legend Drug over 200mg tabs • Naproxen (Anaprox DS, Naprosyn, EC Naprosyn) - OTC Drug 200mg tabs and Legend Drug over 200mg tabs • Indomethacin (Indocin) - Legend Drug • Diclofenac (Voltaren) - Legend Drug • Nabumetone (Relafen DS) - Legend Drug • Oxaprozin (Daypro) - Legend Drug • Piroxicam (Feldene) - Legend Drug • Sulindac - Legend Drug • Fenoprofen (Nalfon) - Legend Drug • Flurbiprofen - Legend Drug • Etodolac (Lodine) - Legend Drug • Diflunisal - Legend Drug • Ketoprofen - OTC 12.5mg and Legend Drug over12.5mg tabs • Ketorolac Tromethamine - Legend Drug • Meclofenamate - Legend Drug • Salsalate (Disalcid) - Legend Drug • Tolmetin - Legend Drug • Meloxicam (Mobic, Vivlodex) - Legend Drug • Diclofenac/Misoprostol (Arthrotec) - Legend Drug Cox-2 Selective Drugs: Side Effects: • Kidney damage Example: • Celecoxib (Celebrex) - Legend Drug Prostaglandin Analog Use • Glaucoma: decrease intraocular pressure Mechanism of Action • Increasing the outflow of aqueous fluid from the eyes Side Effects • Blurred vision • Burning and stinging • Foreign body sensation • Itching • Lengthening and thickening of the eyelashes Examples • Bimatoprost (Lumigan), Legend Drug • Travoprost (Travatan Z), Legend Drug • Latanoprost (Xalatan), Legend Drug (requires refrigeration) Prostaglandins Uses • NSAID ulcer prevention • Abortifacient (abortion) Examples: • Misoprostol (Cytotec) - Legend Drug • Dinoprostone (Prostin E2) - Legend Drug • Alprostadil (MUSE, Caverject) - Legend Drug

Emulsions

are preparations containing oil and water. Oil is suspended in the water with the help of emulsifying agents. In time, the oil and water separate to form two clearly visible layers. Shaking the Page | 52 ©Pass Assured, LLC | Version 21.c emulsion will redisperse the layers. Emulsions must be shaken before dispensing and a "shake well" auxiliary label placed on the patient's prescription bottle. Example: • Calamine Lotion

Controlled Room Temperature

between 15 - 30 degrees centigrade and 59 86 degrees Fahrenheit.

Waiting

customer is waiting

Drug - OTC interaction

o Theophylline and Cimetidine o Ciprofloxacin and Antacids

Maintenance

prescriptions used to treat conditions that are long-term such as asthma, diabetes, and high blood pressure.

Sublimation

the process of distilling volatile solids

Levigation

the process of producing a smooth dispersion of a drug with a spatula.

Compounding pharmacies and pharmacists may advertise or otherwise promote the fact that they provide prescription compounding services. true or false

true

Gelatin capsules

used for extemporaneous compounding. Sizes vary from 5 (the smallest) to 000 (the largest)

Parasympathetic Nerves

• "Feed & breed" • Nerves which direct restorative and conservative processes • The chemical messenger is Acetylcholine Parasympathetic nerves stimulate the following: • GI tract - increased movement and secretion • GU tract (detrusor) - contraction (urination) • GU tract (sphincter) - relaxation (urination) • Heart - decreased heart rate/impulse conduction • Blood vessels - dilation • Lungs - increased mucus secretion • Eyes - decreased intraocular pressure

Antivirals for the Herpes Virus

• Acyclovir (Zovirax®) - Legend Drug • Famciclovir - Legend Drug • Valacyclovir (Valtrex®) - Legend Drug Side effects • Nausea/ vomiting

Non-Controlled Substances Prescription Transfer

• Any number of refills of a non-controlled substance may be transferred up to the number of refills remaining on the original prescriptions • The prescription at the second pharmacy that accepts the transferred information may be transferred later to another pharmacy if refills remain.

Inventory Control

• Assess inventory • In-stock status • Commercially prepared vs. compounded

Disease states of the respiratory system:

• Chronic Obstructive Pulmonary Disease (COPD) - Lung disease that causes obstructed airflow from the lungs o Signs and Symptoms: chronic cough, shortness of breath, wheezing, chest tightness • Emphysema - Lung condition which causes difficulty breathing because of destruction of the lungs o Signs and Symptoms: chronic cough, shortness of breath, fatigue, wheezing, blue lips or fingernails • Asthma - Long-term lung disorder that is characterized by recurring attacks of wheezing and difficulty breathing o Signs and Symptoms: difficulty breathing, wheezing, shortness of breath, chest pain, coughing • Cystic Fibrosis - Hereditary disease causes buildup of thick mucus in the lungs making it difficult to breathe o Signs and Symptoms: chronic cough, frequent chest colds, wheezing, fatty stools

Cardiovascular System

• Composed of the heart, arteries, capillaries, and veins • Transports nutrients to tissues and removes wastes from tissues

Verification of Automated Compounding Devices for Parenteral Nutrition Compounding

• Extensively used in hospitals and other healthcare facilities • Automated compounding devices are initially tested for weight and volume accuracy • Precision of the ACD can be determined by compounding personnel keeping a daily record of variations in performance of accuracy assessments and reviewing the results

All the following could contribute to a medication error

• Failure to rotate stock appropriately • preparing three prescriptions at a time • reading the drug product label fast • abbreviations are frequently the source of medication errors

Verification

• Five "Rights" of Medication: o Right medication (NDC a great check) o Right patient o Right dose o Right route o Right time • Three Check Points: o Retrieving bottle from stock o Counting from bottle o Returning bottle to stock • Pharmacist's Authorization: o Pharmacist is ultimately accountable to patient.

Bottles

• Glass bottles used to dispense liquid medications: o Theophylline o Valproic Acid • Plastic bottles used to dispense liquid medications: o Lindane Shampoo - Requires "External Use Only" label o Cough syrups • Amber in color to protect the contents from light • Sizes: o 1-16 fluid ounces o ii = 2 fluid ounces = 60cc o iii = 3 fluid ounces = 90cc o xvi = 16 fluid ounces = 480cc • Dropper Bottles o Glass bottles with droppers inside the cap; used for small doses o Used for infant drops: ▪ Ear drops o NOT eye drops unless sterile

Glycylcyclines

• Glycylcyclines are a new class of antibiotics derived from tetracycline. • These tetracycline analogues are specifically designed to overcome tetracycline resistance bacteria. Side Effects • GI upset • Diarrhea Example • Tigecycline (Tygacil ®) - Legend Drug

Misinterpretation of Abbreviations can lead to:

• Improper transcription of physician instructions for medication use • Dispensing the wrong drug, strength, or dosage form • Inappropriate therapeutic or formulary substitution

Non-Sterile HD Compounding

• In a C-PEC located in a C-SEC • C-PEC must be Externally vented (preferred) or have a redundant HEPA filter • C-SEC must o Be externally vented o Be physically separate o Have 12 ACPH o Have a negative pressure of 0.01 - 0.03 inches of water column relative to adjacent areas

Sterile HD Compounding

• In a C-PEC located in a C-SEC • C-PEC must o Be externally vented o Provide an ISO Class 5 or better environment • C-SEC can be either an o An externally vented, negative pressure ISO Class 7 buffer room/ante room with 30 ACPH or o A negative pressure containment segregated compounding area that is externally vented with 12 ACPH

Routes of Exposure

• Inhalation • Accidental Injection • Consumption of contaminated products • Contacting the mouth with contaminated hands • Skin absorption

Herbal Products

• Medications originated from plants • Unlike prescription medication- can be sold without being tested to prove they are safe and effective • Are used to treat a variety of conditions such as: asthma, eczema, premenstrual syndrome, rheumatoid arthritis, migraines, menopausal symptoms, chronic fatigue, irritable bowel syndrome • Come in many dosage forms: pills, capsules, syrups, oils, teas, and tinctures • Naturopathic physicians, pharmacists, medical doctors, herbalists, and chiropractors all may use herbs to treat illness • Most herbal products are regulated as dietary supplements by the Food and Drug Administration. • The FDA can remove a product from sale if it proves to be harmful. • They may contain additives and contaminants that aren't listed on the label • May interact with other drugs • Should consult physician or pharmacist before taking Completed dietary supplement products and dietary ingredients are regulated by the FDA under a different set of regulations than other products. The Dietary Supplement Health and Education Act of 1994 (DSHEA) states that before a dietary supplement or dietary ingredient can be marketed, the manufacturer must ensure it is safe. Unsafe dietary supplements are the responsibility of the FDA after they reach the market. Registration or approval with the FDA is not usually needed to manufacture or sell dietary supplements. Product labeling must be truthful and not confusing. Dietary Supplement Current Good Manufacturing Practices must be used by all companies involved in the manufacturing or handling of dietary supplements. In the United States it is mandatory for the manufacturer, packer, or distributor listed on the label to report all adverse incidents connected with the use of dietary supplements to the FDA. Product information is the responsibility of the FDA. Dietary supplement advertising is regulated by the Federal Trade Commission. Examples, uses and side effects: Echinacea (Echinacea purpurea) • Increases natural immunity • Used to fight infections such as the common cold • Side effects: nausea, stomach pain, diarrhea, sore throat, dry mouth, fever, unpleasant taste, numbness of the tongue, joint and muscle aches, insomnia • People with autoimmune disorders or particular allergies should refer to a physician before using St. John's wort (Hypericum perforatum) • Used for mild to moderate depression, anxiety • Has fewer side effects than most prescription antidepressants • Can cause skin sensitivity to sunlight • Interacts with several medications, only take under guidance of health care professional • Side effects include: stomach upset, fatigue, restlessness, constipation Ginkgo (Ginkgo biloba) • Memory improvement • Treats circulatory disorders • May increase risk of bleeding • Caution for people taking blood thinners, people with seizure disorders, and people with fertility issues • Side effects include headache, dizziness, nausea, diarrhea, heart palpitations Kava kava (Piper methysticum) • Uplifts mood • Increases feelings of well-being and contentment • Used to treat anxiety, stress, and insomnia • May cause liver toxicity • Do not drive or operate machinery Saw Palmetto (Serenoa repens) • Reduces signs of an enlarged prostate • Sometimes used for cough, cold, sore throat, and bronchitis • Side effects nausea, vomiting, constipation, diarrhea, headache, and dizziness Ginseng • May boost the immune system • Lowers blood sugar levels • Side effects: insomnia, nervousness, headaches, upset stomach, dizziness Valerian (Valeriana officinalis) • Helps with sleep problems • Interacts with psychiatric medications • May cause sleepiness or over stimulate instead of sedating Ginger • Used to treat stomach problems- morning sickness, motion sickness, gas, diarrhea, colic, upset stomach • Other uses relief from arthritis, muscle ache, menstrual pain, upper respiratory infection, cough and bronchitis • Side effects: diarrhea, heartburn, stomach pain • Might slow blood clotting Evening Primrose • Oil used for psoriasis, acne, and eczema o Also used for osteoporosis, rheumatoid arthritis, multiple sclerosis, high cholesterol, heart disease, breast pain • Side effects include: nausea, upset stomach, diarrhea, and headache • Contraindicated in individuals with bleeding disorders, epilepsy, or schizophrenia Milk Thistle • Used to treat liver problems: jaundice, hepatitis, cirrhosis, and gallbladder disorders • Lowers cholesterol • Side effects: diarrhea, nausea, gas, bloating, upset stomach

Personnel allowed in the pharmacy:

• Pharmacists • Pharmacy technicians • Cashiers/ clerks

Finished Preparation Release Checks and Tests

• Physical inspection • Compounding accuracy checks • Sterility testing • Bacterial endotoxin testing • Identity and strength verification of ingredients

The Poison Prevention Packaging Act of 1970

• Requires that most over-the-counter medications and prescription medications use child resistant container

Unit dose cups (TJDC):

• Used for oral liquids in hospitals

Aminoglycosides

• Used in mainly in hospitals Side Effects • Kidney damage • Ototoxicity Examples: • Gentamicin - Legend Drug • Tobramycin (Tobrex) - Legend Drug • Amikacin (Amikin®) - Legend Drug • Neomycin (Mycifradin Sulfate®) - Legend Drug • Streptomycin - Legend Drug • Kanamycin (Kantrex) Legend Drug • Plazomicin (Zemdri) Legend Drug Lincosamides • Used to treat a variety of bacterial infections Side Effects • Abdominal pain • Diarrhea • Skin reactions Examples: • Lincomycin (Lincocin) - Legend Drug • Clindamycin (Cleocin®) - Legend Drug - Use: anaerobes - serious respiratory infection, GI infection Carbapenems • Used to treat a variety of bacterial infections, often reserved for severe infections Side Effects • Nausea and vomiting • Diarrhea • Headache Examples: • Imipenem/Cilastatin (Primaxin) - Legend Drug • Meropenem (Merrem) Legend Drug • Ertapenem (Invanz) Legend Drug

Information that a Transferring Pharmacist records on the original prescription:

• name and address of receiving pharmacy • name of receiving pharmacist • name of transferring pharmacist • date of the transfer • number of refills transferred • if all refills are transferred, the original prescription shall be marked "void"

Compounders engaging in compounding should have to continually expand their compounding knowledge by:

• participating in seminars • studying appropriate literature • consulting colleagues

It is the compounder's responsibility for compounding preparations of acceptable:

• strength • quality • purity • appropriate packaging • labeling • official standards • relevant scientific data and information

Colation

(straining) the process of separating a solid from a fluid by pouring the mixture on a cloth which will permit the fluid to pass through, but will retain the solid.

Standard Laboratory tests

-Complete Blood Count (CBC) It measures the types and numbers of cells in the blood, including red and white blood cells and platelets. This test is used to determine general health status, screen for disorders and evaluate nutritional status. It can help evaluate symptoms such as weakness, fatigue and bruising, and can help diagnose conditions such as anemia, leukemia, malaria and infection. -Prothrombin Time (PT or Pro Time) This test measures how long it takes blood to clot. This test can screen for bleeding abnormalities, and may also be used to monitor medication treatments that prevent the formation of blood clots. -Basic Metabolic Panel This test measures glucose, sodium, potassium, calcium, chloride, carbon dioxide, blood urea nitrogen and creatinine which can help determine blood sugar level, electrolyte and fluid balance as well as kidney function. -Comprehensive Metabolic Panel This test combines the Basic Metabolic Panel with six more tests for a more comprehensive evaluation of metabolic functions, with a focus on organ systems. -Lipid Panel The lipid panel is a group of tests used to evaluate cardiac risk. It includes cholesterol and triglyceride levels. Hemoglobin A1C This test is used to diagnose and monitor diabetes

Administration Devices(2)

-Metered Dose Inhalers (MDI) Deliver medication the respiratory tract Can be difficult to use Require coordination and timing to receive the maximum benefit Examples: • Atrovent Inhalation Aerosol • Albuterol MDI -Nebulizers Deliver medication to the respiratory tract through a mouthpiece or mask Attached to a source of compressed air that propels medication in the form of very fine particles or as tiny droplets to the respiratory tract Example: • Albuterol used in a Nebulizer - Spacers Placed on inhaled medication canisters to improve a patient's administration technique Available in a variety of shapes and sizes Require a prescription from a physician Example: • Aero-chamber - Nasal Sprays Topical or systemic effects depending on the drug Examples:• Nasonex Nasal Spray (delivers topical medication to the nasal passages) • Butorphanol Nasal Spray (delivers systemic medication) - Eye/Ear Droppers Allows patients to administer accurate doses of medication to the eye or ear easily Most medications intended for this use are supplied with a dropper bottle, although it may need to be assembled Eyedroppers must be sterile - Plunger Applicators Used most commonly to apply medication to the vaginal canal Can be filled with creams or foams to be expelled into the vaginal canal Example: • Gyne-Lotrimin - Roll-on Applicators Provide a convenient way to apply gels, lotions, and other topical dosage forms A roller ball is placed on the top of a bottle to allow patients to apply topical medications without having to touch the medication with their hands Example: • Cleocin T, ATS are topical solutions and should be stored in the topical section - Syringes Available in various sizes and can administer a large variety of liquid medications. Size is based on three variables: • Volume the syringe can hold (e.g., 10cc) • Increments of the marking (e.g., 1/2cc) • Size of the needle, width, length (e.g., 29-gauge ½ inch needle) In the ambulatory care setting, syringes are most commonly used for insulin injections by the patients with diabetes Syringes are commonly used in the hospital setting Oral or respiratory syringes must not be able to accept a needle - Infusion Pumps Deliver parenteral medication at a specific rate

Other Dosage Forms

-Tape Quick and easy way to apply topical medications Medication is allowed to absorb from the tape into the skin Improves absorption of the medication and provide a protective barrier Example: • Cordran Tape -Transdermal Patches Hold medication in a reservoir designed to provide a continual supply of medication over a period of time Medication is absorbed into the blood through the skin. Example: • Nitroglycerin patch, Duragesic (Fentanyl) • Estraderm (Estradiol patch) • Catapres TTS (Clonidine) - Aerosols Provide medication to the respiratory tract Can be accomplished by using a metered dose inhaler or a nebulizer system Medication travels through the air in very small particles or within tiny water droplets and lands on the mucous membranes of the respiratory tract to provide a therapeutic effect Example: • Albuterol MDI or Inhalation Solution - Implants Surgically placed subcutaneously to release medication over a long period of time Surgically removed after the period of effectiveness ©Pass Assured, LLC | Version 21.c Page | 55 Example: • Norplant - Chewing Gum Can be used to deliver medication to the oral cavity or systemically if the medication is absorbed through the oral mucosa As the patient chews, the gum releases medication Release can be controlled with special chewing patterns Example: • Nicorette Gum

Drug - Drug Interactions

-Tech should notify pharmacist -A change in the magnitude or duration of the pharmacological response of one drug because of the presence of another drug Possible Detrimental Effects: • Increased risk of side effects • Increased risk of toxicities • Decreased pharmacological response desired Possible Beneficial Effects: • Additive Response: o Occurs when two or more drugs combined together yield a response when the drugs by themselves are not enough • Synergistic Response: o Occurs when the effect of two or more drugs is greater than the sum of the drugs o Examples: ▪ Trimethoprim + Sulfamethoxazole = Bactrim/Septra -Examples: • Fluoxetine and Phenelzine o Taking Fluoxetine and Phenelzine together can cause central serotonin syndrome. This condition increases the risk of hallucinations, confusion, mental status changes, agitation, tachycardia, and death. • Digoxin and Quinidine o Taking Digoxin and Quinidine together can lead to an increase in the blood level of Digoxin because Quinidine decreases the excretion rates of Digoxin. The effects from this interaction can cause nausea and vomiting, headache, fast or slow heartbeat or death. • Sildenafil and Isosorbide Mononitrate o Taking Sildenafil and Isosorbide Mononitrate together can cause a severe fall in blood pressure which may result in cardiovascular collapse. • Potassium Chloride and Spironolactone o Taking Potassium Chloride and Spironolactone together may result in hyperkalemia. Hyperkalemia can lead to kidney failure, cardiac arrest, and death.

most commonly used

-pastilles and lozenges- Pastilles, Lozenges Dissolve in mouth Provide medication to the oral cavity Look similar to hard candy Example: • Cough Drops -Troches Can be hard or have gummy consistency Provide medication to the oral cavity Example: • Clotrimazole Troches - Powders Solid dosage forms which have been crushed to make a fine powder Can be used internally or externally Internally - typically mixed into a liquid to improve the taste and make it easier to swallow Example: • Internal: Questran Powder • External: Tinactin Powder - Suppositories Designed to be inserted into a body cavity: • Rectum • Urethra • Vagina Designed to melt at internal body temperature (98.6F or 37C) to release medication into the body Can provide a local effect or be absorbed into the blood stream to give systemic effect Example: • Anusol HC Suppositories - local effect, stable at room temperature. • Phenergan Suppositories - systemic effect, should be stored in a refrigerator • Chlorpromazine - systemic effect, stable at room temperature. • Tigan - systemic effect, stable at room temperature. • Compazine - systemic effect, stable at room temperature. - Vaginal Tablets Inserted into the vagina where they dissolve to provide a topical effect or systemic effect.

six common tablet dosage forms

1) buccal tablets - designed to dissolve slowly when placed between the cheek and gums. this process bypasses the digestive tract& give prolonged release of medication. 2) sublingual tablets(sl tablets)- designed to dissolve immediately & produce a rapid drug response when placed under the tongue where the skin is thin. * these tablets should not be swallowed. this method bypasses digestive tract. ex: nitroglycerin tablets 3) chewable tablets- designed to be easily chewed and then swallowed. tablets assist patients who have difficulty swallowing other types of tablets. ex: amoxicillin in chewable tablet form. 4) effervescent tablets- use a chemical reaction to hasten tablet dissolution. accomplished by the release of carbon dioxide gas when subjecting the compound to water or other liquids used for ingestion. * tablets should never be taken without dissolving the tablet in a suitable liquid first. ex: alka seltzer 5) enteric coated tablets- coated to delay the release of medication until the tablet has reached the intestinal tract. tablets are used when the release of certain medication into the stomach may render the medication inactive or may irritate the stomach lining. ex: enteric coated asprin 6) film coated tablets- used to mask the taste of drugs. ex: tylenol tablets.

Process

1. Appointment Scheduling o Appointments are needed if the pharmacy does not provide walk-in service o You will need to know the immunizing pharmacist's schedule 2. Consent Form and Vaccine Information Statements o Check to see if the vaccine is in stock and not expired o When the patient asks for a vaccine, ask the patient what particular vaccines they are needing o If the patient needs a series vaccine, ask the patient if this is the first dose or if they have received previous doses. If they have received previous doses, find out how many. o A Vaccine Information Statement (VIS) is required by law to be given to the patient. VIS can be found on the CDC website (http://www.cdc.gov/vaccines/hcp/vis/index.html) o The patient will need to fill out a consent form 3. Pharmacist Evaluation o The pharmacist will review the consent form after the patient fills it out. o The pharmacist will decide if there is any reason the patient cannot get the vaccine. 4. Data Entry o Enter the vaccine in the computer like a regular prescription o The consent form is used as the hard copy 5. Receive payment o Before proceeding with the vaccine let the patient know the cost o Receive payment from patient

Screening checklist for adults:

1. Are you sick today? 2. Do you have allergies to medications, food, a vaccine component, or latex? 3. Have you ever had a serious reaction after receiving a vaccination? 4. Do you have a long-term health problem with heart, lung, kidney, or metabolic disease (e.g., diabetes), asthma, a blood disorder, no spleen, complement component deficiency, a cochlear implant, or a spinal fluid leak? Are you on long-term aspirin therapy? 5. Do you have cancer, leukemia, HIV/AIDS, or any other immune system problem? 6. Do you have a parent, brother, or sister with an immune system problem? 7. In the past 3 months, have you taken medications that affect your immune system, such as prednisone, other steroids, or anticancer drugs; drugs for the treatment of rheumatoid arthritis, Crohn's disease, or psoriasis; or have you had radiation treatments? 8. Have you had a seizure or a brain or other nervous system problem? 9. During the past year, have you received a transfusion of blood or blood products, or been given immune (gamma) globulin or an antiviral drug? 10. For women: Are you pregnant or is there a chance you could become pregnant during the next month? 11. Have you received any vaccinations in the past 4 weeks?

Screening checklist for children and teens

1. Is the child sick today? 2. Does the child have allergies to medications, food, a vaccine component, or latex? 3. Has the child had a serious reaction to a vaccine in the past? 4. Does the child have a long-term health problem with lung, heart, kidney or metabolic disease (e.g., diabetes), asthma, a blood disorder, no spleen, complement component deficiency, a cochlear implant, or a spinal fluid leak? Is he/she on long-term aspirin therapy? 5. If the child to be vaccinated is 2 through 4 years of age, has a healthcare provider told you that the child had wheezing or asthma in the past 12 months? 6. If your child is a baby, have you ever been told he or she has had intussusception? 7. Has the child, a sibling, or a parent had a seizure; has the child had brain or other nervous system problems? 8. Does the child have cancer, leukemia, HIV/AIDS, or any other immune system problem? 9. Does the child have a parent, brother, or sister with an immune system problem? 10. In the past 3 months, has the child taken medications that affect the immune system such as prednisone, other steroids, or anticancer drugs; drugs for the treatment of rheumatoid arthritis, Crohn's disease, or psoriasis; or had radiation treatments? 11. In the past year, has the child received a transfusion of blood or blood products, or been given immune (gamma) globulin or an antiviral drug? 12. Is the child/teen pregnant or is there a chance she could become pregnant during the next month? 13. Has the child received vaccinations in the past 4 weeks?

Typical Parenteral Admixture Order Work Flow

1. Physician writes admixture order. 2. Order is transmitted to a pharmacy. 3. Order is checked for appropriate dose, drug allergies, compatibility, and stability. 4. Label and parenteral admixture worksheets are prepared. 5. Preparation of admixture is done by pharmacist or supervised technician. 6. Admixture is checked by pharmacist including correct additive amount, particulate matter or other indications of incompatibility, and comparison of label against original order. 7. Delivery to patient. 8. Storage in patient setting (admixture may require refrigeration). 9. Administration to patient.

Introduce Liquid into a Plastic IV Bag

1. Remove plastic IV bag from the outer wrap and inspect for leaks, tears, or particulates. 2. Swab the rubber port of the bag with an alcohol swab, being careful not to block the airflow from the port. Inside of the medication port is a diaphragm. Needle must be at least ½" to penetrate the diaphragm so that liquid drug will reach IV solution. 3. Insert the needle straight on to into the diaphragm to avoid puncturing sides of the plastic bag. 4. Inject contents of the syringe, and remove the needle from the port. 5. Mix the final product by inverting the bag and squeezing the port to be sure that all of the medication is diluted in the solution and has not been retained in the diaphragm.

Introducing Liquid into a Glass IV Bottle

1. Remove protective cover from the IV bottle and swab the rubber closure with an alcohol swab. 2. Inject the contents of the syringe into the rubber entry port, using the technique described previously. Some glass IV bottles are created with a vacuum which "pulls" the medication from the syringe into the bottle. 3. After withdrawing the syringe, place a protective covering over the injection site to prevent contamination or tampering.

Withdrawing Liquid from a Vial

1. Remove the cover of the vial and wipe rubber surface with an alcohol swab. 2. Withdraw the same volume of air into the syringe as the volume of drug intended to be withdrawn. 3. Uncap the needle, and insert it with the bevel side up at a 45 degree angle. NOTE: Once the rubber surface has been penetrated, the syringe may then go into the rest of the vial straight on, prevent coring (cutting out part of the rubber stopper). 4. Inject the sterile air in the syringe into the vial This creates pressure inside of the vial forcing the liquid out. 5. Keeping the needle in the vial, invert the vial and hold it with one hand to control the syringe. 6. Pull back the plunger of the syringe to withdraw the liquid. 7. Needle should penetrate the rubber closure, but not go much further into the vial so that all medication can be withdrawn. 8. Once the medication has been withdrawn, tap the syringe to make all of the bubbles go to the top of the syringe. 9. Pull down on the plunger to remove the bubbles and then push the plunger back up to the desired volume. 10. Remove the bubbles for accurate measurement. 11. Remove needle from vial and recap the syringe with a Luer-tip cap. (Check with your institution and JCAHO requirements for the handling and disposal of needles.)

How to Draw a Vaccine

6. Preparation o Gather supplies ▪ Vaccine ▪ Diluent ▪ Syringe ▪ Needle ▪ Alcohol swab ▪ Sharps container ▪ Gloves ▪ Cotton ball ▪ Band-Aid ▪ Consent form o Wash hands o Put on gloves 7. Vaccine o Check http://immunize.org/catg.d/p3085.pdf for correct dose, route, site and needle size for vaccines o Check the label with the consent form to verify correct o Check the expiration date of the vaccine and write the lot number on the consent form o If it is a multi-dose vial, write the date on the vial to specify original use o Check vial for color changes, particles, or any additional variations o Ready-to-use vials ▪ Prepare the vial ▪ Remove the cap ▪ Wipe with alcohol swab ▪ Prepare the syringe ▪ Make sure the needle is securely connected to the syringe ▪ With the cap still on the needle, draw up the amount of air equal to the amount of vaccine necessary ▪ Remove the needle cap and put on clean surface ▪ Hardly pierce the vial top with tip of needle at a 45 degree angle. Keep the bevel up. After piercing the vial top, move the needle to a straight vertical angle and fully pierce the vial top. ▪ Inject air into vial ▪ With the needle still inside, turn the vial upside down. Draw the correct volume of vaccine by pulling back on the plunger. ▪ Remove needle from vial and immediately recap by scooping up cap on clean surface. Make sure the cap is on good by pushing down until you hear a snap. o Powder Vials With Diluent ▪ Remove the caps from the vaccine powder vial and diluent vial and wipe with alcohol swabs ▪ Draw up the diluent by following the prepare the syringe procedure ▪ Inject diluent into powder vial. Do not reuse needle and syringe but place them a in Sharps container. ▪ Softly swirl powder and diluent until totally mixed ▪ Withdraw vaccine into a syringe following the prepare the syringe procedure o Prefilled Syringes ▪ Collect vaccine and correct needle ▪ Open needle package ▪ Twist off vaccine stopper ▪ Securely twist on needle ▪ Remove air bubble o Air Bubbles ▪ Very tiny air bubbles are tolerable and will not cause harm ▪ Large air bubbles must be removed ▪ Draw more air into the syringe making the air bubble larger. To do this tilt the vial on its side and position needle into air pocket to draw up more air. Return vial to upside down position and inject air back into vial. ▪ Inject vaccine dose back into vial and start over again. ▪ Carefully tap on syringe to move air bubbles to the top Series Vaccine Follow-Up When the patient asks for a series vaccine, find out if this is the initial dose or if they have received prior doses. 1. Let the patient know that additional doses will be needed and you can help schedule them 2. To complete the series of doses ask the patient how they would like to be reminded 3. Check with the pharmacist to see when the patient should come back 4. Reminder card should be given to patient about next dose 5. Use the pharmacy reminder system 6. A week prior to the next dose due date remind the patient

An Anaphylactic Reaction

A severe adverse reaction to the administration of a drug This can cause anaphylaxis or anaphylactic shock. Example: • If a patient has a severe adverse reaction after prior administration of Penicillin.

Assisting the Pharmacist in Serving the Patients

Activities related to traditional pharmacy prescription dispensing and medication distribution • A Pharmacy Technician may not take a verbal prescription. Most states mandate that only a pharmacist take verbal prescription orders from a physician. • Only a pharmacist may transfer a prescription to another pharmacy. • Only a pharmacist should handle any drug-drug, drug-disease state, or drug-allergy interaction. • Pharmacy Technicians must have all labels and products checked by a pharmacist. • The technician should not offer medical advice to patients. • Verbal counseling should be done by the pharmacist. • Select appropriate OTC product based on pharmacist recommendation.

Shampoo

An easy method to apply medication to the scalp Due to large amount of hair, other topical preparations are difficult to use in this area Example: • Lindane Shampoo - for treatment of head and crab lice

Endocarditis

An infection involving the heart

ALARA

As Low As Reasonably Achievable

Peripheral Nervous System (PNS)

Composed of all the nerves outside the brain and spinal cord These nerves transmit information to and from the brain via chemical and electrical messages

Renal System

Composed of the kidneys and represents a major route to eliminate drugs Produces hormones and regulates body fluid and electrolyte balance

CSP Microbial Contamination Risk Levels

Compounded Sterile Preparations (CSP) risk levels are determined by • compounding setting • physical, chemical, or microbial contamination potential • overall process required

CAI

Compounding Aseptic Isolator

C-SEC

Containment Secondary Engineering Control

C-SCA

Containment Segregated Compounding Area

CVE

Containment Ventilated Enclosure

Fluid Extracts and Tinctures

Contains plant extracts as the active ingredient in water and/or alcohol Example: • Tincture of Benzoin Compound

Common Parenteral Fluids

Dextrose • D5W - 5% dextrose in water • D10W - 10% dextrose in water Sodium Chloride • NS (Normal Saline): o 0.9% sodium chloride o Isotonic with blood (osmotic pressure is the same as blood) o Used in reconstitution of most antibiotics (e.g. Ampicillin) Note: Hypotonic solutions have a lower osmotic pressure than a surrounding medium or red blood cells, thus causing the red blood cells to burst. • ½ NS: o 0.45% sodium chloride Sterile Water for Injection • Not isotonic • Commonly used for reconstitution Ringer's Solutions • Lactated Ringer's injection • Ringer's injection

Point-of-care (POC) testing

Diagnostic tests performed outside of a laboratory that provides quick, reliable results. Point-of-care testing available at some pharmacies: • Influenza • Strep A • HIV • Hepatitis C • Lipids • A1c • INR

Narrow Therapeutic Index (NTI) Drugs:

Drugs with a narrow TI (NTIDs) have a narrow window between their effective doses and those at which they produce adverse toxic effects. The therapeutic index (TI, also known as therapeutic ratio) is a ratio that compares the blood concentration at which a drug causes a therapeutic effect to the amount that causes toxicity. A higher therapeutic index is preferable to a lower one: a patient would have to take a much higher dose of such a drug to reach the toxic threshold than the dose taken to elicit the therapeutic effect. Examples: • Aminoglycosides • Cyclosporine • Carbamazepine • Digoxin • Flecainide • Lithium • Phenytoin • Phenobarbital • Rifampicin • Theophylline • Warfarin

Vitamin

Essential food factors, chemicals in nature, present in certain food, can be synthesized Vitamins are necessary for normal body functions. Many vitamins are not produced in the body and must be obtained from a well-balanced diet.

Suggested Standard Operating Procedures

Every compounding facility shall have written, properly approved standard operating procedures that safeguard the quality of the environment in which a CSP is prepared. Some examples of SOPs are: • Nonessential objects not to be brought into the buffer area • Before entering IV room remove all outerwear, makeup and jewelry Compounding personnel must follow cleaning and gowning policies • Aseptic hand washing techniques should be followed • 70% isopropyl alcohol must be used to disinfect all additive containers • Laminar air hood blowers continuously in operation • Aseptically arrange supplies in hood to decrease air flow turbulence • Syringes and needles to be discarded in sharps container at end of compounding • Label all compounded products properly

indirect Acting

Facilitate the release of Norepinephrine or block the re-uptake of Norepinephrine in the neuronal membrane Mechanism of Action: • Increase release of Norepinephrine Examples: • Amphetamines, Legend, Schedule II o Amphetamine o Dextroamphetamine o Mixed Salts (Adderall) Side Effects: o Headache o Blurred Vision o Irritability o Insomnia o Nausea o Loss of appetite Use: o ADHD o Narcolepsy • Dextroamphetamine, Legend, Schedule II o ProCentra Side Effects: o Headache o Dizziness o Tachycardia Use: o ADHD o Narcolepsy • Methylphenidate, Legend Schedule II o Concerta o Daytrana o Ritalin o Cotempla Side Effects: o Headache o Insomnia o Nausea o Trouble Sleeping o Weight loss Use: o ADD/ADHD (Concerta) o ADD (Daytrana and Ritalin, Cotempla) • Lisdexamfetamine, Legend, Schedule II o Vyvanse Side Effects: o Decreased appetite o Dizziness o Trouble sleeping o Vomiting Use: o ADHD, moderate to severe binge eating in adults Mechanism of Action: Block re-uptake of Norepinephrine Example: • Tricyclic Antidepressants • Bupropion Hydrochloride (Zyban), Legend Side Effects: o Nausea o Headache o Blurred vision o Increased sweating Use: o Antidepressant • Doxepin (Zonalon), Legend Drug • Amitriptyline, Legend Drug • Clomipramine (Anafranil), Legend Drug • Imipramine (Tofranil), Legend Drug • Nortriptyline (Pamelor), Legend Drug Side Effects: o Drowsiness o Dizziness o Dry mouth Use: o Treatment of depression • Trimipramine maleate (Surmontil), Legend • Desipramine Hydrochloride (Norpramin), Legend Side Effects: o Weakness o Dry mouth o Constipation o Blurred vision o Ringing in ears Use: o Treatment of depression • Nortriptyline Hydrochloride (Pamelor), Legend Side Effects: o Tingly feeling o Weakness o Lack of coordination o Blurred vision Use: o Treatment of depression

Requirements and Personnel

Facilities that handle HDs should include: • Standards in occupational safety plans • Health and safety management systems to include the following minimum items: o A list of HDs o Facility and engineering controls o Competent personnel (trained personnel) o Safe work practices o Proper use of appropriate personal protective equipment (PPE) o Policies for HD waste segregation and disposal

Information that a Receiving Pharmacist records:

First, they will create a prescription containing the usual prescription information, then: • "TRANSFER" is written on the face of the prescription • Original dates of issue and dispensing (if different) • Original prescription number and number of refills authorized on original prescription • Number of valid refills remaining and date of last refill • Name and address of transferring pharmacy • Name of transferring pharmacist

Medical Surveillance

Healthcare workers who handle HDs should be enrolled in a medical surveillance program. The purpose of surveillance is to reduce adverse health effects in personnel possibly exposed to HDs. Data collected in a medical surveillance program includes: • Baseline and after HD exposure assessments • Labs • Medical history • Work history (previous hazardous drug exposure) • Estimated amount of HD handling • Symptoms that arise post handling of HDs

Kinase Inhibitor

Mechanism of Action • Reduces action of proteins that control cell division, growth and survival Side Effects • Fluid retention • Headache • GI upset • Swelling of limbs • Rash • Itching • Fever • Dizziness • Muscle pain Example • Imatinib Mesylate (Gleevec)- Legend Drug

Medication Reconciliation

Medication reconciliation is the process in which a healthcare provider makes the most accurate list possible of the medications the patient is taking and comparing it to the medication order. This is to ensure the correct medications are given, that there are no duplications, dosing errors, potential interactions, or forgotten medications.

Medication Therapy Management (MTM)

Medication therapy management's (MTM) primary objective is to ensure patients are using medications correctly, and to improve therapeutic outcomes. MTM is very helpful for people who take several medications. Benefits of MTM include improving patient adherence and health, reducing the risk of potential errors or adverse effects, and helping to avoid waste, and decrease costs. Support roles of pharmacy technicians in MTM include: • Gathering, accessing, and maintaining pharmacy records • Creating and updating a list of all the medications a patient is taking • Communicating with patients and health care providers • Inform the pharmacist if a patient is late getting medication refilled

MethCheck

MethCheck is an electronic tracking system for the sales of OTC medication containing pseudoephedrine. The patient's driver's license number or other personal identifying information is entered along with the product name and amount. If a patient has purchased the federal, state, or local limit set for pseudoephedrine, then the transaction is blocked and the sale is denied. Pharmacies that have implemented MethCheck can access a database to view the pseudoephedrine purchase history of the patient.

Personal Protective Equipment (PPE)

PPE is important for the health professional to protect against occupational hazards of HDs. PPE includes gloves; gowns; head, hair, shoe, and sleeve covers; eye and face protection; and respiratory protection. PPE as defined by pharmacy policy must be worn when handling HDs at all times. PPE worn when handling hazardous drugs should be disposed of as hazardous drug waste • Chemotherapy Gloves o When chemotherapy gloves are required, they must meet American Society for Testing and Materials (ASTM) standard o Chemotherapy gloves should be worn for handling all HDs including non-antineoplastics o Should be powder free o For sterile compounding, outer glove must be sterile o Change gloves every 30 minutes unless otherwise recommended by manufacturer's documentation • Gowns o Must be disposable o Must be shown to resist permeability by HDs o Must close at the back, be long sleeved and have closed cuffs that are elastic or knit o Change per manufacturer's recommendations or every 2-3 hours and always after a spill /splash • Head, Hair, Shoe & Sleeve Covers o When compounding, second pair of shoe covers must be donned before entering the CSEC and taken off when exiting • Face and Eye Protection o Health professionals must use appropriate eye and face protection o Properly vented C-PECs provide eye (and respiratory) protection, so no additional protection is required when compounding. o Goggles must be used when eye protection is needed during incidents or procedures such as a spill cleanup or opening the work tray of a C-PEC. • Respiratory Protection o Surgical masks are required when compounding any sterile medication (and should be considered for nonsterile compounding as well), but they do not provide respiratory protection for the compounder. Surgical masks provide protection from contamination of the compounded preparation. o Respiratory protection provides protection for the compounder and may be required when unpacking HDs that are not contained in plastic, when cleaning up spills, during certain decontaminating and cleaning procedures, or when vapor or gas exposure is suspected. o A facility's policy should describe respirators that are acceptable and available at the facility.

Contents of Prescriptions

Patient information: • Patient name • Home address, including the street number, city, state and zip code • Date the prescription was written • Name of product • Brand or generic • Strength • Dosage form • Quantity • Sig. (directions) Label instructions • Refills Prescriber information which includes: • Name of physician or prescriber • Office address including street number, street name (office or suite number if applicable), city, state and zip code • DEA number for controlled substances • National Provider Identifier or NPI is a unique 10- digit identification number issued to healthcare providers in the United States by the Centers for Medicare and Medicaid Services (CMS) • CMS requires all Medicare and Medicaid prescriptions to be written on a tamper-resistant pad

Injection sites:

Peripheral: • For drugs that do not irritate the veins: o Isotonic solutions (safest for all patients) • For patients who require only short-term IV therapy: o Dorsal forearm surface Central: • For administration of irritating drugs or hypertonic solutions • For patients requiring long-term IV therapy • When a peripheral line cannot be maintained • Large veins in the thoracic cavity Subclavian • Due to the high amount of blood flow which allows for rapid dilution of the solution Other Routes Less Commonly Used: • Intra-arterial (artery) • Intracardiac (heart) • Intra-articular (joint) • Intraspinal (spinal cord) (Must be Preservative-free) • Intrasynovial (lining of joint cavity) • Intrathecal (brain-spinal cord) (Must be Preservative-free) Disadvantages of a Parenteral Route • Risk of infection • Tissue Damage • Pain

Brand vs. Generic

Pharmacist may substitute a generic product for a brand name product is the following criteria are met: • The physician has not indicated "Dispense as Written" • The purchaser requests or agrees with the substitution • The substituted drug is equal to or less in price than the brand name drug. • If savings are passed onto the consumer or a third party payer • And, if certain labeling requirements are met: The labeling requirement states the manufacturers name must be on the label and the statement "generic equivalent for..." must be on the label. • And last and most important is bio-availability. Bioavailability must be the same in order for a pharmacist to exercise professional judgment in selecting a generic product for a patient. The FDA reviews the generic products to make certain they are equivalent in composition and have the same rate and extent of absorption in the systemic circulation to the original brand name product. The Orange Book contains two letter codes assigned to drugs for therapeutic equivalence and is an appropriate reference for drug related information. A rated Drugs are those which the FDA considers to be therapeutically equivalent and therefore, substitutable where permitted by the prescriber.

Airflow

Pre-Filter • Removes large particles, i.e., lint, dust High Efficiency Particulate Air (HEPA) Filters / Laminar Flow Hood: • Remove 99.97% of particles and airborne microorganisms 0.3 microns or larger • Must be replaced on a regular basis to sustain environment • Require regular maintenance (inspection and certification) every six months Two Types of Hoods • Horizontal Hood - air flows horizontally across the work area • Vertical laminar flow hood (biological safety cabinets) - air flows vertical (downward) onto the surface of the work area • Used in the preparation of antineoplastic and other potentially hazardous products • Some of the air recirculated and filtered again; remainder is vented to the outside Safer for the preparer • Air is not blowing directly at them, avoiding the possibility of carrying potentially hazardous particles or small droplets.

Antiretrovirals used for HIV and AIDS

Protease inhibitors Side Effects: • Nausea/ vomiting • Muscle weakness Examples: • Indinavir (Crixivan®) - Legend Drug • Nelfinavir (Viracept®) - Legend Drug • Ritonavir (Norvir®) - Legend Drug • Saquinavir (Invirase®) - Legend Drug • Atazanavir (Reyataz®) - Legend Drug • Darunavir (Prezista®) - Legend Drug • Fosamprenavir (Lexiva®) - Legend Drug Non-nucleoside Reverse Transcriptase Inhibitors • Nevirapine (Viramune®) - Legend Drug • Delavirdine (Rescriptor®) - Legend Drug • Efavirenz (Sustiva) Legend Drug • Intelence (Etravirine) Legend Drug • Abacavir (Ziagen) Legend Drug Reverse Transcriptase Inhibitors Side Effects: • Nausea/ diarrhea • Anemia • Headache • Insomnia • Fatigue • Peripheral neuropathy Examples: • Zidovudine (AZT®, Retrovir®) - Legend Drug • Didanosine (Videx®) - Legend Drug • Lamivudine (Epivir®) - Legend Drug • Stavudine (Zerit®) - Legend Drug

Electrolytes

Salts which are dissolved in body fluids and are necessary in proper concentration to maintain normal body functions Uses • Replacement of depleted salts Side Effects • Stomach upset • Constipation • Diarrhea Examples: • Ammonium • Bicarbonate • Calcium • Chloride • Magnesium • Phosphate • Potassium • Sodium

Cephalosporins

Side Effects • Allergy • Nausea/vomiting/diarrhea First generation Cephalosporins are moderate spectrum agents. They are effective alternatives for treating staphylococcal and streptococcal infections and therefore, are alternatives for skin and soft-tissue infections, as well as for streptococcal pharyngitis. First Generation: • Cephalexin (Keflex®) - Legend Drug • Cefadroxil - Legend Drug • Cefazolin - Legend Drug Second generation Cephalosporins have a greater gram-negative spectrum while retaining some activity against gram-positive bacteria. They are also more resistant to beta-lactamase. They are useful agents for treating upper and lower respiratory tract infections, sinusitis, and otitis media. Second Generation: • Cefaclor - Legend Drug • Cefoxitin - Legend Drug • Cefprozil - Legend Drug • Cefuroxime (Ceftin®) - Legend Drug • Cefotetan (Cefotan®) - Legend Drug • Cefmetazole (Zefazone®) - Legend Drug • Cefuroxime sodium (Zinacef) Legend Drug Third generation Cephalosporins have a broad spectrum of activity and further increased activity against gram-negative organisms. Third Generation: • Cefdinir - Legend Drug • Cefixime (Suprax®) - Legend Drug • Cefpodoxime - Legend Drug • Ceftriaxone - Legend Drug • Cefotaxime (Claforan®) - Legend Drug • Ceftibuten (Cedax®) - Legend Drug • Ceftazidime (Fortaz®, Tazicef) - Legend Drug • Cefditoren (Spectracef®) - Legend Drug Fourth generation Cephalosporins are extended spectrum agents with similar activity against gram-positive organisms as first generation cephalosporins. They also have a greater resistance to beta-lactamases than the third generation cephalosporins. Many can cross the blood brain barrier and are effective in meningitis. Fourth Generation: • Cefepime (Maxipime®) - Legend Drug • Ceftaroline (Teflaro®) - Legend Drug

Medication Guides

The FDA requires that medication guides must be issued with certain medications when there are specific preventative measures to avoid serious side effects, the product must be used exactly as prescribed to be effective, or the patient's decision to choose the medication can be affected by a known serious side effect.

General Overview of USP 800

The USP published General Chapter 800 with a public health motivation to provide a legally enforceable standard to limit occupational exposure to HDs (Hazardous Drugs) and to protect patients, health care personnel, and the environment from the effects of handling HDs. General Chapter 800 addresses handling HDs throughout the entire spectrum: • receipt • transfer • storage • compounding • dispensing • administration • disposal of HD USP 800 applies to any personnel who handle or come into contact with HDs, including: • nurses • pharmacists • pharmacy technicians • physicians • physician assistants • veterinarians • veterinary technicians • home health care workers The extent of 800 includes health care settings, which includes all types of pharmacies: • Hospital pharmacy • Sterile compounding outpatient infusion / cancer center pharmacy • Retail pharmacy • Mail order pharmacy • Non-sterile compounding pharmacy It does not include the following non-health care settings: • Wholesaler supplier • Patient's home • Manufacturing plant USP 800 focus is to minimize the risk of and limit exposure to HDs by: • Containment • Risk assessment • Work practices Note: The HD information in 797 will be removed once 800 becomes official on July 1, 2018. 800 supplements (but does not replace) General Chapters 795 Pharmaceutical Compounding: Nonsterile Preparations, and 797 Compounding: Sterile Preparations

Renal System / Urinary System

The renal system removes waste from the blood in the form of urine; and helps keep a stable balance of salts, glucose and water in the blood. It includes the bladder, kidneys, ureters, and the urethra.

Needles

Types • Filter - used for drawing up liquids from ampules to filter out glass shards • Vented - used to add liquid to a vial of powder Parts • Shaft • Hub • Beveled Tip • Beveled Heel • Bevel Size • Outside diameter is the gauge of the needle • Larger the gauge number the smaller the diameter • Smaller the gauge number the larger the diameter Length • Measured in inches; the length of the needle

Risk Assessment Considerations for Final Dosage Forms

USP 800 says • Hazardous Drugs that only require counting or repackaging of final dosage forms may be prepared for dispensing without any further requirements for containment unless o Required by the manufacturer (Manufacturer Safe Handling Guidance (MSHG)) o If visual indicators of HD exposure hazard are present (i.e. dust / leakage) • Counting / repackaging of HDs should be done carefully • Use clean equipment dedicated for use with HDs • Decontaminate equipment after each use • Do not place HD tablets / capsules in automated counting machines • Healthcare personnel should avoid crushing tablets or opening capsules of HDs • If manipulation is required, must wear PPE and use a plastic pouch to contain any dust or particles

795

USP General Chapter 795 Pharmaceutical Compounding—Nonsterile Preparations

797

USP General Chapter 797 Pharmaceutical Compounding—Sterile Preparations

800

USP General Chapter 800 Hazardous Drugs—Handling in Healthcare Settings

Airflow 2

Unidirectional Flow • Airflow moving in one direction in a vigorous and constant way and at adequate speed to reproducibly sweep particles away from the critical processing or testing area First air • The air leaving the HEPA filter in a unidirectional air stream that is in essence free of particles.

USP

United States Pharmacopeia

United States Postal Service Mailing Requirements for Controlled Substances

United States Postal Services regulations permit the mailing of controlled substances by drug manufacturers or their agents, pharmacies, or other authorized handlers when distribution is lawful under DEA regulations and if the mailer or the addressee meets one of the following conditions: • The mailer or the addressee is registered with DEA. • The mailer of the addressee is exempt from DEA registration as permissible by law. United States Postal Service regulations permit mailing of any controlled substance, provided it is not outwardly dangerous and will not cause injury to a person's life or health, and if the following preparation and packaging standards are met. • The inner container of any parcel containing controlled substances is marked and sealed as required by the provisions of the CSA and its implementing regulations, and is placed in a plain outer container or securely wrapped in plain paper. • If the controlled substance consists of prescription medicines, the inner container is also labeled to show the name and address of the pharmacy, practitioner, or other person dispensing the prescription. • The outside wrapper or container is free of markings that would indicate the nature of the contents.

Universal Precautions

Universal Precautions are a simple set of effective practices designed to protect health workers and patients from infection with a range of pathogens. "Universal Precautions" is the process of preventing the transmission of blood-borne pathogens. These practices are used when caring for all patients regardless of diagnosis. In practice, the implementation of Universal Precautions includes the following interventions: • Handwashing after any direct contact with patients • Safe collection and disposal of needles (hypodermic and suture) and sharps (scalpel blades, lancets, razors, scissor), with required puncture-and liquid-proof safety boxes in each patient care area • Wearing gloves for contact with body fluids, non-intact skin and mucous membranes • Wearing a mask, eye protection and a gown (and sometimes a plastic apron) if blood or other body fluids might splash • Covering all cuts and abrasions with a waterproof dressing • Promptly and carefully cleaning up spills of blood and other body fluids • Using a safe system for hospital waste management and disposal The Center for Disease Control or CDC is responsible for infection control.

Amebicides

Use • Amoeba infections Side effects - same as Antabuse • Avoid alcohol due to a vomiting reaction Examples: • Metronidazole (Flagyl®) - Legend Drug (avoid alcohol) • Chloroquine - Legend Drug - indication; treatment of extraintestinal amebiasis. • Iodoquinol (Yodoxin®) Legend Drug-treatment of intestinal amebiasis • Tinidazole (Tindamax) Legend Drug

Loop Diuretics

Use • Congestive Heart Failure • Potent diuretic Side Effects • Increased urination • Weakness • Muscle cramps • Stomach upset • Dizziness Examples: • Furosemide (Lasix®) - Legend Drug • Bumetanide - Legend Drug • Ethacrynic acid (Edecrin®) - Legend Drug • Torsemide (Demadex®) - Legend Drug

Potassium Sparing Diuretics

Use • Congestive Heart Failure • Weak diuretics, often used in combination with other diuretics • No potassium supplement needed Side Effects • Increased urination • Weakness • Muscle cramps • Stomach upset • Dizziness Examples: • Spironolactone (Aldactone®, Carospir) - Legend Drug • • Triamterene (Dyrenium®) - Legend Drug • Amiloride - Legend Drug

Anticoagulants

Use • Deep vein thrombosis (DVT) • Pulmonary emboli • Atrial fibrillation with embolism • Prophylaxis of systemic emboli after myocardial infarction Mechanism of Action • Stop or slow the normal blood clotting processes Patient Information • Instruct patient not to take aspirin or any new medications and (including non-prescription medications without his/her provider's knowledge. • Anticoagulants are considered high-alert medications and should be monitored Side Effects • Excess bleeding Examples: • Warfarin (Coumadin, Jantoven) - Legend Drug • Heparin (Hemochron, Hep-Lock) - Legend Drug • Enoxaparin (Lovenox) - Legend Drug • Danaparoid (Orgaran) - Legend Drug • Dalteparin (Fragmin) - Legend Drug • Anisindione (Miradon) - Legend Drug • Dabigatran Etexilate (Pradaxa) - Legend Drug • Dicumarol (Dicumarol) - Legend Drug • Tinzaparin - Legend Drug • Desirudin (Iprivask) - Legend Drug • Lepirudin (Refludan) - Legend Drug • Argatroban - Legend Drug • Bivalirudin (Angiomax) - Legend Drug • Fondaparinux (Arixtra) - Legend Drug • Apixaban (Eliquis) - Legend Drug • Antithrombin III (Thrombate III) Legend Drug • Edoxaban (Savaysa) Legend Drug

Anticonvulsants

Use • Epilepsy o Seizures accompanied by loss or disturbance of consciousness and possibly abnormal body movements (convulsions) o Needs to be individualized by dose and addition of other anticonvulsant agents o Prevent the occurrence of seizures; they do not cure the disease Mechanism of Action • Control the excessive discharge of signals from the brain (seizures) Side Effects • Drowsiness • Slurred speech • Addiction • Tolerance and dependence Respiratory and cardiac depression (with high doses) Examples: The anticonvulsant drug chosen depends on the type of seizure the patient has (e.g. partial vs. generalized onset seizures). Valium and Ativan are the drugs of choice to treat a life-threatening seizure disorder called Status Epilepticus • Phenobarbital (available in tablets, capsules, oral suspension and I.V. injection dosage), Legend Drug, Schedule IV • Phenytoin (Dilantin) (available in tablets, capsules, oral suspension and I.V. injection dosage), Legend Drug • Fosphenytoin (Cerebyx) Injection, Legend Drug • Carbamazepine (Tegretol) (available in tablets, oral suspension), Legend Drug, Schedule IV • Valproic acid and its derivatives (Depakene, Depakote) (available in tablets, capsules, oral syrup and I.V. injection dosage), Legend Drug • Gabapentin (Neurontin) (available in capsules), Legend Drug • Lamotrigine (Lamictal) (available in tablets), Legend Drug • Clonazepam (Klonopin) (available in tablets), Legend Drug, Schedule IV • Clorazepate (Tranxene) (available in tablets), Legend Drug, Schedule IV • Lorazepam (Ativan) (tablets Injection), Legend Drug, Schedule IV • Diazepam (Valium) (oral, injectable, inhalation, and rectal), Schedule IV • Ethosuximide (Zarontin) (available in caps and oral syrup), Legend Drug • Oxcarbazepine (Trileptal) (available in tablets), Legend Drug • Eslicarbazepine acetate (Aptiom) (available in tablets), Legend Drug • Felbamate (Felbatol) (available in tablets, oral suspension), Legend Drug • Lamotrigine (Lamictal) (available in tablets), Legend Drug • Levetiracetam (Keppra) (available in tablets), Legend Drug • Tiagabine (Gabitril) (available in tablets), Legend Drug • Topiramate (Topamax) (available in tablets), Legend Drug • Zonisamide (Zonegran) (available in caps), Legend Drug • Primidone (Mysoline) (available in tablets), Legend Drug, • Eslicarbazepine (Aptiom) (available in tablets), Legend Drug, Schedule IV • Trimethadione (Tridione) (available in tablets), Legend Drug • Lacosamide (Vimpat) (available in tablets), Legend Drug, Schedule IV • Pregabalin (Lyrica) (available in capsules and oral solution), Legend Drug, Schedule V • Ruginamide (Banzel) (available in tablets), Legend Drug • Vigabatrin (Sabril), (available in tablets), Legend Drug • Ethotoin (Peganone) (available in tablets), Legend Drug • Methsuximide (Celontin) (available in capsules), Legend Drug • Perampanel (Fycompa) (available in capsules), Legend Drug, Schedule III

Renin Inhibitors

Use • Hypertension Mechanism of Action • Inhibit the renin-angiotensin-aldosterone system (RAAS), namely the conversion of angiotensinogen to angiotensin I Side Effects • Fatigue • Headache • Dizziness • Diarrhea Examples • Aliskiren (Tekturna) - Legend Drug • Aliskiren Hydrochlorothiazide (Tekturna HCT) - Legend Drug • Eplerenone (Inspra)- Legend Drug

ACE I and Calcium Channel Blocker

Use • Hypertension Mechanism of Action • Inhibits angiotensin converting enzyme Effects • Lightheaded/dizziness • Swelling or rapid weight gain • Little or no urination Example: • Benazepril and Amlodipine (Lotrel) - Legend Drug

Ace Inhibitor and Diuretic

Use • Hypertension Mechanism of Action • Long-acting ACE inhibitor Side Effects • Eye pain/vision problems • Slow heart rate/weak pulse • Muscle weakness • Confusion • Extreme thirst • Increased urination Example • Lisinopril and Hydrochlorothiazide (Zestoretic) - Legend Drug

Angiotensin II Receptor Blocker and Calcium Channel Blocker

Use • Hypertension Mechanism of Action • Relaxes heart muscles • Reduces vasoconstriction and blood pressure Examples: • Amlodipine / Olmesartan (Azor®) - Legend Drug • Amlodipine / Valsartan (Exforge, Exforge HCT) - Legend Drug

Calcium Channel Blockers

Use • Hypertension • Angina Mechanism of Action • Dilate coronary arteries, reduce oxygen demand on the heart, and decrease heart rate • Calcium channel blockers work by blocking voltage-gated calcium channels (VGCCs) in cardiac muscle and blood vessels. Side Effects • Constipation Examples: • Nifedipine (Procardia®) - Legend Drug • Verapamil (Calan®) - Legend Drug • Diltiazem (Cardizem®, Cartia XT®) - Legend Drug • Nicardipine - Legend Drug • Amlodipine (Norvasc®, Katerzia) - Legend Drug • Felodipine - Legend Drug • Nisoldipine (Sular®) - Legend Drug • Bepridil (Vascor®) - Legend Drug • Isradipine - Legend Drug • Clevidipine (Cleviprex®) - Legend Drug

Angiotensin II Receptor Blockers (ARB)

Use • Hypertension • Congestive Heart Failure (CHF) • Congenital heart disease Mechanism of Action • Inhibits Angiotensin II • Reduces vasoconstriction and blood pressure Examples: • Losartan (Cozaar®) - Legend Drug • Valsartan (Diovan®, Prexxartan) - Legend Drug • Irbesartan (Avapro®) - Legend Drug • Irbesartan and hydrochlorothiazide (Avalide) - Legend Drug • Candesartan (Atacand®) - Legend Drug • Telmisartan (Micardis®) - Legend Drug • Eprosartan - Legend Drug • Olmesartan (Benicar®) - Legend Drug • Azilsartan (Edarbi®) - Legend Drug

Hemorrheologic Agents

Use • Intermittent claudication - severe cramping in legs Mechanism of Action • Decrease blood viscosity and help to increase blood flow to areas of need Side Effects • Nausea/vomiting • Dizziness Example: • Pentoxifylline (Trental) - Legend Drug

Alpha/Beta-Adrenergic Blocking Agents

Use • Management of hypertension Mechanism of Action • Combines alpha-1-adrenergic blocking and beta-adrenergic blocking activity in a single substance. Side Effect • Dizziness and tiredness may occur Examples • Labetalol - Legend Drug • Carvedilol (Coreg®) Legend Drug

Thiazide and Related Diuretics

Use • Reduce blood pressure Mechanism of Action Causes kidney to secrete more, decreases water retention, decreased blood pressure Side Effects • Increased urination • Weakness • Muscle cramps • Stomach upset • Dizziness Examples: • Hydrochlorothiazide (Hyzaar, Microzide) - Legend Drug • Chlorothiazide (Diuril®) - Legend Drug • Indapamide - Legend Drug • Metolazone - Legend Drug

Antithrombotics

Use • To decrease platelet aggregation (stickiness) and to decrease unwanted clot formation (e.g., heart attack prevention) Examples: • Aspirin (Anacin, Bayer, Bufferin, Ecotrin) - OTC Drugs • Dipyridamole - Legend Drug • Clopidogrel (Plavix) - Legend Drug • Ticlopidine - Legend Drug • Rivaroxaban (Xarelto) - Legend Drug

Thrombolytics

Use • To dissolve existing blood clots • To decrease the muscle damage associated with heart attacks • To treat pulmonary emboli Side Effect • Excessive bleeding Examples: • Alteplase (Activase, t-PA) - Legend Drug • Streptokinase (Streptase) - Legend Drug • APSAC (Eminase) - Legend Drug • Reteplase (Retavase) - Legend Drug • Urokinase (Abbokinase) - Legend Drug

Osmotic Diuretics

Use • To produce an intense diuresis in a hospital setting Mechanism of Action • Pull water out of the body and into the kidneys Examples: • Mannitol - Legend Drug o Solutions of mannitol may crystallize when exposed to low temperatures. o If crystals are observed, the container should be warmed by appropriate means to not greater than 60°C (140°F), shaken, and then cooled to body temperature before administering. If all crystals cannot be completely re-dissolved, the container must be rejected • Urea • Glycerin

Antianemics

Use • To treat anemia caused by iron or vitamin deficiencies (e.g., megaloblastic anemia) Patient Information • Take with meals to avoid stomach upset Side Effects • Diarrhea or constipation • Nausea/vomiting Examples: • Iron Sulfate (Slow-Fe) - OTC Drug • Ferrous Gluconate (iron supplement) - OTC Drug • Folic Acid - OTC Drug • Thiamine (Vitamin B6) - OTC Drug • Cyanocobalamin (Vitamin B-12) - tablets OTC Drug/ injection Legend Drug

Hormones

Use • To treat hormone dependent cancers such as breast and prostate cancers • Both natural and synthetic hormones are used Side Effects • Nausea/vomiting/diarrhea • Hot flashes • Insomnia

Alkylating Agents

Use • To treat leukemia, testicular and ovarian cancers, and bladder cancers Mechanism of Action • Bind to DNA (the genetic material of the cell) and prevent its relocation • Utilized to a greater extent in cancer cells • Caution should be used during reconstitution because these agents can cause severe itching and burning upon contact. • The technician, when accidentally having skin contact with a cytotoxic drug, should wash hands thoroughly with soap and water immediately and seek medical attention. • Cytotoxic drugs must be prepared in a vertical hood to protect the technician • Luer-lock syringes should be used when mixing any cytotoxic agents Side Effects • Nausea/vomiting/diarrhea • Testicular atrophy • Impotence • Bone marrow suppression • Hepatotoxicity • Nephrotoxicity • Rash • Loss of taste and hearing • Seizures • Mental cloudiness • Depression Examples: • Carmustine (BiCNU) - Legend Drug • Busulfan (Myleran) - Legend Drug • Chlorambucil (Leukeran) - Legend Drug • Cisplatin (Platinol) - Legend Drug • Mechlorethamine (Nitrogen Mustard, Mustargen) - Legend Drug • Cyclophosphamide -Legend Drug • Ifosfamide (Ifex) - Legend Drug • Carboplatin - Legend Drug • Lomustine (Gleostine) - Legend Drug • Dacarbazine - Legend Drug • Nedaplatin (Aqupla) - Legend Drug - Produces less nausea, vomiting • Temozolomide (Temodar) Legend Drug • Altretamine (Hexalen) Legend Drug

Antiparasitic Agents

Use • To treat parasitic infections (parasites are organisms which need a host to complete their life cycle) Patient Information • Many of these agents can cause stomach upset, so they need to be taken with food

Interleukin inhibitors

Use • To treat plaque psoriasis, psoriatic arthritis Patient Information • Interleukin inhibitors are immunosuppressive agents which inhibit the action of interleukins. • They function especially in regulation of the immune system. Side Effects • Upper respiratory tract infection • Headache • fatigue Examples: • Ustekinumab (Stelara)- Legend Drug • Secukinumab (Cosentyx) - Legend Drug • Ixekizumab (Taltz) - Legend Drug • Risankizymab (Skyrizi) - Legend Drug

Antifungals

Use • To treat topical and systemic fungal infections Patient Information • Many of these need to be protected from light and heat • Most need to be taken with meals to help with stomach upset Side Effects • Kidney damage with systemic antifungals Examples: • Amphotericin B - Legend Drug - must protect from light. • Ketoconazole (Nizoral®) - Legend Drug • Miconazole (Monistat®) - Legend Drug • Oxiconazole Nitrate Cream (Oxistat Cream) - Legend Drug • Fluconazole (Diflucan®) - Legend Drug • Nystatin (Mycostatin®) - Legend Drug • Clotrimazole (Gyne-Lotrimin®) - OTC Drug/Legend Drugs • Griseofulvin (Fulvicin P/G®) - Legend Drug • Griseofulvin microcrystalline ultra (Gris Peg) - Legend Drug • Itraconazole (Sporanox®) - Legend Drug • Terbinafine (Lamisil®) - cream: OTC Drug/ tablets: Legend Drug • Voriconazole (Vfend®) - Legend Drug - is generally used to treat serious, invasive fungal infections. • Posaconazole (Noxafil®)-Legend Drug-used to prevent serious fungal infections in people with a weakened ability to fight infection

Antitubercular Agents

Use • To treat tuberculosis • Combination therapy with several agents is usually required to avoid resistance • Purified protein derivative is an agent used to detect tubercular infections Side Effects • Red urine • Liver damage • Optic neuritis Examples: • Rifampin (Rifadin®) - Legend Drug • Isoniazid (INH®) Legend Drug • Ethambutol (Myambutol®) - Legend Drug • Pyrazinamide - Legend Drug • Aminosalicylic Acid (Paser®) - Legend Drug • Bedaquiline (Sirturo®) - Legend Drug • Ethionamide (Trecator®) - Legend Drug

Disease modifying anti-rheumatic drug (DMARD)

Use • To treat ulcerative colitis, rheumatoid arthritis Patient Information • DMARDs act by altering the underlying disease rather than treating symptoms. • They are not painkillers, but they will reduce pain, swelling, and stiffness over a period of weeks or months by slowing down the disease and its effects on the joints. Side Effects • Aching joints • Fever • Headache • Vomiting Examples: • Sulfasalazine (Azulfidine)- Legend Drug • Leflunomide (Arava)- Legend Drug

5-alpha Reductase Inhibitor

Use • Treat Benign Prostatic Hyperplasia (BPH) Mechanism of Action • Prevents the conversion of testosterone to dihydrotestosterone (DHT) in the body Side Effect • Dizziness and chills may occur Examples • Finasteride (Proscar) - Legend Drug • Dutasteride (Avodart) - Legend Drug

Endothelin Receptor Antagonists

Use • Treat pulmonary arterial hypertension (PAH). Mechanism of Action • These medications reverse the effect of endothelin, a substance in the walls of blood vessels that causes them to narrow. Side Effects • Pale skin • Troubled breathing with exertion • Unusual bleeding or bruising • Unusual tiredness or weakness Contraindication • Females: Women of childbearing potential must have a negative pregnancy test prior to starting treatment and monthly pregnancy test during treatment. Examples: • Macitentan (Opsumit) • Bosentan (Tracleer) • Ambrisentan (Letairis)

Selective Alpha-2 Adrenergic Agonist

Use • Treatment of glaucoma or ocular hypertension Example • Brimonidine Tartrate (Alphagan P Opth)

Antihelminthics

Use • Treatment of worm infections Side Effects • Stomach upset nausea/diarrhea Examples: • Mebendazole (Emverm) - Legend Drug - Used to treat worms, whipworms, pinworms, roundworms, hookworms • Pyrantel Pamoate - Legend Drug - Used to treat roundworms, pinworms • Albendazole (Albenza®) - Legend Drug - tapeworms • Piperazine - Legend Drug - pinworms, roundworms • Praziquantel (Biltricide®) - Legend Drug - effective against flatworms • Ivermectin (Stromectol ®) - Legend Drug - broad-spectrum antiparasitic agent (treat worms)

Neuromuscular Blocking Agents

Used in hospitals for people going to surgery Uses: • Preoperative skeletal muscle relaxation Mechanism of Action: • Blocks the transmission of nerve impulses to skeletal muscles resulting in paralysis of skeletal muscle There is a narrow therapeutic index with these agents. When these drugs are used, life sustaining respiratory support equipment must be available. Examples: (Used mainly in hospitals) • Cisatracurium (Nimbex), Legend Drug • Succinylcholine (Anectine), Legend Drug • Pancuronium (Pavulon), Legend Drug • Vecuronium (Norcuron), Legend Drug • Mivacurium (Mivacron), Legend Drug • Rocuronium (Zemuron), Legend Drug

Antianginals

Uses • Angina Mechanism of Action • Decrease the amount of blood that returns to the heart, decreasing the heart rate or decreasing the resistance to pump, and decreases the amount of work for the heart Side Effects • Headaches - because of dilation of blood vessels • Dizziness • Low blood pressure Examples: • Nitroglycerin (Nitrostat®) - Legend Drug • Isosorbide Dinitrate (Isordil®) - Legend Drug • Isosorbide Mononitrate (ISMO®)- Legend Drug • Ranolazine (Ranexa) - Legend Drug • Calcium channel blockers • Nitroglycerin is also available as transdermal patches. *NOTE: Nitroglycerin should avoid heat and be stored with a tightly sealed lid. Nitroglycerin must be administered in a glass I.V. container because Nitroglycerin readily undergoes absorption to many soft plastics.

Diuretics

Uses • Congestive heart failure • Hypertension • Fluid retention • Cardiomyopathy • Congenital Heart Disease Mechanism of Action • Alter the body's electrolyte pattern by prohibiting or enhancing excretion of electrolytes. NOTE: Most diuretics increase potassium excretion. This can be corrected by eating high-potassium foods (bananas, orange juice), or taking a potassium sparing diuretic

Antilipidemic Agents

Uses • Heart disease (Cardiomyopathy) • High cholesterol • Helps reduce risk of Coronary Artery Disease Mechanism of Action • Reduces serum lipids and minimizes the rate of new fat deposition. • Decreases LDL, decreases Triglycerides Side Effects • Diarrhea • Constipation • Flushing Examples: • Lovastatin (Altoprev) - Legend Drug • Gemfibrozil (Lopid®) - Legend Drug • Nicotinic acid/Niacin - B3 vitamin, plus increases HDL • Cholestyramine (Questran®) - Legend Drug • Pravastatin (Pravachol®) - Legend Drug • Simvastatin (Zocor®) - Legend Drug Atorvastatin (Lipitor®) - Legend Drug • Fluvastatin (Lescol®) - Legend Drug • Colestipol (Colestid®) - Legend Drug • Colesevelam (WelChol®) - Legend Drug • Rosuvastatin (Crestor®) - Legend Drug • Fenofibrate (Tricor®) - Legend Drug • Ezetimibe (Zetia®) - Legend Drug • Pitavastin (Livalo®,Zypitamag) - Legend Drug • Lomitapide (Juxtapid®) - Legend Drug • Omega 3 Fish Oil- (Lovaza)- Legend Drug • Lovastatin and Niacin - Legend Drug • Simvastatin and Ezetimibe (Vytorin) - Legend Drug • Fenofibric Acid (Trilipix) - Legend Drug • Simvastatin and Niacin (Simcor) Legend Drug

Antiarrhythmics

Uses • Help to restore and maintain normal heart rhythms Mechanism of Action • Multiple classes have different effects on the heart to affect its rhythm. Side Effects • Nausea/vomiting • Confusion • Arrhythmias Examples: • Lidocaine (Xylocaine®) - Legend Drug • Procainamide (Procan®) - Legend Drug • Quinidine (Quinidex®) - Legend Drug • Amiodarone (Pacerone) - Legend Drug • Disopyramide (Norpace®) - Legend Drug • Mexiletine- Legend Drug • Flecainide- Legend Drug • Propafenone- Legend Drug • Adenosine (Adenocard®) - Legend Drug • Dofetilide (Tikosyn®) - Legend Drug • Ibutilide (Covert®) - Legend Drug • Dronedarone (Multaq®) - Legend Drug

Beta-Adrenergic Blockers

Uses • Hypertension • Angina • Cardiomyopathy • Congenital heart disease Mechanism of Action • Inhibits the action at the beta receptors on the heart • Some are selective for the beta cells only on the heart, while others are non-selective and can act in other places within the body, e.g. lungs. Side Effects • Hypotension • Bronchoconstriction - not used with asthma patient- If used, must be with caution. • Dizziness Examples: • Atenolol (Tenormin®) - Legend Drug • Metoprolol (Lopressor®) - Legend Drug • Propranolol (Inderal XL®) - Legend Drug • Nadolol (Corgard®) - Legend Drug • Pindolol - Legend Drug • Sotalol (Betapace®) - Legend Drug • Acebutolol - Legend Drug • Timolol (Blocadren®, Timoptic®) - Legend Drug o Ophthalmic: for the management of glaucoma • Bisoprolol - Legend Drug • Betaxolol - Legend Drug • (Note: Betoptic®) - Legend Drug o Ophthalmic: for the management of glaucoma • Nebivolol (Bystolic®) - Legend Drug • Penbutolol (Levatol®) - Legend Drug • Atenolol / Chlorthalidone (Tenoretic) - Legend • Metoprolol XL (Toprol XL) - Legend Drug

Angiotensin-Converting Enzyme (ACE) Inhibitors

Uses • Hypertension • Congestive Heart Failure (CHF) • Cardiomyopathy • Congenital Heart Disease Mechanism of Action • Prevents the conversion of Angiotensin I to Angiotensin II NOTE: Angiotensin II causes vasoconstriction and fluid retention Side Effects • Cough - If the cough is persistent try another ACE Inhibitor Examples: • Captopril - Legend Drug • Enalapril (Vasotec®) - Legend Drug • Lisinopril (Zestril®, Prinivil®) - Legend Drug • Benazepril (Lotensin®) - Legend Drug • Fosinopril - Legend Drug • Quinapril (Accupril®) - Legend Drug • Ramipril (Altace®) - Legend Drug • Moexipril - Legend Drug • Perindopril - Legend Drug • Trandolapril - Legend Drug

Alpha-Adrenergic Blockers

Uses • Hypertension • Severe Congestive Heart Failure (CHF) • Benign prostatic hyperplasia (BPH) Mechanism of Action • Inhibits the action at the alpha receptors in the blood vessels Side Effects • Orthostatic hypotension • Dizziness Examples: • Prazosin (Minipress®) - Legend Drug - Hypertension • Terazosin - Legend Drug - Hypertension and BPH • Doxazosin (Cardura®) - Legend Drug - Hypertension and benign prostatic hyperplasia (BPH) • Tamsulosin (Flomax) - Legend Drug - Benign prostatic hyperplasia • Alfuzosin (Uroxatral) - Legend Drug - Benign prostatic hyperplasia (BPH) • Silodosin (Rapaflo) - Legend Drug - Benign prostatic hyperplasia (BPH)

Sympathomimetic Agents

Uses • Hypertension • Shock • Heart block • Asthma • Depression The effects of these agents are complex and depend upon the specific receptor where the drugs exert their action. Side Effects: • High blood pressure • Increased heart rate • Depends on the receptor site where drugs exert effects

Immunosuppressants

Uses • Inhibit or prevent activity of the immune system • When the immune system malfunctions, the immune cells move through the lymph nodes into the brain and other parts of the CNS. • In the CNS, these immune cells attack healthy tissue incorrectly assuming that it's a foreign substance and damaging it. Mechanism of Action • The way it works is not known. However, by keeping immune cells from moving out of the lymph nodes and into the CNS may help prevent them from damaging it. Side Effects • Nausea and vomiting • Stomach pain • Tiredness • Yellowing of eyes or skin Example: • Ozanimod (Zeposia), Legend Drug

Vasodilators

Uses • Peripheral vascular disease caused by arteriosclerosis and advanced diabetes Mechanism of Action • Dilate peripheral blood vessels • Increase blood flow to extremities by relaxing the smooth muscles of the blood vessels Side Effects • Tachycardia (increased heart rate) Examples: • Hydralazine- Legend Drug - Use to decrease blood pressure • Nitroprusside (Nitropress®) - Legend Drug - Used in hospitals to decrease blood pressure • Papaverine (Pavabid®) - Legend Drug • Isoxsuprine - Legend Drug • Nitrates (Nitroglycerin, Isosorbide Dinitrate) - Legend Drug • Aspirin - Dipyridamole (Aggrenox) - Legend Drug

Gout Agents

Uses • Prevention and treatment of gout attacks • Mechanism of Action • Enhance the excretion of uric acid • Side Effect • Rash, Kidney Stones Examples: • Allopurinol (Zyloprim) - Legend Drug • Probenecid - Legend Drug • Febuxostat (Uloric) Legend Drug • Pegloticase (Krystexxa) Legend Drug Use • Drug of choice for acute attacks Mechanism of Action • Reduces the pain and swelling of gouty flares Side Effect • Gastrointestinal complaints Example: • Colchicine (Colcrys) - Legend Drug

Narcotic Analgesics

Uses • Relief of moderate to severe pain • Cough suppressant (Antitussives) o Antitussives are often combined with Expectorants to decrease viscosity of respiratory tract secretions (Expectorants help the patient cough up phlegm) • Severe diarrhea Mechanism of Action • Bind to specific receptors within the brain and depress certain parts of the CNS to cause pain relief, respiratory depression, decreased GI motility, and suppression of cough Side Effects • Drowsiness • Constipation • Nausea/vomiting • Addiction, tolerance, and physical psychological dependence • Overdoses can cause respiratory depression, profound coma, and pinpoint pupils (narcotic antagonists are used to treat overdoses - Naloxone (Narcan)) Examples: Single Agents: • Codeine, Legend Drug, Schedule II • Morphine Sulfate (MS Contin, Roxanol, Kadian), Legend Drug, Schedule II • Oxycodone (Roxicodone, OxyContin, Oxaydo, Roxybond), Legend Drug, Schedule II • Nalbuphine (Nubain), Legend Drug, Schedule II • Meperidine (Demerol), Legend Drug, Schedule II • Fentanyl (Duragesic) available in a patch, injection and Lozenges, not a tablet. Legend Drug, Schedule II • Hydromorphone (Dilaudid), Legend Drug, Schedule II • Remifentanil (Ultiva), Legend Drug, Schedule IV • Pentazocine (Talwin), Legend Drug, Schedule IV • Levorphanol, Legend Drug, Schedule IV • Butorphanol, Legend Drug, Schedule IV • Tramadol (Ultram), Legend Drug, Schedule IV Combination Products: • Acetaminophen with Codeine (Tylenol with Codeine) (No. 2 has 15mg codeine, No. 3 has 30mg of codeine and No. 4 has 60mg codeine), Legend Drug, Schedule III • Hydrocodone and Ibuprofen (Vicoprofen) - Legend Drug, Schedule II - used for treatment of pain, Schedule II • Hydrocodone and Acetaminophen (Lorcet, Lortab, Vicodin, Norco), Legend Drug, Schedule II • Oxycodone and Acetaminophen (Percocet), Legend Drug, Schedule II • Oxycodone and Aspirin (Percodan), Legend Drug, Schedule II ©Pass Assured, LLC | Version 21.c Page | 73 • Tramadol and Acetaminophen (Ultracet), Legend Drug, Schedule IV - used for treatment of pain • Aspirin / Butalbital / Caffeine (Fiorinal), Legend Drug, Schedule III Miscellaneous Drugs: • Buprenorphine/Naloxone (Suboxone), Legend Drug, Schedule III - is an opioid agonist. It is used to treat opioid addiction such as oxycodone and heroin. • Buprenorphine - exerts its analgesic effect via high affinity binding to opiate receptors in the CNS; displays partial agonist and weak kappa antagonist activity. • Naloxone, Pure opioid antagonist that competes and displaces opioids at opioid receptor sites. • Diphenoxylate/Atropine (Lomotil), Legend Drug, Schedule V - used for treatment of diarrhea. • Acetaminophen, Butalbital, and Caffeine (Fioricet), Legend Drug, non-narcotic analgesic used to treat tension headaches

Skeletal Muscle Relaxants

Uses • Relieve muscle spasm associated with muscle inflammation and injury • Useful in neuromuscular disorders such as Multiple Sclerosis and Cerebral Palsy Mechanism of Action • Not understood, but may block nerve response within the spinal column. This has an effect of reducing muscle tone and relieving muscle spasm and tension Side Effects • Drowsiness • Addiction • Tolerance and dependence • Respiratory and cardiac depression (with high doses) Examples: • Diazepam (Valium), Legend Drug, Schedule IV • Cyclobenzaprine (Fexmid), Legend Drug • Methocarbamol (Robaxin), Legend Drug • Baclofen (Lioresal), Legend Drug • Chlorzoxazone, Legend Drug • Carisoprodol (Soma), Legend Drug, Schedule IV • Metaxalone (Skelaxin), Legend Drug • Tizanidine (Zanaflex), Legend Drug • Orphenadrine (Antiflex) Legend Drug

Antipsychotics

Uses • Relieve the signs and symptoms of psychosis (e.g. Schizophrenia) • Have a much better effect on the positive symptoms of psychosis: o Auditory and visual hallucinations, agitation, suspiciousness, feeling of persecution, ideas of reference, and intrusion of unwanted thoughts • Noncompliance is the leading cause of recurrent positive psychotic symptoms in those patients who initially responded • Negative symptoms include emotional apathy, extreme inattentiveness, and social withdrawal • Some analgesic, antiemetic, anti-nausea, and antihistaminic effects Mechanism of Action • Originally, it was proposed that these drugs block dopamine (a chemical in the brain) receptors in the brain • Chemical effects unknown Side Effects • Sedation • Extrapyramidal symptoms (abnormal body movements) • Anticholinergic symptoms • Orthostatic hypotension • Abnormal heart rhythms (arrhythmias) Examples: Typical: (also known as first generation antipsychotics) • Haloperidol (Haldol), Legend Drug • Chlorpromazine, Legend Drug • Prochlorperazine (Compazine), Legend Drug • Fluphenazine (Prolixin - Permitil), Legend Drug • Thioridazine, Legend Drug • Thiothixene, Legend Drug Trifluoperazine, Legend Drug Atypical: (also known as second generation antipsychotics) • Clozapine (Clozaril), Legend Drug • Risperidone (Risperdal), Legend Drug • Olanzapine (Zyprexa), Legend Drug • Aripiprazole (Abilify), Legend Drug • Quetiapine (Seroquel), Legend Drug • Asenapine (Saphris), Legend Drug • Iloperidone (Fanapt), Legend Drug • Paliperidone (Invega), Legend Drug • Ziprasidone (Geodon), Legend Drug • Brexpiprazole (Rexulti), Legend Drug • Lurasidone (Latuda), Legend Drug

Sedative Hypnotics

Uses • Short-term use (days to a few weeks) for insomnia; not for long term use • Long-term use (months or years); long-term use can cause drug-induced abnormalities in the patient's sleep cycle • Antidotes for overdoses of stimulants • In combination with analgesics in painful situations • Preoperative anesthetics Mechanism of Action • Not sure, but is thought to reduce the activity of the brain and spinal cord Side Effects • Drowsiness ©Pass Assured, LLC | Version 21.c Page | 69 • Addiction • Tolerance and dependence • Respiratory and cardiac depression (with high doses) Examples: • Benzodiazepines: o Flurazepam, Legend Drug, Schedule IV o Alprazolam (Xanax), Legend Drug, Schedule IV o Lorazepam (Ativan), Legend Drug, Schedule IV o Diazepam (Valium), Legend Drug, Schedule IV o Oxazepam, Legend Drug, Schedule IV o Midazolam, Legend Drug, Schedule IV o Temazepam (Restoril), Legend Drug, Schedule IV o Triazolam (Halcion), Legend Drug, Schedule IV o Estazolam, Legend Drug, Schedule IV o Clonazepam (Klonopin), Legend Drug, Schedule IV o Quazepam (Doral), Legend Drug, Schedule IV o Clorazepate (Tranxene), Legend Drug, Schedule IV o Chlordiazepoxide, Legend Drug, Schedule IV • Barbiturates: o Secobarbital (Seconal), Legend Drug, Schedule II o Amobarbital (Amytal), Legend Drug, Schedule II o Pentobarbital (Nembutal), Legend Drug, Schedule II o Butabarbital (Butisol) Legend Drug, Schedule III o Mephobarbital (Mebaral), Legend Drug, Schedule IV • Miscellaneous Z Drugs are a group of nonbenzodiazepine drugs with effects similar to benzodiazepines which are used in the treatment of insomnia and whose names mostly start with the letter "Z". Some "Z" drugs may have advantages over benzodiazepines: o Zolpidem (Ambien), Legend Drug, Schedule IV o Eszopiclone (Lunesta), Legend Drug, Schedule IV o Zaleplon (Sonata), Legend Drug, Schedule IV o Ramelteon (Rozerem), Legend Drug, is a melatonin receptor agonist - mimics the action of melatonin • Orexin receptor antagonists Used to treat insomnia. They inhibit the effect of orexin, a neurotransmitter, in the brain. This works because orexin is involved in keeping you awake and blocking it can help you fall asleep more easily. o Lemborexant (Dayvigo), Legend Drug, Schedule IV o Side effects: headache, nightmares or abnormal dreams, fatigue • Antihistamines Diphenhydramine (Benadryl, Compoz, Nytol, Sominex), Over the counter 25 mg / Legend Drug 50 mg • Alcohol

CNS Stimulants

Uses • To improve mental function, elevate mood, overcome fatigue, and produce a general feeling of well being • Narcolepsy • Hyperkinesis (Attention Deficit Hyperactivity Disorder - ADHD in children) • Anorexiants (Management of Obesity) Mechanism of Action • Amphetamines stimulate activity and are mediated by the release of Norepinephrine and Dopamine in the brain Page | Pemoline and Methylphenidate's action is unknown Side Effects • Dependence • Increased blood pressure • Increased respiratory rate • Stomach upset Examples: • Caffeine • Methylphenidate (Ritalin, Cotempla XR ODT, Daytrana), Legend Drug, Schedule II • Dextroamphetamine (Procentra), Legend Drug, Schedule III • Pemoline (Cylert), Legend Drug, Schedule III • Dextroamphetamine-amphetamine (Adderall, Mydayis), Legend Drug, Schedule II • Dexmethylphenidate and Serdexmethylphenidate (Azstarys), Legend Drug, Schedule II • Modafinil (Provigil), Legend Drug, Schedule IV - Modafinil is a "wakefulness promoting agent" rather than a classic amphetamine-like stimulant. • Dexmethylphenidate (Focalin), Legend Drug, Schedule III • Lisdexamphetamine (Vyvanse), Legend Drug, Schedule II - Developed for the intention of creating a longer lasting and more difficult to abuse version of Dextroamphetamine. • Armodafinil (Nuvigil), Legend Drug, Schedule IV - Armodafinil is a "wakefulness promoting agent" rather than a classic amphetamine-like stimulant. Armodafinil and Modafinil are mirror images of each other. • Atomoxetine (Strattera) - Legend, treats ADHD Examples of Anorexiants: • Benzphetamine (Regimex), Legend Drug, Schedule III • Phentermine (Adipex-P), Legend Drug, Schedule III • Diethylpropion, Legend Drug, Schedule III • Phendimetrazine (Bontril SR 105, Melfiat, Prelu-2), Legend Drug, Schedule III • Lorcaserin (Belviq) Legend Drug, Schedule IV Anorexiants (not a CNS stimulant): Lipase Inhibitors Mechanism of Action • Lipase is an enzyme secreted into the gut by the pancreas and the stomach • Lipase metabolizes dietary fat so that it can be absorbed by the intestine Side effects: • Oily spotting • Fecal incontinence • Flatus with discharge • Abdominal cramping Orlistat (Xenical), Legend Drug

Antianxiety Agents (Anxiolytics)

Uses • To relieve nervousness and tension in normal or neurotic patients • Have muscle-relaxing capabilities • Some have anticonvulsant activity Mechanism of Action • Benzodiazepines work by binding to and affecting certain receptors and neurotransmitters (GABA) in the brain • The second-generation drug, Buspirone, has an effect at the serotonin and dopamine receptors. Side Effects • Drowsiness • Dizziness • Fatigue • Abrupt termination of high dosages can cause coma, convulsions, and death Examples: Benzodiazepines: • Alprazolam (Xanax), Legend Drug, Schedule IV • Lorazepam (Ativan), Legend Drug, Schedule IV • Diazepam (Valium), Legend Drug, Schedule IV • Oxazepam, Legend Drug, Schedule IV • Flurazepam, Legend Drug, Schedule IV • Midazolam (Nayzilam), Legend Drug, Schedule IV Miscellaneous: • Buspirone (BuSpar), Legend Drug • Doxepin (Zonalon), Legend Drug • Hydroxyzine (Vistaril), Legend Drug

Anti-Parkinson's Agents

Uses • To treat the shaking, rigidity, salivation, and slowing of initial movements associated with Parkinson's disease Mechanism of Action • Parkinson's is a disease characterized by loss of dopamine manufacturing neurons. There is an imbalance in the brain between Acetylcholine (increased) and dopamine (decreased). • Anticholinergics decrease the amount of CNS Acetylcholine • Drugs such as Levodopa increase the amount of dopamine in the CNS • Amantadine augments dopamine release from presynaptic nerve terminals and inhibits dopamine reuptake • Dopamine agonist is a compound that activates dopamine receptors in the absence of dopamine. • Monamine Oxidase B Inhibitors (MAO-B inhibitor) prevent the metabolism of dopamine by MAOB and hence increase its brain levels. • Catechol-O-Methyl Transferase (COMT) inhibitor: COMT is an enzyme that degrades dopamine. Side Effects Anticholinergics: • Dry mouth • Blurred vision • Constipation • Hallucinations • Memory impairment Amantadine: • Dizziness • Insomnia • Nervousness • Irritability • Confusion • Nausea and vomiting • Constipation Levodopa: • Nausea and vomiting • Confusion • Depression • Restlessness • Postural hypotension Arrhythmias Dopamine agonist: • Euphoria • Hallucinations • Weight Loss • Nausea • Insomnia • Unusual tiredness or weakness • Dizziness Examples: • Levodopa/Carbidopa (Sinemet), Legend Drug, L-DOPA enters the brain and is converted into dopamine; Carbidopa prevents the peripheral synthesis of dopamine from L-DOPA to prevent undesirable sympathomimetic side effects. • Bromocriptine (Parlodel), Legend Drug, are dopamine receptor agonists which directly increase the activity of the dopamine system. • Pramipexole (Mirapex), Legend Drug, are dopamine receptor agonists which directly increase the activity of the dopamine system. • Ropinirole (Requip), Legend Drug, are dopamine receptor agonists which directly increase the activity of the dopamine system. • Amantadine (Gocovri), Legend Drug, augments dopamine release from presynaptic nerve terminals and inhibits dopamine reuptake. • Selegiline (Emsam), Legend Drug, prevent the metabolism of dopamine by MAOB and hence increase its brain levels. • Rasagiline (Azilect), Legend Drug, prevent the metabolism of dopamine by MAOB and hence increase its brain levels. • Benztropine (Cogentin), Legend Drug, is to prevent hyperkinesia (a state of overactive restlessness). • Entacapone (COMTan®), Legend Drug, used to prevent the metabolism of dopamine by COMT and hence increase dopamine brain levels. • Tolcapone, Legend Drug, used to prevent the metabolism of dopamine by COMT and hence increase dopamine brain levels. • Rotigotine Transdermal System (Neupro®) is a patch that is used to treat the signs and symptoms of idiopathic Parkinson disease *NOTE: used to treat moderate-to-severe primary Restless Legs Syndrome (RLS) **Special Note Alcohol and other CNS depressants can have additive CNS depressant effects and simultaneous use should be avoided. Levodopa is considered the "gold standard" of treatment of Parkinson's disease. Levodopa can also have negative effects when used long-term. Because of this, dopamine agonists such as pramipexole and ropinirole often are used first. Other non-dopamine drugs may be used early in the course of the disease. These include amantadine, monoamine oxidase inhibitors (such as selegiline) and anticholinergics (such as trihexyphenidyl). As the disease progresses levodopa will likely need to be added.

Phosphodiesterase Type 5 Inhibitor (PDE-5)

Uses • Treat erectile dysfunction • Treat pulmonary arterial hypertension (PAH). Mechanism of Action • A phosphodiesterase type-5 (PDE-5) inhibitor works to increase blood flow in the penis through vasodilation. • PDE-5 is also used to treat pulmonary arterial hypertension (PAH) through vasodilation. Side Effect • The occurrence of side effects with PDE5 inhibitors appears to be dose related. • Headache • Dizziness • Flushing • Dyspepsia • Nasal congestion • Rhinitis Contraindications • PDE5 inhibitors are contraindicated in patients taking nitrate medication. They are also contraindicated in men for whom sexual intercourse is inadvisable because of cardiovascular risk factors. Examples: There are six PDE5 medications taken by mouth that are approved in the United States. • Sildenafil (Viagra) - Legend Drug - is a drug used to treat erectile dysfunction • Sildenafil (Revatio) - Legend Drug - is used to treat pulmonary arterial hypertension (PAH) • Tadalafil (Cialis) - Legend Drug - is a drug used to treat erectile dysfunction • Tadalafil (Adcirca) - Legend Drug - is used to treat pulmonary arterial hypertension (PAH) • Vardenafil (Levitra) - Legend Drug - is a drug used to treat erectile dysfunction • Avanafil (Stendra)- Legend Drug-is a drug used to treat erectile dysfunction **These medications reverse the effect of endothelin, a substance in the walls of blood vessels that causes them to narrow

Antidepressants

Uses • Treat severe depression Mechanism of Action • Exact mechanism unknown • Appear to increase neurotransmitters in the brain (Norepinephrine and serotonin) • Usually takes 3-6 weeks for these drugs to relieve the depression Side Effects • Sedation • Anticholinergic • Abnormal heart rhythm • Seizures Examples: Tricyclic antidepressants (TCAs): • Amitriptyline, Legend Drug • Desipramine (Norpramin), Legend Drug • Imipramine (Tofranil), Legend Drug • Nortriptyline (Pamelor), Legend Drug • Trimipramine (Surmontil), Legend Drug • Clomipramine (Anafranil), Legend Drug • Mirtazpine (Remeron), Legend Drug • Doxepin (Zonalon), Legend Drug • Protriptyline, Legend Drug Serotonin-reuptake inhibitors: • Fluoxetine (Prozac), Legend Drug • Paroxetine (Paxil), Legend Drug Sertraline (Zoloft), Legend Drug • Fluvoxamine, Legend Drug • Citalopram (Celexa), Legend Drug • Escitalopram (Lexapro), Legend Drug • Vilazodone (Viibryd), Legend Drug • Vortioxetine (Trintellix), Legend Drug Serotonin and Norepinephrine reuptake inhibitors: • Duloxetine (Cymbalta), Legend Drug • Venlafaxine (Effexor XR), Legend Drug • Desvenlafaxine (Pristiq, Khedezla), Legend Drug • Levomilnacipran (Fetzima), Legend Drug • Milnacipran (Savella), Legend Drug (In the US, it is used for the management of fibromyalgia) Miscellaneous: • Trazodone (Oleptro), Legend Drug • Nefazodone, Legend Drug • Bupropion (Zyban), Legend Drug • Lithium (Lithobid), Legend Drug Serotonin agonist: o Rizatriptan (Maxalt), Legend Drug o Eletriptan (Relpax), Legend Drug o Sumatriptan (Imitrex, Tosymra), Legend Drug Serotonin antagonist: o Ondansetron (Zofran), Legend Drug Serotonin receptor agonist: o Zolmitriptan (Zomig), Legend Drug Monoamine oxidase inhibitors: • Phenelzine (Nardil), Legend Drug • Tranylcypromine (Parnate), Legend Drug **Important to do a drug interaction check!

Hemostatics

Uses • Treatment of excessive bleeding (e.g., surgical bleeding, hemophilia, vitamin K deficiency) Mechanism of Action • Affects the blood clotting process Examples: • Gelatin (Gelfoam) - Legend Drug • Thrombin (Thrombinar) - Legend Drug • Aminocaproic acid (Amicar) - Legend Drug • Phytonadione (Mephyton) Vitamin K - Legend Drug • Factor VII (Monoclate) - Legend Drug • Aprotinin (Trasylol) - Legend Drug • Tranexamic acid (Cyklokapron) - Legend Drug

Parasympatholytic (Anticholinergic) Agents

Uses: • Anti-spasmodic • Anti-Parkinsonism • Bronchial disorders • Eye exams • Motion sickness • Treatment of overactive bladder Mechanism of Action: • Inhibit or reverse the actions of the parasympathetic nervous system • Bind with the cholinergic receptors and prevent binding of Acetylcholine (they are antagonists) Side Effects: • Urinary retention • Tachycardia • Dry mouth • Constipation • Mydriasis Examples: • Atropine • Benztropine (Cogentin), Legend Drug • Scopolamine (Transderm-Scop), Legend Drug Use: Motion sickness • Cyclopentolate (Cyclogyl), Legend Drug Use: dilates pupils of eyes • Hyoscyamine (Anaspaz, Levbid, Levsin), Legend Drug • Ipratropium (Atrovent HFA), Legend Drug • Propantheline, Legend Drug • Trihexyphenidyl (Artane), Legend Drug • Dicyclomine (Bentyl), Legend Drug • Albuterol / Ipratropium, Legend Drug • Tiotropium (Spiriva HandiHaler), Legend Drug Use: • Treatment of overactive bladder Examples: • Solifenacin (Vesicare), Legend Drug • Flavoxate, Legend Drug • Oxybutynin (Gelnique), Legend Drug • Tolterodine (Detrol), Legend Drug • Trospium, Legend Drug • Darifenacin (Enablex), Legend Drug • Fesoterodine (Toviaz), Legend Drug

Parasympathomimetics (Cholinergic) Agents

Uses: • Glaucoma • Bladder problems • Gastrointestinal problems • Alzheimer's disease Mechanism of Action: • Salivation • Lacrimation • Urination • Defecation • Mimic actions of Acetylcholine • Enhance the actions of the parasympathetic nervous system • Opposes the effects of the sympathetic nervous system • May be a direct action on cholinergic receptors or an indirect action through inhibition of enzymes that destroy Acetylcholine Side Effects: • Diarrhea • Bradycardia • Miosis • Decreased blood pressure • Bronchoconstriction • Sweating Examples: • Pilocarpine (Salagen), Legend Drug • Carbachol (Miostat), Legend Drug Use: Glaucoma, decrease intraocular pressure • Bethanechol (Urecholine), Legend Drug Use: Bladder problems • Edrophonium (Tensilon), Legend Drug • Physostigmine (Antilirium), Legend Drug • Acetylcholine, Legend Drug • Donepezil (Aricept), Legend Drug • Neostigmine (Prostigmin), Legend Drug • Pyridostigmine (Mestinon), Legend Drug • Tacrine (Cognex), Legend Drug • Rivastigmine (Exelon), Legend Drug • Galantamine (Razadyne), Legend Drug • Memantine (Namenda), Legend Drug Use: to treat Alzheimer's Disease

Sympatholytic (Adrenergic Blocking) Agents

Uses: • Hypertension • Heart disease • Migraine headaches • Overactive bladder Mechanism of Action: • Oppose the action of the natural messengers, epinephrine and Norepinephrine, as their receptor sites • Often referred to as adrenergic antagonists (blockers) Side Effects: • Dizziness • Fainting • Nasal stuffiness

Calcitonin Gene-Related Peptide (CGRP) Antagonists

Uses: • Migraine headaches Mechanism of Action: • Blocks a protein called calcitonin gene-related peptide (CGRP). CGRP is produced in both peripheral and central neurons. It is a potent peptide vasodilator. The CGRP receptor is located within pain-signaling pathways, intracranial arteries and mast cells and its activation is thought to play a causal role in migraine pathophysiology. CGRP may cause inflammation and pain in the nervous system of people who have migraine attacks. Side Effects: • Upset stomach • Feeling sleepy • dizziness Examples: • Ubrogepant (Ubrelvy), Legend Drug • Rimegepant (Nurtec ODT), Legend Drug • Galcanezumab-gnlm (Emgality), Legend Drug

Local Anesthetic

Uses: • Minor surgery Mechanism of Action: • Block conduction of impulses along nerves and prevents the sensation of pain from reaching brain Side Effects: • Allergy Examples: • Lidocaine (Xylocaine, Lidoderm Patch), Legend Drug • Benzocaine (Anbesol, Benzodent, Lanacane, Orajel, Solarcaine), Legend Drug • Tetracaine (Pontocaine), Legend Drug • Bupivacaine (Marcaine), Legend Drug • Cocaine, Schedule II • Dibucaine (Nupercainal), OTC

Medication Order

Utilized in an institutional setting - hospitals, nursing homes Contents of a Medication Order: • Patient Information o Patient's address o Height o Weight o Patient's room number o Patient's record number o Primary physician o Patient's allergy history • Date • Time of day • Product name • Dosage form • Prescriber information • Sig. (directions, route, duration) There are specific packaging preparations for Prescriptions and Medication Orders. Prescriptions must be packaged appropriately with consideration of light sensitivity. Medication Orders can be packed in Unit Dose or Multiple Dose. When labeling prescriptions and medication orders, a prescription label should be affixed to the medication packaging so that it can be read easily. There is a list of things that each label should contain. Each label should contain: • Name and address of pharmacy • Date of issuance • Prescription number • Drug name, strength, and quantity • Directions • Patient's name • Prescriber's name • Expiration date • Number of refills • Pharmacists initials • Auxiliary labels • Federal transfer label

Storage

Vaccines must be stored correctly from the time they are manufactured until the time they are administered. This is called the cold chain. In the event that the usual storage unit is not functioning properly there must be a back-up storage location available. If a vaccine is not stored at the proper temperature or has been compromised in any way, the pharmacy must contact the local or state health department immunization program, vaccine manufacturer, or both for the appropriate guidelines to follow. Vaccines should not be discarded unless the immunization program and/or the manufacturer have given instructions to do so

Therapeutic Incompatibility

When the effectiveness of two drugs is decreased when given together Example: • Ampicillin and Gentamicin therapeutic incompatibility.

Hazardous drug:

any drug identified by at least one of the following six criteria: o Carcinogenicity o Teratogenicity or developmental toxicity o Reproductive toxicity in humans o Organ toxicity at low doses in humans or animals o Genotoxicity o New drugs that mimic existing hazardous drugs in structure or toxicity

Suspending or thickening agents

are added to suspensions to thicken the suspending medium and the sedimentation rate. o Examples ▪ Acacia ▪ Tragacanth ▪ Bentonite ▪ Carboxymethylcellulose

Elixirs

are clear sweet combinations of water and alcohol intended for oral use. Example: • Nyquil

Suspensions (two-phase system)

are liquids in which the medication does not completely dissolve, but rather is suspended in a liquid formulation. In time, the suspended particles will settle to the bottom and must be redistributed by shaking. Bottles of suspension medications must be shaken before dispensing. A "shake well" auxiliary label should be placed on the prescription bottle. Can be taken internally or applied externally. Example: • Bactrim Oral Suspension

Preparation:

compounded drug dosage form or dietary supplement or a device to which a compounder has introduced a drug

Moderate compounding

is a step up and requires special calculations or procedures to determine quantities of components for the preparation or per individualized dosage units or making a preparation for which stability data is not available and the USP default BUDs are used. This even includes the mixing of two commercial products for which stability of the mixture is not known.

Simple compounding

is described as making a preparation from a USP monograph or that appears in a peer-reviewed journal article containing specific quantities of all components, procedures and equipment and stability data; it also involves reconstituting or manipulating commercial products that may require the addition of one or more ingredients as directed by the manufacturer

Aseptic Technique / IV Admixtures

must be prepared under special circumstances to prevent the introduction of contaminants such as bacteria and other microorganisms from the environment, devices, equipment, and people.

Reconstitution

o Liquids that are stored as powders because of stability limitations o Must add water o Label with time and date when reconstituted o Expiration date on label - Exp. in 14 days o Refrigeration is often (not always) required to increase stability

Supplemental information at the direction of the pharmacist • Patient Package Inserts (PPI): document provided by the manufacturer, contains additional information about the medication; required every time drug dispensed:

o New Rx and refills o Oral contraceptives o Estrogens o Progesterones o Isotretinoin o Intrauterine devises o Isoproterenol inhalation products o Albuterol Inhalers • Computer generated patient information sheets • Websites • Patient education videos • Medication guides - FDA required handouts for certain medications o Prescriptions that require federal medication guides • Consumer information sheets- required with new prescriptions

Process(compounding)

o Paper is placed on each pan o Balance or "zero" o Desired weight is placed on right tray (weights) o Substance on the left to be measured until balanced

medication order

r is a written order by a physician, dentist, nurse practitioner, or other designated health professional for a medication to be dispensed by a pharmacy for administration to a patient. Medication orders are required for all medications administered in a healthcare facility such as hospitals, nursing homes, and correctional facilities. Unit dose dispensing systems provide a single dose of medication for one administration time. Each label on a medication order must contain: • Drug name and strength • Lot number • Expiration date • Directions for administration • Auxiliary labels Page | 262 ©Pass Assured, LLC | Version 21.c • Name and address of dispensing pharmacy Multiple Dose Medications should have labels that contain: • Patient name and room number • Drug name, strength, and quantity • Directions for administration • Lot number • Expiration date • Auxiliary labels

Complex compounding

requires special training, environment, facilities, equipment and procedures to produce an acceptable preparation. This can include transdermal dosage forms, modified- release preparations, some inserts and suppositories where a systemic effect is intended. It would also include innovative dosage forms for which little information may be currently available.

second most common dosage form(capsules)

solid dosage forms in which the medication is enclosed in a shell of either hard or soft gelatin. hard capsules contain powders,granules, or beads. ex: amoxicillin soft capsules contain medication in liquid form. ex: vitamin e

Tinctures

solutions that contain alcohol Example: • Benzoin Compound Tincture

drug

substance intended for use in the diagnosis, cure, mitigation, treatment, or prevention of disease in human beings or animals.

Syrups(solutions)

that contain sugar Example: • Zyrtec Syrup used as antihistamine, • Syrup of Ipecac: used to induce vomiting and treatment of poisoning

Stability

the ability for medication to maintain chemical and physical integrity over time.

Trituration

the grinding of tablets into a fine powder in a porcelain mortar

Compounding:

the preparation, mixing, assembling, altering packaging and labeling of a drug, drug delivery device or device in accordance with a licensed practitioner's prescription, medication order, or initiative based on the practitioner-patient-pharmacist-compounder relationship in the course of professional practice. o Compounding includes the following: ▪ Preparation of drug dosage forms for both human and animal patients ▪ Preparation of drugs or devices in anticipation of prescription drug orders, on the basis of routine, regularly observe prescribing patterns ▪ Reconstitution or manipulation of commercial products that may require the addition of one or more ingredients ▪ Preparation of drugs or devices for the purposes of, or as an incident to, research (clinical or academic), teaching, or chemical analysis, and ▪ Preparation of drugs and devices for prescriber's office use where permitted by federal and state law.

Filtration

the process of separating liquids from solids with the purpose of obtaining optically transparent liquids

Desiccation

the process of using dehydration to remove moisture from a solid substance. This is the complete or nearly complete deprivation of moisture or of water not chemically combined.

Distillation

the process that involves a change of state - from liquid to vapor and back to liquid

Pharmacology

the study of drugs and interactions with the human body to produce therapeutic effects.

Weighing

to ascertain a definite weight of a material to be used in compounding or manufacturing a dosage form. o Two classes of balances or scales: ▪ Class A Torsion Balance ▪ 6 mg sensitivity ▪ Accurately weighs between 120 mg and 15 gm ▪ Class B Balance ▪ 30 mg sensitivity ▪ Accurately weighs between 650 mg and 120 gm

Pharmacists may compound drugs in limited quantities prior to receiving a valid prescription, on the basis of a history of receiving valid prescriptions that have been generated solely within an established pharmacist-patient-prescriber relationship, and provided that the prescriptions are maintained on file for all such preparations dispensed at the pharmacy. true or false

true

Pharmacists may compound non-prescription medications in commercially available dosage forms or in alternative dosage forms to accommodate patient needs as allowed by individual state boards of pharmacy. true or false

true

Pharmacists may compound, in reasonable quantities, drug preparations that are commercially available in the marketplace if a pharmacist-patient-prescriber relationship exists and a valid prescription is presented. true or false?

true

Pharmacists should not offer compounded medications to other pharmacies for resale; however, a practitioner may obtain compounded medication to administer to patients, but it should be labeled with the following: "For Office Use Only," date compounded, use-by date, and name, strength, and quantity of active ingredients. An exception to this may be the outsourcing of some compounded preparations by hospitals to contract compounding pharmacies. true or false

true

Sympathetic Nerves

• "Fight or Flight" • Nerves which facilitate mobilization of the body for quick action • The chemical messenger is Norepinephrine or epinephrine Sympathetic nerves stimulate the following: • Heart - increased heart rate/impulse • Lungs - bronchial relaxation • Blood vessels - constriction • GI tract - decreased movement • GU tract (detrusor) - relaxation (holds urine) • GU tract (sphincter) - contraction (holds urine)

Preparation

• "Pour bottles" with a screw cap (glass or plastic) • Introduction of an additive into an irrigation bottle must be done with aseptic technique in laminar hood

Homeopathy

• A method for treating illness that uses very minor quantities of substances that would in higher quantities produce symptoms of the sickness in healthy individuals • This structure of therapeutics was established in 1796 by Samuel Hahnemann on the belief that "like cures like." Homeopathic remedies: Cough: • Aconite • Belladonna • Bryonia • Phosphorus • Drosera • Hepar Sulph Cold • Aconitum • Allium Cepa • Anas Barbariae • Calcarea carb • Natrum mur Anxiety • Argentum Nitricum • Arsenicum Album • Calcarea Carbonica • Gelsemium Cuts and Wounds • Bellis Perennis Hemorrhoids • Aesculus hippocastanum • Hamamelis Burns, bites, stings • Urtica Urens • Ledum

Blood

• A mixture of water, cells, proteins, and dissolved salts. Blood serves as the transportation system for hormones, nutrients, and waste products within the body.

Fat - Soluble Vitamins

• Accumulate and are stored in fat tissues • Excess intake can result in toxicity since accumulation occurs in fat tissue. Examples and Uses: • Vitamin A - Skin and vision • Vitamin D (Drisdol) - Calcium regulation, bone formation • Vitamin E - Reproduction and skin • Vitamin K (Mephyton) - Blood clotting All others are water-soluble.

Disease states of the endocrine system:

• Addison disease- disorder that happens when the adrenal glands do not produce enough steroid hormones o Signs and Symptoms: extreme fatigue, weight loss, darkening of skin, low blood pressure, low blood sugar, abdominal pain, depression, salt craving • Graves' disease-autoimmune disease affecting the thyroid o Signs and Symptoms: anxiety, hand tremor, increased sweating, bulging eyes, fatigue, thick red skin on shins • Hypothyroidism-underactive thyroid o Signs and Symptoms: fatigue, sensitivity to cold, dry skin, weight gain, puffy face, hoarseness, thinning hair • Cushing syndrome- caused by excess levels of cortisol in the body o Signs and Symptoms: thinning skin, easy bruising, acne, weight gain around midsection and upper back, moon face, stretch marks, slow healing wounds

Intravenous (IV)

• Administration into veins for rapid effects • No retreat of the drug once it has been administered • Solutions and some emulsions (lipids) • Never a suspension

IV Piggy Back (IVPB)

• Administration of a second solution through the site of an already established primary line NOTE: Must be hung higher than primary solution. • Eliminates the need for another puncture site in the patient. • Compatibility between two solutions and their additives must always be considered.

Patient factors that influence drug effects

• Age-drugs metabolize differently in certain age groups such as newborns and the elderly. Newborns and infants do not have fully developed organ systems and do not eliminate drugs the same as adults. Metabolism of certain drugs occurs more rapidly in children than adults. • Height and weight - body mass affects metabolism • Genetics - depending on genetic makeup some people metabolize drugs more quickly or more slowly. • Gender - medications may affect men and women differently due to certain hormones, or body composition. • Diet - certain foods can have interactions with medication

Deactivating, Decontaminating, Cleaning and Disinfecting

• All areas where hazardous drugs are handled and all reusable equipment must be deactivated, decontaminated, and cleaned • Sterile compounding areas and devices must be subsequently disinfected

Disposal

• All disposable items that have potentially come in contact with antineoplastic drugs during preparation or administration must be disposed of in containers designated with the biohazard symbol. • Hazardous waste containers should be removed from the work area by appropriate personnel and destroyed according to work site policy and procedure.

Personnel

• All personnel must receive special training to work with antineoplastic agents. • Number of personnel involved in working with these agents should be kept to a minimum. • Technicians should be observed regularly by supervisory personnel to insure compliance. • Maintain a permanent registry of all employees who handle antineoplastic drugs.

Personnel Training

• All personnel who handle hazardous drugs must be trained and pass competency before they handle HDs. • Every 12 months training / competency assessment must be documented and must include: o An overview of the entity's HD list o Review of the entity's HD SOPs o Proper use of PPE o Proper use of equipment and devices (engineering controls) o Response to known or suspected HD exposure o Spill management o Proper disposal of HDs and trace-contaminated materials

Antivirals for treatment of influenza (flu)

• Amantadine (Gocovri) - Legend Drug • Rimantadine (Flumadine®) - Legend Drug • Zanamivir (Relenza®) - Legend Drug • Oseltamivir (Tamiflu®) - Legend Drug • Baloxavir marboxil (Xofluza) Legend Drug Side Effects • Nausea • CNS effects

HMG - CoA Reductase Inhibitor - Calcium Channel Blocker

• Amlodipine and Atorvastatin (Caduet) - Legend Drug

Withdrawing Liquid from an Ampule

• Ampules are containers made entirely of glass. • They are broken at the neck, which is usually pre-weakened. 1. Hold the ampule upright and tap the top to remove any liquid trapped in this area. 2. Wipe the neck of the ampule with an alcohol swab to reduce contamination. 3. Wrap the gauze pad around the neck when breaking it open to reduce the chance of cutting fingers and preventing glass fragments. 4. Grasp the ampule using the thumb and index fingers of both hands on each side of the ampule neck. Page | 152 ©Pass Assured, LLC | Version 21.c 5. Snap the ampule quickly, breaking it away from yourself, and the filter to avoid glass fragments. 6. Tilt the ampule and insert the filter needle or filter straw attached to the syringe. 7. Avoid touching the neck of the ampule with the needle. 8. A filter needle or filter straw always must be used when withdrawing liquid from ampules to prevent glass particles from being introduced into the product, and thus, the patient. 9. To remove liquid, hold the ampule in one hand and the syringe in the other. 10. Push the plunger back with the thumb of the hand holding the syringe to the desired volume. 11. Before injecting contents of the syringe into a parenteral product, be sure to remove the filter straw or filter needle, and replace it with a regular needle. 12. Removal of filter needle before injection is necessary so that the filtrate will not be injected into the product. 13. Hold the syringe upright, tap out bubbles, and push the plunger up to the desired volume.

Iron Deficiency Anemia

• Anemia due to a decrease in circulating red blood cells and resulting in decreased delivery of oxygen to body tissues. • Treated with iron salts (ferrous sulfate)

Megaloblastic Anemia

• Anemia due to increased circulation of immature abnormal red blood cells resulting in decreased delivery of oxygen to body tissues. • Treated with specific vitamins and minerals depending on which ones are needed (vitamin B12, folic acid).

Environment Contamination

• Aseptic technique requires control of the environment. • Laminar Flow Hood, Laminar Airflow Workbench (LAFW), Vertical Flow Hood: o Designed to reduce the risk of airborne contamination during preparation of sterile products o Provides a constant flow of air to the controlled area o Air is filtered

Placement of Items to Prepare

• Avoid working over open containers or a preparation to prevent contaminates falling into the preparation area.

Disease states of the nervous system:

• Bell's Palsy - Condition that causes the muscles on one side of the face to become paralyzed o Signs and Symptoms: facial muscle weakness or droop, drooling, dry eyes • Epilepsy - Neurological disorder where brain activity becomes abnormal often resulting in seizures o Signs and Symptoms: seizures, loss of consciousness • Multiple Sclerosis - Autoimmune disease affecting the brain and spinal cord causing problems with muscle control and other bodily functions o Signs and Symptoms: numbness or weakness in the limbs, slurred speech, fatigue, dizziness, tremor, partial or complete loss of vision • Parkinson's Disease - Chronic progressive neurological disease that leads to deterioration of motor function o Signs and Symptoms: tremor, loss of smell, constipation, rigid muscles, speech changes, impaired posture

Adenosine Triphosphate-citrate lyase inhibitor and cholesterol absorption inhibitor

• Bempedoic acid and ezetmibe (Nexlizet)- Legend Drug

Adenosine Triphosphate-citrate lyase inhibitor

• Bempedoic acid(Nexletol) - Legend Drug

Hazardous Drugs

• Biological safety cabinet (BSC) or compounding aseptic containment isolator (CACI) required for compounding • NIOSH guidelines • Preparation and storage in negative pressure ISO 7 with ISO 7 ante area • Must follow state and federal guidelines for waste disposal • PPE to be worn • Stored separately from other inventory • External exhaust of primary engineering controls

Facility Requirements

• Buffer area o ISO Class 7 o Primary Engineering Control is located here o If separated from ante area must have positive pressure differential o If not separated from ante area displacement airflow principles must be used o HEPA air filter • Ante Area o Between the buffer area and the common pharmacy o ISO Class 8 or better o Pressure relationships continuously kept o Supplies should be removed from cardboard containers here before passing into the buffer area • Compounding Aseptic Isolator (CAI) o Designed for compounding pharmaceutical ingredients or preparations • Compounding Aseptic Containment Isolator (CACI) o Designed to provide worker protection • Environmental Sampling o Airborne particles are measured electronically o Volumetric air sampling every 6 months o Surface sampling o Glove fingertip monitoring (USP 797 requires 3 negative samples as evidence of posttraining competency of proper garbing and gloving procedures) • Environmental and Engineering Controls o Is the integration of science and engineering principles to improve the quality of air in aseptic compounding • Cleaning Procedures o Detailed cleaning procedures should be in place o Ceilings, walls, and shelves of buffer area and ante-area must be cleaned monthly o Counters, work surfaces, and floors of buffer area and ante area must be cleaned every day o 70% Isopropyl alcohol is used to clean compounding area • Personnel Cleansing and Garbing o Prior to entering buffer area or segregated compounding area ▪ Remove all personal outer garments (i.e. jackets) ▪ Remove makeup ▪ Remove jewelry ▪ No fake nails permitted ▪ Don PPE in the following order: 1. Shoe covers 2. Hair covers, Facial Hair covers 3. Face masks/eye shields 4. Hand cleaning 5. Disposable non-shedding gown with cuffs at wrists and closure at the neck o Upon entering buffer area or segregated compounding area ▪ Antiseptic hand cleansing with surgical scrub ▪ Put on sterile powder-free gloves ▪ Repeatedly apply 70% IPA to gloves *Note: In the event that you leave the ante room you can hang up your gown so you can use it again during the same shift. However, you cannot reuse your mask, hat, gloves, or shoe covers. When you come back to re-enter the clean room, you should repeat the entire process, with a new gown or the one you hung up, and with fresh shoe covers, hat, mask, and gloves. • Personnel Training and Competency Testing o Garbing o Aseptic technique o Maintaining ISO conditions o Cleaning and disinfecting o Aseptic work skills media fill testing o Personnel glove fingertip testing o Didactic training

Disease states of the lymphatic system:

• Castleman disease - Rare disease of the lymph nodes o Signs and Symptoms: fever, weight loss, fatigue, nausea, night sweats, enlarged liver or spleen, enlarged lymph node • Lymphedema - Localized fluid retention due to a blockage in the lymphatic system o Signs and Symptoms: swelling in affected area either the leg or arm, dimpled skin, swollen lymph nodes • Lymphoma - Cancer of the lymph nodes o Signs and Symptoms: swollen lymph nodes, fatigue, night sweats, shortness of breath, fever • Lymphangiomatosis - Severe disease in which many tumors grow in the lymph system of the body o Signs and Symptoms: fatigue, dizziness, pain

Type of Unit Dose Systems

• Centralized: o Definition: med. cart, one pharmacy • Decentralized: o Definition: satellite pharmacy o Combination of Both

Visual and Quality Control Inspection of Parenteral Products

• Check for particulate matter, crystals, and precipitation. • Isotonicity is important because the injectable solution needs to be isotonic with the blood. • Acid content or the pH of the solution is an important characteristic. • Color and clarity of an IV is an important characteristic. • Hold product in front of well illuminated light or dark background to detect particles • TPNs that contain lipid emulsion are not clear, therefore precipitation cannot be seen.

Drug Names

• Chemical name meaningful to the pharmaceutical chemist • Generic name (nonproprietary) • Brand name (proprietary) • Multiple source products: more than one manufacturer o Prinivil - (Lisinopril) o Zestril - (Lisinopril) Example: • Brand name: Soma • Generic name: Carisoprodol • Chemical name: N-ISO-PROPYL-2-METHYL-2-PROPANESIOL-DICARBAMATE

Closed System Transfer Devices & Environmental Sampling

• Closed system transfer devices should be used for compounding HDs when the dosage form allows • Closed system transfer devices should be used when administering antineoplastic HDs • Environmental wipe sampling for HD surface residue every 6 months o Include areas where contamination from HDs likely o If measurable contamination found identify, document and contain contamination then repeat wipe test

Low-Risk Level CSPs

• Compounded using sterile drugs and sterile devices • Aseptic technique is used • Operations are restricted to aseptically opening ampules, penetrating sterile stoppers on vials, and transferring sterile liquids in sterile syringes to sterile administration devices and packages of other sterile products • Compounded in ISO Class 5 environment or higher • No more than 3 sterile products • Closed or sealed packing systems used while transferring, measuring, and mixing • Not more than 2 entries into each sterile container • ISO 5 engineering control required to be stationed inside an ISO 7 buffer area • PPE to be worn and quality assurance procedures to be followed • Compounding personnel must have annual media-fill and competency testing

Patient Monitoring and Adverse Events Reporting

• Compounding facilities must follow their state regulations and guidelines to clinically monitor patients • Compounding facilities must provide patients a way to address questions and report concerns • Standard Operating Procedure (SOP) manuals at each compounding facility shall have instructions on handling adverse events • Compounding supervisors should quickly and methodically review reports of adverse events to correct and stop future incidences • Encouraged to report to FDA and USP

Encompasses TPNs and Other Multiple-ingredient CSPs

• Compounding happens over a lengthy time period • Administered over numerous days and contain no bacteriostatic agents • Quality assurance practices are the same as low risk level CSPs • Annual media-fill evaluation is more challenging

Urinary Anti-Infectives

• Concentrated in the urine and are used for urinary tract infections (UTIs) Examples: • Nitrofurantoin (Macrodantin, Macrobid®) - Legend Drug- take with food, drink plenty of fluid • Phenazopyridine (Pyridium) - Legend Drug *Note: often given with urinary anti-infectives for urinary pain, discolor urine and should have auxiliary label "May Discolor Urine Red".

Disease states of the cardiovascular system:

• Coronary Artery Disease - Buildup of plaque around the coronary arteries o Signs and Symptoms: nausea, vomiting, back pain, jaw pain, shortness of breath, chest pain, tightness, sweating, dizziness • Congenital Heart Disease - Malformation of the heart at birth o Signs and Symptoms: abnormal heart rhythm, shortness of breath, bluish tint to skin, swelling • Cardiomyopathy - Chronic disease of the heart muscle o Signs and Symptoms: abnormal heart rhythm, fatigue, dizziness, shortness of breath, chest pain, swelling • Endocarditis - Inflammation of the endocardium o Signs and Symptoms: fever, chills, night sweats, fatigue, heart murmur, muscle pain, chest pain

When is counseling by a pharmacist required?

• Counseling is required before dispensing any new medication • Counseling is required if anything has changed such as strength, dose, directions, or administration route Important! A pharmacy technician can perform non-judgmental duties only.

Vials

• Cylindrical shaped plastic containers • Available in variety of sizes • Typically amber in color to protect the contents from light which may cause the contained medication to deteriorate

Authority to Prescribe

• Determined at the state level • State also determines the extent of a practitioner's prescription authority based on the scope of his or her practice Example: o Dentist cannot treat acne o Podiatrist cannot give eye care • Prescribers may write prescriptions for OTC items.

Additional Patient Information Which Should be Maintained

• Diagnosis • Desired therapeutic outcome • Medication use • Herbals used • Dietary supplements used • Adverse reactions • Medical history • Psychosocial history • Patient characteristics • Socioeconomic history • Reimbursement • List of all prescription medications obtained from the pharmacy in the preceding two years • Pharmacist comments relevant to patient drug therapy

Disinfection

• Disinfection should be done at least at the beginning and end of each shift, hourly during operation, and after spills or known contamination. • Use parallel sweeping motions from the back of the hood to the front, not circular motions • Isopropyl Alcohol 70% should be used for cleaning and disinfection

Protective Coverings

• Disposable gloves (double gloving (two pair of gloves) is recommended). • Protective barrier gown or other garment with a closed front, long sleeves, and tight-fitting cuffs. • Potentially contaminated garments or gloves must not be worn outside of the work area and should be disposed of properly. • Wash hands after removing and disposing of gloves.

Non-Essential Items

• Do not introduce items that are not essential for the preparation process into the hood (i.e., paper, pencils, etc.).

Require Strict Inventory Control

• Documentation of Receipt - Commercial invoice • Documentation of Distribution - Narcotic inventory record • DEA Form 222 must be used to purchase or transfer schedule I and II controlled substance • DEA Form 106 is used to report theft or loss of controlled substances • DEA strongly encourages submitting the DEA Form 106 and 222 online • Compounded Products o The label of a compounded product should contain the following: ▪ Name, address, and phone number of the pharmacy ▪ Pharmacist and technician's signature or initials involved in preparation ▪ Prescriber's name ©Pass Assured, LLC | Version 21.c Page | 279 ▪ Date prepared ▪ BUD/expiration ▪ Patient's name ▪ Medication name ▪ Additives ▪ Directions for use When the Americans with Disabilities Act (ADA) was amended in 2010, it clarified instructions on how pharmacies must provide auxiliary aids and services to blind or low-vision customers in order to provide effective communication. This requirement may be in the form of large printed or Braille labels to talking labels.

Parenteral Routes Intradermal (I.D.)

• Drug is injected into the superficial layer of the skin. • Only small volumes (0.2 ml) can be administered by this route. • Generally used for diagnostic test and a limited number of vaccines: o TB skin test o Small pox vaccine Absorption is slow, and therefore onset of action is slow.

Disease states of the integumentary system:

• Eczema - Skin condition with rough, itchy, inflamed patches of skin o Signs and Symptoms: dry, sensitive skin, redness, bumps, flaky, peeling skin . • Impetigo - Contagious bacterial skin infection usually caused by staph. Marked by yellow, crusty blisters o Signs and Symptoms: red sores that rupture and ooze forming a yellow crust • Folliculitis - Inflammation of the hair follicles o Signs and Symptoms: itchy, burning, tender skin, small red bumps or white-heads developed around hair follicles, pus-filled blisters • Psoriasis - Skin condition marked by scaly, red, itchy patches of skin o Signs and Symptoms: rash on the skin, dry skin, redness, scaly skin

Immediate-Use CSPs

• Emergency situations or immediate use only situations • Cannot be stored • No batch compounding • Not more than 3 sterile nonhazardous drugs can be used • Compounding procedure is continuous taking less than one hour • Aseptic technique is used • If not administered within an hour after preparation begins must be thrown out

Disease states of the reproductive system:

• Endometriosis (females) - Occurs when endometrial tissue grows on the outside of the uterus o Signs and Symptoms: painful periods, painful intercourse, painful bowel movements, heavy periods, infertility, bloating, nausea • Pelvic inflammatory disease (females) - Infection of the female reproductive system o Signs and Symptoms: pain in the pelvis, abdomen, lower back and vagina, fever, nausea, cramping, vaginal discharge, abnormal uterine bleeding • Erectile dysfunction (males) - Sexual dysfunction in which the male is unable to maintain an erection o Signs and Symptoms: inability in males to get or keep an erection, anxiety • Benign prostatic hypertrophy (males) - Noncancerous enlargement of the prostate gland o Signs and Symptoms: frequent urge to urinate, increased frequency of urination at night, weak urine stream, inability to completely empty bladder

Elements of Quality Control

• Ensuring quality and safety of CSPs is accomplished through training. • There should be a written employee-training and evaluation program for each site at which CSPs are prepared. • Attention is paid to the integrity of both sterile and nonsterile ingredients, • Written protocols should give guidance on how to inspect components as well as elements to be incorporated. • Written protocols should give the importance of using equipment that operates properly and within acceptable tolerance limits. • Policies and Procedures should have a list of procedures that must be established for the proper use of compounding devices. • Adhering to policies and procedures is the best means of ensuring quality and patient safety.

The Combat Methamphetamine Epidemic Act of 2005 (CMEA) was to regulate, retail over-thecounter sales of:

• Ephedrine (decongestant used illegally to make methamphetamine) • Pseudoephedrine (decongestant used illegally to make methamphetamine) • Phenylpropanolamine products (decongestant used illegally to make amphetamine) Retail provisions of the CMEA include: • Daily sales limits (3.6g/day/per customer) • Monthly purchase limits (9g/30days/per customer) • Placement of product out of direct customer access • Customer ID: (photo identification issued by a State or the federal government) • Employee training • Self-certification of regulated sellers • Sales logbooks (can be written or electronic) require the following Page | 258 ©Pass Assured, LLC | Version 21.c o Products by name o Quantity sold o Names and addresses of purchasers o Signature of purchaser o Date and time of sales Note: If your customer buys a single package containing not more than 60 milligrams of Pseudoephedrine* (one 60 mg tablet or two 30 mg tablets), your customer does not have to sign the logbook. Your customer does not have to show identification. Some states require cough medicines that contain guaifenesin, dextromethorphan and codeine be kept behind the counter, as well emergency contraceptives. Check with your state board of pharmacy for the specific regulations and age requirement to purchase

Alpha Blockers:

• Ergotamine Use: Migraine headaches • Prazosin (Minipress), Legend Drug Use: Blood Pressure • Terazosin, Legend Drug Use: Blood Pressure • Phenoxybenzamine (Dibenzyline), Legend Drug • Doxazosin (Cardura), Legend Drug Use: Blood Pressure • Tamsulosin (Flomax), Legend Drug • Alfuzosin (Uroxatral), Legend Drug Use: treat Benign Prostatic Hyperplasia (enlarged Prostate) • Silodosin (Rapaflo), Legend Drug Use: treat Benign Prostatic Hyperplasia (enlarged Prostate)

Personal Protective Equipment

• Gloves o Powder free o 2 pairs recommended o During batch compounding gloves should be changed every 30 minutes • Gowns o Disposable o Lint free o Low permeability fabric o Closed front o Long sleeves o Tight fitting cuffs • Eye and face protection o Should be worn when splashing or aerosolization possible o Face shields o Respirators • Shoe and hair coverings

Growth Factor

• Granulocyte colony stimulating factor (G-CSF) - makes the body produce white blood cells to reduce the risk of infection after some types of cancer treatment. Store at 2 to 8°C. (must be refrigerated) Examples: o Lenograstim (Granocyte) o Filgrastim (Neupogen, Zarxio, Nivestim, Ratiograstim) o Pegfilgrastim (Neulasta) o Lipegfilgrastim (Longquex)

Storage of HDs

• HDs requiring manipulation must be stored separately from non-hazardous medications (separate refrigerator) in an externally ventilated, negative-pressure room with at least 12 air changes per hour (ACPH) • Non-antineoplastic, reproductive risk only drugs and final dosage forms of antineoplastic HDs may be stored with other inventory if permitted by entity policy

Compounding Considerations

• Handling, preparation, and administration of antineoplastic agents are of special concern because of their mutagenic and suspected carcinogenic effects.

Quinolones

• Have many drug interactions - antacids decrease the absorption and should be given 2 to 4 hours apart. • Cimetidine (Tagamet®) - OTC Drug - increases the effect • Caffeine clearing from the body is reduced • Theophylline levels are increased Side Effects • GI upset • Headache Examples: • Ciprofloxacin (Cipro®) - Legend Drug • Ofloxacin - Legend Drug • Levofloxacin (Levaquin®) - Legend Drug • Moxifloxacin (Avelox®) - Legend Drug, considered a drug of last resort when all other antibiotics have failed. • Gemifloxacin mesylate (Factive®) - Legend Drug

Waste Disposal

• Hazardous waste buckets should be accessible. • Needles used in IV preparation should be disposed in a Sharps Container.

Radiopharmaceuticals

• Highly particulate generating materials, like lead containers, are required to be used for the protection of handlers • Are to be compounded in ISO Class 5 containment device in an ISO Class 8 or higher buffer area • Appropriate radioactivity containment and shielding • ALARA (As Low As Reasonably Achievable) principals must be used

Faxed Prescriptions

• If a Schedule II prescription is faxed it must be followed up with a written prescription within seven days • Must be on the physician's letterhead • Most commonly used by hospitals

Safety Data Sheets (SDS)

• In a workplace, it is mandatory for employers to have SDS accessible for all hazardous agents • SDS database must be observed and updated as part of the overall safety program • The manufacturer or distributer is responsible for providing an SDS the first time a hazardous drug is purchased • Handling precautions, including protective equipment, controls, and spill management linked with the drug should be included on the SDS • Several SDSs are accessible online through the particular manufacturer or through safety information services • Drugs requiring safe handling precautions should be plainly labeled at all times during their transportation and usage.

Intramuscular (I.M.)

• Injection into muscle mass Common sites: • Deltoid muscle in the upper arm (max. volume in adult 2 mL) • Gluteal medial muscle hip (max. volume in adult 5 mL) • Absorption is more rapid than by S.C. • Prolong absorption by using aqueous or oil vehicle

Subcutaneous (S.C.)

• Injections of small volumes are given in the loose tissue beneath the skin: o Generally into the outer surface of arm or thigh o Response is more rapid with S.C. than I.D.

Ways to improve medication adherence:

• Involve the patient in decision making regarding their medications • Simplify medication instructions as much as possible • The pharmacist needs to let the patient know the common side effects • Provide medication calendars or schedules • Recommend tools such as pill organizers and dosing alarms • Recommend patients to enroll in auto refill programs • Schedule follow up appointment with pharmacist to conduct medication review • Send reminders for refills through letters, telephone calls, e-mails, or text messages • For the elderly and disabled, involve the patient's care givers

Criteria required for an Exposure Control Plan, according to OSHA Bloodborne Pathogens Standard:

• It must be written specifically for each facility • It must be reviewed and updated at least yearly (to reflect changes such as new worker) • Positions or technology used to reduce exposures to blood or body fluids) • It must be readily available to all workers Employer must regularly educate workers on the uses of the Exposure Control Plan and where it's kept, so it is available when needed. OSHA requires that SDS preparers provide specific minimum information as detailed in Appendix D of 29 CFR 1910.1200. The SDS preparers may also include additional information in various section(s). • Identification • Hazard(s) Identification • Composition/Information on Ingredients • First-Aid Measures • Fire-Fighting Measures • Accidental Release Measures • Handling and Storage • Exposure Controls/Personal Protection • Physical and Chemical Properties • Stability and Reactivity • Toxicological Information • Ecological Information • Disposal Considerations • Transport Information • Regulatory Information • Other Information

Security Measures

• Keep the pharmacy locked • Locked cabinets, safes • Alarm systems and panic buttons • Cameras which have visuals of entrances, exits, and counter • Thorough screen of all potential employees • Current employees should be regularly audited

Alpha/Beta Blockers:

• Labetalol, Legend Drug Carvedilol (Coreg), Legend Drug Use: Blood Pressure

Authorized personnel with identification:

• Law enforcement officers • Board of pharmacy inspectors • FDA investigators

Prostate Cancer Treatment

• Leuprolide Acetate (Lupron Depot) - Legend Drug, also used to treat endometriosis, uterine fibroids • Estramustine (Emcyt) - Legend Drug • Bicalutamide (Casodex) - Legend Drug • Flutamide - Legend Drug • Nilutamide (Nilandron) - Legend Drug • Darolutamide (Nubequa) Legend Drug • Relugolix (Orgovyx) Legend Drug

Local Hormones vs. Systemic Hormones

• Local hormones are synthesized in various tissue types. • Systemic hormones are produced by one specific tissue (gland). • Local hormones are released and act locally. • Systemic hormones act throughout the body. • Local hormones exert profound changes in the body. • Systemic hormones have a regulatory effect.

Prevent Shadowing

• Make sure you block areas of preparation that must remain sterile from the air flow, so that there is no contamination. • One must be careful not to place hands, equipment, vials, etc., in front of critical areas of preparation products. • "Dead spaces" are created behind objects in the airflow: • Areas on products that must remain sterile should never be placed in dead spaces.

Dose Packs

• Medications packaged to improve patient compliance • Usually provide medication which is taken every day or has complicated instructions • Examples o Month supply of birth control pills o Medrol dose pack

Beta-3 Adrenergic Agonist:

• Mirabegron (Myrbetriq), Legend Drug Use: To treat overactive bladder, bladder hyperactivity, increased urinary frequency, urinary urge incontinence, urinary urgency Side effects: headache, hypertension, UTI, nausea • Vibegron (Gemtesa), Legend Drug Use: To treat urinary frequency, urinary urge incontinence, urinary urgency Side effects: headache, painful urination, nausea

Walk-In Prescriptions

• Most common form of prescription in community pharmacy • Tamper evident

Medium-Risk Level

• Multiple individual or small doses of sterile products are combined to create a CSP that will be administered to several patients or to the same patient multiple times • Complex aseptic operations

Disease states of the muscular system:

• Muscular Dystrophy - Condition that causes progressive weakness and loss of muscle mass o Signs and Symptoms: muscle weakness, trouble walking, falling, loss of ability to sit and lift objects, trouble breathing, scoliosis • Tendinitis - Inflammation of the tendon o Signs and Symptoms: dull pain at the affected site, inflammation, tenderness, swelling • Fibromyalgia - Disease characterized by chronic musculoskeletal pain, stiffness, tenderness, and fatigue o Signs and Symptoms: fatigue, pain, anxiety, depression, memory problems, headaches • Cerebral palsy - Usually caused from damage to the brain before or at birth. It causes impaired muscle coordination. o Signs and Symptoms: floppy muscles, difficulty walking, coordination problems, slow growth, speech disorder, paralysis

Institutional / Long-Term Care Patient Profile Contents:

• Name • Date of Birth (DOB) • Address • Height • Weight • Room number • Patient record number • Primary physician • Allergies • Automatic stop order (are acceptable with antibiotics)

Ambulatory Patient Profile Contents:

• Name • Date of Birth (DOB) • Address • Phone • Insurance • Allergies • Weight for children and infants

High-Risk Level

• Non-sterile ingredients or with non-sterile devices • Sterile ingredients are used but compounding environment is below ISO Class 5 for greater than 1 hour • Personnel are not garbed or gloved properly • Nonsterile water -containing preparations are kept longer than 6 hours before they are sterilized • Purity and content strength of components are not verified but are assumed • Quality assurance procedures conform with low risk level CSPs • Compounding personnel are required twice-yearly to complete a media fill evaluation

Telephone Prescriptions

• Only a pharmacist can transcribe the verbal order (in most states) • Called in prescriptions can come from physicians, physician's assistants, and nurses • Most common for refills

Disease states of the skeletal system:

• Osteoporosis - Bone disease where bones become weak and brittle o Signs and Symptoms: stooped posture, bone fracture, loss of height over time, back pain • Paget's disease - Chronic bone disorder that causes excessive deterioration of bone tissue o Signs and Symptoms: hip pain, overgrowth of skull, weakened bones, nerve root compression in spine • Bursitis - Inflammation of the bursa o Signs and Symptoms: pain, swelling, stiffness, tenderness, and redness in the affected joint • Scoliosis - Abnormal sideways curvature of the spine o Signs and Symptoms: uneven shoulders and waist, one shoulder blade more prominent than the other

Factors that affect medication adherence:

• Patient's ability to read and understand medication directions • Behavioral health conditions • Cultural factors • Gender • Patient can't afford medication • Patient's fear of side effects or adverse events • Patient feels medication prescribed is unnecessary • Difficulty of drug regimen

The compounder is responsible for ensuring that the quality is built into the compounded preparations of products, with key factors including the following general principles.

• Personnel are capable and qualified to perform their assigned duties. • Ingredients used in compounding have their expected identity, quality, and purity. • Compounded preparations are of acceptable strength, quality, and purity, with appropriate packaging and labeling, and prepared in accordance with good compounding practices, official standards, and relevant scientific data and information • Critical processes are validated to ensure that procedures, when used, will consistently result in the expected qualities in the finished preparation. • The compounding environment is suitable for its intended purpose. • Appropriate stability evaluation is performed or determined from the literature for establishing reliable beyond-use dating to ensure that the finished preparations have their expected potency, purity, quality, and characteristics, at least until the labeled beyond-use date. • There is assurance that processes are always carried out as intended or specified and are under control. • Compounding conditions and procedures are adequate for preventing errors. • Adequate procedures and records exist for investigating and correcting failures or problems in compounding, testing, or in the preparation itself.

Possible Prescribers

• Physicians (MD, DO) • Podiatrists (DPM) • Dentists (DDS, DMD) • Optometrists (OD) • Veterinarians (DVM) • Physician assistants (PA) • Nurse practitioners • Medical interns and residents

Parts of a Syringe

• Plunger • Barrel • Tip for needle attachment Luer-lock • Graduated markings for measurement • Top Collar • Flat end (lip)

Delivery systems used in pharmacies to distribute medications:

• Pneumatic tubes • Robotics • Runners

Places to Avoid Touching or Blocking Air Flow during Preparation

• Portions of equipment, containment, and devices which come into contact with the sterile product: • Needle shaft • Inside of needle hub • Syringe plunger • Tip of syringe barrel that attaches to needle hub • Surface of rubber entry on vial, bottle, or bag

Electronic Prescriptions

• Preferred method of prescribing to prevent errors • Transmitted directly to the pharmacy from the physician's office • Saves time and money

Cisplatin

• Preparation of I.V. solutions with any form of aluminum, such as I.V. needles, syringes, or sets having aluminum components should NOT be used in preparation or administration of cisplatin solutions • If Cisplatin becomes in contact with aluminum, a visible black precipitation will form.

Exemptions

• Prescribing physician or patient request non-safety/easy open • Obtain patient's signature in writing • Prescription dispensed to care facilities if staff dispensing • Manufacturers of over-the-counter products are allowed to market non-safety closures on a single size of a product for use by the elderly or handicapped individuals.

Beta-1 Blockers:

• Propranolol (Inderal LA, InnoPran XL), Legend Drug - Can block B-2 Receptors • Atenolol (Tenormin), Legend Drug • Metoprolol (Lopressor), Legend Drug • Nadolol (Corgard), Legend Drug • Timolol (Timoptic, Betimol), Legend Drug • Dorzolamide and Timolol Ophthalmic (Cosopt) - Legend Drug o Combination carbonic anhydrase inhibitor and beta blocker Use: Glaucoma, decrease intraocular pressure and fluid in the eye • Acebutolol (Sectral), Legend Drug • Sotalol (Betapace), Legend Drug • Betaxolol (Betoptic S), Legend Drug • Bisoprolol, Legend Drug • Nebivolol (Bystolic), Legend Drug • Penbutolol (Levatol), Legend Drug • Bisoprolol (Ziac), Legend Drug • Esmolol Hydrochloride (Brevibloc), Legend Drug Selectivity • B-1 receptors affect heart • B-2 receptors affect lungs • B-3 receptors affect bladder

Quality Control

• Quality control is a process of checks and balances. • Quality is defined by what our patients perceive. • Quality improvement is an important part of meeting regulatory agency (e.g., JCAHO) requirement

Receipt and Unpacking of HDs

• Receipt and unpacking must occur in a neutral or negative pressure area

Direct Acting

• Receptor agonists which mimic the effects of endogenous chemicals (Norepinephrine and epinephrine) by combining with receptors in the sympathetic nervous system • Enhance the actions of the sympathetic nervous system Examples: • Phenylephrine (Neosynephrine), OTC Drug, alpha-1 receptors Use: Nasal decongestion, vasoconstrictor • Clonidine (Catapres), Legend Drug, alpha-2 receptors Use: blood pressure • Dobutamine (Dobutrex), Legend Drug, beta-1 receptors Use: Increase cardiac output • Terbutaline, Legend Drug, beta-2 receptors Use: breathing (bronchodilator) • Pirbuterol (Maxair), Legend Drug, beta-2 receptors Use: breathing • Olodaterol (Striverdi), Legend Drug, beta-2 receptors Use: Chronic obstructive pulmonary disease (COPD) • Arformoterol (Brovana), Legend Drug, is a long-acting beta-2 receptor Use: COPD • Levalbuterol (Xopenex), Legend Drug, beta-2 receptors Use: breathing • Salmeterol (Serevent Diskus), Legend Drug, beta-2 receptors Use: maintenance treatment asthma • Albuterol, Legend Drug, beta-2 receptors Use: breathing • Albuterol HFA (Proair HFA), Legend Drug • Epinephrine (Adrenalin), Legend Drug - Non-selective • Norepinephrine (Levophed), Legend Drug - Non-selective Dopamine (Intropin), Legend Drug - Non-selective • Isoproterenol (Isuprel), Legend Drug - Non-selective

Advantages of Unit Dose

• Reduce medication errors • Increase drug use control within institutions • Minimize drug waste and pilferage • Reduce nursing preparation time • More accurate and efficient billing • Fully utilize involved members of the health care team • Enhance or improve the quality of patient care Unit-dose systems provide each patient with a storage bin with a twenty-four hour supply of drugs

Compounding Techniques

• Remember that airflow is downward and it is important not to block the airflow by moving hands or objects over the top of the product being compounded and equipment being used. • Syringes and IV sets with Luer-lock fittings should be used whenever possible. • Vials should not be pressurized by injecting air into them. • If a vial is over pressurized, a spray or spill may occur when removing the needle. • Devices are available, which fit onto vials, and allow air to be injected into the vial without fear of aerosolization of the drug. • When removing a needle from a vial, wrap the needle and injection site of the vial or bag with an alcohol swab to prevent spilling droplets or release of aerosolized drug.

Leucovorin

• Rescue therapy • Some protocols use massive amounts of chemotherapy to kill off cancer cells. This treatment is given over a short period followed by an antidote drug immediately thereafter to spare the normal cells.

Hazardous Waste Containment and Disposal

• Resource Conservation and Recovery Act (RCRA) legislated in 1976, tracks hazardous waste from its beginning to removal • Trace chemotherapy waste: needles, syringes, "RCRA-empty" containers, gowns, gloves, pads, and empty IV sets can be incinerated by a regulated medical waste incinerator • Sharps are disinfected in an autoclave or microwave • Hazardous waste must be collected in leak proof, spill-proof, accurately labeled containers • Glass should be placed in puncture resistant containers • Waste with blood or other body fluids not to be combined with hazardous waste

Safety Measures

• Safety Data Sheet • Policies and procedures for safe handling • Hazardous drugs must be clearly labeled • Personal protective equipment must be worn for the duration of their handling

Low-Risk Level with 12-hour or Less BUD

• Same techniques as defined for low-risk level CSPs, except, ISO Class 5 main engineering control (PEC) is not stationed inside an ISO Class 7 buffer area • Administration must start within 12 hours or less after preparation • Compounding area is isolated from high traffic areas • The ISO 5 PEC cannot be next to a sink • PPE to be worn and quality assurance procedures to be followed • No hazardous drugs

Ways to measures productivity, efficiency, and customer satisfaction

• Set a baseline to measure against • To measure productivity the pharmacy can compare to oneself and/or compare to other pharmacies similar to that pharmacy • Utilize software programs to track how many prescriptions employees dispense per hour. • Spreadsheets can be used to calculate productivity • Collect customer feedback by means of survey • Productivity can be measured by profit

Environment

• Should be compounded in controlled area • Contained rooms with negative air pressure, anterooms, and rooms protected by airlock are preferable • Essential personnel and patients receiving treatment should only have access to administration area • No eating or drinking allowed • Area should be easy to clean and decontaminate • No carpet and upholstery • Break room's location should be located away from area • Hazardous drug spill kits, containment bags, and disposal containers are required to be available

HMG - CoA Reductase Inhibitor and dipeptidyl peptidase-4 inhibitor

• Simvastatin and sitagliptin (Juvisync) - Legend Drug

Water - Soluble Vitamins

• Soluble in water • Excess intake does not usually cause problems since excess amounts are readily excreted Examples and uses Thiamine (Vitamin B1) • Energy production, growth and functioning of nerve tissue, memory and emotional stability • Deficiency can cause beriberi. Riboflavin (Vitamin B2) • Energy production • Synthesis of fats and amino acids Pyridoxine (Vitamin B6) • Role in multiplication of all cells especially red blood cells and the cells of immune system • Needed to synthesize neurotransmitters Drug induced deficiency of this with: o Isoniazid o Hydralazine o Oral contraceptives Cyanocobalamin (Vitamin B12) • Important in carbohydrate and fat metabolism • Necessary for normal growth and formation of healthy red blood cells • Used to treat pernicious anemia Niacin/Nicotinic Acid • Implant in energy producing reactions involving enzymes • Large doses are used to treat elevated cholesterol Ascorbic acid (Vitamin C) • Essential for tooth and bone formation, healthy gums, formation of collagen, resistance to infections, and wound healing • Prevents scurvy • Large doses may cause kidney stones Folic Acid • Used to treat megaloblastic anemia • Used before conception and during early pregnancy reducing the risk of neural tube defects (NTDs.

Components of a Parenteral Product Label

• Solution name, lot number, and volume (note this may be part of the manufacture's label) • Patient name, record number, and room number • Bottle/bag sequence number • Additive names, strengths, and quantities • Date of preparation and initials of preparer • Expiration and initials of preparer • Expiration time and date • Flow rate • Administration: time, date, and by whom • Appropriate auxiliary labels

Class II Biological Safety Cabinets (Vertical Airflow)

• Special aseptic techniques and precautions are necessary because of the downward flow of filtered air. • No admixtures other than antineoplastic medications should be compounded in the designated vertical flow hood. • Should be certified at least annually or any time the cabinet is moved. • Should be operated with the blower on at all times. • Admixture compounding should only take place with the front window down, leaving an opening just high enough to allow the preparer to work comfortably.

Stability Considerations

• Stability time • Appropriate vehicle solution • Light protection • Do not agitate/shake, thoroughly rotate instead

Mailed Prescriptions

• State laws should be observed when mailing or shipping prescriptions • Storage requirements must be observed such as refrigeration • If a patient's DME is paid for by Medicare, it cannot be mailed. DME must be signed for by the patient from the provider if the equipment is being paid for by Medicare. It cannot be mailed. • Most commonly seen as a result of verbally authorized prescription for Schedule II drugs • The US Postal Service may not be used to send controlled substances to patients. FedEx or UPS may be used also.

Location of Sterile Room

• Sterile product preparation room should be free of dust, especially cardboard as a source of particles. • Should be kept away from common routes of personnel traffic.

Sterilization Methods

• Sterilization by filtration o Helps to remove bacteria from large volumes of fluid, especially fluid containing heatlabile components such as antibiotics and solutions of sugars o Most pharmacies use a pore size of 0.2 m • Sterilization by steam o Steam autoclave is the oldest, safest, and most cost-effective method of sterilization in the medical equipment industry o Steam reaches 121-148°C in the pressure chamber at 15 "Pounds per square inch" (P.S.I.) o Sterilization period is dependent on the temperature and size of load and can range from 10-60 minutes • Sterilization by dry heat o Conducted at 160-170°C for a minimum of two hours o Due to its high temperatures, its applicable use is limited • Depyrogenation o Removal of pyrogens and sustainable microbes

Labeling and Packaging

• Storage areas, shelves, bins, and drug packages must be labeled • Separation of hazardous drugs from the rest of the inventory increases control and decreases exposure • Should be stored in space with enough overall exhaust ventilation to dilute and eliminate any airborne pollutants • If hazardous drugs are stored in inventory must be protected from possible breakage by storage in containers that have high fronts and on shelves that have guards to avoid unintentional falling • Should double glove when stocking and inventorying • Staff members should have safety training • Spill kits should be readily available • Warning labels and signs should be universally recognized

Legend Drugs that are Exempt

• Sublingual Nitroglycerin • Sublingual or chewable Isosorbide Dinitrate in strengths of 10mg or less • Packages of Sodium Fluoride products containing 264mg or less • Anhydrous Cholestyramine powder • Packages of Methylprednisolone tablets containing 84mg or less • Packages of Mebendazole tablets containing 600mg or less • Packages of Betamethasone tablets containing 12.6mg or less • Potassium supplements one unit dose forms containing 50 mEq or less • Erythromycin Ethylsuccinate granules in packages of 8gm or less • Erythromycin Ethylsuccinate tablets containing 16gm or less • Packets of Colestipol powder of 5g or less • Containers of aerosol inhalation therapy • Pancrelipase preparations • Packages of Prednisone containing 105mg or less • Oral contraceptives in manufacturers calendar packs • Conjugated estrogen tablets when dispensed in mnemonic dispenser packages containing not more than 32.0 milligrams of the drug Medroxyprogesterone acetate tablets • Sacrosidase (Sucrase) preparations in a solution of glycerol and water • Hormone Replacement Therapy products that rely solely upon the activity of one or more progestogen or estrogen substances

Minerals

• Substances necessary for normal body functions Calcium • Essential for bone and tooth formation • Activating and relaxing smooth muscle • Nerve impulse transmission Example: o Calcitriol (Rocaltrol) - Legend, used for the treatment of hypoparathyroidism Fluoride • Prevention of dental caries Examples: o Lozi-tabs, Phos-Flur Gel-Kam, PreviDent, Poly-Vi-Flor, (Multivitamins with Fluoride). These products are Rx only. Iodine • Used as germicides, antiseptics, and dyes Magnesium • Needed for bone, protein, new cells, clotting blood, insulin function Phosphorus • Blood has excess Potassium • Important for water balance • Regulating muscle contractions • Protein and glycogen synthesis • Nerve transmission • This electrolyte can become depleted with the use of diuretics, coffee, and alcohol Example: • Potassium Chloride (Klor-Con) - Legend Drug Sodium • An essential element for all animal life (including human) and for some plant species • Abundantly found in nature • Most common table salt Iron • Important for the formation of blood and oxygen transport

Antibacterial Sulfonamides (Sulfa Agents)

• Sulfacetamide (Sulamyd®) - Legend Drug • Sulfamethoxazole (Gantanol®) - Legend Drug • Sulfisoxazole (Truxazole) Legend Drug • Acetic Acid - Legend Drug • Povidone - Iodine (Betadine®, Medicated douches) - OTC Product • Hexachlorophene (pHisoHex®) - OTC Product Mupirocin Calcium Cream (Bactroban Cream) - Legend, treats skin infection

Antibiotics

• Synthesized by microorganisms - grown • Can be bacteriostatic or bactericidal Patient Information • Most are taken on an empty stomach (one hour before or two hours after a meal) to ensure proper absorption • Should be taken for the full course of therapy • Certain liquid antibiotics (procaine penicillin G for injection Bicillin L-A) need refrigeration and certain powders need to be reconstituted. Once reconstituted, some of these products should have 10 - 14 day expirations. Mechanism of action • Prevents bacteria from growing Examples: • Penicillins - Legend Drug • Cephalosporins - Legend Drug

Ways to measure customer service productivity:

• The amount of time it takes a customer to be served. This can be in person or on the phone. • The amount of time it takes for a customer's order to be completed • The number of customers that return • The number of customers retained for extended periods of time • The number of products returned • The number of customer complaints received over a certain period of time

formulary

• The formulary listing is typically adapted by individual reimbursement companies as a guide for payment schedules for specific drugs. • Used in institutional facilities • HMO's preferred products reimbursement differential Page | Goals: to manage the cost of rational drug therapy

Single Dose Containers and Multiple Dose Containers

• The main difference between a multi-dose vial and a single-dose vial is a multi-dose vial by definition contains a preservative • Single dose containers in less than ISO 5 conditions must be used within 1 hour • Single dose containers in ISO 5 conditions may use for up to 6 hours • Ampules after opening may not be kept for any period of time • Multiple dose containers have a Beyond Use Date of 28 days unless stated differently by the manufacturer Note that if any type of contamination of a multi-dose vial is suspected, discard the vial immediately

Contamination by Personnel

• The person compounding is the most frequent cause of contamination, followed by contaminated equipment and contaminated raw material. • Proper attitudes and strict adherence to aseptic techniques is essential to reducing the likelihood of contamination. • The first line of defense against infection is proper handwashing

Examples of patient non-adherence:

• The prescriber writes a prescription but the patient never fills it • Patient decides to stop taking the medication without prescriber's knowledge • Patient does not take medication as prescribed • Patient skips doses • Patient forgets to take medication • Patient takes less or more medication than prescribed

Cancer

• The uncontrolled growth and spread of abnormal human cells • Difficult to treat because drugs cannot differentiate between cancer and normal cells and therefore both normal and cancer cells are killed

Other agents - vitamin A used to treat acne

• Tretinoin (Retin-A)- Legend Drug o Also used for wrinkles • Isotretinoin (Absorica, Claravis)- Legend Drug

Measuring and Counting

• Two methods to measure liquids o Conical - Easy to handle, has a wide mouth o Cylindrical - More accurate by using the meniscus Note: use the measuring device closest to the amount of fluid that needs to be measured. This method produces a more accurate measurement. The meniscus should be read at eye level using the bottom of the meniscus. • When choosing use appropriate package for dosage form, perform necessary calculations / verification ▪ Must be checked and verified by a pharmacist ▪ Calculate twice, compound once

Oral syringes

• Unable to accept a Luer-lock needle. They are often used for dispensing liquid medication to children and for dispensing liquid medication in respiratory devices. • Provide an accurate measurement

Antibacterials

• Unlike antibiotics, antibacterials are not synthesized from microorganisms. • Usually bacteriostatic, but some are considered bactericidal Side Effects • Photosensitivity - protect from the sun • Allergy

Allergen Extracts

• Unpreserved allergen extracts must follow all aspects of the USP 797 • Preserved allergen extracts are exempt from some portions of USP 797: o Hand hygiene o PPE used o Simple aseptic transfer o Contain effective amount of preservative o Single patient only o Gloves are disinfected with "Isopropyl Alcohol" (IPA) o Vial stoppers disinfected o Labeling requirements

Disease states of the renal system:

• Urinary Tract Infection - Infection of the kidney, ureter, bladder, or urethra o Signs and Symptoms: persistent urge to urinate, burning when urinating, cloudy urine, blood in the urine, strong smelling urine, urinating frequently • Kidney stones - Hard mass that forms in the kidneys due to high levels of minerals in the urine o Signs and Symptoms: severe pain in the side or back, nausea, vomiting, blood in urine, frequent urination • Nephroptosis - Abnormal condition that occurs when the kidney drops down into the pelvis when patient stands up o Signs and Symptoms: nausea, vomiting, blood in urine, sharp side pain, excessive protein in urine • Polycystic kidney disease - Genetic disorder causing multiple cysts to grow in the kidneys o Signs and Symptoms: back or side pain, feeling of fullness in abdomen, blood in urine, kidney stones, headache, urinary tract infection

Parenteral Bags

• Used to administer infusion medications. This is covered in Aseptic Techniques.

Irrigation

• Used to bathe or flush open wounds or body cavities • Used topically (never parentally) • Use "For Irrigation Only" auxiliary label

Quality Assurance Program

• Used to monitor, evaluate, correct, and improve the compounding of sterile products • Emphasis on improving quality of methods and delivery of patient care • Appropriate follow up after identified problems • Reevaluated annually

Unit Dose

• Used to supply medicine to patients in nursing homes, assisted living centers, or hospitals • Can be filled to provide medication for a designated period of time: 7 days, 30 days, etc.

Miscellaneous

• Vancomycin (Vancocin®) - Legend Drug - is a glycopeptide antibiotic used in serious or severe infections not treatable with other antimicrobials • Sulfamethoxazole and Trimethoprim (Bactrim®, SMZ-TMP®) - Legend Drugs • Imipenem and Cilastatin (Primaxin®) - Legend Drugs - For I.V. use • Bacitracin - topical - Legend Drug- A broad spectrum antibiotic • Metronidazole (Flagyl®) - Legend Drug - used particularly for anaerobic bacteria and protozoa (avoid alcohol)

Ventilation Controls

• Ventilated cabinets • Class II BSCs • Class III BSCs • HEPA filters • Glove boxes • Isolators • Closed-system drug transfer devices

Vinca Alkaloids

• Vinblastine - Legend Drug • Vincristine - Legend Drug • Vinorelbine (Navelbine) - Legend Drug Mechanism of Action • Arrests mitotic division at the metaphase of cell division Side Effects • Bone marrow suppression • Nausea/vomiting • Hair loss

How vaccines work

• When the body is invaded by germs, they reproduce and attack healthy cells in the body which causes infections. The immune system will then fight back. If the outcome is positive, a supply of cells will remain that will identify the disease if the body is exposed again. These cells react rapidly to fight off future infections. • Before the body is confronted with a virus or bacteria, vaccines work by assisting the body develop these cells. Vaccines are either inactivated or live attenuated. • It takes around two weeks for the body to develop antibodies and be effective once a person receives a vaccine.

Personnel Precautions

• While laminar air flow hoods prevent airborne contamination, they do not guarantee a sterile product. • Use precautions to minimize contamination in the product preparation area. • Use strict aseptic technique to avoid introduction of contaminants into the hood.

Ointment Jars

• White plastic jars used to hold ointments and creams • Prevent the penetration of light which may cause the contents to deteriorate • No child-resistant closures

Work Area Utilized

• Work at least six inches within the hood for maximum benefit • Avoid working close to the outer edge of the hood as the product may be contaminated.

Work Practices

• Working in BSCs o Essential material only in workspace o Vertical air flow o HEPA filter (ISO class 5) o Wash hands o PPE should be worn o Front shield should be lowered o 70% alcohol used as disinfectant • Working in Isolators o 70% alcohol used as disinfectant o Cleaning and disinfecting at beginning of each shift o Cleaning and disinfecting between CSP's o Cleaning and disinfect the background environment • Aseptic Technique o *Covered in the Aseptic Techniques section* o Avoid pressurization o Syringe should not be more than three-fourths full • Training and demonstration of proficiency o Aseptic technique o Negative pressure techniques o Regular assessment of competency • Preparation and handling of non-injectable hazardous drug dosage forms o Must be labeled properly o No crushing tablets or opening capsules o Personal protective equipment must be worn • Decontamination, deactivation, and cleaning o Decontamination per manufacturer recommendations o Many SDS of hazardous drugs recommend sodium hypochlorite solution as a suitable deactivating agent o A continuous running ventilated cabinet should be cleaned at beginning of day and regular intervals throughout the day o Cabinets for aseptic compounding must be disinfected at the beginning of the day, at the beginning of each shift, and routinely during compounding • Spill management o Written procedures should be established o Immediate action by trained workers should be taken to contain and clean o Spill kits should be readily available • Worker contamination o Procedures and protocols must be established o Eyewash kits and soap must be readily available o Medical attention