Pharmacy Technician – PTCE (Quickstudy Medical) [1 ed.] 1423238761, 9781423238768

Table of contents :
Certification
The PTCE
Licensure/Registration by State
Laws
Federal Food, Drug & Cosmetic Act of 1938 (FDCA)
Health Insurance Portability & Accountability Act of 1996(HIPAA)
Occupational Safety & Health Act of 1970
Controlled Substance Act of 1970
Poison Prevention Packaging Act of 1970
Drug Listing Act of 1972
Prescription Drug Marketing Act of 1987
Omnibus Budget Reconciliation Act of 1990 (OBRA-90)
Combat MethamphetamineEpidemic Act of 2005
MATH
Alligations
Cross Multiplication
IV Flow Rate/Drip Rate
Dosage Calculations
Roman Numerals
Metric Conversions
Apothecary Measurement Conversions
Sig Abbreviations
Frequency
Quantity
Route
Tapers & Titrations
Topicals
Liquids
Forms
EAR & EYE
Other
TOP 100 DRUGS
Drug Classes
Controlled Substances
Prescription Elements
Transmission
Refills
Records
Pharmacology
Interactions &Contraindications
Adverse Drug Event Reporting
COMPOUNDING
Non-Sterile Compounding (USP 795)
Sterile Compounding (USP 797)
Prescription Intake & Order Entry
Intake
Order Entry
Billing
Fraud, Waste & Abuse
Medicare
Medicaid
Private Insurance & PBMS
Quality Assurance
Refrigerants
Storage
Expired Medication & Returns

Citation preview

WORLD’S #1 QUICK REFERENCE GUIDE

PHARMACY

PTCE

Everything you need to know about passing the PTCE Certification The PTCE The PTCE is computer based and lasts two hours. It has 90 multiple-choice questions that must be answered in the first hour and fifty minutes. The PTCB offers a “blueprint,” with an approximate percentage of questions related to specific content areas. However, there are several versions of the

PTCE exam, and students taking the same test in the same location will receive different versions of the exam. Some may contain more or less of a particular content area than another. Once you have passed the PTCE, you are entitled to use the CPhT designation. You must recertify with the PTCB every two years and complete 20 hours of continuing education (CE) per two-year recertification cycle.

Licensure/Registration by State In addition to the national certification, you may be required to become certified or registered with your state pharmacy board. Each state has different requirements for pharmacy technicians, and some do not require either national certification or state registration.

Laws Federal pharmacy laws are listed below. Individual states also have pharmacy laws. Where they differ, always follow the stricter law. EX: Some medications are considered a controlled substance under state laws, but not federal.

Federal Food, Drug & Cosmetic Act of 1938 (FDCA) • Effectively created the Food and Drug Administration (FDA), giving them the responsibility to approve all new drugs and ensure purity standards by enforcing the rules against adulteration and misbranding. Adulteration includes contamination or failure to meet purity and quality standards. Misbranding includes false, inaccurate, improper, or confusing labeling or if the product is harmful when used according to the label directions. • The FDCA gives the FDA the power to enforce recalls if any product is in violation of these rules. These recalls may occur at the wholesaler, retail, or consumer level. There are three levels of FDA recalls: ––Class I: For risk of “serious adverse health consequences or death.” ––Class II: For risk of “temporarily or medically reversible adverse health consequences” or low-probability of serious adverse health consequences. ––Class III: For products unlikely to have adverse health consequences.

Health Insurance Portability & Accountability Act of 1996 (HIPAA) HIPAA is far reaching and regulates the way health care personnel handle Protected Health Information (PHI). HIPAA defines PHI as any individually identifiable health information. Under HIPAA, pharmacies must: • Ensure the confidentiality of PHI. This includes all manner of transmission, whether written, electronic, or oral (patient counseling, phone calls with providers, etc.). Under HIPAA, pharmacy staff may not disclose any PHI to anyone other than the patient, including spouses and relatives unless the patient has given express consent. • Train pharmacy staff on HIPAA regulations and periodically retrain or update training. • Protect against possible breaches with security measures. • Dispose of PHI in accordance with HIPAA (through measures such as incineration or shredding).

AB6390467.

• Appoint a designated privacy officer. • Inform patients of their privacy rights and how the pharmacy handles their information. • Provide patients with their PHI records if requested. Most importantly, any breach must be reported in a timely manner to the Department of Health and Human Services Office for Civil Rights. If the breach affects fewer than 500 individuals, it must be reported within 60 days of the end of the calendar year. If it affects more than 500 individuals, it must be reported within 60 days of the breach.

6 + 9 + 4 = 19 3 + 0 + 6 = 9 × 2 = 18 19 + 18 = 37 Since the B in the DEA number matches the “B” in Bryant, and the 7 in 37 matches the check digit, this is a potentially valid DEA number.

Schedules (I-V)

Occupational Safety & Health Act of 1970 The Occupational Safety and Health Act of 1970 created the Occupational Safety and Health Administration (OSHA) to ensure the safety of workers nationwide. As it relates to pharmacy, OSHA requires workers to be trained in safety measures, safety sheets to be available for all hazardous substances, and personal protective equipment (PPE) to be worn/utilized when exposure to hazardous substances is possible.

• Requires wholesale distributors to be licensed. • Samples of prescription medication may only be given to licensed prescribers. • Exported prescription drugs may not be reimported.

EX: Illegal drugs such as LSD and heroin

Omnibus Budget Reconciliation Act of 1990 (OBRA-90)

Schedule II: High abuse potential. According to the DEA, use of schedule II drugs potentially leads to “severe psychological or physical dependence.” EX: ADHD drugs such as Ritalin, Concerta, and Adderall; opioid analgesics such as morphine and oxycodone; and synthetic opioids such as fentanyl

This act created formal scheduling of drugs with the potential for abuse and dependency as controlled substances. It led to the creation of the Drug Enforcement Administration (DEA) in 1973 to help with regulatory enforcement.

Schedule III: Moderate abuse and dependency potential. EX: Codeine-containing products (less than 90 mg) and testosterone

DEA Number Calculations

A DEA number is required to prescribe controlled substances except for by military practitioners and employees in public-health services, prisons, and certain long-term care facilities. Each DEA number has its own validation within its digits. Each DEA number consists of two letters and seven digits, enabling you to manually validate a DEA number. Here’s how: • The first letter corresponds to the prescriber’s registration type. • The second letter is the first letter of the prescriber’s last name. • The 1st, 3rd, and 5th numbers are added together, and the 2nd, 4th, and 6th letters are added together and multiplied by 2. Add the two resulting figures together, and the final digit should match the 7th digit, also known as the check digit.

Schedule IV: Low abuse and dependency potential. EX: Benzodiazepines and sleep aids such as Ambien Schedule V: Lowest abuse and dependency potential. EX: Codeine-containing cough syrups, Lyrica, Vimpat

Poison Prevention Packaging Act of 1970 This act requires child safety caps on all dispensed prescriptions. Easy open caps may be used if requested, and a record must be kept of the request.

Drug Listing Act of 1972 This act established rules for all drug manufacturers to supply a current drug list to the FDA. Each drug is assigned its own NDC (national drug code). The NDC is

EX: Dr. James Bryant sends in a prescription with a DEA number of 1

Prescription Drug Marketing Act of 1987

Controlled substances are categorized into five different schedules, according to their potential for abuse and dependency: Schedule I: No accepted medical use/high abuse potential. Note: Cocaine is not schedule I, but schedule II, although it is rarely used medically.

Controlled Substance Act of 1970

unique to the manufacturer and package size; thus, the same medication from different manufacturers (e.g., generics) will each have their own NDC. An NDC is usually broken down into three sections. • The first section refers to the manufacturer or repackager. • The second section refers to the specific drug itself (including strength and form). • The third section refers to the packaging size.

OBRA was a widespread federal deficit reduction budget bill, the pharmacy implications of which initially only pertained to Medicaid recipients. However, as it was up to individual states to determine how to enforce OBRA, most expanded the act to include all patients. Under OBRA, three major requirements are pertinent for pharmacy: • Pharmacists must offer counseling to all patients, documenting patient refusals for counsel. (Under no circumstances should a technician counsel patients.) • Pharmacists must perform a “prospective drug utilization review” (DUR) prior to filling each prescription, which evaluates therapy for potential problems (e.g., interactions, allergies, therapeutic duplication, and other adverse effects). • Record-keeping mandates: Pharmacies must keep patient profiles of medications dispensed for two years on-site.

Combat Methamphetamine Epidemic Act of 2005

• Requires pharmacies to limit sales of over-the-counter medications containing pseudoephedrine or ephedrine to 3.6 grams per purchaser per day and no more than 7.5 grams within a 30-day period. Products containing these ingredients must be kept behind the pharmacy counter or in a locked cabinet and can only be purchased by customers over the age of 18 with a valid photo ID. • Pharmacies must maintain a logbook of each regulated purchase, including the customer’s signature, address, product purchased, quantity purchased, and date and time of the sale. This logbook may be physical or electronic and must be maintained for a period of two years.

MATH Alligations Alligation is a method of calculating quantities needed to produce a mixture with a certain percentage of a drug when you have stock products in two other percentages. Alligation is often referred to as the tic-tac-toe method. EX: I want a 30% solution of substance A. I have a 20% solution and a 50% solution. What mixture will I need of the two solutions to make what I want? In alligation, place the percentage you want in the center of the tic-tac-toe board. Place the higher percentage you have in the top left corner. Place the lower percentage you have in the bottom left corner.

50 30 Subtract the percentage you want from the higher percentage you have and place it in the bottom right corner. Subtract the lower percentage you have from the percentage you want and place it in the top right corner. 10

Multiply diagonal values and place on two sides:

EX: IV is 5 (V) minus 1 (I) or 4. I II III IV V VI VII VIII IX X

250 * x = 5 * 500 or 250x = 2,500 Divide both sides by 250: x = 10 You should give 10 mL three times per day. It may seem easy to calculate these figures in your head, especially when they seem straightforward. But it is always a good idea to doublecheck your mental math with cross-multiplication. Many errors have been prevented by doing so—miscalculating by a single digit could have devastating effects.

20

10 parts of the 50% solution to 20 parts of the 20% solution (this can be reduced to 1:2 parts)

Cross Multiplication Otherwise known as ratio/proportions math, it is a valuable tool that you can utilize for many pharmacy calculations. You can use it for dosage calculations and calculating day supplies and needed quantities. Cross multiplication can be utilized whenever you have three values and are looking for a fourth. EX: You have a prescription for Amoxicillin Suspension 500 mg TID × 10d. The only available suspension you have is 250 mg/5 mL. How many mL should be given three times per day? First, place the known proportion on the left-hand side. Then, set up the right-hand side with the units matching the proportion, with one blank spot being x.

1 2 3 4 5 6 7 8 9 10

XI XII XIII XIV XV XVI XVII XVIII XIX XX

11 12 13 14 15 16 17 18 19 20

XXX XL L LX LXX LXXX XC C D M

30 40 50 60 70 80 90 100 500 1000

Metric Conversions Most numbers and calculations in pharmacy use metric measurements in variants of grams or liters. You can remember the metric prefixes using this mnemonic:

At its core, calculating drip rates can be done by conversions and cross multiplication. Drip rates are usually expressed as drops per minute (DPM). The formula to calculate DPM is:

Kittens Hate Diving Under Dusty Couches Most Mischievously Kittens kilo1000 kilogram kg* kiloliter kL

Total volume (in mL) Drop factor Drops × = Total time (in minutes) 1 mL Minute

The drop factor is usually indicated in drops per mL on the tubing or administration set that you select (e.g., 60 gtts/mL).

Dosage Calculations

30 20

Below are common Roman numerals. When a smaller Roman numeral precedes a larger one, it is subtracted from the larger one.

IV Flow Rate/Drip Rate

20

50

Roman Numerals

250 mg 500 mg = 5 mL x mL

Hate hecto100 hectogram hg hectoliter hL

Diving deca10 decagram dag decaliter daL

Under UNIT 1 gram g* liter L*

Dusty deci.1 decigram dg deciliter dL

Couches centi.01 centigram cg centiliter cL

Most milli.001 milligram mg* milliliter mL**

Mischievously micro.0001 microgram µg*, mcg* microliter µL

*Most frequently used in pharmacy **Also known as cc (cubic centimeter)

QS is a sig abbreviation that stands for “quantity sufficient” and is used when doctors want the pharmacy to calculate the necessary quantity for the duration of the course they have specified. QS is never allowable on controlled substance prescriptions, where the prescriber must specify the quantity. Dosage calculation questions are fairly straightforward and usually consist of how many tablets will be given in a day? and how much of the medication is needed? This is usually a case of simple interpretation of the sig.

In pharmacy strengths, you will most often see milligrams and micrograms. Pay close attention: mg and mcg can look alike in poor handwriting. One drug to pay close attention to is Levothyroxine (Synthroid), which is often labeled in micrograms (but not always). Levothyroxine 100 mcg is the same as Levothyroxine 0.1 mg. Common conversions of household measurements into metric are: one teaspoon one tablespoon one fluid ounce one pint one ounce

EX: Q: How many tablets will be needed for a prescription that reads 3 tablets QID 10d? A: 3 tablets 4 times per day for 10 days. 3 × 4 × 10 = 120 tablets

5 mL 15 mL 30 mL (29.57, but can be rounded for most calculations) 480 mL (473.176) 30 g (28.35)

Apothecary Measurement Conversions Two apothecary measurements you may come across are drams and grains. The vials typically used in a pharmacy are sized according to fluid drams (by volume). Drams are also a unit of weight equal to 60 grains. Rarely, you will come across drugs labeled according to grains rather than milligrams. The typical example is phenobarbital. For conversion, remember that 1 grain (gr, not to be confused with g for gram) equals 64.8 mg.

Q: For a prescription that reads 1 tablet TID, how many tablets would you need to give quantity sufficient for a 30-day supply? A: 1 tablet 3 times per day for 30 days = 1 × 3 × 30 = 90 tablets.

Sig Abbreviations Frequency q qam qpm qhs qd qod, qad qh q12, q12h* q#, q#°, q#h q#–#, q#–#h qw, qweek

every every morning every evening every night at bedtime (hs = hour of sleep) every day every other day every hour every 12 hours every # hours every #–# hours (e.g., q4–6 = every 4–6 hours) weekly

Route bid* tid qid prn**

twice daily three times daily four times daily as needed

ac pc cf stat d/c, dc MDD

before a meal after a meal with food immediately discontinue maximum daily dose after

p¯

*Note: q12 and bid could conceivably produce the same dosing schedule because there are 24 hours in a day; however, they are not equivalent. If a prescriber writes “q12,” they may want to ensure the doses are separated by 12 hours, whereas this is not necessarily the case with “bid.”

- one - two (or

)

- three (or - four (or

) )

**Note: Best prescribing practices is to include a frequency together with prn on orders to prevent overdose. You will often see pain medicine prescribed this way (e.g., q4h prn [every four hours as needed]).

Quantity • qs: quantity sufficient • #: signifies quantity to follow (e.g., #30 is a quantity of 30) • Disp: dispense; signifies quantity to follow • IU: international unit • g: grams • oz: ounces 2

PO NPO RECT, PR VAG, PV AT, top AAA IM SC, SubQ IV SL IN NEB INH

by mouth nothing by mouth rectally vaginally apply topically apply to affected area inject intramuscularly inject subcutaneously intravenously sublingually intranasally via nebulizer by inhalation

Tapers & Titrations Tapers and titrations often consist of lengthy instructions that may not

always fit on the prescription label. If you are unable to reduce the directions to clear and understandable instructions that fit, it may be necessary to provide a separate instruction sheet. Obtain prescriber permission before doing so. You may then write “Take as directed according to taper instructions.” Prescribers know this and will often do the same for their patients. If you receive a prescription that refers to outside instructions (for tapers, bowel prep, or any other medication), make sure to ask the patient if they have a copy of the instructions, and whether they would mind sharing it with you. • ud, ad: as directed

Topicals • ung., oint: ointment • cr: cream

Liquids • tsp: teaspoon • tbsp: tablespoon • oz: ounce • sol: solution • susp: suspension • syr: syrup • liq: liquid

• • • • • • • • •

SR: slow release SA: sustained action CD: controlled diffusion CR: controlled release tab: tablet cap: capsule loz: lozenge supp: suppository amp: ampule

• • • • • •

gtt: drop gtts: drops OU: both eyes OS: left eye OD: right eye AU: both ears

EAR & EYE

Forms • ER, XL, XR: extended release • LA: long acting • DR: delayed release

• AS: left ear • AD: right ear Out of all of the SIG abbreviations, the ones for eyes and ears can sometimes be the most difficult to remember. Perhaps this is because we tend to deal with them less frequently than with tablets and liquids. Here are some tips to help you remember: • S (left) and D (right): The term for left-handed in Latin is sinister. Anecdotally, a left-handed person was influenced by the devil, and so “sinister” came to etymologically acquire evil connotations. The original meaning

persists in OS (oculus sinister) and AS (auris sinistra). • OU/AU: Both of the letters in the abbreviation are vowels, so they mean both eyes or both ears. • O versus A: Look at the shape. The O looks like a staring eye. Note: You need to know these abbreviations because they are still used; however, they are no longer recommended by various patient safety organizations. A badly written “a” can be misread as an “o” and vice versa. On top of that, there are some eye drops that can be used in the

ear and vice versa, and there are eye/ear drops that have the same name, the only difference being eye versus ear formulation. Consult with a pharmacist if there is any confusion, and they may decide to consult with the MD.

Other • K: potassium • NaCl: sodium chloride • NS: normal saline (0.9% sodium chloride) • PCN: penicillin • SMZ-TMP: Bactrim DS

TOP 100 DRUGS There is no guarantee that questions about particular drugs on the PTCE test will fall within the top 100 drugs. But these are the most prescribed drugs and the most important to know about. As you are studying these drugs, pay attenBrand Name (Not All Names Are Listed)

Zestril, Prinivil

Generic Name

Class/What It’s For

ACE inhibitor / hypertension (high blood pressure) thyroid hormones / Synthroid, Levothyroxine hypothyroidism (low thyroid Levoxyl production), goiter “statin” or HMG CoA reductase inhibitor / Lipitor Atorvastatin hypercholesterolemia (high cholesterol) Fortamet, antihyperglycemic, not Metformin Glucorelated to other classes / type HCl phage 2 diabetes (DMII) “statin” or HMG CoA reductase inhibitor / Zocor Simvastatin hypercholesterolemia (high cholesterol) “PPI” or proton pump inhibitor / gastrointestinal Prilosec Omeprazole reflux disease (GERD), erosive esophagitis, heartburn calcium channel blocker / Norvasc Amlodipine angina, hypertension Metoprolol Lopressor, Tartrate, beta-blocker/angina, Toprol XL Metoprolol hypertension Succinate Vicodin, Hydrocodone/ opiate analgesic (narcotic) / Norco, Acetaminopain Lortab† phen† Proventil, Ventolin, Albuterol bronchodilator/asthma ProAir Hydrochloro- thiazide diuretic (water pill) / Microzide, thiazide congestive heart failure, Hydrodiuril (HCTZ) edema, hypertension Losartan angiotensin II receptor Cozaar Potassium agonists / hypertension anticonvulsant / neuropathic Neurontin Gabapentin pain, seizures selective serotonin reuptake inhibitor (SSRI) / Sertraline Zoloft depression, obsessive-comHydrochloride pulsive disorder, PTSD, anxiety loop diuretic (water pill) / Lasix Furosemide congestive heart failure, edema, hypertension Acetaminoanalgesic, antipyretic / pain, Tylenol phen fever beta-blocker / angina, Tenormin Atenolol hypertension “statin” or HMG CoA Pravastatin Pravachol reductase inhibitor/ Sodium hypercholesterolemia penicillin antibiotic / Amoxil Amoxicillin infection Lisinopril

tion to the generic (chemical) name. Names with similar endings are often in the same class, so if you have the top 100 drugs down, you can often make educated guesses about similar sounding drugs. Additionally, since the questions selective serotonin reuptake inhibitor (SSRI) / depression, Fluoxetine obsessive-compulsive Hydrochloride disorder, premenstrual dysphoric disorder selective serotonin reuptake Celexa Citalopram* inhibitor (SSRI) / depression Trazodone serotonin modulator / Desyrel Hydrochloride depression benzodiazepine / anxiety, Xanax† Alprazolam† panic disorders Flonase, corticosteroid / nasal Fluticasone Flovent congestion, allergies Wellbutrin, aminoketone antidepressant / Buproban, Bupropion depression, smoking Zyban cessation beta-blocker / heart failure, Coreg Carvedilol hypertension essential mineral / Klor-Con, Potassium hypokalemia (low K-Tab potassium) Tramadol opioid analgesics (narcotic) / Ultram† Hydrochlopain ride† proton pump inhibitor (PPI) / Pantoprazole gastrointestinal reflux Protonix Sodium* disease (GERD), erosive esophagitis leukotriene inhibitor / Singulair Montelukast asthma prevention, allergies selective serotonin reuptake Escitalopram Lexapro inhibitor (SSRI) / Oxalate* depression, anxiety corticosteroid / anti-inflamDeltasone Prednisone* matory or immunosuppressant “statin” or HMG CoA Rosuvastatin Crestor reductase inhibitor / Calcium hypercholesterolemia non-steroidal anti-inflammaAdvil, Motrin Ibuprofen tory (NSAID) / fever, pain, inflammation non-steroidal anti-inflammaMobic Meloxicam tory (NSAID) / rheumatoid arthritis, osteoarthritis Insulin long-acting insulin / diabetes Lantus Glargine types 1 and 2 HydrochloroZestoretic, thiazide diuretic and ACE thiazide/ Prinzide inhibitor / hypertension Lisinopril benzodiazepine / seizures, Klonopin† Clonazepam† panic disorders non-steroidal anti-inflammaAcetylsalicylic Aspirin tory (NSAID) / pain, fever, Acid inflammation antiplatelet / blood thinner, Clopidogrel Plavix lowers chance of stroke, Bisulfate heart attack Glucotrol, sulfonylurea / diabetes type Glipizide Glucotrol XL 2 anticoagulant / blood Coumadin Warfarin thinner, lowers chance of stroke, heart attack Prozac, Serafem

3

on the PTCE are multiple choice, you may be able to use your knowledge of the top 100 drugs to aid with the process of elimination. Cyclobenzaprine Insulin Humulin R Regular Tamsulosin Flomax Hydrochloride Zolpidem Ambien† Tartrate† Ortho Cyclen, Ethinyl Ortho Estradiol / Tri-Cyclen Norgestimate Flexeril

Cymbalta

Zantac

Effexor, Effexor XR

Advair Oxycontin, Roxicodone† Zithromax Evekeo

Lorazepam†

Zyloprim

Allopurinol

Paxil

Paroxetine

Ritalin, MethylpheniConcerta, date† Metadate ER†

Hyzaar

Femhrt

short-acting insulin / diabetes types 1 and 2 alpha-blocker / improves urination hypnotic / insomnia, sleep disorders progestin and estrogen / contraception

selective serotonin and norepinephrine reuptake Duloxetine inhibitor (SSNRI) / depression, anxiety, neuropathy histamine-2 blocker / acid Ranitidine reducer, gastroesophageal reflux disease (GERD) selective serotonin and norepinephrine reuptake Venlafaxine inhibitor (SSNRI) / Hydrochloride depression, anxiety, panic disorders corticosteroid and Fluticasone/ bronchodilator / asthma Salmeterol attack prevention, COPD opioid analgesic (narcotic) / Oxycodone† pain macrolide antibiotic / Azithromycin bacterial infections central nervous system Amphetamine stimulant / ADHD, Sulfate narcolepsy

Ativan†

Estrace

muscle relaxant / pain

Estradiol Hydrochlorothiazide / Losartan Potassium Ethinyl Estradiol / Norethindrone

benzodiazepine/anxiety xanthine oxidase inhibitor / gout, kidney stones selective serotonin reuptake inhibitor (SSRI) / depression, obsessive-compulsive disorder, anxiety central nervous system stimulant / ADHD, narcolepsy estrogen replacement for menopause symptoms thiazide diuretic and angiotensin II receptor agonist / hypertension estrogen replacement for menopause symptoms

Tricor

Fenofibrate

Inderal, Inderal LA

Propranolol beta-blocker / angina, Hydrochloride hypertension sulfonylurea / diabetes type Glimepiride 2 vitamin / vitamin D Ergocalciferol deficiency

Amaryl Vitamin D2

fibrate/hypercholesterolemia

Nexium

Esomeprazole*

Aldactone

Spironolactone

Claritin

Loratadine

Aleve, Naprosyn

Naproxen

Lamictal, Lamictal XR

Lamotrigine Hydrochlorothiazide/ Triamterene Cetirizine Hydrochloride Sulfamethoxazole/ Trimethoprim

Dyazide, Maxzide Zyrtec Bactrim DS, Septra DS

proton pump inhibitor (PPI) / gastrointestinal reflux disease (GERD), erosive esophagitis potassium sparing diuretic / hypertension, hypokalemia antihistamine/allergies non-steroidal anti-inflammatory (NSAID) / pain, inflammation phenyltriazine (anti-epileptic) / seizures, bipolar disorder diuretic (water pill) / edema, hypertension antihistamine/allergies sulfonamide antibiotic / bacterial infections

“statin” or HMG CoA reductase inhibitor / hypercholesterolemia Diltiazem calcium channel blocker / Hydrochloride hypertension, angina central alpha agonist / Clonidine hypertension

Mevacor

Lovastatin

Cardizem, Tiazac Catapres

Topamax

Topiramate

Augmentin

Amoxicillin / Clavulanate Potassium

Lyrica†

Pregabalin†

sulfamate (anticonvulsant) / seizures, migraines penicillin antibiotic / bacterial infection alpha-2 delta ligand (anticonvulsant) / seizures, fibromyalgia

vitamin B9 / anemia, folic acid deficiency Alendronate bisphosphonate/ Fosamax Sodium osteoporosis Hydrocodone opioid analgesic Hysingla ER† Bitartrate† (narcotic) / pain tricyclic antidepressant / Elavil Amitriptyline depression non-steroidal anti-inflamVoltaren Diclofenac matory (NSAID) / pain fast-acting insulin / Novolog Insulin Aspart diabetes types 1 and 2 bronchodilator / COPD, Spiriva Tiotropium emphysema, asthma attack prevention dibenzothiazepine / Seroquel, Quetiapine schizophrenia, bipolar Seroquel XR Fumarate disorder Enalapril ACE inhibitor / hypertenVasotec Maleate sion Folate

Neosporin, Triple Antibiotic Ointment Januvia Valium, Diastat† Xalatan

Folic Acid

Cipro Symbicort Vistaril Aviane Colace Diovan Propecia, Proscar Zofran

Drug Classes Sometimes it’s easier to memorize the drugs if you see a general breakdown of the classes. Here are some of the most common ones found in the top 200 drugs. Antibiotics

Depression

Blood Pressure

Pain

penicillins sulfonamides cephalosporins macrolides tetracyclines

tri-cyclic antidepressants SSRI SNRI MAOI

diuretics ACE inhibitors angiotensin receptor II blockers calcium channel blockers beta blockers

NSAIDs opioid narcotics COX-2 inhibitors non-narcotic analgesics

Bacitracin / Neomycin / Polymyxin B

topical antibiotic / bacterial infection

Sitagliptin Phosphate

DPP-4 inhibitor / diabetes type 2 benzodiazepine / anxiety, Diazepam† seizures prostaglandin analogue / Latanoprost glaucoma fluoroquinolone Ciprofloxacin antibiotic / bacterial infection corticosteroid and Budesonide bronchodilator / asthma, Formoterol COPD antihistamine / sedative, Hydroxyzine anxiety, hives Ethinyl Estradiol / progestin and estrogen / Levonorgcontraception estrel Docusate stool softener / Sodium constipation angiotensin II receptor Valsartan agonist / hypertension type II 5 alpha-reductase inhibitor / hair loss, Finasteride benign prostatic hyperplasia (BPH) selective 5-HT3 receptor Ondansetron antagonist / nausea and vomiting

*LOOK ALIKE / SOUND ALIKE DRUGS are common in pharmacy, and labels and packaging often use TALL MAN lettering to help distinguish between look alike / sound alike drugs. This is when certain syllables are presented in all capitals to draw attention to differences. EX: Prednisone and prednisolone would be rendered as predniSONE and prednisoLONE, respectively. † Controlled substances

aminoglycosides

Controlled Substances The FDA requires the following to be on all labels for controlled substances: “CAUTION: Federal law prohibits the transfer of this drug to any person other than the patient for whom it was prescribed.” The DEA has specific regulations for controlled substances and how they may be handled and prescribed. Again, as in all other areas of pharmacy, state boards may be stricter.

Prescription Elements All of the following elements must be present: Date written (may not be postdated), patient’s name, patient’s address, drug name, drug strength, drug form, quantity prescribed, directions for use, and the name, address, signature, and registration number (DEA number) of the practitioner. Various state pharmacy boards have different rules as to which elements can be added or changed with or without the prescriber’s authorization. EX: In New York State, a pharmacist may not add a date or quantity even via communication with the prescriber. However, they may change a quantity, but not a date. They may add a patient’s address without prescriber authorization.

Transmission Controlled substances may be prescribed electronically when the transmission system meets all of the DEA’s requirements.

• Controlled substance prescriptions that are printed must be manually signed by the physician. • CII prescriptions may be faxed by the prescriber and considered the original prescription in the following circumstances: ––For immediate parenteral, IV, IM, SC, or intraspinal infusion administration ––For use in a long-term care facility (LTCF must be indicated on the prescription) ––For use in hospice • CIII-V prescriptions may be faxed. • CII prescriptions may be phoned in for emergency supplies only when: ––The immediate administration of the drug is necessary for proper treatment of the intended ultimate user ––No alternative non-controlled treatment is available ––It is not possible for the prescribing practitioner to provide a written prescription for the drug at that time. The prescriber must provide the pharmacy with a “cover” (a written prescription to match the oral order) within 7 days, with “Authorization for Emergency Dispensing” written on it. If the prescriber fails to do so, the pharmacy is required to report it to the local DEA diversion field office. • CIII-V prescriptions may be phoned in (but many states will require a cover).

Refills • CII prescriptions may be partially filled if and only if the remaining portion is supplied within 72 hours (e.g., the pharmacy does not have the full quantity on hand). If the remaining portion is not supplied within 72 hours, then the balance is void, and the prescriber must be notified. • CII prescriptions may not have refills. • CIII and CIV prescriptions may have five refills for up to six months from the date written, whichever comes sooner. • CV prescriptions may be refilled as authorized. • When a controlled substance is refilled at the pharmacy, the dispensing pharmacist must initial and date the back of the prescription along with noting the quantity dispensed. If the prescription was received electronically, the pharmacist must make an electronic note.

Records • Records of CII prescriptions must be kept separately from other prescription records and must be maintained for two years. • When a pharmacy obtains a DEA license, an initial inventory of all controlled substances must be performed and every two years thereafter. • CII prescriptions must be inventoried with exact counts of all open bottles. You may use approximate counts for open bottles of CIII, CIV, and CV pre4

scriptions if the bottle is 1,000 ct. or less (if it is over, you must provide an exact count). A record must be kept of these inventories; however, you are not required to submit the inventories to the DEA. • All controlled substances must have their schedule (CII–CV) printed on the bottle’s label. • CII prescriptions must be ordered on a DEA 222 form in triplicate. Copies 1 and 2 are sent to the supplier, and copy 3 is retained for the pharmacy’s records. Each of these forms has a serial number. Pharmacies may only have six books of seven forms each in their possession. If the forms are lost or stolen, it must be reported to the DEA. The United States Pharmacopeia & National Formulary (USP-NF or USP) • The USP contains monographs detailing strength, quality, purity, packaging, and labeling standards for all drugs and dietary supplements, as well as inactive ingredients and food additives. • Manufacturers (including compounders) of prescription and over-the-counter drugs must comply with USP standards by law. Manufacturers of vitamins, herbs, and supplements may comply and use the designation USP-NF.

Pharmacology Pharmacology is the study of pharmaceuticals and how they act in the body. For the most part, this is knowledge that is the responsibility of the pharmacists and the prescribers. Yet, as technicians, it is important to have a basic understanding of some of the broadest topics of pharmacology. The possibility for error arises from every step of the prescribing process, from incomplete information gathered from patients, to incorrect prescribing, incorrect interpretation, and incorrect dispensing. Since we are part of the dispensing process, pharmacology knowledge will help us to assist pharmacists. Most interactions will be flagged by your pharmacy software, but the system cannot flag information it has not been given, which is why it is extremely important to ask about other medications or supplements patients may be on, diseases they may have, and allergies to be aware of (even food/dye allergies).

Interactions & Contraindications An interaction is anything that can alter a drug’s effect on the body. There are several types of interactions to be aware of: • Drug-disease: Some drugs are contraindicated with certain diseases and may produce unwanted side effects. • Drug-allergy: When a patient has an allergy to a drug or a potential crosssensitivity (e.g., a person with a penicillin allergy has a 10% chance of being allergic to cephalosporins). • Drug-drug: When a drug alters the effect of another. These can be synergistic

(increasing the effects of both drugs) or antagonistic (decreasing the effect of one or both drugs). The interactions can also be metabolic, meaning they change the way another drug is processed in the body. • Drug-dietary supplement, drugnutrient: You should always encourage patients to tell the pharmacist about any over-the-counter medications or supplements they may be using. Additionally, there are some drugs that require dietary restrictions (e.g., patients on certain statins should avoid grapefruit and grapefruit juice). • Drug-laboratory: When drugs interfere with or affect laboratory results. A drug is considered contraindicated with another when an interaction could be severe enough that a therapy change should be considered (one or both drugs d/c’d or changed). A contraindicated drug presents a risk to the patient, but may still be administered with prescriber discretion, given other factors. A drug is absolutely contraindicated when the therapy is inappropriate for any reason whatsoever due to risk for severe adverse reactions or death. Some typical examples of interactions and contraindications to be aware of are: • QT prolongation ––The QT interval is a heart-related measurement. ––A long QT interval can indicate risk for cardiac problems such as arrhythmias and even sudden death. This is a topic still under current study, and there is a growing list of drugs that

prolong the QT interval, such as certain antidepressants and antipsychotics that have traditionally been prescribed together. ––The co-administration of two drugs that prolong the QT interval involves complicated risk assessments that should be conducted between the patient, pharmacist, and the prescriber. • Acetaminophen ––Excessive doses of acetaminophen can cause liver failure. The FDA currently recommends an MDD (maximum daily dose) of 4,000 mg, but a max of 3,000 mg is often recommended on OTC packaging. ––Acetaminophen is contained in many over-the-counter products and prescription products, so if a patient has a prescription for a product containing acetaminophen, make sure to ask them about any other over-the-counter medications they may be taking. • Warfarin ––Warfarin is a blood thinner that interacts with or is contraindicated with many medications, including overthe-counter supplements. The two biggest to watch out for with warfarin are NSAIDs and aspirin. ––A warfarin interaction can cause excessive bleeding and can be extremely dangerous. Patients on warfarin should get routine PT/INR checks done to see whether their dose needs adjustment. ––When a new therapy is started with a drug that interacts with warfarin, the physician may choose to lower

the dose, change therapies, or monitor PT/INR levels more closely for the duration of the therapy. • Digoxin ––Digoxin interacts with certain medications such as verapamil and amiodarone and has the potential for digoxin toxicity. • Metronidazole ––Metronidazole interacts severely with alcohol. Pharmacists recommend that patients not even use mouthwash containing alcohol for the duration of a metronidazole treatment and for three days afterward.

Adverse Drug Event Reporting An adverse drug event is any harm (e.g., allergic reaction, medication errors, and overdose) that is related to medication treatment. There are two primary adverse event voluntary reporting programs: the ISMP-MERP and MedWatch. • ISMP-MERP (or Medication Error Reporting Program) is run by the Institute of Safe Medication Practices (ISMP). ––The ISMP provides pharmacies with other safety measures such as black box warnings, error-prone abbreviation lists, do not crush lists, and suggested tall man lettering. ––All reported information is made available to regulatory agencies and manufacturers. • MedWatch is run by the FDA and is entered into their database: FAERS (FDA Adverse Event Reporting System).

COMPOUNDING Compounding occurs both in retail pharmacies and hospital pharmacies and can be performed by practitioners or pharmacists (or interns and technicians under the supervision of a pharmacist). • Compounding: Mixing two or more products together to arrive at a formulation that is not otherwise available. • The USP (United States Pharmacopeia) provides proprietary standards for both sterile and non-sterile compounding as well as monographs for many pre-established compounding formulations. • Compounded products are subject to beyond use dating (BUD), which is dictated according to the compounding procedures and is not the same as a manufacturer’s expiration date. The maximum length of a BUD is either 6 months or 1 year, depending on the state board of pharmacy.

suppositories or custom-made capsules. Scales must be inspected annually by the department of taxation.

Non-Sterile Compounding (USP 795) Repackaging is considered compounding under the USP and must be performed according to USP standards, including labeling. • Repackaged labels must include the generic name of the drug, strength, dosage form, manufacturer, lot number, and beyond use date. • Pharmacies that repackage must maintain a log containing all of this information in addition to the date, manufacturer’s original expiration date, quantity repackaged, pharmacy tech’s initials, and the signature of the pharmacist. Other types of non-sterile compounding include reconstitution of powdered antibiotics or injectables, admixtures of topical applications, and preparation of

Sterile Compounding (USP 797) The sterility of compounded sterile products (CSPs) depends on aseptic technique and a sterile (typically ISO class 5) environment. • All sterile compounding personnel must be trained and pass both written and procedural examinations at least annually. • Sterilization of materials may be completed through filters, dry heat, or autoclaving. Procedures are determined by whether the CSP is considered a low, medium, or high risk of contamination. The higher the risk of contamination, the stricter the time limits are for storage before administration.

• Special PPE to cover clothing and prevent particle shedding is donned in order from dirtiest to cleanest areas. All personal outer garments must be removed, including jewelry and cosmetics. USP provides an appropriate order of garbing that must be followed in the buffer area. • A laminar flow hood may be vertical or horizontal and directs HEPA filtered air over the CSP and toward the user to prevent any particles from the user from contaminating the CSP. Flow hoods should be running for at least 30 minutes before use. • Negative pressure isolation rooms are used to store radioactive materials and other hazardous substances. In these rooms, the air pressure is lower than surrounding rooms, thus preventing airflow out of the room.

Prescription Intake & Order Entry Intake The pharmacy technician is the first source ensuring that all the necessary information is gathered. When you are presented with the prescription, you should verify that all of the necessary elements are present. Required elements: • Patient’s full name • Patient’s address (pharmacy may add if not present) • Prescriber’s name • Prescriber’s address

• Prescriber’s phone number • Prescriber’s identification numbers (DEA [if controlled] and/or NPI) • Date of prescription (check to ensure it is not expired—one year for noncontrolled substances) • Drug name • Drug strength • Drug form • Directions for use • Route of administration • Dispense quantity • Number of refills • Signature of the prescriber

• DAW (dispense as written) if required If one or more of these elements are missing, notify the pharmacist, who will decide whether they are able to get clarification from the physician or whether they will refuse the prescription. In addition to these elements, there are pieces of information you should ask the patient for: • Date of birth • Any known allergies (medication or otherwise) • Whether they have had this medication before • Whether their insurance has changed 5

or they have received any new insurance cards

Order Entry Each pharmacy software system is different as to which information you need to input first. 1. Usually, you will need to select the right patient first. Verify the spelling of the patient’s name and date of birth. Always double check every piece of information as you go along, and then double check again once the entire prescription has been entered.

PRESCRIPTION INTAKE & ORDER ENTRY (continued) 2. If the patient has any allergies, be sure they are entered into the system before processing the rest of the prescription, or else your software will not know to flag a potential allergy interaction. 3. When selecting the right drug, be very certain that you are choosing the correct name (and not a look alike / sound alike drug), the correct strength, and the correct form. Be careful not to choose an ER formulation when an immediate release version was prescribed and vice versa. 4. At this point, you may need to select the appropriate DAW code. These are required by Medicaid and many Medicare part D plans; however, some states require them for all prescriptions. The codes are as follows: 0 1 2 3 4 5 6 7 8 9

no product selection indicated substitution not allowed by prescriber substitution allowed—patient requested brand substitution allowed—pharmacist selected product dispensed substitution allowed—generic drug not in stock substitution allowed—brand drug dispensed as generic override substitution not allowed—brand drug mandated by law substitution allowed—generic drug not available in marketplace other

5. You may need to perform a day supply calculation, depending on if your software does it for you or not. Day supply = Quantity of the drug ÷ Dose ÷ Number of times per day a dose is given. EX: If you have a prescription written for 120 tablets, 3 tablets 4 times a day, divide 120 by 3 by 4, or a 10-day supply. Note: Prescribers most often write for 30-day supplies, and if a 10-day supply seems odd, it’s possible that the prescriber did not write for the correct quantity, particularly if there are refills. This may be something to check with the pharmacist. 6. The day-supply process works the same with liquids, but always ensure that the quantity measurement and the dose measurement are the same as you are calculating the day supply. EX: Insulin often comes in 10 mL vials, but the directions will be for a certain number of units. You must first determine how many total units are in the vial before you are able to calculate a day supply. 7. At some point in the process, usually after all of the information has been entered, the system will perform a DUR (drug utilization review). This checks the current prescription against the patient’s prescription history and flags potential allergy interactions, drug-drug interactions, or therapeutic duplications. If anything comes up during the DUR, it is important that you note the specific wording of the notification, and the drug or problem that the DUR is flagging against. Notify the pharmacist, who may choose to halt the prescription, do further research, or continue to fill the prescription. Sometimes a DUR may produce an alert that will require prescriber approval in order to continue. 8. After the DUR, the prescription will go through adjudication (insurance / claims billing process). Ensure that you have all of the correct insurance information. The minimum amount of information you will need to successfully process a claim is the BIN (business identification number), patient identification number, and the PCN (processor control number).

Billing Fraud, Waste & Abuse The Centers for Medicaid and Medicare Services (CMS) requires that all pharmacy personnel undergo yearly fraud, waste, and abuse training and keep a record of their certification. The difference that CMS distinguishes involves intent and knowledge. Fraud is considered a crime and is subject to significantly high fines and/or prison time, while waste and abuse are not. In order for pharmacies to accept Medicare, CMS requires an established compliance program with a designated compliance officer to ensure this training is completed along with other CMS regulations. • Fraud: Entails the intent and knowledge of presenting false claims or information. This can be on the part of the pharmacist, the doctor, or the patient. ––Pharmacies billing for prescriptions they did not dispense or altering or misrepresenting claims in order to receive a higher payment is fraud (including altering day supply or other aspects of a claim in order to push an adjudication through). ––Patients presenting forged prescriptions or misrepresenting their need for a medication to a doctor is fraud. –– Physicians knowingly writing unnecessary prescriptions or sending in claims for services they did not provide is fraud. • Waste: Entails the misuse of or overuse of services. • Abuse: Similar to fraud in actions (incorrect or misrepresented billing, or billing unnecessarily), but is unintentional. Several laws apply to FWA: • Anti-kickback statute: Prescribers may not pay or receive money or gifts in exchange for referrals. • Civil false claims act: Applies to fraud. • Stark statute: Prohibits physicians from self-referrals to organizations they have a financial interest in (e.g., obtaining medical services from their own practice).

Medicare Patients age 65 or older as well as disabled patients are eligible for Medicare coverage. • Part A covers hospital care. • Part B is generally used for medical care, but certain things like vaccines, diabetic test strips, and durable medical equipment, in addition to certain specialty drugs are covered by Medicare part B. • Part D covers normal prescription products and consists of many separate private plans. ––As opposed to parts A and B, patients must enroll in part D. It is not automatic.

––Pharmacies may not suggest particular part D plans to patients when they are looking at enrollment, but they can provide information and resources. ––Part D plans will often have a donut hole, or a period of time in which a patient has utilized all of their initial coverage and is responsible for either 80% or all of their prescription costs until they reach the out of pocket limit and obtain catastrophic coverage. ––Part D plans vary widely in their formularies (lists of covered drugs) and their level of coverage.

Medicaid Medicaid provides coverage for children, pregnant women, the elderly, disabled, and low-income people. • Although Medicaid is a federal program, it is jointly funded by the federal government and individual states, and thus specific rules for coverage vary greatly among different states. Medicaid formularies may include preferred manufacturers and even preferred count bottles (unlike private insurance), chosen according to calculated costs. EX: You may get a rejection for lisinopril 20 mg, a very common drug, because you chose a 100-count stock bottle when Medicaid prefers a 1,000-count bottle. It would be considered fraud to change your NDC choice in the system to the 1,000-count bottle if you only have 100-count bottles. • Medicaid may carry minimal copays. However, if a Medicaid patient is unable to pay, it is illegal to refuse them their medication. They may waive their copays and be billed at a later date; however, many pharmacies decide to eat this cost.

Private Insurance & PBMS Private insurance companies are the typical coverage one would receive from a workplace. • PBMs or Pharmacy Benefit Managers are companies that are often attached to private insurance that manage the prescription benefit portion of private insurance. • The primary purpose of PBMs is to reduce costs through methods such as step therapy (requiring patients to try cheaper alternatives before more expensive ones), quantity limitations, copay tiers, and prior authorizations. In addition, they negotiate allowable claim amounts with in-network pharmacies.

Quality Assurance Refrigerants Refrigerants (e.g., biologics, insulin) each have specific storage criteria outlined in the supplied manufacturer inserts, some allowing for up to 60 days out of refrigeration at the consumer level. Excursions may be permitted, but due effort must be made to store these products in the refrigerator as soon as they are received.

Storage Pharmacies are responsible for maintaining their own quality assurance procedures. Many factors affect a drug’s stability, including humidity, light, temperature, ingredients, and the packaging materials. • USP storage temperatures (USP 659) must be maintained according to manufacturer recommendations,

U.S. $6.95 Author: Sarah Liu, MA, CPhT

NOTE TO STUDENT: This guide should only be used as a quick reference and supplement to course work and assigned texts. BarCharts, Inc., its writers, editors, and design staff are not responsible or liable for the use or misuse of the information contained in this guide. All rights reserved. No part of this publication may be reproduced or transmitted in any form, or by any means, electronic or mechanical, including photocopying, recording, or any information storage and retrieval system, without written permission from the publisher. Made in the USA ©2018 BarCharts, Inc. 0818

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and all storage facilities for controlled temperatures must be regularly inspected and documented. The ranges are as follows (in Celsius). ––Freezer: -25° and -10° ––Cold: Not exceeding 8° ––Refrigerator: Between 2° and 8° ––Cool: Between 8° and 15° ––Controlled cold temperature: Refrigerated with excursions between 0° and 32° during storage, shipping, and distribution ––Room temperature: The temperature prevailing in a working area ––Controlled room temperature: Between 20° to 25° with excursions between 15° and 30° during storage, shipping, and distribution ––Warm: Between 30° and 40°

Expired Medication & Returns All pharmacies must have a system in place to periodically check for expired and soon-to-be-expired medications within their stock. Stock should always be rotated so that product with the earliest expiration date is used first. Once identified, expired medications must be separated from the rest of the inventory until they can be processed. Pharmacies may often have contracts with their distributors that allow them to return expired medication for partial credit. Opened bottles may not be returned. Approved Drug Products with Therapeutic Equivalence Evaluations (The Orange Book) is the FDAʼs database of all approved drugs. Look up drugs by name, dosage form, manufacturer, or route of administration.