PTCB - Chapter 8 - Compounding - Key Concepts

Compounding

• Extemporaneous compounding is the on demand preparation of a drug product according to a physician's prescriptions, to meet the unique needs of an individual patient
• Compounding is regulated by individual state boards of pharmacy. Some states have their own regulations by many accept standards of the United States Pharmacopeia - National Formulary (USP-NF)

Regulations

• The pharmacist has the responsibility and authority to manage the compounding area
• Ingredients of USP-NF purity or better are to be used when compounding formulation
• A compounding record and formulation record are required for each compounded formulation

Stability and Beyond use dates

• Beyond use dates are required on compounded formulation

Compounding Considerations

• There are four area of considerations when compounding
• whether or not to compound
• before compounding
• during compounding
• after compounding

Equipment

• Class A torsion balances can weigh as little as 120mg of material with a 5% error
• When weighing an amount of ingredient that is less than 120mg, an aliquot or analytical balance can be used

Using a Balance

• Class A torsion balances and electronic balances need to be leveled before weighing ingredients
• Weighing papers or weighing boats should always be placed on the balance pans before weighing ingredient

Volumetric Equipment

• Liquid drugs, solvents, or additives are measured in volumetric glassware or plasticware such as graduated cylinders, syringes, and pipets
• Erlenmeyer flasks, beakers, and prescription bottles, regardless of markings, are not volumetric glassware

Measuring Liquids

• Always use the smallest device that will accommodate the desired volume of liquid
• When reading a volume of liquid against a graduation mark, hold the graduated cylinder so the meniscus is at eye level and read the mark at the bottom of the meniscus

Mixing Solids and Semisolids

• Trituration is the fine grinding of a powder. Levigation is the trituration of a powder drug with a solvent in which the drug is insoluble. Both techniques reduce the drug's particle size
• Geometric dilution must be used when mixing powders of unequal quantity

Compounding Select Dosage Forms

• Aqueous solutions are clear liquids (but not necessarily colorless) made most commonly with purified but which may also contain ethanol, glycerin, or propylene glycol
• Non-aqueous solutions include elixirs, tinctures, spirits, liniments, and oleaginous solutions
• Suspensions are a two phase system consisting of a finely divided solid dispersed in a liquid
• The flavor experience is a complex combination of taste, smell, texture, appearance, and temperature
• An emulsion is unstable system consisting of at least two immiscible (unmixable) liquids, one that is dispersed as small droplets throughout the other, and a stabilizing agent
• There are two major methods of compounding ointments:
• incorporating a drug into an ointment base
• forming the base as a part of the compounding process
• There are three classes of suppository bases defined by their composition and physical properties: oleaginous bases, water soluble or miscible bases, and hydrophilic bases
• When preparing capsules, the smallest capsule capable of containing the final formulation is used since patients often have difficulty swallowing large capsules
• Tablets are compounded in either molded, compressed, or rapid dissolve form

PTCB - Chapter 8 - Compounding - Definitions

Chapter < 795 >
- regulations from USP-NF pertaining to compounding non sterile formulations

Chapter < 797 >
- regulations from USP-NF pertaining to compounding sterile formulations

Compounding record
- a record of what actually happened when the formulation was compounded

Formulation record
- formulas and procedures (ie. recipes) for what should happen when a formulation is compounded

Grade of Chemical

1. Technical (commercial): commercial or industrial quality, generally of indeterminate quality
2. CP (chemically pure): more refined than technical grade, but still of unknown quality; only partial analytical information available
3. USP or NF: meets standards set by the USP-NF
4. FCC: meets specifications of Food Chemical Codex
5. ACS reagent: high purity; meets specifications of the Reagent Chemicals Committee of the American Chemical Society
6. AR (analytical reagent): very high purity
7. HPLC: very high purity; used in high pressure chromatography
8. Spectroscopic grade: very high purity
9. Primary standard: highest purity; used in standard solutions for analytical purposes

Storage Temperature Definitions

1. Freezer ⮞ -20C to -10C
2. Protect from Freezing ⮞ store above 0C
3. Cold ⮞ any temperature not exceeding 8C
4. Refrigerator ⮞ between 2C and 8C
5. Cool ⮞ between 8C and 15C
6. Room Temperature ⮞ temperature in the work area
7. Controlled Room Temperature ⮞ thermostatically controlled at 20C to 25C
8. Warm ⮞ between 30C and 40C
9. Excessive Heat ⮞ any temperature above 40C

Records must be kept for each formulation

• a formulation record
• a compounding record
• standard operating procedures (SOPs) for equipment maintenance, equipment calibration, handling and disposal of supplies, etc
• an ingredients record with certificates of purity and Material Safety Data Sheets (MSDS)

Beyond use date

- a date assigned to compounded prescription beyond which the formulations should not be used

Stability

- the extent to which a dosage form

Aliquot

- a portion of a mixture

Calibrate

- to set, mark, or check the graduations of a measuring device

Sensitivity

- the amount of weight that will move the balance pointer one division mark on the marker plate

* Class A torsion balances have a sensitivity requirement of up to 6mg

* Class A torsion balances have a minimum weighable quantity of 120mg with a 5% error

* Sometimes a prescription calls for less than 120mg of an ingredient. When this happens, the ingredient is mixed with an inert (inactive) powder so that the resulting mix will contain the precise amount of drug needed and also weigh at least 120mg

Arrest knob

- the knob on a balance that prevents any movement of the balance pans

Volumetric

- measures volume. Volumetric vessels are either TD (to deliver) or TC (to contain)

Meniscus

- the curved surface of a column of liquid

Geometric dilution

- a technique for mixing two powders of unequal quantity

Spatulation

- mixing powders with a spatula

Trituration

- the process of grinding powders to reduce particle size

Levigation

- triturating (grind) a powder with a solvent in which it is insoluble to reduce its particle size

Sonification

- exposure to high frequency sound waves

Flocculating agent

- electrolytes used in the preparation of suspensions to form particles that can be easily redispersed

Thickening agent

- an ingredient used in the preparation of suspensions to increase the viscosity of the liquid

Emulsifier

- a stabilizing agent in emulsions

Hydrophilic emulsifier

- a stabilizing agent for water based dispersion mediums

Immiscible

- cannot be mixed

Lipophilic emulsifier

- a stabilizing agent for oil based dispersion mediums

Mucilage

- a wet, slimy liquid formed as an initial step in the wet gum method

Oil in water Emulsion

- an emulsion in which oil is dispersed in a water base

Primary Emulsion

- the initial emulsion to which ingredients are added to create the final product

Water in oil Emulsion

- an emulsion in which water is dispersed in an oil base

Miscible

- capable of being mixed together

Compression molding

- a method of making suppositories in which the ingredients are compressed in a mold

Fusion molding

- a suppository preparation method in which the active ingredients are dispersed or dissolved in a melted suppository base

Finger cots

- protective coverings for fingers

Punch method

- a method for filling capsules by repeatedly pushing, or "punching", the capsule into an amount of drug powder

Capsule size / Liquid volume (mL)

000                 1.37    largest

00                   0.95

0                     0.68

1                     0.50

2                     0.37

3                     0.30

4                     0.20

5                     0.13     smallest

PTCB - Chapter 7 - Routes and Formulations - Key Concepts

Routes and Formulations

• The way in which the body absorbs and distributes drugs varies with the route of administration and the dosage form used
• Enteral refers to anything involving the alimentary tract from the mouth to the rectum. There are four enteral routes: oral, sublingual, buccal, and rectal
• Parenteral refers to anything next to or beside the enteral route. Some parenteral routes use formulations that are injected. Other parenteral formulations do not require injection
• A local effect occurs when the drug activity is at the site of administration (e.g. eyes, ears, nose, skin)
• A systemic effect occurs when the drug is introduced into the circulatory system and carried to the site of activity

Enteral Routes and Formulations

• Oral administration means the dosage form is to be swallowed
• Drugs administered in liquid dosage forms generally reach the circulatory system faster thand rugs formulated in solid dosage forms
• The primary goal of modified release dosage forms is to reduce the number of doses a patient must take per day
• The mouth has two enteral routes of administration: sublingual (under the tongue) and buccal (in the cheek pouch)
• Rectal administration is used for both systemic and local effects. Suppositories, ointments, and solutions are common dosage forms

Parenteral Routes and Formulations

• Some parenteral routes requiring injection for administration are intravenous, intramuscular, intradermal, and subcutaneous. Intravenous solutions must be sterile (bacteria free) and free of particulate material
• Intramuscular injections generally result in lower but longer lasting blood concentrations than with intravenous administration
• The subcutaneous route can be used for both short term and very long term therapies. Insulin is the most important drug routinely administered by this route
• Intradermal administration is used for diagnostics, desensitization, and immunization
• Ophthalmic administration can lead to a significant loss of dose due to spillage and drainage
• Intranasal administration of some drugs produce blood concentrations similar to intravenous administration
• Inhalation dosage forms deliver drugs to the lungs. MDI aerosols, dry powder inhales, and nebulizers are common devices used to administer drugs by this route
• Dermal formulations vary from solutions and lotions to aerosols, ointments, and pastes. Transdermal patches are also common dosage forms
• Vaginal dosage forms (e.g. suppositories, tablets, solutions) are most often used for local effect. However, long term systemic effects can be achieved with IUDs

PTCB - Chapter 7 - Routes and Formulations - Definitions

Local effect
- when drug activity is at the site of administration (ex. mouthwash)

Systemic effect
- when a drug is introduced into the venous (circulatory) system and carried to the site of activity (ex. swallow tablet)

DOSAGE FORMS

• Enteral route
• oral
• buccal (between the cheek)
• sublingual (under the tongue)
• rectal (rectum)
• Parenteral route
• intraocular (eye)
• intranasal (nose)
• inhalation (inhale)
• intravenous, intramuscular, intradermal ➤ injections
• dermal (topically on skin)
• subcutaneous
• vaginal

Disintegration

- the breaking apart of a tablet into smaller pieces

Dissolution

- when the smaller pieces of a disintegrated tablet dissolve in solution

pH

- the pH scale measures the acidity or the opposite (alkalinity) of a substance. Seven is the neutral midpoint of the scale, values below which represent increasing acidity, and above which represent increasing alkalinity

Gastrointestinal Organs and their pH

- stomach (pH 1-2)

- large intestine (pH 7-8)

- small intestine (pH 5-7)

Aqueous

- water based

Solution

- a clear liquid made up of one or more substances dissolved in a solvent

Liquid Formulations

• Solution
• a clear, not necessarily colorless, liquid made up of one or more ingredients dissolved in a solvent. A solvent is a liquid that can dissolve another substance to form a solution
• Aqueous solutions
• are the most common kind of oral solution. Water was used as the solvent
• Nonaqueous solutions
• solutions that predominately contain solvents other than water, either alone or in addition to water
• Syrups
• concentrated or nearly saturated solutions of sucrose (sugar) in water. They are more thicker than water, and contain less than 10% alcohol
• Elixirs
• clear, sweetened, hydroalcoholic liquids intended for oral use. They can contain either alcohol soluble or water soluble drugs. Usually less sweet and less thicker than syrups, and are generally less effective in masking taste. Their alcohol content ranges from 5-40% (10-80 proof), though a few commercial elixirs contain no alcohol
• Spirits or essences
• alcoholic or hydroalcoholic solutions of volatile substances (usually volatile oils) with alcohol contents ranging from 62-85% (124-170 proof). They are most frequently used as flavoring agents but some spirits are used for their medicinal effect
• Tinctures
• alcoholic or hydroalcoholic solutions of nonvolatile substance. Tinctures of potent drugs have 10 grams of the drug in each 100 mL of tincture; they are called 10% tinctures. Nonpotent tinctures generally have 20 grams of the drug per 100 mL of tincture
• Suspensions
• formulations in which the drug does not completely dissolve in the solvent. The drug particles are suspended in the formulation. Since they are intended for oral administration, suspensions are sweetened and flavored
• Emulsions
• mixture of oil and water
• Gels
• made using substances called gelling agents that increase the viscosity of the medium in which they are placed

Emulsifier

- a stabilizing agent in emulsions

Emulsions

- mixture of two liquids that do not mix with each other in which one liquid is dispersed through the other by using a stabilizer called an emulsifier

Buccal

- pouch between the teeth and cheek in the mouth

Sublingual

- under the tongue

Water soluble

- the property of a substance being able to dissolve in water

Hemorrhoid

- painful swollen veins in the anal/rectal area, generally caused by strained bowel movements from hard stools

Buffer system

- ingredients in a formulation designed to control the pH

Necrosis

- increase in cell death

Sterile

- a sterile condition is one which is free of all microorganisms, both harmful and harmless

Syringe needle recommendations

- intravenous 🠊 needle gauge 16-20 🠊 needle length 1-1.5'' 

- intramuscular 🠊 needle gauge 19-22 🠊 needle length 1-1.5'' 

- subcutaneous 🠊 needle gauge 24-27 🠊 needle length 3/8-1''

- intradermal 🠊 needle gauge 25-26 🠊 needle length 3/8''

🠊 needle with smallest number causes coring

🠊 needle with highest gauge hurts less

Intravenous

- injections are administered directly into veins (ex. blood transfusion)

Intramuscular

- injections are administered into muscle tissue and generally result in a slower onset but longer duration of action compared to IV administration (ex. haloperidol)

Subcutaneous

- injections are administered into the subcutaneous tissue of the skin (ex. insulin, vaccines)

Intradermal

- injections are administered into the top layer of the skin at a slight angle using short needles (ex. immunization)

Diluent

- a solvent that dissolves a freeze dried powder or dilutes a solution

Injectability

- the ease of flow when a suspension is injected into a patient

Syringeability

- the ease with which a suspension can be drawn from a container into a syringe

Intravenous administration complications

- thrombus (blood clot) formation can result from many factors: extremes in solution pH, particulate material, irritant properties of the drug, needle or catheter trauma, and selection of too small a vein for the volume of solution injected

- phlebitis, or inflammation of the vein, can be caused by the same factors that cause thrombosis

Colloids

- particles up to a hundred times smaller than those in suspensions that are, however, likewise suspended in a solution

Depot

- the area in the muscle where the formulation is injected during an intramuscular injection

Biocompatibility

- not irritating; does not promote infection abscess

Viscosity

- the thickness of a liquid. A measure of a liquid's resistance to flow

Wheal

- a raised, blister like area on the skin caused by an intradermal injection

Conjunctiva

- the eyelid lining

Lacrimal canalicula

- the tear ducts

Lacrimal gland

- the gland that produces tears for the eye

Ophthalmic

- related to the eye

🠊 normal volume of tears in the eye is 7 microliters

🠊 eye can hold up to 10 microliters without spillage

🠊 ophthalmic ointment tubes are typically small, holding approx. 3.5 grams of ointment

Nasal cavity

- the cavity behind the nose and above the roof of the mouth that filters air and moves mucus and inhaled contaminants outward and away from the lungs

Nasal inhaler

- a device that contains a drug that is vaporized by inhalation

Nasal mucosa

- the cellular lining of the nose

Alveolar sacs (alveoli)

- the small sacs of specialized tissue that transfer oxygen out of inspired air into the blood and carbon dioxide out of the blood and into the air for exhalation

🠊 Particle size is the critical factor with inhalation dosage forms

🠊 Large particles (about 20 microns) hit in the back of the mouth and throat are eventually swallowed rather than inhaled

🠊Particles from 1 to 10 microns reach the bronchioles

🠊 Smaller particles (0.6 microns) penetrate to the alveolar sacs (alveoli) of the lungs where absorption is rapid, but retention is limited since a large fraction of the dose is exhaled

Hydrates

- absorbs water

Percutaneous absorption

- the absorption of drugs through the skin, often for a systemic effect

Stratym corneum

- the outermost cell layer of the epidermis

Contraceptive

- device or formulation designed to prevent pregnancy

Intrauterine device (IUD)

- an intrauterine contraceptive device that is placed in the uterus for a prolonged period of time

PTCB - Chapter 6 - Calculations - Key Concepts

Numbers

• The amount of a drug in its manufactured or prescribed form is always stated numerically - that is, with numbers
• In pharmacy we use two different number systems: Arabic (such as 1, 1/2, 0.5, or 50%) and Roman (such as I, V, X)

Fractions

• Fractions have numerators and denominators; the denominator of a fraction cannot be zero
• Reciprocals are two different fractions that equal 1 when multiplied together
• The least common denominator is needed when adding or subtracting fractions

Decimal Numbers

• Decimal numbers are another way to express fractions
• Calculations with decimal numbers can be less challenging than fractions with numerators and denominators

Significant Figures

• When working with measured amounts, significant figures provide us with information about the sensitivity of equipment used

Measurement

• Common systems of measurement in pharmacy include the metric, English, apothecary, and avoirdupois systems
• The metric system is the primary system used in pharmacy

Equations and Variables

• Equations are used to calculate unknown amounts that are needed to fill prescriptions or calculate dosages
• An equation is a mathematical statement in which two terms are equal

Alligation

• Alligation is a way to solve problems associated with mixing two different strengths of the same ingredient to make a strength that is in between the two starting preparations
• Once the alligation method is mastered, it becomes an easy and quick way to perform difficult calculations that involve mixing different strengths of the same ingredient

Powder Volume

• Some medications are provided to the pharmacy in powder form but are constituted by the pharmacy so they are dispensed in liquid form
• The final volume of the constituted liquid is equal to the volume of the diluent plus the powder volume of the medication

PTCB - Chapter 6 - Calculations - Definitions

Roman Numerals
ss = 1/2
I = 1
V = 5
X = 10
L = 50
C = 100
D = 500
M = 1000

Rule 1 = when the second of two letters has a value equal to or smaller than that of the first, add their values together
         XX = 10 + 10 = 20            DC = 500 + 100 = 600                  LXVI = 50 + 10 + 5 + 1 = 66

Rule 2 = when the second of two letters has a value greater than that of the first, subtract the smaller from the larger
        IX = 10 - 1 = 9                   XXXIX = 30 + 9 = 39                   XC = 100 - 10 = 90


Positional notation
- a system used in Roman numerals whereby the position of the numeral signifies its mathematical value

Denominator
- the bottom or right number in a fraction

Numerator
-  the top or left number in a fraction

Least Common Denominator
- smallest possible denominator for an equivalent fraction so that two fractions can be added or subtracted and have the same denominator

Rules for Assigning Significant Figures

1. Digits other than zero are always significant
2. Final zeros after a decimal point are always significant
3. Zeros between two other significant digits are always significant
4. Zeros used only to space the decimal are never significant

Conversions

- a changing one unit of measure into another so that both amounts remain equal

Liquids

liter = L ⮞ 1 L = 10 dL = 1000 mL

deciliter = dL ⮞ 1 dL = 0.1 L = 100 mL

milliliter = mL ⮞ 1 mL = 0.001 L = 0.01 dL

Solids

kilogram = kg ⮞ 1 kg = 1000 g

gram = g ⮞ 1 g = 0.001 kg = 1000 mg

milligram = mg ⮞ 1 mg = 0.001 g = 1000 mcg

microgram = mcg or ug ⮞ 1 mcg = 0.001 mg = 0.000001 g

Avoirdupois System

pound = lb ⮞ 1 lb = 16 oz

ounce = oz ⮞ 1 oz = 437.5 gr

grain = grain ⮞ 1 gr = 64.8 mg

Apothecary System

gallon = gal ⮞ 1 gal = 4 qt

quart = qt ⮞ 1 qt = 2 pt

pint = pt ⮞ 1 pt = 16 fl oz

fluid ounce = fl oz ⮞ 1 fl oz = 8 fl oz

fluid dram = fl dr, ʒ ⮞ 1 ʒ = 60 min

minim = min or Mx

Household Units

teaspoon = tsp ⮞ 1 tsp = 5 mL

tablespoon = tbsp. ⮞ 1 tbsp. = 3 tsp = 15 mL

cup = cup ⮞ 1 cup = 8 fl oz

Temperature

F = (9/5) C + 32

C = (5/9) (F - 32)

Conversion

1 L = 33.8 fl oz                     1 oz = 28.35 g

1 pt = 473.167 mL                1 g = 15.43 gr

1 fl oz = 29.57 mL                1 gr = 64.8 mg

1 kg = 2.2 lb                         1 tsp = 5 mL

1 lb = 453.59 g                     1 tbsp. = 15 mL

Variable

- an unknown value in a mathematical equation

Flow rate

- the rate (in mL/hour or mL/min) at which a solution is administered to a patient; also known as rate of administration

Concentration

- the strength of a solution as measured by the weight-to-volume or volume-to-volume of the substance being measured

Percents and Solutions

weight-to-volume: grams per 100 mL ⮞ g/100 mL

volume-to-volume: milliliters per 100 mL ⮞ mL/100 mL

Milliequivalent (mEQ)

- the unit of measure for electrolytes in a solution

qs ad

- the quantitiy needed to make a prescribed amount

Total parenteral nutrition (TPN)

- administration of all nutrients intravenously; also known as hyperalimentation

Valence

- the number of positive or negative charges on an ion

Percent Solution Formula

(x volume needed / want %) = (volume prescribed / have %)

Powder Volume

The final volume of the constituted product (FV)

The volume of the diluent (D)

The powder volume (PV)

FV = D + PV

Body Surface Area

- a measure used for dosage that is calculated from the height and weight of a person and measured in square meters

Nomogram

- a chart showing relationships between measurements

Calculation of Children's Doses

Clark's Rule

    (weight of child / 150 lb) x adult dose

Young's Rule

    (age of child / age + 12) x adult dose

Body Surface Area Formula

    (child BSA x adult dose) / avg adult BSA

Determining Selling Prices for Prescriptions

average wholesale price (AWP) + professional fee = selling price

Gross Profit

gross profit = selling price - acquisition cost

Net Profit

Net profit = selling price - acquisition cost - dispensing fee

or 

Net proft = gross profit - dispensing fee

PTCB - Chapter 5 - Prescriptions - Key Concepts

Prescriptions

• A prescription is a written or verbal order from a practitioner for the preparation and administration of a medicine or a device
• Medical doctors (MD), doctors of osteopathy (DO), dentists (DDS), and veterinarians (DVM) are the primary practitioners who write prescriptions. Podiatrists and optometrists are also allowed to write prescriptions. All practitioners must write within the scope of their practice
• In many states, nurse practitioners, physicians assistants, and/or pharmacists are also allowed limited rights to prescribe medications
• In community pharmacies, pharmacy technicians generally the prescription, collect patient data (correct spelling of name, address, allergy, and insurance information, etc) and enter it into a computerized prescription system

Prescription Information

• The pharmacist should be consulted on all OTC and Schedule II prescriptions
• The prescription is entered into the computer and drug-drug, drug-disease, and drug-allergy information is automatically checked by the pharmacy software. If third party billing is involved, this is done only simultaneously

The Fill Process

•  Once the prescription and third party billing is confirmed by the online computer system, the label and receipt are printed and the prescription is prepared
• Since the patient is expected to self administer the medication, the label's directions for use must be clear, unambiguous, and concise
• Pharmacists must provide counseling to patients on all new prescriptions and on any refilled prescriptions when clarification is required. A patient may refuse counseling
• In institutional settings, nursing staff generally administer medications to patients
• Technicians must require the advice of the pharmacist whenever judgement is required

Labels

• Many computerized prescription systems will automatically indicate which auxiliary labels to use with each drug

HIPAA

• The Health Insurance Portability and Accountability Act (HIPAA) contains regulations related to privacy and protected health information (PHI)
• Examples of PHI are name and address, date of birth, Social Security number, payment history, account number, name and address of healthcare provider and/or health plan, and medical or prescription history
• Under HIPAA, pharmacies and other covered entities are required to provide a written notice of their privacy practices to their patients
• A pharmacy may disclose PHI to business associates that perform services for the patient
• All personnel who have access to PHI must be formally trained regarding HIPAA

PTCB - Chapter 5 - Prescriptions - Common abbreviations

Route of Administration

a.d. = right ear                                                p.r. = rectally
a.s., a.l. = left ear                                            p.v. = vaginally
a.u. = each ear                                                inh. = inhalation
o.d. = right eye                                               per neb = nebulizer
o.s., o.l. = left eye                                          SC, subc, subq = subcutaneous (under the skin)
o.u. = each eye                                               IM = intramuscular
p.o. = by mouth                                             IV = intravenous
SL = sublingual, under the tongue                IVP = intravenous push
top. = topically                                              IVPB = intravenous piggyback


Dosage Form

tab. = tablet                                                      syr. = syrup
cap. = capsule                                                  liq. = liquid
SR, XR, XL = slow/extended release             supp. = suppository
sol = solution                                                  crm = cream
susp = suspension                                           ung., oint = ointment


Timing of Administration

bid = twice a day                                            prn = as needed
tid = three times a day                                    a.c. = before food
qid = four times a day                                    p.c. = after food
am/qam = morning/each morning                 stat = immediately
pm = afternoon/evening                                q_h = every _ hour
h.s. = at bedtime


Measurement

i, ii = one, two, etc                                 mcg, ug = microgram
ss = one half                                          mg = milligram
gtt = drop                                               g = gram
mL = milliliter                                       mEq = milliequivalent
tsp = teaspoon (5 mL)                           aa = of each
tbsp. = tablespoon (15 mL)                   ad = to, up to
fl oz = fluid ounce (30 mL)                  aq ad = add water up to
L = liter                                                qs, qs ad = add sufficient quantity


Other

UTD = as directed                          w/ = with
NR = no refill                                 w/o = without
DAW = dispense as written

PTCB - Chapter 5 - Prescriptions - Definitions

Extemporaneous compounding
- the on demand preparation of a drug product according to a physician's prescription, formula, or recipe

Over the counter (OTC) drugs
- medications that do not require a prescription but may be filled with a prescription

Prescription
- an instruction from a medical practitioner that authorizes a patient to be issued a drug or device

The Prescription Process

1.  A prescription is ordered by a prescriber
2. The prescription arrives at the pharmacy
3. Patient and prescriber information is gathered
4. The prescription data is entered into the computer system
5. Insurance and billing information is processed
6. The label is generated
7. The prescription is prepared
8. The pharmacist checks the prescription
9. The patient receives the prescription
10. The pharmacist provides counseling

Signa

- from the latin word signa meaning "to write". It is abbreviated to Sig or S (or left out entirely). It indicates the directions for use and the administration route

DAW (dispense as written)

- a code specifying that the brand name drug, rather than its generic equivalent, is to be dispensed

Schedule II drugs

- drugs that have a high potential for abuse or addiction but that also have safe and accepted medical uses; they require special handling

Health Insurance Portability and Accountability Act (HIPAA)

- a federal act that protects the privacy of individuals and the sharing of protected health information

Protected health information (PHI)

- any personal information that could be used to identify an individual or their health history

PTCB - Chapter 4 - Terminology - Key Concepts

Terminology

• Much of medical science terminology is made up of a combination of root words that originated from either Greek or Latin words, suffixes, and prefixes
• A prefix is added to the beginning of a root word and a suffix is added to the end of a root word to clarify the meaning
• Combining vowels are used to connect the prefix, root word, or suffix parts of the term

Organ System Terminology

• The cardiovascular system circulates blood throughout the body in blood vessels called arteries, capillaries, and veins
• The endocrine system consists of the glands that secrete hormones (chemicals that assist in regulating body function)
• The GI tract contains the organs that are involved in the digestion of foods and the absorption of nutrients
• The integumentary system (ie, the body's covering) is the first line of defense against disease and physical hazards
• The lymph and blood systems are the center of the body's immune system
• The body contains more than 600 muscles that give it shape and produce movement
• The nervous system is the body's system of communication. The neuron (nerve cell) is its basic functional unit
• The skeletal system protects soft organs and provides structure and support for the body's organ systems
• The female reproductive system produces hormones (estrogen, progesterone), controls menstruation, and provides for childbearing
• The male reproductive system produces sperm and secretes the hormone testosterone
• The respiratory system brings oxygen into the body through inhalation and expels CO2 gas through exhalation
• The primary organ of the urinary tract is the kidney; each kidney has millions of nephrons that help remove waste materials and drugs from the blood
• The ear provides the sense of hearing maintains the body's equilibrium
• The eye is the sensitive organ involved in sight. Several body functions are involved in protecting this organ (eg, tear production, blinking)

Drug Classifications / Medical Abbreviations

• The same system used in medical science terminology can be applied to the names given to various drug classes
• There are an estimated 10,000 abbreviations used in medical science. Many abbreviations are specific to an institution or area of the country

PTCB - Chapter 4 - Terminology - Roots

ROOT - BODY

card = heart                         mast = breast

cyst = bladder                     my = muscle

derma = skin                       nephr = kidney

dont = teeth                         neur = nerve

gastr = stomach                   ocul = eye

glyc = sugar                        opia = vision

hemat = blood                     oste = bone

hepat = liver                        ot = ear

lingu = tongue                     partum = bring forth

thorax = chest                      pector = chest

thyroid = thyroid                 pneumon = lung

ven = vein

CARDIOVASCULAR SYSTEM

aneur = widening                oxy = oxygen

angi = vessel                       pector = chest

aort = aorta                         phleb = vein

arter = artery                      stenosis = narrowing

ather = plaque                    thromb = clot

card = heart                        vas (cu) = blood vessel

cyte = cell                           ven = vein

embol = embolus

ENDOCRINE SYSTEM

aden = gland                     pancreat = pancreas

adrena = adrenal               plas = development

crine = to secrete              somat = body

glyc = sugar                     tetan = tetanus

lipid = fat                         thym = thymus

myx = mucus                   thyroid = thyroid

nephr = kidney

GASTROINTESTINAL TRACT

chol = bile                          hepat = liver

col = colon                         herni = hernia

duoden = duodenum          lapar = abdomen

enter = intestine                 orexia = appetite

esophag = esophagus        pancreat = pancreas

gastr = stomach                 pepsia = digestion

hemat = blood                   phag = swallow

INTEGUMENTARY SYSTEM

adip = fat                     mast = breast

cutane = skin               melan = black

derm (at) = skin           necr = death (of cells, etc)

hist = tissue                 pnych = nail

kerat = hard

LYMPH AND BLOOD SYSTEMS

aden = gland              lymph = lymph

bacter = bacteria        phleb = vein

cyt = cell                   splen = spleen

hemat = blood          sepsis = to putrefy

hemo = blood           thromb = clot

leuk = white             thym = thymus

MUSCULAR SYSTEM

burs = bursa

chondr = cartilage

fibr = fiber

my = muscle

rhabdo = rod

tendin = tendon

NERVOUS SYSTEM

alges = pain                    myel = spinal cord

cerebr = cerebrum          neur = nerve

encephala = brain           phas = speech

esthes = sensation           psycho = mind

mening = meninges        somat = body

ment = mind

SKELETAL SYSTEM

arthr = joint                                                  oste = bone

carp = wrist                                                  patell = knee cap

crani = skull                                                 ped, pod = foot

dactyl = finger or toe                                   pelv = pelvis

femor = thigh bone                                      phalang = bones of fingers and toes

fibul = smaller lower leg bone                     scoli = crooked, bent

humer = upper arm bone                              rachi = vertebrae

lord = curve                                                  spondyl = vertebrae

tibi = large, lower leg bone                          stern = sternum, breast bone

FEMALE REPRODUCTIVE SYSTEM

cervic = cervix                           men = menstruation

condyle - knob, knucle              metr = uterus

eclamps = shining forth             ovari = ovary

gynec = woman                         salping = fallopian tube

hyster = uterus                           toc = birth

lact = milk                                 uter = uterine

mamm = breast                         vagin = vagina

mast = breast

MALE REPRODUCTIVE SYSTEM

andr = male                             semin = semen

balan = glands penis               sperm = sperm

crypt = hidden                        vas = vessel duct

orch = testis                            varic = varicose veins

orchid = testis                         test = testis, testicle

prostat = prostate gland

RESPIRATORY SYSTEM

aer = air                                      ox = oxygen

aero = gas                                   pector = chest

bronch = bronchus                     pneumon = lung, air

capn = carbon dioxide               pulmon = lung

cyan = blue                                respire = breath

laryng = larynx                          rhin = nose

nas = nose     sinus = sinus

URINARY TRACT

albumin = protein                 ur = kidney

cyst = bladder                       uresis = urination

glycos = glucose                  ureter = ureter

keto = ketones                     urethr = urethra

lith = stone                          uria = urine, urination

nephr = kidney                    vesic = bladder

ren = kidney 

SENSES - HEARING

acous = hearing                           miring = eardrum

acusis = hearing condition          ot = ear

audi = hearing                             salping = eustachian tube

cerumen = wax like                    tympan = eardrum

labyrinth = inner ear

SENSES - SIGHT

ambly = dim, dull                           ocul = eye

blephar = eyelid                              ophthalm = eye

conjunctiv = conjunctiva                opia = vision

corne = cornea                                opt = eye, vision

glauc = gray                                    retin = retina

irid, ir = iris                                    stigmat = point (ed)

lacrim = tear duct

PTCB - Chapter 4 - Terminology - Definitions

Combining vowel
- a vowel used to connect the prefix, root word, or suffix parts of a term

Prefix
- a modifying component of a term, located at the beginning of the term

Root word
- the base component of a term which gives it a meaning that may be modified by other components

Suffix
- a modifying component of a term located at the end of the term

Diastolic phase / Relaxation phase
- the blood pressure after the heart has completed a pumping stroke

Endocrine system
- a system of glands that secrete hormones into the bloodstream

Systolic phase
- the blood pressure as the heart is pumping blood into the cardiovascular system

Blood pressure
- reported as systole/diastole
- a sphygmomanometer is used to measure blood pressure
- diastole number: over 90 - hyper, below 60 - hypo

Alimentary tract
- the organs from the mouth the to anus. The GI tract is a portion of the alimentary tract

Integumentary system
- the body covering: skin, hair, nails

Lymphocyte
- a type of white blood cell (leukocyte) that helps the body defend itself against bacteria and diseased cells

Flexor movement
- an expansion or outward movement by muscles

Neuron
- the functional unit of the nervous syste,

Osseous tissue
- the rigid portion of the bone tissue

Alveolar sacs (alveoli)
- the small sacs of specialized tissue that transfer oxygen out of inspired air into the blood and CO@ out of the blood and into the air for expiration

Nephron
- the functional unit of the kidney responsible for removing wastes from the blood and producing urine

Conjunctiva
- the eyelid lining

Cornea
- the transport outer part of the eye

Eustachian tube
- the tube that connects the middle ear to the throat

Lacrimal gland
- the gland that produces tears for the eyes

Retina
- the inner lining of the eye that translates light into nerve impulses

Tympanic membrane
- the membrane that transmits sound waves to the inner ear

PTCB - Chapter 3 - Drug Regulation and Control - Key Concepts

Drug Regulation

• In the US, the leading federal enforcement agency for regulations concerning drug products is the Food and Drug Administration
• The distribution of drugs that may be easily abused is controlled by the Drug Enforcement Administration (DEA) within the Justice Department
• Manufacturers' containers for prescription drugs must have this legend on the label: "Rx only"

New Drug Approval

• Before it is approved for marketing, a new drug must be shown to be both safe and effective and that its benefits substantially outweigh its risks
• Placebos are inactive substances used to test the effectiveness of drugs

Marketed Drugs

• Once a patient fir a brand drug expires, other manufacturers may copy the drug and release it under its generic name

Behind the Counter OTC Medications

• Some OTC medications are kept behind the counter even if they do not require a prescription; these include OTC medications containing ephedrine and pseudoephedrine, exempt narcotics, and emergency contraceptives

Sample Labels

• The minimum requirements on prescription labels for most drugs are as follows: name and address of dispenser, prescription serial number, date of prescription or filling, name of prescriber, name of patient, directions for use, and cautionary statements

Controlled Substances

• Manufacturers must clearly label controlled drugs with their control classification
• All prescribers of controlled substances must be registered with the DEA and are assigned a DEA number that must be used on all controlled drug prescriptions

Additional DEA Forms

• Although DEA Form 222 is the most frequently used DEA form, manufacturers, distributors, and dispensers of controlled substances are also required to use other specific DEA forms to register with the DEA and otherwise monitor inventory

Public Safety

• Recalls are, with a few exceptions, voluntary on the part of the manufacturer

Law and the Technician

• Federal laws provide a foundation for the state laws that govern pharmacy practice
• State boards of pharmacy are responsible for licensing all prescribers and dispensers and administering regulations for the practice of pharmacy in the state
• Legal liability means you can be prosecuted for misconduct, including negligence

Ethics and Compliance

• Taking on ethical perspective means examining a situation with moral standards
• Institutions form committees such as institutional review boards to provide guidance on ethical issues and ensure compliance

PTCB - Chapter 3 - Drug Regulation and Control - Extras

1914 Harrison Tax Act
In response to growing addiction to opiates and cocaine containing medicines, the Harrison Tax Act establishes the manufacturers, pharmacists, importers, and physicians prescribing narcotics should be licensed and required to pay a tax

1938 Food, Drug and Cosmetic (FDC) Act
In response to the fatal poisoning of 107 people, primarily children, by an untested sulfanilamide concoction, this comprehensive law requires new drugs be shown to be safe before marketing

1951 Durham Humphrey Amendment
Defines which drugs require a prescription by a licensed practitioner and requires them to include this legend on the label: "Caution: Federal law prohibits dispensing without a prescription" or "Rx only"

1962 Kefauver Harris Amendment
Requires drug manufacturers to provide proof of safety and effectiveness before marketing a drug

1970 Poison Prevention Packaging Act (PPPA)
Requires childhood packaging on all controlled and most prescription drugs dispensed by pharmacies. Non-childproof containers may only be used if the prescriber or patient request one

1970 Controlled Substances Act (CSA)
Classifies five levels of controlled substances that have potential for abuse and therefore restricts their distribution; establishes the Drug Enforcement Administration (DEA) as a division of the Justice Department

1990 Omnibus Budget Reconciliation Act (OBRA)
Among other things, this act requires pharmacists to offer counseling to Medicaid patients regarding medications

1996 Health Insurance Portability and Accountability Act (HIPAA)
Among other things, this act defined the scope of health information that may and may not be shared among health care providers without patient consent and provided for broad and stringent regulations to protect patients' right to privacy. These regulations govern the transfer of patient health information whether it is communicated electronically, on paper, or orally

2005 Combat Methamphetamine Epidemic Act
Establishes strict controls on OTC sales of pseudoephedrine, ephedrine, and phenylpropanolamine

Testing Phases in Humans

• Phase 1: 20 - 100 patients, several months
• Purpose: safety
• Phase 2: up to several hundred patients, several months to 2 years
• Purpose: short term safety but mainly effectiveness
• Phase 3: several hundred to several thousand patients, one to 4 years
• Purpose: safety, dosage, and effectiveness
• Phase 4: for when a drug found another use

Controlled Substances Schedules

• Schedule 1: Drugs with a high potential for abuse and no accepted medical use in the U.S. They may not be prescribed. Heroin, various opium derivates, and hallucinogenic substances are included on this schedule
• Schedule II: Drugs that have a high potential for abuse which may lead to physical or psychological dependence but that also have currently accepted medical uses in the U.S. Amphetamines, opium, cocaine, methadone, and various opiates are included on this schedule
• Schedule III: Drugs with a potential  for abuse less than those in Schedules I and II. These drugs have currently accepted medical uses in the U.S., but their abuse may lead to moderate or low physical dependence. Anabolic steroids and various compounds containing limited quantities of narcotic substances such as codeine are included on this schedule
• Schedule IV: Drugs with low potential for abuse relative to Schedule III drugs. These drugs have currently accepted medical uses in the U.S. but their abuse may lead to limited physical dependence or psychological dependence. Phenobarbital, the sedative chloral hydrate, and the anesthetic methohexital are included in this group
• Schedule V: Drugs with a low potential for abuse relative to Schedule IV drugs. These drugs have currently accepted medical uses in the U.S. but their abuse may lead to limited physical dependence or psychological dependence. Compounds containing limited amounts of a narcotic such as codeine are included in this group

Recall classification

• Class 1: Where there is a strong likelihood that the product will cause serious adverse effects or death
• Class 2: Where a product may cause temporary but reversible adverse effects, or in which there is little likelihood of serious adverse effects
• Class 3: Where a product is not likely to cause adverse effects

Recall Process

1. Reports of adverse effects
2. Manufacturer agrees to recall
3. Customers contacted
4. Recalls listed publicly

Basic values in ethical considerations

1. Autonomy: patients have the right to choose their treatment
2. Beneficence: the actions of the health care provider should be in the best interest of the patient
3. Dignity: the health care provider should treat the patient with dignity and respect
4. Non-maleficence: the health care provider should do no harm in providing care to the patient
5. Justice: fairness and equally should be applied when providing care to all patients
6. Truthfulness and honesty: health care providers should be truthful and honest when providing care to patients