PTCB Exam Notes

Hazardous Materials

Any chemical or drug that poses potential harm to the person preparing or coming in contact with it, requiring proper handling and storage as per OSHA standards.

Federal Requirements

Federal requirements refer to the regulations and laws set forth by federal agencies, such as OSHA or the Environmental Protection Agency (EPA), which govern the safe use, management, storage, and disposal of hazardous materials to protect public health and the environment.

Types of Hazardous Materials

Hazardous materials can be classified into various categories including flammable, corrosive, reactive, and toxic substances.

OSHA Standards

The Occupational Safety and Health Administration (OSHA) provides regulations and guidelines to ensure safe handling, storage, and disposal of hazardous materials.

Hazard Communication Standard

A standard developed by OSHA to ensure that information about chemical hazards is communicated to workers through labels and safety data sheets.

Personal Protective Equipment (PPE)

Specialized clothing or equipment worn by workers to protect against hazardous materials, including gloves, goggles, and respirators.

Emergency Response Plan

A protocol that outlines steps to be taken in the event of a hazardous materials spill or exposure, including evacuation procedures and reporting requirements.

Hazardous Materials

• Hazardous materials, defined as chemicals or drugs posing harm, must be handled with caution and proper PPE as per Safety Data Sheets (SDS).

• Products should be stored separately in leakproof containers labeled "hazardous drug waste." Use emergency equipment (eyewash, showers) in case of accidental exposure. Report incidents to a supervisor.

Non-Hazardous Materials

• Non-hazardous materials should be disposed of correctly to prevent environmental harm. While they may not pose immediate risk to individuals, they can impact waterways if improperly disposed. Options include solid landfill or incineration.

Pharmaceutical Substances

• Pharmaceutical substances are medications or ingredients for therapy. Hazardous pharmaceuticals include medications like warfarin and methotrexate. Non-hazardous substances include drugs like amoxicillin and atorvastatin. Expired pharmaceuticals can be returned for reverse distribution, while sharps must go in a designated container.

Controlled Substances

• Controlled substances are medications with high abuse potential, regulated by the DEA. They require strict inventory management and controlled movement from manufacturer to patient. Schedule II prescriptions must be electronic or handwritten; refills are not allowed. Schedule III-V prescriptions have different handling guidelines and can be transferred under certain conditions.

DEA Controlled Substances Schedules

• Schedules I-V categorize substances by potential for abuse, with Schedule I having no accepted medical use, and Schedule V carrying the least risk.

Calculations Involved

• Knowledge of days supply calculations is crucial, particularly for opioid prescriptions, which should not exceed 100 morphine milliequivalents (MME) combined. Example: 84 oxycodone tablets prescribed for chronic pain equals a 28-day supply and meets MME guidelines.

Controlled Substances Act of 1970

A federal law regulating the manufacture and distribution of controlled substances in the United States.

DEA

Drug Enforcement Agency, responsible for enforcing controlled substance laws and regulations.

DEA Number

A unique identification number assigned to practitioners and pharmacies for prescribing and dispensing controlled substances.

Scheduling of drugs

The classification of drugs into different categories (I-V) based on their potential for abuse and medical use.

Prescription Monitoring Program (PMP)

A state-run program that tracks prescribed controlled substances to prevent misuse.

Black Box Warning

A warning required by the FDA on certain medications indicating serious potential adverse effects.

Opioid Analgesic Risk Evaluation and Mitigation Strategy (REMS)

A program mandated by the FDA to ensure safe use of opioid medications.

Reverse Distribution

The process of sending outdated or unusable drug products back to manufacturers for disposal.

DEA 222 Form

A specific form used for ordering Schedule II controlled substances.

DEA 106 Form

A form that must be filled out when controlled substances from Schedules II-V are lost or stolen.

Restricted Drug Programs

Programs that establish criteria for prescribing potentially harmful medications to certain patient groups, such as pregnant women.

Risk Evaluation and Mitigation Strategies (REMS)

A program designed by the FDA to ensure the safe use of medications by requiring specific precautions and monitoring.

Isotretinoin Safety and Risk Management Act

Legislation that mandates blood tests and counseling for isotretinoin patients to avoid risks, particularly teratogenic effects.

Recall Classifications

FDA classifications of drug recalls: Class I (likely to cause severe health consequences), Class II (may cause temporary health issues), Class III (not likely to cause adverse effects).

Maximum Pseudoephedrine Purchase

An individual can legally purchase up to 3.6 grams (or 146 tablets of the base chemical) per day from pharmacies, due to CMEA restrictions.

Medical Device Recalls

Recalled medical devices can include insulin pumps, glucose meters, and infusion pumps due to defects or health hazards.

Common Recall Reasons

Reasons for medication recalls include contamination, mislabeling, product impurities, and adverse effects after market release.

Generic Names

Lower-cost versions of brand name drugs, typically after the original patent expires.

Brand Names

Shorter, trademarked names for drugs used for advertising after their patent protection.

Medication Classifications

Categories of drugs based on their mechanism of action and effects on the body.

Therapeutic Equivalence

Designated when two drug products meet FDA criteria allowing substitution of a generic for a brand name drug.

Drug Interactions

Potential effects when two or more drugs are taken together, ranging from mild to life-threatening.

Drug-Disease Interaction

When a medication used for one disease may worsen another condition.

Drug-Drug Interaction

Interactions between prescription drugs that can affect the efficacy or safety of the medications.

Drug-Dietary Supplement Interaction

Potential interactions between drugs and vitamins or supplements that can alter drug efficacy.

Drug-Nutrient Interaction

Effects that food or nutrients have on the absorption and effectiveness of medications.

Dosage Forms

Physical forms of drugs, including tablets, capsules, solutions, and topical preparations.

Administration Routes

Ways a drug is delivered to the body, including oral, topical, or injection methods.

Calculations in Pharmacy

Mathematical computations necessary for determining dosages, strengths, and therapy duration.

1 mL = 20 drops

Conversion factor used in pharmacy calculations.

1 teaspoon = 5 mL

Common measurement conversion in pharmacy.

1 kg = 2.2 lb

Conversion used for weight measurement in pharmacy calculations.

Duration of Drug Therapy

Determined by diagnosis and patient-specific factors; can vary from chronic to acute treatment.

Adverse Effects

More severe reactions to drugs that may warrant discontinuation of therapy or emergency medical attention.

Side Effects

Unwanted and often mild reactions to medication that can be predicted based on a drug's mechanism of action.

Narrow Therapeutic Index (NTI) Medications

Drugs where small differences in dose or blood concentration may lead to serious therapeutic failures or adverse drug reactions.

Allergic Reactions

Less predictable reactions to drugs, which can be life-threatening and account for about 10% of drug side effects.

Reconstitution

The process of mixing a dry powder medication with a diluent before administration.

Physical Incompatibility

Changes in a medication product that can be seen, such as formation of a precipitate or color change.

Chemical Incompatibility

Unseen changes in the chemical makeup of medications that can result in a toxic or unstable product.

Medication Storage Requirements

Guidelines on how to properly store medications, including temperature and light sensitivity.

Controlled Substances

Medications with a high potential for abuse, requiring restricted access and secure storage.

Insulin Stability

Insulin must be stored in the refrigerator before use and has a limited stability once opened.

Non-Sterile Compounding

Refers to any preparation that does not meet the standards for sterile compounding and must follow USP 795 regulations.

Ointments

Medication preparations used topically to treat dermatologic conditions; oil-based and considered preparations of water in oil.

Spatulation

The process of mixing semi-solids and powders on an oil slab using a spatula, requiring geometric mixing for uniformity.

Mixtures

Various formulations in pharmacy compounding that can consist of multiple active and inactive ingredients.

Suspension

A pharmacy mixture composed of a medication in powder form suspended in a liquid vehicle, typically sterile water.

Liquid Dosage Form

Composed of a solute (active drug) and solvent (liquid vehicle), ensuring homogenous dispersion of the active ingredient.

Emulsion

A formulation of two immiscible liquid substances where one liquid is dispersed throughout the other.

Suppositories

Solid formulations used rectally (or vaginally) which melt at body temperature to release medication.

Enemas

Solution formulations used rectally to treat various conditions, working at the site of action in the colon.

Percentage Strengths

Refers to how concentrations of ingredients are measured, including weight/weight (w/w%), volume/volume (v/v%), and weight/volume (w/v%).

Dimensional Analysis

A calculation method using ratios to convert quantities from one unit to another.

Conversion Factor (CF)

A ratio that expresses how many of one unit are equal to another unit.

Ratio

A relative value between two numbers, often expressed as a fraction or in the format a:b.

Proportion

An expression of equality between two ratios, indicating that they are equivalent.

Alligation Method

A technique for calculating the volume of solutions needed to achieve a desired concentration from solutions of different strengths.

Volume Conversion

The process of changing the measurement of volume from one unit to another, e.g., 1 tsp = 5 mL.

Prescription Calculation

The process of determining the appropriate quantity and dosage of medication to provide to a patient.

Parts per Ratio

A representation of the proportion of components in a mixture.

Weight Conversion

The process of converting weight measurements from one unit to another, e.g., 1 kg = 2.2 lb.

Length Conversion

The process of converting length measurements from one unit to another, e.g., 1 inch = 2.54 cm.

Sig Codes

Abbreviations used in the directions section of a prescription to communicate information from prescriber to pharmacy.

BID

Twice daily (from Latin bis in die).

QD

Once daily (from Latin quaque die).

PRN

As needed (from Latin pro re nata).

PO

By mouth (from Latin per os).

Stat

Immediately (from Latin statim).

DS

Days supply, often calculated based on prescribed quantity and directions.

Dilution formula

Concentration 1 x Quantity 1 = Concentration 2 x Quantity 2, used for calculating dilution problems.

IV

Intravenously, a route of administration.

Ou

Both eyes (Latin oculus uterque).

OTC

Over the counter, medications available without a prescription.

NPO

Nothing by mouth (from Latin nil per os).

QID

Four times daily (from Latin quater in die).

Oint

Ointment, a semi-solid preparation.

Susp

Suspension, a liquid preparation containing undissolved particles.

Neb

Nebulization, a method of delivering medication in vapor form.

Amp

Ampule, a sealed vial used to contain a sample.

Sig Codes

Abbreviations used in the directions section of a prescription to communicate information from prescriber to pharmacy, typically derived from Latin.

QD

Code meaning 'once daily' in prescription sig.

BID

Code meaning 'twice daily' in prescription sig.

PRN

Code meaning 'as needed' in prescription sig.

PO

Route of administration meaning 'by mouth'.

IM

Route of administration meaning 'intramuscularly'.

IV

Route of administration meaning 'intravenously'.