By the end of this chapter, you should be able to:
Define the core concepts of medication safety, including the medication use process and high-alert medications.
Identify the key requirements of USP <795> and USP <797> for non-sterile and sterile compounding.
Explain the purpose of the DEA Controlled Substances Act and the classification of drugs into schedules.
Describe the function of REMS and the FDA's role in drug safety labeling.
Apply HIPAA Privacy Rule principles to protect patient health information.
Recognize common medication errors, including look-alike/sound-alike (LASA) drugs and abbreviation hazards.
Perform fundamental calculations related to days' supply and dose verification.
1.1 The Medication Use Process and Error Prevention
The medication use process is a multi-step system that begins with prescribing and ends with patient monitoring. A breakdown at any point can lead to a medication error. As a pharmacy technician, you are the final checkpoint before a medication reaches the patient.
Key Steps in the Process:
16.Prescribing: The provider orders a medication.
17.Transcribing: The order is entered into the pharmacy computer system.
18.Dispensing: The medication is prepared, labeled, and checked.
19.Administration: The nurse or patient takes the medication.
20.Monitoring: The patient's response is evaluated.
Error Prevention Strategies:
Independent Double Checks: A second technician or pharmacist verifies the drug, dose, and patient without looking at the first person's work. This is critical for high-alert medications.
Barcode Scanning: Used at dispensing and administration to verify the "Five Rights": Right Patient, Right Drug, Right Dose, Right Route, and Right Time.
Tall Man Lettering: Using capital letters to differentiate look-alike drug names (e.g., DOBUTamine vs. DOPamine). This is an ISMP recommendation to reduce confusion.
1.2 High-Alert Medications and ISMP Guidelines
The Institute for Safe Medication Practices (ISMP) maintains a list of drugs that bear a heightened risk of causing significant patient harm when used in error. These are called High-Alert Medications. Even when used correctly, these drugs have a narrow therapeutic index or a high potential for toxicity.
Use standard concentrations for IV infusions (e.g., no concentrated KCl on patient care units).
Limit access to high-alert medications.
Use automated dispensing cabinets (ADCs) with profile-based access.
Require independent double-checks for dose calculations and IV preparation.
Do Not Use List (ISMP):
The ISMP publishes a list of dangerous abbreviations, symbols, and dose designations that are prohibited. You must never use these in order entry or labeling.
Never use "U" for units (write "units"). Mistaken for "0" or "4".
Never use "QD" for daily (write "daily"). Mistaken for "QID" (four times daily).
Never use "QOD" for every other day. Mistaken for "QD" or "QID".
Never use trailing zeros (e.g., 1.0 mg). Use a leading zero for doses less than 1 (e.g., 0.1 mg).
Never use "MS" or "MSO4" for morphine sulfate. Mistaken for magnesium sulfate. Write "morphine sulfate".
1.3 Compounding Standards: USP <795> and USP <797>
Compounding is the preparation of a medication that is not commercially available, tailored to a patient's specific needs. The United States Pharmacopeia (USP) sets the standards for compounding quality.
USP <795> (Non-Sterile Compounding):
This chapter covers the preparation of creams, ointments, suspensions, capsules, and other non-sterile dosage forms.
Beyond-Use Date (BUD): The date after which a compounded preparation should not be used. For non-sterile preparations, the BUD is determined by the water activity of the formulation and the storage conditions. Generally, BUDs range from 14 days to 180 days, but never exceed the manufacturer's expiration date of the ingredients.
Facility Requirements: Requires a designated compounding area with adequate lighting, ventilation, and cleaning supplies.
Documentation: Requires a master formulation record and a compounding record for each batch.
USP <797> (Sterile Compounding):
This chapter covers preparations that must be sterile, such as IV admixtures, ophthalmic solutions, and irrigations. This is a high-risk area due to the potential for contamination and patient harm.
Risk Levels:
Low-Risk: Compounding in a primary engineering control (PEC) using sterile ingredients and closed systems (e.g., adding a drug to a premixed IV bag).
Medium-Risk: Compounding that involves multiple sterile ingredients or complex manipulations, often done in batches.
High-Risk: Compounding using non-sterile ingredients or exposing sterile products to non-sterile environments (e.g., crushing tablets to make a suspension).
Primary Engineering Control (PEC): A laminar airflow workbench (LAFW) or a compounding aseptic isolator (CAI) that provides ISO Class 5 air quality.
Buffer Room: The room surrounding the PEC, which must meet ISO Class 7 air quality standards.
Garbing: Technicians must wear low-shedding gowns, gloves, masks, and hair covers. Gloves must be disinfected with sterile 70% IPA before beginning work.
Beyond-Use Date (BUD): Sterile preparations have much shorter BUDs.
Low-Risk: BUD is 48 hours at room temperature or 14 days if refrigerated (when placed in an ISO Class 5 environment).
Medium-Risk: BUD is 30 hours at room temperature or 9 days if refrigerated.
High-Risk: BUD is 24 hours at room temperature or 3 days if refrigerated.
1.4 The DEA Controlled Substances Act and 21 CFR
The Controlled Substances Act (CSA), enforced by the Drug Enforcement Administration (DEA), regulates the manufacturing, distribution, and dispensing of substances with a potential for abuse. The regulations are detailed in Title 21 of the Code of Federal Regulations (21 CFR).
Drug Schedules (C-I to C-V):
The schedule is based on the drug's accepted medical use and its abuse potential.
Schedule I (C-I): High abuse potential, NO accepted medical use in the US. Examples: Heroin, LSD, Marijuana (federally).
Schedule II (C-II): High abuse potential, but with accepted medical use. Severe physical and psychological dependence. Examples: Oxycodone, Morphine, Adderall, Fentanyl. No refills allowed without a new prescription.
Schedule III (C-III): Moderate to low physical dependence, high psychological dependence. Examples: Tylenol with Codeine (#3), Ketamine, Testosterone. Refills allowed up to 5 times in 6 months.
Schedule IV (C-IV): Low abuse potential compared to C-III. Examples: Alprazolam (Xanax), Lorazepam (Ativan), Zolpidem (Ambien). Refills allowed up to 5 times in 6 months.
Schedule V (C-V): Lowest abuse potential. Examples: Cough syrups with codeine (e.g., Promethazine with Codeine), Loperamide (Imodium). Refills allowed up to 5 times in 6 months.
Key Technician Responsibilities:
Verification: Always verify the patient's identity and the prescriber's DEA number.
Inventory: C-II drugs require a separate inventory and a biennial (every 2 years) inventory count.
Security: C-II drugs must be locked in a separate, securely locked cabinet or safe.
Record Keeping: C-II prescriptions must be kept separately from all other prescriptions. They cannot be transferred between pharmacies (except in specific, rare instances for C-V controlled substances).
1.5 FDA Drug Labeling and REMS
The Food and Drug Administration (FDA) oversees the approval and safety of drugs. Part of this oversight includes Risk Evaluation and Mitigation Strategies (REMS) .
What is a REMS?
A REMS is a drug safety program designed to manage a known or potential serious risk associated with a medication. The FDA can require a REMS for drugs with significant safety concerns (e.g., teratogenicity, severe organ toxicity).
Components of a REMS:
Medication Guide: A patient-friendly leaflet that must be dispensed with the medication.
Communication Plan: Informing healthcare providers about the risks.
Elements to Assure Safe Use (ETASU): These are restrictive measures, such as:
Prescriber certification (must be specially trained).
Pharmacy certification (must be registered to dispense).
Patient enrollment in a registry.
Restricted distribution (only certain wholesalers can distribute).
Example:iPLEDGE for isotretinoin (Accutane). This REMS requires two forms of birth control for females of childbearing potential, and the pharmacy must verify the patient's status in the system before dispensing.
FDA Drug Labeling:
Prescribing Information (PI): The official label for a drug, often called the "package insert." It contains sections on Indications, Dosage, Warnings, Contraindications, and Adverse Reactions.
Black Box Warning: The strongest warning required by the FDA, placed in a boxed border at the top of the PI. It highlights serious or life-threatening risks (e.g., risk of suicidal thinking with antidepressants).
1.6 HIPAA Privacy Rule
The Health Insurance Portability and Accountability Act (HIPAA) Privacy Rule establishes national standards to protect individuals' medical records and other personal health information (PHI).
Key Concepts:
Protected Health Information (PHI): Any information that relates to a patient's past, present, or future physical or mental health condition, treatment, or payment. This includes name, address, date of birth, Social Security number, and prescription records.
Minimum Necessary Standard: When using or disclosing PHI, you must make reasonable efforts to limit the information to the minimum necessary to accomplish the intended purpose.
Patient Rights: Patients have the right to access their medical records, request amendments, and receive an accounting of disclosures.
Pharmacy Technician Application:
Do not discuss a patient's medication with their family members over the phone unless the patient has authorized it.
Do not leave patient-specific information (e.g., labels, hard copies) visible on the counter.
Shred or securely dispose of documents containing PHI.
Do not share your computer login credentials.
When a patient calls for a refill, verify their identity (e.g., DOB, address) before giving out any information.
1.7 Medication Safety in Practice: Look-Alike and Sound-Alike (LASA) Drugs
LASA drugs are a major source of medication errors. They look alike in spelling or sound alike in pronunciation.
Common LASA Pairs:
Celebrex (arthritis) vs. Celexa (depression) vs. Cerebyx (seizures).
hydroXYzine (antihistamine) vs. hydrALAZINE (blood pressure).
Tegretol (seizures) vs. Trandate (blood pressure).
Glipizide vs. Glyburide (both are diabetes drugs, but different potencies).
Prevention:
Always check the brand name AND generic name.
Use Tall Man letters (e.g., hydrALAZINE vs. hydroXYzine).
Rely on the drug's indication and dose to catch errors. If a dose looks too high or too low for the indication, question it.
1.8 Core Calculations for Safety
You must be able to perform calculations to verify the safety of a prescription.
Days' Supply Calculation:
Formula: Days' Supply = (Quantity Dispensed) ÷ (Number of Doses per Day)
Example: A patient is prescribed a medication to be taken 1 tablet by mouth twice daily. You dispense 60 tablets.
Doses per day = 2
Days' Supply = 60 ÷ 2 = 30 days.
Insulin: If a patient uses 40 units of insulin daily and you dispense a 10 mL vial of U-100 insulin (100 units/mL), the total units are 10 mL × 100 units/mL = 1000 units. Days' Supply = 1000 units ÷ 40 units/day = 25 days.
Dose Verification:
Example: A physician orders 500 mg of a drug. The pharmacy has 250 mg tablets. How many tablets are needed per dose?
Tablets = 500 mg ÷ 250 mg/tablet = 2 tablets.
Metric Conversions:
1 gram (g) = 1000 milligrams (mg)
1 milligram (mg) = 1000 micrograms (mcg)
1 liter (L) = 1000 milliliters (mL)
Critical Point: A decimal point error can be fatal. Always double-check your conversions. For example, 0.5 g is equal to 500 mg, not 5 mg.
Common Exam Traps
Students often miss questions due to subtle but critical misunderstandings. Here are the classic traps:
Trap 1: Confusing "q.d." with "q.i.d." The abbreviation "q.d." (once daily) is on the ISMP Do Not Use list because it is easily mistaken for "q.i.d." (four times daily). A prescription for "q.d." could be given four times a day, leading to a four-fold overdose. Always write "daily" or "four times daily" in full.
Trap 2: Mixing Up DEA Schedules. You must memorize the refill rules. A C-II (e.g., Adderall) cannot be refilled. A C-III or C-IV (e.g., Tylenol #3 or Xanax) can be refilled up to 5 times in 6 months. Students often incorrectly apply the C-II rule to all controlled substances.
Trap 3: Incorrect Metric Conversion. A common error is moving the decimal in the wrong direction. Remember: going from a larger unit (gram) to a smaller unit (milligram) means multiplying by 1000 (move the decimal 3 places to the right). Going from a smaller unit (milligram) to a larger unit (gram) means dividing by 1000 (move the decimal 3 places to the left). 0.5 g = 500 mg, not 50 mg.
Trap 4: Days' Supply with Insulin. Students often forget to calculate the total units in the vial. If you have a 10 mL vial of U-100 insulin, it contains 1000 total units, not 100 units. Failing to multiply by the volume (10 mL) will give you a days' supply that is 10 times too short.
Trap 5: Confusing USP <795> and USP <797>. Remember: <795> is for non-sterile (creams, capsules). <797> is for sterile (IVs, eye drops). A question about a laminar airflow hood or ISO Class 5 is always referring to <797>. A question about a beyond-use date of 180 days for a cream is referring to <795>.
Trap 6: Assuming all "high-alert" drugs are controlled substances. While many high-alert drugs (like opioids) are controlled, many are not. Potassium chloride (KCl) and insulin are high-alert but are not controlled substances. The term "high-alert" refers to the risk of harm from an error, not the abuse potential.
Trap 7: Forgetting the "Minimum Necessary" Rule. When a patient’s spouse calls to ask about a prescription, you cannot share details unless the patient has given explicit permission. The trap is assuming a spouse automatically has access. HIPAA requires authorization.
Trap 8: Misinterpreting REMS. A REMS is not just a "warning label." It is a specific, structured safety program. The iPLEDGE program for isotretinoin is a classic example. A pharmacy must be certified to dispense these drugs, and the patient must be enrolled. Simply checking a drug interaction is not sufficient for a REMS drug.
