Upon completion of this chapter, you should be able to:
4.Interpret and transcribe prescription orders accurately, including patient information, medication names, strengths, dosage forms, and quantities.
5.Distinguish between the various types of prescriptions: new, refill, transfer, and standing orders.
6.Apply correct procedures for entering prescription data into the pharmacy computer system, including the use of sig codes and days-supply calculations.
7.Identify the key components of a valid prescription and recognize common reasons for rejection or clarification.
8.Explain the legal requirements for controlled substance prescriptions under the DEA Controlled Substances Act and 21 CFR, including schedule classifications and prescription elements.
9.Perform accurate calculations for days-supply, quantity dispensed, and refill authorization.
10.Recognize high-alert medications and apply ISMP high-alert medication recommendations during order entry and verification.
11.Apply HIPAA Privacy Rule standards when handling patient health information during the prescription processing workflow.
1.1 The Prescription Order: Components and Validity
A prescription is a legal order for a medication. For a prescription to be processed, it must contain specific elements. While state laws may vary, a valid prescription generally includes the following:
Patient Information: Full name, address, and date of birth. This is critical to prevent mix-ups between patients with similar names.
Date of Issue: The date the prescriber wrote the prescription. This is important for determining the "age" of the prescription and for calculating the expiration of refills.
Prescriber Information: The prescriber's full name, professional designation (e.g., MD, DO, DDS, NP, PA), license number, and signature. The signature may be physical or electronic.
Medication Information: The drug name (brand or generic), strength, dosage form (e.g., tablets, capsules, solution), and route of administration.
Quantity: The amount of medication to be dispensed (e.g., #30, 60 mL).
Directions for Use (Sig): The instructions for the patient, written in a standardized shorthand known as sig codes (e.g., "i po bid").
Refill Information: The number of times the prescription may be refilled (e.g., "Refills: 2" or "PRN" for as needed).
Dispense as Written (DAW) / Product Selection: An indication of whether the prescriber requires the brand-name product or if a generic substitution is permitted.
Prescription Types
New Prescription: A prescription for a medication that the patient has not previously received from the pharmacy.
Refill Prescription: A request to dispense a medication that has been previously dispensed and has remaining authorized refills. The pharmacy must ensure the refill is not beyond the original prescription's expiration date (often 1 year, but state-specific).
Transfer: The process of moving a prescription from one pharmacy to another, typically for a patient's convenience. Only non-controlled substances (Schedule III-V in some states) and certain controlled substances (Schedule III-V, not Schedule II) can be transferred between pharmacies, and the transfer must be communicated between two pharmacists.
Standing Order: A pre-written order that allows a pharmacist to dispense a medication without a new prescription for each patient, often used for emergency contraceptives, naloxone, or immunizations.
1.2 The Order Entry Process
Order entry is the critical step of transcribing the prescription into the pharmacy's computer system. Accuracy here is paramount, as errors made during entry are a leading cause of adverse drug events.
Step 1: Data Verification
Before entering any data, the technician must verify the patient's identity and profile. This includes checking for allergies, current medications, and any relevant health conditions.
Step 2: Medication Selection
The technician must select the correct medication from the pharmacy's drug database. This involves verifying the drug name, strength, and dosage form. This is a high-risk step for errors, especially with look-alike/sound-alike (LASA) drugs.
Step 3: Sig Code Interpretation and Entry
The technician must accurately interpret the prescriber's directions and convert them into the pharmacy's standard sig codes. This is a common source of errors. For example, the abbreviation "q.d." (once daily) is frequently confused with "q.i.d." (four times daily). Because of this, the Institute for Safe Medication Practices (ISMP) recommends using "daily" instead of "q.d." and "four times daily" instead of "q.i.d." to avoid ambiguity.
Step 4: Quantity and Days-Supply Calculation
The quantity is the amount of medication to be dispensed. The days-supply is the number of days the medication will last based on the sig. This calculation is essential for determining refill dates, third-party billing, and for identifying potential misuse or overuse.
Example: A prescription for "Take 1 tablet by mouth twice daily for 30 days" would have a quantity of 60 tablets and a days-supply of 30 days (60 tablets / 2 tablets per day = 30 days).
Topical/Other Forms: For liquids, creams, or inhalers, the days-supply calculation is more complex. For example, a 15 g tube of ointment used "apply to affected area twice daily" might have a specific grams-per-application estimate. For inhalers, the number of puffs per day is divided into the total number of puffs in the canister.
Step 5: Refill Authorization
The technician must enter the number of refills authorized by the prescriber. For non-controlled substances, refills are typically valid for up to one year from the date the prescription was written. For controlled substances, the rules are stricter and schedule-dependent.
Step 6: Final Verification
Before the prescription is finalized, the pharmacist must perform a clinical review to ensure the medication, dose, and directions are appropriate for the patient. The technician's role is to prepare the data for this review, but the pharmacist is ultimately responsible for the final verification.
1.3 Controlled Substances and DEA Regulations
Prescriptions for controlled substances are subject to the DEA Controlled Substances Act and 21 CFR. These regulations are designed to prevent the diversion and abuse of drugs with a potential for dependence.
DEA Schedules
Controlled substances are categorized into five schedules (I-V) based on their accepted medical use and potential for abuse.
Schedule I: High potential for abuse, no currently accepted medical use in the U.S. (e.g., heroin, LSD, marijuana). These are not prescribed.
Schedule II: High potential for abuse, with severe psychological or physical dependence liability. They have an accepted medical use but are heavily restricted (e.g., oxycodone, fentanyl, morphine, amphetamine, methylphenidate).
Schedule III: Moderate to low potential for physical and psychological dependence (e.g., codeine with acetaminophen (Tylenol #3), testosterone).
Schedule IV: Low potential for abuse relative to Schedule III (e.g., alprazolam, lorazepam, zolpidem).
Schedule V: Lowest potential for abuse (e.g., cough preparations containing small amounts of codeine, such as promethazine with codeine).
Prescription Requirements for Controlled Substances
Schedule II: In most states, a prescription for a Schedule II drug must be written and signed by the prescriber. Electronic prescribing for Schedule II is now mandated in many states. They cannot be called in or faxed to the pharmacy (except in specific emergency situations). No refills are permitted on Schedule II prescriptions. A new prescription is required for each fill.
Schedule III-V: These prescriptions may be written, called in, or faxed to the pharmacy. They may be refilled, but no more than five times within a six-month period from the date the prescription was written. After five refills or six months, a new prescription is required.
Partial Fills
Schedule II: A partial fill is permitted if the pharmacy cannot supply the full quantity. The remaining portion must be filled within 72 hours. If not, the pharmacy must notify the prescriber. In long-term care facilities or for terminally ill patients, partial fills are allowed for up to 60 days.
Schedule III-V: Partial fills are permitted, and the remaining quantity can be filled as long as the total quantity dispensed does not exceed the original prescription amount and the refill limits are not exceeded.
1.4 High-Alert Medications and Look-Alike/Sound-Alike Drugs
Certain medications carry a heightened risk of causing significant patient harm when used in error. The ISMP maintains a list of high-alert medications that require special safeguards to reduce the risk of errors.
Categories of High-Alert Medications
Insulin: All formulations (e.g., rapid-acting, long-acting). Errors often occur with U-500 insulin (concentrated) versus U-100.
Opiates and Opioid Analgesics: Including morphine, oxycodone, hydromorphone, and methadone. Errors can occur with dose calculations and confusion between different opioids.
Anticoagulants: Such as warfarin, heparin, and enoxaparin. Dosing errors can lead to severe bleeding or clotting.
Chemotherapeutic Agents: These are often highly toxic and require precise dosing and handling.
Concentrated Electrolytes: Including potassium chloride, sodium chloride (>0.9%), and magnesium sulfate. These must be diluted before administration.
Oral Hypoglycemic Agents: Such as sulfonylureas (e.g., glipizide, glyburide), which can cause severe hypoglycemia.
Look-Alike/Sound-Alike (LASA) Drugs
LASA drugs are medications that look or sound similar to other medications, increasing the risk of selection errors. Examples include:
Celebrex (an anti-inflammatory) vs. Celexa (an antidepressant) vs. Cerebyx (an anti-seizure medication).
hydroxyzine (an antihistamine) vs. hydralazine (a blood pressure medication).
Tegretol (an anti-seizure medication) vs. Tegoderm (a topical patch).
Metformin (for diabetes) vs. Metronidazole (an antibiotic).
To prevent errors, technicians should always use tall man letters (e.g., hydrOXYzine vs. hydrALAZINE) and verify the drug name, strength, and indication against the original prescription.
1.5 REMS, Drug Labeling, and Compounding Standards
REMS (Risk Evaluation and Mitigation Strategies)
The FDA may require a REMS for certain medications that have serious safety concerns. A REMS is a plan to manage known or potential serious risks associated with a drug. It may include elements such as:
A Medication Guide that must be dispensed to the patient.
Communication plans for healthcare providers.
Elements to Assure Safe Use (ETASU) , which may require prescriber certification, patient enrollment, or restricted distribution (e.g., for isotretinoin, clozapine, or thalidomide).
FDA Drug Labeling
The FDA regulates drug labeling, which includes the package insert (professional labeling) and the patient package insert. The package insert contains critical information such as indications, dosage, contraindications, warnings, and adverse reactions. Technicians must be familiar with the concept of beyond-use dating (BUD) for compounded preparations, which is distinct from the manufacturer's expiration date.
USP Compounding Standards
When a pharmacy compounds a medication, it must follow the standards set by the United States Pharmacopeia (USP).
USP <795> covers non-sterile compounding (e.g., creams, ointments, capsules). It defines the BUD for these preparations, which is generally not more than 30 days for water-containing preparations and not more than 180 days for non-water-containing preparations, unless there is specific stability data.
USP <797> covers sterile compounding (e.g., IV admixtures, ophthalmic solutions). It sets strict standards for environmental quality, personnel training, and garbing to prevent contamination. The BUD for sterile preparations depends on the risk level (low, medium, high) and the storage conditions.
1.6 HIPAA and Patient Privacy
The Health Insurance Portability and Accountability Act (HIPAA) Privacy Rule establishes national standards to protect individuals' medical records and other personal health information (PHI). In the pharmacy setting, this means:
Minimum Necessary: Only the minimum amount of PHI necessary to complete a task should be accessed or disclosed. A technician should not look up a patient's profile out of curiosity or for non-work-related reasons.
Disclosures: PHI can be disclosed to the patient, to other healthcare providers for treatment purposes, and to payers for reimbursement. It can also be disclosed as required by law (e.g., to the DEA for controlled substance audits).
Safeguards: Pharmacies must have physical, administrative, and technical safeguards in place to protect PHI. This includes not discussing a patient's health information in public areas, using private counseling rooms, and ensuring computer screens are not visible to other customers.
Patient Rights: Patients have the right to access their medical records, request amendments, and receive an accounting of disclosures of their PHI.
Common Exam Traps
Students often miss questions on this topic due to common misconceptions. Be aware of these classic traps:
104.Sig Code Confusion:
The Trap: Confusing "q.d." (once daily) with "q.i.d." (four times daily) or "q.o.d." (every other day). Also confusing "i" (one) with "ii" (two).
Why Students Fall In: They try to memorize abbreviations without understanding the Latin roots. "q" stands for "quaque" (every), "d" for "die" (day), and "i" for "in" (in). "q.i.d." is "quater in die" (four times a day). Always double-check the context of the medication. A medication for high blood pressure is rarely taken four times a day.
107.DEA Schedule Mix-ups:
The Trap: Confusing Schedule II and Schedule III refill rules. Forgetting that Schedule II drugs have no refills.
Why Students Fall In: They memorize the schedules but not the specific rules. Remember: Schedule II = no refills, no phone-in (except emergencies). Schedule III-V = up to 5 refills in 6 months.
110.Metric Conversion Errors:
The Trap: Incorrectly converting between grams, milligrams, and micrograms. For example, thinking 1 gram = 100 mg instead of 1000 mg.
Why Students Fall In: Rushing through the calculation. Always use the "three-decimal" rule: 1 g = 1000 mg = 1,000,000 mcg. Move the decimal point three places to the right for each step down (g to mg to mcg).
113.Days-Supply Calculation Errors:
The Trap: Forgetting to divide the total quantity by the number of doses per day. For example, a prescription for "1 tablet po bid" with a quantity of 60 tablets is a 30-day supply, not a 60-day supply.
Why Students Fall In: They see the quantity and assume it equals the days-supply. Always calculate the total daily dose first (e.g., 2 tablets/day), then divide the quantity by that number (60 / 2 = 30 days).
116.Refill Authorization Misunderstanding:
The Trap: Assuming a prescription is valid for 1 year from the date of the last fill. It is valid for 1 year from the date it was written.
Why Students Fall In: They confuse the fill date with the issue date. The "clock" starts when the prescriber writes the prescription, not when the patient fills it.
119.High-Alert Medication Oversight:
The Trap: Not recognizing a high-alert medication during order entry, such as insulin or warfarin, and failing to double-check the dose or sig.
Why Students Fall In: They focus on the mechanics of data entry and not the clinical significance of the drug. Always pause and verify high-alert medications, especially insulin (check for U-100 vs. U-500) and anticoagulants.
122.HIPAA Violations:
The Trap: Thinking it is acceptable to discuss a patient's medication with a family member who calls the pharmacy, without verifying that the patient has authorized the disclosure.
Why Students Fall In: They want to be helpful. Under HIPAA, you must verify the identity of the caller and, in most cases, obtain the patient's consent before discussing PHI with a third party. The only exception is if the family member is directly involved in the patient's care or payment, but you must still use professional judgment and confirm the patient's wishes.
