PHRM 591 – Record Keeping and Updates to Pharmacy Law Study Guide

These flashcards cover essential concepts related to recordkeeping and updates to pharmacy law as outlined in the PHRM 591 lecture notes.

What is the foundation for safe, compliant pharmacy practice according to California pharmacy laws?

Accurate, timely, and secure recordkeeping.

What does recordkeeping serve as?

Regulatory and clinical function

What does recordkeeping protect?

Patients

What does recordkeeping ensure?

accountability

What does recordkeeping provide?

evidence of proper pharmacist judgment and oversight

What core principle of pharmacy recordkeeping ensures traceability of every prescription dispensed?

Purpose.

What core principle of pharmacy recordkeeping ensures demonstrates compliance with state and federal requirements?

Purpose

What core principle of pharmacy recordkeeping ensures supports patient care continuity and audits?

Purpose

What core principle of pharmacy recordkeeping ensures Documentation is a legal record of all pharmacy operations—dispensing, acquisition, transfers, and destruction of drugs?

Purpose

What is the purpose of pharmacy recordkeeping?

Ensures traceability of every prescription dispensed, Demonstrates compliance with state and federal requirements, Supports patient care continuity and audits, Documentation is a legal record of all pharmacy operations—dispensing, acquisition, transfers, and destruction of drugs

What are the required records for pharmacy recordkeeping?

Prescription orders and refills, Acquisition and disposition of all dangerous drugs and diabetes testing products (OTC). Records for controlled substances must be kept separately, Inventory logs, DEA 222 forms, invoices, CS Inventory reconciliation, Self Assessments, Policies and procedures with tracking for changes (name of who and date), Records of returned, destroyed, or transferred drugs, Pharmacist verification and counseling documentation

What is the required retention period for most pharmacy records?

3 years minimum.

What must controlled substance records be?

Readily retrievable for inspection.

Examples of prescription records?

Hard copy, e-prescriptions, refill documentation

Prescription records retention rate?

3 years

Examples of Controlled Substance Records?

Inventory, DEA 222 forms, acquisition/disposition logs

Controlled Substance Records retention rate?

3 years

Examples of Inventory Reports?

Initial, biennial, and reconciliation reports

Inventory Reports retention rate?

3 years

Examples of QA (Quality Assurance) Records?

Medication error reports, reviews

QA (Quality Assurance) Records retention rate?

1 year (minimum)

Examples of Personnel & Training?

Pharmacist, intern, technician licenses, training docs

Personnel & Training retention rate?

3 years

For electronic systems, what must be allowed?

on-demand printing or viewing

What must be included in a prescription record?

Patient name and address, prescriber’s name and license number, drug name, strength, quantity, directions, date of issuance and date dispensed, pharmacist initials or ID number/biometric tracking.

Where should electronic prescriptions be?

securely stored and backed up

What must electronic prescriptions prevent?

alteration of original records

What must electronic prescriptions have for controlled substances??

Signature capture required

What must records show when a prescription is transferred between pharmacies?

Date and name of receiving pharmacy and pharmacist, Original prescription number, Number of refills remaining, Confirmation that original prescription was voided or closed in the system

When recordkeeping controlled substances CII, what must be done every 3 months?

physical count of pills

How often must a C-II inventory be conducted in California?

At least every 3 months (quarterly).

What must inventory reconciliation report include?

A physical count of all quantities, Review of all acquisitions and dispositions since last count, Identification and documentation of any variances, Written explanation for discrepancies.

What drugs are required for yearly inventory?

alprazolam 1mg and 2mg and promethazine with codeine

What are the federal requirements for recordkeeping?

Complete inventory of all controlled substances every 2 years (biennial), Must separate drugs by schedule

What is needed for C-II drugs recordkeeping?

Separate storage and separate files from non-controlled drugs

What must be traceable for CII drugs?

All records — purchases, dispensing, returns, and destructions

What forms is required for all C-II purchases?

DEA 222 or CSOS forms

What must controlled substances logs reflect?

Date dispensed, Patient name, Quantity, Prescriber, Pharmacist initials

What are Electronic Prescribing of Controlled Substances (EPCS)?

Mandatory in California (with limited exceptions), Digital records must meet DEA security and audit standards

What must pharmacists document?

Prescription verification and release to patient., Patient counseling or refusal of counseling, Clinical interventions or clarifications with prescribers, Medication error reviews and outcomes (under QA program).

What type of documentations is required for all community pharmacies?

Quality Assurance (QA) Program Documentation

What is the purpose of Quality Assurance (QA) records in pharmacies?

To document medication errors, corrective actions, and ensure confidentiality while being available for inspection.

What must all QA records be?

confidential but must be available for inspection

What is the primary goal of a QA program in pharmacy practice?

System-based improvement, not punishment.

Medication Error

Any discrepancy in prescribing, dispensing, or administration that reaches the patient

Near Miss

Detected before reaching the patient (should still be reviewed).

Timing

Review must occur within 2 business days after discovery

Confidentiality

QA records are not public and cannot be used in civil litigation

Who is collecting data outside the BOP-ISMP?

Agency

What is the QA reports used for?

identify recurring patterns

What are examples of identify recurring patterns?

wrong strength errors due to look-alike packaging

What are expected components in the pharmacy?

Continuous staff training and workflow redesign

When destroying expired CII drugs what must be done?

witnessed and documented

What documentation must accompany the destruction of expired C-II drugs?

DEA Form 41 and vendor receipts or reverse distributor records.

What also must be recorded during drug destruction?

CIII–V returns must also be recorded

What should pharmacies do within 72 hours of a relevant inspection?

Produce requested records for the California Board of Pharmacy.

Noncompliance

potential citation, fine, or disciplinary action

What is the biggest tip for recordkeeping?

Keep all records organized, dated, and categorized for rapid retrieval

What must be documented when a pharmacist releases a prescription to a patient?

Prescription verification and release.

What is mandatory for electronic prescribing of controlled substances (EPCS) in California?

Must meet DEA security and audit standards.

What happens to QA records in regards to civil litigation?

They cannot be used in civil litigation.

What type of logs must controlled substances have?

Controlled substance logs reflecting date dispensed, patient name, quantity, prescriber, and pharmacist initials.

What must be included in an inventory reconciliation report?

Physical count of all quantities, review of acquisitions and dispositions, identification of variances, and written explanation for discrepancies.

When must a QA review occur after discovery of a medication error?

Within 2 business days.

What is the definition of a 'near miss'?

A discrepancy detected before reaching the patient that should still be reviewed.

What must be done when transferring prescriptions between pharmacies?

Record must show date and name of receiving pharmacy and pharmacist, original prescription number, number of refills remaining, and confirmation that original prescription was voided or closed in the system.

What types of records must pharmacies maintain for controlled substances?

Purchases, dispensing, returns, and destructions.

What is the retention period for QA records?

1 year (minimum).

What is required for the acquisition and disposition of dangerous drugs?

Records must be kept separately for controlled substances.

What is the legal status of medication error reports?

Confidential but must be available for inspection.

What must a pharmacy do to comply with electronic recordkeeping regulations?

Electronic systems must allow on-demand printing or viewing.

What constitutes a legal record of all pharmacy operations?

Documentation of dispensing, acquisition, transfers, and destruction of drugs.

Which agency collects data for quality improvement reporting outside the BOP?

ISMP.

What should be documented when a controlled substance is dispensed?

Date dispensed, patient name, quantity, prescriber, pharmacist initials.

How should discrepancies in controlled substance inventories be handled?

Identified and documented with a written explanation for variances.

What must pharmacists document during patient counseling?

Patient counseling or refusal of counseling.

What does California law require regarding prescription orders and refills?

They must be documented accurately.

What must be conducted for all Schedule II substances in terms of inventory?

A physical count, not an estimate.

How often must controlled substance inventories occur according to federal requirements?

Every 2 years (biennial).

How long must records of returned, destroyed, or transferred drugs be retained?

3 years.

What principle serves both clinical and regulatory functions in pharmacy practice?

Recordkeeping.

What must electronic systems prevent regarding prescription records?

Alteration of original records.

What key aspects must be included in a QA program document?

Description of medication error, circumstances, corrective actions, follow-up review, and participation in the review.

What must be documented in the event of a near miss?

Reviewed for prevention and improvement.

What do pharmacists need to verify and document when handling controlled substances?

Verification and responsibilities pertaining to dispensing, including initials and tracking.

What is the role of California Board of Pharmacy in recordkeeping?

They oversee compliance and can inspect pharmacy records.

True or False: QA records can be used as public documents for patient review.

False.

What is the consequence of noncompliance during an inspection?

Potential citation, fine, or disciplinary action.

What should pharmacies ensure about their records for rapid retrieval?

All records must be organized, dated, and categorized.

What documentation is mandatory for controlled substance disposal?

DEA Form 41 and other relevant documentation.

In what way is confidentiality maintained for QA reports?

Records cannot be public and are not subject to civil litigation.

Why is quality improvement important in pharmacy practice?

To address systemic issues, not to assign blame.

What should be monitored regarding electronic prescription systems?

Security features and alterations to original records.

What must be recorded when handling dangerous drugs?

Acquisition and disposition logs.

In quality assurance, what type of errors must be documented?

Medication errors and corrective actions taken.

What is the purpose of accurate and timely documentation in pharmacies?

To ensure legal compliance and patient safety.

What type of training documentation needs to be maintained?

Licenses and training documents for pharmacists, interns, and technicians.

What actions must be taken when discrepancies in medications are found?

Document and explain discrepancies in inventory logs.

What types of records are categorized under personnel & training?

Licenses and training documentation for pharmacy staff.

What role does the ISMP play in pharmacy quality assurance?

Collects data for quality improvement reporting.