Questions and Answers
When did the DEA publish the interim final rule for electronic prescriptions for controlled substances?
What must a pharmacy application provider obtain to process electronic prescriptions for controlled substances?
Which part of the Code of Federal Regulations outlines the electronic prescription requirements?
What condition must be satisfied for a pharmacy to fill electronic prescriptions for controlled substances?
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What does the rule revise regarding the writing of prescriptions for controlled substances?
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Can a pharmacy process electronic prescriptions for controlled substances without a certification report?
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Which of the following statements is TRUE about electronic prescriptions for controlled substances?
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What is the date when the interim final rule became effective?
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What is the consequence if a pharmacy application does not accurately import, store, and display DEA-required prescription information?
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Which of the following must be included in electronic prescriptions to meet the requirements?
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How should a pharmacist act if both an electronic prescription and a paper prescription are received?
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What information must not be altered unless permitted under DEA regulations?
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What is required when a pharmacist receives a paper prescription indicating it was originally transmitted electronically to another pharmacy?
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What annotation is required when filling an electronic prescription, if it were required on a paper prescription?
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Which employees should be granted access to enter information regarding controlled substance prescriptions?
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What should a pharmacy do if a third-party auditor finds deficiencies in the pharmacy application related to prescription information?
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Which regulation requires practitioners to indicate 'Authorization for Emergency Dispensing' on prescriptions?
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How must all required annotations for electronic prescriptions be stored?
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Study Notes
Electronic Prescriptions Overview
- DEA's interim final rule on Electronic Prescriptions for Controlled Substances was published on March 31, 2010, taking effect on June 1, 2010.
- The rule allows practitioners to write controlled substance prescriptions electronically and enables pharmacies to receive, dispense, and archive these prescriptions.
- Compliance with existing prescription regulations remains mandatory; electronic prescriptions are an addition to existing rules.
Requirements for Electronic Prescribing
- Practitioners must select software that complies with DEA regulations, specifically 21 CFR Part 1311, to use electronic prescriptions for controlled substances.
- Only DEA-registered pharmacies with compliant electronic pharmacy applications can receive and process electronic prescriptions as of June 1, 2010.
Pharmacy Compliance Standards
- To fill electronic prescriptions for controlled substances, pharmacies must ensure a pharmacy application meets the requirements set forth in 21 CFR 1311.205.
- A third-party audit or certification is required for pharmacies to verify compliance with DEA standards; the audit report must confirm the application's ability to accurately handle required prescription information.
Audit and Certification Process
- The pharmacy application must accurately import, store, and display essential information: practitioner details, patient information, drug specifics, and digital signatures when necessary.
- If compliance issues are found, pharmacies cannot accept or process electronic prescriptions for controlled substances until corrections are made.
Annotation and Access Control
- Pharmacies must identify which employees can enter and modify information regarding controlled substance prescriptions.
- Logical access controls in pharmacy software must restrict these functions to authorized individuals.
Handling of Electronic Prescriptions
- Pharmacists must annotate electronic prescriptions as they would for paper prescriptions, ensuring all required information is stored electronically.
- Procedures are in place for pharmacists to follow if receiving multiple prescription formats (i.e., electronic vs. paper/oral).
Voiding and Cancelling Prescriptions
- If a pharmacy receives both an electronic and paper prescription for the same medication, one must be marked void.
- If a paper prescription indicates it was sent electronically to another pharmacy, pharmacists must verify its status with that pharmacy before dispensing.
Key Regulations and Citations
- 21 CFR 1311.120(a) details the software selection requirements for electronic prescriptions.
- 21 CFR 1306.08 and 21 CFR 1311.200 outline the filling, annotation, and cancellation procedures for electronic prescriptions.
- Specific provisions exist for emergency dispensing and special patient categories (e.g., hospice patients), indicating the need for additional annotations.
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Description
This quiz delves into the DEA's interim final rule on Electronic Prescriptions for Controlled Substances, published on March 31, 2010. Understand the regulations that allow practitioners to write and pharmacies to handle electronic prescriptions for controlled substances effectively.
