Iowa E-health FAQs
What is the DEA rule on electronic prescriptions for controlled substances?
The revised DEA regulations provide practitioners with the option of writing prescriptions for controlled substances electronically. These regulations will also permit pharmacies to receive, dispense, and archive these electronic prescriptions. The rule went into effect on June 1, 2010. The revised DEA regulations are available at http://www.deadiversion.usdoj.gov/fed_regs/rules/2010/fr0331.htm.
What effect does the Iowa Board of Pharmacy rule (657-21.8) have?
The change allows for practitioners and pharmacies to begin transmitting controlled substance prescriptions electronically in Iowa. The design of the rule was to coincide with the established DEA revision. Practitioners and pharmacies must still meet all the rules and regulations for electronic prescriptions for controlled substances established by the DEA prior to introducing electronic prescribing of controlled substances into practice.
Have any locations begun to send/receive controlled substance prescriptions electronically?
Now that networks must meet stringent DEA security requirements for e-prescribing of controlled substances, a limited deployment in three states (Texas, California, and Virginia) began in 2011. Surescripts said in a statement in October 2011 that it has started to certify e-prescribing software and pharmacy information systems to ensure that those products follow DEA requirements. It is the first organization to do so. Thus far, few physicians have been able to take advantage of the change in the law. A federally funded pilot project in Berkshire County, MA has been underway since September 2009, thanks to a DEA waiver, but adoption has not occurred elsewhere.
When must a third-party audit or certification be conducted?
The third-party audit or certification must be conducted before the electronic prescription application is used to sign or transmit electronic prescriptions for controlled substances or before the pharmacy application is used to process electronic prescriptions. Thereafter, a third-party audit or certification must be conducted whenever a function related to controlled substance prescription requirements is altered or every two years, whichever occurs first.
To whom does the third-party audit/certification requirement apply?
The requirement for a third-party audit applies to the application provider, not to the individual practitioner, institutional practitioner, or pharmacy that uses the application. The practitioner or pharmacy is not subject to the requirement unless they have developed their own application.
Does the DEA have a list of application providers who have software to meet the current requirements for e-prescribing?
No. The DEA did not require audits to be submitted upon completion because the requirements and standards of third-party auditors within the industry have demonstrated sufficient competencies. The DEA expects that those wishing to register will be made aware of approved application software through commercial advertising.
Who can conduct an audit or certify an application?
Application providers must obtain a third-party audit or certification that each electronic prescription and pharmacy application used to sign, transmit, or process controlled substance prescriptions is in compliance with DEA regulations. Acceptable audits must be conducted by qualified personnel, like a Certified Information System Auditor. The application may have organizational certification approved by the DEA to verify that the application meets the DEA requirements.
When can a practitioner start issuing electronic prescriptions for controlled substances?
A practitioner will be able to issue electronic controlled substance prescriptions when the electronic prescription or electronic health record (EHR) application the practitioner uses complies with the requirements set forth by the DEA.
How will a practitioner or pharmacy be able to determine that an application complies with the DEA rule?
The auditor or certification body will issue a report that states whether the application complies with the DEA requirements and whether there are any limitations on its use for controlled substance prescriptions. The application provider must provide a copy of the third party audit to practitioners or pharmacies to allow them to determine whether the application is compliant.
As a practitioner, until I have received an audit/certification report from my application provider indicating that the application meets the DEA requirements, how can I use my electronic prescription application or EHR application to write controlled substance prescriptions?
Nothing in this rule prevents a practitioner from using existing electronic prescription or EHR applications. Until the application is compliant with the final rule, the practitioner will have to print the prescription for manual signature. Such prescriptions are still paper prescriptions and subject to the existing requirements.
When can a pharmacy start processing electronic prescriptions for controlled substances?
A pharmacy will be able to process electronic controlled substance prescriptions when the pharmacy application the pharmacy is using complies with the requirements in the final rule.
As a pharmacy, until I have received an audit/certification report from my application provider indicating that the application meets the DEA requirements, how can I use my pharmacy application to process controlled substances prescriptions?
A pharmacy cannot process electronic prescriptions for controlled substances until its pharmacy application provider issues the third party audit/certification report verifying that the application complies with the DEA requirements. The pharmacy may continue to use its pharmacy application to store and process controlled substance prescriptions, but the paper records must be retained.
What should a pharmacist do if he/she receives a paper or oral prescription that was originally transmitted electronically to the same pharmacy?
The pharmacist must check the pharmacy records to ensure that the electronic version was not received and the prescription dispensed. If both prescriptions were received, the pharmacist must mark one as void.
What should a pharmacist do if he/she receives a paper or oral prescription that indicates that it was originally transmitted electronically to another pharmacy?
The pharmacist must check with the other pharmacy to determine whether the prescription was received and dispensed. If the pharmacy that received the original electronic prescription had not dispensed the prescription, the original pharmacy must mark the electronic version as void or canceled. If the pharmacy that received the original electronic prescription dispensed the prescription, the pharmacy with the paper version must not dispense the prescription and must mark the prescription as void.
What are the DEA requirements regarding the storage of electronic prescription records?
Once a prescription is created electronically, all records of the prescription must be retained electronically. As is the case with paper prescription records, electronic controlled substance prescription records must be kept for a minimum period of two years.
(Questions adapted from the DEA general questions and answers on electronic prescriptions for controlled substances)
Links for sources/more information:
Full list of FAQs from the DEA: http://www.deadiversion.usdoj.gov/ecomm/e_rx/faq/faq.htm
American College of Physicians FAQs: http://www.acponline.org/running_practice/technology/eprescribing/dea.pdf
Black Book Rankings 2011 State of the E-prescribing industry: http://www.practicefusion.com/resources/2012_State_of_the_e-Prescribing_Industry.pdf