e-Prescribing: Current or Future Health Care in Utah? Mark Munger, Pharm.D. Professor, University of Utah Presented at Digital Commission Meeting on 1/08/2009

e-Prescribing: What is it? Conducted via: –Personal digital assistant (PDA), –“smart phones: –Web-browser on a desk-top application It is not: –Facsimile transmission –Phone transmission –Paper presentation

Potential for e-Prescribing e-Prescribing systems: –Avoid 2 million adverse drug events –130,000 life-threatening drug events –$27 Billion in cost-savings in the United States Johnston D, et al. Center for Information Technology Leadership, 2004 E-Health Initiative: Electronic Prescribing: Toward Maximum Value and Rapid Adoption, 2004

Current Use of e-Prescribing Current Systems Use –65% Americans use Rx drugs –NCVHS: 5-18% of prescriptions by e-Prescribing Problems to the wide-spread use: –Lack of standards throughout the industry –HIPPA Rules –DEA Rules on Controlled Substances –Disconnect between Incentives for M.D. e-Prescribing and Increased Pharmacy Fees

e-Prescribing: CMS Definition (CMS) –An accurate, error-free, and understandable prescription directly to the pharmacy from the point- of-care. –Included in the Medicare Modernization Act of 2003 –2006 IOM Report: e-Prescribing as a means to improve patient safety –e-Prescribing is currently optional for physicians and pharmacies –Drug plans participating in prescription benefit must support electronic prescribing (communicating in same technology with practitioners)

CMS: Part D Standards To extent practicable, the standards would not impose undue administrative burdens on prescribing healthcare professionals and dispensing pharmacies and pharmacists?? Standards would be compatible with current legislation and with general health information technology standards Standards would permit electronic exchange of drug labeling and drug listing information by the FDA and NLM. 2007: Executive Summary: Pilot Testing of Initial Electronic Prescribing Standards

Initial Standards for Pilot Testing: HHS Formulary and Benefit Information Technically OK –Displays formulary status and alternative drugs and co-pays and other status information NCPDP Formulary and Benefit Standard Version 1.0 Exchange of Medication History Technically OK –Includes the status, provider, patient, coordination benefit, request and response segments of NCPDP SCRIPT Version 8.1 Fill Status Notification Technically OK, but not yet generally used –Informs when Rx is filled, not filled, or partially filled. 2007: Executive Summary: Pilot Testing of Initial Electronic Prescribing Standards

Initial Standards for Pilot Testing: HHS Structured and Codified SIG (NCPDP SCRIPT Version 8.1) Technically not OK –Indication, dose, dose calculation, dose restriction, route, frequency, interval, site, administration time and duration, and stop order instructions. Clinical Drug Terminology (RxNorm) Technically not OK –A clinical drug nomenclature that provides standard names for clinical drugs and for dose forms as administered. Link between clinical drugs to active ingredients, drug components, and most brand names. Prior Authorization Messages Technically not OK –Requires header information, requester, subscriber, utilization management, and other relevant information for prior authorization requests.

HIPPA Personal Health Information Exchange –Requires encryption throughout the electronic process to meet HIPPA requirements –SureScripts and other Vendors No encryption is currently offered End Game: –e-Prescribing is probably a violation of HIPPA!!!!

DEA Rules on e-Prescribing of Controlled Substances Practitioner must authenticate himself to the system using two-factor authentication; System must allow display for practitioner’s review prior to signature; “I, the prescribing practitioner whose name and DEA # appear on the controlled substance prescription(s), being transmitted, have reviewed all of the prescription information for each prescriptions is accurate. I further declare that by transmitting the prescription(s) information, I am indicating my intent to sign and legally authorize the prescription(s).” The system may not allow any other person but the authenticated user to sign the prescription. Fed Reg 21 CFR 1300, 1304 et al. Electronic Prescriptions for Controlled Substances Proposed Rule

DEA Rules on e-Prescribing of Controlled Substances Electronic Prescription System must transmit prescription immediately upon signature of practitioner; System must not allow transmission of an electronic prescription if the prescription has been printed; The service provider or first provider (pharmacy) must ensure the signed prescription is signed as received and archives the digitally signed prescription; System must retain prescription for 5 years from the date of issuance; The contents of the prescription must not be altered during transmission or the prescription is invalid; An electronic prescription must be transmitted from the practitioner to the pharmacy in its electronic form. At no time may an electronic prescription by converted to another form for transmission. Fed Reg 21 CFR 1300, 1304 et al. Electronic Prescriptions for Controlled Substances Proposed Rule

DEA Rules on e-Prescribing of Controlled Substances System must be capable of downloading an electronic copy of CS records into a database or spreadsheet that is easily readable and can be easily sorted by the data elements. Must be able to be printed. $$$ System must be able to create and maintain a backup copy of all CS prescriptions at an alternate storage site away from the original site. $$$ System must create an internal audit trail that indicates each time a CS prescription file is opened, annotated, altered, or deleted and the identity of the person taking the action and maintained for 5 years. $$$ System must establish and implement a list of auditable events. System must analyze the audit logs every 24 hours and generate an incident report that identifies each event. $$$ Pharmacy must determine whether the auditable event is a security breach that compromised or could have compromised the prescription records. Any such incidents must be reported to the DEA within one business day. The pharmacy system must have a qualified third party conduct an audit that meets SysTrust or SAS 70 audit for the system prior to accepting any CS prescriptions and annually thereafter. $$$ If the system is found wanting, then the system may not accept any CS prescriptions. Fed Reg 21 CFR 1300, 1304 et al. Electronic Prescriptions for Controlled Substances Proposed Rule

Disconnect to Facilitate Implementation of e-Prescribing 2009: prescribers using e-Prescribing equipment will receive incentive payments of 2% from Medicare. Whereas, pharmacists are charged $0.30 to receive a prescription and $0.30 to send a refill request to a prescriber by SureScripts. Estimated costs: $9-$25 K per year/pharmacy.

Current e-Prescribing in State of Utah Pharmacy Survey (UPhA) –Number of e-Scripts From: many electronic scripts per day at Smiths To: 3-4 total over last several months (only being accepted by fax due to agreement and costs) –E-Scripts appear to be well accepted “Decrease in human errors” “Technicians like them, decrease in workload from input of data” –Processing issues Software Compatibility Treating e-Scripts in normal processing (Hard Copy)