Wednesday, September 10, 2008

Electronic Prescriptions for Controlled Substances

I've recently been asked about the timeline for the DEA to support the electronic prescribing of controlled substances. The prohibition against prescribing controlled substances is a significant barrier to the adoption of e-Prescribing since it requires a separate workflow to write for Lipitor verses Librium.

The DEA has published a notice of proposed rulemaking (NPRM) and offered a comment period until September 25. The DEA has not specified the timeframe for implementation or next steps after the comment period.

In general, the NPRM describes the requirements for the use of electronic systems to create, sign, dispense and archive controlled substance prescriptions.

From reading the NPRM, it is clear that the DEA has framed the issue around law enforcement, which is appropriate given the mission of the DEA:
"These regulations provide pharmacies, hospitals, and practitioners with the ability to use modern technology for controlled substance prescriptions while maintaining the closed system of controls on controlled substances dispensing; additionally, the proposed regulations would reduce paperwork for DEA registrants who prescribe or dispense controlled substances and have the potential to reduce prescription forgery."

The NPRM contains a description of the business processes required to ensure
1. authentication of the prescriber
2. non-repudiation of the prescription
3. integrity of the record keeping process

Each practitioner must have their identity verified through an in-person identity proofing process before they can use an electronic system to prescribe controlled substances. Entities that may conduct in-person identity proofing of a prescriber include:
1. The credentialing office of a DEA-registered hospital;
2. The State professional licensing Board or State controlled substance authority
that authorized the practitioner to prescribe controlled substances; or
3. A State or local law enforcement office.

In order for a prescriber to access the system and write electronic prescriptions, the practitioner must authenticate using a two-factor authentication process, which means using something that you have (a smart card, token or thumb drive containing a digital certificate) plus something that you know (a strong password). This process will have to be used each time the practitioner wants to sign a controlled substance prescription.

Other requirements include:
1. A two minute timeout on the e-prescribing application, requiring two factor re-authentication to return to the e-prescribing screens after timeout
2. For each prescription, the provider must "check a box" confirming the patient's name, the drug being prescribed, the dosage, the applicable DEA number, and a statement indicating that the practitioner understands that he has reviewed the prescription information and intends to sign and authorize the prescription being transmitted.
3. The prescription must be transmitted immediately and cannot be printed in the future if it was transmitted electronically
4. The eRx system must generate a log of all controlled substance prescriptions which the provider must review monthly. Logs must be kept for 5 years
5. Electronic prescriptions of controlled substances cannot be converted to non-electronic form, such as faxes, at any time.

Given the impact of the NPRM on providers, pharmacies, intermediaries (such as Surescripts/Rxhub) and vendors, I am sure there will be many comments made before September 25. Check out the testimony of Paul L. Uhrig, EVP Corporate Development,
General Counsel, & Chief Privacy Officer of Surescripts/RxHub. After the comment period closes, I would guess that we'll have a year before a final rule is published. One the one hand, I want to accelerate e-prescribing by creating a seamless electronic workflow for all medications. On the other, I am not looking forward to supporting tokens, smartcards, and other forms of two factor authentication.

7 comments:

unfoldingscene said...

unfortunately, the wrong folks are writing policy here. the same government org that is putting people in jail for non-violent crimes shouldn't be writing a policy that physicians and the FDA should be writing.

these people have been taught to think about "control" rather than doing things properly.

i have to damn near sign away my life to pick up cough medicine.

JPMD said...

BTW, if this model sails through unaltered, what havoc do you think it will wreak on patient flow in the ED? Two minute time outs? An eternity for the not-so-patient ED doc...

David Szabo said...

What is your opinion of a cell phone as an authentication token? My recollection is that it is permitted under the NPRM.

GuitarZero said...

Allscripts, McKesson and others are already using BIO-key fingerprint biometrics for controlling access to applications such as this. BIO-key works with any fingerprint scanner, such as the ones integrated into laptops, and requires that a prescriber carry nothing except their finger. It also can't be shared, stolen, lost or otherwise compromised. Most importantly, users like it better than usernames and passwords, because they just swipe to positively ID. Why isn't this part of the strong authentication options the DEA contemplates?

平平 said...

^^Thanks!!

婚前徵信婚姻感情大陸抓姦外遇抓姦法律諮詢家暴婚前徵信尋人感情挽回大陸抓姦離婚工商徵信婚前徵信外遇抓姦感情挽回尋人大陸抓姦離婚家暴工商徵信法律諮詢跟蹤工商徵信婚前徵信感情挽回外遇抓姦法律諮詢家暴尋人大陸抓姦離婚大陸抓姦外遇尋人家暴工商徵信法律諮詢家暴感情挽回大陸抓姦外遇婚前徵信離婚尋人工商徵信外遇抓姦法律諮詢家暴婚前徵信大陸抓姦尋人感情挽回外遇抓姦婚前徵信感情挽回尋人大陸抓姦工商徵信法律諮詢離婚家暴工商徵信外遇抓姦法律諮詢家暴婚前徵信尋人感情挽回大陸抓姦離婚婚前徵信工商徵信外遇抓姦尋人離婚家暴大陸抓姦感情挽回法律諮詢離婚感情挽回婚前徵信外遇抓姦家暴尋人工商徵信外遇抓姦法律諮詢家暴婚前徵信尋人感情挽回">徵大陸抓姦離婚婚前徵信工商徵信外遇抓姦尋人離婚家暴大陸抓姦感情挽回法律諮詢

Affordable Luxurious Wedding Dress Blog said...

cheap wedding gowns,
discount bridal gowns,
China wedding dresses,
discount designer wedding dresses,
China wedding online store,
plus size wedding dresses,
cheap informal wedding dresses,
junior bridesmaid dresses,
cheap bridesmaid dresses,
maternity bridesmaid dresses,
discount flower girl gowns,
cheap prom dresses,
party dresses,
evening dresses,
mother of the bride dresses,
special occasion dresses,
cheap quinceanera dresses,
hot red wedding dresses

Affordable Luxurious Wedding Dress Blog said...

cheap wedding gowns,
discount bridal gowns,
China wedding dresses,
discount designer wedding dresses,
China wedding online store,
plus size wedding dresses,
cheap informal wedding dresses,
junior bridesmaid dresses,
cheap bridesmaid dresses,
maternity bridesmaid dresses,
discount flower girl gowns,
cheap prom dresses,
party dresses,
evening dresses,
mother of the bride dresses,
special occasion dresses,
cheap quinceanera dresses,
hot red wedding dresses