Testimony by Eleni Z. Anagnostiadis for the December 8, 2004 NCVHS Subcommittee on Standards and Security Hearing

Testimony on Electronic Signatures 

Submitted to the National Committee on Vital and Health Statistics
Subcommittee on Standards and Security

December 8, 2004

Presented by
Carmen A. Catizone, MS, RPh, DPh
Executive Director/Secretary

And

Eleni Z. Anagnostiadis, RPh
Patient Safety Senior Manager
National Association of Boards of Pharmacy

Mr. Chairman and Members of the Subcommittee on Standards and Security: thank you for the opportunity to submit the following information on the important and developing concept of electronic signatures as they relate to the electronic transmission of prescriptions.  The state boards of pharmacy and NABP recognize the importance of regulating the electronic transmission of prescriptions within a regulatory framework that focuses on patient safety.

NABP was founded in 1904.  Our members are the pharmacy regulatory and licensing jurisdictions in the United States, District of Columbia, Guam, Puerto Rico, and the Virgin Islands, eight provinces of Canada, three Australian States, New Zealand, and South Africa.  The purpose of NABP is to serve as the independent, international, and impartial Association that assists states and provinces in developing, implementing, and enforcing uniform standards for the purpose of protecting the public health.

During our previous testimony, presented on July 28, 2004, NABP provided the NCVHS with comprehensive background information regarding NABP’s involvement over the past twenty years in the area of electronic transmission of prescriptions.  In November 2001, an NABP task force was convened to study the electronic transmission of prescriptions.  The task force noted that approximately 44 states allowed for the electronic transmission of prescriptions, in some form, either through explicit statutory and regulatory language defining and allowing its use or by default in omitting any prohibition of this activity.  In 2004, that number is closer to 50.

Our testimony today will focus specifically on electronic signatures. NABP’s primary concern regarding electronic prescribing is to ensure the authenticity, legitimacy and integrity of electronically transmitted prescriptions.  The Model State Pharmacy Act and Model Rules of the National Association of Boards of Pharmacy (Model Act)suggests that either an electronic or a digital signature can be used to process electronic prescriptions as long as the technology that exists allows for a secure transmission.

Electronic Signature Defined in the NABP Model Act

NABP recognizes the importance of ensuring the integrity and authentication of prescriptions transmitted through electronic channels. Based on a NABP task force recommendation in September 2001, NABP incorporated the Food and Drug Administration’s (FDA) definitions of “electronic signature” and “digital signature” into model regulations for electronic transmission of prescriptions.

The Model Act defines the concepts of electronic and digital signature as follows:

“Electronic signature” is an electronic sound, symbol, or process attached to or logically associated with a record and executed or adopted by a person with the intent to sign the record.

“Digital signature” means an electronic signature based upon cryptographic methods of originator authentication, and computed by using a set of rules and a set of parameters so that the identity of the signer and the integrity of the data can be verified.

The NABP Model Act, language regarding electronic and digital signatures is as follows:

“If an electronically transmitted Prescription Drug Order, prescribing Practitioner’s electronic or digital signature;”

Nearly half of the states require some form of electronic signature and/or other secure method of validation, while a few states require digital signatures for electronically transmitted prescriptions (Attachment A). One state had required use of digital signatures but updated their regulations to allow for use of electronic signatures. Roughly one-third of the states do not specifically address this issue.

Many state regulations also include that the electronic order must identify the transmitter’s phone number for verbal confirmation, the time and date of transmission, and the identity of the pharmacy intended to receive the transmission. The language found in a number of state practice acts and regulations can also be traced back to the NABP Model Act.

Ensuring the Integrity of the Prescription Order

NABP’s experience with the electronic transmission of prescriptions and electronic signature extends beyond the definitions and provisions of the NABP Model Act.  The Verified Internet Pharmacy Practice Sites (VIPPS) program, which was launched in 1999, identifies and verifies legal and legitimately operating Internet pharmacies.  The electronic transmission of prescriptions by Internet pharmacies is an area specifically identified in the VIPPS Criteria (Attachment B) and examined during the accreditation inspection.  Again, NABP’s particular interests concern the authentication of the prescription and maintaining the integrity of the prescription process.

Qualifying VIPPS Pharmacies, in accordance with applicable state and federal laws and regulations, must:

Prescription Information

Maintain and enforce policies and procedures that assure the integrity, legitimacy, and authenticity of the Prescription Drug Order and seek to prevent Prescription Drug Orders from being submitted, honored, and filled by multiple pharmacies. Maintain and enforce policies and procedures that assure that prescription medications are not prescribed or dispensed based upon telephonic, electronic, or online medical consultations without there being a pre-existing patient-prescriber relationship that has included an in-person physical examination.

NABP is also concerned that the transmission of prescriptions electronically must safeguard patient confidentiality and be conducive to patient counseling and drug use review.  The NABP Model Act and VIPPS criteria include several references to this concern.  Specifically, from the VIPPS Criteria:

Patient Information

Maintain and enforce policies and procedures ensuring reasonable verification of the identity of the patient, prescriber, and, if appropriate, caregiver, in accordance with applicable state law;

Obtain and maintain in a readily accessible format, patient medication profiles and other related data in a manner that facilitates consultation with the prescriber, when applicable, and counseling of the patient or caregiver;

Conduct a prospective drug use review (DUR) prior to the dispensing of a medication or device in accordance with applicable state law; and

Maintain and enforce policies and procedures to assure patient confidentiality and the protection of patient identity and patient-specific information from inappropriate or non-essential access, use, or distribution while such information is being transmitted via the Internet and while the pharmacy possesses such information.

DEA Regulations for Controlled Substances

It is important to note that although state regulations regarding electronic and digital signatures include controlled substances prescriptions, the basis for, or overriding authority on the permissiveness of the electronic transmission of controlled substances prescriptions will be the Drug Enforcement Agency (DEA).  States are working cooperatively with the DEA to achieve a productive intertwining of federal and state requirements for the transmission of controlled and non-controlled prescription orders.   To date, the DEA has not yet released their regulations pertaining to electronic/digital signatures for controlled substances prescriptions that are transmitted electronically.  The NCVHS, as it is well aware, should take the DEA regulations, once released, into consideration prior to providing a recommendation on electronic signatures to the Secretary of Health and Human Services (HHS).  The electronic signature requirements for controlled and non-controlled substances should be consistent in order to minimize fragmentation and potential barriers to electronic prescribing.

Conclusion

In closing, NABP recognizes the benefits of the electronic transmission of prescriptions and understands the positive impact this technology has on patient safety and the facilitation of the processing of prescription orders. Electronic or digital signature considerations and qualifications will be critical to the entire validation process and extremely dependent on the technology and standards used to ensure the authenticity, legitimacy and integrity of the electronically transmitted prescription.  While many arguments can be made to support the rapid adoption of electronic prescribing, consideration should be given to the development of a national standard that is focused on patient safety, public protection, and the provision of quality health care.

NABP is committed to assisting the NCVHS, CMS, and other interested stakeholders in developing standards, laws, and regulations for electronic transmission which ensure appropriate regulation and safeguards that enhance public safety and engender public trust.

Thank you once again, for the opportunity to address this important issue.