Testimony on State Issues Related to the
Electronic Prescribing of Controlled Substances
Submitted to the National Committee on Vital and Health Statistics
Subcommittee on Standards and Security
February 1, 2005
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 state issues related to the electronic transmission of controlled substances prescriptions. The state boards of pharmacy and NABP recognize the importance of creating a regulatory environment that facilitates and regulates the electronic transmission of prescriptions for both controlled and non-controlled substances in the interest of 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 previous testimony to the NCVHS, NABP provided comprehensive background information regarding NABP’s involvement in the area of electronic transmission of prescriptions, an overview of state regulations, and information specifically addressing electronic signatures.
Pursuant to the current request of the Subcommittee, NABP’s testimony focuses specifically on state issues related to the electronic transmission and prescribing of controlled substances prescriptions. It is important to note that state board of pharmacy authority encompasses controlled and non-controlled substances. However, the regulations regarding controlled substances, including the electronic transmission and prescribing of prescriptions, bear significantly on the regulations and policies of the Drug Enforcement Administration (DEA). The primary concern of NABP regarding electronic transmission and prescribing is to ensure the authenticity, legitimacy and integrity of electronically transmitted prescriptions for all prescription medications, controlled and non-controlled.
DEA Regulations for Controlled Substances
State regulations pertaining to controlled substances intersect with the federal Controlled Substances Act (CSA) and DEA authority. The CSA, which focuses on the ordering, handling, distribution and dispensing of controlled substances, is enforced by the DEA. Although states have no explicit authority to enforce federal laws, states have enacted state-specific Controlled Substances Acts which incorporate the federal CSA at a minimum and, in a limited number of states, include more stringent provisions.
The complementary and sometimes conflicting relationship of state and federal laws regarding controlled substances highlights the importance of defining federal requirements and DEA policy for the electronic transmission and prescribing of controlled substances. NABP understands that the DEA presented information to NCHVS outlining their position on the electronic transmission of controlled substances. Beyond the information presented to NCVHS, NABP is not aware of any proposed changes in the CSA or regulations from the DEA for the electronic transmission or prescribing of controlled substances.
The DEA has however authorized and participated in a pilot project at the Hines VA hospital to evaluate the effectiveness and security of transmitting controlled substances (CII – CV) prescriptions electronically. NABP is hopeful that the pilot project results will provide DEA with the information needed to develop and release requirements for the electronic transmission of controlled substances. The release of these requirements is critical to any recommendation of the NCVHS or action by the states because the states typically defer to the DEA and federal CSA for guidance. For example, Nevada’s January 2005 newsletter states, “The near future will reveal a federally approved Drug Enforcement Administration electronic prescription prescribing system. The Board office has been hesitant to establish one mechanism, soon to be superceded by another. Regardless, any electronic signature transmission system needs Board of Pharmacy approval and none have been given.” In any event, the more stringent laws and regulations will take precedent whether the regulation or requirement is state or federal.
NABP strongly recommends that the NCVHS exert whatever influence it may have to foster the release of regulations and requirements from the DEA. Recommendations regarding the electronic transmission and prescribing of controlled substances must encompass the actions or anticipated actions of the DEA. To do otherwise could create conflicting regulations at both the federal and state levels. As mentioned earlier, the states will follow the lead of the DEA and incorporate additional (over and above regulations for non-controlled substances) security measures and limitations placed on the electronic transmission and prescribing of controlled substances into state requirements. NABP is hopeful that the electronic transmission and prescribing requirements for controlled and non-controlled substances will be consistent in order to minimize fragmentation and potential barriers to electronic prescribing and transmission. Standards for electronic transmission and prescribing should incorporate the necessary security, accountability, and privacy domains whether the substances are controlled or non-controlled.
An analysis of current DEA regulations for controlled substances (Appendix A), appears to indicate that the DEA requirements do not directly address the electronic transmission of the prescription. It appears that the following areas of DEA regulations would be impacted by the development of federal requirements for the electronic transmission and prescribing of controlled substances:
- DEA requirements for Schedule II controlled substances that mandate a prescription must be written in ink or indelible pencil or typewritten and must be manually signed by the practitioner and thus do not allow for the transmission of CII prescriptions orally.
- DEA requirements for Schedule II controlled substances that require a written prescription which must be signed by the practitioner.
- DEA requirements for Schedule III – V controlled substances that specifically limit the transmission of prescriptions for controlled substances to oral, writing, or facsimile.
Also absent from current DEA regulations and requirements, but a significant consideration of the electronic transmission and prescribing of prescriptions, is the use of electronic or digital signatures. NABP anticipates that this area of interest will be a primary focus of any DEA regulation or requirement and developed specifically to meet the concerns of the DEA, regardless of the relation to overall standards or requirements for electronic transmission or to creating a regulatory environment that facilitates the electronic transmission or prescribing of prescriptions. As mentioned earlier, the states do not have the ability to override more stringent DEA requirements. Under current DEA regulations and requirements, prescriptions for controlled substances cannot be transmitted or prescribed electronically until the DEA updates their regulations to allow for electronic transmission and prescribing. If the standards or requirements for electronic transmission or prescribing of prescriptions do not satisfy the DEA’s needs and result in a separate set of standards for electronic transmission and prescribing then a cumbersome and fragmented system will result, imposing burdens on practitioners and patients throughout the system.
State Controlled Substances Acts
In previous testimony submitted to the NCVHS, NABP noted that only five states have statutes or regulations that limit or, in some circumstances, prohibit the electronic transmission of prescriptions. In all states, the regulation of the electronic transmission and prescribing of controlled substances will be impacted by any regulation or requirement issued by the DEA. Absent any federal regulations or requirements, the states will be forced to develop requirements for the electronic transmission and prescribing of controlled substances. In the past, the states have treated controlled substances differently than non-controlled substances and imposed additional requirements for controlled substances because of the highly addictive and susceptibility to diversion that characterize controlled substances.
Upon conducting a brief search of state regulations regarding the electronic transmission of controlled substances, NABP identified New Jersey and Wisconsin as states that have language in their regulations that would potentially allow for the electronic transmission of controlled substances prescriptions pursuant to the DEA establishing federal regulations that would allow for the electronic transmission of controlled substances. Wisconsin regulations do not specifically include language pertaining to the electronic transmission of CIII –V prescriptions but clearly do not allow for the electronic transmission of CII prescriptions. As an example of a state regulation addressing electronic transmission of controlled substances, New Jersey’s language reads:
NJ BReg 13:39-5.8B. Electronically Transmitted Prescriptions. (Adopted Sept. 15, 2003. Updated 6/2004.)
(a) A pharmacist may accept for dispensing an electronic prescription, consistent with the requirements of this section. For purposes of this section, electronic prescription means a prescription which is transmitted by a computer device in a secure manner, including computer to computer and computer to facsimile transmissions.
A pharmacist may fill a prescription for a Schedule II controlled substance transmitted electronically, provided that the original signed prescription is presented to the pharmacist prior to the dispensing of the controlled substance. If permitted by federal law, and in accordance with federal requirements, an electronic prescription shall serve as the original signed prescription.
(i) A pharmacist may fill a prescription for a Schedule III, IV, or V controlled substance transmitted electronically, provided that the pharmacist has obtained original signed prescription, an oral prescription, or a facsimile prescription from the prescribing practitioner or the prescribing practitioner’s authorized agent prior to the dispensing. If permitted by federal law, and in accordance with federal requirements, and electronic prescription shall serve as the original signed prescription.
According to the NABP 2005 Survey of Pharmacy Law, all fifty states as well as the District of Columbia have a state-specific Controlled Substance Act (CSA). While the CSA in nearly half the states falls under the purview of the Board of Pharmacy, in the remaining states, some aspects of the regulation of controlled substances may fall to another state agency such as the Dangerous Drugs Bureau, Drugs and Narcotics Agency, or Bureau of Drug Control. It is through state-specific CSA’s that state regulatory agencies define their authority for the regulation of controlled substances. Ultimately, authority for the electronic transmission and prescribing of prescriptions for controlled substances will rest with the individual state board of pharmacy, or similarly charged agency, because this practice is an integral component of the practice of pharmacy. In states where other agencies share the regulatory authority for controlled substances, again the board of pharmacy or similarly charged-agency will bear responsibility for the electronic transmission and prescribing of prescriptions, controlled and non-controlled, and regulate other requirements through a complementary arrangement.
Recommendations from the NCVHS must account for the regulations and requirements of the DEA as well as existing state regulations or requirements. NABP again urges caution in any preemption of state laws and regulations, particularly those governing the dispensing of controlled substances because of the highly addictive nature of these substances and problems with diversion and trafficking the states have experienced.
In closing, NABP recognizes the benefits of the electronic transmission of prescriptions and understands the positive impact this technology can have on patient safety and the prescribing 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.