Electronic Prescriptions for Controlled Substances
Encyclopedia
Electronic Prescriptions for Controlled Substances was originally a proposal for the DEA to revise its regulations to provide practitioners with the option of writing electronic prescriptions
for controlled substances. These regulations would also permit pharmacies to receive, dispense, and archive these electronic prescriptions. These proposed regulations would be an addition to, not a replacement of, the existing rule.
In 2010, DEA regulations were modified which lifted previous restrictions against the use of electronic prescribing for controlled substances that have presented a major obstacle to e-prescribing proliferation. As healthcare providers move to implement these new regulations, e-prescribing can be expected to reduce paperwork for pharmacies and practitioners, reduce prescription forgery and help integrate prescription records in electronic medical records.
The rule “Electronic Prescriptions for Controlled Substances” (75 FR 16236, March 31, 2010) [Docket No. DEA-218, RIN 1117-AA61] provides practitioners with the option of writing and transmitting prescriptions for controlled substances electronically. The regulations also permit pharmacies to receive, dispense, and archive these electronic prescriptions. The rule became effective on June 1, 2010.
The nation’s first public end-to-end electronic controlled substance prescribing system was demonstrated at the 2010 Agency for Healthcare Research and Quality
(AHRQ) Annual Health IT Grantee and Contractor meeting in Washington, DC. This system, which has been in use since 2009, was developed through the collaboration of the Massachusetts Department of Public Health, Berkshire Health Systems, Inc., DrFirst Inc., eRx Network (a division of Emdeon) and the Brandeis University
Heller School for Social Policy and Management. This earlier system was designed to meet most of the requirements of the DEA’s earlier “Notice of Proposed Rulemaking” (73 FR 36722, June 27, 2008) [Docket No DEA-218P, RIN 1117-AA61], and operated under a waiver issued by the DEA.
The first software application that meets the current prescription processing requirements set by the DEA and the identify proofing requirements set by the National Institute of Standards and Technology
was introduced in August, 2011. The application allows for the flagging and sending of multiple prescriptions for different doctors and pharmacies.
, also known as the Controlled Substances Act
(CSA) (21 U.S.C. 801–971). At this time, most transactions, and particularly prescriptions were done on paper.
These regulations ensure an adequate supply of controlled substances for legitimate medical, scientific, research, and industrial purposes. The regulations also deter the diversion of
controlled substances to illegal purposes. The CSA mandates that DEA establish a closed system of control for manufacturing, distributing, and dispensing controlled substances. Part of CSA mandate included that some records must be created and kept on forms that DEA provides and that many controlled substance prescriptions must be manually signed.
s, while being mindful that the records had to be usable in legal actions. On April 1, 2005, after extensive consultation with the regulated community, DEA published a final rule that allowed the electronic creation, signature, transmission, and retention of records of orders for Schedule I and Schedule II controlled substances, orders that prior to that time had to be created on preprinted forms that DEA issued.
At the same time, DEA began to examine how to revise its rules to allow electronic prescriptions for controlled substance
s. The DEA had to mindful that regulations on electronic prescriptions must be consistent with other statutory mandates and Federal regulations. Looking back, E-Sign was signed into law on June 30, 2000. It establishes the basic rules for using electronic signatures and records in commerce, and it electronic commerce by giving legal effect to electronic signatures and records and to protect consumers.
was implemented. It contained a requirement pertaining to electronic transmission of prescriptions and prescription-related information for its medicare program. One of the considerations in support of this move to electronic prescriptions was the view that using electronic prescriptions in lieu of written or oral prescriptions could reduce medical errors that occur
because handwriting is illegible or phoned in prescriptions are misunderstood as a result of similar sounding medication names. Another consideration is that, if prescription records are linked to other medical records, practitioners can be alerted at the time of prescribing to possible interactions with other drugs the patient is taking or allergies a patient might
have. Electronic prescribing systems also can link to insurance formulary lists to inform the practitioner prior to prescribing whether a drug is covered by a patient’s insurance.
The Secretary of the Department of Health and Human Services
(HHS) adopted a rule on the transmission standard for electronic prescriptions in November 2005 (revised in June, 2006). The standard focuses on the format for the transmitted information, not with the process of creating the prescription or maintaining the record at the pharmacy. The standard specifies fields (name, date, address, etc.) and field lengths for certain transactions including issuing new prescriptions and refills. However there is no requirement that practitioners or pharmacies use electronic prescriptions. It does require that companies that sponsor medicare perscription drug coverage establish and maintain an electronic prescription program that meets the standard.
s and therefore not designed to provide safeguards against the diversion of controlled substances. The responsibility for establishing regulatory safeguards against diversion of controlled substances falls upon DEA as the agency charged with administering and enforcing the CSA. Accordingly, while the DEA's rule is designed to work in tandem with the HHS standard, its scope is necessarily distinct from the HHS standard.
, utilizing two of the following potential identification factors: (1) password or response to a question whose answer is known only to the practitioner (2) unique physical information, such as fingerprint or iris scan, otherwise know as biometric data or (3) physical object such as cryptographic key or hard token. Specific security measures must also be implemented. These include the requirement that two people need to authorize each controlled-drug e-prescription. One person confirms that the practitioner is authorized to sign the prescription. The second person is the practitioner who confirms his identity using the two-factor authentication system described above.
Every provider workflow is likely to be somewhat different. One potential workflow for renewal requests would proceed as follows. The patient calls the pharmacy to request renewal. The pharmacy sends the electronic renewal request to the prescriber’s office. The prescriber reviews and authorizes. The response is then sent electronically to the pharmacy. Staff involvement in generating prescriptions for the prescriber to sign varies by practice. The new method of dispensing allows pharmacists to submit an accurate electronic request for a renewal, decreasing the burden of phone calls on medical office staff. No major changes are expected in the new prescription workflow since the prescriber is the primary actor in the current best practice and is expected to remain so after electronic prescriptions for controlled substances is implemented.
The American Medical Association
and four partner organizations in April 2011 issued an updated version of "A Clinician's Guide to Electronic Prescribing." The organizations said the guide reflects changes in the health care environment including the DEA's rule allowing electronic prescribing of controlled substances.
Some state laws and regulations will require changes before controlled substance e-prescribing will be fully legal. State boards of pharmacy are offering guidance to licensees regarding DEA e-prescribing software requirements and the legality of controlled substance e-prescribing in their respective states. While the legality of e-prescribing controlled substances will vary from state-to-state for some time to come, e-prescribing as a whole will likely take a firm hold throughout the country and achieve its potential as a universal, efficient, and safer method of helping patients access their medications.
Life as a Healthcare CIO blog stated that: “With fully electronic workflows, I can write for all needs, digitally sign the enter order set, get a PIN sent to my cell phone in 2 seconds and then send the transactions to the pharmacy of the patient's choice without a pen, paper or hassle.”
Electronic prescribing
Electronic prescribing or e-prescribing is the ability to send error-free, accurate, and understandable prescriptions electronically from the healthcare provider to the pharmacy. E-prescribing is meant to reduce the risks associated with traditional prescription script writing. It is also one of...
for controlled substances. These regulations would also permit pharmacies to receive, dispense, and archive these electronic prescriptions. These proposed regulations would be an addition to, not a replacement of, the existing rule.
In 2010, DEA regulations were modified which lifted previous restrictions against the use of electronic prescribing for controlled substances that have presented a major obstacle to e-prescribing proliferation. As healthcare providers move to implement these new regulations, e-prescribing can be expected to reduce paperwork for pharmacies and practitioners, reduce prescription forgery and help integrate prescription records in electronic medical records.
Background
Approximately 423 million electronic prescriptions were issued in 2010, an increase of 125% over the 2009 figure. The lack of e-prescribing for controlled substances has been a barrier to further adoption of e-prescribing.The rule “Electronic Prescriptions for Controlled Substances” (75 FR 16236, March 31, 2010) [Docket No. DEA-218, RIN 1117-AA61] provides practitioners with the option of writing and transmitting prescriptions for controlled substances electronically. The regulations also permit pharmacies to receive, dispense, and archive these electronic prescriptions. The rule became effective on June 1, 2010.
The nation’s first public end-to-end electronic controlled substance prescribing system was demonstrated at the 2010 Agency for Healthcare Research and Quality
Agency for Healthcare Research and Quality
The Agency for Healthcare Research and Quality is a part of the United States Department of Health and Human Services, which supports research designed to improve the outcomes and quality of health care, reduce its costs, address patient safety and medical errors, and broaden access to effective...
(AHRQ) Annual Health IT Grantee and Contractor meeting in Washington, DC. This system, which has been in use since 2009, was developed through the collaboration of the Massachusetts Department of Public Health, Berkshire Health Systems, Inc., DrFirst Inc., eRx Network (a division of Emdeon) and the Brandeis University
Brandeis University
Brandeis University is an American private research university with a liberal arts focus. It is located in the southwestern corner of Waltham, Massachusetts, nine miles west of Boston. The University has an enrollment of approximately 3,200 undergraduate and 2,100 graduate students. In 2011, it...
Heller School for Social Policy and Management. This earlier system was designed to meet most of the requirements of the DEA’s earlier “Notice of Proposed Rulemaking” (73 FR 36722, June 27, 2008) [Docket No DEA-218P, RIN 1117-AA61], and operated under a waiver issued by the DEA.
The first software application that meets the current prescription processing requirements set by the DEA and the identify proofing requirements set by the National Institute of Standards and Technology
National Institute of Standards and Technology
The National Institute of Standards and Technology , known between 1901 and 1988 as the National Bureau of Standards , is a measurement standards laboratory, otherwise known as a National Metrological Institute , which is a non-regulatory agency of the United States Department of Commerce...
was introduced in August, 2011. The application allows for the flagging and sending of multiple prescriptions for different doctors and pharmacies.
The mandate
In 1970, the DEA implemented the Comprehensive Drug Abuse Prevention and Control Act of 1970Comprehensive Drug Abuse Prevention and Control Act of 1970
The Comprehensive Drug Abuse Prevention and Control Act of 1970, Pub. L. No. 91-513, 84 Stat. 1236 , is a United States federal law that, with subsequent modifications, requires the pharmaceutical industry to maintain physical security and strict record keeping for certain types of drugs...
, also known as the Controlled Substances Act
Controlled Substances Act
The Controlled Substances Act was enacted into law by the Congress of the United States as Title II of the Comprehensive Drug Abuse Prevention and Control Act of 1970. The CSA is the federal U.S. drug policy under which the manufacture, importation, possession, use and distribution of certain...
(CSA) (21 U.S.C. 801–971). At this time, most transactions, and particularly prescriptions were done on paper.
These regulations ensure an adequate supply of controlled substances for legitimate medical, scientific, research, and industrial purposes. The regulations also deter the diversion of
controlled substances to illegal purposes. The CSA mandates that DEA establish a closed system of control for manufacturing, distributing, and dispensing controlled substances. Part of CSA mandate included that some records must be created and kept on forms that DEA provides and that many controlled substance prescriptions must be manually signed.
DEA examines revision
In 1999, in response to requests from the regulated community, the Drug Enforcement Agency (DEA) began to examine how to revise its regulations to allow the use of electronic systems within the limits imposed by the existing statuteStatute
A statute is a formal written enactment of a legislative authority that governs a state, city, or county. Typically, statutes command or prohibit something, or declare policy. The word is often used to distinguish law made by legislative bodies from case law, decided by courts, and regulations...
s, while being mindful that the records had to be usable in legal actions. On April 1, 2005, after extensive consultation with the regulated community, DEA published a final rule that allowed the electronic creation, signature, transmission, and retention of records of orders for Schedule I and Schedule II controlled substances, orders that prior to that time had to be created on preprinted forms that DEA issued.
At the same time, DEA began to examine how to revise its rules to allow electronic prescriptions for controlled substance
Controlled substance
A controlled substance is generally a drug or chemical whose manufacture, possession, or use are regulated by a government. This may include illegal drugs and prescription medications ....
s. The DEA had to mindful that regulations on electronic prescriptions must be consistent with other statutory mandates and Federal regulations. Looking back, E-Sign was signed into law on June 30, 2000. It establishes the basic rules for using electronic signatures and records in commerce, and it electronic commerce by giving legal effect to electronic signatures and records and to protect consumers.
Electronic prescriptions
In 2003, the Medicare Prescription Drug, Improvement, and Modernization ActMedicare Prescription Drug, Improvement, and Modernization Act
The Medicare Prescription Drug, Improvement, and Modernization Act is a federal law of the United States, enacted in 2003. It produced the largest overhaul of Medicare in the public health program's 38-year history.The MMA was signed by President George W...
was implemented. It contained a requirement pertaining to electronic transmission of prescriptions and prescription-related information for its medicare program. One of the considerations in support of this move to electronic prescriptions was the view that using electronic prescriptions in lieu of written or oral prescriptions could reduce medical errors that occur
because handwriting is illegible or phoned in prescriptions are misunderstood as a result of similar sounding medication names. Another consideration is that, if prescription records are linked to other medical records, practitioners can be alerted at the time of prescribing to possible interactions with other drugs the patient is taking or allergies a patient might
have. Electronic prescribing systems also can link to insurance formulary lists to inform the practitioner prior to prescribing whether a drug is covered by a patient’s insurance.
The Secretary of the Department of Health and Human Services
United States Secretary of Health and Human Services
The United States Secretary of Health and Human Services is the head of the United States Department of Health and Human Services, concerned with health matters. The Secretary is a member of the President's Cabinet...
(HHS) adopted a rule on the transmission standard for electronic prescriptions in November 2005 (revised in June, 2006). The standard focuses on the format for the transmitted information, not with the process of creating the prescription or maintaining the record at the pharmacy. The standard specifies fields (name, date, address, etc.) and field lengths for certain transactions including issuing new prescriptions and refills. However there is no requirement that practitioners or pharmacies use electronic prescriptions. It does require that companies that sponsor medicare perscription drug coverage establish and maintain an electronic prescription program that meets the standard.
A distinct scope
The rule has been written to be consistent with the above delineated HHS standard. However, the context in which the HHS standard was issued was not specific to controlled substanceControlled substance
A controlled substance is generally a drug or chemical whose manufacture, possession, or use are regulated by a government. This may include illegal drugs and prescription medications ....
s and therefore not designed to provide safeguards against the diversion of controlled substances. The responsibility for establishing regulatory safeguards against diversion of controlled substances falls upon DEA as the agency charged with administering and enforcing the CSA. Accordingly, while the DEA's rule is designed to work in tandem with the HHS standard, its scope is necessarily distinct from the HHS standard.
Impact on physicians and pharmacies
Before issuing electronic prescriptions for controlled substances, practitioners must meet several key requirements. One, they must use a software application that conforms to regulatory standards. They must also be credentialed for two-factor authenticationTwo-factor authentication
Two-factor authentication is an approach to authentication which requires the presentation of two different kinds of evidence that someone is who they say they are. It is a part of the broader family of multi-factor authentication, which is a defense in depth approach to security...
, utilizing two of the following potential identification factors: (1) password or response to a question whose answer is known only to the practitioner (2) unique physical information, such as fingerprint or iris scan, otherwise know as biometric data or (3) physical object such as cryptographic key or hard token. Specific security measures must also be implemented. These include the requirement that two people need to authorize each controlled-drug e-prescription. One person confirms that the practitioner is authorized to sign the prescription. The second person is the practitioner who confirms his identity using the two-factor authentication system described above.
Every provider workflow is likely to be somewhat different. One potential workflow for renewal requests would proceed as follows. The patient calls the pharmacy to request renewal. The pharmacy sends the electronic renewal request to the prescriber’s office. The prescriber reviews and authorizes. The response is then sent electronically to the pharmacy. Staff involvement in generating prescriptions for the prescriber to sign varies by practice. The new method of dispensing allows pharmacists to submit an accurate electronic request for a renewal, decreasing the burden of phone calls on medical office staff. No major changes are expected in the new prescription workflow since the prescriber is the primary actor in the current best practice and is expected to remain so after electronic prescriptions for controlled substances is implemented.
The American Medical Association
American Medical Association
The American Medical Association , founded in 1847 and incorporated in 1897, is the largest association of medical doctors and medical students in the United States.-Scope and operations:...
and four partner organizations in April 2011 issued an updated version of "A Clinician's Guide to Electronic Prescribing." The organizations said the guide reflects changes in the health care environment including the DEA's rule allowing electronic prescribing of controlled substances.
Some state laws and regulations will require changes before controlled substance e-prescribing will be fully legal. State boards of pharmacy are offering guidance to licensees regarding DEA e-prescribing software requirements and the legality of controlled substance e-prescribing in their respective states. While the legality of e-prescribing controlled substances will vary from state-to-state for some time to come, e-prescribing as a whole will likely take a firm hold throughout the country and achieve its potential as a universal, efficient, and safer method of helping patients access their medications.
Life as a Healthcare CIO blog stated that: “With fully electronic workflows, I can write for all needs, digitally sign the enter order set, get a PIN sent to my cell phone in 2 seconds and then send the transactions to the pharmacy of the patient's choice without a pen, paper or hassle.”