> September 25, 2008
>
> The Drug Enforcement Administration
>
> Attention: DEA Federal Register Representative/ODL
>
> 8701 Morrissette Drive
>
> Springfield, Virginia 22152
>
> **Re: The Drug Enforcement Administration proposed rule on *the
> Electronic Prescriptions for Controlled Substances*, 21 CFR Parts
> 1300, 1304, et al. (June 27, 2008). Docket No. DEA---218.**
>
> To Whom It May Concern:
>
> The American Medical Directors Association (AMDA) appreciates the
> opportunity to provide comments on the Drug Enforcement
> Administration's (DEA) proposed rule on electronic prescriptions for
> controlled substances. Electronic prescribing for physicians whose
> practice is focused on institutional care of the frail elderly
> requires special consideration from the DEA. Our membership provides
> care in long term care facilities, currently exempt from e-Prescribing
> standards but soon to be brought into the scope of regulations. This
> exemption will expire in 2010 and standard solutions will need
> implementation. The ability to support a practical electronic solution
> will be essential to creation of a fully electronic physician order
> entry system in long term care. This will result in greater patient
> safety as well as prescriber accountability.
>
> In addition, our physicians provide care for residents in the final
> stages of chronic illness across a variety of residential settings,
> including assisted living facilities and home based care. We are also
> important providers of end of life care through hospice programs, both
> inpatient and outpatient. The ability to treat pain associated with
> chronic or acute illness or the dying process, in a timely fashion, is
> critical to our patients and membership.
>
> The electronic process of ordering medications especially controlled
> substances is considerably different in the long term care setting. In
> the nursing home setting, many patients, especially short-stay,
> post-acute care patients, will be cared for by physicians who have not
> yet had the opportunity to evaluate the patient on site. Initiating
> orders over the phone with a licensed nurse based on transfer
> documents and a nursing
>
> assessment is not uncommon. As in acute hospital care, changes in
> condition requiring urgent administration of controlled substances
> occur often, at all hours of the day and night. Commonly, a prescriber
> phones in an order that is transcribed by the staff, the drug is
> provided, and the provider reviews and signs a written prescription at
> a later date.
>
> While the current proposal for electronic prescribing does not
> eliminate standard written protocols and prescribing practices, the
> goals of improving security and efficiency may make electronic
> prescribing necessary for all in the near future. Building the
> functionality necessary to meet the needs of long-term care
> prescribers and patients up front for important components of the
> health system is useful for all concerned. Despite large per-capita
> requirements for controlled substance prescribing, long-term care
> facilities have not been a significant source of drug diversion based
> on illicit prescribing. Before finalizing this proposed rule, please
> consider the special requirements for health informatics system
> functionality and support practical and affordable long term care
> electronic health records and e-Prescribing systems to facilitate
> widespread adoption in the long term care setting.
>
> **Areas of concern:**
>
> ***Federal register topic: Agent of the Prescriber - A prescription
> may be prepared by the secretary or agent of a practitioner. 21 CFR
> 1306.05(f)***
>
> **Roles:**
>
> **"Agent of the Prescriber"** in the rule currently does not recognize
> the nurse as the agent of the prescriber in long term care (LTC)
> settings. The workflow in the long term care facility needs to
> accommodate verbal orders and orders communicated by fax to a nursing
> unit. Because physicians are not typically in a long term care setting
> 24/7 the nurses play a critical role in communicating with the
> physician, transcribing verbal orders, and entering and transmitting
> medication orders to the pharmacy. The nurse in long term care acts as
> the agent of the prescriber the same way that a nurse in the acute
> care setting acts as an agent of the prescriber. Also, the nurse
> normally reviews the medication orders prior to the order being sent
> to the pharmacy and consults with the prescriber if a question arises
> such as a previous adverse reactions experienced by a patient or
> duplicative therapy. In the absence of clear guidelines regarding
> roles, nursing facilities which proceed with electronic orders and
> electronic prescribing will need to conform to these general
> standards.
>
> **Recommendations:**
>
> **1) The DEA provides more granular information regarding specific
> roles which support a physician's ability to generate an electronic
> prescription, especially when the physician is not physically present
> in the building.**
>
> **2) As we move forward to implement e-prescribing the DEA needs to
> recognize the nurse as an agent of the prescriber by allowing the
> nurse to review the controlled substance order prior to transmission
> to the pharmacy.**

**Prescribers**

> ***Federal register topic: Eligibility Requirements: 1) Submit to
> in-person identity proofing by a permitted entity 21 CFR 1311.105(a)
> 2) Permitted entities include a DEA-registered hospital that has
> previously granted that practitioner privileges at the hospital
> (provided the practitioner's privileges are active and in good
> standing), a State professional licensing board or controlled
> substances authority, or a State or local law enforcement agent.***
>
> ***21 CFR 1311.105(b)***
>
> **In-Person** **Identity Proofing** is a new requirement in the
> proposed rule. Clearly the opportunity to reduce fraudulent
> prescriptions needs to be captured as part of the move to electronic
> prescriptions and the integrity of an identity provider is paramount.
> Clearly, the new requirements for identity proofing are far greater
> than current requirements and may impose a significant burden on some
> providers. Long-term care physicians and non physician providers such
> as physician's assistants and nurse practitioners may not have
> hospital privileges. The facilities themselves may not qualify to
> provide identity proofing. Many of our prescribers live in rural
> communities that may make it very difficult if a prescriber can only
> submit to in-person identify proofing at a DEA-registered hospital or
> State professional licensing board or controlled substances authority
> or State or local law enforcement agent. The time and cost it requires
> to meet this requirement may pose a barrier to adoption.
>
> **Recommendation: Therefore we urge the DEA not to require in-person
> identity proofing.**
>
> ***Federal Register Topic: If a hard token has been lost, stolen or
> compromised, the practitioner must notify the service provider within
> 12 hours of discovery. If notice is not provided timely, the
> practitioner may be held responsible for any controlled substance
> prescriptions written using the hard token. 21 CFR 1311.55(c)***
>
> **Reporting Lost or Stolen Token** must be reported within 12 hours.
> Those who work in healthcare recognize that loss of a token will not
> be recognized until it is needed next. Setting an arbitrary time
> standard unfairly punishes responsible practitioners. This is
> difficult to enforce and is vague. There needs to be notification as
> soon as practical, however, there should be no penalty for failing to
> notify a lost token.
>
> **Recommendation: The time frame for reporting a lost or stolen token
> be extended to the next working day.**
>
> ***Federal Register Topic: The practitioner will be required to review
> a monthly log of all electronic prescriptions for controlled
> substances that the practitioner issued during the previous month
> using the system, to determine whether the prescriptions issued under
> his DEA registration number were, in fact, issued by him and whether
> any prescriptions appear to be unusual based on the practitioner's
> known prescribing pattern. 21 CFR 1311.55(d)***
>
> **Monthly Log** is a new requirement. The proposed rule states the
> practitioner will be required to review a monthly log of all
> electronic prescriptions for controlled substances that the
> practitioner issued during the previous month using the system, to
> determine whether the prescriptions issued under his DEA registration
> number were, in fact, issued by him and whether any prescriptions
> appear to be unusual based on the practitioner's known prescribing
> pattern. This will be an imprecise control over unauthorized
> utilization since the log will not represent all prescriptions
> generated by the provider as there will possibly be prescriptions done
> on paper. However, it would be useful for detecting increased
> prescribing patterns. This could also be done automatically at the
> level of the prescription hub service such as Sure Scripts and should
> be their responsibility since they have a greater perspective on the
> total volume of prescriptions written for any individual. The review
> of the log monthly is not unreasonable. However, two minutes budgeted
> to perform this task does not allow for a thoughtful review. The
> provider needs to be made whole financially through incentives for
> providing this service.
>
> **Recommendation: Add the review requirement in the Medicare payment
> formula for long term care visits.**
>
> ***Federal Register Topic: Prescriber Access The practitioner must
> authenticate herself to the system using two-factor authentication
> immediately before signing the prescription. The system may allow the
> practitioner to sign the multiple prescriptions at the same time.
> However, the physician/prescriber will need to re-authenticate herself
> if, after having logged in using two factor authentication, the
> prescription is not signed within two minutes.***
>
> ***For all prescriptions to be signed, the practitioner must indicate
> agreement with the following statement which must be displayed for the
> practitioner's review for all prescriptions that are to be transmitted
> in connection with that signature. Either the registrant or her agent
> may enter data for a controlled substance prescription.***
>
> ***21 CFR 1311.125(a)(b) 21 CFR 1311.120(a)***
>
> **Prescriber Access/Authentication** is the process by which a
> prescriber is granted the ability to send a prescription for a
> controlled substance electronically. The proposed rule states the
> prescriber must authenticate herself to the system using two-factor
> authentication immediately before signing the prescription. The system
> may allow the practitioner to sign multiple prescriptions at the same
> time.
>
> The larger issue of "nurse as agent" remains the greatest challenge
> for prescriber authentication for long term care orders transmitted
> electronically.
>
> **Recommendation:**
>
> **That the DEA provides guidelines for prescriptions for inpatients of
> long term care facilities where the chain of command of the drug is
> secure and the recipient of the drug is positively identified upon
> administration and the drug is accompanied by a specific clinical
> indication.**
>
> ***Federal Register Topic Transmission: The electronic prescription
> system must not allow the printing of an electronic prescription that
> has been transmitted and must not allow the transmission of an
> electronic prescription that has been printed. At no time may an
> electronic prescription be converted to another form (e.g. facsimile)
> for transmission. 21 CFR 1311.130 (b-c), 21 CFR 1311.130 (g)***
>
> **Transmission of a controlled substance prescription,** according to
> the proposed rule, states the electronic prescription system must not
> allow the printing of an electronic prescription that has been
> transmitted and must not allow the transmission of an electronic
> prescription that has been printed. At no time may an electronic
> prescription be converted to another form for transmission.
>
> In the case of long-term care facilities and assisted living
> facilities the DEA must permit the transmission of electronic copies
> to the nursing facility and assisted living facilities particularly in
> those instances where the provider maintains a paper chart. The
> facility must have a copy of each physician's order in each resident's
> chart. If their charting system is paper-based, a printed version of
> the e-prescription would be the only mechanism for adding the order to
> the chart.
>
> Facilities with electronic orders and prescribing systems but no
> electronic health record may need to create a paper report for review
> by surveyors.
>
> **Recommendation:**
>
> **Permit the nursing home to print documentation of a controlled
> substance prescription. The DEA needs to consider those nursing homes
> that still have paper charts because a printed version of the
> e-prescription could be the only mechanism for demonstrating the order
> for a third party and for tracking purposes.**
>
> ***Federal Topic Transmission: Provide for information to be linked to
> the prescription including the number of units or volume of controlled
> substance dispensed, the date of dispensing, the name of the person
> who dispensed the prescription, and the number of refills.***
>
> ***21 CFR 1311.165(e)***
>
> The proposed rule describes the requirement for a dispensed amount and
> number of refills. For Assisted Living and Long Term Care, a Start and
> Stop Date may be more appropriate.
>
> **Recommendation:**
>
> **That the DEA allow a 30 day supply with no stop date provided the
> prescriber signs the Physician Plan of Care (medication order sheet)
> within the required periods mandated by Federal and State
> regulations.**
>
> **Therapeutic Equivalents:** The proposed regulations make no mention
> of therapeutic interchange. Significant savings for residents in their
> Part D Medicare expenses would be achieved by allowing pre-approved
> therapeutic interchange. Generic substitutions and therapeutic
> interchange information when contained in structured, standardized
> prescription messages should be honored and the pharmacy should be
> allowed to transmit dispensing information which is different from the
> original order within the guidelines of a signed agreement between the
> Medical Director and the pharmacy detailing all allowed substitutions.
> In addition, the facility should be allowed to populate an
> administration record with the dispensed medication data.
>
> **We strongly recommend the DEA includes Long Term Care Physicians on
> an advisory panel looking at the development of processes for
> e-prescribing since the needs in LTC e-prescribing are different from
> the acute care setting. The proposed rule needs to include the unique
> prescribing process of LTC settings where the prescriber and the
> patient many times are not in the same location when the prescriptions
> are written and the nurse is the agent of the prescriber. We do
> believe that e-prescribing has the potential to improve patient safety
> and decrease inappropriate prescribing in the frail elderly.**
>
> If you have any further questions please contact Associate Director of
> Clinical Affairs, Nancy Robinson at <nrobinson@amda.com> or (410)
> 992-3125.
>
> Sincerely,
>
> ![](media/image2.png){width="3.2263888888888888in" height="1.0in"}
>
> Charles Crecelius, MD, PhD, CMD
>
> President