An electronic prescription is created, recorded or stored by electronic means; issued and validated with an electronic signature; and transmitted by electronic means directly from the prescriber to a pharmacist .
Prescribers and pharmacists must have a secure (encrypted or encoded) system for electronic transmission from computer to computer. Any equipment used for electronic transmission of prescriptions must be so located to ensure the security and confidentiality of the transmission. Procedures for electronic transmission of prescriptions should be documented. Electronically transmitted prescriptions must:
The information retained electronically should be capable of being reconstructed in the event of a computer malfunction or accident resulting in the destruction of data.
Other electronic transfer requirements are outlined in the following questions and answers.
YES. All records required under laws, rules and regulations administered by the Education Department may be maintained in an electronic format. At this time, certain records for controlled substances and for programs such as Medicare may have additional, hard-copy requirements. Pharmacists should check with these programs directly for specific requirements.
The signing and transmission of an electronic prescription are two distinct actions. Only the practitioner may review and electronically sign the prescription. Once signed, an agent or employee of the practitioner may transmit the prescription on behalf of the practitioner. The act of transmission must be independent of the review and signature process.
YES. Education Law 6810 allows the prescriber to electronically sign and insert an electronic direction to dispense the drug as written.
Effective March 27, 2016, practitioners are mandated to electronically prescribe both controlled and non-controlled substances. However, there are a number of exceptions in which a practitioner may issue an Official New York State prescription (ONYSRx) form, oral prescription or a fax of an ONYSRx.
Education law section 6802 specifically excludes facsimiles from the definition of an electronic prescription AND requires a manual signature.
A document that originated as an electronic prescription, but due to a temporary network outage or because your pharmacy is not enabled to receive prescriptions electronically, was converted to a computer-generated fax is NOT a valid prescription. A pharmacist receiving this order must call the prescriber, obtain confirmation of this prescription information, and document said confirmation as a telephoned prescription.
As noted, a facsimile is not considered an electronic prescription and must meet the following criteria:
Patients have the right to choose the pharmacy where they wish to have their prescription(s) filled. Practitioners who exert undue influence on a patient (known as steering) to have a prescription filled at any one pharmacy over another whether electronically transmitted or via a written or oral prescription are subject to charges of unprofessional conduct.
Pharmacists are responsible for assuring the validity of all written, oral and electronic prescriptions. There are a number of ways to do this, such as using new software programs that require a password; personal identification numbers (PINs) or other authentication of the prescriber. These programs also notify the pharmacist if an encrypted or encoded electronic message or "envelope" has been tampered with or altered. Prescribers and pharmacists must use compatible programs. If a pharmacist has reason to question the authenticity of an electronic prescription, the pharmacist's professional judgment must prevail. If verification is not possible, the pharmacist can choose not to accept the electronic prescription and can request transmission by another means from the prescriber.
For faxed prescriptions, we suggest that pharmacists apply strategies similar to those now used to verify oral and written prescriptions received when authenticity is not apparent. The best professional judgment of the pharmacist is the key to a safe and effective process. The steps used to verify phoned prescriptions may also be useful for faxed prescriptions. These steps may include:
Without special security features and safeguards, E-mail transmissions do not independently assure the required confidentiality of patient records and do not, therefore, meet the definition of an electronically transmitted prescription in the new rules and regulations.
A hard copy is not required to be maintained as long as the electronic prescription is securely stored and maintained. The same applies to refills. Similar to other records, the electronic records must be maintained for five (5) years and must be reproducible in hard copy and provided to the Department upon demand. Likewise, facsimile copies must be maintained in a readable fashion for five (5) years.
All pharmacists, including those providing prescriptions through a mail order service, are required to maintain a medication profile for each patient and to check for adverse drug reactions. Each pharmacist must practice according to his or her best professional judgment and the law. If there are concerns that a prescription can cause harm to a patient, a pharmacist may contact the prescriber. If a pharmacist believes that a prescription can cause harm to a patient, even after discussion with the prescriber, the pharmacist can choose not to fill the prescription.
If a prescriber cannot legally order the prescription based upon the prescriber's scope of practice, the pharmacist must not fill the prescription.
Amendments to Title 10 NYCRR Part 80 Rules and Regulations on Controlled Substances have been adopted and became effective as final regulations on March 27, 2013. The amendments authorize a practitioner to issue an electronic prescription for controlled substances (EPCS) in Schedules II through V and allow a pharmacy to accept, annotate, dispense and electronically archive such prescriptions. The practitioner and pharmacy must use a certified software application that is consistent with all federal security requirements to process electronic prescriptions for controlled substances. The federal security requirements for EPCS are included in the Drug Enforcement Administration Interim Final Rule, 21 CFR §1300 et seq., and can be accessed via the following link: www.deadiversion.usdoj.gov/ecomm/e_rx/. New York State regulations also require each pharmacy and practitioner to register their certified software application with the Department of Health, Bureau of Narcotic Enforcement (BNE). Please visit BNE's webpage at www.health.ny.gov/professionals/narcotic for additional information.
As of March 27, 2016, all prescriptions (including prescriptions for controlled substances) issued in New York State must be electronically transmitted, with certain limited exceptions.
The mailing address for all offices listed below is: Office of the Professions, State Education Building - 2nd floor, 89 Washington Avenue, Albany, New York 12234