STATE BOARD
OF PHARMACY[49 PA. CODE CH. 27] Technology and Automation [34 Pa.B. 3146] The State Board of Pharmacy (Board) proposes to amend §§ 27.1 and 27.14 (relating to definitions; and supplies) and to add §§ 27.201--27.204 (relating to technology and automation) to read as set forth in Annex A.
Effective Date
The proposed rulemaking will be effective upon final-form publication in the Pennsylvania Bulletin.
Statutory Authority
The proposed rulemaking is authorized under sections 4(j) and 6(k)(1) and (9) of the Pharmacy Act (63 P. S. §§ 390-4(j) and 390-6(k)(1) and (9)).
Background and Purpose
The use of computer-based information and communications systems are now prevalent in the fields of medicine and pharmacy. Current regulations of the Board do not reflect nor regulate the use of this technology. The proposed rulemaking allows the incorporation of this technology into the practice of pharmacy and brings the Commonwealth up to date with regulations of other states that currently regulate this technology. The purpose of the proposed rulemaking is to set standards for the use of this technology.
Currently, the Board's regulations do not govern whether pharmacies may accept the transmission of prescriptions of a lawful prescriber by electronic means. Prescriptions may be sent to the pharmacy by telephone or facsimile under §§ 27.18(n) and 27.20 (relating to standards of practice; and facsimile machines). The proposed rulemaking allows pharmacies to accept a prescription that was transmitted electronically through the Internet or intranet. Pharmacies would also be permitted to maintain the prescription electronically, thus eliminating a need to maintain an original paper prescription. The proposed rulemaking also allows pharmacies to maintain required records on a computer as opposed to keeping paper files. Pharmacies can then begin moving toward a paperless recordkeeping system.
The proposed rulemaking also provides for the use of centralized prescription processing and automated medication systems. By implementing these innovations into the practice of pharmacy, a pharmacist may spend more time dealing with the clinical aspects of the practice of pharmacy.
Description of the Proposed Rulemaking
Section 27.14(c)(11) permits the use of a computerized recordkeeping system in a pharmacy and lists two standards for the use of a computerized recordkeeping system. Proposed § 27.202 (relating to computerized recordkeeping systems) provides a more comprehensive set of standards for a pharmacy's use of a computerized recordkeeping system. Therefore, the proposed amendment to § 27.14(c)(11) removes standards for computerized recordkeeping to the extent they are under proposed § 27.202 and instead cross references § 27.202. The Board also proposes to amend § 27.14 to remove the direct reference to 21 CFR 1304.04(h) (relating to maintenance of records and inventories) and replace that language with a broader reference to State and Federal laws and regulations. The Board recognizes that 21 CFR 1304.04(h) is not the only law or regulation that governs controlled substance prescription records. The proposed rulemaking is more accurate with regard to the duty of a pharmacy to maintain records in accordance with both State and Federal law.
Proposed § 27.201 (relating to electronically transmitted prescriptions) regulates prescriptions transmitted to a pharmacy by electronic means. Currently, the regulations allow for a pharmacist to accept prescriptions transmitted through the telephone or a facsimile machine, but they do not address the acceptance of prescriptions transmitted through electronic means such as a computer or palm device. The proposed rulemaking sets forth the requirements of the electronic prescription that a pharmacist may accept. To protect the prescription from being altered, it must be electronically encrypted or protected by some other means to prevent access, alteration, manipulation or use by an unauthorized person. The patient is able to choose the pharmacy where the prescription will be transmitted. If a pharmacist believes that the prescription does not comply with State and Federal Law, the pharmacist may choose not to fill the prescription. This section also sets forth the recordkeeping requirements for electronic prescriptions. The regulation requires that either a hard copy or a readily retrievable image must be kept for at least 2 years from the date of the most recent filling of the prescription. This 2-year time frame mirrors the length of time that paper prescriptions are required to be kept on file. Like the existing regulations dealing with facsimile machines, this section prohibits any pharmacy or pharmacist from supplying electronic equipment to any prescriber for transmitting prescriptions. Additionally, the proposed rulemaking clarifies that as an electronic transaction, the transmittal of a prescription through electronic means would also be governed by the Electronic Transactions Act (73 P. S. §§ 2260.101--2260.5101).
Proposed § 27.202 provides standards for maintaining records on a computer as opposed to keeping paper files. The records must be immediately retrievable for prescriptions filled within the previous 12 months or retrievable within 3 working days for prescriptions filled within the previous 24 months. The Board feels that these timeframes are reasonable and will not adversely affect patient care. The proposed rulemaking sets forth the information that must be retrievable. Information that is currently required to be on prescriptions under § 27.18(b)(1), as well as identification of the pharmacist responsible for prescription information entered into the computer system, must be retrievable. This section also provides the procedures to be followed when the system experiences down time. To ensure patient safety, prescription information must be entered into the computerized recordkeeping system as soon as it is available for use. Furthermore, when the information from the computerized recordkeeping system is not available, prescriptions may only be refilled if the number of refills authorized by the prescriber has not been exceeded. Finally, safeguards must be in place to prevent access by unauthorized individuals and to identify any modification or manipulation of information in the system.
Proposed § 27.203 (relating to centralized prescription processing) sets forth the standards applicable to centralized prescription processing. Centralized prescription processing is a process where a prescription is tendered to one pharmacy (the proposed rulemaking calls it the ''originating pharmacy''), then transmitted to a central fill pharmacy where the prescription is filled or refilled. Generally, given the volume of prescriptions that it fills, the central fill pharmacy uses an automated medication system to fill prescriptions. The filled prescription is then transferred to the delivering pharmacy where the filled prescription is ultimately delivered to the patient. This section sets forth definitions for each pharmacy involved in centralized prescription processing and specifies which pharmacy is responsible for each step in the prescription filling process. The Board has determined that because a central processing center may be considered the ''originating pharmacy'' as defined by this section, the central processing center must also be a licensed pharmacy. Because the Board understands that the primary focus of the central processing center will be to process prescriptions and not actually dispense them, the Board has decided to exempt the central processing center from the requirement to maintain $5,000 worth of nonproprietary drugs and devices in § 27.14(a).
Proposed § 27.204 (relating to automated medication systems) regulates the use of automated medication systems to fill prescriptions. This section defines an automated medication system and sets forth the requirements and safeguards that must be in place to use a system such as this. Automated medication systems may be used either in a licensed pharmacy or offsite as long as the operation of the automated medication system is supervised by a pharmacist. The proposed rulemaking requires that automated medication systems be validated to accurately dispense medication prior to going into use. The proposed rulemaking also requires an audit trail of the activity of each pharmacist, technician or other authorized personnel working on the automated medication system. The Board may inspect the system to further validate the accuracy of the system. This section sets forth a comprehensive list of requirements pertaining to policies and procedures in operating these systems, conducting maintenance and in the case of disaster. The proposed rulemaking requires written policies and procedures of operation, quality assurance programs, plans for recovery from disaster and preventative maintenance.
Fiscal Impact and Paperwork Requirements
The proposed rulemaking has no fiscal impact, nor would it impose any additional paperwork requirement on the Commonwealth. The proposed rulemaking should alleviate some paperwork requirements on the regulated community.
Sunset Date
The Board reviews the effectiveness of its regulations on an ongoing basis. Therefore, no sunset date has been assigned.
Regulatory Review
Under section 5(a) of the Regulatory Review Act (71 P. S. § 745.5(a)), on June 8, 2004, the Board submitted a copy of this proposed rulemaking and a copy of a Regulatory Analysis Form to the Independent Regulatory Review Commission (IRRC) and to the Chairpersons of the Senate Consumer Protection and Professional Licensure Committee and the House Professional Licensure Committee. A copy of this material is available to the public upon request.
Under section 5(g) of the Regulatory Review Act, IRRC may convey any comments, recommendations or objections to the proposed rulemaking within 30 days of the close of the public comment period. The comments, recommendations or objections shall specify the regulatory review criteria which have not been met. The Regulatory Review Act specifies detailed procedures for review, prior to final publication of the rulemaking, by the Board, the General Assembly and the Governor of comments, recommendations or objections raised.
Public Comment
Interested persons are invited to submit written comments, suggestions or objections regarding this proposed rulemaking to Melanie Zimmerman, State Board of Pharmacy, P. O. Box 2649, Harrisburg, PA 17105-2649 within 30 days following publication of this proposed rulemaking in the Pennsylvania Bulletin.
RICHARD R. SIGMA, R.Ph.,
ChairpersonFiscal Note: 16A-5410. No fiscal impact; (8) recommends adoption.
Annex A TITLE 49. PROFESSIONAL AND VOCATIONAL STANDARDS PART I. DEPARTMENT OF STATE Subpart A. PROFESSIONAL AND OCCUPATIONAL AFFAIRS CHAPTER 27. STATE BOARD OF PHARMACY GENERAL PROVISIONS § 27.1. Definitions.
The following words and terms, when used in this chapter, have the following meanings, unless the context clearly indicates otherwise:
* * * * * Automated medication system--
(i) A process that performs operations or activities, other than compounding or administration, relative to the storage, packaging, dispensing or distribution of medications, and which collects, controls and maintains all transaction information.
(ii) The term does not mean an automatic counting device.
* * * * * Central fill pharmacy--A pharmacy engaging in centralized prescription processing by filling and refilling prescriptions, which includes the preparation and packaging of the medication.
Centralized prescription processing--The processing, under the direction of a pharmacist, of a request to fill or refill a prescription, to perform functions such as refill authorizations, interventions or other matters related to the practice of pharmacy for subsequent delivery to the delivering pharmacy.
Central processing center--A pharmacy operated under the direction of a pharmacist that engages solely in centralized prescription processing.
* * * * * Delivering pharmacy--The pharmacy that receives the processed prescription or the filled or refilled prescription for delivering to the patient or the patient's authorized representative.
* * * * * Originating pharmacy--The pharmacy that receives the patient's or prescribing practitioner's request to fill or refill a prescription and performs functions such as the prospective drug review. The central processing center or the central fill pharmacy may be considered the originating pharmacy if the prescription was transmitted by the prescriber directly to the centralized pharmacy or if the patient requested the refill from that pharmacy.
* * * * * STANDARDS § 27.14. Supplies.
* * * * * (c) A pharmacy shall maintain at least the following equipment and supplies:
* * * * * (11) Prescription files for keeping prescriptions of nonproprietary drugs in accordance with the act and, for controlled substance prescriptions, [the regulations of the DEA in 21 CFR 1304.04(h) (relating to maintenance of records and inventories)] State and Federal laws and regulations. The original prescription or image of the original prescription shall be retained for 2 years from the date of the most recent filling. A pharmacy may make use of a computerized recordkeeping system for keeping track of telephone prescriptions, refills, counseling, and the like[, if the system has safeguards to prevent accidental erasure and the information can be transferred to hard copy within 72 hours] in accordance with § 27.202 (relating to computerized recordkeeping systems).
* * * * * TECHNOLOGY AND AUTOMATION § 27.201. Electronically transmitted prescriptions.
(a) For the purposes of this section, an electronically transmitted prescription means the communication to the pharmacist by means of data base exchange or e-mail (which does not include telephone or facsimile machine) of original prescriptions or refill authorizations, which have been sent directly from an authorized licensed prescriber or an authorized agent to the pharmacy of the patient's choice and which have not been altered, accessed, viewed, screened or manipulated by an intervening entity or person unless authorized by law.
(b) Except for Schedule II controlled substances which must conform to § 27.18(b)(2) (relating to standards of practice), a pharmacist may accept an electronically transmitted prescription, from a prescriber or a designated agent which has been sent directly to a pharmacy of the patient's choice if the following requirements are met:
(1) The prescription must contain the signature or the electronic equivalent of a signature of the prescriber made in accordance with the Electronic Transactions Act (73 P. S. §§ 2260.101--2260.5101).
(2) The prescription must include the following information:
(i) The information that is required to be contained on a prescription under State and Federal law.
(ii) The prescriber's telephone number.
(iii) The date of the transmission.
(iv) The name of the pharmacy intended to receive the transmission.
(3) The prescription must be electronically encrypted or transmitted by other technological means designed to protect and prevent access, alteration, manipulation or use by any unauthorized person.
(4) A hard copy or a readily retrievable image of the prescription information that is transmitted must be stored for at least 2 years from the date of the most recent filling.
(5) An electronically transmitted prescription must be processed in accordance with the act and this chapter.
(c) The pharmacist and pharmacy may not provide electronic equipment to a prescriber for the purpose of transmitting prescriptions.
§ 27.202. Computerized recordkeeping systems.
(a) A computerized system used by a pharmacy for recording and maintaining information concerning prescriptions under State and Federal laws must be designed so that it is capable of providing immediate retrieval (by means of monitor, hard-copy printout or other transfer medium) of patient information for all prescriptions filled within the previous 12 months and retrieval within 3 working days of all prescriptions dispensed within the previous 24 months from the last activity date. This information must include the following data:
(1) The information required to be on prescriptions under § 27.18(b)(1) (relating to standards of practice).
(2) Identification of the pharmacist responsible for prescription information entered into the computer system.
(b) The system must be able to transfer all patient information to hard copy within 3 working days.
(c) Prescriptions entered into a computer system but not immediately dispensed must meet the following conditions:
(1) The complete prescription information must be entered in the computer system.
(2) The information must appear in the patient's profile.
(3) There must be positive identification, in the computer system or on the hard-copy prescription, of the pharmacist who is responsible for entry of the prescription information into the system.
(4) The original prescription must be filed according to § 27.18(b).
(d) If the computerized recordkeeping system experiences down time, the prescription information must be entered into the computerized recordkeeping system as soon as it is available for use. During the time the computerized recordkeeping system is not available, prescriptions may be refilled only if the number of refills authorized by the prescriber has not been exceeded.
(e) The system must have adequate safeguards to:
(1) Prevent access by any person who is not authorized to obtain information from the system.
(2) Identify any modification or manipulation of information concerning a prescription.
(3) Prevent accidental erasure of information.
§ 27.203. Centralized prescription processing.
(a) Centralized prescription processing. A central fill pharmacy or central processing center may fulfill a request for the processing, filling or refilling of a prescription from either the originating pharmacy or from the patient or the prescriber and may deliver the processed, filled or refilled prescription to a delivering pharmacy provided:
(1) The central fill pharmacy or the central processing center that is to process, fill or refill the prescription has a contract with or has the same owner as the originating pharmacy and the delivering pharmacy. Contractual provisions must include confidentiality of patient information.
(2) The prescription container:
(i) Is clearly labeled with the information required by Federal and State laws and regulations.
(ii) Clearly shows the name, address, telephone number and DEA number of the delivering pharmacy.
(3) Pharmacies that either utilize or act as central fill pharmacies or central processing centers shall have policies and procedures in place that include an audit trail that records and documents the central prescription process and the individuals accountable at each step in the process for complying with Federal and State laws and regulations including recordkeeping.
(4) Pharmacies that engage in centralized prescription processing share a common electronic file.
(5) Each pharmacy engaging in centralized prescription processing shall be jointly responsible for properly filling the prescription.
(6) The delivering pharmacy is responsible for making the offer to counsel to the patient under § 27.19(e) (relating to prospective drug review and patient counseling).
(b) Exemption. The central processing center is exempt from maintaining an inventory of at least $5,000 worth of nonproprietary drugs and devices under § 27.14(a) (relating to supplies).
§ 27.204. Automated medication systems.
(a) This section establishes standards applicable to licensed pharmacies that utilize automated medication systems which may be used to store, package, dispense or distribute prescriptions.
(b) A pharmacy may use an automated medication system to fill prescriptions or medication orders provided that:
(1) The pharmacist manager, or the pharmacist under contract with a long-term care facility responsible for the dispensing of medications if an automated medication system is utilized at a location which does not have a pharmacy onsite, is responsible for the supervision of the operation of the system.
(2) The automated medication system has been tested and validated by the pharmacy and found to dispense accurately prior to the implementation of the system. The pharmacy shall make the results of the testing available to the Board upon request.
(3) The pharmacy shall make the automated medication system available to the Board for the purpose of inspection, whereby the Board may validate the accuracy of the system.
(4) The automated medication system shall electronically record the activity of each pharmacist, technician or other authorized personnel with the time, date and initials or other identifier in a manner that a clear, readily retrievable audit trail is established. It is the intent of this section to hold responsible each pharmacist for the transaction performed by that pharmacist, precluding the need for a final check of a prescription by one individual pharmacist prior to delivery.
(c) The pharmacist manager or the pharmacist under contract with a long-term care facility responsible for the delivery of medications shall be responsible for the following:
(1) Reviewing and approving the policies and procedures for system operation, safety, security, accuracy, access and patient confidentiality.
(2) Ensuring that medications in the automated medication system are inspected, at least monthly, for expiration date, misbranding and physical integrity, and ensuring that the automated medication system is inspected, at least monthly, for security and accountability.
(3) Assigning, discontinuing or changing personnel access to the automated medication system.
(4) Ensuring that the automated medication system is stocked accurately and an accountability record is maintained in accordance with the written policies and procedures of operation.
(5) Ensuring compliance with applicable provisions of State and Federal law.
(d) When an automated medication system is used to fill prescriptions or medication orders, it must be operated according to written policies and procedures of operation. The policies and procedures of operation must:
(1) Include a table of contents.
(2) Include a description of all procedures of operation.
(3) Set forth methods that shall ensure retention of each amendment, addition, deletion or other change to the policies and procedures of operation for at least 2 years after the change is made. Each change shall be signed or initialed by the registered pharmacist in charge and include the date on which the registered pharmacist in charge approved the change.
(4) Set forth methods that ensure that a pharmacist currently licensed in the transmitting jurisdiction reviews and approves the transmission of each original or new prescription or medication order to the automated medication system before the transmission is made.
(5) Set forth methods that ensure that access to the records of medications and other medical information of the patients maintained by the pharmacy is limited to licensed practitioners or personnel approved to have access to the records.
(6) Set forth methods that ensure that access to the automated medication system for stocking and removal of medications is limited to licensed pharmacists or qualified support personnel acting under the supervision of a licensed pharmacist. An accountability record which documents all transactions relative to stocking and removing medications from the automated medication system must be maintained.
(7) Identify the circumstances under which medications may be removed from the automated medication system by a licensed medical practitioner for distribution to a patient without prior order review by a licensed pharmacist.
(e) A pharmacy that uses an automated medication system to fill prescriptions or medication orders shall, at least annually, review its written policies and procedures of operation and revise them, if necessary.
(f) A copy of the written policies and procedures of operation adopted under this section shall be retained at the pharmacy and at the long-term care facility where the automated medication system is utilized. Upon request, the pharmacy shall provide to the Board a copy of the written policies and procedures of operation for inspection and review.
(g) The pharmacist manager shall be responsible for ensuring that, prior to performing any services in connection with an automated medication system, all licensed practitioners and supportive personnel are trained in the pharmacy's standard operating procedures with regard to automated medication systems as set forth in the written policies and procedures. The training shall be documented and available for inspection.
(h) A pharmacy that uses an automated medication system to fill prescriptions or medication orders shall operate according to a written program for quality assurance of the automated medication system which:
(1) Requires monitoring of the automated medication system.
(2) Establishes mechanisms and procedures to test the accuracy of the automated medication system at least every 6 months and whenever any upgrade or change is made to the system.
(3) Requires the pharmacy to maintain all documentation relating to the written program for quality assurance for at least 2 years. Upon reasonable notice from the Board, the pharmacy shall provide information to the Board regarding the quality assurance program for automated medication systems.
(i) A pharmacy that uses an automated medication system to fill prescriptions or medication orders shall maintain a written plan for recovery from a disaster that interrupts the ability of the pharmacy to provide services. The written plan for recovery must include:
(1) Planning and preparation for a disaster.
(2) Procedures for response to a disaster.
(3) Procedures for the maintenance and testing of the written plan for recovery.
(j) A pharmacy that uses an automated medication system to fill prescriptions or medication orders shall maintain a written program for preventative maintenance of the system. Documentation of completion of all maintenance shall be kept on file in the pharmacy for a minimum of 2 years.
[Pa.B. Doc. No. 04-1066. Filed for public inspection June 18, 2004, 9:00 a.m.]
