Report Title:

Remote Dispensing Pharmacies

 

Description:

Provides for the establishment of remote dispensing pharmacies.

 


HOUSE OF REPRESENTATIVES

H.B. NO.

2490

TWENTY-FOURTH LEGISLATURE, 2008

 

STATE OF HAWAII

 

 

 

 

 

 

A BILL FOR AN ACT


 

 

Relating to remote dispensing.

 

 

BE IT ENACTED BY THE LEGISLATURE OF THE STATE OF HAWAII:

 


SECTION 1.  The purpose of this Act is to amend the law governing pharmacists and pharmacies to permit the operation of remote dispensing pharmacies.

     SECTION 2.  Chapter 461, Hawaii Revised Statutes, is amended by adding five new sections to be appropriately designated and to read as follows:

"§461-    Remote dispensing machine.  Drugs dispensed to patients from a remote dispensing machine shall be dispensed as packaged.

The remote dispensing machine shall include the following safety features:

(1)  Secure double-locked cabinets;

     (2)  Bar-coding or similar technology to identify the product in each unit of use container;

(3)  Delivery of only one bar-coded unit of use container per dispensation per prescription;

     (4)  Technology allowing the unit of use container bar code to be scanned upon release of the container from the remote dispensing machine to confirm that it is the correct container, and upon such confirmation, producing a patient-specific label with a bar code that is scanned to confirm that it is the correct label for the prescription; and

     (5)  A telecommunications and live audio and video component allowing the patient to have a face-to-face consultation with a pharmacist of the responsible pharmacy at the time the drug is dispensed.

     §461-    Remote dispensing pharmacy.  Each remote dispensing pharmacy shall serve only one responsible pharmacy.  The responsible pharmacy may operate more than one remote dispensing pharmacy.  The following shall be conspicuously displayed on the premises of the remote dispensing pharmacy:

(1)  A copy of the license of the responsible pharmacy; and

     (2)  A copy of the license of the pharmacist-in-charge of the responsible pharmacy.

§461-    Responsible pharmacy.  A responsible pharmacy shall be:

     (1)  Physically located in this state;

     (2)  Granted a permit by the board; and

     (3)  Maintain the following records and documentation with respect to the remote dispensing pharmacy:

         (A)  Prescriptions dispensed at the remote dispensing pharmacy;

         (B)  Movement of inventory at the remote dispensing pharmacy; and

         (C)  Policies and procedures of the remote dispensing pharmacy.

§461-    Remote dispensing pharmacy; operations.  (a)  A remote dispensing pharmacy shall be secured at all times to prevent unauthorized access.

(b)  Drugs shall not be dispensed by the remote dispensing pharmacy when the responsible pharmacy is closed.

(c)  Controlled substances shall not be dispensed from remote dispensing machines.

(d)  A remote dispensing pharmacy shall be connected via live computer link, video link, and audio link to the responsible pharmacy, and shall use the information technology system of the responsible pharmacy.

(e)  The pharmacist-in-charge of the responsible pharmacy shall supervise the operations of the remote dispensing pharmacy and ensure that the remote dispensing pharmacy is in compliance with all laws, including rules, governing the practice of pharmacy.

(f)  A pharmacist of the responsible pharmacy shall:

(1)  Maintain visual oversight and continuous surveillance of the remote dispensing pharmacy when the remote dispensing pharmacy is in operation;

(2)  Approve each prescription before it is dispensed to a patient at the remote dispensing pharmacy; and

(3)  Maintain visual oversight of the final dispensing of a drug to the patient from a remote dispensing machine.

     (g)  At least one remote dispensing technician shall staff the remote dispensing pharmacy.  The remote dispensing technician shall offer the patient counseling by a pharmacist for each prescription to be filled at the remote dispensing pharmacy.  The remote dispensing pharmacy shall maintain an area appropriate for confidential communications between the patient and a pharmacist of the responsible pharmacy.

     (h)  Each unit of use container dispensed by a remote dispensing machine shall have a label affixed to the container that meets the requirements set forth in section 328-16 and includes the address of the remote dispensing pharmacy.  Labels shall be generated at the remote dispensing pharmacy.

     (i)  Records of prescriptions filled at the remote dispensing pharmacy shall be maintained at the responsible pharmacy and shall be distinguishable from the records of prescriptions filled at the responsible pharmacy.

     §461-    Responsible pharmacy; duties, responsibilities, and requirements.  (a)  The responsible pharmacy shall:

     (1)  Develop written policies and procedures prior to using a remote dispensing machine that ensure the following:

         (A)  The safe and effective dispensing of pharmaceutical products to the correct patient, including ensuring that a prescription drug shall not be dispensed at the remote dispensing pharmacy until a pharmacist of the responsible pharmacy has verified the finished prescription drug using the live computer, video, or audio link;

         (B)  Patient confidentiality;

         (C)  That only one prescription shall be dispensed from and labeled by the remote dispensing machine before another prescription is released from the remote dispensing machine;

         (D)  The physical presence of the patient when the drug is dispensed from the remote dispensing machine;

         (E)  The safety, accuracy, and security of the remote dispensing machine and remote dispensing pharmacy;

         (F)  Defined access to the remote dispensing machine and to medications contained within or associated with the remote dispensing machine, including but not limited to policies that assign, discontinue, or change access to the remote dispensing machine and medications; provided that a pharmacist of the responsible pharmacy shall have secured access to the drugs in the remote dispensing machine;

         (G)  Compliance with all state and federal laws and regulations;

         (H)  That if a patient refuses the prescription drug at the time it is dispensed, the prescription drug shall be locked in a secured cabinet accessible only to a pharmacist of the responsible pharmacy; and

         (I)  Proper inventory control at the remote dispensing pharmacy, including the following:

              (i)  Only a pharmacist of the responsible pharmacy shall stock the remote dispensing machine;

             (ii)  A pharmacist of the responsible pharmacy is responsible for maintaining the integrity of the drugs in the remote dispensing machine;

            (iii)  Drugs for the remote dispensing machine are provided to the remote dispensing pharmacy only from the responsible pharmacy; and

             (iv)  A reconciliation of the physical inventory of the remote dispensing pharmacy shall be conducted at least annually;

     (2)  Train all personnel who operate the remote dispensing machine at the remote dispensing pharmacy:

         (A)  In a manner that ensures the competence and ability of all personnel who operate any component of the remote dispensing pharmacy and the remote dispensing machine; and

         (B)  With documentation of such training to be retained by the responsible pharmacy;

     (3)  Ensure that the remote dispensing machine is stocked accurately and in accordance with the established written policies and procedures, including ensuring that a pharmacist of the responsible pharmacy checks the accuracy of the product supplied for stocking the remote dispensing machine; and

     (4)  Ensure that entry to the remote dispensing pharmacy is limited to authorized personnel.

     (b)  The pharmacist-in-charge of the responsible pharmacy shall be responsible for ensuring the meeting of the requirements in subsection (a)."

SECTION 3. Section 461-1 is amended by adding six new definitions to be appropriately inserted and to read as follows:

""Remote dispensing" means the dispensing of drugs by a responsible pharmacy at a location other than that of the responsible pharmacy through the use of a remote dispensing machine.

     "Remote dispensing machine" means a machine that contains unit of use drugs for dispensing that is operated using information technologies and connected to the responsible pharmacy by telecommunications and live audio and video technology.

     "Remote dispensing pharmacy" means the area in an institutional health care facility located in this state that is used exclusively for the storage and dispensing of pharmacy-dispensed prescription drugs through the use of one or more remote dispensing machines.

"Remote dispensing technician" means an individual who assists the pharmacist in operating a remote dispensing pharmacy by providing services that include technical assistance in the preparation of pharmaceuticals for remote dispensing while under the supervision of a pharmacist.

     "Responsible pharmacy" means the pharmacy that operates the remote dispensing pharmacy.

     "Unit of use" means drugs packed in a container in separate, one-dose units."

     SECTION 4.  Section 461-9, Hawaii Revised Statutes, is amended to read as follows:

     "§461-9  Pharmacist in charge; pharmacy personnel.  (a)  A registered pharmacist shall be in personal and immediate charge of the pharmacy and personnel employed in the pharmacy.  Temporary absences of the registered pharmacist shall be unlawful except for periods of time and under circumstances as authorized under the rules of the board.  During any absence of the registered pharmacist, prescriptions may not be filled, compounded, or received by telephone and no drugs shall be sold; provided that this shall not preclude the sale at those times of things that might be sold were the pharmacy a store not subject to this chapter.  No person other than a registered pharmacist or a pharmacy intern under the registered pharmacist's immediate supervision shall fill or compound prescriptions except as provided by subsection (c).

     (b)  No person shall practice as a pharmacy intern without having first obtained a permit from the board.  The board shall adopt rules pursuant to chapter 91 defining the functions of a pharmacy intern, establishing the requirements to be met by an applicant for a pharmacy intern permit, and specifying the duration of the permit and the procedures for the immediate supervision of the pharmacy intern by a registered pharmacist.

     (c)  A pharmacy technician may be employed to assist the registered pharmacist under rules adopted by the board pursuant to chapter 91 that define the qualifications and functions of the pharmacy technician and provide the procedures for control and supervision by a registered pharmacist.

(d)  A pharmacist of the responsible pharmacy shall supervise at all times any remote dispensing technicians at the remote dispensing pharmacy."

     SECTION 5.  Section 461-14, Hawaii Revised Statutes, is amended to read as follows:

     "§461-14  Permits for operation of pharmacy[.]; notification of remote dispensing pharmacy.  (a)  It shall be unlawful for any person to operate, maintain, open, change location, or establish any pharmacy or remote dispensing pharmacy within the [State] state without [first] having first obtained a permit or prior notification from the board.

     (b)  Application for permits and notifications shall be made on a form to be prescribed by the board.  Separate [application] applications shall be made and separate permits and notifications issued for each separate place at which is carried on any of the operations for which a permit or notification is required.

     (c)  On evidence satisfactory to the board, a permit or notification shall be issued[, provided:]; provided that:

     (1)  [That the] The pharmacy for which the permit or notification is sought is or will be[,] in full compliance with this chapter and rules of the board;

     (2)  [That the] The location and appointments of the pharmacy are such that it can be operated and maintained without endangering the public health or safety; and

     (3)  [That the] The pharmacy will be under the personal and immediate supervision of a registered pharmacist.

     (d)  [No application] An application for a permit shall be refused [except pursuant to] for noncompliance with this section [and] but only after notice to the applicant and a full and fair hearing.

     (e)  To operate a remote dispensing pharmacy, a responsible pharmacy shall submit to the board the following information:

     (1)  A completed form prescribed by the board;

     (2)  The name, address, and permit number of the responsible pharmacy;

     (3)  The name and license number of the pharmacist-in-charge of the responsible pharmacy;

     (4)  The name of the institutional health care facility and the address of the remote dispensing pharmacy;

     (5)  A floor plan of the remote dispensing pharmacy, which shall indicate the space or location of the remote dispensing machine;

     (6)  The date the remote dispensing pharmacy will be ready for operations;

     (7)  A description of the security system;

     (8)  A description of the computer link, video link, and audio link; and

     (9)  Photographs of the remote dispensing pharmacy area, including but not limited to the remote dispensing machine, the security system, computer link, video link, audio link, confidential-communications area, and locked cabinet.

     A remote dispensing pharmacy's failure to notify the board in writing within thirty days of any changes to the information described in paragraphs (1) to (9) or failure to comply with this chapter shall be considered a violation of this chapter and shall result in disciplinary action against the pharmacist-in-charge and the responsible pharmacy.

     (f)  Permits and licenses issued under this section and section 461-15 may be closed upon written request from the holder of the permit or license.  The board shall approve all requests by the holder for closure of a permit or license.  Once the closure is approved, the holder of the closed permit or license shall be required to reapply as a new applicant to conduct business where a permit or license is required."

     SECTION 6.  Section 461-16, Hawaii Revised Statutes, is amended to read as follows:

     "§461-16  Fees for permits and licenses; renewal.  (a)  The board shall collect application, license, and permit fees for each permit to operate a pharmacy or for each license to operate as a wholesale prescription drug distributor and a fee for the issuance of a permit in accordance with section 461-15(a)(1), (5), (6), and (7).

     (b)  Permits issued under sections 461-14 and 461-15 and licenses issued under section 461-8.6 shall be conspicuously displayed in the place for which the permit or license was granted.  The permits and licenses shall not be transferable, shall expire on December 31 of each odd-numbered year following the date of issuance, and shall be renewed biennially.

     (c)  The holder of an expired permit or an expired license to operate as a wholesale prescription drug distributor may have the same restored within three years of the date of expiration upon due application therefor and payment of the delinquent fees and a penalty fee; provided that in the case of an expired permit, the holder of the expired permit meets the requirements for the renewal of permits.

     (d)  Permits and licenses issued under sections 461-14 and 461-15 may be closed upon written request from the holder of the permit or license.  The board shall approve all requests by the holder for closure of a permit or license.  Once the closure is approved, the holder of the closed permit or license shall be required to reapply as a new applicant to conduct business where a permit or license is required."

     SECTION 7.  Statutory material to be repealed is bracketed and stricken.  New statutory material is underscored.

     SECTION 8.  This Act shall take effect upon its approval.

 

INTRODUCED BY:

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