Section 1330.97  Division VI Pharmacies

a)         Division VI pharmacies are pharmacies that provide remote medication order processing to patients of institutions that are serviced by pharmacies with a Division II or Division III license, but the Division VI pharmacy does not maintain a supply of drugs.  Division VI pharmacies may provide pharmacy services only in cooperation with an institution's pharmacy or pharmacy provider. 

1)         Any nonresident pharmacy applying for a Division VI license shall first be registered in its resident state.

2)         There shall be a secure, HIPAA compliant, electronic communication system that shall include but not be limited to computer, telephone and facsimile connections.

3)         This system shall give remote access to the computer system of the Division II pharmacy or Division III pharmacy to allow the Division VI pharmacist to perform remote medication order processing and shall include all laboratory results and every patient's or resident's medication profile.

4)         The secure electronic communication system shall be maintained on a daily basis.  If this system malfunctions, the Division VI pharmacy shall cease operations related to the institution affected.

5)         Nothing in this Section shall relieve the pharmacist-in-charge of Division II and Division III pharmacies of compliance with Sections 1330.92 and 1330.93, respectively.

b)         Recordkeeping Requirements

1)         A policy and procedure manual shall be maintained by a Division VI pharmacy pertaining to the pharmacy's operations.  The manual shall:

A)        Be accessible to the Division VI pharmacy staff and the staff at the institution who are involved in remote medication order processing and dispensing;

B)        Be available for inspection by the Department;

C)        Outline the responsibilities of the Division VI pharmacy staff and the staff at the institution who are involved in remote medication order processing;

D)        Include a current list of the name, address, telephone number, and license number of each pharmacist involved in remote medication order processing;

E)         Include policies and procedures for:

i)          Protecting the confidentiality and integrity of patient information;

ii)         Ensuring that pharmacists performing prospective drug utilization review have access to appropriate drug information resources;

iii)         Ensuring that medical and nursing staff understand how to contact a pharmacist;

iv)        Maintaining records to identify the name, initials, or identification code of each pharmacist who performs any processing function for a medication order;

v)         Complying with federal and state laws and regulations;

vi)        Operating or participating in a continuous quality improvement program for pharmacy services designed to objectively and systematically monitor and evaluate the quality and appropriateness of patient care, pursue opportunities to improve patient care, and resolve identified problems;

vii)        Reviewing the written policies and procedures and documenting the review annually.

2)         Every pharmacist providing remote medication order processing services shall record on the order, in the computer system, or on another appropriate, unalterable, uniformly maintained and readily retrievable record the following information for every drug order or prescription processed on behalf of a Division II or III pharmacy:

A)        The name, initials or other unique identifier of the pharmacist who verifies the drug order or prescription;

B)        The name of the patient or resident;

C)        The name, dose, dosage form, route of administration, and dosing frequency of the drug;

D)        The date and time of verification;

E)         The name of the prescribing/ordering physician;

F)         Any other information that is required by the institution being served for use in its own records.

3)         The records for medications entered at the Division VI pharmacy must be distinguishable and readily retrievable from those entered at the institution being served.

4)         The pharmacist-in-charge of the Division VI pharmacy shall maintain and have access to the following records for a minimum of 5 years:

A)        Records of medication orders processed;

B)        Records of the electronic communication system maintenance.

5)         The Division VI pharmacy shall maintain a record containing the names and license numbers of all Division II and Division III pharmacies to which they are providing services and the number of hours per day the services are being provided.

c)         Staffing of the Pharmacy

1)         No pharmacy shall be granted a certificate of licensure for a Division VI pharmacy without a pharmacist being designated on the pharmacy license application as pharmacist-in-charge.  No pharmacist may be designated as a pharmacist-in-charge on more than one pharmacy license.  The responsibilities of the pharmacist-in-charge shall include:

A)        Supervision of all the activities of all employees as they relate to the practice of pharmacy.

B)        Establishment and supervision of the recordkeeping system for all the documents, electronic communication and all the transfers of information between the pharmacy and the institution that is being provided services.

C)        The operation of the pharmacy and maintenance of security provisions for the records and the electronic communication system of the pharmacy.  The owner of the Division VI pharmacy shall be equally responsible.

2)         Within 10 days after the change of a pharmacist-in-charge, the Division shall be so notified in writing by the departing pharmacist-in-charge.

3)         All Division VI pharmacists shall be licensed in Illinois.

4)         Only licensed pharmacists at a Division VI pharmacy shall conduct the drug utilization evaluation or review and validation of any order processed within the Division VI pharmacy.

(Source:  Added at 30 Ill. Reg. 16930, effective October 12, 2006)