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REGS : 10.34.03 Institutional Pharmacy (BOARD OF PHARMACY)

 

 Content Editor

 
PROPOSAL
Maryland Register
Issue Date:  June 28, 2013
Volume 40 • Issue 13 • Pages 1089—1091
 
Title 10
DEPARTMENT OF HEALTH AND MENTAL HYGIENE
Subtitle 34 BOARD OF PHARMACY
10.34.03 [Inpatient] Institutional Pharmacy (BOARD OF PHARMACY)
Authority: Health Occupations Article, §12-205, Annotated Code of Maryland
Notice of Proposed Action
[13-178-P]
 
The Secretary of Health and Mental Hygiene proposes to amend Regulations .02, .03, .06, and .12 and adopt new Regulation .17 under COMAR 10.34.03 Institutional Pharmacy. This action was considered by the Board of Pharmacy at a public meeting held on February 20, 2013, notice of which was given by publication on the Board of Pharmacy website, http://dhmh.maryland.gov/pharmacy/SitePages/Home.aspx, from February 1, 2013, through February 20, 2013, pursuant to the State Government Article, §10-506(c), Annotated Code of Maryland.
 
Statement of Purpose
The purpose of this action is to address the numerous decentralized pharmacies that exist within hospitals that are operating under one hospital pharmacy permit. The Board has concerns that many times these outlying pharmacy areas, or decentralized pharmacies, are not inspected since there is no way the Board would know that they exist. Additionally, many of the outlying pharmacy areas actually function as independent pharmacies. The revisions require separate licensure for pharmacy areas not located in the same building or pavilion as the main hospital pharmacy, include definitions for a “decentralized pharmacy” and “pavilion”, and include specific requirements for decentralized pharmacies located in hospitals.
 
Comparison to Federal Standards
There is no corresponding federal standard to this proposed action.
 
Estimate of Economic Impact
I. Summary of Economic Impact. The economic impact of this proposal depends on the number of pharmacies located on a hospital campus that do not qualify to be decentralized pharmacies. For smaller hospitals there would be no impact. For larger hospitals spread over a large campus with numerous pavilions or buildings, the impact may be the requirement of several new pharmacy permits at $700 for initial licensure of each new pharmacy. The renewal fee for these pharmacies is $600 every 2 years. The cost of this licensure is offset by the increased protection to the public as the Board regulates and inspects these pharmacies, over which, up until recently, the Board did not have oversight.
 
 
Revenue
(R+/R-)
 
II. Types of Economic Impact.
Expenditure (E+/E-)
Magnitude
 

 
 
 
 
 
A. On issuing agency:
(R+)
Minimal
 
(E-)
Minimal
B. On other State agencies:
(E-)
Minimal
C. On local governments:
NONE
 
 
 
Benefit (+)
Cost (-)
Magnitude
 

 
 
 
 
 
D. On regulated industries or trade groups:
(-)
$700 per pharmacy, $600 biennial renewal
E. On other industries or trade groups:
NONE
 
F. Direct and indirect effects on public:
(+)
Indeterminable
III. Assumptions. (Identified by Impact Letter and Number from Section II.)
A. As hospitals license pharmacies that do not qualify to be decentralized pharmacies, the hospital will incur an initial licensure fee of $700 per pharmacy. The renewal every two years is $600. This may have a slight revenue increase for the Board depending on the number of pharmacies that are identified for licensure; however, it will be offset by expenditures incurred by the Board for additional pharmacies required to be annually inspected.
B. Some State hospitals may be required to acquire licenses for pharmacies on their campuses that do not qualify to be decentralized pharmacies. The Office of Health Care Quality received the proposal for informal comment.
 
D. Hospitals will be required to acquire licenses for pharmacies on their campuses that do not qualify to be decentralized pharmacies. The cost to license each pharmacy is $700 for the initial licensure. There is also a $600 biennial renewal fee. The cost would depend on the number of pharmacies located in other pavilions.
F. This proposal would have a positive effect on the public as it ensures that all pharmacies located on a hospital campus meet State regulations and are routinely inspected to protect the public.
 
Economic Impact on Small Businesses
The proposed action has minimal or no economic impact on small businesses.
 
Impact on Individuals with Disabilities
The proposed action has no impact on individuals with disabilities.
 
Opportunity for Public Comment
Comments may be sent to Michele Phinney, Director, Office of Regulation and Policy Coordination, Department of Health and Mental Hygiene, 201 W. Preston Street, Room 512, Baltimore, Maryland 21201, or call 410-767-6499 (TTY 800-735-2258), or email to dhmh.regs@maryland.gov, or fax to 410-767-6483. Comments will be accepted through July 29, 2013. A public hearing has not been scheduled.
 
.02 Definitions.
A. (text unchanged)
B. Terms Defined.
(1) “Decentralized pharmacy” means an institutional pharmacy which provides services for the population of an institutional facility and is:
(a) Dependent on another institutional pharmacy for:
(i) Administrative control;
(ii) Staffing with a licensed pharmacist physically available on site in the decentralized pharmacy to supervise the performance of delegated pharmacy acts; and
(iii) Drug procurement; and
(b) Located in the same building or pavilion as the other institutional pharmacy.
(1-1) “Direct supervision” means that a licensed pharmacist is physically available to supervise the performance of delegated pharmacy acts.
[(1)] (1-2) (text unchanged)
(2)―(10) (text unchanged)
(11) “Medication order” means a patient-specific order entered on the chart or a medical record of a patient by an authorized prescriber or the authorized prescriber’s designee for a drug or device that is transmitted in writing, verbally or by electronic means and includes the:
(a)―(g) (text unchanged)
(h) Signature, if appropriate, of an:
(i)―(ii) (text unchanged)
(12) (text unchanged)
(12-1) “Pavilion” means a detached or semidetached part of a hospital devoted to a special use.
(13)―(17) (text unchanged)
 
.03 Issuance of Permits.
A. An [inpatient] institutional pharmacy shall obtain required permits in compliance with State and federal laws and regulations.
B. An institutional pharmacy shall:
(1) Staff a pharmacist at each decentralized pharmacy site within the building or pavilion in which it is located; and
(2) List decentralized pharmacy sites within the building in which it is located, on the initial application, or on the renewal application;
C. A decentralized pharmacy that meets the definition as set forth in this chapter may operate under the same permit as the institutional pharmacy located in the same building or pavilion.
D. If full service pharmacy services are provided to discharge patients, employees, clinic patients, or others, an institutional pharmacy shall obtain a full service pharmacy permit.
E. Any other pharmacy that does not meet the requirements of a decentralized pharmacy and is located on the campus or affiliated with an institutional pharmacy shall be separately licensed.
 
.06 Security.
A.―B. (text unchanged)
C. Security Requirements. Entry into an [inpatient] institutional pharmacy area where prescription drugs or devices are held shall be limited to authorized personnel under a pharmacist’s direct supervision.
D. An [inpatient] institutional pharmacy shall be equipped with:
(1)―(7) (text unchanged)
 
.12 Drug Dispensing — Prescribers’ Orders.
A. (text unchanged)
B. Documentation.
(1)―(2) (text unchanged)
(3) The director of pharmacy or designee shall ensure that authorized personnel have access to patient information necessary for drug monitoring including the patient’s:
(a)―(f) (text unchanged)
(g) Pregnancy and lactation status; [and]
(h) Vaccination status; and
(i) Name.
 
.17 Requirements for a Decentralized Pharmacy.
A. A decentralized pharmacy is subject to:
(1) Health Occupations Article, Title 12, Annotated Code of Maryland;
(2) This subtitle; and
(3) Other applicable State and federal laws and regulations.
B. A decentralized pharmacy shall ensure that a licensed pharmacist is immediately available on the premises of the decentralized pharmacy to:
(1) Supervise pharmacy operations; and
(2) Provide the final check for preparing medication orders for administration in the institutional facility.
C. Notwithstanding §B of this regulation, a pharmacist assigned to a decentralized pharmacy may leave the decentralized pharmacy for a short period of time to perform pharmaceutical care functions in the institutional facility.
D. A director of pharmacy of the institutional pharmacy shall be responsible for pharmacy operations involving a decentralized pharmacy, including direct supervision of decentralized pharmacy personnel by a pharmacist and compliance with this chapter.
E. A pharmacy department may store prescription medications and over the counter medications that are approved for use by the institutional pharmacy as required for the treatment of patients in the nursing unit served by the decentralized pharmacy.
F. An institutional pharmacy and the decentralized pharmacy shall have shared common electronic files or appropriate technology to allow access to sufficient information necessary or required to process functions required for the care of patients within the service area of the decentralized pharmacy.
G. A decentralized pharmacy shall have a pharmacist physically located at the decentralized pharmacy to directly supervise pharmacy technicians and pharmacy technician trainees during hours of operation.
H. An institutional pharmacy shall notify the Board in writing within 14 days of a change of location, discontinuance of service, or closure of a decentralized pharmacy.
I. Security.
(1) In addition to the security requirements outlined in COMAR 10.34.05, a decentralized pharmacy shall have adequate security and procedures to:
(a) Prohibit unauthorized access;
(b) Comply with federal and State regulations; and
(c) Maintain patient confidentiality.
(2) Access to the decentralized pharmacy shall be limited to pharmacists, pharmacy technicians, and pharmacy technician trainees employed by the institutional pharmacy, and other personnel authorized by the director of pharmacy.
 
JOSHUA M. SHARFSTEIN, M.D.
Secretary of Health and Mental Hygiene