04-231 Code Vt. R. 04-030-231-X - INSTITUTIONAL PHARMACIES

Section 1 DEFINITIONS

For purposes of these Rules and Regulations, the following definitions apply.

1.1 Institutional Facility. Institutional Facility is defined as:

a. Hospital;

b. Convalescent Home;

c. Nursing Home;

d. Extended Care Facility; or,

e. Any other such organization whose primary purpose is to provide a physical environment for patients to obtain health care services, except those places where physicians, dentists, veterinarians, osteopaths and other practitioners of the healing arts, who are duly licensed, engage in private practice.

1.2 Institutional Drug Outlet Pharmacy.

Institutional Drug Outlet Pharmacy is defined as that portion of an Institutional Facility which is engaged in the practice of pharmacy and which is registered with the Vermont Board of Pharmacy pursuant to Subchapter V. of the Vermont Pharmacy Act. Institutional Drug Outlet shall be hereinafter referred to as Institutional Pharmacy.

Section 2 PURPOSE

The purpose of the following Rules and Regulations is to accomplish the purposes of the Vermont Pharmacy Act, as specified in Section 2021 of Vermont Pharmacy Laws thereof, by implementing the provisions of that portion of the Act concerning Registration of Facilities, as specified in Section 2061 of Vermont Pharmacy Laws thereof.

Section 3 APPLICABILITY

The following Rules and Regulations are applicable to all Institutions and Institutional Pharmacies as defined by Section 1 hereinabove.

Section 4 PERSONNEL

4.1 Director. Each Institutional Pharmacy shall be directed by a Pharmacist, hereinafter referred to as the Director of Pharmacy, who has no fewer than 1500 hours experience in an Institutional Pharmacy. The Director shall be a full-time employee of the Institutional Facility in which the Institutional Pharmacy is located, except that the Director may be a part-time employee and may be exempt from the education and experience requirements above with express permission of this Board upon written application by the person responsible for all activities of the Institutional Pharmacy and for meeting the requirements of the State of Vermont Pharmacy Act and these Rules and Regulations.

4.2 Supportive Personnel

a. Trained technical personnel may be employed provided they have been approved by the Director. Up to a one to one ratio of one registered pharmacist to one trained technical person may be employed. At any given time should additional technical personnel be required the Director may petition the board for a variance. The Director shall develop and implement written policies and procedures to specify the duties to be performed by such technical personnel. These policies and procedures shall at a minimum, specify that ancillary technical personnel are under the direction and supervision of a registered pharmacist and that ancillary technical personnel are not assigned duties which may be performed only by registered pharmacists.

b. Secretarial and clerical assistance and support should be provided as required to assist with record keeping, report submission and other administrative duties; provided however, such personnel does not perform any technical duties.

4.3 Supervision. All of the activities and operations of each Institutional Pharmacy shall be under the direction and supervision of its Director or his designee. All functions and activities of ancillary personnel shall be under the Direction and supervision of a sufficient number of registered pharmacists to insure that all such functions and activities are performed competently, safely and without risk of harm to patients.

Section 5 ABSENCE OF PHARMACIST

5.1 General. During such times as an Institutional Pharmacy may be unattended by a registered pharmacist, arrangements shall be made in advance by the Director for provision of drugs to the medical staff and other authorized personnel of the Institutional Facility by use of night cabinets and in emergency circumstances, by access to the Pharmacy.

5.2 If night cabinets are used, The following should prevail: absence of a registered pharmacist, shall be by locked cabinet(s) or other enclosure(s) constructed and located outside the Pharmacy area, to which only specifically authorized personnel may obtain access by key or combination, and which is sufficiently secure to deny access to unauthorized persons by force or otherwise. The Director shall, in conjunction with the appropriate committee of the Institutional Facility, develop inventory listings of those drugs to be included in such cabinet(s) and shall insure that:

a. Such drugs are available therein, properly labeled;

b. Only prepackaged drugs are available therein, in amounts sufficient for immediate therapeutic requirements.

c. Whenever access to such cabinet(s) shall have been gained, written physician's orders and proofs of use, if applicable are provided;

d. This cabinet(s) shall be inspected by the Pharmacy each day that there is a Pharmacist on duty.

e. Written policies and procedures are established to implement the requirements of this Subsection .2.

5.3 Access to Pharmacy. Whenever any drug is not available from floor supplies or night cabinets, and such drug is required to treat the immediate needs of a patient whose health would otherwise be jeopardized, such drug may be obtained from the Pharmacy in accordance with the requirements of this Subsection .3. One supervisory registered nurse in any given shift is responsible for removing drugs therefrom. The responsible nurse may, in times of emergency, delegate this duty to another nurse. The responsible nurse shall be designated by position in writing by the appropriate committee of the Institutional Facility, and shall prior to being permitted to obtain access to the Pharmacy, recieve thorough education and training in the proper methods of access, removal of drugs, and records and procedures required. Such education and training shall be given by the Director of Pharmacy who shall require, at a minimum, the following records and procedures:

a. Removal of any drug from the Pharmacy by an authorized nurse must be recorded on a suitable form showing name of patient and room number, name of drug, strength, amount date, time and signature of nurse. This record shall be

b. Such form shall be left with container from which the drug was removed, both placed conspicuously so that it will be found by a pharmacist and checked properly and promptly.

5.4 Emergency Kits. For an Institutional Facility which does not have an Institutional Pharmacy, drugs may be provided for use by authorized personnel by emergency kits located at such Facility, provided, however, such kits meet the following requirements:

a. Emergency Kit Drugs Defined. Emergency kit drugs are those drugs which may be required to meet the immediate therapeutic needs of patients and which are not available from any other authorized source in sufficient time to prevent risk of harm to patients by delay resulting from obtaining such drugs from such other source.

b. Supplying Pharmacist. All emergency kit drugs shall be provided by a registered pharmacist.

c. Drugs Included. The Supplying pharmecist and the Nursing and Medical staffs of the Institutional Facility shall jointly determine the drugs, by identity and quantity, to be included in emergency kits.

d. Storage. Emergency Kits shall be stored in secure areas, suitable to prevent unauthorized access by force or otherwise, and to insure a proper environment for preservation of the drugs within them.

e. Labeling -- Exterior. The exterior of emergency kits shall be labeled so as to clearly and unmistakably indicate that it is an emergency drug kit and it is for use in emergencies only; and in addition, such label shall also contain a listing of the drugs contained therein, including name, strength, quantity and expiration of the contents, and the name, address(es) and telephone number(s) of the supplying pharmacist.

f. Labeling -- Interior. All drugs contained in emergency kits shall be labeled in accordance with Subsection 7.3.a. of these Rules and Regulations, and shall also be labeled with such other and further information as may be required by the medical staff of the Institutional Facility to prevent misunderstanding or risk of harm to the patients of the Facility.

g. Removal of Drugs. Drugs shall be removed from emergency kits only pursuant to a valid physician's order by authorized personnel, or by the supplying pharmacist. The kit shall have a breakable seal which indicates access.

h. Notifications. Whenever an emergency kit is opened the supplying pharmacist shall be notified and the pharmacist shall restock and reseal the kit within a reasonable time so as to prevent risk of harm to patients. In the event the kit is opened in an unauthorized manner, the pharmacist and other appropriate personnel of the Facility shall be notified.

i. Expiration Dates. The expiration date of an emergency kit shall be the earliest date on any drugs supplied in the kit. Upon the occurence of the expiration date, the supplying pharmacist shall open the kit and replace expired drugs with current dated drugs and reseal it.

j. Procedures. The supplying pharmacist shall, in conjunction with the medical staff of the Institutional Facility, develop and implement written policies and procedures to insure compliance with the provisions of this Subsection .3

Section 6 PHYSICAL REQUIREMENTS

6.1 Area. An Institutional Pharmacy shall have within the Institutional Facility its services, sufficient floor space allocated to it to insure that drugs are propared in sanitary, well lighted and enclosed places, and which meet the other requirements of this Section.

6.2 Equipment and Materials. Each Institutional Pharmacy shall have sufficient equipment and physical facilities for proper compounding, dispensing and storage of drugs, including parenteral preparations, and where appropriate, the following:

a. United States Pharmacopoeia;

b. American Hospital Formulary Service;

c. Periodicals on drug therapy such as American Journal of Hospital Pharmacy, Drug Intelligence and Clinical Pharmacy or Journal of Parenteral and Enteral Nutrition;

d. Remington's Practice of Pharmacy;

e. Compatibility charts;

f. Drug interaction references;

g. Antidote information;

h. Current editions of text and reference works covering theoretical and practical pharmacy;

i. Reference materials on general, organic, pharmaceutical and biological chemistry;

j. Reference materials on toxicology, pharmacology, bacteriology, sterilization and disinfection and,

k. Sufficient drugs to meet the needs of the patients of the Institutional Facility.

l. Vermont Pharmacy laws, rules and regulations and Institutional rules and regulations.

6.3 Storage. All drugs shall be stored in designated areas within the Institutional Pharmacy which are sufficient to insure proper sanitation, temperature, light, ventillation, moisture control, segregation and security.

6.4 Security. All areas occupied by an Institutional Pharmacy shall be locked by key or combination when unattended, so as to prevent acces: by unauthorized personnel. The Director shall designate those person: who shall have access to particular areas within the Pharmacy.

Section 7 DRUG DISTRIBUTION AND CONTROL

7.1 General. The Director of Pharmacy Services shall establish written procedures for the safe and efficient distribution of pharmaceutical products. An annual updated copy of such procedures shall be on hand for inspections.

7.2 Responsibility. The Director shall be responsible for the safe and efficient distribution of, control of and accountability for drugs. The other professional staff of the Institutional Facility shall cooperate with the Director in meeting this responsibility and in ordering, administering and accounting for pharmaceutical material so as to achieve this purpose. Accordingly, the Director shall be responsible for the following:

a. Preparation and sterilization of parenteral medications manufactured within the Institutional Facility:

b. Admixture of parenteral products, including education and training of nursing personnel concerning incompatibility and provision of proper incompatibility information when the admixture of parenteral products is not accomplished within the Institutional Pharmacy;

c. Manufacture of Drugs, if applicable

d. Participation in development of a formulary for the Institutional Facility;

e. Filling and labeling all containers to which drugs are transferred or from which drugs are to be administered;

f. Maintaining and making available a sufficient inventory of antidotes and other emergency drugs, both in the Pharmacy and patient care areas;

g. Records of all transactions of the Institutional Pharmacy as may be required by applicable law, state and federal and as may be necessary to maintain accurate control over and accountability for all pharmaceutical materials;

h. Participation in those aspects of the Institutional Facility's patient care evaluation program which relate to pharmaceutical material utilization and effectiveness

i. Fullest cooperation with teaching and/or research programs in the Institutional Facility, if any;

j. Implementation of the policies and decisions of the appropriate committee(s) of the Institutional Facility;

k. Effective and efficient messenger and delivery service to connect the Pharmacy with appropriate parts of the Facility on a regular basis throughout the normal workda of the Facility; and,

l. Meeting all inspection and other requirements of the Vermont Pharmacy Act and all applicable Rules and Regulations.

7.3 Labeling.

(a.) For Use Inside the Institutional Facility. All drugs dispensed by an Institutional Pharmacy, intended for use within the Facility, shall be dispensed in appropriate containers and adequately labeled so as to identify, at a minimum, brand name or generic name, strength, quantity. Whenever possible drugs should be dispensed in unit of use packaging which specifies the drug name, strength, manufacture, lot number and expiration date.

(b.) For use outside the Institutional Facility. All drugs dispensed by an Institutional Pharmacy for use outside of the Institutional Facility shall be packaged and labeled according to Federal and State Laws and Regulations.

c. Drugs added to Parenteral Admixtures. Whenever any drugs are added to parenteral admixtures, whether within or outside the direct and personal supervision of a registered pharmacist, such admixtures shall be labeled with a distinctive supplementary label indicating the name and amount of the drug added, date and time of addition, expiration time, and name of person so adding. Standards for dating, record keeping and a quality assurance program for admixtures shall be established by the Director of Pharmacy.

7.4 Discontinued Drugs. The Director shall develop and implement policies and procedures to insure that discontinued and outdated drugs and containers with worn, illegible, or missing labels are returned to the Pharmacy for proper disposition, or that the Director or his or her designee make proper disposition or dispose of such drugs at the storage site.

7.5 Physician's Orders. Drugs may be dispensed for an individual patient from the Institutional Pharmacy only upon an original or direct copy of an authorized physician's order.

a. Authorization. The appropriate committee of the Institutional Facility shall, from time to time as appropriate, designate those physicians who are authorized to issue orders to the Pharmacy.

b. Telephoned orders. Orders which are telephoned in should be immediately transcribed into the patient's chart with the individual transcribing the order indicating that it is a "Telephoned" order and needs to be countersigned by the attending Physician. The Physician should co-sign the order within 2 hours. Only an RN and LPN should receive the telephone order and they should indicate their name after the transcription.

c. Abbreviations. Orders employing abbreviations and chemical symbols shall be utilized and filled only if such abbreviations and symbols appear on a published list of accepted abbreviations developed by the appropriate Committee of the Institutional Facility.

d. Requirements -- Orders for Drugs for Use by Inpatients. Orders for use by inpatients shall, at a minimum, contain patient name and location, drug name, dose directions for use, date and physician's signature or that of his or her authorized representative.

7.6 Controlled Drug Accountability. The institutional facility shall establish effective procedures and maintain adequate records regarding use and accountability of controlled substances and such other drugs as the appropriate institutional committee may designate which may specify at least the following.

A. Name of drug,

B. Dose,

C. Physician,

D. Patient,

E. Date and time of administration,

F. And person administering the drug.

7.7 Recall. The Director shall develop and implement a recall procedure that can be readily activated to assure the medical staff of the Institutional Facility and the Pharmacy staff and the Director that all drugs included on the recall, whether within or outside the Facility, are returned to the Pharmacy for proper disposition.

7.8 Suspected Adverse Drug Reactions.

Any and all suspected adverse drug reactions shall be reported orally immediately to the ordering physician and in writing to the Pharmacy. Appropriate entry on the patient's record shall also be made.

7.9 Records and Reports.

The Director shall maintain and submit, as appropriate, such records and reports as are required to insure patient health, safety and welfare and, at a minimum, the following:

a. Physician's orders or direct copies thereof

b. Proofs of use;

c. Reports of suspected adverse drug reactions;

d. Inventories of night cabinets and emergency kits;

e. Inventories of the Pharmacy;

f. Bi-annual controlled substances inventories;

g. Alcohol and flammables reports;

h. Removal of drugs from the pharmacy by an authorized nurse;

i. Such other and further records and reports as may be required by law and these Rules and Regulations.

7.10 Brought by Patients.

Whenever patients bring drugs into an Institutional Facility, such drugs shall not be administered unless they can be precisely identified by the pharmacy; administration shall be pursuant to a specific physican's order for each drug only. If such drugs are not to be administered then the Director of Pharmacy shall, develop procedures to store and return them to the patient upon discharge or destroy as appropriate.

Section 8 INVESTIGATIONAL DRUGS

Investigational drugs shall be administered only under the person and direct supervision of the principal physician-investigator or his or her authorized clinician(s) with prior approval of the appropriate Committee(s) of the Institutional Facility. Nurses may administer such drugs only after they have been educated and trained concerning relevant pharmacologic information about such drugs by the clinician or the Pharmacy. The pharmacy shall store, dispense and maintain essential information on such drugs. Patients or representatives informed consent must be obtained prior to investigational drug therapy.

Section 9 INSPECTION

9.1 Monthly. The Director of Pharmacy shall no less than once per month, personally or by qualified designee, inspect all matters within his or her jurisdiction and responsibility and make appropriate written records and notations of such inspections. Such inspections shall, at a minimum verify that:

a. Drugs are dispensed only under direct supervision of registered pharmacists;

b. Ancillary Pharmacy personnel are properly directed and supervised;

c. Disinfectants and drugs for external use are stored separately and apart from drugs for internal use or injection;

d. Drugs requiring special storage conditions to insure their stability are properly stored;

e. No outdated drugs are stocked in the Institutional Pharmacy or the Facility it serves;

f. Distribution and administration of controlled substances are properly and adequately documented and reported by both Pharmacy and medical personnel;

g. Emergency drugs designated pursuant to Section 5 hereinabove are in adequate and proper supply both within the Pharmacy and at outside storage locations;

h. All necessary and required security and storage standards are met;

i. Metric-apothecariest weight and measure conversion tables and charts are reasonably available to all medical personnel; and,

j. All policies and procedures of the Director and of Appropriate Committees of the Institutional Facility relevant to Pharmacy are followed.

Notes

04-231 Code Vt. R. 04-030-231-X

Effective Date: July 22, 1979 (Secretary of State Rule Log #79-52)
* Formerly Rule No. 04 057 002. This rule has not been changed. It has been renumbered and relocated to insure that all rules issued under this Office are properly and uniformly numbered.

Statutory Authority: Not Available