Wyo. Code R. 059-0001-12
Pharmacy, Board of
Chapter 12: Institutional Pharmacy Practice Regulations
Effective Date: 12/13/2005 to 11/16/2009
Rule Type: Superceded Rules & Regulations
Reference Number: 059.0001.12.12132005
These regulations are promulgated as authorized by the Act.
The purpose of these sections is to provide standards in the conduct, practice activities, and operation of a pharmacy located in a hospital or other inpatient facility that is licensed under the Wyoming Department of Health. The intent of these standards is to establish a minimum acceptable level of pharmaceutical care to the patient so that the patient's health is protected while contributing to positive patient outcomes.
This chapter applies to any person, partnership, corporation, Limited Liability Company or other entity engaging in the practice of pharmacy in an institutional facility within this state.
(a) 'Institutional facility' means a hospital, convalescent home, nursing home, extended care facility, correctional or penal facility, or any other organization, public or private, which provides a physical environment for patients to obtain medical, surgical, and/or nursing services, except those places where physicians, dentists, veterinarians, or other practitioners of the healing arts engage in private office practice.
(b) 'Institutional pharmacy' means a pharmacy where medications are dispensed to other health care professionals for administration to institutionalized patients served by an institutional facility, and which is:
(i) Located within the institutional facility, or
(ii) Located outside the facility but only provides pharmaceutical services to institutionalized patients.
(c) 'Drug Room' means a secure and lockable location within an inpatient care facility that does not have an institutional pharmacy.
(d) 'Floor Stock' means prescription drugs not labeled for a specific patient and maintained at a nursing station or other hospital department (excluding the pharmacy) for the purpose of administration to a patient of the facility.
(e) 'Formulary' means a continually revised compilation of pharmaceuticals that reflects the current clinical judgment of the medical staff of the facility.
(f) 'Medication Order' means a written or verbal order from a practitioner, authorized by law to prescribe dangerous drugs, or his authorized agent for administration of a drug.
(g) 'Emergency Drug Cart (Crash cart)' means a cart containing those drugs, which may be required to meet the immediate therapeutic needs of inpatients or emergency room 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.
(h) 'Clean Room' means a room in which the concentration of airborne particles is controlled and there are one or more clean zones according to Federal Standard 209E.
(a) All institutional pharmacies shall register annually with the Board of Pharmacy on a form provided by the Board. Institutional pharmacies which also provide outpatient pharmacy services shall also register as a retail pharmacy.
(b) All institutional pharmacy licenses shall expire on June 30. Renewal notices will be sent by the Board's office at least sixty days prior to June 30.
(c) The fee established in Chapter 2, section 25 (a)(xi) will be charged for issuance of a new license and renewal. The late fee established in Chapter 2, section 25 (b)(vi) will be charged, in addition to the renewal fee, for any license renewal application which is postmarked after June 30 or is hand delivered to the Board's office after June 30.
(a) If an institutional pharmacy changes ownership, it must obtain a new and separate registration from the Board. In the case of a corporation, limited liability company or partnership holding an institutional pharmacy license, the Board shall be notified and a new license applied for anytime the majority of stock in the corporation is sold or a majority of the partners of the partnership or members of the limited liability company change.
(a) A pharmacist hereinafter referred to, as the Pharmacist-In-Charge (PIC), who is licensed to engage in the practice of pharmacy in Wyoming, shall direct each institutional pharmacy.
(b) The storage, compounding, repackaging, dispensing, and distribution of drugs by an institutional pharmacy shall be under the direction, supervision, and responsibility of the PIC.
Depending upon the size and needs of the institutional facility, pharmacy service may be provided on a full or part-time basis.
(i) Hospitals with 50 or more acute care beds. In hospitals with 50 acute care beds or more, a pharmacist shall be in the hospital during the time the pharmacy is open for pharmacy services, except in case of emergencies. Pharmacy services shall be provided for a minimum of 40 hours per week, unless an exception is made upon written request by the hospital and with express permission of the Board.
(ii) Hospitals with less than 50 acute care beds. In hospitals with less than 50 acute care beds, a pharmacist shall be in the hospital during the time the pharmacy is open for pharmacy services. Upon written request by the hospital and with the express permission of the Board, the services of a pharmacist may be on a part-time basis, according to the needs of the hospital. The services of a pharmacist shall be required as follows:
(A) 1-25 acute care beds, A pharmacist shall be available a minimum of 5 hours per week.
(B) 26-49 acute care beds, A pharmacist shall be available a minimum of 20 hours per week.
(iii) In a non-hospital institutional facility, a pharmacist shall be available commensurate with the needs of the facility. The hours shall be identified on the initial application and provided with each license renewal.
(c) Written policies and procedures defining the pharmaceutical services to be provided and the responsibilities of the pharmacy shall be established. Such policies and procedures shall be made available to the Board and/or its authorized representative upon request.
(d) The responsibilities of the PIC shall include, at a minimum, the following:
(i) Providing the appropriate level of pharmaceutical care services to patients of the facility;
(ii) Ensuring that drugs and/or devices are dispensed and distributed safely, and accurately as prescribed;
(iii) Developing a system for the compounding, sterility assurance, quality assurance and quality control of sterile pharmaceuticals compounded within the institutional pharmacy;
(iv) Developing a system to assure that all pharmacy personnel responsible for compounding and/or supervising the compounding of sterile pharmaceuticals within the pharmacy receive appropriate education, training, and competency evaluation;
(v) Providing written guidelines and approval of the procedure to assure that all pharmaceutical requirements are met when any part of preparing, sterilizing, and labeling of sterile pharmaceuticals is not performed under direct pharmacy supervision;
(vi) Participating in the development of a formulary for the facility, provided a formulary is utilized at the facility, and the formulary is subject to approval of the appropriate committee of the facility;
(vii) Developing a system to assure that drugs to be administered to inpatients are distributed pursuant to an original or direct copy of the practitioner's medication order;
(viii) Maintaining 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 including pharmaceuticals, and components used in the compounding of pharmaceuticals.
(ix) Participating in those aspects of the facility's patient care evaluation program, which relate to pharmaceutical utilization and effectiveness;
(x) Assuring that a reasonable effort is made to obtain, record, and maintain patient medication records; and
(xi) Assuring the legal operation of the pharmacy, including meeting all inspection and other requirements of all state and federal laws or rules governing the practice of pharmacy.
(e) The PIC shall be assisted by a sufficient number of additional licensed pharmacists as may be required to operate the institutional pharmacy competently, safely, and adequately to meet the needs of the patients of the facility. All pharmacists shall assist the PIC in meeting the responsibilities as outlined in subsection (c) of this section and in ordering, accounting for, and other administrative duties regarding pharmaceutical products.
(f) Pharmacy technicians may assist the PIC provided the ratio of pharmacy technicians and pharmacy technicians-in-training to licensed pharmacists does not exceed 3:1. The duties of the pharmacy technicians or pharmacy technicians-in-training shall be established by the PIC and may not exceed the responsibilities as outlined in Chapter 10 of the Board's Rules.
(g) The PIC may be assisted by secretarial and clerical assistance as required to assist with record keeping, report submission, and other administrative duties.
(a) The institutional pharmacy shall be enclosed and lockable.
(b) The institutional pharmacy shall have adequate space necessary for the storage, compounding, labeling, dispensing, and sterile preparation of drugs prepared in the pharmacy depending on the size and scope of pharmaceutical services provided.
(c) A sink with hot and cold running water exclusive of restroom facilities shall be available to all pharmacy personnel and shall be maintained in a sanitary condition at all times.
(d) The institutional pharmacy shall be arranged in an orderly fashion and shall be kept clean. All required equipment shall be clean and in good operating condition.
(e) The institutional pharmacy shall be properly lighted and ventilated.
(f) The temperature of the institutional pharmacy shall be maintained within a range of 59 to 86 degrees F (15 to 30 degrees C). The temperature of the refrigerator shall be maintained within a range of 36 to 46 degrees F (2 to 8 degrees C) and the freezer shall be maintained within a range of -14 to -4 degrees F (-20 to -10 degrees C).
(g) The institutional pharmacy shall store antiseptics, other drugs for external use, and disinfectants separately from internal and injectable medications.
(h) If the institutional pharmacy compounds sterile pharmaceuticals they shall be prepared in accordance with Chapter 13, Section 10 of the Board's rules.
Section 9. References.
Each institutional pharmacy shall maintain in its library at least one current reference book ( text or electronic format) from each category listed below. The Board reserves the right to accept new references in lieu of the following.
(a) Drug Monograph Reference:
(b) Stability and Incompatibility Reference:
(iii) Micromedex or equivalent
(c) Reference on Drug Availability and Identification:
(ii) Refrigerator including a system or device to monitor the temperature daily to ensure that proper storage requirements are met; and
(iii) Computer and software appropriate for the institutional facility.
(iv) Fax machine located in the pharmacy.
(b) If the institutional pharmacy compounds medication orders, which require the use of a balance, a Class A prescription balance or electronic balance shall be available. Such balance shall be properly maintained by the PIC and may be inspected at least every three years by the Board of Pharmacy.
(c) If the institutional pharmacy compounds sterile pharmaceuticals, the pharmacy shall have equipment and supplies listed in Chapter 13, Section 10 of the Board's rules.
(a) No one shall be permitted in the pharmacy unless the pharmacist is on duty except as provided in Chapter 12, Section 12. If the pharmacist must leave the pharmacy for an emergency or patient care duties, pharmacy technicians may remain to perform duties as authorized by the PIC, provided that the pharmacist remains in the hospital.
(b) All institutional pharmacy areas shall be capable of being locked by key or programmable lock, so as to prevent access by unauthorized personnel. The Director shall designate in writing, by title and specific area, those persons who shall have access to specific pharmacy areas.
(c) Each pharmacist on duty shall be responsible for the security of the institutional pharmacy, including provisions for adequate safeguards against theft or diversion of drugs including controlled substances and the records thereof.
(d) Pharmacists, technicians, clerical staff, and interns working in the institutional pharmacy shall wear identification badges, including name and position, whenever on duty.
(e) The pharmacist-in-charge shall be responsible for policies and procedures for the safe distribution and control of prescription blanks bearing identification of the hospital.
(a) General. During such times as institutional pharmacy services are not available on-site, arrangements shall be made in advance by the pharmacist-in-charge for provision of drugs to the medical staff and other authorized personnel of the hospital by use of floor stock and/or access to the pharmacy under the standing order of the pharmacist-in-charge.
(b) If floor stock is used, the following shall prevail:
(i) In the absence of a registered pharmacist, medication for inpatients shall be obtained from a locked cabinet(s) or other enclosure(s) located outside the pharmacy to which only nurses, specifically authorized in writing by the pharmacist-in-charge, may obtain access by key or combination, and which is sufficiently secure to deny access to unauthorized persons.
(ii) The pharmacist-in-charge shall, in conjunction with the appropriate committee, if any, of the institutional facility, develop inventory listings of those drugs to be included in such floor stock, and shall insure that:
(A) Such drugs are available therein, properly labeled;
(B) Such drugs are prepackaged in amounts not to exceed thirty dosage units; unless commercially prepared package creates difficulty, e.g. ophthalmics, otics, topicals, etc.
(C) All drugs therein shall be checked and replenished as needed;
(D) A record shall be made on a copy of the physician's order or in a separate file or logbook located where the floor stock is maintained, and shall include:
(1) The date and time of removal of a drug;
(2) The patient's name and location,
(3) The name, strength, dosage form, and quantity of drug removed; and
(4) The signature of the nurse removing the drug.
(E) The nurse removing the drug shall leave a direct copy of new physician's order for the medication with the above record, or if the copy of the physician's order is utilized in place of the log book, then this copy must be left in a designated area where floor stock is maintained; and
(F) Written policies and procedures are established to implement the requirements of this paragraph.
(c) Access to the Pharmacy. Whenever any drug is not available from floor stock, 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 paragraph. Only supervisory or charge nurses may have access to the pharmacy and may remove drugs therefrom. Such nurses shall be designated in writing by the pharmacist-in-charge.
(i) Removal of any drug from the pharmacy by an authorized nurse must be recorded on a suitable form at the pharmacy showing:
(A) The date and time of the removal of the drug; (B) The patient's name and location; (C) The name, strength, dosage form, and quantity of drug removed; and (D) The signature of the nurse.
(ii) The nurse removing the drug shall leave a copy of the physician's order for the new drug with the above record.
(iii) The quantity of drug removed shall not exceed the amount of medication needed until the pharmacy reopens. Drugs, which are usually, dispensed as a unit of use package, such as MDI's, otics, topicals, insulin and ophthalmics are excluded.
(iv) A procedure shall be established to allow verification by the pharmacist of the drug removed (such as by leaving the identifying container or unit-dose sample of the drug with the records).
(d) If off-site pharmaceutical care is provided, whenever an institutional pharmacy is closed, then the following requirements must be met:
(i) The institutional pharmacy shall have a pharmacist on duty at the institutional facility the minimum number of hours required in chapter 12, Section 7 of the Board's rules.
(ii) Any pharmacist providing off-site pharmaceutical care under this section shall be licensed to practice pharmacy in Wyoming.
(iii) Any pharmacy that provides office space for a pharmacist to provide off-site pharmaceutical care under this section shall be licensed to operate a pharmacy in Wyoming.
(iv) The Board shall be notified in writing by the institutional pharmacy of any arrangement whereby pharmaceutical care is provided off-site. This notification shall include the following:
(A) The name, address, and Wyoming license number of each pharmacist who will be providing this service.
(B) The name, address, and Wyoming license number of each pharmacy exchanging information with the institutional facility.
(C) Description of the audio, video, and data link that will be utilized to exchange information between the facility and the off-site pharmacist.
(D) Description of the scope of work of any pharmacist who provides off-site pharmaceutical care under this section.
(E) Description of patient information that is to be shared between the facility and the off-site pharmacist. As a minimum the off-site pharmacist shall have access to the patient's medical record.
(v) A pharmacist providing off-site pharmaceutical care shall provide the following services as a minimum.
(A) Review of any new medication order or change in existing medication order prior to administration by the nursing staff at the institutional facility.
(B) Review of all sterile compounding performed by nursing staff. Review shall be via a real time audio/video link. Medications compounded during cardio-pulmonary resuscitation or similar medical emergency or procedure shall be exempt from an off-site pharmacist review prior to administration. In all other circumstances all sterile compounding is subject to review by the off-site pharmacist.
(C) The off-site pharmacist shall communicate with the institutional pharmacy staff on a daily basis or if the institutional pharmacy is not opened on a daily basis then communication shall occur whenever the institutional pharmacy is open for business.
(a) Hospitals, which provide for the administration and distribution of emergency pharmaceuticals to outpatients and/or inpatients being discharged during hours when normal community or outpatient hospital pharmacy services are not available, may:
(i) Allow a designated nurse on the original written order of a practitioner to administer and distribute medications pursuant to the following requirements:
(A) A written order of a practitioner authorized to prescribe a drug is presented.
(B) The medication is prepackaged by a pharmacist or a technician under a pharmacist's supervision or is administered and distributed utilizing an automated drug dispensing device;
(C) The quantity of medication administered and distributed is limited to a 72-hour supply. Exceptions to the 72-hour supply include: pediatric antibiotic preparations (PO), otitis, ophthalmics, topicals, or metered dose inhalers; and (D) The labeling of the administered and distributed medication includes:
(1) Name, address and telephone number of the hospital; (2) Name of patient; (3) Name of drug, strength, and quantity; (4) Directions for use; (5) Date; (6) Accessory cautionary information as required for patient safety; (7) Name of practitioner; and (8) Initials of the nurse administering and distributing the medication.
(b) The written order may be in the form of a separate written prescription or a prescription entered in the patient's medical record. A practitioner must sign the order. A copy of the prescription order must be readily available for review by the pharmacist.
(c) A record shall be maintained for recording all medications administered and distributed from the hospital's emergency room. The record shall include the following information:
(i) Name of patient; (ii) Date of issuance; (iii) Name of Drug; (iv) Patient's hospital record number; and (v) Initials of the nurse who administered and distributed the drug.
(d) The emergency room log for drugs administered and distributed after hours shall be reviewed by the pharmacist at least weekly. Inventory levels will be compared to drugs administered and distributed. Discrepancies will be reviewed with the emergency room nursing supervisor.
(e) Security of all drugs prepackaged must be maintained in a locked cabinet or storeroom location in the emergency room area to which only specifically authorized personnel shall have a key or combination.
Emergency drug carts may be used by hospitals if:
(a) All drug kits are supplied, and kept up-to-date, under the supervision of a licensed pharmacist;
(b) A committee composed of the pharmacist-in-charge, nursing staff, and medical staff of the hospital develops a standard drug inventory, including kind and quantity of each drug;
(c) All drug kits are equipped with a breakable seal, and are secure from access by unauthorized persons;
(d) A listing of all drugs, their respective strength, quantity, and location, shall be placed on the cart in a conspicuous location. If the pharmacy which services this emergency drug cart is not located within the facility, the name, address, and telephone number of the pharmacy shall be displayed in a conspicuous location;
(e) All drugs are properly labeled;
(f) The drugs are distributed, pursuant to a valid order, by authorized personnel, and the pharmacist is notified of entry into the emergency drug cart; and
(g) The pharmacist, nursing staff, and medical staff develop and implement written policies and procedures for using emergency drug carts (crash carts).
(a) No drug shall be distributed or issued by the use of any automated dispensing device unless the device and method of operation have been found by the Board to insure the purity, potency, and integrity of the drug, and to protect the drug from diversion; and provided that:
(i) The device shall be stocked with drugs only by or under the supervision of a pharmacist;
(ii) The device shall be used only for the furnishing of drugs for administration to patients of that institutional facility; and
(iii) At the time of removal of any drug from the device, it shall automatically make a written record to be retained by the pharmacist for at least one (1) year, indicating:
(A) The date of removal of the drug; (B) The name, strength, dosage form, and quantity of drug removed; (C) The name of the patient for whom the drug was ordered; and (D) The name or identification code of the nurse removing the drug from the device.
Section 16. Parenteral Medications.
(a) The pharmacist-in-charge shall be responsible for the preparation, sterilization, labeling, and dispensing of parenteral medications prepared within the institutional facility; and shall participate in the education and training, including the provision of appropriate incompatibility information, of all personnel involved in the preparation of parenteral medications.
(b) If intravenous admixtures are prepared within the facility, the pharmacy shall have adequate equipment, personnel, and space for such preparation. The compounding and labeling of intravenous admixtures, including all hyperalimentations, shall be performed by, or under, the direct supervision of a pharmacist; however, if 24-hour pharmacy service is not provided at the facility, the pharmacist-in-charge shall establish written policies and procedures to be followed in the preparation of intravenous admixtures when the pharmacy is closed or in emergency situations.
(c) All admixtures shall be labeled with a distinctive supplementary label indicating the name and amount of drug added, date and time of addition, expiration date and rate of administration, and the name or identification code of the person adding the drug.
Section 17. Practitioner's Orders.
(a) All orders for drugs shall be transmitted to the pharmacy by electronic order entry, or by means of an order format, which is capable of producing a direct copy or an electronically reproduced facsimile. A pharmacist shall review the practitioner's order before the initial dose of medication is dispensed, provided that in emergencies or when pharmacy services are not available, the medication order shall be reviewed by the pharmacist as soon thereafter as possible. Verification of the accuracy of the medication dispensed and of any transcriptions made of that order shall be documented by the initials of the pharmacist so certifying.
(b) Orders for drugs for use by inpatients shall, at a minimum, contain patient name and location, drug name, strength, directions for use, date and practitioner's signature or signature of practitioner's agent.
(c) Orders for outpatient dispensing shall meet the requirements of Chapter 2, Section 19.
(a) If unit-dose packaging is used, medication for each patient, when not supplied by an automated dispensing device, shall be distributed and stored in separate trays, drawers, compartments, or containers assigned to that patient and bearing the patient’s name and location.
(a) All investigational drugs shall be stored in the pharmacy and distributed only from the pharmacy. Basic information concerning the dosage form, route of administration, strength, actions, uses, side effects, adverse effects, interactions and symptoms of toxicity of such drugs shall be available in the pharmacy. Investigational drugs shall be properly labeled and shall be administered only under the personal 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 hospital and with verifications that the patient (or his legal designee) has signed the informed consent form.
(b) A copy of all investigational drug protocols shall be on file in the pharmacy.
The pharmacist-in-charge or his designee shall document on at least a quarterly basis an inspection of all drug storage areas in the institutional facility. Records of such inspections shall be dated, signed, and maintained so as to be readily retrievable at the pharmacy for at least two (2) years. These inspections must ascertain that:
(a) Test reagents, germicides, and disinfectants are stored separately from medications;
(b) External medications are stored separately from internal medications;
(c) Thermolabile drugs are stored at the proper temperature;
(d) There are no outdated or deteriorated drugs;
(e) All drugs are properly labeled;
(f) Emergency drug carts (crash carts) are adequate and in proper supply;
(g) Medication storage areas are locked when not in use, and only authorized individuals have access to these areas;
(h) Distribution and administration of controlled substances are properly and adequately documented;
(i) Telephone numbers of regional poison control center and other emergency assistance organizations are posted;
(j) Metric-apothecaries' weight and measure conversion tables and charts are available; and
(k) Adequate pharmaceutical reference texts are at these areas.
Whenever patients bring drugs into an institutional facility, such drugs shall not be administered unless they can be precisely identified; administration shall be pursuant to a practitioner's order. If such drugs are not to be administered, they shall be delivered to the pharmacy, packaged, sealed, and returned to an adult member of the patient's immediate family; or they shall be stored and returned to the patient upon discharge, provided on discharge, advice is provided regarding continuing the returned medication.
(a) All controlled substances issued by the institutional pharmacy to any hospital department, excluding those controlled substances for which the dispensing and record-keeping are maintained utilizing an automated drug dispensing device, shall be labeled and accompanied with control sheets (proof of use forms) which provide space for recording:
(i) The drug name, strength, and dosage form;
(ii) The date and time of administration;
(iii) The quantity administered;
(iv) Name of patient;
(v) The signature of the nurse who administered the medication, when issued to nursing units; and
(vi) The signature of the practitioner who administered the medication and a witness, when issued to surgery.
(b) Such drugs shall be limited both in kind and quantity commensurate with the needs of the area to which they are distributed; and the pharmacy shall maintain a record of such distribution. The pharmacist-in-charge, in consultation with the Director of Nursing or other appropriate hospital staff shall establish written requirements for the frequency of controlled substance inventories in drug storage areas outside of the pharmacy.
(c) All control sheets must be returned to the pharmacy upon completion. The pharmacist shall verify the returned sheets for accountability and control prior to drug reissuance. These control sheets, as well as any records generated must be maintained so as to be readily retrievable at the pharmacy for two (2) years. Records of controlled substance, which are dispensed utilizing an automated drug dispensing device, shall be maintained at the pharmacy for two (2) years.
(d) All controlled substances, which must be wasted, shall be destroyed by a method approved by the PIC. Documentation of all destruction must occur on the control sheet or utilizing the format available with an automated drug dispensing device, and be signed by the nurse/physician destroying and one witness who observed the destruction.
(e) Transdermal patches containing controlled substances shall be handled in the following manner.
(i) The pharmacist-in-charge in coordination with the Director of Nursing will implement a policy requiring all nursing personnel applying a transdermal patch containing a controlled substance to write the date on the patch when it is first applied to a patient.
(ii) All used transdermal patches containing a controlled substance shall be destroyed (cut and flushed) in front of a witness, and documented in a manner similar to Section 22 (d).