Where are unit dose drug dispensing systems applicable?

hosptial or long-term care facility

What are the requirements for unit-dose dispensing systems?

(1) any equipment oustide the pharmacy used to house drugs to be administered in a unit dose system shall be fitted witha locking mechanism at all times when unattended.

(2) A signed order by the prescribing practitioner shall accompany the requests for a Schedule II drug, except that a verbal order for a hospital patient for a Schedule II controlled substance may be transmitted to a licensed nurse or pharmacist at the hospital who shall promptly reduce the order to writing in the patient's chard. Such an order shall be signed by the prescriber within 72 hours.

(3) all dosages and drugs shall be labeled with the drug name, strength, lot number and expiration date when indicated.

(4) all unit dose drugs intended for internal use shall be maintained in the patient's individual drawer or tray unless special storage conditions are necessary.

(5) a back-up dose of a drug of not more than one dose unit may be maintained in the patient's drawer, tray, or special storage area provided that the dose is maintained in the patient's drawer, tray, or special storage area with the other drugs for that patient.

A record shall be made and maintained within the pharmacy for a period of one year showing:

(i) the date of filling of the drug cart

(ii) the location of the drug cart

(iii) the initials of the person who filled the drug cart

(iv) the initials of the pharmacist checking and certifying the contents of the drug cart

A patient profile record or medication card will be accepted as the dispensing recrod of the pharmacy for unit dose dispensing systems only, subject to the following conditions?

(1) the record of dispensing must be entered on the patient profile record or medication card at the time the drug drawer or tray is filled

(2) in the case of Schedule II through V drugs, after the patient profile record or medication card has been completed, the card must be matintained for two years

(3) in the case of the computer-based distribution system, a uniformly maintained "fill list" or other document containing substantially the same information may be accepted as the dispensing record for Schedule II thorugh VI drugs.

In providing unit dose systems to hospitals or long-term care facilities where only those persons licensed to administer are adminstering drugs, the pharmacy shall dispense not more than a seven-day supply of a drug in solid, oral dosage form at any one given time.

Regarding unit-dose dispensing systems. What needs to be followed to those long-term care facilities in which unlicensed persons adminster drugs?

(1) pharmacy providing medications to such facility shall dispense no more than a 72 hour supply of drugs in a solid, oral dosage form at any one given time

(2) pharmacy shall provide to persons administering medications training specific to the particular unit dose system being used

(3) pharmacy shall provide a medication administration record to the facility listing each drug to be administered with full dosage directions to include no abbreviations

(4) drugs in a unit dose system shall be placed in slots within a drawer labeled or coded to indicate time of administration

Floor Stock Drugs

A pharmacist shall check all Schedule II-VI drugs deliverd to a hospital unit as floor-stock before the drugs leave the pharmacy and shall initial or sign manually or electronically the record of distribution verifying the accuracy of the distribution.

Statement. Not a question.

Floor Stock Drugs

A delivery receipt shall be obtained for schedule II through V drugs supplied as floor stock. This record shall include the date, drug, drug name and strength, quantity, hospital unit receiving drug and the manual or electornic signatures of the dispensing pharmacist and the receiving nurse.

Statement. Not a question.

Floor Stock Drugs

A record of dispostion/administration shall be used to document administration of Schedule II through V drugs when a floor stock system is used for such drugs. The record shall be returned to the pharmacy within three months of its issue. The PIC or his designess shall?

(1) match returned records with delivery receipts to verify that all records are returned

(2) periodically audit returned administration recrods for completeness as to patients name, dose, date and time of administration, signature or initials of person administering the drug, and date the record is returned

(3) Verify that all additions to inventory are recorded, that all additions to and deductions from inventory are correctly calculated, that sums carried from one rcord to the next are correctly recorded, and periodically verify that doses documented on administration records are reflected in the medical record

(4) initial the returned record

Floor Stock Drugs

Record keeping responsibilities?

All records required by this section shall be filed chronoligcally by date of issue, and retained for two years from the date of return at the address of the pharmacy.

Schedule VI may be maintained off site or as an electronic image that provides an exact image of the document that is clearly legible provided such offsite or electronic storage is retrievable and made available for inspection or audit wihtin 48 hours of a request by the board or an authorized agent

Schedule II-V records may only be stored offiste if authorized by DEA or in federal law regulation

Regarding emergency kits what are the responsibilites of the PIC and individual pharmacist?

the PIC of the hospital pharmacy shall be responsible for all prescription drgus contained in the emergency drug kit.

A pharmacist shall check each drug kit after filling the kit, and initial the filling record certifying the accuracy and integrity of the contents of the kit.

What happens to an emergency drug kit after it has been opened?

When the drug kit has been opened, the kit shall be returned to the pharmacy and exchanged for an unopened kit. The record of the drugs administered shall accompany the opened kit when exchanged. An accurate record shall be maintained by the pharmacy on the exchange of the drug kit for a period of one year.

Emergency Kit.

The record of the drugs administered shall be maintained as part of the pharmacy records of not less than ____ years.

two

_____ ____ provided by a hospital pharmacy to an emergency medical services agency may be stored seprately outside the drug kit.

intravenous solutions

Pharmacists can prepare an emergency kit for a long-term care facility in which access to the kit is restricted to a licensed ______, _____, or _____ and only these licensed individuals may administer a drug taken from the kit and only under the following conditions?

nurse, pharmacist, prescrscriber

(1) contents of the emergency kit shall be of such a nature tha the absense of the drugs would threaten the sruvival of the patients

(2) the contents of the kit shall be determined by the provider pharmacist in consultation with the medical and nursing staff of the institution

(3) the kit is sealed in such a manner that it will preclude any possible loss of the drug:

(i) if a seal is used, it shall have a unique numeric or alphanumeric identifier to preclude replication and/or resealing. The pharmacy shall maintain a record of the seal identifiers when placed on a box or kit and maintain the record until such time as the seal is replaced.

(4) the kit shall have a form to be filled out upon opening the kit and removing contents to write the name of the person opening the kit, the date, time and name and quantity of item(s) removed. The opened kit is maintained under secure conditions and returned to the pharmacy within 72 hours for replenishing.

(5) any drug used from the kit shall be covered by a prescription, signed by the prescriber, when legally required, within 72 hours

What is a stat-drug box?

A drug-box prepared by a pharmacy to provide for initiating therapy pior to the receipt of ordered drugs from the pharmacy.

Access to the stat-drug box is restricted to a licensed nurse, pharmacist, or prescriber and only these licensed individuals may adminster a drug taken from the stat-drug box.

A valid prescription or lawful order of a prescriber must exist prior to the removal of any drug from the stat-drug box.

What are the conditions of the stat-drug box?

(1) box is sealed in such a manner that will preclude the loss of drugs

(i) dispensing pharmacy must have a method of sealing such boxes so that once the seal is broken; it cannot be reasonably resealed without the breach being detected

(ii) if a seal is used, it shall have a unique numeric or alphanumeric identifier to preclude replication and/or resealing. The pharmacy shall maintain a record of the seal identifiers when placed on a box and maintain the record until such time as the seal is replaced.

(2) the box shall have a form to be filled out upon opening the box and removing contents to write the name of the person opening the box, the date, the time and the name and quantity of item(s) removed. When the stat-drug box has been opened, it is returned to the pharmacy

(3) there shall be a listing of the contents of the box maintained in the pharmacy and also attached to the box in the facility. This same listing shall become a part of the policiy and procedure manual of the facility served by the pharmacy

(4) the drug listing on the box shall bear an expiration date for the box. The expiration date shall be the day on which the first drug in the box will expire

(5) the contents of the box shall be limited to those drugs in which a delay in intiating therapy may result in harm to the patient

(i) listing of the drugs contained in the stat-drug box shall be determined by the provider pharmacist in consultation with the medical and nursing staff of the long-term care facility

(ii) The stat-drug box shall contain no more than 20 solid dosage units per schedule of Schedule II through V drugs except that one unit of liquid, not to exceed 30 ml, may be substituted for a solid dosage unit.

Define "floor stock" and what may be contained such stock?

In additional to an emergency box or stat-drug box, a long-term care facility in which only those persons licensed to administer are administering drugs may maintain a stock of intravenous fluids, irrigation fluids, heparin flush kits, medicinal gases, sterile water and saline, and prescription devices.

Such stock shall be limited to a listing to be determined by the provider pharmacist in consultation with the medical and nursing staff of the institution.

All prescription drugs at any correctional facility shall be obtained only on an individual prescription basis from a pharmacy and subject to the following conditions?

(1) all drugs are to be locked up with only the person responsible for administering the drugs having access

(2) complete records to be maintained to show:

(i) patient name

(ii) Drug name and strength

(iii) number of dosage units received

(iv) prescriber's name

(v) date, time and signature of the person administering the individual dose of drug

(3) all unused or discontinued drugs shall be sealed and the amount in the container at the time of the sealing shall be recorded on the drug administration record. Such drugs shall be returned to the provider pharmacy or to a secondary pharmacy along with the drug administration record, a copy of the drug administration record, or other form showing substantially the same information, within thrity days of discontinuance.

(i) the provider or secondary pharmacy shall conduct random audits of returned drug administration records for accountability

(ii) drugs may be returned to pharmacy stock in compliance

(iii) drug adminstration records shall be filed in chronological order by the provider or secondary pharmacy and maintained for a period of one year or, at the option of the facility, the records may be returned by the pharmacy to the facility

(4) alternatively, drugs for destruction may be forwarded by a pharmacist directly from the correctional facility to a returns company after performing the audit

Emergency box and stat-drug box may be prepared for a correctional facility served by the pharmacy provided the facility employes one ore more full-time?

physicians, registered nurses, licensed practical nurses, or physician assistants.

NOTE: pharmacist are required (of course, lol!)

Distribution by any method, of any hypodermic needles or syringes, gelatin capsules, quinine or any of it salts, in excess of ______ ounce shall be restricted to licensed pharmacists or to others who have received a license or a permit from the Board.

1/4

No such devices, substances or items shall be sold or distributed to persons under the age of ______ years except by a physician for legitimate purpose or upon his prescription.

16

Any person who permits or causes, directly or indirectly, such controlled paraphernalia to be used for any other purpose than that for which it was lawfully obtained shall be guilty of a _____ misdemeanor

Class I

Schedule V substance may be dispensed without a prescription if?

(1) the preparation is dispensed only by a pharmacist directly to a person requesting the preperation

(2) the preparation is dispensed only to a person who is at least 18 years of age (NOT 16).

(3) the pharmacist requires the person requesting the preparation to furnish suitable identification including proof of age when appropriate

(4) as long as the recepient isn't receiving more than, within a 48 hour period, 200 miligrams of opium, more than 270 miligrams of codeine, or more than 130 miligrams of dihydrocodeinone, or more than 65 miligrams of ethylmorphine, or more than 32 5/10 miligrams of diphenoxylate.

Any pharmacist shall, at the time of dispensing, make and keep a record showing the date of dispensing, the name and quantity of the preparation, the name and address of the person to whom the preparation is dispensed, and enter his initials thereon.