Lecture 21 Flashcards
(29 cards)
856 IAC 1-28.1 Definitions
Cabinet: a mechanical storage device for dispensing drugs
Consultant pharmacist: a pharmacist who practices pharmacy at a LTCF or other residence other than as a supplying pharmacist
Consulting: provision of nonsupply related cognitive services
Emergency drugs: drugs that are required to meet immediate therapeutic patient needs, and are not available from another source in sufficient time to prevent risk of harm to patients
Pharmacist in charge: pharmacist who directs the activities of the institutional pharmacy
856 IAC 1-28.1 Definitions
Quality-related event: inappropriate provision of pharmaceutical services which may result in an adverse health incident
Reversible condition: condition that requires intervention to resolve in a reasonable time
Sentinel event: unexpected occurrence involving a serious adverse effect
Temporary condition: condition that resolves in a reasonable time without intervention
Pharmacist in Charge Responsibilities
The pharmacist in charge must:
1.Establish and carry out a performance improvement program
2.Develop a policies and procedures manual of sufficient scope and detail to allow safe and effective pharmacy practice, and include:
-Provisions for a continuous quality improvement committee comprised of staff members of the pharmacy
-Committee review of quality related events at least every 3 months
3.Develop policies and procedures that specify duties to be performed by pharmacy technicians.
Absence of a pharmacist – Cabinet Access
Cabinets as a source for drugs
All drugs in the cabinet must be properly labeled and prepackaged, in amounts sufficient for a maximum of 24 hours of use.
When drugs are used from the cabinet, they must be tied to a physician’s order or accountability record.
Drugs in cabinets must be reviewed by a pharmacist upon return to duty, not more than 24 hours later
Policies and procedures must be established to implement this section
Absence of a pharmacist – Pharmacy Access
One supervisory licensed nurse in any shift may have access to the pharmacy and may remove drugs. That nurse must record on a suitable form:
Name and strength of the drug
Amount
Date and time
Signature of the nurse
A copy of the order
Absence of a pharmacist – Emergency Drugs
For any emergency drugs, pharmacy policy and procedures must assure the:
Availability;
Control; and
Security;
of emergency drug carts, kits, or boxes in the pharmacy and patient care areas
Procedures must include at minimum:
-Determination of drugs and quantities of drugs to be included
-Labeling for expiration date
-Process for restocking
-Security measures to prevent unauthorized access
LTCF Emergency Drug Kits
The drug kit must be labeled with
-Drug name
-Drug strength or size
-Quantity included
-Expiration date of the kit (earliest expiration of any of the drugs in the kit)
Drugs contained in an emergency drug kit for a LTCF must be labeled with:
Drug name
Drug strength or size, if applicable
Name of the manufacturer, packer, or distributor
Lot number
Expiration date
A nurse removing drugs from an emergency kit must document:
Name of the patient
Name of the drug
Strength of the drug
Quantity removed
Date and time of removal
Must notify the pharmacy whenever an emergency kit is opened for any reason
Quality Related Events
Any quality related or sentinel event shall be cause for intensive analysis of causal factors and plans for corrective actions.
Records of processes, analysis, and corrective measures related to these events must be maintained for at least 2 years.
Quality related events
Documentation requirements include:
1.Each quality related or sentinel event is documented by the pharmacist to whom it is first described on the same day as it is described
2.A description of the event sufficient to permit analysis
3.Pharmacist in charge shall summarize efforts to improve processes
4.No patient or employee names shall be included in the reporting
5.A member of the board may review this documentation to assure compliance
Institutional Drug Labeling Requirements
All drugs,OTHER THAN unit-of-use packages, dispensed by an institutional pharmacy must be labeled with:
Patient identification
Drug name
Strength if applicable
Route of administration
Quantity
Pharmacist’s initials
Location of patient within the institution
Institutional Drug Labeling Requirements: Unit-of-use
Unit-of-use packages in an institutional setting must have on their label, at minimum:
Drug name
Strength, if applicable
Control number and/or expiration date
Institutional Self-Administration
A patient may only self-administer drugs at an institutional facility if specifically authorized by the treating or ordering physician and:
1.The patient’s knowledge of self-administration has been evaluated; or
2.The patient has received training in the proper manner of self-administration:
-By a pharmacist; or
-According to hospital policy; and
- There is no risk of harm to the patient.
Patient’s own medication
An institutional pharmacy may not touch drugs that are brought into the institution by the patient.
Use of a patient’s own medication may be permitted if:
1.The patient can maintain their own medication at the bedside or under control of nursing personnel if special storage requirements apply; and
2.The nurses in charge of that patient’s care witness the administration and maintain records of medication use
Sterile Pharmaceutical Definitions
Biological safety cabinet
specialized, enclosed, ventilated workspace suitable for preparation of low to moderate risk agents
Sterile Pharmaceutical Definitions:
Class 100 environment (ISO Class 5):
environment containing less than 100 particles 0.5 microns in diameter per cubic foot of air.
Sterile Pharmaceutical Definitions:
Cytotoxic:
pharmaceutical capable of killing living human cells
Sterile Pharmaceutical definitions:
Sterile pharmaceutical:
a drug which is free from living microbes and chemical or physical contamination
Sterile Pharmaceuticals: Physical Requirements
1.Environmental control capable of at least ISO Class 5 in the designated area
2.A sink with hot and cold running water convenient but outside the buffer area for hand washing purposes
3.Disposal containers, including for hazardous waste as needed
4.Biohazard cabinetry if hazardous drugs are prepared
5.A refrigerator with a thermometer
6.Infusion devices if appropriate
7.Documentation of adequate cleaning and sanitizing of the environment
8.Environmental control capable of at least ISO Class 8 conditions in the buffer area
Sterile Pharmaceuticals: Supply Requirements
1.Needles, syringes, and supplies needed for aseptic admixture
2.Disinfectant cleaning tools and solutions
3.Antibacterial hand washing agent
4.Disposable towels or wipes
5.Filters and filtration equipment, if utilized
6.A hazardous drug spill kit if hazardous drugs are prepared
7.Disposable gowns and gloves
Sterile Pharmaceuticals: Reference Requirements
A pharmacy preparing sterile products must have sufficient current reference materials. They must have at a minimum:
1.The Handbook on Injectable Drugs, published by ASHP;
2.The King’s Guide to Parenteral Admixtures; or
3.Another board-approved printed or electronic database with similar guidance to the above publications
If the pharmacy is preparing hazardous drugs, they must have a copy of the OSHA requirements for handling hazardous drugs.
Each sterile pharmaceutical product dispensed to a patient must be labeled with:
1.Date of preparation
2.Patient name and bed number if patient is institutionalized
3.Name of each drug in the preparation, strength, and amount
4.Expiration date of the preparation (including time if applicable)
5.Identification of the dispensing pharmacist and personnel responsible for preparing the sterile pharmaceutical
6.Storage requirements or special warnings as required
If the patient resides at home, the label must also contain:
1.Prescription number
2.Prescriber’s full name
3.Name address, and telephone number of the pharmacy
4.Directions for use, including infusion rate and date and time of administration
