Department of Pharmacy Policies & Procedures

Number: 5:32

Effective Date: 01/2007

Revisions: 3/08; 10/09

Reviewed:

Approval: 01/2007

Subject: STORAGE OF MEDICATIONS IN PATIENT CARE AREAS

A. POLICY

The Director of Pharmacy is responsible for the storage of medications used at UAMS as governed by hospital policy and procedure. The director of each nursing service/clinical department is responsible for ensuring support and assistance in the execution of the policy outlined in the document and in its application to the performance of employees under his/her direction.

The policy for the storage of medications in patient care areas is detailed below:

Ø Medication will be stored in specialized compartments in the automated dispensing machines or secured drawers at all times when not in use.

Ø Storage areas shall be accessible only to designated and authorized personnel.

Ø Products for internal use must be stored separately from products for external use.

Ø The proper environmental control (i.e., proper temperature, light, and humidity, conditions of sanitation, ventilation, and segregation) will be maintained wherever medications and supplies are stored in patient care areas.

Ø Medications will be stored in an orderly manner in medication drawers and in carts of sufficient size to prevent crowding or in separate compartments in the automated dispensing machine.

Ø Medications bearing an expiration date will not be dispensed or distributed beyond the expiration date.

Ø Expired, discolored, damaged, or inappropriately labeled medications shall be returned to the pharmacy for proper credit and/or disposal.

Ø Pharmacy will perform monthly audits of patient care areas to ensure compliance with proper patient safety considerations regarding the storage of medications.

Nursing personnel should adhere to the following procedures regarding the storage of medications in patient care areas.

Assigned pharmacy personnel shall perform monthly audits of medication storage areas and shall document that proper environmental control is maintained.

All Clinic/Unit Personnel must observe proper storage and labeling requirements for all medications during the performance of their daily tasks and shall demonstrate safety in regard to the potency of medications administered as evidenced by:

Ø Removal of outdated medications from active stock, returning them to the pharmacy where they will be quarantined together until all such medications are disposed of according to the policy and procedure 6:08 Returned Goods.

Ø Labeling of all medications prepared for IV administration with patients name, date and time of preparation with employee initials, medication name and dose and solution base.

Ø If the dose is pharmacy prepared, all this is done by pharmacy personnel before the nurse receives the medication. The pharmacy technician will load the medication into separate bins in the automated dispensing machine.

Ø Assembling ready-to-use syringes only when administration is imminent. If pre-assembled in anticipation of need (other than on-going crisis), each syringe must be labeled with date and time of assembly, including employee’s initials. Pre-assembled syringes that are NOT used must be discarded

within 24 hours.

Ø Limiting use of multidose containers for single patient use unless reasonably justified. Multiple Dose Vials must be discarded monthly after it is opened or when the manufacturer’s expiration date is reached (See 8:03.5 Expiration Dating for Multiple Dose Vials of Injectables) whichever is less. Vials marked as single dose shall be discarded immediately after use.

Ø Nitroglycerin sublingual tablets readily deteriorate once exposed to light, air and elevated temperatures. Once the bottle has been opened, it should be discarded within thirty days.

Nursing personnel that handle medications under refrigeration or Viaflex containers are to adhere to the following guidelines:

Medications must be stored at appropriate temperatures according to the following:

o Room Temperature: between 15° C to 30° C (59° F to 86° F)

o Cool Place: between 8° C to 15° C (46° F to 59° F)

o Refrigerate: between 2° C to 8° C (36° F to 46° F)

o Freeze: between -20° C to -10° C (-4° F to 14° F)

o Warm: between 30° to 40° C (86° to 104° F)

o Excessive Heat: any temp >40° C (or > 104° F)

**********************PHARMACY DEPARTMENT ONLY ***********************

Room Temperature Monitoring

1. Room temperature is monitored by the MadgeTech Temp 101 system.

2. Daily temperatures are recorded electronically and data is managed by Inpatient QA technician and reports are generated quarterly.

Refrigerators

· The normal operating range is

o 3 to 6˚C for ACRC (tag # 219037, 231267 & 282323)

o 3 to 5˚C for Inpatient (tag # 240177, 240178, 240170)

· All refrigerators should be plugged into red outlets as the power source.

· Medication refrigerators shall have a working thermometer ensuring the proper temperature range.

o ACRC Pharmacy refrigerators have a secondary temperature monitoring system that record daily high and low temperatures, which are recorded manually onto a temperature log.

· The refrigerator alarm monitor panel sounds and turns on an indicator light when the temperature is outside the set range (2-8˚C for ACRC Refrigerators I-III; 2 to 7˚C for Inpatient Pharmacy Refrigerators).

o ACRC refrigerator alarms: Life Safety Security Management (physical plant) receives the out of range alarm and calls ACRC pharmacy during business hours (8am to 6:30pm) or Ward tower Inpatient Pharmacy during non-business hours. During normal business hours, response time to the alarm is usually no less than 30 minutes and pharmacy will be notified if it will be longer. Emergency response priorities determine response time for physical plant. During non-business hours, the inpatient pharmacy director or his designee will be notified and staff will be sent to ACRC pharmacy to move drug to a functioning refrigerator.

o Inpatient Refrigerator alarms: The alarm panel is monitored by pharmacy staff 7 days a week, 24 hours daily. In the event of an alarm, the pharmacy staff will turn the acknowledge key on the monitor panel, which will stop the indicator light from flashing, turn the indicator light on, silence the alarm and engage a 2 hour timer to turn the audible alarm back on. Pharmacy staff will contact Life Safety Security Management (physical plant) at 686-6424 and request that maintenance service the refrigerator. During normal working hours, a technician will respond in no less than 30 minutes, depending on emergency response priorities. Pharmacy will be notified if the response time will be longer.

· Maintenance cleaning and checks are done every 90 days, this includes alarm testing.

· Refrigerator Reports for the automatic continuous monitoring are available through Susan Higgins in Quality Control Lab in the inpatient pharmacy.

-70 Freezer (ACRC Pharmacy)

· The normal operating range (Tag # 752437) is -69 to -71˚C.

· The alarm sounds and turns on a light at a temperature above -60˚C. During normal business hours, the pharmacy staff will notify Life Safety Security Management at 686-6424 to request freezer maintenance. (Need to get attached to alarm that transmits to central control.) During normal business hours, maintenance response will be no less than 30 minutes and they will contact pharmacy if response time will be longer depending on other emergent priorities.

· Maintenance cleaning and checks are done every 90 days, including alarm test and annual battery replacement.

-20˚C Freezer (Inpatient Pharmacy)

· The normal operating temperature is -17 to -26˚C.

· The alarm on the freezers sounds and turns on a light when the temperature is above -20˚C as long as the battery lasts. The pharmacy is staffed 24 hours a day, 7 days a week.

· If an alarm is triggered, pharmacy staff will notify Life Safety Security Management at 686-6424 to request freezer maintenance. During normal working hours, a technician will respond in no less than 30 minutes and they will contact pharmacy if response time will be longer depending on other emergent priorities.

· Maintenance cleaning and checks are done every 90 days, including alarm test and annual battery replacement

Investigational Drugs:

Room Temperature

· Temperature reports for both ACRC and inpatient pharmacy areas are generated for the Investigational Drug Service every quarter.

· Once reports are generated, a copy of the reports are maintained in the investigational drugs office files. For drug studies requiring a copy of the reports, the information is copied and kept with study accountability records for study monitors to review.

· Investigational Drugs Service will not maintain separate manual room temperature logs for individual drug studies.

· All temperature deviations above 78^oF will be recorded in “Note to File” by Pharmacist(s) and stored with accountability records. Study monitors will be contacted at time of event, if temperature deviation is greater than 2 hours.

Refrigerator/Freezer Malfunction

· In case of a refrigerator or freezer malfunction, investigational drug supply will be moved to a functioning refrigerator or freezer. See above “Refrigerator and Freezer sections”.

· A Note to File will be placed in with the Drug Accountability Record Forms for all refrigerated or freezer drugs affected, once the issue has been resolved. If needed, the study monitor/supplier will be notified of the issue.

· ACRC Refrigerator Procedure: Investigational drugs will be stored in a separate refrigerator in the ACRC pharmacy segregated from commercial drugs. A manually recorded, daily log of the temperature range of the investigational drugs refrigerator will be maintained for each month.

a. The log will record the daily high and low temperature for the refrigerator.

b. The log will be filed by month in the ACRC refrigerator files.

c. Refrigerator #1 is the designated Investigational Drugs refrigerator.

d. The -70˚C freezer in ACRC (tag #752437) is the designated freezer, unless -20˚C freezer is required, then inpatient -20˚C freezer will be used (tag# 240168).

e. Copies of the refrigerator logs will be made available to study personnel (i.e., study monitors) as needed.

See specific details for freezers and refrigerators above.

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Medications removed from the refrigerator or freezer must be labeled with the date and time of the medication removal and a 24 hour expiration date. These items will not be returned to stock, but discarded in accordance to the manufacturer’s stability guidelines.

Medication refrigerators shall not be used to store food.

All medication refrigerators should be plugged into red outlets as the power source.

All medication refrigerators shall be clean and free of excess frost. Each unit/department will follow their own procedure for defrosting the refrigerators.

A temperature log must be maintained for each medication refrigerator. The documentation must indicate that the temperature is monitored on a daily basis.

The manufacturer’s expiration date requires storage of the following items at temperatures between 2° and 8° C. Removal from refrigeration, regardless of whether the item was re-refrigerated or not, requires that these items be used within the guidelines shown below:

Item Stability at Room Temp

(Not to exceed 75° F)

Pancuronium Bromide (Pavulon®) 6 months1

Insulin, Human (Humulin®) 28 days2

Lorazepam (Ativan®) 60 days2

Once removed from the protective over wrap, I.V. solutions are to be stored for no more than the time periods shown below:

Container Size Stability at Room Temp

(Not to exceed 75° F)

50 ml 15 days4

100 ml or greater 30 days4

Viaflex containers may be placed in warmers if the protective over wrap is not removed and the temperature does not exceed 115° F according to the guidelines shown below:

Container Size Stability in Warmer

(Temperature not to exceed 115° F)

25 ml or greater Manufacturer’s shelf life4

Note: Once removed from warmer, solution may not be reheated. Solution should be discarded.

Assigned pharmacy personnel must record the findings of his/her monthly audit of each medication storage area. The results are distributed to:

· CSM of area surveyed

· Assistant Director of Pharmacy for Medication Safety

· Others, as needed

References

1AHFS Drug Information (2002), p. 1307.

2Applied Therapeutics, The Clinical Use of Drugs (1992), p. 72-75.

3Product Information, Wyeth Laboratories Technical Services.

4Product Information, Baxter Healthcare Corporation.