General Pharmaceutical اﻹدارة اﻟﻌﺎﻣﺔ ﻟﻠﺮﻋﺎﯾﺔ اﻟﺼﯿﺪﻟﯿﺔ
Care Administration
Administrative Policies and Procedures
اﻟﺴﯿﺎﺳﺎت واﻹﺟﺮاءات اﻹدارﯾﺔ
for MOH hospitals /PHC Centers
ﺑﻤﺴﺘﺸﻔﯿﺎت وﻣﺮاﻛﺰ وزارة اﻟﺼﺤﺔ
TITLE: Storage of Medications
APPLIES TO: Hospital-wide
NO. OF PAGES:
ORIGINAL DATE:
REVISION DATE :
1.0 PURPOSE
1.1 To describe the process by which drugs including vaccines, human plasma
fractions and insulin are stored safely and according to the manufacturer’s
temperature requirement, and separating antiseptics, disinfectants and drugs for
external use from injectables and drugs for internal use.
1.2 To describe the monitoring and recording process for all refrigerators and freezers
located within the department, store room, and patient care areas.
2.0 DEFINITION
2.1 Refrigerate: (2 – 8 ºCentigrade / 35 – 46 degrees Fahrenheit).
2.2 Freeze: (Below 0 degrees Celsius, between -10 and -25 ºC). Consult
manufacturer’s literature per products as some products required lower freezer
temperatures than others.
2.3 Room temperature: Between (15 – 25 ºC).
2.4 Digital read-out: The temperature of the air within the unit right now.
2.5 Scimetrics: Refrigeration alarm system that monitors temperatures twenty four
hours a day.
3.0 RESPONSIBILITY
3.1 Pharmacist: is responsible for performing monthly audits of patient care areas to
ensure patient safety regarding the storage of medications.
3.2 Pharmacy staff and Head Nurses: are responsible for recording daily and
maintaining a log sheet, for temperature of refrigerators in patient care areas, in
the pharmacy and wards.
3.3 Maintenance supervisor: is responsible for calling the physical plant to repair
the malfunction, when a refrigeration problem occurs.
3.4 The charge nurse: is responsible for calling maintenance, for after duty hour’s
refrigeration problems, and other role in storing medications in the ward.
4.0 CROSS REFRENCES POLICY
4.1 Pharmacy Safety Measures (Handling of Hazardous Material.
General Pharmaceutical اﻹدارة اﻟﻌﺎﻣﺔ ﻟﻠﺮﻋﺎﯾﺔ اﻟﺼﯿﺪﻟﯿﺔ
Care Administration
4.2 Narcotic and Controlled Drugs.
5.0 POLICY
5.1 All medications are well stored, separated and properly labeled upon display on
the shelves.
5.2 All refrigerators and freezers located within the department will be routinely
monitored to assure that the correct temperature range is maintained with respect
to the items being stored in each respective refrigerator or freezer.
Documentation of the monitoring activity will be maintained.
5.3 All antiseptics, disinfectants, and drugs for external use are stored separately
from injectables and internal medications.
5.4 All medications are stored according to manufacturer’s recommendations
(temperature, light, humidity, sanitation).
5.5 No food or drinks will be allowed inside medication refrigerators.
5.6 The pharmacy department will keep temperature records for at least three years.
6.0 PROCEDURE
6.1 Storage Of Medications In The Pharmacy And Wards:
6.1.1 All medications are stored in designated areas to ensure proper
sanitation, temperature, light, moisture control, segregation, and
security.
6.1.2 All medications are well separated and properly labeled upon display
on the shelves in the store room, inpatient pharmacies, outpatient
pharmacies, E.R., and other pharmacy units (TPN room, Narcotics &
controlled drugs, etc.) as well as in the wards in the form of floor
stocks, IV fluids, and refrigerated drugs.
6.1.3 The proper environmental control (i.e. proper temperature, light, and
humidity, conditions of sanitation, ventilation and segregation) will be
maintained wherever medicines and supplies are stored in patient care
areas.
6.1.4 All clinic/unit must observe proper storage and labeling requirements
for all medicines during the performance of their daily tasks and
should demonstrate safety in regard to the potency of medications
administered, such duties include:
6.1.4.1 Removal of outdated medications from active stock, returning
them to the drug store where they will be quarantined together
until all such medications are disposed of according to the
policy and procedure “Drugs returned from clinics,
departments, and nursing stations”.
General Pharmaceutical اﻹدارة اﻟﻌﺎﻣﺔ ﻟﻠﺮﻋﺎﯾﺔ اﻟﺼﯿﺪﻟﯿﺔ
Care Administration
6.1.5 Labeling of all medications prepared for IV administrations with
patient name, date and time of preparation with employee initials,
medication name and dose and solution base.
6.1.6 Limiting use of multi-dose containers for single patient use unless
reasonably justified.
6.1.7 Multiple dose vials must be discarded according to the hospital’s
stability guidelines.
6.1.8 Vials marked, as single dose should be discarded immediately after
use.
6.1.9 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.
6.1.10 High-Alert Medications are identified by special labels or color
marks which are placed on all storage locations for High Risk
Medications in the pharmacy and wards. Limited quantities of
concentrated KCL 15% (2mmol/ml, 10ml vial) is kept as ward stock:
6.1.10.1 In the Operating Room (OR) - to treat cardioplesia
during cardiac surgery.
6.1.10.2 In the Intensive Care Unit & Coronary Care Unit - to
treat cardiac arrhythmias.
6.1.11 Look-Alike / Sound-Alike Medications which have potential for
confusion due to similarity in packaging or names are identified (light
blue color tag) and stored separately as extra precautions to prevent
error.
6.1.12 Multiple dose vials that contain preservatives to make extended use
possible are dated with the date opened and will be discarded 28 days
after date opened. Single dose vials / containers are discarded
immediately after a single use.
6.1.13 All Controlled Substances are secured behind two locks.
Administration and wastage is documented on the proper records, and
prescription pads are secured at all times and not accessible to
unauthorized persons.
6.1.14 Nutritional Products: All parenteral nutrition bags must be stored in
the drug fridge or fridge designated for PN at temperature between “2
to 8 C”. The expiry date is stated on the labels. Pharmacy should be
notified of any unused bags. Discard in clinical waste. Parenteral
nutrition bags should be removed from the fridge at least 1/2 hour prior
to use, to allow fluid to reach room temperature. If the bag is in any
way damaged or leaking please notify the Pharmacy Department
immediately and send the bag to the pharmacy so that the cause can be
determined. The compounded products of PN are good for 24 hours
only.
6.1.15 Sample Medications are not stored in any inpatient unit. They are
stored and arranged alphabetically in a locked cabinet in the OPD
General Pharmaceutical اﻹدارة اﻟﻌﺎﻣﺔ ﻟﻠﺮﻋﺎﯾﺔ اﻟﺼﯿﺪﻟﯿﺔ
Care Administration
pharmacy with a list of the Sample Medications and their expiration
dates. Samples are labeled when dispensed without using
abbreviations.
6.1.16 All Emergency Medication Carts are secured with serial numbered
locks (Plastic seal) issued by the nursing department. They are checked
daily in each shift and documented to verify lock is not broken and the
medications are not expired. Other emergency medications that are
kept outside the crash carts are safely stored in cabinets with the floor
stocks in the nursing stations.
6.1.17 Other drugs which require special storage precautions and safe
handling procedure (e.g. Flammables, chemicals, narcotic &
controlled drugs, & hazardous drugs and wastes), are labeled as
such treated according to their special storage and handling
requirements and precautions in the pharmacy, with spill kits and fire
extinguishers on hand (See policy for Pharmacy Safety Measures, and
policy for Narcotic and Controlled Drugs).
6.1.18 In patient care areas medications will be stored in medication shelves
or specialized compartments and secured drawers at all times when not
in use.
6.1.19 Medications will be stored in an orderly manner (Products for internal
use are separated from for external use) in areas only accessible to
designated and authorized personnel.
6.1.20 Pharmacist will perform monthly inspections of patient care areas to
ensure compliance with the proper patient safety considerations
regarding the storage of medications’ stock. Areas maintain copies of
past Pharmacy Unit inspections including corrective action taken when
an infraction occurs. Nurses will inspect medications on the floors on
weekly basis.
6.1.21 Medications will not be dispensed or distributed beyond the expiration date,
“First expiry/First out” (FEFO) principle will be followed.
6.1.22 Any expired, discolored, damaged, or inappropriately labeled
medication shall be returned to the pharmacy store for proper disposal.
Unused or not needed medications for a specific patient (or not
intended for stock) are also returned to the pharmacy for processing or
disposal by the pharmacy store.
6.1.23 Any notification of a drug quality issue (e.g. discoloration,
precipitation, etc.), the medication will be recalled and reported to the
MOH Medical Supply and the Saudi FDA, as required.
6.2 Storage of Antiseptics, Disinfectants And Drugs For External Use:
6.2.1 All antiseptics, disinfectants, and drugs for external use are stored
separately from injectables and other internally used medications. This
General Pharmaceutical اﻹدارة اﻟﻌﺎﻣﺔ ﻟﻠﺮﻋﺎﯾﺔ اﻟﺼﯿﺪﻟﯿﺔ
Care Administration
applies to the pharmacy store, Inpatient and outpatient pharmacies, and
the wards.
6.3 Storage Of Refrigerated Drug Items:
6.3.1 Refrigerated medications must be stored at appropriate temperatures
according to the following:
6.3.1.1 Room temperature: between 15-25 0C
6.3.1.2 Cool place: between 8-15 0C
6.3.1.3 Refrigerator: between 2-8 0C
6.3.1.4 Freezer: between -10 and -25 ºC
6.3.2 Pharmacy staff in Inpatient, OPD, ER and store room, and Head
Nurses in patient care areas is responsible for recording daily and
maintaining a log sheet for temperature of refrigerators in the
pharmacy and wards.
6.3.3 Medication refrigerators should have a working thermometer ensuring
the proper temperature range.
6.3.4 Notify the maintenance department of any problem, which will in turn
evaluate the situation and contact the respective supervisor for repair if
required.
6.3.5 Corrective action for units displaying temperature outside desired
range should be taken immediately by first calling the maintenance
department for repair within 30 minutes. If not repaired then transfer
all contents to a similar unit within the department, attach an inventory
list to the broken unit, listing all items removed, quantity and new
location. Attach a copy of the inventory list to the temporary new
location. Inform the maintenance manager of the refrigeration problem
and the transfer of the inventory. During normal hours the maintenance
supervisor is responsible to call physical plant to repair the
malfunction. For after hour's refrigeration problems, the charge nurse
is responsible for calling maintenance.
6.3.6 Medication refrigerators should not be used to store food, drinks,
biological samples, or culture media.
6.3.7 A temperature log must be maintained for each medication refrigerator
and will be checked at least once daily.
6.3.8 The documentation must indicate that the temperature is monitored on
a daily basis.
6.4 Refrigerators: 2 types –
6.4.1 Large units (room size) refrigerators:
6.4.1.1 Used for storing large quantities of refrigerated drug items such
as vaccines, insulin, heparins, and other drugs, these
refrigerators are found in the Pharmacy Store and the Main
Pharmacy.
General Pharmaceutical اﻹدارة اﻟﻌﺎﻣﺔ ﻟﻠﺮﻋﺎﯾﺔ اﻟﺼﯿﺪﻟﯿﺔ
Care Administration
6.4.1.2 Equipped with a temperature monitoring device which is
connected to the maintenance department who will in turn
evaluate the situation and contact the respective area supervisor
if required.
6.4.2 Small and medium size refrigerators:
6.4.2.1 Used to store small stocks of refrigerated drug items and is
available in inpatient, outpatient, and ER pharmacies and also
in patient care areas.
6.4.2.2 Some of these refrigerators are equipped with a portable
temperature monitoring device (thermometer) in the pharmacy
areas, while other refrigerators have the device (thermometer)
mounted on the unit itself as in patient care areas.
6.4.3 The small units' refrigerators are checked daily. If any problem, the
maintenance department will be contacted to evaluate the situation and
correct the problem or contact the respective area supervisor if
required.
6.5 Storage of Vaccines, Human Plasma Fractions & Insulin:
6.5.1 Delivery from Medical Supply Stores:
6.5.1.1 The Drug store pharmacist ensures that the supplied vaccines,
human plasma fractions and insulin were in good conditions
during delivery from Medical Supply Stores.
6.5.1.2 If the Drug store pharmacist verified that the supplied
vaccines, human plasma fractions and insulin were broken,
he/she must inform the Medical Supply immediately by a
written notification (a copy to Head of Pharmacy Dept.) to be
returned or replaced.
6.5.1.3 The Drug store pharmacist ensures to keep all the vaccines,
human plasma fractions and insulin in a suitable temperature.
These products should be kept under specified storage
temperature during and after supply from company, until it
reaches the Drug Store Refrigerator and then, being transferred
to In-patient, Out-Patient Pharmacies and Nursing Units.
6.5.2 Vaccines, human plasma derivatives and insulin are kept in a
temperature between +2 0C & +8 0C and not allowed to freeze except
for Oral Polio vaccine which is kept below –20 0C.
6.5.3 As a general rule, multi-dose vaccines should be kept for one hour
after opening if there is no preservative. Vaccines which contained a
preservative should be discarded after THREE HOURS from the
opening time. Insulin vials should be kept in the refrigerator for ONE
MONTH after opening. Unused human plasma derivatives should be
discarded immediately after opening.
General Pharmaceutical اﻹدارة اﻟﻌﺎﻣﺔ ﻟﻠﺮﻋﺎﯾﺔ اﻟﺼﯿﺪﻟﯿﺔ
Care Administration
6.5.4 Specific rules:
6.5.4.1 Oral Poliomyelitis vaccine stable for three hours in the
refrigerator.
6.5.4.2 Tetra-act HIB vaccine stable for 24 hours in the refrigerator.
6.5.4.3 BCG vaccine stable for four hours after opening in the
refrigerator.
6.5.4.4 Insulin Flexpen stable for one month after first use and can be
kept at room temperature.
6.5.5 In-Charge Nurses are instructed to give particular attention to the
importance of shaking vaccine containers after the addition of diluents
immediately before use.
6.5.6 The Head of Pharmacy and/or designee monthly checks the hospital
staff clinic for:
6.5.6.1 Availability of the vaccines.
6.5.6.2 Proper storage at proper temperature.
6.5.6.3 The Staff Nurse daily checks the refrigerators temperature of the
staff clinic.
6.5.6.4 No food stuff is allowed to be kept inside medicine refrigerators.
6.5.7 Various medication stores in hospital is as follows:
6.5.7.1 Drug store
6.5.7.2 Inpatient nursing unit
6.5.7.3 Outpatient clinics
6.5.7.4 Emergency Room
6.5.7.5 In-patient Pharmacy
6.5.7.6 Out-patient Pharmacy
6.5.8 Table below provides a list of available vaccines and required
temperature for storage:
Vaccine Names Storage Temperature Stability
1. Hemophilus vaccine + 2 to + 8 0C Single dose
2. BCG Vaccine “N.B. Protect from light” + 2 to + 8 0C 4 hours
3. Di Te vaccine (Diphtheria Tetanus vaccine) + 2 to + 8 0C One hour
3. DPT vaccine (Diphtheria, Pertussis , + 2 to + 8 0C One hour
Tetanus
vaccine)
5. Hepatitis B vaccine + 2 to + 8 0C Single dose
0
6. Inactivated hepatitis A virus vaccine + 2 to + 8 C Single dose
7. Inactivated split influenza vaccine + 2 to + 8 0C Single dose
0
8. Measles vaccine “N.B. Protect from light” + 2 to + 8 C Single dose
0
9. Meningococcal Meningitis type A&C + 2 to + 8 C Three hours
vaccines. N.B. Protect from light.
General Pharmaceutical اﻹدارة اﻟﻌﺎﻣﺔ ﻟﻠﺮﻋﺎﯾﺔ اﻟﺼﯿﺪﻟﯿﺔ
Care Administration
10. MMR (Mumps, Measles, Rubella vaccine) + 2 to + 8 0C Single dose
11. Oral poliomyelitis vaccine (N.B. after - 20 to-26 0C Three hours
thawing it can be kept between +2 and +8
degrees 0C for six months).
0
12. Rabies vaccine + 2 to + 8 C Single dose
0
13. Scorpion venom antitoxin + 2 to + 8 C Single dose
0
14. Snake venom antitoxin + 2 to + 8 C Single dose
0
15. Tetanus antitoxin (for passive + 2 to + 8 C Single dose
immunization)
16. Tetanus toxoid for active immunization + 2 to + 8 0C One hour
17. Typhoid vaccine (Typhim Vi) + 2 to + 8 0C Single dose
7.0 FORMS
7.1 Physician’s Order Sheet.
7.2 Temperature Monitoring Log Sheet.
8.0 EQUIPMENT
8.1 N/A.
9.0 REFERENCES
9.1 CBAHI resource manual.
