What is the storage of pharmaceuticals?

Storage of pharmaceuticals is part of the pharmacy policy and procedures.

As usual with most of the policies sample posted here, there is some default data that should be listed in the policy header and footer. Below are some of the info that you need to include in your storage of pharmaceuticals policy header:

  • Hospital name, obviously.
  • Pharmacy department operational policy and procedure, this header just to notify the reader that the following policy belongs to which department.
  • Policy code or Number, for filing/indexing purposes.
  • Edition Number, same purpose as above.
  • The title of the policy, in our case; would be storage of pharmaceuticals.
  • Important dates [date reviewed, approved date, effective date, and due for review date].
  • Applies to [department] in this case it should be pharmacy department
  • And last but not least, you’ll mention the nature of the policy, whether it’s going to be multidisciplinary or department-specific. (Multidisciplinary policy)
Storage of pharmaceuticals
Storage of pharmaceuticals

Storage of pharmaceuticals Policy

Definitions

The provision of optimal conditions, that necessary for maintaining the safety and efficacy of all drugs, nutritional, chemicals, and IV. fluids on the storage.

Purpose

To provide a procedure that shall be followed to maintain the safety and the optimal storage conditions of drugs, nutritional, chemicals, and IV. fluids.

Policy

  1. Unauthorized persons are not allowed to enter storage areas.
  2. The optimum storage conditions should be regularly monitored and maintained by a registered pharmacist/technician in compliance with regulations and product labeling
  3. The optimum storage conditions shall be followed as recommended by the manufacturer, specification, and other international standards.
  4. All medications shall be arranged on shelves alphabetically so as to be identified easily during their storage except for Look-Alike Sound-Alike Medications should be separated, segregated labeled, and recognized inside the pharmacy and non-pharmacy areas.
  5. All medication needs refrigeration should be kept in medication refrigerator immediately upon receiving.
  6. All frozen medications should be kept in freezer immediately up on receiving.
  7. All short-dated medications should be stored separately and labeled clearly for both unit dose and non-unit dose medications.
  8. Expired medications should be stored separately till returning to the vendor or destruction.
  9. The antiseptic solution should be stored separately from oral preparations.
  10. All drugs sensitive to light should be protected from light or as recommended by the manufacturer.
  11. Any medication presenting a special risk of abuse or considered as hazardous chemical or drug should be labeled and stored in a dedicated area that is subjected to additional safety and security measures e.g. Narcotic, controlled medications, high alert medications, and Look-Alike sound-alike medications.
  12. Material safety data sheets (MSDS) should be kept in pharmacy laboratory for hazardous materials.
  13. The optimum storage conditions for nutritional items (liquid/Powder) as recommended by the manufacture in Pharmacy St Non-Pharmacy Area.

Procedures and responsibilities

Pharmacy supervisor/Pharmacy staff

  • All pharmaceuticals shall be stored on shelves and should not be stored on the floor.
  • The pharmacy shall maintain computerized records for controlling the stocks, reordering, and monitoring of receiving and issuance.
  • First-in First-out medication arrangement system shall be restrictedly adhered to especially for these drugs with short-dated shelf life.

Pharmacy supervisor

Cabinet for files and other reports shall be available at each pharmacy section.

Pharmacy supervisor Safety and Loss preventive officer

Fire alarm and smoke detector shall be fixed and tested regularly.

Pharmacy Supervisor/Maintenance Department

Security Alarm shall be fixed and tested regularly as a preventive measure against theft in non 24 Hours pharmacies.

Pharmacy supervisor/Pharmacy staff/Housekeeping Department

Storage area should be kept clean, dry and tidy.

All pharmacy staff/Nursing Department

  • Room temperature shall be maintained below 25◦C, Humidity below 60 %, and recorded twice daily.
  • Refrigerated items shall be stored between 2-8◦C and the frozen drugs shall be stored at -20◦ or below.
  • Oral Polio vaccine, Alteplase PFS, and Propess vaginal pessaries shall be stored at -20◦C or below or as recommended by the manufacturers except in vaccination room oral polio could be kept in the refrigerator between 2-3◦C, not more than six months.
  • All refrigerated medications should be arranged on refrigerator shelves with sufficient space in between in order to allow air circulation.
  • Thermometers shall be used for reading the temperature in all medication storage areas twice daily.
  • Temperature Auditing:
  1. Refrigerators and freezers’ temperature shall be monitored and checked twice daily.
  2. Automatic temperature chart recorders, LED Reading and regular thermometers are used in monitoring and checking of refrigerators and freezers’ temperatures.
  3. The temperature readings shall be recorded in the daily record sheet twice daily at 7:00 and 15:00 pm and any discrepancy shall be noted in this sheet.
  4. In case of refrigerators/freezers failure or if the refrigerator/freezers temperature is out of range, or any discrepancies in the temperature readings, maintenance shall be notified immediately and the incident shall be reported to the unit supervisor. Special arrangements will take place to transfer temporarily medications into ice boxes with ice bags or to another refrigerator if needed.
  5. A regular daily follow-up for the temperature records shall be conducted by nursing unit twice daily and discrepancies shall be reported to the concerned department head.
  6. A monthly follow-up for the temperature records in Medication Room inwards/department by pharmacy in order to ensure proper temperature checking and documentation.
  • Storage of multi-dose vials:
  1. After puncturing or accessing it should be swabbed again with alcohol and covered with aluminum foil.
  2. The proper labeling with opening date, expiry date, and initial will take place.
  3. All multi-dose parenteral vials must be used within the expiration dates refer to Multi-dose pharmaceutical Expiration as recommended by the manufacturing unless contamination is suspected, integrity of stopper is a compromise, or deposits settled at the bottom of the vials or found without a revised expiry date based on the date opened.
  • Antiseptics, disinfectants, and drugs for external use shall be stored separately from oral and injectable medications.
  • All light-sensitive drugs should be protected from light e.g. Heparin injection, metronidazole injection…etc.

All pharmacy staff/Nursing Department/Maintenance Department/Vaccination room staff nurse

  • Vaccine refrigerators and medication refrigerators shall be connected to an emergency power source, outlets shall be marked red as such and should connect to alarm system in Hospital Operator and the emergency power source shall be properly functioning.
  • Vaccines in the vaccination room should be stored separately and a Logbook is maintained to document at least the following data:
  1. Vaccine name and number of doses received.
  2. Date of vaccines received and issued.
  3. Vaccine expiry date and batch number.

Narcotic and Controlled In Charge

Controlled and Narcotic drugs should be stored in compliance with M.O.H/FDA laws and regulations.

All pharmacy staff/Nursing Department/Dietician Department

  • All lV fluids, nutrition, and RTF Milk products should be stored at the dry clean place and at room temperature in pharmacy and other patient care areas, monitoring of the room temperature should be carried out twice daily.
  • Any unused portion should be discarded.

Pharmacy Department/Nursing Department

WARMING OF INTRAVENOUS (IV) FLUIDS ANDlRRlGATlON SOLUTIONS

  1. Whenever it is necessary to warm IV fluids and/or irrigation solutions, a dry warming cabinet with carefully controlled temperature will be utilized.
  2. PVC plastic bottles / NON PVC bags of IV fluids and/or irrigation solutions to be pleased at the same time of preparing for the procedure in which the Warm solution/irrigation is needed.
  3. It is allowed to warms the solution to the body temperature (37◦C) just before use, with a clear label indicate the date and time that solution placed in the warmer.
  4. Once removed from the warming cabinet, the warmed IV fluid/irrigation solution cannot be returned to the warmer. And identified as warmed by making a note on the label.
  5. Fluid/solution will not be returned back to stock supply or re-warmed.
  6. Don’t store or keep any intravenous (IV) fluids and irrigation solutions inside the warmer if no procedure running.
  7. Any used or unused warmed solution should be discarded after any end of procedure.
  8. Monthly inspection for warmer cabinets is carried out by Pharmacy to assure proper implementation is in place.

All pharmacy staff/Operating Theater Head/Nursing Department

Storage and Handling of Anesthesia Medications inside the Pharmacy and Operating Theater should be carried out by following special precautions. See attached (special precautions during storage and handling anesthetic agents).

All pharmacy staff

  • All Hazardous Chemicals are stored in a separated ventilated yellow cabinet and (MSDS) martial safety data sheet are kept at the same area for staff use and all hazardous medications (chemotherapy) are stored separated from other medications and handled following (Hazardous Drugs Handling Technique, Staff Training, and disposal of Cytotoxic Waste Policy).
  • Stock Transfer & Receiving:
  1. All Pharmaceuticals transferred to the hospital pharmacies inside vehicles with controlled temperature (below 25◦C). Upon receiving the shipment, the vehicle temperature will be checked and documented by the attending pharmacy staff. (See Attachment D)
  2. For fridge items and vaccines, which transferred in the cool box: the attending pharmacy staff on the arrival will check the content for damage, leakage, discrepancies and will check and document the temperature to assure that it was maintained within the range of 2-8◦C. (the thermometer must be kept in the center of the cool box).
  3. For transferring vaccines to the vaccination room the receiving staff nurse will assure that the temperature is maintained 2-8◦C. Then the staff nurse will sign for receiving without any discrepancies, finally she will complete the vaccine log book.
  4. If the thermometer reading was outside the recommended range, the shipment will not be accepted and the receiving staff will report the reason for non-acceptance. An incident report should be initiated.

Attachments

  1. Attachment A- Refrigerator temperature daily record (Inpatient and outpatient pharmacies) and room temperature daily record.
  2. Attachment B- Special Precautions during Storage and Handling of anesthetic Agents.
  3. Attachment C- Light sensitive list.
  4. Attachment D- Temperature Recording Sheet for vaccines.
  5. Attachment E- Temperature Log for Vaccines.

You’re almost done and pharmacy storage of pharmaceuticals policy is almost ready, what’s remaining is just a few basic policy layout filling.

  • References.
  • Revisions: Revised as per timescale.
  • Distribution: Here you should mention where this policy will be sent, and which departments will get a notification for it:
    • Medical/Hospital Director.
    • Nursing Director.
    • All Pharmacy Staff.
    • Dietary Department.
    • Maintenance Department.
    • Housekeeping Department.
    • Head of Anesthesia.
    • Pharmacy Department.
    • Signed original is maintained in Manual & Indexing Office.

The policy is now finished, and it’s time to get proper signatures, whether your hospital is implementing an electronic signatures, or manual sign and stamp.


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