Sie sind auf Seite 1von 6

Health Authority Abu Dhabi

-
Reference Number: PPR/DMP/P0003/07
Issue Date: October 2007
Revision Date: October 2009
Division/Department/Section: PPR/DMP
Subject: Policy on the Expiry Date of
Medicines, Medical Consumables
and Chemicals in Public Pharmacy Version: 1

Page 1 of 6

1. PURPOSE

The aim of this policy is to standardize the process of identifying, tracking and checking
expiry dates of medicines, medical consumables and chemicals in public pharmacies and
pharmacy stores.

2. POLICY STATEMENT

Health Authority Abu Dhabi (HAAD) states that, all public Health Care Facilities (HCFs)
shall follow the standard guidelines on identification and checking of expiry dates of
medicines, medical consumables and chemicals in their pharmacies and pharmacy stores:

2.1. The expiry date of the product may be written as:
dd/mm/yy or mm/yy.
If the expiry date is written as:
dd/mm/yy: then the product is considered expired on that specified date.
But if the expiry date is written as:
mm/yy: the product shall expire on the last day of the specified month
2.2. All products shall be stored as specified by the manufacturer to maintain stability of
the products which may be affected by environmental conditions (Good Storage
Practices to be followed, Reference: WHO Guidelines).
2.3. For open medicine containers, the expiry dates are identified in the attached table
expiry of open medicine containers in patient care area (Appendix I) or as per the
manufacturer date, whichever is less.
2.4. Any medicine with unknown expiry date shall be treated as expired medicine and
disposed.
2.5. This policy is applicable for all public pharmacy and pharmacy stores in the
Emirate of Abu Dhabi and is effective immediately





Health Authority Abu Dhabi

-
Reference Number: PPR/DMP/P0003/07
Issue Date: October 2007
Revision Date: October 2009
Division/Department/Section: PPR/DMP
Subject: Policy on the Expiry Date of
Medicines, Medical Consumables
and Chemicals in Public Pharmacy Version: 1

Page 2 of 6

3. SCOPE

To implement best practices, to improve efficiency, proper utilization and patient safety in
regards to medicines, medical consumables and chemicals in public pharmacies and
pharmacy stores.


4. TARGET AUDIENCE

Health care professionals, pharmacists, and staff working in: purchasing, material
management, stores and warehouses.

5. RESPONSIBILITY

- It is the responsibility of the health care staff in the public HCFs pharmacies, stores,
warehouses, purchasing and material management to comply with the policy and
implement the standard practice
- It is the responsibility of Drugs and Medical Products Department in HAAD to audit
and confirm the compliance of HCFs with the policy

6. PROCEDURE

6.1 On receiving any new batch of medicines, medical consumable or chemical, the staff
involved shall check the expiry date on the outer package of the product
6.2 All staff dealing with medicines or medical products shall check the expiry date of the
product prior to dispensing or using it
6.3 The expiry date on the product must be visible and clear, if not , the staff shall refuse
to accept or keep the product
6.4 The products in all areas of health care facilities should be stored under the conditions
specified by the manufacturer and according to guidelines of Good Storage Practice
(Reference: WHO Guidelines).

Health Authority Abu Dhabi

-
Reference Number: PPR/DMP/P0003/07
Issue Date: October 2007
Revision Date: October 2009
Division/Department/Section: PPR/DMP
Subject: Policy on the Expiry Date of
Medicines, Medical Consumables
and Chemicals in Public Pharmacy Version: 1

Page 3 of 6

6.5 The staff shall check the expiry date of the products on regular basis according to
their approved facility procedure; the products with near expiry date shall be flagged
and kept in front of the shelf
6.6 In outpatients clinics, pharmacists are encouraged to dispense medicines with at least
two months validity until the expiry date (example: if the medicine expires at 10/07,
the pharmacist shall dispense the medicine to the outpatients till the end of 08/07, after
this date, the medicine should not be dispensed to outpatients). If there is no
alternative, the pharmacists must clearly label the medicine and inform the patient of
the expiry date
6.7 For open containers of medicines in patient care areas, staff shall follow the attached
table for the expiry date (Appendix I), or the manufacturer expiry date, whichever is
less. The expiry date must be written on the label of the container
6.8 For powders for reconstitution, manufacturer instructions shall be followed for expiry
after reconstitution
6.9 If a medicine is dispensed from bulk pack, the expiry date of the medicine must be
written on the label in addition to name of the medicine and lot number
6.10 For formulated medicines prepared in the pharmacy, the expiry date shall be
determined as recommended by the reference used for this formulation
6.11 All expired medicines, chemicals and medical products shall be collected, labeled
clearly as expired items and kept in a separate place for proper disposal.

7. DEFINITIONS AND ABBREVIATIONS

Expiry date
It is the date before which the quality of a medicine or medical
products remains acceptable for its intended use. It is predicted
from stability tests under general / normal storage conditions
or by accelerated stability testing under extreme conditions

Medicine
is a drug taken to cure and/or ameliorate any symptoms of an
illness or medical condition, or may be used as preventive
medicine that has future benefits but does not treat any
existing or pre-existing diseases or symptoms.

Health Authority Abu Dhabi

-
Reference Number: PPR/DMP/P0003/07
Issue Date: October 2007
Revision Date: October 2009
Division/Department/Section: PPR/DMP
Subject: Policy on the Expiry Date of
Medicines, Medical Consumables
and Chemicals in Public Pharmacy Version: 1

Page 4 of 6

Medical consumable
Any product which intended to be used for a medical purpose
other than medicine, ex. Diagnostic kits, biological products,
syringes, ext
Chemical Includes raw materials, active pharmaceutical ingredients and
excipients used in compounding


8. CROSS REFERENCE

1. United States Pharmacopeia, 2007. Stability Considerations in dispensing practice.
2. FDA Guidelines on Current Good Manufacturing Practice for Finished
Pharmaceutical, accessed at www.fda.gov/cder/dmpq/cgmpregs.htm on 07/08/2007
3. GAHS Policy, Disposal of Expired and Damaged Consumables and
Pharmaceuticals - PUR-0708
4. GAHS Policy, Dealing with near expiry, slow moving and non moving items -
PUR-0704
5. WHO Expert Committee on Specifications for Pharmaceutical Preparations thirty
seventh report, Geneva- 2003. Annex. 9 Guide to Good Storage Practices for
Pharmaceuticals













Health Authority Abu Dhabi

-
Reference Number: PPR/DMP/P0003/07
Issue Date: October 2007
Revision Date: October 2009
Division/Department/Section: PPR/DMP
Subject: Policy on the Expiry Date of
Medicines, Medical Consumables
and Chemicals in Public Pharmacy Version: 1

Page 5 of 6

9. APPENDIX I

Table of Expiry Date of Open Medicine Containers in Patient Care Areas

Type Detail Expiry date
Bulk bottles not requiring
reconstitution
3 months after opening with proper storage
conditions
Oral Liquids
Bulk bottles requiring reconstitution As per manufacturers recommendations for
expiry date
Ampoules Discard remainder immediately after use
Single dose vials (preservative free) Discard remainder immediately after use
Injectables
Multiple dose vials (with
preservative)
30 days after opening with proper storage
conditions
Insulins 30 days after opening with proper storage
conditions
Topicals Creams, ointments, lotions, pastes 3 months after opening with proper storage
conditions
Drops and ointments with
preservative
30 days after opening with proper storage
conditions
Ophthalmics
Drops and ointments without
preservative
Discard remainder immediately after use
Inhalers Inhaled medical devices as Turbo
halers, MDI, Evohaler s
3 months after opening with proper storage
conditions
Salbutamol Solution for nebulization 30 days after opening with proper storage
conditions
Sublingual tablets 8 weeks after opening with proper storage
conditions
Nitroglycerin
Sublingual spray 3 months after opening with proper storage
conditions


Health Authority Abu Dhabi

-
Reference Number: PPR/DMP/P0003/07
Issue Date: October 2007
Revision Date: October 2009
Division/Department/Section: PPR/DMP
Subject: Policy on the Expiry Date of
Medicines, Medical Consumables
and Chemicals in Public Pharmacy Version: 1

Page 6 of 6

If any signs of deterioration or physical changes seen on the product, discard it
immediately
If the manufacturer expiry date is less than the assigned date, use the manufacturers
expiry date
Assure the integrity of injection port each time vial is entered
Good Storage Conditions guidelines should be followed

Das könnte Ihnen auch gefallen