arabic exam 4_1

Health Authority – Abu Dhabi

أبوظبي -هــيئـــــة الصحة

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

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 (HCF’s) 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






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 HCF’s 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 HCF’s 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).






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.






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






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 manufacturer’s 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






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 manufacturer’s expiry date

• Assure the integrity of injection port each time vial is entered • Good Storage Conditions guidelines should be followed

arabic exam 4_1

Documents

Transcript of arabic exam 4_1