PHARMACY NEWSLETTER MARCH 2 0 2 3 VOL. 3 , ISSUE 1 MEDICINES EXPIRY: WHY IS IT IMPORTANT? By Muhammad Asyraf Bin Harun, Drug Information Services (DIS) Pharmacist HOW TO DEFINE EXPIRY DATES? GENERAL GUIDELINE ON MEDICINE STORAGE RECOMMENDATION OF DRUG EXPIRY AFTER OPENING IS IT SAFE TO CONSUME MEDICINES BEYOND THEIR EXPIRY DATE? IN THIS ISSUE Brought to you by Drug Information Services Unit, Pharmacy Department, Hospital Al-Sultan Abdullah UiTM Introduction: Medicines play an integral role in optimizing our wellbeing and general health. As such, rational use of medicines is paramount in ensuring the most optimum outcomes & safety from consumption of medicines. One of the key elements in optimizing rational use of medicine & medication safety is via a good understanding on expiry of medicines and good practice on medicines storage. Therefore, it is hoped that this newsletter could provide important insights on understanding expiration of medicines.
Expiry dates as displayed Interpretation ‘Use by’ Use before the end of the previous month e.g. Use by January 2022 = use before 31st Dec 2021 'Use before’ Use before the beginning of the month e.g. Use before January 2022 = use before 1st Jan 2022 Exact expiry date E.g. Exp: 15/01/2022 Exp: 31/01/2022 Expires at the specific date as per display E.g.: Exp: 15/01/2022 would mean the medicine expires on 15/01/2022 Expiry date (no exact date) E.g. Exp: 01/2022 Expires at the end of the month E.g.: Exp: 01/2022 = expires 31st January 2022 MARCH 2 0 2 3 VOL. 3 , ISSUE 1 How do we define expiry dates? Definition of expiry date: According to the United States Food & Drug Administration (FDA), drug expiration dates reflect the time period during which the product is known to remain stable, which means it retains its strength, quality, and purity. However, the expiry dates of the medicine as given by its manufacturer are only reliable if the medicine is stored according to its labeled storage conditions and has not been repackaged. PHARMACIST'S MESSAGE Interpretation of manufacturer’s expiry dates: ALWAYS SEEK ADVICE WHEN UNSURE. ALWAYS DOUBLE CHECK WITH THE DRUG EXPIRY PRIOR TO ADMINISTERING MEDICINES
Management of Near-Expiry medicines All medicines stored in each sub-store are under the responsibility of the person-in-charge (PICs) in that respective unit (e.g. ward sister, clinic sister) Arrangement of medicines received from pharmacy must be according to First Expiry, First Out (FEFO) method, followed by First In, First Out (FIFO) method. The PICs in each unit are also responsible to ensure monitoring & identification of near-expiry medicines. Any medical items that are identified to have expiry date within 6 months must be tagged with appropriate colour coding labels as follow: Green colour code: Expiry date within 6 months Yellow colour code: Expiry date within 3 months Red colour code: Expiry date within 1 month MARCH 2 0 2 3 VOL. 3 , ISSUE 1
P H O T O B Y M A R T I N R . S M I T H Store your medicines in their original container as per dispensed by the pharmacy & according to the manufacturer’s instructions. Keep all medicines in their original packaging to protect them from sunlight, especially for medicines that are sensitive to light. All medicines should be stored in a dry and cool place (below 25°C or unless otherwise stated). If storage in the refrigerator is required, the appropriate temperature is in the range of 2°C to 8°C. Always check and monitor the expiry date for each individual medicine as some products may have variable expiry dates. Mark the date of opening & its consequent new expiry date on the label or container when you first open the medicine’s original container. If containers are unopened, please follow the manufacturer's expiry date. Any product whose condition indicates that the product is no longer suitable for use or the quality cannot be ascertained such as there is a change in color, presence of clearly visible precipitation; the product should be disposed of irregardless of the expiration date. MARCH 2 0 2 3 VOL. 3 , ISSUE 1 General Guideline on Storage of Medicines
Dosage forms Type of packaging Recommended expiry after opening Justifications Tablets / capsules In manufacturers’ original packaging (blister/box/bottle/ strips) Manufacturers expiry date displayed on the original container of medicines. Discard if no expiry date is found. The container is closed, the contents are not exposed to the environment openly. There are risks that the product has already expired if there is no expiration date on the medicine container. Unit of dose (UOD) tablet/capsules (as per dispensed from Ward Supply Pharmacy) Expiry date on the UOD label placed behind the medicine’s strips / on the drug envelope. Return to pharmacy if no expiry date is found. The blister is closed, the contents are not exposed to the environment openly. Since our Ward Supply Pharmacy had enforced UOD expiry date labelling for each drug supplied to the ward/unit. However, some labels may have come off; thus return to the pharmacy if no expiry date is found. MARCH 2 0 2 3 VOL. 3 , ISSUE 1 *AS THIS TABLE CONTAINS GENERAL RECOMMENDATIONS, ACTUAL SPECIFIC EXPIRY DATE MAY VARY. PLEASE REFER TO ORIGINAL MANUFACTURER'S RECOMMENDATION; OR CONSULT PHARMACIST FOR FURTHER CLARIFICATION. General Recommendation on Expiry Dates of Medicines After Opening*
Dosage forms Type of packaging Recommended expiry after opening Justifications Topical preparations (creams/ointments) cream/ointment in tubs 1 month once opened The contents had been exposed and there is possibility of contamination. cream/ointment in tubes with cap. 3 months once opened unless the manufacturer advises otherwise (whichever is shorter). In a closed container, the contents are not exposed openly to the environment. Pump dispensers Please follow manufacturer’s expiry date Different brands have different expiry dates. Liquids / lotions (in original manufacturer’s packaging) 6 months once opened unless the manufacturer advises otherwise (whichever is shorter). Liquid exposure to the environment when dosing the drug measured may affect the product's stability. Drops Eye / ear/ nose drops or ointments 1 month once opened unless manufacturer advises otherwise (whichever is shorter). MARCH 2 0 2 3 VOL. 3 , ISSUE 1 *AS THIS TABLE CONTAINS GENERAL RECOMMENDATIONS, ACTUAL SPECIFIC EXPIRY DATE MAY VARY. PLEASE REFER TO ORIGINAL MANUFACTURER'S RECOMMENDATION; OR CONSULT PHARMACIST FOR FURTHER CLARIFICATION. General Recommendation on Expiry Dates of Medicines After Opening*
Dosage forms Type of packaging Recommended expiry after opening Justifications Liquids (internal use) Original bottles of liquid as per manufacturer's packaging. E.g. syrup Paracetamol 6 months once opened unless manufacturer advises otherwise. Please mark the date of opening. Exposure of the liquid to the environment when the drug dose is measured may cause contamination. Liquids prepared/transferred into pharmacy bottle As per the new expiry date label placed by the pharmacy. Return to the pharmacy if no expiry date is found. Different oral preparations have different expiry dates due to differences in stability. Antibiotics in liquid form E.g. syrup/suspension. Seek pharmacist’ advice. Generally 7-14 days once reconstituted, however please confirm with the pharmacy. Different brands of oral antibiotic in liquid form have variable expiry date & storage requirements once reconstituted. Insulin In their original container (e.g. Flexpen) Store in the fridge at temperature 2°C and 8°C when unopened. Once in use, keep at room temperature (below 25°) for maximum of 1 month Once used, the sterile cover has broken and can be stored outside at room temperature. Inhalers & nasal sprays In their manufacturer’s packaging. Please follow manufacturer’s expiry date MARCH 2 0 2 3 VOL. 3 , ISSUE 1 *AS THIS TABLE CONTAINS GENERAL RECOMMENDATIONS, ACTUAL SPECIFIC EXPIRY DATE MAY VARY. PLEASE REFER TO ORIGINAL MANUFACTURER'S RECOMMENDATION; OR CONSULT PHARMACIST FOR FURTHER CLARIFICATION. General Recommendation on Expiry Dates of Medicines After Opening*
Impact of consuming expired medications: The utmost importance in ensuring consumption of medicines prior to their expiry date is to protect patients from unwanted harmful effects. Although little data are available regarding cases of harmful events following consumption of expired medicines, the risks shall never be taken lightly; especially by the healthcare providers. This is especially true as certain expired medicines are at greater risk of bacterial contamination; while antibiotics that had lost their full potency beyond their expiry date could fail to treat infections, leading to more serious illnesses and antimicrobial resistance. Therefore, when it comes to administering medicines, always ensure the drugs have not expired yet. After all, patient safety is our utmost priority. MARCH 2 0 2 3 VOL. 3 , ISSUE 1 Conclusion: is it safe to consume medicines beyond its expiry date? FURTHER INFORMATION: Kindly contact our Drug Information Services (DIS) unit via the following channel: 03-3396 3000 ext 10302 [email protected] References: 1. Expiration Dates - Questions and Answers. Available from: https://www.fda.gov/drugs/pharmaceutical-quality-resources/expiration-dates-questions-andanswers 2. Why do medicines have expiry dates?. Available from: https://www.nhs.uk/common-healthquestions/medicines/why-do-medicines-have-expiry-dates 3. Rotherham Clinical Commissioning Group. Good Practice Guidance on Expiry Dates of Medicines. Available from: http://www.rotherhamccg.nhs.uk/Rotherham%20CCG%20good%20practice%20guidance%20on%20exp iry%20dates%20of%20medicines%20Approved.pdf. 4. Care Homes - Good Practice Guidance Expiry Dates For Medication. Available from: https://www.ghc.nhs.uk/wp-content/uploads/CHST-Expiry-Dates-of-Medication.pdf 5. Panduan Tarikh Luput dan Penyimpanan Ubat-Ubatan, Bahagian Perkhidmatan Farmasi, Jabatan Kesihatan Negeri Sabah, Kementerian Kesihatan Malaysia. PUBLISHED FOR INTERNAL CIRCULATION ONLY