PRN expiry date guide ® for Webstercare systems PRN Packing Guide Pharmacy professional standards and guidelines state that a PRN medicine should be packed separately and clearly show an expiry date calculated from the date of packing. This is to ensure the medicine is safe and effective over the intended “shelf life” of the pack. Once removed from the manufacturer's original packing the manufacturer's recommended expiry date is no longer valid and the pharmacist must decide on an appropriate expiry date based on available evidence. 1 Some medications may not be suitable for packing in a PRN Webstercare® system. The list for PRN medicines not suitable for packing may have additional medicines to the regular list as a PRN Webster‐pak could be stored for longer than a regular pack. For more information please refer to the Webstercare information sheet titled “ Medications not suitable for packing in Webstercare Systems” 2 Webstercare foils and blisters are specifically designed to provide an effective barrier (seal) to protect medicines from moisture. It is important that the correct sealing technique is followed. For more information please refer to “Webstercare Sealing Techniques” 3 Consider how many doses are supplied at one time. The Pharmaceutical Society of Australia (PSA) recommends the quantity packed should not exceed the quantity that reasonably could be required during 8 weeks1. * If PRN medicine is not administered within the 8 week period consideration may be given to reviewing and ceasing the medicine. 4 Paracetamol tablets: Studies tested chemical stability of Paracetamol tablets packed in a Webster‐pak and stored for 12 months. Results demonstrated no significant changes to the tablets2.. Based on these results Webstercare suggests pharmacists conduct a risk – benefit assessment and recommend a 12 month expiry on Paracetamol PRN Webster‐packs. 5 Other tablets and capsules: After examining evidence from US FDA3 and US pharmacopeia Webstercare suggests the pharmacist consider the following expiry dates for tablets and capsule packed in a PRN Webstercare system, whichever is less: · an expiry date of 6 months from the date the medicine is packed into a single unit dose container. OR · 25% of the remaining time of manufacturer's original expiry date. 6 Advise the RACF to have procedures to regularly check stock rotation and expiry dates on a PRN pack. T (02) 9563 4900 I FREE CALL 1800 244 358 I F (02) 9563 4955 I FREE FAX 1800 626 739 [email protected] I www.webstercare.com.au v 1.0 Please see over for references. PRN expiry date guide ® for Webstercare systems PRN Packing Guide 1 PSA Guidelines and Standards for pharmacists 6.4 2 Stability of Paracetamol tablets repackaged in dose administration aids for PRN use: implication for practice: Glass et al. Journal of Pharmacy Practice and Research Vol 43, No3,13 3 FDA Guidance: CPG Sec. 480.200 Expiration Dating of Unit Dose Repackaged Drugs. US FDA Compliance made the following recommendation based on evidence from US pharmacopeia standards for unit dose repackaging. • an expiry date of 6 months from the date the medicine is packed into a single unit dose container. • or the six month expiration period does not exceed 25% of the remaining time between the date of repackaging and manufacturer’s original expiry date. • or evidence from stability or the manufacturer’s information indicates otherwise. Unit Dose 7® Webstersystem® Unit Dose 7 Wesbtercard™ T (02) 9563 4900 I FREE CALL 1800 244 358 I F (02) 9563 4955 I FREE FAX 1800 626 739 [email protected] I www.webstercare.com.au © (06/06) Manrex Pty Ltd (ABN: 63 074 388 088) t/as Webstercare ‐ 2014. Webstercare, Webster‐pak, Unit Dose 7, Webstersystem and W‐Device are Registered Trade Marks of Manrex Pty Ltd t/as Webstercare. v 1.0 Multi Dose Wester‐pak