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  • Good Pharmacy Practice in Spanish Community

    Pharmacy

    Medicines Waste Management, Expiry Dates and Returns from

    the Community Pharmacy09

    GENERAL PHARMACEUTICALCOUNCIL OF SPAIN

  • This document has been developed by the Good Pharmacy Practice Working Group from the General Pharmaceutical Council of Spain, constituted by:

    General Pharmaceutical Council of Spain: Ana Aliaga, Luis Amaro, Carmen Recio and Laura MartnPharmacy Chamber Barcelona: M Pilar GascnPharmacy Chamber Cdiz: Encarnacin lvarezPharmacy Chamber Gipuzkoa: Miguel ngel GastelurrutiaPharmacy Chamber Zaragoza: Ramn JordnFoundation Pharmaceutical Care: Mara GonzlezSpanish Society of Community Pharmacy (SEFAC): Eduardo SatuUniversity of Granada: Fernando Martnez

    The General Pharmaceutical Council of Spains Plenary approved the circulation of this document at the session held on 27rd January 2016

    Published by: General Pharmaceutical Council of Spain Villanueva, 11, 7th Floor. 28001 Madrid E-mail congral@redfarma.org Web: www.portalfarma.com

    Legal Deposit: M-4319-2016

    Layout and graphic production: Comuniland S.L.

    Copyright of the original texts: General Pharmaceutical Council of Spain, 2016. All rights reserved. No part of this publication may be reproduced or transmitted in any form or by any means, electronic or mechanical, including photocopying, recording or any production system, without the written permission of the copyright holders.

    mailto:congral%40redfarma.org?subject=www.portalfarma.com
  • Good Pharmacy Practice in Spanish Community

    Pharmacy

    Medicines Waste Management, Expiry Dates and Returns from

    the Community Pharmacy09

  • Good Pharmacy Practice in Spanish Community Pharmacy

    Medicines Waste Management, Expiry Dates and Returns from the Community Pharmacy09

    CONTENTS Introduction........................................................................................... 5

    Managementofexpiredmedicinesandreturnofmedicines

    fromtheCommunityPharmacy................................................................. 6

    Medicinewastemanagement,expirydatesandreturns

    fromtheCommunityPharmacy.......................................................... 7

    Flowchartoftheexpiredandreturnedmedicinesmanagement

    processattheCommunityPharmacy......................................................... 10

    Flowchartofthemanagementprocessformedicineswaste

    ofhouseholdorigin............................................................................... 11

    References............................................................................................. 12

  • 5

    Good Pharmacy Practice in Spanish Community Pharmacy

    Medicines Waste Management, Expiry Dates and Returns from the Community Pharmacy 09

    Introduction

    The medicine cycle begins with the research and development of the medicine in question and continues with its production, distribution, prescription and dispensing. However, it does not end with its proper administration, but rather it concludes with the proper management of the waste generated at the end of this process, in terms of both the medicine itself and the packaging that contains or contained it, in light of the possible presence of trace amounts that it might present.

    The community pharmacy acquires the medicines and medical devices with a view to dispensing them in the future, in order to ensure an optimal level of service. However, medicines sometimes expire in the community pharmacy before they are dispensed. It is therefore necessary to return these medicines to the original supplier (whether this be the distribution warehouse or the pharmaceutical industry) or dispose of them when their return is no longer possible.

    The role of the community pharmacy in the proper management of medicines, medicines waste and their packaging materials must address:

    I) Expired medicines and returns from the community pharmacy: the withdrawal of medicines (prior to dispensing) as the result of monitoring to detect expired products, those which are no longer to be kept in stock for whatever reason (see the Procedure for acquisition, storage, custody and conservation of medicines and medical devices), and medicines affected by vigilance and health alerts (the latter point is dealt with in the Procedure for recalls, shortages, emergencies and alert management).

    II) Medicinal product packaging and medicines waste from households: the collection of medicine waste, medicinal product packaging and medicines returned by patients (that cannot be reintroduced into the cycle) at the collection point at the pharmacy (Integrated Management System1) and their delivery to the appropriate agent.

    Current legislation (Law 22/2011, of 28 July) defines waste and soil contamination as follows:

    a) Waste: any substance or object whose owner disposes of it or has the intention or obligation to dispose of it.

    b) Hazardous waste: waste that has one or more of the hazardous characteristics cited in Annex III, and any others that may be approved by the Government in accordance with the provisions of European regulations or international agreements to which Spain is a party, as well as the containers and product packaging that have contained them.

    Likewise, according to the definition provided by the Ministry of Agriculture, Food and the Environment:

    a) Health waste: this refers to all waste, regardless of its condition, that is generated in health and veterinary centres, including the product packaging and waste from the product packaging that contain or have contained them2. For the purposes of their management, most Autonomous Communities in Spain have approved specific regulations to control the places where they are generated, the agents involved and the obligations that must be accepted. Community pharmacies are expressly referred to in some cases.

    b) Medicine waste of household origin: these are leftover or expired medicines and their packaging, regardless of whether they are full or empty, that are generated in private households3. They must not be disposed of down the drain or with the ordinary rubbish, due to their potentially negative effects on the environment.

    Medicine waste and medicinal product packaging of household origin can be generated:

    Upon finishing a package of a medicine or compounded medicine/officinal preparation. Upon finishing a pharmacological treatment. When checking the medicines cabinet (expired medicines and/or those that are no longer needed).

    1 Currently, SIGRE is the only Integrated Management System authorised in Spain for the management of medicinal product packaging and medicines waste of household origin. For this reason, and regardless of the possibility that other Integrated Management Systems might be authorised in the future, this procedure will refer to the characteristics of how the SIGRE system works.

    2 Available at: http://www.magrama.gob.es/es/calidad-y-evaluacion-ambiental/temas/prevencion-y-gestion-residuos/flujos/residuos-sanitarios/

    3 Available at: http://www.magrama.gob.es/es/calidad-y-evaluacion-ambiental/temas/prevencion-y-gestion-residuos/flujos/domesticos/fracciones/medicamentos/

    http://www.magrama.gob.es/es/calidad-y-evaluacion-ambiental/temas/prevencion-y-gestion-residuos/flujos/residuos-sanitarios/http://www.magrama.gob.es/es/calidad-y-evaluacion-ambiental/temas/prevencion-y-gestion-residuos/flujos/domesticos/fracciones/medicamentos/http://www.magrama.gob.es/es/calidad-y-evaluacion-ambiental/temas/prevencion-y-gestion-residuos/flujos/domesticos/fracciones/medicamentos/
  • 6

    Good Pharmacy Practice in Spanish Community Pharmacy

    Medicines Waste Management, Expiry Dates and Returns from the Community Pharmacy09

    Community pharmacies, as one of the agents (along with the industry and distribution) involved in the manufacture, distribution and dispensing of medicines, has its share of responsibility in the proper environmental management of this waste. Specifically, through the Integrated Management Systems (IMS), they are assigned the role of serving as the point where citizens, assisted as necessary by the community pharmacist, can deposit their medicines waste and medicinal products packaging.

    The distribution channel is then responsible for collecting them from the community pharmacies and taking them to their warehouses, where an authorized waste manager will then transport them to authorised centres for their separation and corresponding processing (recycling of packaging and energy recovery or the elimination of medicine waste).

    However, the community pharmacy is far from being just a simple medicine waste collection point for environmental purposes: it closes the life cycle of a medicine and can provide a good opportunity for community pharmacists to advise and assist patients with regard to responsible use as part of their healthcare efforts. The return of medicines waste may provide the opportunity for the pharmacist to detect possible problems related to the adherence to certain medicines, offering advice on the proper management of household medicines cabinet, etc.

    The present document sets out, on the one hand, the procedure for managing expired medicines and the return of medicines from the community pharmacy, and on the other, the procedure for the proper management of medicinal product packaging and medicines waste of household origin4.

    Management of expired medicines and return of medicines from the Community Pharmacy

    Objectives

    a) To ensure that all medicines that are dispensed in the community pharmacy have not exceeded the legally established expiry date.

    b) To ensure that medicines which have been immobil

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