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 MartínPharmacy Chamber – Barcelona: Mª Pilar GascónPharmacy Chamber – Cádiz: Encarnación ÁlvarezPharmacy Chamber – Gipuzkoa: Miguel Ángel GastelurrutiaPharmacy Chamber – Zaragoza: Ramón JordánFoundation Pharmaceutical Care: María GonzálezSpanish Society of Community Pharmacy (SEFAC): Eduardo SatuéUniversity of Granada: Fernando Martínez
The General Pharmaceutical Council of Spain’s 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 [email protected] 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.
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
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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/
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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 immobilised or recalled by the health authorities are separated from the rest of the stock and are returned according to the established procedures.
Procedure
For the proper maintenance of the medicines stored in the community pharmacy, the pharmacist must monitor the expiry dates according to the following steps:
1. Enter the expiry date of the medicines in stock at the community pharmacy in the pharmacy’s management software: First, the expiry date for each one of the medicines and medical devices available in the pharmacy must be entered into the computer. If there are several units of the same medicines or medical device with different expiry dates, the earliest date must be recorded. The expiry date is considered to be the last day of the indicated month. As an alternative, a manual system may be used to manage expired or soon-to-expire medicines.
2. Update the information upon receiving the order: When receiving the orders, the new expiry dates must be updated and added. To do this, when putting away products when the inventory is greater than zero, it is necessary to check that the expiry date of the replacement products received is later than that of the products already in stock. If this is not the case, the earliest expiry date must be recorded. In addition, their placement must give priority to dispensing medicines that are soon to expire.
4 At the pharmacy itself, medicine waste may be generated in association with the activities involved in producing the compounded medication. The return of raw materials and other products used in the production of compounded medications must be delivered to a manager authorised by the Autonomous Community for their proper disposal. The management of raw materials and other products for the production of compounded medications and officinal preparations will be dealt with in a specific procedure on this topic.
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Good Pharmacy Practice in Spanish Community Pharmacy
Medicines Waste Management, Expiry Dates and Returns from the Community Pharmacy 09
Products with an expiry date of less than 6 months will be rejected, unless the product is a special order, there are supply problems or the pharmacist considers it necessary to accept it.
3. Generate a monthly list to monitor expiry dates: At the start of the month, a list of the medicines expiring that month must be generated. This is to be used by the person responsible for separating them, who must also update the expiry dates if they do not match those recorded on the list. Expired units must be removed from the pharmacy stock.
4. Separate expired or soon-to-expire medicines: ln order to prevent any confusion, medicines that have been removed and are no longer suitable for dispensing must be placed, properly labelled, in an area set aside for expired products until they are returned.
5. Return the expired medicines: Medicines, batches or units of expired products may be returned to the manufacturers within six months of their expiry date. The expired products must be returned through the normal supplier.
a) Medicines identified and separated from the stock must be placed inside a return bag or container from the supplier and labelled as “return - expired products”.
b) A “return order” must be generated to the supplier, with the total amount of the return and a list of the returned medicines.
6. Returning expired narcotic medicines: in the case of expired medicines that contain narcotics, they must be returned to the manufacturer via the normal supplier within 6 months. A narcotics voucher or equivalent means must be included with the return, clearly indicating “RETURN”.
7. Returning deteriorated or immobilised products: medicines that are to be removed from the market due to the cancellation of the registration or format, temporary suspension or market recall by the competent authority, deterioration due to causes for which the manufacturer has acknowledged its responsibility or any other type of immobilisation by the Administration must be separated from the rest and properly labelled until they are returned through the usual channels. (See Procedure for recalls, shortages, emergencies and alert management).
Medicine waste management, expiry dates and returns from the Community Pharmacy
Objectives
a) To ensure the proper collection of medicines waste and empty medicinal product packaging from users and their proper safeguarding until their removal by the distribution.
b) To close the cycle of medicines waste through the recycling of its product packaging and energy recovery, as well as the elimination of elements that cannot be recycled.
c) To minimise the environmental impact of medicines waste and medicinal product packaging.d) To enable community pharmacies to comply with the principle of shared responsibility set out in the waste
regulations, by contributing to the proper management of waste generated after the dispensing of medicines to patients.
e) To advise patients on the follow-up of their treatment and the responsible use of their medicines, including any type found in their medicines cabinet, with regard to risks and the need for periodic revision.
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ProcedureWhen a user requests to turn in their medicines waste, the community pharmacist must consider:
1. Delivery conditions:
a) Place: the container for depositing medicines waste and medicinal product packaging must be located inside the community pharmacy, in a visible area that is accessible to the public. The collection point must not be located outside the pharmacy, since it is a selective collection point and not merely a rubbish bin. Furthermore, it may be necessary to contact the user who turns in the waste. The location must also permit care and control by the pharmacist.
b) Container: the container must have hygiene and safety systems that prevent the improper removal of waste deposited. Examples are a lock and a double ramp at the container opening. Inside, there must be another container5 with a self-closing system or other safety closure that enables it to be closed immediately after being removed from the container. The containers may only be opened by the authorised agent in order to separate the waste. The companies providing the containers will be responsible for ensuring that they meet the requirements established by current legislation.
2. Providing information to the user: The pharmacist must offer the user the option to discuss any aspect of the medicine that he/she has wishes to turn in. If necessary, the user must be escorted to a personalised attention area in the pharmacy, for example, to evaluate the poor adherence to a treatment that has been detected by the return of unfinished packs, to give advice on the management of home medicines cabinet and, in general, to offer information on the responsible use of medicines in order to obtain the best possible results in terms of health, while avoiding misuse, abuse or waste.
3. Contents of medicines waste and medicinal product packaging: the products accepted in the container must be empty containers, remains of unused medicines in their product packaging, including the information leaflet, expired medicines and the packaging materials containing them and individual medicines waste (for example, loose tablets or capsules). These include the packaging and waste from dispensed compounded medicines/officinal preparations.
TAll medicines that may be deposited in the waste management container must have the following logo on their
packaging:
In the case of Personalised Dosage Systems (PDS), community pharmacies preparing this type of systems must take the precaution of procuring material from PDS manufacturers that belong to an Integrated Management System in order to ensure the proper elimination of the PDS. These systems may bear the logo .
The waste from the medicines used to produce the PDS must also be deposited in the container.
In no case shall products that are not analogous to medicines be deposited in this type of container. Examples of prohibited products are needles6, reactive strips, sharp objects, clamps, prosthetics, thermometers, batteries, x-rays, gauze, bandages, etc. This type of products generated by the citizens will require a specific type of waste processing, depending on the type of product. Needles and sharp objects have specific containers in some Autonomous Communities, while batteries, x-rays and electronic devices for medical use must be deposited in the collection systems or recycling centres provided on a municipal level. Gauze, bandages, plasters, etc. for home use must be disposed of with the organic household waste.
Medicines considered to be hazardous, such as cytotoxic and cytostatic drugs7, that are returned by patients and their packaging are deposited in the pharmacy’s SIG container. In accordance with current legislation, since this waste is of household origin, it is not necessary to collect them separately in the community pharmacy. Therefore, these medicines must be deposited along with the rest of the medicines and the authorised agent is responsible for their corresponding separation, according to the applicable regulations.
5 Currently, self-closing plastic bags are used.
6 Devices for the parenteral administration of medicines that form part of the packaging of the medicinal product are included in the SIGRE system.
7 The list of this type of medicines can be consulted at www.portalfarma.com
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Good Pharmacy Practice in Spanish Community Pharmacy
Medicines Waste Management, Expiry Dates and Returns from the Community Pharmacy 09
By law, medicines waste, once deposited at the collection points, cannot be handled or used for any other purpose, such as being sent to developing countries. Pharmaceutical waste does not comply with the directives of the World Health Organization on donated medicines.
Furthermore, the dispensing, sale and marketing of any medicine that has been returned or turned in to community pharmacies by patients or the public is also prohibited8.
4. Removal of medicines waste: the container must be removed when it is approximately 75% full. (Overfilling must be avoided in order to make it easier to remove the container and to prevent it from breaking). Generally speaking, the current collection system is a reverse logistics system, which means that the distribution channel is used to collect the medicines waste and medicinal product packaging that have been deposited at the community pharmacies. For this reason, the pharmacist must request that the usual distributor remove it, preventing individuals who are not part of the system from accessing the container. Extreme caution must be used when removing and closing the container, which must be held away from the body. The distributors store the waste collected in hermetic containers, which are then removed and transported to a specific separation plant, from where they will finally be transported to the treatment plant.
5. Other services: as a result of the interview with the patient regarding the appropriate use of medicines, it may be necessary to refer him or her to other pharmaceutical services, such as Medication Review with Follow-up Service, PDS, etc.
8 Section 6, Article 2, Law 29/2006, of 26 July, on the guarantees and rational use of medicines and medical devices.
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Good Pharmacy Practice in Spanish Community Pharmacy
Medicines Waste Management, Expiry Dates and Returns from the Community Pharmacy09
RECORDEXPIRYDATES/OTHERSYSTEM
SEPARATION-NON-COMPLIANT
PRODUCTS
GENERATIONOFARETURNORDER
GENERATIONOFLISTEDMATERIALS
NO YES
ISTHEMEDICINEEXPIREDORABOUTTOEXPIRE?
Flowchart of the expired and returned medicines management process at the Community Pharmacy
REVISIONOFMEDICINESEXPIRYDATES
MEDICINESUITABLEFORDISPENSING
DELIVERYTOTHEDISTRIBUTOR
•Annual/semi-annualinventory•Uponreceivinganorder
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Good Pharmacy Practice in Spanish Community Pharmacy
Medicines Waste Management, Expiry Dates and Returns from the Community Pharmacy 09
DEPOSITINTHEIMSPOINTOTHER
PHARMACEUTICALSERVICES
NO
NO
YES
YES
ISTHECONTAINERINAVISIBLEANDPUBLICLYACCESSIBLEPLACEINTHEPHARMACY?
ISTHERETHEPOSSIBILITYOFOFFERINGTHEUSERANYOTHERPHARMACEUTICAL
SERVICE?
Flowchart of the management process for medicines waste of household origin
PLACETHECONTAINERIN
ANAPPROPRIATELOCATION
REMOVALOFWASTEBY
THEDISTRIBUTOR
•Healtheducation(responsibleuseofmedicines),MedicinesReviewwithFollow-up,PDS,etc.
•Expiredmedicines•Unused/unwantedmedicines•Packagingmaterialsandcompoundedmedicines/officinalpreparations
•Emptypackagingmaterialsandmedicinesleaflets
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Good Pharmacy Practice in Spanish Community Pharmacy
Medicines Waste Management, Expiry Dates and Returns from the Community Pharmacy09
Referencias
• Guidelines on Good Pharmacy Practice in Spanish Community Pharmacy. General Pharmaceutical Council of Spain. 2013. Available at: http://www.portalfarma.com/Profesionales/Buenas-practicas-profesionales/Paginas/Buenas-practicas-Farmacia-Comunitaria.aspx
• Law 11/1997, of 24 April, on Packaging and Packaging Waste. Available at: http://www.portalfarma.com/Profesionales/legislacion/recopilacion/Paginas/envases.aspx
• Law 10/1998, of 21 April, on Waste. Available at: http://www.portalfarma.com/Profesionales/legislacion/recopilacion/Paginas/envases.aspx
• Law 29/2006, of 26 July, on the guarantees and rational use of medicines and medical devices. Available at: http://www.portalfarma.com/Profesionales/legislacion/recopilacion/Paginas/leygarantiasyusoraciona.aspx
• Law 22/2011, of 28 April, on waste and soil contamination. Available at: http://www.portalfarma.com/Profesionales/legislacion/recopilacion/Paginas/envases.aspx
• Royal Decree 726/1983, of 17 March, regulating the expiry and return of proprietary medicinal products to pharmaceutical industry. Available at: http://www.boe.es/diario_boe/txt.php?id=BOE-A-1982-9070
• Resolution of the Directorate General of Pharmacy and Medicinal Products of 2 December 1983, establishing the regulations governing the return of proprietary medicinal products containing narcotics on List I of the Single Convention on Narcotic Drugs of 1961. Available at: http://www.boe.es/diario_boe/txt.php?id=BOE-A-1983-33186
• Order MAM/304/2002, of 8 February, publishing the operations for waste recovery and disposal and the European waste list. Available at: http://www.boe.es/boe/dias/2002/02/19/pdfs/A06494-06515.pdf
• Guidelines for Medicine Donations. World Health Organization. 1996. Available at: http://www.who.int/selection_medicines/emergencies/guidelines_medicine_donations/en/
• Instructions for medicine exports for the purposes of humanitarian aid. AEMPS. 2013. Available at: http://www.aemps.gob.es/medicamentosUsoHumano/donaciones/docs/instrucciones-donacion-med.pdf
GENERAL PHARMACEUTICALCOUNCIL OF SPAIN
