HEALTH TECHNICAL MEMORANDUM

Transcription

1 HEALTH TECHNICAL MEMORANDUM Disposal of pharmaceutical waste in community pharmacies 2007 STATUS IN WALES APPLIES For queries on the status of this document contact or telephone Status Note amended March 2013

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3 Environment and sustainability Health Technical Memorandum 07-06: Disposal of pharmaceutical waste in community pharmacies

4 DH INFORMATION READER BOX Policy Estates HR / Workforce Performance Management IM & T Estates Planning Finance Clinical Partnership Working Document Purpose Best Practice Guidance ROCR Ref: 0 Gateway Ref: 8563 Title Author Publication Date Target Audience Health Technical Memorandum 07-06: Disposal of pharmaceutical waste in community pharmacies Department of Health Estates and Facilities Division September 2007 PCT CEs, NHS Trust CEs, SHA CEs, Care Trust CEs, Foundation Trust CEs, Medical Directors, Directors of Nursing, PCT PEC Chairs, NHS Trust Board Chairs, Special HA CEs, GPs, Pharmacists Circulation List Department of Health libraries, House of Commons library, Strategic Health Authorities, UK Health Departments Description This document provides guidance on the disposal of pharmaceutical waste produced in community pharmacies in England and Wales Cross Ref Superseded Docs Action Required Timing HTM 07-01: Safe management of healthcare waste 0 n/a 0 n/a 0 n/a Contact Details Lorraine Brayford Department of Health Finance and Investment Directorate Estates and Facilities Division Quarry House Leeds LS2 7UE lorraine.brayford@dh.gsi.gov.uk For Recipient's Use

5 Environment and sustainability Health Technical Memorandum 07-06: Disposal of pharmaceutical waste in community pharmacies London: The Stationery Office

6 Environment and sustainability HTM 07-06: Disposal of pharmaceutical waste in community pharmacies Published by TSO (The Stationery Office) and available from: Online Mail, Telephone, Fax & TSO PO Box 29, Norwich NR3 1GN Telephone orders/general enquiries Fax orders Textphone TSO Shops 16 Arthur Street, Belfast BT1 4GD Fax Lothian Road, Edinburgh EH3 9AZ Fax and other Accredited Agents Crown copyright 2007 Published with the permission of the Estates and Facilities Division of the Department of Health, on behalf of the Controller of Her Majesty s Stationery Office. This document/publication is not covered by the HMSO Click-Use Licences for core or added-value material. If you wish to re-use this material, please send your application to: Copyright applications The Copyright Unit OPSI St Clements House 2 16 Colegate Norwich NR3 1BQ ISBN First published 2007 Printed in the United Kingdom for The Stationery Office The paper used in the printing of this document (Greencoat Velvet) is produced in a mill that has obtained both ISO 9001 and ISO accreditations, which means that all responsibilities to the local environment and manufacturing processes are strictly monitored. Greencoat Velvet boasts the following environmental credentials: 80% recycled post-consumer fibre 10% TCF (Totally Chlorine Free) virgin fibre 10% ECF (Elemental Chlorine Free) fibre FSC certification NAPM recycled certification ii

7 Preface About Health Technical Memoranda Engineering Health Technical Memoranda (HTMs) give comprehensive advice and guidance on the design, installation and operation of specialised building and engineering technology used in the delivery of healthcare. The focus of Health Technical Memorandum guidance remains on healthcare-specific elements of standards, policies and up-to-date established best practice. They are applicable to new and existing sites, and are for use at various stages during the whole building lifecycle. main source of specific healthcare-related guidance for estates and facilities professionals. The core suite of nine subject areas provides access to guidance which: is more streamlined and accessible; encapsulates the latest standards and best practice in healthcare engineering; provides a structured reference for healthcare engineering. Figure 1 Healthcare building life-cycle DISPOSAL CONCEPT RE-USE OPERATIONAL MANAGEMENT DESIGN & IDENTIFY OPERATIONAL REQUIREMENTS MAINTENANCE Ongoing Review SPECIFICATIONS TECHNICAL & OUTPUT COMMISSIONING PROCUREMENT INSTALLATION CONSTRUCTION Healthcare providers have a duty of care to ensure that appropriate engineering governance arrangements are in place and are managed effectively. The Engineering Health Technical Memorandum series provides best practice engineering standards and policy to enable management of this duty of care. It is not the intention within this suite of documents to unnecessarily repeat international or European standards, industry standards or UK Government legislation. Where appropriate, these will be referenced. Healthcare-specific technical engineering guidance is a vital tool in the safe and efficient operation of healthcare facilities. Health Technical Memorandum guidance is the Structure of the Health Technical Memorandum suite The series of engineering-specific guidance contains a suite of nine core subjects: Health Technical Memorandum 00 Policies and principles (applicable to all Health Technical Memoranda in this series) Health Technical Memorandum 01 Decontamination Health Technical Memorandum 02 Medical gases iii

8 Environment and sustainability HTM 07-06: Disposal of pharmaceutical waste in community pharmacies Health Technical Memorandum 03 Heating and ventilation systems Health Technical Memorandum 04 Water systems Health Technical Memorandum 05 Fire safety Health Technical Memorandum 06 Electrical services Health Technical Memorandum 07 Environment and sustainability Health Technical Memorandum 08 Specialist services Some subject areas may be further developed into topics shown as -01, -02 etc and further referenced into Parts A, B etc. Example: Health Technical Memorandum Part A will represent: Electrical Services Electrical safety guidance for low voltage systems In a similar way Health Technical Memorandum will simply represent: Environment and Sustainability EnCO 2 de. All Health Technical Memoranda are supported by the initial document Health Technical Memorandum 00 which embraces the management and operational policies from previous documents and explores risk management issues. Some variation in style and structure is reflected by the topic and approach of the different review working groups. DH Estates and Facilities Division wishes to acknowledge the contribution made by professional bodies, engineering consultants, healthcare specialists and NHS staff who have contributed to the review. Figure 2 Engineering guidance HE ALTH HTM 08 Specialist Services SPECIFIC INDUSTRY DOCUMENTS HTM 01 Decontamination STANDARDS H E A LT H S P E C IF HTM 07 Environment & Sustainability I C HTM 06 Electrical Services D O C U M E N T S HTM 05 Fire Safety INTERNATIONAL & EUROPEAN STANDARDS INTERNATIONAL & EUROPEAN STANDARDS HTM 00 Policies and Principles IN D USTRY STA N DA R D S HTM 04 Water Systems HTM 02 Medical Gases HTM 03 Heating & Ventilation Systems H E A LT H D O C U M E N T S S P E C I FI C iv

9 Executive summary This document provides guidance on the disposal of pharmaceutical waste produced in community pharmacies in England and Wales. Pharmaceutical waste refers to the disposal of unwanted medicines, out-of-date or obsolete stock, sharps, and waste arising from diagnostic testing. Aim of this guidance This guidance has been produced to help community pharmacies to meet legislative requirements. The advice in this document and any recommended courses of action are not in themselves mandatory (except where specified to the contrary), but pharmacies choosing not to follow them are advised that it is essential that alternative steps be taken to comply with all relevant legislation. Key recommendations a. Pharmacies should institute written standard operating procedures (SOPs) for the disposal of unwanted medicines. These procedures should: include a description of how returned controlled drugs should be denatured and recorded; incorporate the current guidance from the Royal Pharmaceutical Society of Great Britain (RPSGB) on the denaturing of controlled drugs; include a list of hazardous medicines that may be encountered in the pharmacy; include instructions to staff on dealing with products other than medicines that are handed in to the pharmacy; include instructions on identifying incompatible products such as flammable products and oxidising agents; include the protective measures to be adopted by staff when segregating controlled drugs and incompatible products; include reference to monitored dosage system trays and the disposal of blister packs; set out the retention and audit requirements for transfer notes, consignment notes and quarterly returns. b. Pharmacies should ensure that they apply for a carrier s licence if they are to carry waste medicines from a patient s home or residential home to the pharmacy. c. It is recommended that all sharps be treated as hazardous waste. Pharmacies should ensure that they segregate sharps along the following guidelines: a purple-lidded sharps bin should be used for sharps contaminated with cytotoxic or cytostatic medicines; a yellow-lidded sharps bin should be used for all other sharps contaminated with nonhazardous medicines; other sharps, for example fully discharged syringes, may be disposed of in an orangelidded sharps bin. d. When completing any documentation needed for the transfer and transportation of waste from the pharmacy, pharmacies are advised to ensure that all waste coding and descriptions are robust and accurate, particularly with regard to the presence of medicinal waste and medicinally contaminated sharps. Related guidance For further information and guidance on waste management issues in healthcare, refer to Health Technical Memorandum Safe management of healthcare waste. v

10 Environment and sustainability HTM 07-06: Disposal of pharmaceutical waste in community pharmacies Contents Preface Executive summary Chapter 1 Introduction 1 Definitions Chapter 2 Standard operating procedures (SOPs) 2 Chapter 3 Legislation 3 Background to the legislation Duty of care Waste Management Licensing (WML) Regulations 1994 Registration for storage of waste medicines Storage of controlled drugs (controlled under the Misuse of Drugs Regulations 2001) Chapter 4 Household waste medicines 5 Chapter 5 Carriage of waste 6 Chapter 6 Treatment of waste 7 Chapter 7 Hazardous waste 8 Hazardous properties Mixed wastes Incompatible products Liquid medicines How can incompatible products be identified and segregated? Chapter 8 Identifying hazard risks to carriers and waste contractors 11 Sources of data on hazardous properties Chapter 9 Monitored dosage systems (MDS) 15 Chapter 10 Hazardous waste producer notification 16 Chapter 11 Sharps 17 The segregation of syringes and sharps Chapter 12 Waste disposal companies 19 Chapter 13 Documentation 20 Change of ownership Licensing and registration Audit trail Transfer notes Consignment notes Chapter 14 Frequency of collection 22 References 23 Acts and Regulations European legislation Department of Health guidance Department for Environment, Food and Rural Affairs (Defra) guidance vi

11 1 Introduction 1.1 This document provides guidance on the disposal of pharmaceutical waste produced in community pharmacies in England and Wales. 1.2 The waste generated is likely to consist of: pharmaceutical products returned from individuals and households as part of the essential services (that is, the disposal of unwanted medicines a service provided by all pharmacies); out-of-date or obsolete stock; needles and syringes; and waste arising from diagnostic testing such as blood-glucose- and cholesterol-monitoring schemes. Definitions 1.3 For a definition of terms used in this document, see the glossary contained in Health Technical Memorandum Safe management of healthcare waste. 1

12 Environment and sustainability HTM 07-06: Disposal of pharmaceutical waste in community pharmacies 2 Standard operating procedures (SOPs) 2.1 The clinical governance framework under the National Health Service (Pharmaceutical Services) Regulations 2005 requires the pharmacy to have procedures for each of the services provided under the community-pharmacy contractual framework. 2.2 Pharmacies should institute written SOPs for the disposal of unwanted medicines in order to ensure that all staff and locum pharmacists are aware of the procedures in place in the pharmacy. 2

13 3 Legislation Background to the legislation 3.1 The legislation relevant to pharmaceutical waste derives mainly from European directives. The storage, carriage, processing and supply of waste are all subject to stringent controls designed to minimise the negative effects of waste on the environment. As the impact of inappropriate handling of waste could have a considerable effect on the environment, the penalties for breach of the regulations are severe. Fines of up to 50,000 or terms of imprisonment of up to six months are possible in a magistrates court, with stricter penalties on indictment. The Environment Agency or the relevant local authority is the enforcement authority for the legislation. Depending on the circumstances, and in cases of doubt, either can be contacted for advice. The Environment Agency helpline number is Duty of care 3.2 The Environmental Protection Act 1990 introduced the concept of duty of care. Under this framework, everyone who deals with waste is under a duty to ensure its safe handling, transport and disposal. This duty continues throughout the waste chain and involves all intermediaries until final disposal. If any part of the disposal chain fails, the initial producers or subsequent holders could be found to have failed in their duty of care; therefore, only reputable waste disposal contractors should be used to remove waste from the pharmacy. In England and Wales, waste disposal contractors are contracted by the primary care trust (PCT) or local health board (LHB) as part of the pharmacy contractual framework. Waste Management Licensing (WML) Regulations The storage of waste on the premises of production by the producer does not normally require a waste management licence. This means that a community pharmacy does not require a licence to temporarily store its own date-expired or obsolete stock, pending its collection and disposal. However, the pharmacy does need to ensure that its waste is stored appropriately to benefit from this general exemption. 3.4 The holding of waste from other sources requires a licence or registered exemption under the Waste Management Licensing Regulations 1994 (WML Regulations). 3.5 Paragraph 39(1) of Schedule 3 of the WML Regulations provides a conditional exemption for community pharmacies for the secure storage at a pharmacy (pending the disposal there or elsewhere) of waste medicines (including those which are hazardous waste) that have been returned to the pharmacy from households or by individuals if: a. the total quantity of such returned waste medicines at the pharmacy does not exceed 5 m 3 at any time; and b. any waste medicine so returned to the pharmacy is not stored there for longer than six months. Registration for storage of waste medicines 3.6 The waste management licensing exemption for each community pharmacy must be registered with the local Environment Agency office. It is important to notify the Environment Agency of all premises used for the storage of waste, including the pharmacy itself, and any outbuildings or off-site stores. All locations in which waste is stored must be secure. 3.7 An application form is available from the Environment Agency using the following link: acrobat/wmx39_ pdf 3

14 Environment and sustainability HTM 07-06: Disposal of pharmaceutical waste in community pharmacies 3.8 Whenever a change in ownership of a community pharmacy takes place, the new owner must register this exemption. 3.9 It should be noted that registering the waste management licensing exemption is only one stage of the process. Producers of hazardous waste (which includes pharmacies) must also notify the Environment Agency under the Hazardous Waste Regulations 2005 (see Chapter 7). Action point Check that the pharmacy has registered its exemption with the Environment Agency. Storage of controlled drugs (controlled under the Misuse of Drugs Regulations 2001) 3.10 In a community pharmacy, all controlled drugs included in Schedules 1, 2 (except quinalbarbitone) and 3 (except any 5,5-disubstituted barbituric acid, cathine, ethchlorvynol, ethinamate, mazindol, meprobamate, methylphenobarbitone, methyprylon, pentazocine, phentermine or any stereoisomeric form of the above, or any salts of the above) of the regulations must be stored in a cabinet which complies with the Misuse of Drugs (Safe Custody) Regulations Date-expired or obsolete pharmacy stock must be retained in the cabinet to await denaturing in the presence of an authorised witness If controlled drugs are returned from households or individuals, they too must be stored in a controlled drugs cabinet until they are denatured to render them irretrievable To avoid accidental use of date-expired, obsolete or returned controlled drugs stored in a controlled drugs cabinet, they should be clearly marked as awaiting denaturing Currently, there are no legal provisions requiring controlled drugs returned from households or individuals to be denatured in the presence of an authorised witness; however, as a result of recommendations following the Shipman Inquiry, it is suggested that denaturing of returned unwanted controlled drugs should, if possible, be witnessed by a registered healthcare professional such as a registered dispensing technician, or (if there is no registered dispensing technician) by another appropriately trained member of staff Since 1 January 2007, the Controlled Drugs (Supervision of Management and Use) Regulations 2006 have required pharmacies in England to have SOPs that include arrangements for recording the return of Schedule 2 controlled drugs from patients, which would include recording the denaturing of such controlled drugs Controlled drugs returned from patients should be denatured as soon as possible: to avoid the danger of their being mixed in with pharmacy stock; and to reduce the security risk of holding unnecessary quantities of controlled drugs It is strongly recommended that the Royal Pharmaceutical Society of Great Britain s (RPSGB) guidance on controlled drugs and their safe destruction is followed (available on org/worldofpharmacy/useofmedicines/controlled drugs.html) Denaturing of controlled drugs constitutes treatment of waste, which would normally require a licence, but see Chapter 6 for further information. Action point Does the pharmacy s SOP describe how returned controlled drugs should be denatured and recorded? 4

15 4 Household waste medicines 4.1 As the exemption from the need to hold a waste management licence (WML) applies to storing medicines returned from households or individuals, it is important to understand the limitations in what is meant by household. 4.2 The Controlled Waste Regulations 1992 define what is meant by the term household waste. Waste medicines from a patient s own home are included, as are waste medicines from a residential home. But clinical waste (including medicines) from a care home providing nursing care (the term nursing home is used in this document for brevity) is classed as industrial waste. Note Throughout this guidance document, reference is made to residential home and nursing home. These terms have been superseded by care home and care home with nursing, respectively. 4.3 Nursing homes and other healthcare practices are not households. Waste medicines from these premises cannot be accepted back at the pharmacy under the paragraph 39(1) WML exemption. Although the paragraph 28 WML exemption may be applicable in some circumstances, it would place additional hazardous-waste-consignee requirements on the pharmacy. 4.4 Hazardous waste medicines removed from a nursing home or other healthcare practice would require consignment to the pharmacy. The pharmacy then becomes a hazardous waste consignee and is required to keep a site inventory, to make quarterly returns to both the producer and the Environment Agency, and to pay fees for each batch received. Transfer notes would be required for non-hazardous medicines. Any pharmacy contemplating removing or receiving waste from these premises should seek guidance from the Environment Agency. 4.5 Some unwanted medicines from households may be handed to nurses or other healthcare professionals whilst carrying out home visits, or be returned to the prescribing general practitioner s surgery. A pharmacy is able to accept these unwanted medicines from households, which are transported by the nurse or other healthcare professional from the patient s home to the pharmacy. 4.6 In England and Wales, medicines held by the pharmacy for dispensing that become obsolete can be disposed of with the unwanted medicines returned by patients using the same waste bins provided by the PCT (in England) or LHB (in Wales). There is no requirement to segregate obsolete pharmacy stock from returned medicines, although they must be properly described on any waste transfer note or consignment note (see Chapters 8 and 13). Action point Does the pharmacy s SOP either: highlight that unwanted medicines cannot be accepted from nursing homes or other healthcare premises; or detail procedures for compliance with hazardouswaste-consignee records and reporting procedures for receipt of such waste? 5

16 Environment and sustainability HTM 07-06: Disposal of pharmaceutical waste in community pharmacies 5 Carriage of waste 5.1 If waste is carried as part of a business or is undertaken for profit, the carrier must be registered with the Environment Agency. 5.2 Carrier registration is required for collections of waste medicines from households. This means that every pharmacy that carries unwanted medicines from a household must register with the Environment Agency as a carrier, even if accepting and carrying waste is an irregular and infrequent event. Registration is required for each pharmacy owner, not per pharmacy premises. 5.3 If a community pharmacy is commissioned to provide a service to care homes (residential homes only) and this includes the removal of waste medicines from the home, this is a contractual (and funded) service; therefore, a carrier s registration will be required. 5.4 The Environment Agency produces guidance at the following link, where an application form for a carrier s licence can also obtained (www. environment-agency.gov.uk/subjects/waste/ / /?lang=_e). Action point Ensure that a carrier s licence is held if the pharmacy carries waste medicines from a patient s home or residential home to the pharmacy. 6

17 6 Treatment of waste 6.1 The treatment of waste normally requires a licence. However, for the limited purpose of denaturing controlled drugs, it is unlikely that the Environment Agency would take enforcement action if the controlled drugs are removed from their containers and denatured provided the method of denaturing did not create a risk to people or the environment. Ideally, a controlled drug denaturing kit should be used but, in all cases, the guidance issued by the RPSGB should be followed when denaturing controlled drugs this applies to both stock and returned medicines (visit controlleddrugs.html). 6.2 With regard to medicines that are not controlled drugs (which are dealt with above), the simple removal of blister packs from cardboard cartons (that is, so that the waste can be disposed of appropriately) is not classed as waste treatment that would require a licence from the Environment Agency. However, this concession does not mean that there is an obligation for pharmacists to remove blister packs from cardboard cartons. Action point Does the pharmacy s SOP incorporate the current guidance from the RPSGB on the denaturing of controlled drugs? 7

18 Environment and sustainability HTM 07-06: Disposal of pharmaceutical waste in community pharmacies 7 Hazardous waste 7.1 The Hazardous Waste Regulations 2005 introduced significant changes for community pharmacies. They required pharmacies to separate hazardous waste medicines from non-hazardous waste medicines, if technically and economically feasible. 7.2 It is not necessary for pharmacies to separate hazardous waste medicines from non-hazardous waste medicines before they are sent to a suitably authorised waste contractor for incineration. However, whenever waste that may contain some hazardous waste medicine is sent for incineration, it is required to be consigned as though it were hazardous and needs to be accompanied by a hazardous waste consignment note. 7.3 If a pharmacy is certain that no hazardous medicines are present, the bin can be disposed of as normal non-hazardous pharmaceutical waste using a duty-of-care transfer note. Hazardous properties 7.4 Under the Hazardous Waste Directives, only cytotoxic or cytostatic medicines are classified as hazardous waste. Note Cytotoxic and cytostatic products are identified as an absolute entry in the European Waste Catalogue 2002, because they exhibit one of the hazardous properties H6 (toxic), H7 (carcinogenic), H10 (toxic for reproduction) or H11 (mutagenic). Medicines may have a range of hazardous properties, but only those with one of the hazardous properties denoted by H codes will be classified as a hazardous waste. Other medicines are not hazardous within the meaning of the legislation. 7.5 Almost all medicines in community pharmacy are relatively inert and pose no particular danger to staff or waste carriers who collect the waste from the pharmacy. This is because most medicines in community pharmacies are in tablet or capsule form, many of which are individually packed in blisters, which provide adequate protection for anyone handling the container. This blister packaging also protects against the mixing of incompatible medicines with each other. Provided they are incinerated properly, they do not pose a risk to the environment. 7.6 It is reasonable for a pharmacist to anticipate that in the course of receiving unwanted medicines returned by patients, the type of medicines returned will be broadly the same as those dispensed. For example, pharmacists who dispense products that are flammable can reasonably expect that some flammable products will be returned. 7.7 As an aid to pharmacists, a suitable starting point for identifying hazardous medicines would be to adopt the National Institute for Occupational Safety and Health s (NIOSH) list of hazardous drugs (as advocated by the Environment Agency), which also includes the relevant hazard codes (see Table 2 for NIOSH s sample list of hazardous drugs). Action point Does the pharmacy s SOP include a list of hazardous medicines that may be encountered in the pharmacy? The NIOSH list in Table 2 may provide a suitable starting position, but the pharmacy should be alert to the possibility of other hazardous medicines being returned. Mixed wastes 7.8 Pharmacists should remain alert to the possibility that mixed wastes returned to pharmacies may contain products that they do not expect to see. Examples that have been returned to a pharmacy include bottles of mercury, bottles of strychnine and other products used as pesticides. Medicines that are not commonly prescribed in the area might also be returned. 8

19 7 Hazardous waste 7.9 When a bag of mixed medicines is returned, the contents could be examined either through the opening of the bag or by emptying the contents onto a suitable tray so that any items that clearly should not be accepted or which should be treated with particular care can be identified Staff safety is paramount. Handling of the waste should be minimal and carried out with great care. Acceptance of waste other than medicines returned from households is not part of the NHS community pharmacy framework in England and Wales. The exemption from the need to hold a WML does not cover items such as mercury or strychnine; therefore, people attempting to hand these in should be directed to seek specialised assistance from a waste contractor. Action point Does the pharmacy s SOP include instructions to staff on dealing with products other than medicines that are handed in to the pharmacy? Incompatible products 7.11 Products that might cause particular hazards if mixed should be kept separate in order to protect pharmacy staff from the consequences of mixing incompatible products. This will be a matter for the professional judgement of the pharmacist, but if, for example, a patient returns a 500 ml bottle of a highly flammable liquid, this should be stored in a metal cabinet (to comply with fire safety legislation) and be handed to the waste carrier separately when the waste is collected Certain products pose a risk if mixed together (for example an oxidising agent and a highly flammable material). The pharmacist should be aware of these risks and provide relevant guidance to staff if such products are likely to be returned to the pharmacy. It may be necessary to carry out an assessment of the waste being returned so that it is not mixed inappropriately in the waste bins. Action point Does the pharmacy s SOP include instructions on identifying incompatible products such as flammable products and oxidising agents? Liquid medicines 7.13 Liquids should generally not be decanted and mixed. Where liquid medicines are being discarded, they should be retained within their individual containers and placed in the waste bins provided for the purpose If the waste contractor has provided a waste bin specially designed for liquids and suggests that the liquid medicines can be emptied from containers and mixed in the waste bin, the pharmacist has a duty of care to ensure that only compatible products are mixed. If incompatible liquids are mixed, resulting in a fire and/or the release of noxious fumes or other health and safety hazards, this could result in the Environment Agency and/or the Health and Safety Executive taking robust action, potentially leading to prosecution The only way in which liquid medicines could safely be mixed would be if the pharmacist knew the constituents of all medicines emptied into the container and was able to say for certain that no incompatibilities existed. For this reason, it is highly recommended that pharmacies do not mix liquids, since the same individual pharmacist may not be involved with every returned medicine Empty medicine containers that have held liquids must be disposed of as waste medicines for incineration, as it is not possible to ensure that the contents have been completely removed (containers cannot be rinsed into the sewerage system). If residues of liquid controlled drugs are present, these should be emptied, so far as possible, and denatured before the container is placed in the waste container. How can incompatible products be identified and segregated? 7.17 Health and safety considerations apply to the assessment of returned waste; staff should not put themselves at risk when handling returned medicines. For this reason, it is necessary for pharmacists and their staff to make enquiries of the person returning the waste as to the products that are being returned (for example Are there any liquids? or Are all the medicines in their original blister packs? ). This may help them reach a reasoned decision about whether the contents of an assortment of returned medicines need to be examined in greater detail. 9

20 Environment and sustainability HTM 07-06: Disposal of pharmaceutical waste in community pharmacies 7.18 Knowledge of the identity of the patient may also be useful; for example, the knowledge that a particular patient has received controlled drugs would stimulate further inquiry to establish whether there are any controlled drugs that must be denatured. If pharmacy staff are not certain whether controlled drugs are present, the contents should be carefully examined It is dangerous for staff to put their hands into bags of returned medicines, as needle-stick injuries may occur. If the contents of a bag of assorted waste must be examined because, for example, there is good reason to believe there is a controlled drug present, the contents of the bag could be either examined through the opening or emptied temporarily onto a tray (which will contain the waste and avoid spillage onto other surfaces). Attempting to identify individual, loose tablets is impracticable and is not required If a pack of controlled drugs is present, this should be carefully removed for denaturing the remainder of the returned medicines and the bag in which they are held should be placed directly into the waste bin. Protective gloves must be worn by staff handling waste in this way Of course, not all unwanted medicines are returned to pharmacies as mixed waste. In these cases, identification and segregation of controlled drugs and incompatible products can be more easily achieved If there are any flammable products easily identifiable in the same way, these should be carefully removed and stored separately, pending collection by the waste carrier. The use of protective clothing, for example gloves, may be necessary Some waste disposal companies may request that aerosols are segregated. If so, similar arrangements to those described above should be used in order to protect the staff undertaking this activity There have been reported cases where incompatible pharmaceuticals derived from a community pharmacy have become mixed during waste disposal, causing spontaneous combustion. The likelihood of an adverse incident occurring in a typical community pharmacy is low, but the consequences of a fire, explosion or release of toxic gases would be catastrophic for staff, the public and the environment. Such an incident would lead to the Environment Agency and the Health and Safety Executive taking rigorous enforcement action. Preventing the mixing of incompatible products is therefore in the best interests of the pharmacy and of waste carriers and waste treatment firms. Action point Does the pharmacy s SOP include the protective measures to be adopted by staff when segregating controlled drugs and incompatible products? 10

21 8 Identifying hazard risks to carriers and waste contractors 8.1 So that waste may be disposed of safely, and to comply with duty of care, all waste being removed from the pharmacy must be accompanied by sufficient information to allow the carrier and waste processors to handle the waste safely and appropriately. The information should be provided to the waste contractor who collects the waste in the form of a waste transfer note. 8.2 If the waste is likely to be of a uniform type throughout the year (for example, if the waste collected is likely to consist of mixed waste medicines), an annual notification can be made, which removes the need to complete a waste transfer note on each occasion waste is transferred from the pharmacy. But if the waste contains or is likely to contain any hazardous waste, a consignment note must be completed for each collection of waste. 8.3 If medicines have been segregated in order to avoid interaction between incompatible substances, these should be handed to the waste carrier with a written record of the nature of the hazard. This will allow safe handling during carriage and will also help to ensure safe disposal. 8.4 In community pharmacies, it is recommended that all sharps, including retractable sharps used for blood testing, be treated as hazardous. The reason for this is that if there has been no assessment carried out of the sharps themselves or of the patient, or there is reason to believe that there are special requirements to prevent infection, sharps must be disposed of as hazardous. In a community pharmacy, there is unlikely to be sufficient knowledge of patients who return sharps or of the risk of infection. 8.5 The first stage of identifying hazardous pharmaceuticals is to consider the hazard codes relevant to hazardous materials. Hazardous materials are those that demonstrate one or more of the following hazardous properties: H1 Explosive : substances and preparations that may explode under the effect of flame or which are more sensitive to shocks or friction than dinitrobenzene. H2 Oxidising : substances and preparations that exhibit highly exothermic reactions when in contact with other substances, particularly flammable substances. H3-A Highly flammable : liquid substances and preparations having a flash-point below 21oC (including extremely flammable liquids); or substances and preparations that may become hot and finally catch fire in contact with air at ambient temperature without any application of energy; or solid substances and preparations that may readily catch fire after brief contact with a source of ignition and which continue to burn or to be consumed after removal of the source of ignition; or gaseous substances and preparations that are flammable in air at normal pressure; or substances and preparations that, in contact with water or damp air, evolve highly flammable gases in dangerous quantities. H3-B Flammable : liquid substances and preparations having a flash-point equal to or greater than 21oC and less than or equal to 55oC. H4 Irritant : non-corrosive substances and preparations that, through immediate, prolonged or repeated contact with the skin or mucous membrane, can cause inflammation. H5 harmful : substances and preparations that, if they are inhaled or ingested or if they penetrate the skin, may involve limited health risks. H6 Toxic : substances and preparations (including very toxic substances and 11

22 Environment and sustainability HTM 07-06: Disposal of pharmaceutical waste in community pharmacies preparations) that, if they are inhaled or ingested or if they penetrate the skin, may involve serious, acute or chronic health risks and even death. H7 Carcinogenic : substances and preparations that, if they are inhaled or ingested or if they penetrate the skin, may induce cancer or increase its incidence. H8 Corrosive : substances and preparations that may destroy living tissue on contact. H9 Infectious : substances containing viable microorganisms, or their toxins, that are known or reliably believed to cause disease in man or other living organisms. H10 Teratogenic : substances and preparations that, if they are inhaled or ingested or if they penetrate the skin, may induce non-hereditary congenital malformations or increase their incidence. H11 Mutagenic : substances and preparations that, if they are inhaled or ingested or if they penetrate the skin, may induce hereditary genetic defects or increase their incidence. H12: substances and preparations that release toxic or very toxic gases in contact with water, air or an acid. H13: substances and preparations capable by any means, after disposal, of yielding another substance. H14 Ecotoxic : substances and preparations that present or may present immediate or delayed risks for one or more sectors of the environment. 8.6 Pharmacists will recognise that some medicines handled in the pharmacy do exhibit one or more of these properties (for example, cytotoxic products may exhibit H6, H7, H10 and H11 properties). Some of the hazardous properties would be applicable only if certain activities were undertaken. For example, H9 Infectious may apply in the case where the pharmacy participates in a needle-andsyringe exchange scheme. Others, such as H1 Explosive, are unlikely to occur in community pharmacies. 8.7 For the purpose of completing a consignment note, the producer of the waste must provide sufficient information to allow the safe handling and the appropriate disposal of the waste. In addition to the hazard codes above, the pharmacy must describe the waste by reference to the European Waste Catalogue (EWC) code. 8.8 The different types of waste that might be produced within a community pharmacy include: sharps limited to those sharps that are not clinical waste; * wastes whose collection and disposal is subject to special requirements in order to prevent infection; * chemicals consisting of or containing dangerous substances; * cytotoxic and cytostatic medicines; medicines other than those mentioned in Waste medicines returned from households and individuals would include: * cytotoxic and cytostatic medicines; medicines other than those mentioned in A mixed container of waste in the pharmacy may therefore contain: cytotoxic medicines returned by patients ( *); obsolete cytotoxic medicines from dispensing stock ( *); non-hazardous medicines returned by patients ( ); and non-hazardous obsolete medicines from dispensing stock ( ) If sharps are accepted from patients, these would have the EWC code * (all sharps in a pharmacy are recommended to be treated as hazardous, because the pharmacy will generally be unable to carry out an assessment of the sharp or patient to enable the non-hazardous code to be used) Taking all these into account, Table 1 is an example of how the entry in section B3 of the consignment note might appear. 12

23 8 Identifying hazard risks to carriers and waste contractors 8.13 A consignment note is required to list the hazardous medicines that are being consigned so that they can be handled safely and disposed of appropriately (no list of individual non-hazardous medicines is required). In Table 1, no attempt has been made to list the actual hazardous medicines; instead a continuation sheet should be provided, which lists the hazardous medicines included in the bin (see example given in Table 2). Table 1 Example section of consignment note Description of the waste Mixed cytotoxic and cytostatic medicines and other medicines and sharps List of wastes (EWC code 6 digits) Quantity (kg) The chemical/biological components of the waste and their concentration are: Component Concentration (% or mg/kg) Physical form (gas, liquid, solid, powder, sludge or mixed) Hazard codes * 0.1 kg See attached continuation Mixed H3B, H4, kg H5, H6, H7, H8, * 0.1 kg H9, H kg H11, H * 0.5 kg Container type, number and size 1 x 14 L bin and 1 x 2 L sharps bin Table 2 Standard continuation sheet Pharmaceutical 1 Classification Hazardous properties Aldesleukin, Alemtuzumab, Alitretinoin, Altretamine, Amsacrine, Anastrozole, Arsenic trioxide, Asparaginase, Azacitidine, Azathioprine, Bacillus Calmette- Guerin, Bexarotene, Bicalutamide, Bleomycin, Busulfan, Capecitabine, Carboplatin, Carmustine, Cetrorelix acetate, Chlorambucil, Chloramphenicol, Choriogonadotropin alfa, Cidofovir, Cisplatin, Cladribine, Colchicine, Cyclophosphamide, Cytarabine, Cyclosporin, Dacarbazine, Dactinomycin, Daunorubicin HCl, Denileukin, Dienestrol, Diethylstilbestrol, Dinoprostone, Docetaxel, Doxorubicin, Dutasteride, Epirubicin, Ergonovine/methylergonovine, Estradiol, Estramustine phosphate sodium, Estrogenprogestin combinations, Estrogens, conjugated, Estrogens, esterified, Estrone, Estropipate, Etoposide, Exemestane, Finasteride, Floxuridine, Fludarabine, Fluorouracil, Fluoxymesterone, Flutamide, Fulvestrant, Ganciclovir, Ganirelix acetate, Gemcitabine, Gemtuzumab ozogamicin, Gonadotropin chorionic, Goserelin, Hydroxyurea, Ibritumomab tiuxetan, Idarubicin, Ifosfamide, Imatinib mesilate, Interferon alfa-2a, Interferon alfa-2b, Interferon alfa-n1, Interferon alfa-n3, Irinotecan HCl, Leflunomide, Letrozole, Leuprolide acetate, Lomustine, Mechlorethamine, Megestrol, Melphalan, Menotropins, Mercaptopurine, Methotrexate, Methyltestosterone, Mifepristone, Mitomycin, Mitotane, Mitoxantrone HCl, Mycophenolate mofetil, Nafarelin, Nilutamide, Oxaliplatin, Oxytocin, Paclitaxel, Pegaspargase, Pentamidine isethionate, Pentostatin, Perphosphamide, Pipobroman, Piritrexim isethionate, Plicamycin, Podoflilox, Podophyllum resin, Prednimustine, Procarbazine, Progesterone, Progestins, Raloxifene, Raltitrexed, Ribavirin, Streptozocin, Tacrolimus, Tamoxifen, Temozolomide, Teniposide, Testolactone, Testosterone, Thalidomide, Thioguanine, Thiotepa, Topotecan, Toremifene citrate, Tositumomab, Tretinoin, Trifluridine, Trimetrexate glucuronate, Triptorelin, Uracil mustard, Valganciclovir, Valrubicin, Vidarabine, Vinblastine sulfate, Vincristine sulfate, Vindesine, Vinorelbine tartrate, Zidovudine * H3B, H4, H5, H6, H7, H8, H9,H10 H11, H14 See Note * See Note Note 1 For obsolete dispensing stock, the pharmacy will know which hazardous medicines are being consigned and therefore will be able to particularise them including the weight, the medicine name, and the hazard code. For hazardous waste medicines consigned from the pharmacy, dispensing stock should be readily identifiable, and therefore the entry under EWC code * should be specific. 13

24 Environment and sustainability HTM 07-06: Disposal of pharmaceutical waste in community pharmacies 8.14 If the pharmacy has identified all the hazardous medicines that are included in a waste bin, a list specifying the actual hazardous medicines and hazard codes should be included on the continuation sheet Pharmacies may not be able to identify all the hazardous medicines that are present (this is particularly the case if, for health and safety reasons, no attempt has been made to identify and segregate hazardous medicines from non-hazardous medicines). In these cases, the Environment Agency accepts that the pharmacy may prepare a standard continuation sheet, which lists the products that may conceivably be present (see Table 2) If the pharmacy is certain that no hazardous medicines are present, the bin can be disposed of as normal non-hazardous pharmaceutical waste using a duty-of-care transfer note In the standard continuation sheet example given in Table 2, the pharmaceutical name is taken from an American list prepared by NIOSH as being pharmaceuticals that may be hazardous in use. It has no statutory basis in England and Wales, but is recommended by the Environment Agency as a useful starting position. If pharmacists know for certain that other hazardous medicines are included in the bin or that particular medicines specified in the specimen standard continuation list are not present, the list should be amended so that it reflects as near as possible the composition of the hazardous waste in the waste bin. Sources of data on hazardous properties 8.18 Community pharmacists may find that safety data sheets for medicines available from manufacturers (or, if not available, their component chemicals) are useful for the completion of continuation sheets. Action point Check the entries in the standard continuation sheet are these conceivably going to be present in the pharmacy waste? If not, delete the unlikely entries. Are there any missing products? If so, add them so that the standard list can be printed out to accompany any consignment notes issued. Does the pharmacy s SOP include the maintenance of a list of hazardous medicines added to the bin? 14

25 9 Monitored dosage systems (MDS) 9.1 Some monitored dosage systems (MDS) are reusable and some are intended for single use. Where the MDS is disposable, the tray should be disposed of intact that is, the individual compartments should not be opened to extract the contents (other than where these contain controlled drugs that must be denatured before being placed with other waste medicines). Where the MDS is reusable, the individual compartments can be opened for removal and disposal of the unwanted medicines. 9.2 The pharmacist must ensure that the MDS is suitable for reuse, and precautions must be taken to avoid contamination of medicines supplied in reusable MDS. Action point Does the pharmacy s SOP include reference to MDS trays and disposal of blisters? 15

26 Environment and sustainability HTM 07-06: Disposal of pharmaceutical waste in community pharmacies 10 Hazardous waste producer notification 10.1 All premises that produce hazardous waste must notify the Environment Agency, unless they fall within one of the exemptions Notification can be made on-line, by telephone or by post (there is a charge for this) Shop premises that produce less than 200 kg of hazardous waste per year are exempt from the need to notify However, unless hazardous waste medicines are segregated from non-hazardous medicines (so that the non-hazardous can be disposed of as nonhazardous), all the waste needs to be included in the total. There would be advantage in notifying the Environment Agency so that if the total exceeds the 200 kg limit, there would be no offence committed Notifying the Environment Agency that the pharmacy is a hazardous waste producer is only one stage of the process. Movements of hazardous waste from any premises must be accompanied by a consignment note, including premises that are exempt from registration. Pharmacies must also register the conditional exemption from waste management licensing for the storage of any returned medicines (see Chapter 2). Action point Has the pharmacy notified the Environment Agency that it is a hazardous waste producer? 16

27 11 Sharps 11.1 Sharps may be generated from a number of sources Sharps may be returned to a local pharmacy: as part of a formal needle-and-syringe exchange scheme; or from patients with diabetes; or from other users of sharps Pharmacists are able to accept sharps, but should do so only if there are suitable arrangements for their safe disposal. This will include provision of containers suitable for their safe storage. In England and Wales, the NHS funding arrangements for essential services do not include the disposal of sharps. Therefore, this should be arranged locally An increasing number of community pharmacies are participating in cholesterol or blood-glucose monitoring, which may generate sharps. The sharps generated within the pharmacy may be stored and disposed of, provided that they are stored safely and disposed of through a suitably authorised waste contractor Retractable finger-prick devices should also be treated as hazardous, because it is unlikely in a pharmacy that it will be possible to assess the patient in order to find out whether he/she has any infections that would require special handling of the device (see also paragraph 8.4) Syringes are classified as follows: a syringe body contaminated with waste medicines is a pharmaceutical waste and should be assigned the codes * and , as appropriate, for the contaminating medicine. The needle is a sharp and is coded separately as indicated below; a needle, or other sharp, contaminated with body fluids will be assigned the code * where it is clinical waste due to a risk of infection; a needle, or other sharp, that has been identified as not presenting a risk of infection will be assigned the code and is neither clinical nor hazardous waste If the needles themselves have been assessed as nonhazardous (in that they have not been used for administration of hazardous medicines and there are no special requirements needed in their handling to prevent infection) and if they have been used, there is no reason to believe, from assessment of the patient, that there is a risk of infection. The sharps can be disposed of as nonhazardous waste under the EWC code This is likely to arise, for example, if a sealed, unused pack of lancets is being sent for destruction. However, if there has been no assessment carried out of the needles themselves or of the patient, or if there is reason to believe that there is a risk of infection, the sharps must be disposed of as hazardous waste using EWC code * In community pharmacy, there is unlikely to be sufficient knowledge of patients who return sharps or of the risk of infection therefore, it is recommended that all sharps are disposed of as hazardous using EWC code * for the needles. The appropriate medicine codes should also be provided for medicinally contaminated syringe bodies. Note The Environment Agency no longer has an enforcement position on fully discharged syringes. The segregation of syringes and sharps There is no requirement under waste legislation to remove the needle from a syringe. Segregation of sharps on the basis of infectious/noninfectious is not required. It is good practice rather than a legal requirement to segregate syringes contaminated with cytotoxic/ 17