Nursing Home Guidance on Medicine Disposal and Record Keeping

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November 2011

Contents Page

1.0 Introduction 3 2.0 The Legislation and Good Practice Guidelines 4 3.0 Disposal of Medicines in Nursing Homes 5 3.1 Storage of unwanted medicines 5 3.2 Record Keeping 5 3.3 Staff Training and Policies and Procedures 6 4.0 Disposal of Controlled Drugs 7 4.1 Methods of Destruction 8 4.2 Record Keeping 9 4.3 Standard Operating Procedures 9 4.4 Staff Training 9 5.0 Further information 9 References 10 Useful Websites 11

1.0 Introduction

For many years, it has been the practice for nursing homes in Northern Ireland to return unwanted medicines to community pharmacies for disposal. In August 2011, the Health and Social Care Board wrote to all nursing home registered managers to advise them of changes to the arrangements for the disposal of unwanted medicines in nursing homes, and of the action that homes must take to ensure these changes are implemented by 1 December 2011. Under The Controlled Waste Regulations (Northern Ireland) 2002, as amended, the movement of waste medicines from nursing homes is not included under the definition of household waste. Such medicines must therefore be taken to facilities that are licensed or permitted to receive them. Unless community pharmacies have a waste management licence, they cannot accept unwanted medicines back from nursing homes. Nursing homes are therefore required to review their current processes to ensure all pharmaceutical waste is dealt with legally. The safe disposal of controlled drugs will be of particular importance. Registered managers/persons are also reminded of the need for appropriate stock control procedures to ensure pharmaceutical waste is minimised. This guidance document has been produced by the Regulation and Quality Improvement Authority (RQIA). It aims to help nursing homes: review their current disposal systems; to implement polices and procedures which comply with legislative requirements and DHSSPS guidance: and meet the minimum standards laid down in the Nursing Homes Minimum Standards, DHSSPS (2008).

2.0 The Legislation and Good Practice Guidelines

Nursing homes in Northern Ireland are required to be registered with RQIA under The Regulation and Improvement Authority (Registration) Regulations (Northern Ireland) 2005. RQIA has responsibility for, and powers to, regulate nursing homes. In February 2008, the DHSSPS published The Nursing Homes Minimum Standards. The standard statements and associated criteria cover key areas of service provision. These are the minimum provisions below which no provider is expected to operate. The disposal of medicines is covered under Management of Medicines, Standard 37: Medicines are handled safely and securely, and the associated Criterion 37.6 which states: “Pharmaceutical waste is disposed of in accordance with legislative requirements and DHSSPS guidance.” The Waste Management Licensing Regulations (Northern Ireland) 2003 and The Controlled Waste Regulations (Northern Ireland) 2002 specify the legal requirements for the disposal of medicines, and the special licences required for the movement of such waste. It has been determined that the current practice of returning unwanted medicines in nursing homes to the community pharmacies must be reviewed as it does not, in the majority of cases, conform with this legislation. The disposal of controlled drugs in nursing homes is of particular importance. A number of publications provide guidance on the safe disposal of controlled drugs. These include: Safer Management of Controlled Drugs – A Guide to Good Practice in Primary Care (Northern Ireland); General Legal Requirements – A Guide for Pharmacists in Northern Ireland (2010); and The Royal Pharmaceutical Society, Medicines, Ethics and Practice professional guide for pharmacists (July 2011). During the disposal process personnel and the environment should be protected . All processes should comply with the Northern Ireland Environment Agency guidance and regulations.

3.0 Disposal of Medicines in Nursing Homes

Pharmaceutical waste in nursing homes must be disposed of in accordance with legislative requirements and DHSSPS guidelines (Minimum Standard 37, Criterion 37.6, DHSSPS Nursing Homes Minimum Standards 2008). Any movement of waste medicines from nursing homes must be taken to licensed or permitted facilities. This includes any medicines prescribed for those in receipt of residential care.

3.1 Storage of unwanted medicines

3.1.1 Waste medicines must be kept in secure waste containers, provided by a company licensed to collect pharmaceutical waste from nursing homes. 3.1.2 Waste containers must be stored securely, and there must be evidence that storage arrangements have been risk-assessed and deemed appropriate. 3.1.3 Staff should ensure that any patient identifiable information, e.g. medicine labels, is destroyed or totally obscured. 3.1.4 Tablets and capsules should not be removed from blister strips prior to being placed in the waste container. 3.1.5 Some monitored dosage systems (MDS) are reusable, and others are intended for single use. Where the MDS is disposable, the tray should be disposed of intact and 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. 3.1.6 For liquid medicines, the whole bottle should be placed in the waste container as the mixing of different medicines could be hazardous. Exceptions apply to controlled drug liquids which require denaturing. 3.1.7 Sharps should continue to be disposed of separately in the home’s sharps container. 3.1.8 Waste containers should be collected for disposal on a regular basis. Registered managers/persons are reminded that where a patient has died, supplies of all medicines for the patient, including controlled drugs, must be kept for at least seven days before being placed in the waste container, as they may be required as evidence for a coroner’s inquest.

3.2 Record Keeping

3.2.1 A record of each medicine placed in the waste container for disposal must be kept. The record should include the following information: name of patient name, form and strength of medicine quantity of medicine disposed reason for disposal date placed in waste container signature of staff member(s) disposing of medicine 3.2.2 It is strongly recommended that two designated members of home staff should witness medicines being placed in the medicines disposal bin and should sign the disposal record. 3.2.3 The registered manager/person should request and retain a receipt for waste containers that have been collected for disposal.

3.3 Staff Training and Policies and Procedures

3.3.1 All members of staff who dispose of medicines in the home must be trained and deemed competent to do so. Records of training and competency assessments must be maintained.

3.3.2 The nursing home’s written policies and procedures for the management of medicines should clearly detail the arrangements for the disposal of medicines in the home.

3.3.3 Appropriate health and safety measures must be implemented when disposing of medicines. Particular care should be taken with regard to the disposal of cytotoxic drugs.

4.0 Disposal of Controlled Drugs

All controlled drugs in Schedule 2, 3 and 4 (part 1), which includes temazepam, diazepam, nitrazepam and lorazepam, should be denatured and therefore rendered irretrievable before being placed into waste containers. It is recommended that commercially available denaturing kits should, wherever possible, be used to denature controlled drugs. Controlled drugs must not be disposed of into the sewerage system. Supplies of controlled drugs should be disposed of in a timely fashion to prevent the storage of excessive stocks of unwanted medicines.

4.1 Methods of Destruction

Table 1 (overleaf) shows the recommended method of destruction for different dosage forms of controlled drugs. 4.1.1 If grinding or crushing of tablets or capsules takes place, steps must be taken to ensure that particles of drug dust are not released into the air, or that it is minimised. The use of a small amount of water while crushing or grinding may assist. 4.1.2 Personnel involved in the destruction of controlled drugs should work in a well- ventilated area, and wear suitable gloves and face masks . 4.1.3 Two designated members of staff should be involved in the denaturing and disposal of any controlled drugs.

Table 1. Destruction of Controlled Drugs (CDs)

Taken from: The Destruction of Controlled Drugs, Medicines, Ethics and Practice, The Professional Guide for Pharmacists, Edition 35, July 2011. Tablets and capsules Remove from outer packaging and place into a CD denaturing kit. It is recommended that commercially available CD denaturing kits are used to ensure that whole tablets or capsules may not be recovered. Alternatively, Ampoules These should be opened and the liquid poured into a CD the solid dose formulation should be crushed and placed denaturing kit, or added to cat litter as above. The empty Fentanyl or The active ingredient in the patch can be rendered 8 in a small amount of hot, soapy water, ensuring that the ampoule should be put in the sharps bin as normal. For Buprenorphine irretrievable by removing the backing and folding the patch Aerosols The contents of the aerosol should be expelled into water drug has been dispersed or dissolved. The resultant Liquid formulations Should be added to, and absorbed by, an appropriate patches over on itself. The patch can then be placed in the (to prevent droplets of drug from entering the air). The ampoules that contain powder, water should be added to Dosage Form Method of Destruction mixture should be placed in an appropriate medicines amount of cat litter or similar product. This should then be medicines waste disposal bin or preferably a CD resultant liquid should then be disposed of as a liquid the powder and the resulting mixture poured into a CD waste disposal bin. placed in a medicines waste disposal bin. denaturing kit or onto cat litter as above. denaturing kit. preparation.

4.2 Record Keeping

4.2.1 A record of the disposal of a Schedule 2 controlled drug must be made in the home’s controlled drug record book. This must be signed by the two members of staff responsible for the disposal 4.2.2 A separate record of the destruction and disposal of any controlled drug should be kept. This record should include the following information: the name of the patient the name, form and strength of the medicine the quantity of medicine destroyed the reason for destroying the medicine the date of destruction the method of destruction the signatures of the two members of staff destroying the medicine.

4.3 Standard Operating Procedures

The nursing home must have a standard operating procedure (SOP) detailing the arrangements for the destruction and disposal of controlled drugs and record keeping.

4.4 Staff Training

All members of staff who destroy and dispose of controlled drugs in a nursing home must be suitably trained and deemed competent to do so. Records of training and competency assessments must be maintained.

5.0 Further Information

For further information or advice, please contact any pharmacist inspector at RQIA, by telephone at: (028) 9051 7500 (Belfast office) or (028) 8224 5828 (Omagh office), or email: info@rqia.org.uk.

References

The Health and Personal Social Services (Quality, Improvement and Regulation) (Northern Ireland) Order 2003 The Regulation and Improvement Authority (Registration) Regulations (Northern Ireland) 2005 The Nursing Homes Regulations (Northern Ireland) 2005 Nursing Home Minimum Standards (2008), DHSSPS The Waste Management Licensing Regulations (Northern Ireland) 2003 The Controlled Waste Regulations (Northern Ireland) 2002 Safer Management of Controlled Drugs – A guide to good practice in primary care (Northern Ireland) July 2011, DHSSPS General Legal Requirements – A Guide for Pharmacists in Northern Ireland (2010), The Pharmaceutical Society of Northern Ireland Medicines, Ethics and Practice. The Professional Guide for , Edition 35, PharmacistsJuly 2011, Royal Pharmaceutical Society PSNC Contract Notebook 2009 -10. 1 June 2009, Pharmaceutical Services Negotiating Committee

Useful Websites

The Regulation and Quality Improvement Authority: www.rqia.org.uk The Department of Health, Social Services and Public Safety www.dhsspsni.gov.uk The Pharmaceutical Society of Northern Ireland www.psni.org.uk The Northern Ireland Environment Agency www.ni-environment.gov.uk