NHS England BGSW Area Team Controlled Drug Management: Standard Operating Procedures

Transcription

1 NHS England BGSW Area Team Controlled Drug Management: Standard Operating Procedures Authorisation of witnesses to destroy controlled drugs and support and guidance for witnesses Prepared by: Julie McCann, Assistant Director for Pharmacy, Bath, Gloucestershire, Swindon and Wiltshire Area Team, NHS England.

2 Purpose: To ensure legal, secure, safe and appropriate destruction of controlled drugs across the geography of NHS England Bath, Gloucestershire, Swindon and Wiltshire (BGSW) Area Team. Scope: This procedure aims to ensure the safe and timely destruction of controlled drugs across NHS England BGSW commissioned services and those services that legitimately hold CDs but do not require an accountable officer. It covers the process of authorising witnesses and the support and guidance for those witnesses. Background: Authorisation of witnesses to destroy Controlled Drugs The Misuse of Drugs Regulations 2001, as amended, requires that CDs that are held as stock by healthcare professionals and/or organisations must only be destroyed in the presence of an Authorised Witness. The Act designates certain classes of person as Authorised Witnesses. This includes any Police Constable and Inspectors of the General Pharmaceutical Council. Additionally a Controlled Drugs Accountable Officer (CDAO) of NHS England may authorise further persons or class of persons as Authorised Witnesses Within the NHS in England CDs may be legitimately be stocked at a number of organisations including community pharmacies, doctors surgeries, dental surgeries and out of hours services. Should CD stock expire or otherwise become obsolete an Authorised Witness must be present to witness its destruction. 1. NHS England must ensure that there are adequate Authorised Witnesses within the system to allow the timely destruction of CDs when the need arises. 2. Patient held CDs returned to community pharmacies or dispensing doctors practices do not require an Authorised Witness to be present for them to be destroyed. The management of CDs in the health system, including their destruction, is a shared responsibility between NHS England, service providers, regulators and the Police as the prompt and lawful destruction of obsolete CD stock is a matter of patient safety and public protection. It is the aspiration of NHS England that when a healthcare premises where obsolete CD stock requires destruction is visited by an organisation with a duty to ensure patient safety and/or public protection that the destruction should take place. While witnessing the destruction of CDs does not form the core business of any organisation it should be incidental to the core business of any organisation that has a responsibility to ensure patient safety and/or public protection. Suitably trained employees of such organisations should be empowered, as Authorised Witnesses, to assist service providers in managing their obsolete CD stock. In line with the NHS England The Controlled Drugs (Supervision of Management and Use) Regulation 2013 Single Operating Model, NHS England BGSW Area Team will empower Clinical Commissioning Groups (CCG) to assist their members and contractors to manage their obsolete CD stock by designating suitably trained members of CCG employees and/or their agents as Authorised Witnesses. 2

3 The BGSW Area Team Controlled Drug Accountable Officer (CDAO) will designate further suitably trained individuals and/or classes of person as Authorised Witnesses, including its own employees to facilitate the timely destruction of obsolete CDs. Authorised Witnesses Any Police Constable and Inspectors of the General Pharmaceutical Council are, by virtue of their office, Authorised Witnesses. Additionally any NHS England CDAO may designate an individual and/or class of persons as an Authorised Witness. Where an individual and/or class of persons have been designated an Authorised Witness by any NHS England CDAO that authorisation shall be recognised as valid by all NHS England CDAOs. All authorisations granted by an NHS England CDAO must be in writing, name the individual and/or class of persons authorised, have an expiry date (two years from the date of issue) and be signed by the Area Team CDAO (see template letter Appendix 2) NHS England expects any Authorised Witness to facilitate the destruction of obsolete CDs at any premises they visit where they consider there is a risk to patient safety if the CDs are not destroyed. Authorised Witnesses will not be routinely involved in the management and use of CDs in the premises in which they are acting as an Authorised Witness. It is a requirement that an Authorised Witness report any concerns that they may have about the management and safe use of CDs by an individual or at any premises of which they become aware while witnessing the destruction of CDs to the NHS England Area team CDAO. This is a non-delegable duty. The destruction of date expired and obsolete controlled drugs NHS Medical Practices All NHS Medical Practices are required to be members of a CCG. NHS England expects CCGs to assist its member practices in the management of obsolete CDs by providing an Authorised Witness. The CDAO will designate suitably qualified employees and/or agents of the CCG as Authorised Witnesses to facilitate this. Services commissioned by CCGs NHS England expects that where a service is directly commissioned by a CCG such as an out of hours service or a palliative medicine service that CCGs will provide an Authorised Witness to facilitate the destruction of obsolete CDs associated with the commissioned service. NHS England will designate suitably qualified employees and/or agents of the CCG as Authorised Witnesses to facilitate this. NHS Dental Practices Where an NHS Dental Practice requests an Authorised Witness to witness the destruction of obsolete CDs, NHS England will ensure that one is made available. The Authorised Witness may be an employee or agent of NHS England or any other Authorised Witness which may include independent contractors. Independent healthcare providers Where independent healthcare providers such as private GPs or dentists request an Authorised Witness to witness the destruction of obsolete CDs NHS England will ensure that one is made available. The Authorised Witness may be an employee or agent of NHS England or any other Authorised Witness which may include independent contractors. 3

4 The provision of Authorised Witnesses to the independent healthcare sector should be cost neutral to the NHS and NHS England may therefore charge for the provision of an Authorised Witness. Independent contractors acting as Authorised Witnesses will enter into their own contractual arrangements, including the cost, with the independent provider. Where any part of the business of an independent provider consists of services provided on behalf of or commissioned by NHS England no charge will be made for the provision of an Authorised Witness. Community Pharmacies multiples NHS England anticipates that body corporate operating in excess of 5 or more pharmacy premises will seek to have suitably trained employees designated as Authorised Witnesses by the appropriate NHS England CDAO. A body corporate operating 5 or more pharmacies may apply to the appropriate NHS England CDAO to designate suitably trained individual employees and/or class of employees as Authorised Witnesses. The appropriate NHS England CDAO is the one for the Local Area Team where the body corporate s registered office is located. The appropriate NHS England CDAO may designate suitably trained individual employees and/or class of employees in a body corporate as Authorised Witnesses. The Superintendent Pharmacist of the body corporate is accountable to the appropriate NHS England CDAO for the governance arrangements around the witnessed destruction of CDs in their premises. Where an NHS England CDAO designates Authorised Witnesses for a body corporate then the responsibility for the provision of Authorised Witnesses to witness the destruction of obsolete CDs within their premises rest with the body corporate. A body corporate may contract with an independent Authorised Witness to facilitate the witnessed destruction of obsolete CDs. Community Pharmacies - independents Bodies corporate, partnerships and/or individuals operating fewer than 5 community pharmacies may not have suitably trained individuals designated as Authorised Witnesses. To facilitate the timely destruction of obsolete CDs NHS England will designate sufficient, suitably trained, individuals and/or class of person as Authorised Witnesses. This may include NHS England employees and/or agents, representatives of the appropriate Local Pharmaceutical Committee and/or persons nominated as appropriate to undertake the role by a recognised trade association such as the National Pharmacy Association or Independent Pharmacy Federation. An independent community pharmacy may contract with an independent Authorised Witness to facilitate the witnessed destruction of obsolete CDs. 4

5 Where an independent community pharmacy requests an Authorised Witness to witness the destruction of obsolete CDs from NHS England, NHS England will ensure that one is made available. Summary The Regulations place a duty of the NHS England CDAOs to authorise sufficient Authorised Witnesses to secure the timely disposal of obsolete CDs held as stock in the healthcare system. This is a shared responsibility and the approach proposed by NHS England endeavours to recognise this. The ambition is that by devolving the responsibility appropriately service providers and commissioners will be empowered to manage the timely disposal of obsolete CDs and therefore assure patient safety and public protection. The appropriate NHS England Area Team CDAO will remain accountable for assuring the NHS England Board that there are sufficient Authorised Witnesses in their area and that there is a reliable system in place to manage the timely disposal of obsolete CDs and therefore assure patient safety and public protection. 5

6 Appendix 1: CD Destruction Standard Operating Procedure The use of this Standard Operating Procedure (SOP) will ensure that all Area Team authorised witnesses follow a consistent and agreed approach when witnessing controlled drug destruction. Alternatively, with prior agreement, for Authorised Witnesses not directly employed by NHS England, a SOP following similar principles by their employing organisation may be used. Procedures to be followed: Purpose: To ensure the safe and appropriate destruction of CDs in compliance with current legislative requirements and good practice guidance. Scope: This SOP applies to witnesses authorised by BGSW Area Team CDAO and relates to the destruction of out of date CD stock. It will explain how CDs should be destroyed in the presence of authorised witnesses and how any discrepancies/problems found during the destruction process should be addressed. Note - Some premises may also, from time to time, have patient returned CDs. It is not a legal requirement for patient returns to be destroyed in the presence of an Authorised Witness. If, however, whilst attending to witness the destruction of stock CDs, the Authorised Witness may (at their discretion) also witness the destruction of patient returns. Any patient returned CDs destroyed should also be recorded on the destruction log but clearly identified as PATIENT RETURNS. Advice should be given on future destruction of patient returns, including their safe destruction and record keeping. Arranging Visits for the Destruction of CDs When an appropriate body has stock CDs requiring destruction, contact should be made directly with their company Authorised Witness (if appropriate) or with the BGSW CDAO (or their representative) who will in turn, make arrangements with a suitable authorised witness. The authorised witness/ their representative will contact the person/body making the request to arrange a mutually suitable date & time for destruction to take place. Authorised witnesses will not witness destruction in any setting where they have day to day involvement in the management of controlled drugs such as a pharmacy or GP practice where they may regularly work The CDs to be destroyed should have been appropriately marked and segregated as necessary, prior to the visit. Any date-expired CD stock should be stored securely in the CD cabinet/safe clearly labelled as out of date stock and segregated from current CD stock to avoid potential dispensing errors or re-use. The out of date stock must not be entered out of the running balance until it has been destroyed by an authorised witness. For purposes of balance checks, the register may be clearly annotated that some of the stock held is out of date e.g. Balance 5 (3 out of date) or similar wording. Additionally all appropriate equipment (denaturing kit/s) plus protective equipment (gloves, aprons, protective eye wear, face masks) must have been obtained by the stock holder and be available when the visit takes place. 6

7 A UN type medicines waste container (DOOP bin) must also be available. Pharmacies and dispensing practices will already have these but other sites may need to arrange for delivery and collection from their waste contractor. The authorised witness or their representative should check that all appropriate equipment will be available when the appointment is arranged. Whilst an authorised witness is only needed for Schedule 2 CD, the Home Office has advised that all controlled drugs in Schedules 2, 3 and 4 (part 1) should be denatured (rendered irretrievable) before disposal. In addition, for Schedule 2 CDs, appropriate records need be made in the CD register. The T28 Exemption The destruction of CDs requires an appropriate Home Office licence. Pharmacies (and other healthcare providers) are usually exempt from needing a licence- but this exemption needs to be applied for (the T28 exemption). In England and Wales, this exemption is issued by the Environment Agency The responsibility for applying for the T28 exemption falls to the healthcare provider holding the controlled drugs. Record Keeping A CD Destruction Record Sheet should be completed on each occasion that CD destruction is witnessed. Note - This record sheet is not a legal requirement, but it is an audit/feedback tool providing information to the CDAO and the Controlled Drugs Local Intelligence Network. Completed record sheets should be submitted to the CDAO for logging. Procedure for Destruction of CDs On arrival at the premises the authorised witness will identify themselves, (ID badge or equivalent) and provide a copy of their letter of authorisation if requested. 1. All parts of the process must take place in the presence of the Authorised Witness. Theoretically, the Authorised Witness is only WITNESSING the destruction. In practice however, they may also participate in the destruction, particularly where there are a large quantity of CDs to be destroyed. The decision to participate in the destruction is an individual one and must be made clear prior to the visit. 2. The CDs quarantined for destruction should be removed from the CD cupboard and reconciled with the CD Register (CDR) and/or Patient Returns Record Book (PRRB) if appropriate. 3. A methodical approach should be taken when destroying the CDs. Recommended practice is to write up all the records first in the CD register and the CD destruction record sheet, then undertake the destruction. 4. The CDs should be written out of the CDR and/or PRRB. The entry must specify; the name, strength and form of the product, date, quantity destroyed, printed name & employer of authorised witness, followed by their signature, printed name and signature of the second witness and the balance remaining, where a balance is kept. Where the Authorised Witness is a registered health professional, the record should also specify their registration number. 5. A note of the drugs destroyed should also be made on the Controlled Drug Destruction Record sheet. 7

8 6. There is no requirement for the Authorised Witness to undertake a physical balance check*, but where one is made, this should be indicated in the CDR. Where this has been undertaken and a discrepancy has been identified, further checks will need to be made. Time may not allow for an investigation into the discrepancy at this point, nor is the Authorised Witness expected to undertake one. The destruction can still be witnessed at this point and responsible person at the site should be asked to report the discrepancy to the CDAO and provide a report outlining the investigation undertaken into the discrepancy. (see section 9 for further details). *It should be noted that authorised witnesses operating on behalf of multiple pharmacies may automatically require a balance check to be undertaken. This SOP is not intended to override these additional checks, but does not require balance checks as part of the routine process. 7. CDs must be destroyed using a denaturing kit designed for that purpose, with the exception of large quantities of liquid CDs (see information on liquid dose formulations below for further details). 8. CDs should be added to the denaturing kit according to the process described below. Note - CD/Drug Denaturing Kits include instructions for use, these must be followed to ensure effectiveness. This usually consists of agitating the contents of the kit and complying with the fill lines. Methods of denaturing Controlled Drugs The following generic advice has been agreed with the Home Office and reflects the advice given by the Royal Pharmaceutical Society (RPS). All Controlled Drugs in Schedule 2, 3 and 4 (part 1)* should be destroyed by being denatured and rendered irretrievable before being placed into pharmaceutical waste containers and sent for incineration. The destruction by denaturing and rendering irretrievable is to guard against the misuse of drugs, harm to the environment or people and prevent the supply of easily retrievable Controlled Drugs. The agreed methods do not render the detection of active ingredients with specialist equipment impossible, or modify the chemical composition or properties of CDs. *The Authorised Witness is only responsible for witnessing the destruction of Schedule 2 CDs For all forms of denaturing, and particularly if grinding or crushing tablets or breaking containers is involved individuals should work in a well-ventilated area and wear suitable protective gloves, a facemask and goggles as appropriate and at all times follow good Health and Safety practice. Order of adding products to the denaturing kit; 1 st solid oral dose forms (e.g. tablets/capsules), powder containing injections, vials/ampoules and transdermal patches. 2 nd small volume liquids (e.g. injection ampoules/vials), 3 rd large volume liquids (e.g. oral liquids, larger volume injection vials). Processing products before adding to kit; Solid Dose Formulations 8

9 Tablets and capsules should be removed from both the outer packaging and any blister pack. Home Office approved practice; Grind or crush the solid dose formulation before adding to the CD denaturing kit to ensure that whole tablets or capsules are not retrievable. The use of a small amount of water whilst grinding or crushing may assist in minimising particles of dust being released into the air. An alternative method of denaturing is to crush or grind the solid dose formulation and place it into a small amount of warm, soapy water stirring sufficiently to ensure the drug has been dissolved or dispersed. The resulting mixture may then be poured onto an appropriate amount of cat litter (or similar product) and added to an appropriate waste disposal bin supplied by the waste contractor Two-piece hard gelatine capsules can be opened and the contents emptied out. Concerta tablets should be placed directly in the destruction kit as it is not usually possible to crush or dissolve them. Actiq lozenges are best destroyed by dissolving in a small amount of hot water. The resulting liquid should then be disposed of as for liquid dose formulations. The lolly-pop sticks should then be placed in the pharmaceutical waste container. Parenteral Formulations (ampoules and vials) For liquid containing ampoules, open the ampoule and empty the contents into a CD denaturing kit. For powder containing ampoules, open the ampoule and add water to dissolve the powder inside. The resulting mixture can be poured into the CD denaturing kit and the ampoule disposed of as sharps pharmaceutical waste. Where sharps bins are available, empty ampoules can be placed in these. The sharps bins should be labelled contains mixed pharmaceutical waste and sharps- for incineration. Where no sharps bins are available, the empty ampoules should be placed in the CD destruction kits. For ampoules with a rubber bung, it may be necessary to use a disposable hypodermic syringe, to draw out the contents. Alternatively these may be crushed (see below). An alternative (but less preferable), disposal method; crush the ampoules with a pestle inside an empty plastic container. Once broken, a small quantity of warm soapy water (for powder ampoules) or cat litter (for liquid ampoules) is added. If these methods are used, extra care should be taken to prevent injury. The resulting liquid mixture should then be disposed of in a CD denaturing kit or in the bin that is used for disposal of liquid medicines Transdermal Patches The active ingredient can be rendered irretrievable by removing the backing and folding the patch over on itself and then placing it preferably in a CD denaturing kit or, alternatively, directly into a pharmaceutical waste bin. Aerosol formulations These should be expelled into water (to prevent droplets of drug entering the air). A face mask should be worn AND the area should be well ventilated. The resulting liquid can then be disposed of as for liquid 9

10 dose formulations. If this is not possible because of the nature of the formulation, expel into an absorbent material and dispose of this as pharmaceutical waste. Liquid dose formulations Liquid CDs can be poured directly into the CD denaturing kit (best practice). If there is a large quantity of liquid, it may be added to a suitable quantity of cat litter (enough litter to ensure that all the liquid is absorbed). The cat litter should then be disposed of in the pharmaceutical waste bin. GLOVES AND A FACE MASK SHOULD BE WORN if using cat litter. Once ALL products being destroyed have been added to the kit, water should be added, as necessary, in accordance with the kit manufacturer s directions. In most cases there are 2 fill lines on the denaturing kit - one for the CDs to be destroyed and one to where it must be filled with liquid. The inactivation process takes anything from a few minutes to 24 hours or more to take place. This is usually detailed on the side of the destruction kit. Where stated, the destruction kit should be stored in the CD cupboard for the required time (usually 24 hours) before being placed in the pharmaceutical waste bin. Other kits may only take a few minutes and may be placed in the pharmaceutical waste bin after this. If it is not stated on the kit, then store in the CD cupboard first as above. The completed CD Destruction Record should now be returned to the CDAO. 9. Discrepancies: If a stock/ balance record discrepancy is identified at the visit that cannot be traced and corrected (e.g. a mathematical error within the CDR) at the time of the visit, this should be recorded in the CDR and on the CD Destruction Record Sheet. It is not the function of the authorised witness to investigate untraced discrepancies at the time of destruction. However, the authorised witness should make a detailed note of the discrepancy and feed it back to the CDAO and/or Superintendent Pharmacist, preferably within 2 working days. The staff member from the location in which the CDs stocks are held should refer to their internal procedures for follow up and resolution. Where a reason for the discrepancy cannot be found, the CDAO should be informed. The CDAO may then wish to undertake further investigations. Note - The presence of discrepancies does not necessarily prevent the destruction of CDs from taking place. The Authorised Witness should consider the risks (if any) of not destroying the CDs during the visit, recording what has, or has not, been destroyed and include any relevant information. 10. Training: The CDAO will make available appropriate training for all Authorised Witnesses. The CDAO will provide updates and where necessary additional training for all Authorised Witnesses as and when the need arises. 10

11 Appendix 2: Template Letter for Authorised Witnesses Bath, Gloucestershire, Swindon & Wiltshire Area Team Sanger House, 5220 Valiant Court Gloucester Business Park Gloucester GL3 4FE Tel: Mobile: NHS ENGLAND AREA TEAM (BGSW) AUTHORISED WITNESS TO DESTRUCTION OF CONTROLLED DRUGS The Controlled Drug Accountable Officer authorises the individual named to supervise the destruction of controlled drugs at relevant premises across the Area Team geography. This includes controlled drugs held by General Practices and Community Pharmacies. The individual will not witness controlled drug destruction in locations where they are directly involved e.g. in any GP practices or pharmacies where they have day to day involvement with controlled drugs. Appropriate training should be completed and appropriate governance arrangements in place. The individual will maintain appropriate paper and electronic records in support of this and agree to adhere to the BGSW Area Team Standard Operating Procedures for controlled drug destruction or alternatively Standard Operating Procedures for the employer of the witness where previously agreed by the CDAO. Any issues of concern arising from the process or identified during the site visit will be notified to the CDAO. Name of Witness Authorised Position/ Class Comments/ restrictions This authorisation is valid until xx/xx/xxxx (no more than 2 years from the date of issue). Signed: Date: xx/xx/xxxx Julie McCann Accountable Officer for Controlled Drugs NHS England Area Team BGSW 11

12 Appendix 3: Destruction of Controlled Drugs Record On.., the following listed controlled drugs were destroyed using an approved method as described in the SOP for the destruction of controlled drugs at premises, in the presence of the authorised witness by the responsible person named below. The destruction of the controlled drugs was documented at the premises in the Controlled Drugs Register. Controlled Drug Brand Form Strength Quantity Destroyed Patient Returns (indicate if yes) Name of responsible person at premises (please print): Name of authorised witness (please print): Date Signature Signature Time taken: The original copy of this form should be returned to the Accountable Officer. The Authorised Witness should take a photocopy for their own records. 12

13 Appendix 4: Reporting Form - CD discrepancies Date: Location: Drug Name: Strength: Preparation (e.g. tabs / injection): Quantity in stock: Quantity in Register: According to the CD register, when was the last time (date) the stock balance was correct? Date:. Please outline what steps have been taken to identify a reason for the stock discrepancy: Form completed by: Name:. Job title:. The Area Team may wish to investigate this incident further. Please provide contact details and availabilities: Name:. Job title: Contact number:... Availability: Please send this completed form to Julie McCann, Accountable Officer for Controlled Drugs: england.bgsw-controlleddrugs@nhs.net 13