Controlled Drugs Cabinet Misuse of Drugs (Safe Custody) Regulations 1973
Misuse of Drugs (Safe Custody) Regulations 1973. Retail dealers (pharmacists), private hospitals and nursing homes need to store any controlled drugs requiring safe custody in a locked safe, cabinet or room that complies with the requirements of the Misuse of Drugs (Safe Custody) Regulations 1973 or, in respect of which, a certificate of approval has been obtained from the police. Others who are entitled to possess controlled drugs (e.g. doctors, sisters in charge of a hospital ward or department, midwives) have a requirement for them to store controlled drugs in a locked receptacle that can only be opened by them or a person acting on their authority. Current guidelines for care homes state that they should store controlled drugs to be administered by staff in a cabinet that meets the requirements of the Regulations.
Management of controlled drugs in care homes legislation 23 June 2008
Management of controlled drugs in care homes 23 June 2008
Download our guidance about safe practice when controlled drugs are prescribed for care home residents.
Safe management of controlled drugs. Following the Shipman Inquiry the government introduced new methods to monitor and inspect controlled drugs.
We now have a duty to share information with other regulators including the police and the Healthcare Commission to check the use of controlled drugs in care homes.
The guidance describes how this will affect you and the specific role that our pharmacist inspectors will play.
The guidance also explains:
which medicines are controlled drugs what the regulations and national minimum standards say how to decide if a resident can look after and take their own controlled drugs the safeguards that must be in place when your care staff give controlled drugs to residents what we look for during our inspection work.
What is a controlled drugs (CD) cupboard / cabinet? A CD cupboard / cabinet is:
made of steel has a double lock mechanism is permanently fixed to a solid wall with rag or rawl bolts A CD cupboard is not:
a cupboard within a cupboard a locked metal cashbox, fixed to the shelf of a wooden cupboard a metal safe used to store personal effects of value Suppliers of medical equipment sell CD cupboards and their catalogues state when the product meets the requirements of the Regulations.
There may be a problem in some new constructions to find a solid wall to put it on. In this case, a steel plate must be mounted on the wall to attach the cupboard to.
Your local police force may be able to offer advice, depending on whether they have dedicated officers to deal with CD issues.
Does this mean a care home must have the correct type of CD cupboard? Any care home that looks after and is responsible for giving controlled drugs to people they care for must comply with this legislation. Otherwise, you are breaking the law.
All new care homes should comply with this legal requirement before they are registered.
Existing care homes must take responsibility for providing a suitable cupboard when they centrally store CD.
You may not have had CD for people in your care in the past, but you never know when a doctor will prescribe a CD for someone in your care. It may be too late if you wait for this to happen before installing the correct storage facilities.
Safe Management of Controlled Drugs in Care Homes
Help and Advice on Safe Management of Controlled Drugs in Care Homes
1. Inspectors are confident about the special arrangements that care providers should make when controlled drugs are prescribed for people in care homes.
2. Inspectors have a clear understanding: why some medicines are 'controlled drugs' what the regulations and national minimum standards say what is important when people look after and take their own controlled drugs what safeguards must be in place when care workers give controlled drugs to people what the new requirements for controlled drug storage in care homes (personal care) are; and how we will inform providers about the changes what local intelligence networks (LIN) are and the information we will share with them whether care homes can keep a stock of controlled drugs what they should look for.
Why are some medicines defined as 'controlled drugs'?
3. Controlled drugs (CD) are prescribed medicines used to treat severe pain, induce anaesthesia or treat drug dependence. But some people abuse them by taking them when there is no clinical reason to do so or divert them for other purposes. For these reasons, there are legislative controls for some drugs and these are set out in the Misuse of Drugs Act 1971 and related regulations.
4. Different controlled drugs cause dependence or misuse in varying degrees. They are classed according to the extent of harm they may cause when misused. And they are also listed in different schedules (1-5) according to the legal requirements concerning prescribing, storage and record keeping (refer to Appendix).
5. The purpose of legislation is to impose control on CD manufacture, prescribing, supply, possession and record keeping. The impact on care homes is limited but does require special arrangements for storage, administration, records and disposal.
6. The Misuse of Drugs and Misuse of Drugs (Safe Custody) (Amendment) Regulations 2007 include changes that will affect care homes. These include: Secure storage of controlled drugs in care homes (personal care) Midazolam re-classified from schedule 4 to schedule 3 Accountable Officers in primary care trusts will specify who can witness the destruction of stock supplies of controlled drugs.
What do the regulations and national minimum standards say?
7. Regulation 13 of the Care Homes Regulations (2001) states that a registered provider must 'make arrangements for the recording, handling, safekeeping, safe administration and disposal of medicines received into the care home'. This applies to all medicines, including controlled drugs.
8. The national minimum standards specifically include the handling of controlled drugs in care homes for older people and care homes for adults (18-65). The criteria are intended to ensure that care homes meet the requirements of the Misuse of Drugs Act 1971, Misuse of Drugs (Safe Custody) Regulations 1973, Misuse of Drugs Regulations 2001 and Misuse of Drugs and Misuse of Drugs (Safe Custody) (Amendment) Regulations 2007 (9.4, 20.6).
9. Standards 9.5 and 20.7 state that controlled drugs should be kept in a designated CD cupboard when staff are responsible for giving them to people. The 2007 Amendment to Regulations makes this mandatory for all care homes.
10. Standards 9.6 and 20.8 relate only to care homes (nursing). The administration of controlled drugs and all other prescribed medicines should be by 'a medical practitioner or registered nurse' unless the person self-administers his or her medicines.
11. Standards 9.7 and 20.9 relate only to care homes (personal care). Controlled drugs should be given by care workers who have been trained and designated to do so. Another trained and designated member of staff should witness this process.
12. Standards 9.8 and 20.11 state that care homes should keep additional records of receipt, administration and disposal of controlled drugs in a 'register'. This is explained in the Royal Pharmaceutical Society's guidance as 'a bound book or register with numbered pages'. This does not exclude the use of a computerised record provided that it is: secure cannot be altered at a later time attributable to the person who created the record.
What are the issues when people look after and take their own medicines?
13. People can keep and take controlled drugs themselves. For self-administration, the process of risk assessment is important, not the legal classification of the medicine. The care worker should assess whether the person understands: why the medicine is prescribed how much and how often to take it what may happen if he or she does not take the medicine or takes too much.
14. Sensible precautions are important to make sure that controlled drugs are not stolen from the person. Care providers do not need a CD cupboard in each bedroom but a lockable cupboard or drawer is essential. The risk assessment process places responsibility on the person who keeps the controlled drug. And through monitoring and review of the risk factors, the care provider should identify that controlled drugs are not left lying around where they could be taken by someone else.
15. There is no need to keep a record in the CD register when the person is wholly independent. That is, he or she is responsible for requesting a prescription and collecting the controlled drugs personally from the pharmacy.
16. But if the person does not arrange the supply and collection of controlled drugs but relies on the care workers to do so, there should be clear records including: receipt from the pharmacy, supply to the person any subsequent disposal of unwanted controlled drugs. These records should be made in the CD register.
17. The situation may arise when a resident chooses to use illicit drugs as distinct from prescribed controlled drugs. The care provider is responsible for deciding how to deal with illicit use of drugs on the care home premises.
What safeguards must be in place when care workers give controlled drugs to people?
18. Safeguards are essential when any prescribed medicine is given by care workers, including: Respecting the person's choice and preference, particularly when these relate to ethnic or religious observance. And recognising the person's right to refuse treatment. A robust system to make sure there is always an adequate supply of prescribed controlled drugs A safe procedure for giving controlled drugs that will minimise the potential for a drug error. This should include a witness to the controlled drug administration who also signs the CD register when practicable. But no one should be deprived of prescribed medicine because there is only one member of staff on duty when he or she needs it. Providing training for care workers who are designated to give controlled drugs and also to those who will act as a 'witness'. Keeping full records of what has been given, when and by whom.
19. The use of a witness is intended to reduce the possibility of an error occurring. To be effective, the witness must understand what the care worker is doing and therefore needs the same level of training. The witness will confirm that: the care worker selects the correct controlled drug the name on the label attached to the controlled drug is the same as the person the care worker intends to give it to the care worker has prepared the right dose, included on the label and in the MAR chart the care worker gives it to the right person the administration is recorded in the CD register as well as signed on the MAR chart.
20. In care homes (personal care), any controlled drugs given by injection are the responsibility of community nurses. It is important to make sure that the care home retains a record of all controlled drug administration, especially when the community nurse completes a record that is not left in the care home. If the community nurse is not willing to make a duplicate record in the home's CD register, it will be important for the witness to complete this record.
21. For the majority of care homes, the only controlled drugs that care workers will be responsible for will be prescribed for named people. They belong to the named person, not the care service. It is therefore important for care workers to treat controlled drugs as valuables that the person owns.
22. Controlled drugs are a target for theft and it is good practice to regularly check them. The CD register should include the balance that remains, which can be compared with the quantity in the CD cupboard. If a discrepancy is noted, the care provider should have a process to investigate and establish what has happened. For example, has a care worker forgotten to complete the record or have the controlled drugs been stolen. If controlled drugs are missing, this is a serious incident and they must notify us. It may also be necessary to contact the police to discuss how to deal with the situation.
23. If an error occurs when a controlled drug is given, this may have serious consequences for the person involved. The care worker should first of all contact the person's doctor for advice. And if the person requires emergency treatment, the incident should be notified to us. Examples of drug errors include: wrong dose, too much or too little given given at the wrong time, e.g. a tablet that should be given every 12 hours is given every 4 hours. given to the wrong person.
24. When a resident's controlled drugs are no longer required they should be disposed of safely and a record kept of who returned them, the quantity and date. A witness to this transaction is good practice. For care homes (personal care) they can be returned to the supplier. Care homes (nursing) must use a company with a waste management licence.
What are the new requirements for controlled drug storage in care homes for personal care.
25. The secure storage of controlled drugs is specified in the Misuse of Drugs (Safe Custody) Regulations 1973. In the 2007 Amendment the term 'nursing home' has been replaced by 'care home'. The main impact is that every care home must store controlled drugs in a CD cupboard, including care homes registered for personal care.
26. Legal requirements for storage may appear to have little or no impact on the care given to people. What it does achieve is a greater deterrent against diversion and theft. And it should also serve as a constant reminder to care workers that these medicines are potent.
In brief, the requirements for CD storage are: Metal cupboard of specified gauge Specified double locking mechanism Fixed to a solid wall or a wall that has a steel plate mounted behind it Fixed with either Rawl or Rag bolts Suppliers of CD cabinets can confirm that a cupboard meets the legal requirements. We recommend that care homes request formal confirmation when purchasing a CD cabinet.
27. It is a commonly held belief that a CD cupboard must be a 'cupboard within a cupboard'. This is not the case but many NHS hospitals used this method to store controlled drugs at a time when they did not need to comply with the legislation because of Crown Immunity. Stand-alone cupboards with a double locking mechanism that complies with the legislation are available.
How will we inform care providers about the changes in legislation? 28. At registration, we will inform new care home providers that a CD cupboard is mandatory. This will take effect from 01 January 2008.
29. We will publicise the changes in legislation through our external stakeholder reference groups, our website and the Provider Newsletter. Existing registered care home providers are responsible for providing a CD cupboard. If during a site visit we identify that the storage of controlled drugs does not meet current legislation, we will make this a requirement within 3 months of the visit.
30. Failure to provide a CD cupboard will not influence the initial quality rating of that service during 2008. But in subsequent years, failure to comply with legislation will impact on the quality rating.
What are local intelligence networks and what type of information do we have a duty to share with them?
31. We continue to be responsible for regulating the handling of controlled drugs in registered care homes. And when necessary we will use enforcement. But new arrangements in the Health Act 2006 include a duty for us to collaborate at a local level with NHS, police and other named authorities to share information when controlled drugs are not handled correctly. This is the local intelligence network (LIN).
32. Pharmacist inspectors are responsible for this collaboration, primarily with the Accountable Officers (AO) at primary care trusts (PCT).
33. The LIN comprises representatives from other regulators (including Healthcare Commission and Royal Pharmaceutical Society of Great Britain), police and anti-fraud officers. Several PCT may work together in one LIN.
34. We will share information about controlled drugs with the LIN when issues we identify are not within the scope of our regulatory role. An example is poor practice by healthcare professionals that the care home does not employ directly. The information may be essential to the NHS primary care organisation that contracts with the healthcare professional concerned. " Poor clinical practice by a GP that a pharmacist inspector identifies. " A healthcare professional insists on removing unwanted controlled drugs from a care home. " Concern about the practice of a registered nurse from a Nurses Agency who may additionally work in other care homes and/or NHS hospitals.
Can care homes keep a stock of controlled drugs?
35. Care homes (personal care) cannot purchase and keep stocks of prescription only medicines, including controlled drugs.
36. The Medicines Act 1968 does permit a care home (nursing) to purchase and use stocks of controlled drugs so long as they have a domestic licence issued by the Home Office or are mainly maintained by charitable funds. This may be the case in some drug and alcohol rehabilitation units. And as care homes become involved in 'End of Life' care they may apply to the Home Office for a domestic licence. Details of how to make the application can be found on the Home Office website.
37. The main difference for the care home (nursing) that holds stock supplies is that the disposal of stock controlled drugs must be witnessed by an 'authorised person'. The Accountable Officer at the local primary care trust will advise who can do so locally.
Checklist for inspectors
38. Our report 'Handled with Care?' identified that controlled drugs were not particularly a cause for concern in 2004/05. It is therefore important to retain proportionality even though the government has strengthened processes for monitoring and inspecting controlled drugs. It is important to monitor how a care home looks after all prescribed medicines.
39. Any issues with controlled drugs from any source, e.g. inspection, complaints, Reg. 37 reports, must be notified to the regional lead pharmacist so that we can fulfil our legal duty under the Health Act 2006. This does not preclude any decision about Safeguarding Adults referrals or direct contact with the police if the pharmacist is not immediately contactable.
40. Equality and diversity issues associated with controlled drugs relate to the person's choice and preference about taking medicines or exercising the right to refuse to take them.
41. Every social care service that looks after controlled drugs must make an annual declaration to us about controlled drug handling. We have included questions in the Annual Quality Assurance Assessment (AQAA). Our pharmacist inspectors will use this information to randomly select a 10% sample for controlled drug inspection so that we can meet government guidelines.
42. Important issues to follow up during site visits when controlled drugs are prescribed for people include: Are there special arrangements for storage, administration, recording and disposal of controlled drugs? Do care workers know which prescribed medicines are controlled drugs? Are quantities of controlled drugs for individual people the same as the balance recorded in the register? Does the care provider investigate any discrepancies?
Common Controlled Drugs and legal requirements for care homes.
Schedule 2: CD Brand names Legal Requirements Morphine MST Store in a CD cupboard Record in the CD register.
* Oramorph oral solution 10mg/5ml is not a controlled drug. However, CD storage and CD records are a good practice recommendation. Sevredol Oramorph Concentrated oral solution 100mg/5ml * MXL Cyclimorph Dexamphetamine Dexedrine Diamorphine Pethidine Methadone Physeptone Methylphenidate Ritalin Fentanyl Durogesic Pentazocine injection Fortral
Schedule 3: CD Brand names Legal Requirements Buprenorphine Temgesic (tablets) Butrans (patches) " Buprenorphine, and Temazepam must be stored in a CD cupboard. Other listed schedule 3 controlled drugs do not need CD storage. " None of the controlled drugs in this schedule need to be recorded in the CD register but this is a good practice recommendation. ** Epistat is not a licensed medicine.
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