1. What the regulation says
Care and treatment must be provided in a safe way for service users. (Reg 12(1) (the headline duty))
assessing the risks to the health and safety of service users of receiving the care or treatment, (Reg 12(2)(a) (risk assessment))
doing all that is reasonably practicable to mitigate any such risks, (Reg 12(2)(b) (risk mitigation))
ensuring that persons providing care or treatment to service users have the qualifications, competence, skills and experience to do so safely, (Reg 12(2)(c) (staff competence))
the proper and safe management of medicines, (Reg 12(2)(g) (medicines management))
The full text of the regulation is at https://www.legislation.gov.uk/uksi/2014/2936/regulation/12. Where this policy and the regulation diverge, the regulation wins.
2. Plain-English summary
Care and treatment must be provided in a safe way. The regulation lists the areas a provider must address, including risk assessment, risk mitigation, staff competence, safe premises, safe equipment, sufficient equipment and medicines, medicines safety, infection prevention and shared-care planning. Regulation 12 is central to CQC's safety expectations.
3. Purpose
Supporting someone with their medicines in their own home is different from giving medicines in a care home. The person, or their family, may manage most of it themselves, and the Service supports only the parts they need help with. This policy sets out how the Service decides what support each person needs, how workers prompt, assist or administer medicines safely, and how the Service records it and learns from any error.
The Service must verify this policy against current NICE guidance and its own local pharmacy and prescriber arrangements before adoption.
This is the domiciliary-care version. For a cross-sector starting point, use the CQC medication policy template. For a broader audit tool that still applies to home care, use the CQC medicines management audit checklist.
4. Scope
This policy applies to:
- every person the Service supports with medicines in their own home
- prescribed medicines, medicines bought without a prescription, and creams, drops, inhalers and similar
- the workers who support medicines, and the senior staff who assess need and check competence
5. Roles and responsibilities
- Registered Manager: owns the medicines-support system, approves local procedures, makes sure competent staff are available and reviews medicines incidents, audits and improvement actions.
- Medicines lead or delegated senior: completes and reviews medicines-support assessments, keeps prescriber and pharmacy contacts current, checks medicines records and coordinates action when instructions or supplies are unclear.
- Care coordinator or scheduler: identifies visits involving time-critical medicines, protects the agreed visit window and escalates any threatened missed or late call before the medicine is due.
- Care worker: follows the assessed level of support and current medicines record, records support at the time it is given, and reports refusals, omissions, discrepancies, changes and concerns without delay.
- Assessor or reviewer: involves the person, checks what they can manage, confirms consent and capacity considerations, and updates the care plan when needs, medicines or support arrangements change.
- All staff: work only within their training and competence. No worker changes a dose, instruction, administration route or support level without an authorised and recorded change.
6. Step-by-step medicines support procedure
- Assess the person's medicines support needs. Involve the person and identify what they manage independently, what help they want, any capacity or safeguarding concern and the risks of missed or incorrect support.
- Reconcile the current instructions. Obtain a current medicines list from an appropriate source, resolve discrepancies with the prescriber or pharmacy and record who confirmed each change.
- Agree the level of support. Record prompting, assisting or administering for each medicine, including who orders, collects, stores and disposes of it.
- Create the working record. Put the current care-plan instructions, medicines record, PRN protocol, time-critical window and escalation contacts where the worker can use them during the visit.
- Check before giving support. Confirm the person, medicine, instruction, timing, allergies, stock and any recorded change. Stop and seek advice if the record, label, medicine or person's condition does not match.
- Give and record the support. Follow the assessed level, preserve the person's independence and record the outcome at the time. Never sign before the support is completed.
- Respond to exceptions. Record and escalate a refusal, omission, late dose, unavailable medicine, side effect, swallowing difficulty, stock discrepancy or suspected error using the local clinical-advice route.
- Review and close the loop. Update the assessment and working records after a medicines change, discharge, error, repeated refusal, deterioration or change in what the person can manage.
7. The three levels of medicines support
The Service uses the levels of support set out in NICE NG67 and records which level applies to each medicine for each person. The level can differ from one medicine to another for the same person.
- Prompting and reminding. The person manages their own medicines. The worker reminds them it is time to take them. The person decides and acts.
- Assisting. The person directs their own medicines but needs practical help, for example opening a bottle, popping a tablet from a blister pack, or passing a glass of water.
- Administering. The worker gives the medicine to the person, including selecting it, preparing it and recording it.
The level of support is agreed with the person, recorded in the care plan and the medicines record, and reviewed when the person's needs change.
8. Starting from what the person can do
The Service starts from the principle that a person manages their own medicines unless an assessment shows they need help. The Service does not take over more than the person needs.
- The level of support is based on an assessment, the person's wishes and, where relevant, their mental capacity to make decisions about their medicines.
- Where a person manages their own medicines, the Service records that and does not interfere with it.
- Consent is sought before the Service gives any medicine. Where a person may lack the capacity to consent, the Service follows the Mental Capacity Act and section 14 below.
9. The medicines record in the home
Where the Service administers or assists with medicines, it keeps an accurate medicines administration record (a MAR) in the person's home:
- the MAR lists each medicine, the dose, the form and when it is to be given
- the worker records each time a medicine is given, or the reason it was not (for example the person refused, was asleep or was out)
- the worker signs each entry
- the MAR is kept where the next worker can find it, and is legible and up to date
Where a person only needs prompting and manages their own medicines, the Service records that level of support rather than keeping a full MAR.
Records and evidence fields
The medicines support record should include:
- the current prescribed instruction and the source and date of the information
- the assessed support level for each medicine and the person's consent
- allergies, time-critical windows, PRN instructions and relevant risk controls
- who orders, collects, stores, returns and disposes of medicines
- each prompt, assistance or administration and the outcome at the time
- refusal, omission, delay, unavailable stock, side effect, discrepancy or medicine change
- advice sought, who gave it, the action agreed and the follow-up owner
- any linked incident, safeguarding concern, complaint, risk or improvement action
10. Time-critical medicines
Some medicines must be taken close to a set time to work safely, for example medicines for Parkinson's disease, insulin, and some medicines for the heart or for epilepsy. The Service:
- identifies time-critical medicines in the care plan and the medicines record
- plans visits so these medicines can be given on time
- treats a visit that includes a time-critical medicine as a critical visit under the visit scheduling, missed and late visits policy
11. When-required (PRN) medicines
For medicines taken only when needed, such as pain relief, the Service follows a clear plan for each one:
- what the medicine is for and the signs that it is needed
- the dose, how often it can be given and the maximum in a day
- how the person shows or says they need it, including where the person cannot ask in words
- the worker records each time a when-required medicine is given and the reason
12. Storage, ordering, collection and disposal in the home
Medicines in a person's home belong to the person and are stored in their home. The Service:
- supports safe storage, taking account of children or others in the home where relevant
- records who is responsible for ordering and collecting medicines, whether that is the person, a family member or the Service
- follows an agreed route for returning unwanted or out-of-date medicines to a pharmacy, and records what was returned where the Service handles it
13. Controlled drugs in the home
Where a person is prescribed a controlled drug, the Service:
- records the support it provides with that medicine
- counts and records the quantity where it administers the controlled drug, and checks the balance
- reports any discrepancy or concern without delay
The Service confirms its controlled-drug arrangements against current guidance before adoption.
14. Covert medicines and the Mental Capacity Act
Giving medicine to a person without their knowledge, for example hidden in food, is covert administration. It is only ever considered where a person lacks the capacity to decide about that medicine. Before any covert administration the Service ensures:
- a capacity assessment has been completed for the decision about that medicine
- a best-interests decision has been made and recorded, involving the prescriber, the pharmacist, the family or representative, and the Service
- the method is agreed with the pharmacist, because hiding a medicine can change how it works
- the arrangement is recorded, reviewed and stopped as soon as it is no longer needed
A worker never decides to give a medicine covertly on their own.
15. Medicines errors and learning
- A worker reports any medicines error, near miss or concern the same working day, including a missed dose, a wrong dose, the wrong medicine or a recording gap.
- The Service checks whether the person has come to harm and gets medical help where needed.
- The error is logged and runs through to a recorded outcome with any actions completed.
- The Service reviews medicines errors together to find patterns and improve practice, rather than treating each as a single worker's mistake.
16. Staff competency
A worker supports medicines only after training and a check that they can do it safely. The Service:
- trains workers in safe medicines support before they support medicines alone
- checks competence in practice, not only in the classroom, and repeats the check on a stated cadence
- records who is competent for which level of support, and removes a worker from medicines tasks if a concern arises until it is resolved
17. Audit cadence
The Service checks, on a stated cadence, that:
- each person has a recorded level of support for each medicine, agreed with them
- medicines records in homes are accurate, signed and up to date
- time-critical and when-required medicines are managed per the plan
- medicines errors are reported, recorded and learned from
- workers supporting medicines are trained and competent
The Registered Manager reviews the results and records the improvement actions that follow.
Links to registers and action tracking
- Medicines errors, near misses and unexplained discrepancies are logged in the incident register and followed through to a recorded outcome.
- Repeated refusals, missed time-critical support, unsafe storage and recurring supply failures are considered for the risk register.
- Complaints and safeguarding concerns are opened on their own registers rather than being held only in the medicines record.
- Competency restrictions, reassessment and refresher needs are recorded in the training matrix.
- Audit findings become improvement actions with an owner, due date and evidence of closure, then return to governance for review.
18. Related reading
- Article: CQC compliance for domiciliary care: the evidence inspectors expect
- Cross-sector policy: CQC medication policy template
- Related policy: Visit scheduling, missed and late visits
- Audit checklist: CQC medicines management audit checklist
- Sector hub: Domiciliary care guide
19. Sources and further reading
This template is based on CQC's guidance for providers and managers, the Health and Social Care Act 2008 (Regulated Activities) Regulations 2014, and other topic-specific legislation and guidance listed below. It is a starting point for adaptation, not a substitute for legal, clinical, HR, safeguarding or specialist professional advice.
- CQC Regulation 12: Safe care and treatment
- Health and Social Care Act 2008 (Regulated Activities) Regulations 2014 (https://www.legislation.gov.uk/uksi/2014/2936/regulation/12)
- NICE NG67: Managing medicines for adults receiving social care in the community (https://www.nice.org.uk/guidance/ng67)
- CQC medicines optimisation guidance
- MAR (medicines administration record) expectations
- MHRA safety alerts
- Controlled Drugs Regulations; NHS England controlled drugs accountable officer guidance where applicable
- Mental Capacity Act 2005 (consent and best interests, including covert administration) (https://www.legislation.gov.uk/ukpga/2005/9/contents)
- MCA Code of Practice (2007, update in consultation)
- The Service's local arrangements with the person's GP practice and community pharmacy
20. When to seek further advice
Seek specialist advice where the issue involves serious harm, safeguarding, deprivation of liberty, restraint, children, professional misconduct, controlled drugs, radiation, termination of pregnancy, infection outbreak, water safety, employment dismissal, DBS barring referral, or regulatory enforcement.
21. Document control
| Version | Date | Author | Changes |
|---|---|---|---|
| v1.1 | 2026-07-18 | Verivius (sample) | Added role ownership, the end-to-end medicines support procedure, evidence fields and register-to-action controls. |
| v1 | 2026-06-10 | Verivius (sample) | Conformed to the Verivius policy standard: added statutory anchor, verbatim Regulation 12 text, plain-English summary, standard source stack, advice block and document control. Original operational sections preserved and renumbered. |
This sample policy template was issued by Verivius. It is a template, not a substitute for legal advice or the provider's own policy-development process. Where this template and live law or regulator guidance diverge, the live source wins.