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{{org_field_name}}

Registration Number: {{org_field_registration_no}}

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Safe Collection and Handling of Prescriptions Policy

1. Purpose

The purpose of this policy is to ensure that {{org_field_name}} has safe, effective and person-centred arrangements for the ordering, collection, receipt, transportation, handling, storage and associated management of prescribed medicines where {{org_field_name}} has agreed responsibility for providing medicines support.

The policy is intended to ensure compliance with applicable medicines legislation, the Health and Social Care Act 2008 (Regulated Activities) Regulations 2014, CQC requirements and relevant NICE guidance.

{{org_field_name}} will:

• ensure that medicines support is provided only where it has been assessed as necessary and agreed with the service user, and that the nature and extent of that support is recorded in the service user’s care and support plan;
• promote service users’ independence and support them to manage their own medicines wherever they are able and wish to do so;
• obtain and respect valid consent to medicines support and act in accordance with the Mental Capacity Act 2005 where a service user lacks capacity to make the relevant decision;
• ensure medicines are ordered, collected, transported, stored, administered and disposed of safely where these responsibilities have been accepted by {{org_field_name}};
• ensure accurate, complete and contemporaneous medicines records are maintained;
• ensure staff providing medicines support are appropriately trained, assessed as competent and authorised to undertake the tasks required of them;
• minimise the risk of medicines errors, missed medicines, loss, misuse, theft or inappropriate access; and
• ensure medicines incidents are identified, responded to, investigated, recorded and reported externally where a statutory reporting requirement applies.

2. Scope

This policy applies to:

• All staff members involved in prescription collection, handling, and storage.
• All service users who require prescribed medications.
• Families, carers, and healthcare professionals involved in medication administration.
• Pharmacies and external healthcare providers supplying prescriptions.

By implementing this policy, {{org_field_name}} ensures medication safety is prioritised at every stage, from prescription issuance to administration.

3. Legal and Regulatory Compliance

This policy must be read and implemented in accordance with legislation and regulatory requirements applicable to medicines support in supported living services in England, including, where applicable:

• Health and Social Care Act 2008;
• Health and Social Care Act 2008 (Regulated Activities) Regulations 2014, including:
  • Regulation 9 – Person-centred care;
  • Regulation 11 – Need for consent;
  • Regulation 12 – Safe care and treatment;
  • Regulation 13 – Safeguarding service users from abuse and improper treatment;
  • Regulation 17 – Good governance;
  • Regulation 18 – Staffing;
  • Regulation 19 – Fit and proper persons employed; and
  • Regulation 20 – Duty of candour;
• Human Medicines Regulations 2012, as amended;
• Medicines Act 1968, to the extent that its provisions remain applicable;
• Misuse of Drugs Act 1971, where controlled drugs are involved;
• Misuse of Drugs Regulations 2001, as amended, where applicable;
• Misuse of Drugs (Safe Custody) Regulations 1973, where applicable to the particular circumstances;
• Mental Capacity Act 2005 and its Code of Practice;
• Data Protection Act 2018 and the UK General Data Protection Regulation (UK GDPR);
• applicable waste legislation governing the disposal of medicines;
• NICE Guideline NG67 – Managing medicines for adults receiving social care in the community;
• NICE Guideline NG46 – Controlled drugs: safe use and management, where controlled drugs are involved; and
• current CQC guidance relating to medicines management in adult social care and supported living.

Medicines support must be provided in accordance with the service user’s assessed needs, preferences, capacity, consent, agreed care and support plan and any relevant risk assessment.

Where {{org_field_name}} has not accepted responsibility for a particular aspect of medicines management, responsibility will remain with the service user or another agreed person or organisation. Responsibilities must be clearly established and documented so that there are no gaps or unsafe duplication in medicines support.

4. Collection and Supply of Prescribed Medicines

4.1 Responsibility for Ordering Prescribed Medicines

Responsibility for ordering prescribed medicines must be agreed with the service user and, where appropriate and lawfully involved, their representative, family member or carer.

Where possible, service users must be supported to retain responsibility for ordering their own medicines.

Where {{org_field_name}} accepts responsibility for ordering prescribed medicines, this responsibility and the level of support required must be documented within the service user’s care and support plan.

Staff responsible for ordering medicines must be trained, assessed as competent and authorised to undertake this task.

Systems must ensure that sufficient quantities of prescribed medicines are available when required. The timing of repeat prescription requests must take account of the dispensing arrangements, weekends, public holidays and any known supply issues rather than relying solely upon a fixed number of days.

When {{org_field_name}} is responsible for ordering medicines, an appropriate record must be maintained showing:

• the medicine ordered;
• its strength and formulation where applicable;
• the quantity ordered where known;
• the date of the order;
• who placed the order;
• when the medicine was received or supplied; and
• any discrepancy identified and the action taken.

Any uncertainty about a prescription, dose, direction, medicine or supply must be referred to the prescriber or supplying pharmacy before staff provide medicines support.

4.2 Collection and Receipt of Medicines

Only a service user or a person appropriately authorised to collect medicines on their behalf may collect their prescribed medicines.

Where {{org_field_name}} accepts responsibility for collection, the staff member undertaking the collection must be authorised and competent to do so.

On receipt of medicines, staff must undertake appropriate checks against the medicines that were ordered and the information available to the service, including the dispensing label, current medicines information and relevant medicines records.

Checks must include, as applicable:

• the correct service user;
• the correct medicine;
• the correct strength;
• the correct formulation;
• the quantity supplied;
• the directions for use;
• whether the medicine requires specific storage arrangements;
• whether the medicine is time-sensitive;
• whether the medicine is a controlled drug; and
• whether there are any discrepancies, omissions, unexpected changes or unclear directions.

Where a discrepancy or unexpected change is identified, staff must not guess or alter the directions themselves. Advice must be sought promptly from the supplying pharmacist, prescriber or other appropriate healthcare professional before the medicine is administered where the discrepancy could affect safe administration.

Controlled drugs must be collected in accordance with the requirements applicable to the particular controlled drug and the supplying pharmacy’s lawful collection arrangements.

Staff collecting a controlled drug must comply with any lawful identity verification or collection-record requirements requested by the supplying pharmacy. Staff must not be instructed by this policy to make entries in, or sign, a pharmacy’s statutory Controlled Drugs Register unless there is a specific lawful basis requiring them to do so.

5. Safe Handling and Transportation of Medicines

5.1 Transportation

Where {{org_field_name}} accepts responsibility for transporting medicines to or from a service user’s home, the transport arrangements must be risk assessed and appropriate to:

• the medicine being transported;
• the manufacturer’s storage requirements;
• the length and method of transport;
• the risk of loss, theft, damage or unauthorised access;
• any temperature requirements;
• whether controlled drugs are involved; and
• the individual circumstances of the service user.

Medicines must remain secure and under appropriate control while being transported.

A locked bag or container must be used where this is identified as necessary by the risk assessment or local medicines procedure. A locked container is not automatically required for every medicine or every journey.

Medicines requiring refrigeration or other specific storage conditions must be transported in a manner that maintains the required storage conditions as far as reasonably practicable and in accordance with advice from the supplying pharmacist or manufacturer where necessary.

Medicines must not be left unattended in circumstances where they may be lost, stolen, damaged, accessed by an unauthorised person or exposed to unsuitable environmental conditions.

5.2 Documentation and Receipt

Where {{org_field_name}} collects or transports medicines, an audit trail must be maintained sufficient to establish:

• what was collected or transported;
• for whom;
• when;
• by whom;
• whether any discrepancy or problem was identified; and
• when and to whom the medicines were handed over where a handover took place.

Medicines records and prescription-related information must be maintained securely, accurately and contemporaneously in accordance with Regulation 17 and applicable data protection requirements.

There is no requirement to routinely retain a photocopy of every prescription where the necessary information is already accurately recorded within the service user’s lawful medicines records. Records must nevertheless contain sufficient information to demonstrate what medicines support was provided and to ensure safe continuity of care.

6. Storage and Disposal of Medicines

6.1 Storage in Supported Living

Supported living is the service user’s own home. Medicines must therefore be stored in the service user’s home in a way that promotes independence, respects the person’s rights and preferences and provides appropriate security and safety.

Medicines must not automatically be placed in a locked communal medicines cabinet or other central storage area merely because the person receives supported living services.

The service user’s ability and wish to manage and store their own medicines must be considered as part of their medicines support assessment.

The location and method of storage, and responsibility for storage, must be agreed with the service user and documented in their care and support plan where {{org_field_name}} provides medicines support.

Where there is an identified risk arising from unsecured medicines, an individual risk assessment must be completed. Secure storage, such as a lockable cupboard or medicines box, must be introduced where it is necessary and proportionate to manage that identified risk.

Storage arrangements must take account of:

• the manufacturer’s storage instructions;
• required temperature ranges;
• medicines requiring refrigeration;
• the risk of unauthorised access;
• children or other vulnerable people who may have access to the home;
• the service user’s capacity and ability to manage their medicines;
• the risk of accidental or intentional overdose;
• controlled drugs;
• medicines supplied in monitored dosage systems; and
• changes in the person’s circumstances or level of risk.

Where a medicine requires refrigeration, appropriate arrangements must be made to maintain the storage conditions specified by the manufacturer. A dedicated medicines refrigerator is not automatically required in supported living.

Controlled Drugs

Controlled drugs belonging to an individual living in supported living remain the individual’s medicines.

A separate controlled drug cupboard is not automatically required in supported living.

Controlled drugs must be stored safely in the service user’s home according to an individual assessment of risk, the person’s needs and preferences, relevant medicines legislation and any advice from the pharmacist or prescriber.

Access to medicines managed by {{org_field_name}} must be limited to the service user and/or those staff or other persons who are authorised to access them.

Where a statutory controlled drugs record or other specific record is required in the particular circumstances, {{org_field_name}} must ensure that the required record is maintained in accordance with the applicable legislation.

6.2 Unwanted, Expired, Damaged or Discontinued Medicines

Where the service user manages their own medicines, they must be supported with appropriate information about the safe disposal of unwanted, expired or discontinued medicines.

Where {{org_field_name}} has accepted responsibility for disposal, staff must obtain the service user’s agreement or, where appropriate, act in accordance with a lawful best-interests decision or other lawful authority.

Unwanted medicines must normally be returned to a community pharmacy for safe disposal unless an alternative lawful disposal route applies.

Medicines must not be disposed of in household waste, sinks or toilets unless specific lawful professional guidance states otherwise.

The disposal record must include, where applicable:

• the service user’s name;
• the medicine name, strength and formulation;
• the quantity being returned or disposed of;
• the reason for disposal;
• the date;
• the member of staff responsible; and
• the pharmacy or other authorised recipient to whom the medicine was returned.

Specific requirements applying to controlled drugs, sharps, transdermal patches and other hazardous medicines must be followed.

7. Supporting and Administering Medicines Safely

7.1 Authorisation, Consent and Administration

Staff must only provide the level of medicines support that has been assessed, agreed and documented in the service user’s care and support plan.

Before providing medicines support, staff must ensure that:

• the service user has consented to the support; or
• where the service user lacks capacity to make the relevant decision, any decision or action is taken lawfully in accordance with the Mental Capacity Act 2005; and
• there is clear and lawful authority and appropriate directions for the medicine to be administered.

Consent is an ongoing process. A person with capacity may refuse or withdraw consent to medicines support at any time. A refusal must be respected, recorded and responded to appropriately according to the risks associated with the medicine.

Only staff who have received appropriate training, have been assessed as competent and are authorised by {{org_field_name}} may administer or provide the relevant level of medicines support.

Staff providing medicines support must follow the 6 Rs of safe medicines administration:

• right person;
• right medicine;
• right route;
• right dose;
• right time; and
• the person’s right to refuse.

Before administering or supporting a person to take a medicine, staff must also:

• check the current medicines administration record and relevant care plan;
• check the dispensing label and instructions;
• confirm whether the dose may already have been taken or administered;
• check for recorded allergies or other relevant safety information;
• follow any medicine-specific protocol, including protocols for ‘when required’ medicines;
• ensure any required minimum interval between doses has been observed; and
• resolve any discrepancy or uncertainty before proceeding.

Medicines must normally be administered directly from the container or packaging in which they were supplied.

A dose must not be left out for the service user to take later unless this has been agreed with the service user following an appropriate risk assessment and is documented within the person’s care and support plan.

Immediately after medicines support has been provided, the staff member must make an accurate and contemporaneous record of the support given, including whether a medicine was taken, declined, omitted or not administered and the reason where known.

7.2 Refusals, Adverse Effects and Deterioration

Where a service user refuses or declines a medicine, staff must:

• respect the decision where the person has capacity;
• record the refusal accurately;
• follow the person’s care plan and medicine-specific guidance;
• consider whether another attempt is appropriate;
• identify whether pain, difficulty swallowing, side effects or another problem may have contributed to the refusal; and
• seek advice from the prescriber, pharmacist or another appropriate healthcare professional where the missed medicine may present a risk or where refusals are repeated.

Staff must monitor for and respond appropriately to suspected adverse reactions, side effects or deterioration.

Where a suspected reaction is severe, life-threatening or indicates an emergency, including suspected anaphylaxis, staff must call 999 immediately and provide emergency assistance within the limits of their training.

Where the reaction is not immediately life-threatening, appropriate clinical advice must be obtained promptly from the GP, pharmacist, NHS 111 or another appropriate healthcare professional according to the circumstances.

The incident, observations, advice obtained and action taken must be recorded.

8. Medicines Errors, Incidents and Duty of Candour

8.1 Identifying and Responding to Medicines Errors

A medicines error or incident may include, but is not limited to:

• administration of the wrong medicine;
• administration to the wrong person;
• administration of the wrong dose;
• administration by the wrong route;
• administration at the wrong time where this creates a clinical risk;
• an omitted or missed dose;
• administration of a medicine that has been discontinued;
• duplicate administration;
• incorrect transcription;
• incorrect storage that may have affected the medicine;
• loss or theft of medicines;
• a discrepancy in medicines stock or records; or
• an error associated with ordering, collection, supply or disposal.

When a medicines error or suspected medicines error is identified, the immediate priority must be the safety and welfare of the service user.

Staff must:

• assess the immediate situation;
• obtain urgent medical assistance where required;
• seek appropriate clinical advice from the prescriber, pharmacist, NHS 111 or emergency services according to the nature and severity of the incident;
• not make an independent clinical decision to omit, repeat or alter a prescribed dose unless this is within their professional competence and lawful authority;
• follow the advice received from the appropriate healthcare professional;
• inform the manager or person in charge without delay;
• accurately document what happened, including any advice received and action taken;
• complete the organisation’s medicines incident reporting process; and
• preserve relevant medicines, packaging, records or other evidence where required for investigation.

All medicines incidents must be reviewed to establish the cause, contributory factors and any action required to reduce the likelihood of recurrence.

Where an incident raises a safeguarding concern, the organisation’s safeguarding procedures must be followed and the concern must be referred to the appropriate safeguarding authority where required.

8.2 Duty of Candour

{{org_field_name}} must act in an open and transparent manner with service users and relevant persons in relation to care and treatment provided.

Where a medicines incident meets the statutory definition of a notifiable safety incident under Regulation 20 of the Health and Social Care Act 2008 (Regulated Activities) Regulations 2014, {{org_field_name}} must comply with the statutory Duty of Candour requirements.

This includes, as soon as reasonably practicable:

• notifying the relevant person that the incident has occurred;
• providing a truthful account of the facts known at that time;
• explaining what further enquiries or investigations are considered appropriate;
• providing reasonable support;
• offering an apology;
• confirming the required information in writing; and
• maintaining a written record of the communication.

The Duty of Candour procedure must be followed separately from the organisation’s general incident-reporting process.

8.3 Notification to CQC and Other Authorities

A medicines error is not, by itself, automatically notifiable to CQC.

The Registered Manager must consider whether the circumstances associated with the medicines error trigger a statutory notification requirement under the Care Quality Commission (Registration) Regulations 2009 or another applicable requirement.

Where required, CQC must be notified using the appropriate CQC notification process.

Examples include circumstances where a medicines error has caused or contributed to a notifiable event such as:

• the death of a person using the service;
• a serious injury to a person using the service;
• abuse or an allegation of abuse; or
• an incident that has been reported to, or investigated by, the police,

where the applicable statutory notification criteria are met.

Where a safeguarding threshold is met, the appropriate local authority safeguarding process must also be followed.

Where controlled drugs are lost, stolen, diverted or otherwise involved in a significant concern, the Registered Manager must consider and make any report required to the police, the relevant controlled drugs accountable officer, safeguarding authority or other appropriate body according to the circumstances.

Internal reporting does not replace any statutory external reporting requirement.

9. Staff Training, Competence and Responsibilities

9.1 Training and Competency Requirements

Staff must not undertake medicines-related duties unless they have received training appropriate to the duties they are expected to perform and have been assessed as competent to perform those duties safely.

The level and content of training and competency assessment must reflect the person’s role and may include:

• ordering and collecting medicines;
• receipt and reconciliation of medicines;
• medicines administration;
• medicines records;
• ‘when required’ medicines;
• time-sensitive medicines;
• controlled drugs;
• storage and disposal;
• recognising and responding to medicines errors;
• consent and the Mental Capacity Act 2005;
• covert administration where applicable;
• safeguarding concerns associated with medicines; and
• escalation of concerns to healthcare professionals.

Competence must be assessed before a staff member independently undertakes the relevant medicines task.

Competency must be reviewed at appropriate intervals and whenever there is reason to question whether the member of staff remains competent, including following a medicines error, a significant change in medicines processes or procedures, or where additional support or training needs are identified.

{{org_field_name}} may specify an annual refresher-training requirement as an organisational standard, but staff competence must not be assumed solely because training has been attended.

Records of medicines training and competency assessments must be maintained.

9.2 Roles and Responsibilities

Care and Support Staff

Care and support staff are responsible for:

• providing only the medicines support authorised within the service user’s care and support plan;
• working within their training, competency and authority;
• obtaining and respecting consent;
• following medicines records, dispensing labels and agreed protocols;
• making accurate and contemporaneous medicines records;
• promptly identifying and escalating discrepancies, refusals, adverse effects and medicines incidents; and
• maintaining the security and confidentiality of medicines and medicines information.

Senior or Designated Staff

Senior or designated staff responsible for medicines must:

• provide appropriate oversight of medicines systems;
• respond to medicines incidents and concerns;
• ensure appropriate healthcare advice is obtained;
• ensure staff do not undertake medicines duties beyond their competence;
• support investigation and learning following incidents; and
• escalate safeguarding, regulatory or clinical concerns where required.

Registered Manager

The Registered Manager is responsible for:

• ensuring medicines systems comply with applicable legislation, CQC requirements and relevant national guidance;
• ensuring responsibilities for medicines support are clearly assessed and documented;
• ensuring appropriate staff training and competency arrangements are maintained;
• ensuring effective medicines governance and auditing systems are operated;
• ensuring medicines incidents are investigated and learning is implemented;
• ensuring statutory Duty of Candour requirements are followed where applicable;
• ensuring required CQC, safeguarding, controlled drugs or other external notifications and referrals are made; and
• ensuring this policy remains current.

10. Monitoring and Continuous Improvement

10.1 Auditing and Compliance

{{org_field_name}} must operate effective governance arrangements to assess, monitor and improve the safety and quality of medicines support.

Medicines governance must include:

• regular medicines audits at a frequency determined by the organisation’s governance arrangements and level of risk;
• monitoring of medicines administration records and other medicines documentation;
• monitoring of ordering, receipt, storage and disposal arrangements where these are the responsibility of {{org_field_name}};
• review of medicines errors, omissions, near misses, safeguarding concerns and trends;
• monitoring of staff training and competency;
• checking that actions identified through audits or incidents have been completed;
• assessment and mitigation of identified medicines-related risks; and
• consideration of feedback from service users and others involved in their care.

Where an audit, incident or review identifies a deficiency, an appropriate action plan must be implemented, monitored and closed only when sufficient evidence demonstrates that the required improvement has been achieved.

10.2 Policy Review and Quality Assurance

This policy must be reviewed at least annually and sooner where:

• relevant legislation or statutory regulations change;
• CQC requirements or guidance materially change;
• relevant NICE guidance changes;
• a serious medicines incident identifies a deficiency in the policy;
• audit findings demonstrate that the policy is no longer effective; or
• significant changes are made to the medicines systems operated by {{org_field_name}}.

Material changes must be communicated to relevant staff and any additional training or competency assessment required as a result of the changes must be completed.

11. Related Policies

• Medication Administration Policy
• Safeguarding Adults from Abuse Policy
• Infection Prevention and Control Policy
• Incident Reporting and Investigation Policy

12. Policy Review

This policy will be reviewed annually or sooner if significant regulatory or operational changes occur. Updates will be communicated to all staff, and refresher training will be provided where necessary.

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Responsible Person: {{org_field_registered_manager_first_name}} {{org_field_registered_manager_last_name}}
Reviewed on: {{last_update_date}}
Next Review Date: {{next_review_date}}
Copyright © {{current_year}} – {{org_field_name}}. All rights reserved.