This plan gives you a systematic approach to controlled drugs governance. You'll implement daily reconciliation, monthly audits, secure storage, and occurrence reporting that meets Misuse of Drugs Regulations 2001 and satisfies CQC inspections.
This is high-visibility compliance that impresses partners and demonstrates serious risk management capability. CD governance is a CQC hot topic—getting this right shows you understand regulatory requirements and can implement robust safety systems.
Implementation timeframe: 6-8 weeks for full implementation, with immediate improvements in week 1-2
Why This Matters
For Your Practice
Patient safety: Eliminate the risk of CD diversion, theft, or misuse that could seriously harm patients. A single CD incident can be life-threatening.
Regulatory compliance: Meet Misuse of Drugs Regulations 2001 requirements and avoid CQC enforcement action. Non-compliance can result in practice registration restrictions.
Risk reduction: Prevent police investigations, staff suspensions, and criminal proceedings. CD incidents trigger automatic police notification and formal investigation.
Professional protection: Protect your GPs and staff from suspension, GMC referrals, and potential criminal charges. Even innocent staff suffer severe stress during investigations.
Reputation management: Avoid CQC rating downgrades and negative publicity. CD incidents are reported to the Care Quality Commission and can affect your practice's reputation in the community.
For Your Professional Development
By leading this improvement, you'll demonstrate:
Regulatory compliance expertise: Managing complex legal requirements (Misuse of Drugs Regulations 2001, Controlled Drugs Regulations 2013) and demonstrating thorough understanding of CD governance frameworks
Risk management capability: Identifying, assessing, and mitigating serious clinical and operational risks with potential for police investigation and criminal prosecution
System design and implementation: Creating robust daily reconciliation procedures, secure storage protocols, and incident reporting pathways
Stakeholder engagement: Working with GPs, dispensary staff, CD Accountable Officer, and potentially police and regulators
Quality assurance leadership: Implementing monthly audit systems, investigating discrepancies, and demonstrating continuous improvement
Add these achievements to your year-end evaluation: "Led implementation of controlled drugs governance system, achieving 100% daily reconciliation compliance and zero unexplained discrepancies over [X] months, with formal commendation from CD Accountable Officer."
Prerequisites and Preparation
⚠️ Urgent CD Incident? If you've just discovered a discrepancy, loss, or security breach, stop and handle the immediate incident first: contact your CD Accountable Officer within 24 hours, secure the cabinet and records, and document everything. Then return to this plan for systematic improvement.
What You Need Before Starting
Approvals: GP partner sign-off (CDs are a partnership-level risk), budget approval for cabinet meeting Misuse of Drugs (Safe Custody) Regulations 1973 specifications if needed (£800-1,500).
Note: Compliant cabinets typically have 2-4 week lead time for delivery and installation - order early if replacement is required.
Stakeholders: Identify your Medicines Lead (policy owner), CD Accountable Officer (NHS England contact), dispensary manager/staff, prescribing GPs, practice manager
Resources: Budget for secure storage if current cabinet doesn't meet legal specifications, staff time for stock reconciliation checks, monthly audit time (2 hours)
Current state: Audit your existing CD storage, registers, and procedures to identify immediate risks requiring urgent action
Estimated Time Investment
Total implementation
: 6-8 weeks from kick-off to first formal audit
Your time commitment:
Weeks 1-4: 3-4 hours/week (planning, training, document development)
Weeks 5-8: 1-2 hours/week (go-live monitoring, troubleshooting)
Ongoing: 1-2 hours/month (spot audits, supervision, maintenance)
Staff time
: 20 hours total across team (training, procedure development, system setup)
Training time
: 4 hours total (2 hours for dispensary staff, 1 hour for GPs, 1 hour for wider team)
Daily ongoing
: 15 minutes for stock checks once routine is established (frequency depends on volume; weekly minimum per regulations)
The Implementation Plan
Phase 1: Kick-Off and Planning (Week 1-2)
Meeting 1: Initial Kick-Off
Attendees: Practice Manager, GP Partner, Medicines Lead, Dispensary Manager, relevant prescribing GPs
Duration: 60 minutes
Agenda:
Present the problem and business case - Explain legal requirements under Misuse of Drugs Regulations 2001 and consequences of non-compliance (police investigation, CQC enforcement, professional sanctions). If available, reference real CD incidents from your local area to illustrate the risks.
Review scope and objectives - Establish that you will implement systematic stock reconciliation (weekly minimum, daily for high-volume practices), monthly spot audits, quarterly formal audits, secure storage meeting legal specifications, immediate occurrence reporting, and witnessed destruction procedures.
Assign roles and responsibilities - Confirm Medicines Lead as policy owner, identify CD register custodians, establish who holds keys, assign audit responsibility.
Set timeline and key milestones - Week 2: documents approved; Week 4: training complete; Week 6: go-live with daily reconciliation; Week 8: first formal audit.
Identify potential blockers - Current storage inadequate? Staff resistance to daily checks? Unclear CD Accountable Officer contact? Existing discrepancies that need immediate reporting?
Outputs:
Project charter with clear objectives: 100% daily reconciliation, zero unexplained discrepancies, monthly audits, full regulatory compliance
RACI matrix: Medicines Lead (accountable), Dispensary Manager (responsible for daily checks), Practice Manager (consulted), GPs (informed)
Timeline with milestones and owners
Risk register: existing discrepancies, inadequate storage, staff capability gaps, resistance to systematic checks
Action: Create Your Document Package
You'll need these documents from the compliance library:
Policy : Controlled Drugs Governance Policy - establishes legal framework, roles, responsibilities, and governance structure for CD management
SOPs:
CD Stock Reconciliation Procedure - systematic reconciliation process (weekly minimum), register checking with entries made on day of transaction, running balances, discrepancy investigation
CD Occurrence Reporting Procedure - reporting lost, stolen, or unaccounted CDs to CD Accountable Officer within 24 hours
CD Destruction Procedure - witnessed destruction protocol, documentation requirements, approved witness list
Forms:
CD Reconciliation Sheet - structured template for checking register balances against physical stock (adapt frequency to your practice volume)
CD Occurrence Log - recording all discrepancies, losses, security breaches, and actions taken
Audits:
Controlled Drugs Quarterly Assurance Checklist - comprehensive compliance verification covering storage, records, reconciliation, and governance
Three ways to get these documents:
Option 1: Email Assistant (Fastest, no login required)
Email your request to mypm@automate.mypracticemanager.co.uk:
"Draft a CD reconciliation SOP for [Practice Name], 4-doctor practice with on-site dispensary. Include systematic stock checks (weekly minimum), register entries on day of transaction, monthly spot audits, occurrence reporting to CD Accountable Officer within 24 hours, and witnessed destruction procedures."
You'll receive a tailored document within 1-2 minutes as a PDF or Word attachment. Follow up in the same email thread to request edits or ask compliance questions.
Example queries:
"What are the legal requirements for CD register running balances under Misuse of Drugs Regulations 2001?"
"Generate a CD Governance Policy for [Practice Name]. Include roles, storage requirements, reconciliation procedures, and occurrence reporting."
"Review my attached CD policy and suggest improvements for regulatory compliance."
Option 2: Web-Based AI Tools (Best for visual editing) Use our AI document generators at https://app.mypracticemanager.co.uk/ai-tools for step-by-step creation with visual editing. Generation takes ~1 minute, with immediate export to Word or PDF.
Option 3: Compliance Library (Full control) Access pre-built templates at https://app.mypracticemanager.co.uk/library. Each document includes:
Specific regulatory citations (Misuse of Drugs Regulations 2001, Controlled Drugs Regulations 2013)
Clear implementation guidance with realistic timescales
Version control and annual review reminders
Links to related procedures and forms
For manual implementation: Create similar documents ensuring you address:
Misuse of Drugs Regulations 2001 requirements (storage, record-keeping, destruction)
Controlled Drugs (Supervision of Management and Use) Regulations 2013 (governance, occurrence reporting)
CQC Regulation 12 (safe care and treatment)
NHS England CD guidance for primary care
Your CD policy must cover: Access control (who has keys), Receipt and storage (legal specifications per Misuse of Drugs (Safe Custody) Regulations 1973), Prescribing requirements (security, Schedule 2/3 differences), Record-keeping (register entries on day of transaction, running balances), Reconciliation (weekly minimum stock checks), Destruction (witnessed procedure), and Occurrence reporting (24-hour notification to CD Accountable Officer for significant incidents).
See the NHS England Controlled Drugs pages for detailed guidance.
Note: Always review AI-generated content to ensure it meets your specific practice context and regulatory requirements.
Phase 2: Document Development and Review (Week 2-4)
Action: Customize Documents for Your Practice
Follow these steps to adapt the template documents:
Review templates - Read through each document to understand the complete CD governance system: policy sets framework, SOPs provide step-by-step procedures, forms capture evidence
Add practice details - Insert practice name, Medicines Lead name and contact, CD Accountable Officer contact (find via NHS England local team), dispensary location, key holder names
Customize workflows - Adapt daily reconciliation procedure to your register format (bound book vs. electronic), specify your destruction witness list (GP partner, practice manager, senior pharmacist), confirm occurrence reporting escalation path
Add your systems context - Reference your clinical system (EMIS, SystmOne) if using electronic prescribing, note your dispensary opening hours for reconciliation timing, specify your secure storage location and key access process
Clinical review - GP partner confirms prescribing procedures are clinically appropriate and legally compliant
Operational feasibility check - Dispensary manager confirms daily reconciliation is achievable with current staffing (typically 10-15 minutes per day once established)
Using My Practice Manager Tools:
Our AI tools can help you create documents quickly:
Email Assistant (Fastest): Email mypm@automate.mypracticemanager.co.uk with your practice context and requirements. Response within 1-2 minutes with document attached. No login required.
Web AI Tools: Generate documents at https://app.mypracticemanager.co.uk/ai-tools with visual editing. Generation takes ~1 minute, with these features:
Customized CD governance policies based on your practice size and dispensary setup
Support for compliance with Misuse of Drugs Regulations 2001 and Controlled Drugs Regulations 2013
Relevant legal citations and CQC quality statement mappings (Safe.1, Safe.2, Well-led.2)
Export in Word or PDF format ready for partner approval
This reduces document creation from 2-3 days of research and writing to minutes of describing your practice context.
Important: Always review AI-generated content to ensure it meets your specific practice needs and regulatory requirements.
Meeting 2: Document Review Session
Attendees: Implementation team (Practice Manager, Medicines Lead, Dispensary Manager, GP Partner)
Duration: 90 minutes
Agenda:
Review policy and procedures - Walk through each document, confirm roles are correctly assigned, check procedures are achievable
Check for gaps - Ensure all CD types held are covered, verify occurrence reporting pathway is clear, confirm destruction witness list is adequate
Test procedures - Role-play a daily reconciliation check, walk through what happens if a discrepancy is found, practice completing occurrence report
Approve for implementation - GP partner signs off on clinical content, Practice Manager approves operational procedures, Medicines Lead confirms regulatory compliance
Set review dates - Policy annual review, procedures reviewed after 3 months, forms reviewed based on user feedback
Outputs:
Approved document package ready for staff training
Action list: any procedure clarifications needed, forms to be printed/made available, register to be set up
Communication plan: who tells whom about new procedures
Phase 3: Staff Training and Communication (Week 4-6)
Action: Deliver Structured Training Program
Training approach:
Dispensary staff training (2 hours): Detailed session on daily reconciliation procedure, register checking, identifying discrepancies, occurrence reporting, destruction protocol. This is your most critical training—these staff operate the system daily.
Prescribing GPs training (1 hour): Focus on prescribing procedures, prescription security, recognizing red flags for diversion/misuse, their role if a discrepancy is identified. GPs need to understand their professional accountability.
Wider team briefing (1 hour): All staff understand the seriousness of CD governance, know not to touch the CD cabinet or keys, understand they must report any security concerns immediately.
Training materials to prepare:
Dispensary staff pack: Complete procedures, blank reconciliation sheets, occurrence log template, CD Accountable Officer contact card, escalation flowchart
GP prescriber pack: Prescribing requirements summary, red flags for diversion, what to do if discrepancy found, professional accountability reminder
Quick reference cards: Laminated cards for dispensary showing daily reconciliation steps, occurrence reporting trigger points, emergency contact numbers
Common Q&A sheet: "What if the register doesn't balance?", "What counts as an occurrence?", "Who can witness destruction?", "How long do we keep records?"
Communication timeline:
Week 4: Senior team and Medicines Lead (ensuring they can cascade information accurately)
Week 5: Dispensary staff detailed training (hands-on with actual CD cabinet, registers, forms)
Week 5: GP prescribers session (clinical focus, professional obligations)
Week 6: Whole team briefing (context, seriousness, everyone's role in security)
Ongoing: New starter induction includes CD governance module, annual refresher for all staff
Engagement tips:
Use real scenarios: Reference CD occurrence reports from your local area (if available and anonymized) or use examples from NHS England serious incident reports to demonstrate why this matters
Show professional protection angle: Explain how proper procedures protect staff from suspicion and investigation stress
Acknowledge current workarounds: If staff have been doing informal checks, validate that effort and explain how systematic approach is better
Celebrate early adopters: When dispensary staff embrace daily checks, recognize their professionalism and commitment to safety
Address fears directly: Some staff worry they'll be blamed for discrepancies. Clarify that immediate reporting protects everyone; covering up discrepancies creates liability
Phase 4: Go-Live and Monitoring (Week 6-8)
Action: Implement Systematic Stock Reconciliation
Launch approach:
Set clear go-live date - Choose Monday of Week 6. Communicate clearly: "From [date], we will conduct systematic CD stock reconciliation [weekly/daily based on your volume] every [chosen day/morning]." Put reminders in dispensary, add to opening checklist.
Ensure all staff trained - Check attendance records from training sessions. Provide one-to-one catch-up for anyone who missed group training. No one touches CDs without training sign-off.
Position Medicines Lead as support - For first 2 weeks, Medicines Lead available every morning for first hour to support dispensary staff with any questions. This builds confidence.
Monitor closely - Practice Manager checks with Dispensary Manager daily for first week ("Did reconciliation happen? Any problems? How long did it take?"), then weekly for month 1-2.
Hold weekly huddles - 15-minute check-ins with dispensary staff: What's working? What's challenging? Any near-misses? Any suggestions for improvement?
Using My Practice Manager Task Management:
Set up recurring tasks to maintain momentum and create audit trail:
Weekly (Monday): "CD stock reconciliation—verify physical stock against register balances" assigned to Dispensary Manager (15-30 minutes depending on volume; high-volume practices may choose daily)
Weekly (Friday): "Review CD occurrence log for any unreported discrepancies" assigned to Medicines Lead (5 minutes)
Monthly: "CD spot audit—sample 5 register entries and verify against stock" assigned to Practice Manager (30 minutes)
Quarterly: "Formal CD compliance audit using checklist" assigned to Medicines Lead (2 hours)
This ensures nothing gets forgotten and provides clear evidence trail for CQC inspections.
Key metrics to track from Week 6:
Reconciliation compliance: Target 100% (all scheduled reconciliations completed and logged)
Register entry compliance: Target 100% (all register entries made on day of transaction per Regulations 19-20)
Register accuracy: Target 100% (all running balances correct on checked entries)
Discrepancy resolution time: Target <24 hours from identification to investigation completion
Occurrence reporting compliance: Target 100% (all significant occurrences reported to CD Accountable Officer within 24 hours)
Staff confidence: Measured through weekly huddles and feedback
Early warning signs to watch for:
Reconciliation checks being skipped or retrospectively completed
Discrepancies noted but not investigated immediately
Staff completing checks but not understanding what they're doing
Register errors accumulating (corrections, crossing out, unclear entries)
Staff anxiety about finding discrepancies (may indicate fear of reporting)
Phase 5: Review and Continuous Improvement (Month 2-3)
Meeting 3: First Review Session
When: 6 weeks after go-live (Week 12 overall)
Attendees: Implementation team plus frontline dispensary staff member
Agenda:
Review metrics: Present data on reconciliation compliance (% of days completed), discrepancies found and resolved, time taken for daily checks, any occurrences reported
Celebrate successes: Recognize dispensary staff professionalism, commend systematic approach, acknowledge zero unexplained discrepancies (if achieved)
Address problems: Discuss any compliance gaps (missed days, late reconciliations), identify barriers to daily checks, resolve any procedure confusion
Adjust procedures if needed: If daily checks taking too long, streamline process; if occurrence reporting unclear, simplify flowchart; if forms are confusing, revise templates
Plan next cycle: Confirm quarterly audit date, set next review meeting (3 months), identify any additional training needs
Outputs:
Performance dashboard: Line graph showing daily reconciliation compliance over time, bar chart of discrepancies found and resolved
Action plan: Any procedure improvements with owner and deadline (e.g., "Revise reconciliation sheet to add running balance column - Dispensary Manager - by Week 14")
Evidence package: Training records, meeting minutes, metrics dashboard, occurrence reports, audit results—all ready for CQC
Communication to partners: Brief report to partners showing system is working, metrics are good, compliance is strong
Action: Conduct First Formal Audit
Using the Controlled Drugs Quarterly Assurance Checklist from your document package:
Audit scope (2 hours total):
Sample register entries systematically - Select 20 random entries per CD type held over past 3 months. Check each entry for: entered on day of transaction (Regulation 19 requirement), correct date, correct stock movement, running balance calculated correctly, legible handwriting, no unexplained corrections
Verify physical stock against registers - Count actual stock of each CD, compare to register running balance, investigate any discrepancies immediately
Review occurrence log - Check all discrepancies were recorded, investigate times were <24 hours, CD Accountable Officer was notified where required, outcomes were documented
Assess security and storage - Verify CD cabinet meets Home Office standards, check key control log is maintained, confirm only authorised staff have access
Check destruction records - Review all destruction certificates for past 3 months: correct witness signatures, accurate quantities, disposal method documented
Audit findings documentation:
Compliant areas: List what's working well (e.g., "100% daily reconciliation compliance for 12 weeks", "All destruction properly witnessed and documented")
Non-compliances: Identify any gaps (e.g., "3 register entries missing running balance", "One occurrence report filed 36 hours after identification")
Action plan: For each non-compliance, specify corrective action, responsible person, deadline (e.g., "Train dispensary staff on running balance calculation—Medicines Lead—by Week 14")
Follow-up audit: Schedule re-audit of non-compliant areas after deadline (e.g., "Re-sample register entries in Week 16 to verify running balances now complete")
Outputs:
Formal audit report with findings and compliance percentages
Action plan addressing each finding with SMART objectives
Evidence file for CQC inspection: "We conduct quarterly CD audits with documented findings and action plans demonstrating continuous improvement"
Baseline for measuring future performance: Can you demonstrate improvement over time?
Common Problems and Solutions
Problem 1: "The registers never balance—we always have small discrepancies"
Why this happens: Recording errors accumulate when not caught immediately. One person records a prescription but forgets to update running balance. Another person dispenses but records in wrong register. Within days, the register is wrong and no one can trace the error.
How to address it:
Stop and reconcile now: Clear all current discrepancies before implementing new system. Do physical stock count, correct register to match actual stock, document the correction in occurrence log with explanation.
Implement two-person checks: One person records transaction, second person verifies entry and recalculates running balance immediately. Catches errors before they accumulate.
Investigate discrepancies same day: If morning reconciliation finds mismatch, stop and investigate before any more transactions. Don't let errors compound.
Simplify the register format: If using bound book with complex running balance calculations, consider electronic register with automatic calculation (if meets legal requirements for indelible records).
Prevention: Regular systematic reconciliation (weekly minimum, daily for high-volume practices) catches errors when they're fresh and traceable. Less frequent checks allow errors to accumulate—by then, no one remembers the transaction and you can't resolve discrepancies.
Problem 2: "Staff are afraid to report discrepancies because they think they'll be blamed"
Why this happens: Culture of blame rather than learning. If past incidents led to disciplinary action, staff learn to hide problems rather than report them. This makes small issues become serious incidents.
How to address it:
Communicate Just Culture principles: Honest mistakes are learning opportunities. Covering up discrepancies is a disciplinary issue; reporting them promptly is professional and protected.
Protect reporters: When discrepancies are reported, thank the reporter publicly. Investigate the system failure (Why was error possible? How do we prevent it?) not the person.
Practice Manager models reporting: If you find a discrepancy in audit, report it yourself following proper procedure. Show that reporting is normal and safe.
Address intentional concealment seriously: If someone hides a discrepancy, that's when disciplinary action is appropriate. This protects staff who report honestly.
Prevention: Regular supervision conversations where you ask "Any near-misses or concerns this week?" Normalize discussion of errors and system improvements.
Problem 3: "We don't have time for regular reconciliation—we're too busy"
Why this happens: Perception that reconciliation takes ages. Fear that it will disrupt workflow. Underestimating the risk of infrequent checking. Not understanding that frequency can be tailored to practice volume.
How to address it:
Time the task realistically: Ask dispensary staff to time themselves for one week. Most practices find weekly reconciliation takes 15-30 minutes once routine is established, not the hour or more they feared.
Scale frequency to volume: Weekly reconciliation is the legal minimum. High-volume dispensaries (>20 CD transactions/week) should consider daily checks to prevent errors accumulating. Low-volume practices (few CD transactions) may find weekly adequate.
Show time savings from efficiency: Regular checks prevent the hours spent investigating accumulated discrepancies. Preventing one police investigation saves hundreds of staff hours and potential criminal charges.
Build into routine: Like stock ordering and expiry checks, CD reconciliation becomes a scheduled, non-negotiable task.
Prevention: Build reconciliation time into dispensary rota. Assign specific staff member and protected time each week (or day for high-volume practices).
Problem 4: "Our CD cabinet doesn't meet legal specifications but replacing it is expensive"
Why this happens: Old practices may have inherited cabinets that were compliant when installed but don't meet Misuse of Drugs (Safe Custody) Regulations 1973 standards. Budget constraints delay replacement.
How to address it:
Assess the risk immediately: If cabinet is clearly non-compliant (not metal construction, not securely fixed to wall/floor, inadequate lock quality), this is a serious risk requiring urgent action. Don't wait for next budget cycle.
Make business case to partners: Frame as essential risk mitigation, not optional improvement. Compare £1,000 cabinet cost to £50,000+ cost of police investigation, insurance claims, CQC enforcement, potential criminal charges.
Implement interim security measures: While awaiting new cabinet, increase key control (keys locked in practice manager's office out of hours), add CCTV covering cabinet area, increase reconciliation frequency, consider security guard for high-risk periods.
Budget for replacement: Get quotes for cabinets meeting Misuse of Drugs (Safe Custody) Regulations 1973 specifications (typically £800-1,500), schedule installation within 4-8 weeks maximum.
Prevention: Annual premises audit should include CD storage security check against legal specifications. Budget for equipment replacement on 10-year cycle.
Problem 5: "Locum GPs don't know our CD procedures and prescribe inappropriately"
Why this happens: Locums aren't integrated into your governance systems. They assume CD prescribing is same everywhere. Practice doesn't include CDs in locum induction.
How to address it:
Create locum CD briefing pack: One-page summary of your CD prescribing requirements, red flags for diversion, who to contact with concerns, occurrence reporting procedure.
Include in locum induction: Practice Manager or Medicines Lead spends 10 minutes with every locum on first day covering CD governance, not just clinical software.
Flag CD prescriptions for review: If locum prescribes Schedule 2 CD for new patient, dispensary flags for Medicines Lead review before dispensing.
Debrief after each locum shift: Quick check-in: "Any CD prescriptions today? Any concerns? Any questions?"
Prevention: Use regular locums where possible (build relationships and trust). Include CD governance in locum agency contracts (expectation that locums follow practice procedures).
Success Criteria and Evidence
You'll Know You've Succeeded When:
100% reconciliation compliance: All scheduled reconciliations (weekly minimum, or daily for high-volume practices) completed with signed, dated sheets and all running balances verified against physical stock
Timely register entries: All CD register entries made on the day of transaction as required by Misuse of Drugs Regulations 2001 (Regulation 19)
All discrepancies investigated and resolved within 24 hours: Any variance between register and physical stock is investigated same day, with actions documented in occurrence log and reported to CD Accountable Officer where required. Register balances are corrected and explained.
Immediate occurrence reporting: All significant occurrences (losses, thefts, security breaches) reported to CD Accountable Officer within 24 hours with full investigation and outcome
Monthly audits consistently show compliance: Quarterly formal audits score >95% compliance across all checklist items (storage, records, procedures, governance)
Staff confidence and competence: Dispensary staff can describe daily reconciliation procedure accurately, know how to report occurrences, demonstrate understanding in supervision conversations
Register quality is high: Entries are legible, timely, accurate, with running balances calculated correctly and no unexplained corrections or retrospective entries
No significant incidents: No CD losses, thefts, or diversion incidents. No police involvement. No CQC enforcement action related to CD management.
Evidence You Can Show to CQC:
During inspection, you can present:
Documentation and records:
Approved Controlled Drugs Governance Policy with version control, annual review dates, partner signatures
Complete set of procedures (reconciliation, occurrence reporting, destruction) with staff training records
CD registers showing daily balances and running totals with no gaps or unexplained discrepancies
Occurrence log demonstrating immediate reporting and thorough investigation of any discrepancies
Destruction certificates with authorized witness signatures and proper documentation
Audit and assurance evidence:
Monthly spot audit records showing systematic compliance checks
Quarterly formal audit reports with findings, action plans, and follow-up verification
Training attendance records with competency sign-off for all staff handling CDs
Supervision records showing regular discussion of CD governance with dispensary staff
Performance data and trends:
Dashboard showing 100% reconciliation compliance over past 6-12 months (all scheduled checks completed)
Register entry compliance (percentage of entries made on day of transaction per Regulation 19)
Register accuracy metrics (percentage of entries with correct running balances)
Occurrence report response times (average time from identification to investigation completion)
Investigation and resolution of all discrepancies with documented outcomes
Governance and oversight:
Meeting minutes showing regular CD governance discussion at management/partner meetings
Annual policy review documentation with evidence of updates reflecting regulatory changes
Communication records with CD Accountable Officer (occurrence reports, inspection feedback)
Staff feedback from supervision conversations demonstrating culture of safety and reporting
Maintaining the Improvement
Monthly activities (1-2 hours):
Spot audit: Sample 5-10 register entries (check entries made on day of transaction per Regulation 19), verify running balance accuracy, check all reconciliation sheets completed
Review occurrence log: Confirm all discrepancies were investigated, check resolution times, identify any trends
Supervision with dispensary staff: 30-minute conversation about CD governance—any concerns, near-misses, suggestions for improvement
Report to partners: Brief monthly update on CD compliance metrics (reconciliation completion, register entry compliance, occurrences), audit results
Quarterly activities (2-3 hours):
Formal compliance audit: Complete the Controlled Drugs Quarterly Assurance Checklist, document findings, create action plan
Policy and procedure review: Check procedures still reflect actual practice, update any contact details or role changes, confirm staff training is current
Governance meeting: Present audit results to partners or practice management meeting, discuss any trends or concerns, confirm ongoing compliance
External engagement: Share audit results with CD Accountable Officer (demonstrates proactive governance), request feedback or updated guidance
Annual activities (4-6 hours):
Policy review and approval: Full review of CD Governance Policy, update for any regulatory changes, partner sign-off on revised policy
Refresher training: All staff complete CD governance refresher session (1 hour), new scenarios and reminders, test understanding
Deep-dive audit: Extended audit covering full year of records, trend analysis, benchmarking against previous years, identify improvement opportunities
Regulatory update check: Review NHS England CD guidance, check for Misuse of Drugs Regulations updates, ensure procedures reflect current requirements
Embedding the change:
New starter induction: Every new staff member completes CD governance module before handling CDs, includes procedure review, legal requirements (register entries on day of transaction), and competency assessment
Make it routine: Systematic reconciliation becomes as automatic as stock ordering or expiry date checks—no longer a "project", just how we work
Success stories: When CD Accountable Officer commends your governance, share with team. When CQC inspection finds no concerns, celebrate as team achievement.
Continuous improvement: Use audit findings to refine procedures. If reconciliation frequency needs adjusting based on volume, adapt it. If staff have good suggestions, implement them.
Additional Resources
My Practice Manager Tools
Compliance Library Access the complete controlled drugs document package referenced in this plan:
Policy, procedures, forms, and audit checklists
Built-in regulatory citations (Misuse of Drugs Regulations 2001, Controlled Drugs Regulations 2013, CQC Regulation 12)
Implementation guidance with realistic timescales
Annual updates reflecting regulatory changes
Email Compliance Assistant Get instant help throughout your implementation:
Answer compliance questions within minutes
Generate customized documents (policies, SOPs, forms)
Review and improve existing documents
No login required—just email your request
Example queries:
"What are CD reconciliation requirements under Misuse of Drugs Regulations 2001?"
"Generate a CD occurrence reporting procedure for [Practice Name]"
"Review my attached CD policy and suggest improvements"
AI Document Tools Generate customized CD governance documents in ~1 minute:
Visual editing interface for detailed customization
Support for compliance with current regulations
Export in Word/PDF format ready for approval
Always review AI-generated content for your specific context
Task Management Set up automated CD governance tasks:
Weekly (or daily for high-volume) reconciliation reminders for dispensary staff
Weekly occurrence log reviews for Medicines Lead
Monthly spot audits for Practice Manager
Quarterly formal audits with email notifications
Never miss a deadline or compliance check
Related Improvement Plans
Related improvement plans covering complementary medicines management topics are coming soon.
Regulatory Guidance and Standards
Essential regulatory sources:
Misuse of Drugs Regulations 2001 - Primary legislation governing CD management
Controlled Drugs (Supervision of Management and Use) Regulations 2013 - Governance and occurrence reporting requirements
NHS England Controlled Drugs Guidance - Best practice guidance for primary care, includes occurrence reporting forms and templates
CQC Regulation 12 Safe Care and Treatment - CQC regulatory requirements for medicines management
CQC GP Mythbuster 55: Controlled Drugs - What CQC actually looks for during inspections
Professional guidance:
Royal Pharmaceutical Society: Professional Guidance on Safe Management of Controlled Drugs in Community Pharmacy
General Medical Council: Good Practice in Prescribing and Managing Medicines and Devices
Find your CD Accountable Officer: Contact your NHS England regional team or search "NHS England CD Accountable Officer [your area]"
Getting Help
Having trouble with our tools? Our support team can help you customise documents, set up tasks, and make the most of My Practice Manager features: contact@mypracticemanager.co.uk
Urgent CD incident support? For immediate guidance on CD occurrences (discrepancies, losses, security breaches):
Contact your CD Accountable Officer immediately (within 24 hours is legal requirement)
Secure the scene (restrict access to CD cabinet and records)
Document everything (what you found, when, who was involved, actions taken)
Follow your occurrence reporting procedure
Contact us for implementation support if your procedures aren't clear
This improvement plan is provided as practical guidance for GP practice managers implementing controlled drugs governance systems. While based on current regulatory requirements (Misuse of Drugs Regulations 2001, Controlled Drugs Regulations 2013, CQC Regulation 12), you must exercise professional judgment and adapt recommendations to your practice's specific circumstances, current CD stock levels, and dispensary operations. For legal advice or practice-specific risk assessments, consult appropriate professionals. For urgent CD incidents, contact your CD Accountable Officer and follow legal reporting requirements immediately.
