Controlled Drug Reporting
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Controlled Drug Quarterly Occurrence Report For Designated Bodies

When completing this form, please note that the term “controlled drugs” refers to all controlled drugs in schedules 2 to 5.
Examples of these include:
  • Codeine (Schedule 2 and 5)
  • Morphine (Schedule 2 and 5)
  • Fentanyl (Schedule 2)
  • Gabapentin (Schedule 3)
  • Pregabalin (Schedule 3)
  • Anabolic steroids (Schedule 4b)
  • Benzodiazepines and Hypnotics (Schedule 4a)
  • Co-codamol 8/500mg (Schedule 5)
The word incident is used in this report to describe an event or situation arising in the course of work that resulted in or could have resulted in injuries, illnesses, damage to health, or fatalities. “Near miss” or “dangerous occurrence” are also terms for an event that could have caused harm but did not and these maybe treated as an “incident”.
Please note:
This form is for Designated bodies and selected organisations. It can only be completed by selected your organisation from the drop down list. If your organisation is not listed, please contact your Regional Controlled Drug Accountable Officer.
You will be notified by your Controlled Drugs Accountable Officer team if you are a selected organisation to complete this form. Where the term "Controlled Drug Accountable Officer" is used, this will refer to the person responsible for controlled drugs in your organisation. If you have any quesions, please contact your Regional Controlled Drugs Accountable Officer team.
To contact Controlled Drugs Accountable Officer team Click here
All sections in this form are mandatory.
The green submit button below section 5, will show once all sections have been completed.
Section 1: Organisation and Reporter Details
1. Select your Region
2. Select your Designated Body
3. Reporter details
You must select one of the following that will automate your profile:
I am the Controlled Drug Accountable Officer completing this form
I am completing this form on behalf of the Controlled Drug Accountable Officer with their consent
Section 2: Date range of report
1. Select Year
2. Select Quarter
Section 3: Number of recorded incidents
Please record the number of incidents that have occurred in this quarter by category and harm rating.
Please ensure that all the following incidents have been reported as an incident on the Incident Module on the Controlled Drug Reporting website:
  • Persons, professional or staff of interest or concern
  • Actual or suspected diversion of controlled drugs
  • Incidents classified as Severe or Fatal Patient Harm, either physical or psychological harm
  • Any other incidents considered to be significant to the Designated Body Controlled Drugs Accountable Officer
Click here for the Incident Module to open as a separate tab
If your organisation has had no incidents in this quarter, please continue on to Section 4, the incident sections are pre-populated with zero responses and this is your nil report.
Patient Harm
This can be physical or psychological
Categories No Harm Low Moderate Severe Fatal Don't Know
Patient Involved
Where a patient was or could have been involved in the incident
Examples – Administration, Dispensing, Prescribing or Delivery errors
Unaccounted for Losses
Controlled drug or controlled stationary that is not accounted for; not understood or an unexplained loss
Examples – Running balance issues (underage and overage), lost, missing or stolen controlled drugs or prescriptions, recording or register errors
Accounted for Losses
A loss that can be explained and accounted for
Examples – Spillage, Destruction, Manufacture error
Patient or member of the Public of concern
These are incidents or concerns when a patient or member of the public can be identified as involved or suspected of theft, diversion or illicit use
Examples – Allegation or fraudulent activity, including theft and diversion, drug seeking behaviour and illicit use
Professional or Employee of concern
These are incidents or concerns when a professional or employee can be identified as involved or suspected of theft, diversion or illicit use
Examples – Allegation or fraudulent activity, including theft and diversion, drug seeking behaviour and illicit use
Governance
The system by which an organisation is controlled and operates, and the mechanisms by which it, and its people are held to account
Examples – Regulatory body issue, staff handover error, controlled drug cupboard unlocked, storage errors
Other
Anything that is not covered under any of the headings above
Total
Definitions of harm
Low
Low physical harm is when all of the following apply:
  • did not or is unlikely to need further healthcare beyond a single GP, community healthcare professional, emergency department or clinic visit
  • did not or is unlikely to need further treatment beyond simple dressing changes or short courses of oral medication
  • did not or is unlikely to affect that patient’s independence
  • did not or is unlikely to affect the success of treatment for existing health conditions
Moderate
Moderate harm is when at least one of the following apply:
  • has needed or is likely to need healthcare beyond a single GP, community healthcare professional, emergency department or clinic visit, and beyond simple dressing changes or short courses of medication, but less than 2 weeks additional inpatient care and/or less than 6 months of further treatment, and did not need immediate life-saving intervention
  • has limited or is likely to limit the patient's dependence, but for less than 6 months
  • has affected or is likely to affect the success of treatment, but without meeting the criteria for reduced life expectancy or accelerated disability described under severe harm
Severe
Severe harm is when at least one of the following apply:
  • needed immediate live-saving clinical intervention
  • is likely to have reduced the patient's life expectancy
  • has, or is likely to have, reduced the chances of preventing or delaying disability from their existing healthcare conditions
  • needed or likely to need additional inpatient care of more than 2 weeks and/or more than 6 months of further treatment
  • has limited or is likely to limit the patient's independence for 6 months or more
Fatal
  • You should select this option if the patient has died and there is at least a slight possibility the incident that you are recording may have contributed to the death, including stillbirth or pregnancy loss. You will have the option later to estimate to what extent a patient safety incident contributed to this fatal outcome.
Section 4: Submission for NIL Report (no incidents reported)
1. I confirm that this Organisation is submitting a NIL return, in that no controlled drug incidents from the Schedules 2 to 5 have occurred in this quarter.
Please note that this includes Controlled Drugs in Schedules 4 and 5 such as: anabolic steroids, benzodiazepines, hypnotics, codeine, dihydrocodeine, co-codamol 8/500mg, morphine sulphate 10mg/5ml oral solution.
2. Has your organisation handled or managed controlled drugs during this reporting quarter?
3. Do you have a system in place for identifying incidents related to controlled drugs
4. Do you have a system in place for investigating and mitigating risks as described under the Controlled Drugs (supervision of management and use) Regulations 2013?
5. Does your organisation share incidents, mitigations and nil reports, with your Board or Governing Body?
6. Please share any areas of good practice or learning that have been implemented such as a review of certain processes, procedures or safety measures that have been introduced. Only a brief description or subject title is required which can allow trends to be identified and followed up as appropriate.
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