The Safer Management Of Controlled Drugs - Care Quality Commission

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The safer managementof controlled drugsAnnual update 2017Published July 2018

The Care Quality CommissionThe Care Quality Commission is the independent regulatorof health and adult social care in England.We make sure that health and social care services providepeople with safe, effective, compassionate, high-quality care andwe encourage care services to improve.Our role We register health and adult social care providers. We monitor and inspect services to see whether they aresafe, effective, caring, responsive and well-led, and wepublish what we find, including quality ratings. We use our legal powers to take action where we identifypoor care. We speak independently, publishing regional and nationalviews of the major quality issues in health and social care,and encouraging improvement by highlighting good practice.We also have a statutory duty to oversee the safe managementarrangements for controlled drugs in England.Our values Excellence – being a high performing organisation. Caring – treating everyone with dignity and respect. Integrity – doing the right thing. Teamwork – learning from each other to be the best we can.Care Quality Commission The safer management of controlled drugs: Update report for 20172

ContentsIntroduction .4Overview and recommendations .4Progress on recommendations from the 2016 report .6Activity in 2017 .7Register of controlled drug accountable officers.7Updates for providers .7Controlled drug issues found on inspection .8Issues identified when prescribing from multiple sources .12NHS England’s area teams and controlled drug local intelligence networks .12Controlled Drugs National Group .15Sub-groups .15Cross-Border Group .15National trends in the use and management of controlled drugs .16Primary care prescribing of controlled drugs .16Schedule 1 controlled drugs.16Schedule 2 controlled drugs.16Schedule 3 controlled drugs.18Schedule 4 controlled drugs.19Schedule 5 controlled drugs.20Summary of controlled drug prescribing by Schedule .21Ten-year trends .22Non-medical prescribing .25Controlled drug prescribing in the independent sector .26Schedule 2 controlled drugs prescribed privately.26Schedule 3 controlled drugs prescribed privately.27Controlled drug requisitions .28Next steps .29Care Quality Commission The safer management of controlled drugs: Update report for 20173

IntroductionThe Care Quality Commission (CQC) is responsible for making sure thathealth and adult social care providers, and other regulators, maintain a safeenvironment for the management of controlled drugs in England. We do thisunder the Controlled Drugs (Supervision of Management and Use)Regulations 2013.This is our annual report to Government, in which we make recommendationsto help ensure the continuing effectiveness of the arrangements for managingcontrolled drugs in England. These are important for all controlled drugsaccountable officers (CDAOs) in England and their support teams, as well asorganisations that handle controlled drugs, healthcare professionals with aninterest in controlled drugs, commissioners of healthcare services andprofessional healthcare and regulatory bodies.Overview and recommendationsCQC chairs the National Group on Controlled Drugs and the four sub-groups.This enables us to share information and discuss issues with otherorganisations, with a focus on key areas such as thefts and frauds, patientsafety, policy and operational issues, and prescribing. We also met with crossborder colleagues in Wales, Scotland, Northern Ireland, the Republic ofIreland, the Channel Islands and the Isle of Man, to share good practice anddiscuss strategic controlled drugs-related issues across our borders.As part of our oversight activity, we monitor the effectiveness of controlled druglocal intelligence networks across England. NHS England’s CDAOs haveworked collaboratively in these networks and are using a newly-agreedcontrolled drug occurrence reporting template. This improves consistencywhen sharing both concerns and good practice, and has helped to build abetter national picture of issues related to controlled drugs. NHS England’selectronic occurrence reporting tool was rolled out to all regions in late 2017.Based on our learning from work in all these areas, we make fourrecommendations.Our first recommendation relates to prescribing controlled drugs outside ofNHS general practice, for example by independent healthcare professionals,and the importance of informing a patient’s own GP when this happens. Thishelps to ensure that patients are kept safe and that GPs maintain an overviewof all the medicines prescribed to their patients.Care Quality Commission The safer management of controlled drugs: Update report for 20174

Because of the growing complexity of new and emerging models of care, oursecond recommendation is relevant for commissioners of health and care. Allthose involved in commissioning need to be aware of the responsibilities andgovernance arrangements for controlled drugs as part of any newcommissioning arrangements.The third recommendation highlights the importance of vigilance and securityfor healthcare professionals and of reporting any losses of personalidentification mechanisms such as badges and passwords. This follows a risein personal identity theft, sometimes to fraudulently obtain controlled drugs.We also highlight the importance of monitoring controlled drugs in the lowerschedules, such as Schedules 4 and 5, which comprise more than 67% ofcontrolled drugs prescribed in primary care. Regular monitoring will help toidentify diversion and to take swift action to reduce it.Recommendations1. Prescribers should ask patients about their existing prescriptions andcurrent medicines when prescribing controlled drugs. Where possible,prescribers should also inform the patient’s GP to make them aware oftreatment to minimise the risk of overprescribing that could lead to harm.2. Commissioners of health and care services should include the governanceand reporting of concerns around controlled drugs as part of thecommissioning and contracting arrangements so that these are notoverlooked.3. Healthcare professionals should keep their personal identification badgesand passwords secure and report any losses as soon as possible toenable organisations to take the necessary action.4. Health and care staff should consider regular monitoring and auditingarrangements for controlled drugs in the lower schedules, such asSchedules 4 and 5, to identify and take swift action on diversion.Care Quality Commission The safer management of controlled drugs: Update report for 20175

Progress on recommendations fromthe 2016 reportIn our report on activity during 2016, we made three recommendations toimprove the management of controlled drugs.RecommendationProgressNHS England controlled drugsaccountable officers should beaware of new models of careacross their area and, whereappropriate, include them in thecontrolled drugs local intelligencenetwork meetings.NHS England controlled drugsaccountable officers have continuedto review and broaden themembership of local intelligencenetworks. As part of this ongoingreview, they are taking intoconsideration new models of careand the subsequent new range ofhealthcare services that haveresponsibility for controlled drugs.Controlled drugs accountableofficers should ensure that allstaff in their organisation knowhow to report concerns ofdiversion and abuse ofmedicines by fellow colleagues,and that these issues arehandled sensitively andappropriately.Feedback on this recommendationhas been positive, with manyorganisations welcoming therecognition of this often difficult butneglected part of a controlled drugsaccountable officer’s role. Thisrecommendation has helped toinfluence organisational processes.Prescribers must make sure that theyreview patients regularly, dependingon their clinical need. This is to ensurethat the prescribed controlled drugsand length of treatment continues tobe the most appropriate for theircondition and to reduce opportunitiesfor over-prescribing and diversion.Most local intelligence networkshave discussed high volumeprescribing following thisrecommendation. Many CCGs havecommissioned local data studiesand presented their findings atnetwork meetings. In general, thisfound that high volume prescribingis associated with patients withcomplex needs.Care Quality Commission The safer management of controlled drugs: Update report for 20176

Activity in 2017Register of controlled drug accountable officersCQC maintains and publishes an online register of controlled drugsaccountable officers (CDAOs) across England for those organisations that areregistered with CQC and are required under the 2013 Regulations to haveone. We update this register monthly. These organisations are defined asdesignated bodies under the regulations and are required to notify CQC oftheir CDAO appointment.A very small number of organisations are registered solely with the HumanFertilisation and Embryology Authority (HFEA), and not with CQC. Our websitealso provides a link to HFEA’s register of CDAOs.Throughout 2017, there was an average of 996 organisations on our CDAOregister. Of these, 750 CDAOs were from independent healthcareorganisations, 246 were from NHS organisations and the others fromorganisations such as social care providers that fall within the designated bodystatus.To keep the CDAO register up to date, it is important that organisations tell usabout any changes to their CDAOs’ details. If an organisation re-registers withCQC, it needs to submit a new CDAO notification. In 2017, we receivedapproximately 30 notifications each month. Notifications can be made usingthe online webform. Changes to contact details such as email address orphone numbers can be emailed to [email protected] continued to grant exemptions for the need to have a CDAO where it isdisproportionate to appoint one in independent healthcare organisations thathave more than 10 employees but have a low use of controlled drugs.Organisations with fewer than 10 employees are automatically exempted. Theuptake of the exemption by eligible organisations continues to remain low, andin 2017 we received and approved six CDAO notification exemptions.The controlled drugs section on CQC’s website now includes guidance aboutthe exemptions, the criteria that must be met to be appointed as a CDAO, andhow different types of organisations can notify us about changes. Revised selfassessment tools will also be available on our website.Updates for providersAll information about CQC’s activity in relation to controlled drugs is available onour website: This includes links to relevantlegislation, information and tools for controlled drugs accountable officers,notifications forms, and information about the Controlled Drugs National Group.Care Quality Commission The safer management of controlled drugs: Update report for 20177

Controlled drug issues found on inspectionIn response to feedback on our previous annual reports on safely managingcontrolled drugs, we have summarised some of our findings from inspectionsin relation to controlled drugs and the arrangements that we would expect tosee in place.Our findingsOur expectationsGOVERNANCE ISSUESCDAO notificationsWe sometimes find that the details ofthe CDAO on the register do not matchthose of the CDAO in post – particularlywhen the CDAO has recently moved toa new role.We expect a timely notification so thatthe register is up to date to enable theCDAO to be contacted as required.Home Office licences for controlled drugsThere is often a lack of understanding ofwhen a Home Office licence is requiredand for what schedules.Also, there is a lack of awareness thatthere are licences for both Home Officepossession and Home Office supply,which providers may need to appy for.Organisations must seek their ownadvice. We expect to see evidence oninspection to show that the Home Officehas been contacted where a licencemight be required.Lack of awareness of relevant guidance and safety alertsMany queries to CQC can easily beanswered by referencing the NICEguidance NG46, safety alerts and othersources of information and evidencebased resources such as PresQIPP.Organisations should be familiar withrelevant guidance and ensure that theycascade it where required.We would like to see on inspection howthis has been implemented in wards ordepartments.Reporting incidents and concernsThere is a general lack of awareness ofwho to report incidents to (either to theorganisation’s CDAO, the MSO, theNHS England lead CDAO for the area,CQC, other professional and regulatorybodies, the police or the NRLS).We expect organisations to have astandard operating procedure in placethat explains all ways to report and thatencourages open reporting and a nonblame culture. We also expect to seeevidence of incidents and the learningfrom them.Care Quality Commission The safer management of controlled drugs: Update report for 20178

Illicit substancesThis issue is becoming more apparentand we are aware of more frequent andincreasing quantities being brought ontohealthcare premises.Organisations need to have a clearprocedure and maintain a robust audittrail with secure, sealed containment ofunknown substances. A small amountcan be destroyed locally as an unknownsubstance. Larger quantities (not forpersonal use) will need to be notified tothe police.We are aware of some emerging trends,such as patients bringing in their ownsupply of cannabis containing productssuch as CBD oil.If there is a particular trend, this shouldbe communicated to the NHS EnglandCDAO so they can share the issue andany learning with the CDLIN.ORDERING ISSUESControlled drug mandatory requisition formThere is a general lack of understanding Providers need to follow guidance onof when to use the form.the NHS BSA website.Services are also sometimes unawarethat a doctor must sign the requisition ifsupply is from a separate legal entity.We expect the organisation to be awareof the requirements set out in MDR2001.RECORD KEEPING ISSUESRecordsThese are generally completed well,although there is sometimes confusionbetween the controlled drug registerand controlled drug record books inwards and departments.There should only be one controlleddrug register at the premises.Controlled drug record booksNot all theatres follow the good practicerequirement to complete the amountused/amount wasted.We expect organisations to adopt goodpractice initiatives.STORAGE ISSUESWe find that some organisations stillstore controlled drugs in woodencupboards, which do not meet theminimum standard.We expect organisations named in TheSafe Custody Regulations 1973 to complywith the regulations, and organisationsoutside the scope to use the requirementsas a minimum standard.Sometimes the contents of the cupboarddo not match what is in the register. Thisis not usually a stock issue but related toa patient’s own or ‘just in case’medicines for end of life care.All drugs stored in a controlled drugscupboard must be recordedappropriately.Care Quality Commission The safer management of controlled drugs: Update report for 20179

Not all organisations separate high andlow strength preparations or thoseintended for different routes such asepidurals and intravenous injections,which can increase the risk of selectingand administering the wrong preparation.We expect organisations to carry outtheir own risk assessment andincorporate relevant guidance into theirprocesses.Some organisations are unsure how tomanage situations where neither thelegislation nor guidance covers theexact situation they are dealing with, forexample, where controlled drugs arestored in a fridge or robot, or wherethere is no solid wall to affix thecupboard.We expect a documented riskassessment to be in place. Above all,controlled drugs must remain secure, forexample, a separate secure containerfor controlled drugs that needrefrigeration, or secure storage within arobot. An exemption certificate issuedby the police may also be required.Where there is no solid wall, othermeasures should be considered, forexample, strengthening an internal wallor reviewing the location of thecupboard, and the decision recorded ina risk assessment that is reviewedregularly.Access to controlled drugsAccess to keys and cupboards isgenerally managed well.We expect a standard operatingprocedure to be in place that coversaccess to keys, and staff to adhere to it.We also expect to see monitoring inplace as we are aware that controlleddrugs are often diverted by those withlegitimate access.PRESCRIBING ISSUESNationally, there is a general naivetyregarding diversion issues.It is important to minimise the quantity ofa controlled drug prescribed and toregularly review the patient’s ongoingneed. It is particularly important toconsider the quantity issued in anemergency and for temporary residentsuntil checks are carried out.Organisations do not always considerthe need for a reversal agent (amedicine that reverses the effect of themedicine administered to the patient).We expect this to be considered as partof the prescription where appropriate,and it may need to form part of a clinicalprotocol.Care Quality Commission The safer management of controlled drugs: Update report for 201710

ADMINISTRATION ISSUESThere is some uncertainty regardingadministration of controlled drugs by asingle nurse and the need for twosignatures, and some organisations areunclear whether single nurseadministration is allowed.A single nurse can administer acontrolled drug unless the local policysays otherwise. If a second checker isnot a registered nurse, they mustunderstand or be familiar with what theyare being asked to check. We wouldexpect to see that a competencyassessment had been completed.Dose calculations are a common causeof errors – particularly with newformulations or devices.It is important to have training andcompetency assessments for difficultcalculations or unfamiliar devices.Clinicians should be encouraged to askfor a second check if they are unsure orunfamiliar with the product orformulation.Body maps are not always in placewhen applying transdermal patches.There is also a lack of awareness of theeffect of heat, the importance ofremoving a previous patch and the needto check the patch every day.Application and removal of transdermalpatches continues to cause concern,and we expect to see appropriatearrangements in place to ensure thatpatches are managed safely.AUDITING AND MONITORING ISSUESSome organisations are unaware of theimportance of recording and auditing allstages of the controlled drug journey,and the need for standard operatingprocedures and ongoing regular review.We expect the standard operatingprocedures to cover all aspects ofcontrolled drug management and forthese to be kept under review withsupporting audits.We find insufficient monitoring and audit,and are aware of thefts and diversion ofcontrolled drugs, particularly those inlower schedules where there is lesscontrol, for example dihydrocodeine ormorphine sulphate solution 10mg/5ml.We expect organisations to risk-assesstheir controlled drug arrangements, withregular monitoring according to theirorganisational needs, to keep losses toa minimum.DESTRUCTION ISSUESSome organisations are unaware of therequirement to hold a T28 exemptionform for denaturing controlled drugs.Organisations that denature controlleddrugs must obtain a T28 exemption formfrom the Environment Agency.There is also uncertainty arounddisposing of large volume infusions (forexample, hospital PCAs etc).Large volume controlled drugs shouldbe discarded using an absorbentmaterial to soak up the liquid.Organisations are also not always clearwhat to do with completed denaturingkits.These must be stored securely untilremoved for incineration.Care Quality Commission The safer management of controlled drugs: Update report for 201711

Issues identified when prescribing from multiple sourcesIn our last update we highlighted the increasing volumes of controlled drugsbeing prescribed for patients. There are also risks when patients obtaincontrolled drugs from more than one provider, which can enable them tostockpile controlled drugs. This increases the potential for diversion andmisuse, risk of accidental death, and of suicide from overdose, which isparticularly pertinent for patients with long-term pain, a group at high risk ofsuicide.All services should consider these risks, as well as the benefits of informing thepatient’s GP when prescribing opiate-containing painkillers, to enable them toensure that patients are kept safe and that GPs maintain an overview of all themedicines prescribed to their patients.This applies to independent providers as well as NHS providers, including GPout-of-hours, secondary care services and those offering online-onlyconsultations with clinicians using video or questionnaire-based modalities.Safety measures should include prescribing a minimum supply according tothe patient’s individual needs and enquiring whether the patient already has anexisting stock at home.Recommendation 1Prescribers should ask patients about their existing prescriptions andcurrent medicines when prescribing controlled drugs. Where possible,prescribers should also inform the patient’s GP to make them aware oftreatment to minimise the risk of overprescribing that could lead to harm.NHS England’s area teams and controlled drug localintelligence networksNHS England’s lead CDAOs currently run 39 controlled drugs local intelligencenetworks (CDLINs) across the 14 NHS England areas, with membership froma wide range of organisations.There were around 200 meetings of CDLINs during 2017 and membershipcontinued to include a wide range of organisations. Meetings were heldbetween two and four times a year, with many areas meeting three times ayear. CQC continued to attend these, and contributed a written meeting updatewhen unable to send a representative.Care Quality Commission The safer management of controlled drugs: Update report for 201712

There was good attendance during 2017, but we noted an over-reliance bysome organisations on sending different deputies to meetings, which led to alack of continuity and ability to contribute fully to the meeting. Some memberscommented that they have found their CDLIN meetings too large and felt thishad also hampered discussion.The range and depth of issues discussed during 2017 remained broadlysimilar to previous years. The most commonly reported and discussedincidents were reported thefts, amended or wrongly dispensed prescriptionsand general governance issues.We summarise some of the ongoing concerns below.Issues of concernSolutions to considerLACK OF CENTRALISED SYSTEMSThere is a risk that private prescriptions andAn up-to-date national register ofrequests for controlled drugs could be forged. CDPINs would be beneficial.This is because community pharmacies donot have access to a national register ofcontrolled drugs personal identificationnumbers (CDPINs), which means theycannot verify legitimacy of privateprescriptions and requisitions for Schedules 2and 3 controlled drugs.There is a risk of inappropriate use and theftof controlled drugs in dental practices. This isbecause dentists do not use a uniqueidentifier for requesting and prescribing them,therefore NHS England CDAOs andcommissioners cannot monitor theirprescribing for outlying or potentiallydangerous practice.It is important that dentists havetheir own unique identifier.There is a risk of inappropriate andduplicated prescribing of controlled drugs totemporary residents, as there is no centralregister of temporary residents forprescribers to check.A central patient databaseaccessible to prescribers would bewelcome, so that patients who tryto access controlled drugs frommore than one service could beeasily identified and supportedwhere required.Because of changes in primary care supportservices there are risks associated with lackof oversight and control of secure stationeryto private prescribers.The governance arrangements forissuing prescription pads need tobe strengthened to avoid overordering and potential misuse.Care Quality Commission The safer management of controlled drugs: Update report for 201713

RESOURCESIn some areas there is a risk that NHSThe inconsistency in resourcingEngland CDAOs will not be able to fulfil theirrequires a national review.statutory obligations and deliverresponsibilities effectively because of ageneral lack of resource and small supportteams. This may mean less monitoring ofprescribing, leading to concerns being missed.Similarly, some areas do not have access toand support from a controlled drugs liaisonofficer.This also requires a nationalreview so that all areas aresupported.INFORMATION GOVERNANCEThere is a general lack of clarity on issuingcontrolled drug alerts, particularly regardingthe level of detail that should be included.NHS England CDAOs wouldwelcome a national view on this,particularly following new dataprotection legislation. There is alsoa need to consider sharing alertswith cross-border colleagues.Through our attendance at CDLINs we are aware of new organisations andmergers of existing organisations. Ongoing changes to the ways in whichhealth and care are now being delivered have resulted in increasingcomplexity of commissioning arrangements and consequently controlled druggovernance arrangements. It is important to include the oversight of controlleddrug governance and reporting arrangements when commissioning services.Recommendation 2Commissioners of health and care services should include the governance andreporting of concerns around controlled drugs as part of the commissioning andcontracting arrangements, so that these are not overlooked.With regard to thefts of controlled drugs, we have noted some increasinglysophisticated methods, which include stealing identification badges from healthcareprofessionals and impersonating them in order to obtain controlled drugs.Recommendation 3Healthcare professionals should keep their personal identification badgesand passwords secure and report any losses as soon as possible to enableorganisations to take the necessary action.Care Quality Commission The safer management of controlled drugs: Update report for 201714

Controlled Drugs National GroupThe CQC-led Controlled Drugs National Group comprises governmentdepartments, key regulators and agencies with a controlled drugs remit. Thegroup met three times in 2017 to share and discuss emerging issues andidentify ways of working together to reach solutions. Following positivefeedback, we continued to share summarised meeting notes with NHSEngland’s CDAOs, to enable them to update members of CDLINs aboutdevelopments and policy initiatives.In 2017, the National Group welcomed two new member organisations – theNursing and Midwifery Council and the Human Fertilisation and EmbryologyAuthority. We have published a separate summary of highlights from the pastyear showing how member organisations contribute to the overall safermanagement of controlled drugs.Sub-groupsThe sub groups met three times during 2017, either in person or byteleconference. Membership comprised relevant stakeholders, such as NHSEngland lead CDAOs, specialist pharmacists and medicine safety officers,other government bodies, NHS Business Services Authority, and chiefpharmacists. Other healthcare professionals with relevant expertise were alsoinvited as required.We introduced a new style joint newsletter of the sub-groups, which replacesthe four separate newsletters previously produced by the Policy, Vigilance,Prescribing and Patient Safety sub-groups. This was developed using the newGovDelivery system and circulated in September and December to over 3,000subscribers with an interest in controlled drugs.You can subscribe to newsletters on our website.Cross-Border GroupThe Cross-Border Group for safer management of controlled drugs in thedevolved administrations met in March and September 2017. It included theControlled Drugs Accountable Officers’ Network Scotland, the Health andSocial Care Board of Northern Ireland, NHS Wales and the Health ProductsRegulatory Authority of Ireland. The group provided a forum to discusscon

We register health and adult social care providers. We monitor and inspect services to see whether they are safe, effective, caring, responsive and well-led, and we publish what we find, including quality ratings.