Reducing Medication Errors

Reducing Medication Errors 1 st July 2015 Dr David Gerrett Senior Pharmacist April 2015 Patient Safety NHS E Manchester MCC

Content 1. The Pharmacovigilance landscape 2. MSOs 3. What we know of error from the NRLS 4. The NPSAs 5. Needs a multidisciplinary approach 2

Content 1. The Pharmacovigilance landscape 3

the development of the National Medication Safety Network improving the number, quality, timeliness of reports maximising local learning and actions improving adherence to the Patient Safety Alert on improving medication error incident reporting and learning developing the role of the medication safety officer 4

Directive 2010/84/EU DIRECTIVE 2010/84/EU.the term adverse reaction should be amended to ensure that it covers noxious and unintended effects resulting not only from the authorised use of a medicinal product at normal doses, but also from medication errors and uses outside the terms of the marketing authorisation, including the misuse and abuse of the medicinal product. Originally from Directive 2001/83/EC 5

And coming up implementation of. Article 107a(5)of Directive 2001/83/EC outlines the key responsibilities of national competent authorities (MHRA) in relation to the reporting of ADRs associated with medication error: Member States shall ensure that reports of suspected adverse reactions arising from an error associated with the use of a medicinal product that are brought to their attention are made available to the Eudravigilance database and to any authorities, bodies, organisations and/or institutions, responsible for patient safety within that Member State. They shall also ensure that the authorities responsible for medicinal products within that Member State are informed of any suspected adverse reactions brought to the attention of any other authority within that Member State. These reports shall be appropriately identified in the forms referred to in Article 25 of Regulation (EC) No 726/2004. 6

Consultation closed 14/6/2015 7

and.additionally CDAOs Controlled Drugs (Supervision of management and use) Regulations 2013 based on the 2006 Regulation but the 2013 Regulations give CDAOs more flexibility and discretion as to how they should discharge their duties and functions than under the previous regime. Specifically, under Duties..CDAO has a variety of duties and functions such as to: ensure the safe and effective use and management of CDs within their own organisations and by anybody or person providing services to their organisation; assess and investigate concerns Controlled Drugs (Supervision of management and use) Regulations 2013 Information about the Regulations 2013;(Feb):13 ttps://www.gov.uk/government/uploads/system/uploads/attachment_data/file/214915/15-02-2013- controlled-drugs-regulation-information.pdf 8

ADE s, ADR s and Medication Errors No harm Low harm Things we don t know NHS E Medication errors THE FOCUS Preventable (ADEs, ADRs and AEs) NHS E ADE s Potential ADE s Non preventable (ADR, MHRA) Intercepted NHS E 9 Bates DW, Boyle DL, Vander Vliet MB, Schneida J, leape L. Relationship between medication errors and adverse drug events. J. Gen. Intern. Med, 1995;10:199-205.

ADE s, ADR s and Medication Errors No harm Low harm Things we don t know NHS E Medication errors THE FOCUS Preventable (ADEs, ADRs and AEs) NHS E, MHRA ADE s Potential ADE s Non preventable Intercepted NHS E 10 Bates DW, Boyle DL, Vander Vliet MB, Schneida J, leape L. Relationship between medication errors and adverse drug events. J. Gen. Intern. Med, 1995;10:199-205.

ADE s, ADR s and Medication Errors No harm NOT MHRA Low harm Things we don t know NHS E Medication errors THE FOCUS Preventable (ADEs, ADRs and AEs) NHS E, MHRA Potential ADE s Intercepted NHS E But NOT MHRA 11

Some issues as we see them Greater collaboration between NHS England and MHRA (also CQC, NHS IQ) Need for a way of aggregating the MANY medication PSI datasets to meet EU obligations There is a need to engage the Medication Safety Officer and the CDAO in local medication Patient Safety Incidents (PSIs) as they have similar responsibilities We need the learning to take steps nationally to make it safer for patients Fantastic local practice, but how capitalise on the expertise and know how 12

Content 2. MSOs 13

Alert! 14

Alert! 15

Alert! 16

>26 th June 2015 We know: Name, Organisation, Type, Region, sub-region, MSO, MDSO Both, email MSO 371 (MDSO 289) Devolved Governments 54 PV PSNC other 17

MSOs who are they? Essential Network features 1. Acute Sector (159/160?) 2. Mental Health (50/50? community complexity) 3. AT/CCG (75/211) 4. Ambulance (7) 5. Community Pharmacy (18/18 - NPA) 6. Independent Sector (21 growing) 7. Other forces, community trusts 8. Guests (NI, Scotland, Wales. Other) 18

MSOs what are they responsible for? Responsibilities should include the following: i. active membership of the National Medication Safety Network; ii. improving reporting and learning of medication error incidents in the organisation; iii. managing medication incident reporting in the organisation. This may entail reviewing all medication incident reports to ensure data quality for local and national learning and where necessary to investigate and find additional information from reporters. Also, to authorise the release of medication error reports to the NRLS each week; iv. receiving and responding to requests for more information about medication error incident reports from the Patient Safety Doman in NHS England and the MHRA; v. work as a member of the medication safety committee to deliver the responsibilities listed in 7.1.4; and, vi. supporting the dissemination of medication safety communications from NHS England and the MHRA throughout the organisation. 19

MSOs National focus National support 1. Web Events monthly, 4 Regional events, dedicated conferences 2. UKMI, SPS, MSOs, MHRA 3. New avenues - collation of RCAs 4. Community Pharmacy (quarterly) CCG(?) MH(?) dedicated Web Events 5. Outputs alerts, national learning from RCAs, PSIs resources on www site 20

MSOs local and national focus Essential focus 1. Local learning from PSIs 2. Taking National messages and implementing [Alerts] locally 3. Frequency and quality of reporting 4. Training (RCTs, best practice) 5. Conduit between NHS England/MHRA and practice 21

To Summarise the MSO role, to: 1. gather evidence of a local learning culture 2. incrementally improve reporting and learning 3. implement better, safer medication practice locally and nationally 4. work together as discrete groups on common topics 5. be the formal conduit between NHS England Patient Safety and practice for medication safety issues 22

To focus the role - Most importantly 3. implement better, safer medication practice locally and nationally in collaboration with AOs 5. Implement local system safety improvements and be able to prove it 23

Example Schedule 2 CD 16/6/2015 MSO I have been informed by a local pharmacy of four instances where they have received 30 Xenidate XL 36mg tablets with only 29 tablets in the pot. They have informed Mylan and AAH. The batch number and expiry date are the same in every case - B34806B, exp. 10/16. Are you (NHS England) aware of any other cases? 29/6/2015 MHRA have investigated, worked with Industry and issued an Alert yesterday https://www.gov.uk/drug-device-alerts/xenidatexl-36mg-prolonged-release-tabletsmethylphenidate-hydrochloride-incorrectnumber-of-tablets-in-packs-from-a-specificbatch 24

Content 3. What we know of error from the NRLS 25

The National Reporting and Learning System 26

Total Patient Safety Incidents NRLS for March 2014 16000 14000 12000 10000 8000 6000 4000 2000 0 April May June July August September Extraction month 27

In context, reported to NRLS 2005-2014 250000 200000 150000 100000 50000 42398 64484 79280 94280 113837 164907 144609 152460 132069 190619 reported 0 2004 2006 2008 2010 2012 2014 2016 In 2014 the absolute number of medication reports to the NRLS increased more than in any previous year, representing a 15.6% increase on the year before. 28

2014 dataset, not validated Row Labels Administration / supply of a medicine from a clinical area Patient Grand 2013 Death Severe Moderate Low No Harm Group (blank) Total % % 23 84 1605 10509 73228 2 85451 44.8 70415 42.7 Prescribing 7 38 748 3291 36038 2 40124 21.0 34101 20.7 Preparation of medicines in all locations / dispensing in a pharmacy 1 18 425 2406 29171 14 2 32037 16.8 31928 19.4 Other 11 21 402 1909 19914 1 22258 11.7 18808 11.4 Monitoring / follow-up of medicine use 3 11 236 1135 6768 8153 4.3 7524 4.6 Advice 3 51 175 1450 1679 0.9 1482 0.9 Supply or use of over-thecounter (OTC) medicine 1 11 75 828 915 0.5 649 0.4 (blank) 2 2 0.0 0.0 Grand Total 45 176 3478 19502 167397 19 2 190619 100.0 164907 100.0 29

Content 4. The NPSAs 30

NaPSAs Alerting 31

Stages of NaPSAs Stage 1 Notification: Alert Alerts organisations to emerging risk. It will be issued very quickly once a new risk had been identified to allow rapid dissemination of information. Stage 2 Notification: Resource Provision of resources to help mitigate risk identified in stage 1 Stage 3 Notification: Directive Makes it mandatory for organisations to have taken actions based on the stage 1 and stage 2 notifications and implement solutions or actions to mitigate that risk. 32

Naloxone 33

Naloxone http://www.medicinesresources.n hs.uk/getdocument.aspx?pagei d=797289 34

NHS England Alerts http://www.england.nhs.uk/wp-content/uploads/2015/05/psa-skinprep-solutions-may15.pdf http://www.england.nhs.uk/wpcontent/uploads/2014/12/psapotass-prmangant.pdf http://www.england.nhs.uk/wpcontent/uploads/2015/01/psalmwhs.pdf 35

Content 5. Needs a multidisciplinary approach 36

On the shoulders of others 37

MSO Survey Results December 2014 Anonymous - 179 responses (useable, cleaned) Survey provided basic stats and qualitative gold 38

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Experience (years) or Time (hours/week) 10.6 6.7 41 (N=132)/179)

No allocated time. Added to current role with no extra resource to overstretched team. Added to risk register as impact of this new developing role not fully understood (Count missing) 2 hours a week. would do longer if I had the time. Some weeks is more than others (Count 2) This is difficult there is no single MSO multiple people are involved (Count missing) MSO duties carried out by number of individuals & we aren't covering everything required, eg monthly sign off!! (Count missing) 42

Experience About 5 years direct experience with patient safety, interspersed with 10 years of clinical practice. (Count 5) worked as a pharmacist for 25 years not had a specific role on patient safety but all roles have had a patient safety element eg practice support pharmacist, dispensing role within hospitals (Count missing) Qualified for 27 years as clinical pharmacist and 17 years as Pharm Adviser / Head of medicines management (Count missing) 43

Q: What barriers (if any) do you perceive need resolving before medication safety issues can be addressed? Culture should be learning not blame. Systems that support not hinder service delivery IT keeping pace with safety requirements the need for community pharmacies to introduce bar coding at point of dispensing removal of the criminality of dispensing errors getting wider ownership of medication safety outside of pharmacy family / team some proper RCA training would be useful, time limitations. Full buy in from direct patient facing staff at operational level to report issues upwards. Traditionally operational teams have been reluctant to 'land themselves in it' - acknowledge that individual organisations have a large role to play. 44

Q: What barriers (if any) do you perceive need resolving before medication safety issues can be addressed? Board level ownership of the patient safety alert for MSO. Lack of hard evidence to support business cases for investment in MSO functions to reduce incidents and harm Ease of access to information and identifying the relevant sources (clinical notes). Awareness by other clinical staff of this role and authority that it should have to investigate and call to task. time / my capacity to undertake the role effectively with my other duties 45

Q: What barriers (if any) do you perceive need resolving before medication safety issues can be addressed? Overlap between NRLS categories so medication incidents could also be reported in other categories, therefore any learning lost. Too much time spent trying to avoid severe harm or never event criteria rather than using them as a rich learning experience (I suspect the same may happen due to duty of candour with moderate harm events). Still waiting for central standard medicines library. Attitude of press/media to patient harm is unhelpful and would benefit from investment. Could patient safety alerts also be sent to MSO email as well via the CAS system? Vacancies within my team 46

Q: In your opinion, what are the most pressing medication patient safety issues that we need to tackle Nationally Insulin is still the number one issue within our Trust. I feel that we do better with warfarin. NOACs probably need looking at as we have had several incidents involving them. Communication at the interface between primary & secondary care slips and lapses by staff who know what they are supposed to do but do not follow processes or forget due to extreme pressures. revisiting NPSA alerts would be very useful review anticoagulation. Appears we may still be getting a high number of incidents. Is this a true national picture, is there anything more we can do? 47

Q: In your opinion, what are the most pressing medication patient safety issues that we need to tackle Nationally Medicines reconciliation. Anticoagulation (involving pharmacists with dosing etc). Second checking of IVs etc by nurses (in reality nurses not empowered to speak up if they see a mistake by a colleague, too much faith put in the first nurse and the second checker by the first nurse so items not self checked), NPSA alerts for anticoagulants, taking into account patient self testing and NOACs Nationally we need to be able to meet regionally. Perhaps strategic area authorities need to dictate that regional groups form. Currently there seem to be areas where good work is going on but we do not have a strong enough network to share between regions 48

Medication Incident Report to MHRA via Yellow Card Scheme www.mhra.gov.uk/yellowcard Analysis & regulatory action Adverse drug reactions (ADRs) but not Medication errors Healthcare Professionals and Patients Identify and REPORT Medication errors Risk /Complaint Managers Oversight & Quality Assurance OPTION 2 CDAO integrated For CDs Medicines Safety Officer (MSO) Quality Assurance Local Medication Safety Committee Oversight and Support Request additional information Submit reports to NRLS through organisation's system or online e-form MHRA & NHS England Analysis 49

But here is the rub In secondary care 80% of medication administration is by nurses In primary care its self-administration or carers Only through the involvement of the full team (inc pateints) can the MSOs have a full impact They can introduce system changes locally but need buy in best if everyone moves forward together! 50

The minimum to strive for is Where there is serious harm, for a CD there should be automatic involvement of the CDAO and the MSO and this should be recorded and made available for national learning! 51

Content 1. The Pharmacovigilance landscape 2. MSOs 3. What we know of error from the NRLS 4. The NPSAs 5. Needs a multidisciplinary approach 52

What you will remember The EU has some big involvement in this Most MSOs are pharmacists and will need help from everybody to improve patient safety There are some Alerts I need to make sure we are doing something about! Need to ensure MSOs and CDAO are talking Oh and david.gerrett@nhs.net (but be mindful of death by email ) 53

Questions? Many thanks for listening and to HC for the invitation to discuss these matters with you. 54