UKMi Observatory

26th September 2018

Observatory of recent safe medication

practice research, reports, and publications

Presented by

Paula Russell Principal Pharmacist Regional Drug and

Therapeutics Centre, Newcastle upon Tyne

(Paula.Russell@nuth.nhs.uk)

• Provider bulletin:

• Weekly newsletter. Topics include patient safety

• Updates from our partners includes

• NICE New impact report on falls and fragility fractures The report* explores how NICE

guidance has been implemented by the healthcare system and what progress has been

made to improve outcomes.

• Page 9: Detecting and managing osteoporosis and fracture risk

NICE decision support tool incl. benefits of bisphosphonates, ADRs and how to take.

• 2016 FLS-DB clinical audit reported that just 23% of people aged 50 or over, who had

sustained a fragility fracture, were recommended bone protection therapy and 11% were

referred for further clinical input before a treatment recommendation was made. Of those

who were recommended treatment or were referred, only 31% had received it within 4

months of their fracture.

Guidance:

How medicines, medical devices and clinical trials would be regulated if there’s no

Brexit deal 14 September 2018 Department of Health and Social Care

Recent regulator and statutory body activity

* https://www.nice.org.uk/media/default/about/what-we-do/into-practice/measuring-uptake/nice-impact-falls-and-fragility-fractures.pdf

Recent regulator and statutory body activity

• Never Events 1 April to 31 July 2018 (published 30th Aug 18)

• A provisional summary of Never Events that have been reported as

occurring between 1 April and 31 July 2018 - those involving medicines:

• https://improvement.nhs.uk/documents/3178/Provisional_publication_-__NE_1_April_to_31_July_2018_v_6.pdf

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Administration of medication by the wrong route 4

Bladder irrigation given intravenously 1

Oral medication given intravenously 3

Overdose of insulin due to abbreviations or incorrect device 5

Wrong syringe 4

Insulin withdrawn from a pen device 1

Overdose of methotrexate for non-cancer treatment 1

Overdose of methotrexate for non-cancer treatment 1

Alerts and Recalls:

• Class 4 defect information: Olmetec 20mg Film Coated Tablets (MDR 12-

08/18) 3 September 2018. Medical safety alert .

• Error on the blister foil of the batches: hydrochlorothiazide is listed under the

product name. Carton, PIL and tablets in the foils are all confirmed as correct.

Stock not recalled but affected stock no distributed when new batches available

- expected during w/b 24 September 2018.

• Class 4 defect information: Caspofungin 70mg powder for concentrate for

solution for infusion (MDR 11-09/18) 18 September 2018 Medical safety alert

• The PIL sections providing instructions for preparation of both 70mg/m2 and

50mg/m2 infusion for paediatric patients > 3 months of age: in the incorrect

version of the PIL the final concentration of the solution is given as 5.2mg/ml for

both dilutions. The correct final concentration is 7.2mg/ml.

News:

• Change in the classification of certain glucosamine products 5 Sept 2018

• Products containing doses equal to or greater than 1178mg/day of base

glucosamine will now be considered to be medicines. Less than 1178 mg/day of

glucosamine will continue to be widely available as food supplements.

Recent regulator and statutory body activity

Drug Safety Update

• Esmya (ulipristal acetate) and risk of serious liver injury: new restrictions to use

and requirements for liver function monitoring before, during, and after treatment

24 August 2018. Drug safety update Volume 12 Issue 1 August 2018. Alert issued to UK healthcare professionals on 7 Aug

2018

• Esmya (ulipristal acetate) and risk of serious liver injury: new restrictions to use

and requirements for liver function monitoring before, during, and after treatment

• More than one treatment course is authorised only in women not eligible for

surgery

• Liver function monitoring is to be carried out in all women treated with Esmya.

• Before initiation, discuss with women the rare risk of liver damage and advise

them to seek urgent medical attention if they develop any symptoms or signs

of liver injury.

• Resources available to support safe use: A Patient Card in the medicine’s

package to remind women of the need to stop treatment and contact their

doctor immediately should they develop signs or symptoms of liver injury.

• https://assets.publishing.service.gov.uk/government/uploads/system/uploads/attachment_data/file/740604/DSU-Aug-

18.pdf

Recent regulator and statutory body activity

Pharmacovigilance Risk Assessment Committee

(PRAC)

• 13/09/2018 Update on review of valsartan medicines

• Risk from NDMA remains low, a related substance NDEA also being investigated

• The EMA has updated its calculation of the risk from valsartan medicines

containing N-nitrosodimethylamine (NDMA), taking into account results from

latest tests on the active substance from Zhejiang Huahai.

• In line with EMA’s previous assessment, the life-time risk of cancer is considered

low and is estimated to be in the order of 1 in 5,000 for an adult patient who had

taken an affected valsartan medicine at the highest dose (320 mg) every day

from July 2012 to July 2018.

• Improving understanding of biosimilars in the EU 13/09/2018

• The new material includes an animated video for patients that explains key facts

on biosimilar medicines and how EMA works to ensure that they are as safe and

effective as their reference biological medicines. The video is available in eight

European languages.

Human Medicines Highlights – Monthly Newsletter

• Human Medicines Highlights

Monthly Newsletter Issue 114 Sept 2018

Cardiovascular system

Safety communication update

• Review of valsartan containing

medicinal products - updates provided

Diabetes

Communication on prevention of

medication errors

• Amglidia (glibenclamide)

• Treatment of neonatal diabetes

Gynaecology & Obstetrics

Safety communication update

• Review of Esmya (ullipristal acetate) -

EC decision (new measures to minimise

risk of rare but serious liver injury)

• Treatment of uterine fibroids (non-

cancerous tumours of the womb

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Immune system

Supply shortages

• Cinryze (C1 inhibitor (human)) - shortage

ongoing

• Treatment of hereditary angioedema

(swelling beneath the skin)

• Metabolic disorders

Communication on prevention of

medication errors

• Myalepta (metreleptin)

• Treatment of lipodystrophy (loss of fatty

tissue under the skin and accumulation

in liver and muscles)

Other information

• Guidelines: Guidelines open for

consultation Adopted guidelines

• Scientific committee and working party

activities

• Other publications

Direct HCP Communication BIOGEN

• Spinraza▼ (nusinersen) 31st July 2018 :

• Letter advises patients/caregivers should be informed about signs/symptoms of

hydrocephalus before start of treatment and to seek medical attention in case of:

persistent vomiting/headache, unexplained decrease in consciousness, and in

children, increase in head circumference.

MHRA

• Esmya (ulipristal acetate)

• Alert issued to UK healthcare professionals 7 Aug 2018

• Risk of serious liver injury: new restrictions to use and requirements for liver

function monitoring before, during, and after treatment

NHS Improvement

• Provider bulletin: Weekly newsletter. Topics include patient safety

• Updates from our partners includes

• NICE New impact report on falls and fragility fractures The report* explores

how NICE guidance has been implemented and progress made to improve

outcomes.

• Page 9: Detecting and managing osteoporosis and fracture risk NICE decision

support tool incl. benefits of bisphosphonates, ADRs, how to take.

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Direct HCP Communication

Public Health England

• Fentanyl: safety recommendations for first responders

• This guidance for first responders (law enforcement, fire, rescue,

paramedic and emergency department personnel) contains information about

fentanyl, actions to be taken to prevent exposure, and what to do if exposure

occurs.

• Vaccine update: issue 284, August 2018, flu special edition :

• Guidelines on increasing influenza vaccine uptake, flu vaccine ordering for

2018 to 2019 programme, information and training for healthcare

professionals, flu vaccination invitation letters, and uptake summary tool

guide.

9

Manufacturer educational risk minimisation material

Esmya: Risk Minimisation Material - Risk of serious liver injury

• Esmya (UPA) 5mg - UK DHPC 01.08.2018 This is a DHPC letter as approved by

EMA and MHRA

• Pathologist' Guide - Esmya Guide for pathologists dealing with gynaecological

tissue which may have been exposed to Esmya (Ulipristal acetate)

• Physician's Guide to Prescribing - Educational material for prescribers

• Patient Card - present in the Esmya pack for patients

Tenofovir Disoproxil Risk Minimisation Material

• For Children and Adolescent with HIV-1 HIV-1 - Renal & bone effects education

brochure – children

• For Adolescent Children with Chronic Hepatitis B - Renal risk educational

brochure - adolescent children

• For Adults with Chronic Hepatitis B - Renal risk education brochure - adults

• For Adults with HIV HIV - Renal risk education brochure - adults

Manufacturer educational risk minimisation material Drug (Date Published) Risk Minimisation Materials

Colistimethate sodium (19 Sept. 2018) HCP Guide and Patient User Guide

Voriconazole (Zentiva) (19 Sept. 2018) HCP Checklist and HCP Q&A

Tenofovir disoproxil (Ictastan) (19 Sept. 2018) Risk Minimisation Material

Naloxone Nasal Spray (Nyxoid) (19 Sept. 2018) HCP Guidance ; Training Card ; Patient Info. Card

Ipilimumab (Yervoy) (24 Aug.2018) Digital Site includes GCP guide to prescribing (requires

registration for access)

Emtricitabine / tenofovir Glenmark (20/08) Renal and bone effects Children and adolescents with

HIV 1

Renal risk minimisation children and adolescents Hep. B

Renal and bone effects – adults with HIV

Renal risk minimisation adults with Hep B

Atezolizumab (Tecentriq) 1200mg concentrate for

infusion (20 Aug. 2018)

Safety information for immune related adverse effects

Patient Alert Card

Mysimba 8mg/90mg prolonged release tablets

(naltrexone / bupropion) (02 Aug. 2018)

Physician Prescribing Checklist

Epipen Adrenaline Auto Injector 0.3mg (02/08) Epipen Carry Card ; Prescriber Checklist ; Demonstration

Video ; Expiry Alert Service ; Travel Certificate ; Guide to

using Pen

Mefloquine (Lariam) 250mg Tablets (02/08) Checklist ; HCP Guide ; Patient Alert Card

Methylphenidate prolonged release (Xenidate)

54mg Tablets (02 /08)

Physician Guide 11

Drug shortages and discontinuations • Epipen supply update (18th September)

• Further information: Mylan http://www.epipen.co.uk/ and https://www.anaphylaxis.org.uk

• Patients advised to seek alternative product if can’t source usual product.

• Diamorphine Supply Update (11 September 2018)

• Accord confirmed diamorphine 5mg and 10mg injection in all wholesalers w/c 17 Sept

• Ativan (lorazepam) injection supply issue update (12th September 2018)

• Pfizer will not receive any further stock until the end of October, the current expected

availability date is 26 October 2018

• All residual stock has been used to supply Trusts for their August/September allocations.

• Baxter IV Fluids: Hartmann’s and Plasmalyte solutions update (6thSeptember)

• Baxter have confirmed that Plasmalyte solution will be back in stock from Monday 10th

September and available to order in line with historical volumes. The 60% cap on

Hartmann’s solution will also be lifted from Wednesday 12th September in line with the

following recovery plan.

• MHRA has given approval for Baxter to import Hartmann’s 1L solution under a batch

specific variation from Spain and unlicensed sodium chloride 0.9% 1L bags from USA.

• Carbex 2.8g sachet for granules (6thSeptember)

• Panpharma will not have any stock available until October 2018.

• Neither Nordic pharma nor Panpharma will be undertaken any work to extend the shelf

life. Local decision whether to use expired stock.

UKMi Product Safety Report

No new UKMI product safety reports in August 20018

National guidance, publications and resources

RPS Yellow Card Quick Reference Guide and Advice for Pharmacists

Quick Reference Guide: What, why, how etc.

Advice for Pharmacists: Responsibilities of HCP, how HCPs can improve YC

system, types of ADRs reported, online learning modules etc….

Managing the introduction of new generic medicines: Guidance for Chief

Pharmacists and trust medicines procurement leads 5th Sept 2018

NICE Flu vaccination: increasing uptake- guidance (NG103)

This guideline covers how to increase uptake of the free flu vaccination among

people who are eligible.

Medicines Use and Safety Division of the Specialist Pharmacy Service:

Updates on MUS activity 3rd Sept 2018;

Resources Guide 13th Sept 2018: contains links to the most popular resources;

Team Annual Report 2017-18 13th August 2018: Highlights for 2017-18

Letter from Secretary of State to the health and care sector: preparations

for a potential no-deal Brexit 23rd Aug 2018

Medicines management for people receiving social care in the community

QS171 July2018

This month’s papers - overview

• Impact of the communication and patient hand-off tool SBAR on patient

safety: a systematic review BMJ Open

• Communication (CM) tool SBAR (situation, background, assessment and

recommendation) was developed to increase handover quality. Review of 11

studies found moderate evidence for improved patient safety through its

implementation, especially when used to structure CM over phone.

• Evolution of the general practice pharmacist’s role in England: a

longitudinal study Br J Gen Pract 28 August 2018; bjgp18X698849.

• Findings show not only patient-facing role expansion, but also practice

environment and support issues. Pharmacists may appreciate more GP time

invested in their development. Practices need to be realistic about this support

and not expect an immediate reduction in workload.

https://doi.org/10.3399/bjgp18X698849

• What is the place for monitored dosage systems? D &T Bulletin

• These systems may be useful for patients struggling with a high pill burden,

impaired vision or dexterity. However, evidence is sparse and mostly anecdotal.

Where patients are taking medicines in and out of these systems, the benefit

may be outweighed by risk of confusion.

http://dx.doi.org/10.1136/dtb.2018.9.000004

• Medication reminder applications to improve adherence in coronary heart

disease: a randomised clinical trial Heart Cardiovascular system disorders

• RCT (n=163) found that patients with CHD who used medication reminder apps

had better medication adherence compared with usual care (mean MMAS-8

score 7.11 vs. 6.63, respectively; p=0.008), and using apps with additional

features did not improve this outcome further.

• Cardiovascular Safety of Lorcaserin in Overweight or Obese Patients

• New England Journal of Medicine

• RCT (n=12,000) found in this high risk population, lorcaserin facilitated

sustained weight loss vs. placebo [at least 5% at 1 year in 1986 of 5135

(38.7%) on lorcaserin v. 883 of 5083 (17.4%) on placebo; OR 3.01; 95% CI,

2.74-3.30; p<0.001) without higher rate of major CV event

• Conference report: Real-world evidence from Global Anticoagulant

Registry ( GARFIELD-AF) following study of non-vitamin K Antagonists oral

anticoagulants (NOACs) vs. vitamin K antagonists (VKAs) in newly diagnosed

atrial fibrillation. Biospace Inc.

• A new analysis (n=19,134) found 19% fewer deaths in patients initiated on

NOACs than VKAs at the time of diagnosis of AF (aHR 0.81 [95% CI 0.71-

0.92]; p<0.001). 16

This month’s papers - details

Patient Discharge from Hospital to General Practice: Thematic Report 2017-

2018 Key findings and recommendations:

• good discharge relies heavily on effective planning, and that more needs to be done across

Wales to ensure that health professionals (HCPs) work together as effectively as possible.

This means that there needs to be:

• Greater clarity over the roles and responsibilities of those HCPs involved in the discharge

process: staff did not always understand the valuable role that their colleagues play in the

process.

• Increased involvement of pharmacy roles within the discharge process to aid with To Take

Out (TTO) timeliness and clarification; where ward-based pharmacy staff were used more

often, that discharge was more efficient.

• Improved communication with patients and families, with a need to clarify arrangements over

who ensures patients and families are engaged with effectively.

• Stronger relationships between GPs and hospitals: We consistently found issues with a lack

of mutual understanding of roles, impacting the quality of information being shared between

hospitals and GPs.

• One of the key issues from our review is the range of mechanisms used to facilitate the

sharing of discharge information, and how these methods impacted the process.

• E-discharge had a positive impact on both quality of information and timeliness of receipt by

the GPs. even with e-discharge in place there are instances where sparse or incomplete

information is provided.

‘The discharge lacked

effective

communication…and

raised serious concerns

surrounding

controlled medication’

This month’s papers - details

• There were a number of positive and local initiatives

• e.g. the use of dashboards to monitor live discharge data is an example of

technology working to aid the provision of an effective service.

This helps ongoing work to address bottle necks in the system as well as overall

analysis to help develop improvements.

• For technology to be truly effective, IT systems need to be integrated

• What can be improved regardless of IT and e-discharge systems, is

the relationship between secondary care and general practice.

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“The approach to discharge is often

reactive rather than proactive, and

staff just have to

go with it. It is common to find out

about discharges for that day during

ward rounds.”

‘…the electronic

discharge notification

form [sent to the GP] was

incomplete and

therefore inadequate’

“…pharmacy prescriptions…the

carbon copy discharge

summary form is too brief and

illegible”

“From a pilot conducted of the pharmacy attending

ward rounds, this improved the TTO

and discharge process”

“Pharmacy on

ward…helps with sign-

offs and timeframes”