UKMi Observatory

August 2018

Observatory of recent safe medication

practice research, reports, and publications

Presented by

David Erskine – Director London and South East Medicine

Information Service (david.erskine@gstt.nhs.uk)

Resources to support safe and timely management of hyperkalaemia

Several resources are included for organisations to ensure staff have access to

information to guide prompt and appropriate investigation and treatment. .

Resources include the UK Renal Association guidelines for acute

hyperkalaemia in adults and Resuscitation Council guidelines

Recent regulator and statutory body activity

Resources to support safer bowel care for patients at risk of

autonomic dysreflexia

Esmya (ulipristal acetate) for symptoms of uterine fibroids:

restrictions to use and requirement to check liver function before,

during and after treatment Esmya should not be used unless new restricted indication is met, and patient does not have

an underlying liver disorder; more than one treatment course is now authorised only in

women who are not eligible for surgery. Make sure patient knows the signs and symptoms of

liver injury and what to do if they occur. Pharmacists should provide the new patient card to

women when dispensing Esmya (SPC also updated)

Video on valproate use during pregnancy to support healthcare

professionals The video aims to help healthcare professionals in implementing the new 2018 regulatory

measures, including the pregnancy prevention programme and regular patient reviews.

Recent regulator and statutory body activity

Pharmacovigilance Risk Assessment Committee

(PRAC)

Update on review of recalled valsartan medicines: Preliminary assessment of

possible risk to patients EMA estimates there could be 1 extra case of cancer for every 5000 patients taking affected

medicines at highest valsartan dose (320mg) daily for 7 years based on average levels of NDMA

in active substance (60parts/million).

(Similarly FDA scientists estimate that if 8000 people took highest valsartan dose (320mg) from

recalled batches daily for full 4 years, there may be 1 additional case of cancer over lifetimes of

these 8000 people)

European medicines Agency update on valsartan medicines Low levels of N-nitrosodimethylamine (NDMA; probable human carcinogen) have been detected in

the valsartan active substance manufactured by a second company, Zhejiang Tianyu, although

these are much lower than levels seen from Zhejiang Huahai, which triggered the valsartan recall.

Update on medicines containing valsartan from Zhejiang Tianyu Zhejiang Tianyu is no longer authorised to manufacture valsartan active substance for EU

medicines following suspension of its certificate verifying that quality of valsartan meets European

requirements. Low levels of NDMA were detected in valsartan produced by this company

Direct HCP communication

Drug alert class 3, action within 5 days; FDC international, sodium

cromoglicate 2% w/v eye drops 13.5ml; Murine hayfever relief 2% w/v

eye drops 10ml

Specific batches of Sodium Cromoglicate 2% w/v Eye Drops 13.5ml

recalled due to the presence of a precipitate, which has been identified as

sodium cromoglicate, in some bottles.

Nutriflex Omega Special 2500ml: Company-led recall

B. Braun Medical Ltd are recalling specific batches of Nutriflex Omega

Special 2500ml as it's been identified that they may have an out of

specification result in the glucose chamber at the end of their shelf life

MiniMed™ remote controller (MMT-500 or MMT-503)

Report that an unauthorized individual in close proximity of an insulin

pump user could potentially copy the wireless radio frequency (RF) signals

from the user’s remote controller (while they are in the process of

delivering a remote bolus) and play those back later to deliver an

involuntary bolus of insulin to the pump user.

Direct HCP communication

Guardian™ Connect Mobile App (Model Number: CSS7200)

An issue was identified in Apple iOS 11.3 & 11.4 that can

potentially prevent receipt of a 'Lost Communication' alert after

your Guardian™ Connect app is closed by the iPhone's operating

system (iOS) in certain situations. If the app is closed, alerts

associated with hypoglycemic or hyperglycemic events would not

be received

Commercial Name of the Affected Product: Durex Real

Feel, Durex Latex Free

Tests have shown that some batches which are currently on the

market in UK & Ireland (and in other markets) do not pass the

requirements for burst pressure towards the end of the shelf life

for the product. The expiry date of the affected batches is

between Dec. 2020 and Feb. 2021.

Manufacturer educational risk minimisation material

Risk minimisation materials: Checklist for prescribers for combined hormonal

contraceptives

The purpose of this checklist is to support the safe prescribing and use of various combined

hormonal contraceptives including Femodene, Femodette, Qlaira, Triadene, Yasmin, Eloine,

Logynon and Microgynon.

Educational Risk Minimisation Materials to help reduce the risk associated with using

Xenidate (methylphenidate) XL 54 mg Prolonged-release Tablets

Materials for clinicians consist of checklist before prescribing Xenidate tablets and checklist

for ongoing monitoring.

Educational Risk Minimisation Materials to help reduce the risk associated with using

Lariam (mefloquine)

Materials include a guide for healthcare professionals on side effects (especially

neuropsychiatric), a checklist that should always be used when prescribing and supplying

mefloquine chemoprophylaxis, and a Patient Alert Card (enclosed in the product package).

Manufacturer educational risk minimisation material

Physician Prescribing Checklist for Mysimba (8 mg naltrexone /90 mg bupropion)

prolonged-release tablets

Prescriber guide provides reminder of indication, contraindications, warnings and precautions

as well as the patient characteristics that may place patients at higher risk of adverse

reactions to Mysimba. This checklist should be completed prior to initiation of treatment.

EpiPen Adrenaline (Epinephrine) Auto-Injector: patient resources

Resources include Trainer Pen Order Form, demonstration video on how to administer

EpiPen® and a Travel Certificate that GP completes to confirm patient has life threatening

allergy which could result in an anaphylactic reaction so needs to carry an adrenaline auto-

injector.

Drug shortages and discontinuations

Shortage of Adalat (nifedipine) products

Bayer will be out of stock of most of the Adalat range until April-May 2019.

The 5mg immediate release capsules will be out of stock until Dec 2018

and the LA 20mg tabs until Feb 2019. Stock of the 10mg immediate release

capsules is not affected.

Shortage of Ativan (lorazepam) Injection 4 mg in 1 ml

Pfizer, the sole licensed UK supplier of Ativan (lorazepam 4mg/ml injection),

are experiencing supply issues and there may be limited supply and stock

restrictions until late October 2018.

Shortage of Plasmalyte and Hartmann's solution (Baxter)

Pharmacy to put local management plans in place to cope without

Plasmalyte and reduce Hartmann’s usage to approximately 60% of

historical demand. Shortage expected to last until mid-September.

PHE - updated restrictions on use of Varicella Zoster Immunoglobulin

(VZIG) during supply shortage: advice to health professionals

Changes to guidance include restriction of VZIG extended to include all

immunosuppressed individuals except for those where oral aciclovir

[AC]/valaciclovir may be contraindicated

UKMi Product Safety Report

In use product safety assessment report for trastuzumab

An assessment on trastuzumab products (including the biosimilars)

which describes the in-use medication safety considerations resultant

from the product’s presentation or other pre-defined characteristics.

Potential next steps and mitigation actions are suggested.

NOACs and Antidepressants – What are the risks of using these

together and how should these risks be managed?

This article considers the risk of interactions between non-vitamin K

antagonist oral anticoagulants (NOACs; also known as direct oral

anticoagulants [DOACs]) and antidepressants

National guidance, publications and resources

Guidance on Handling of Injectable Cytotoxic Drugs in Clinical Areas in

in NHS Hospitals in the UK (Yellow Cover) Edition 1 July 2018

This document from the NHSQA committee provides guidance on the handling

of cytotoxic chemotherapy and its focus is on traditional small molecule

chemotherapy although there are references to biological therapies including

monoclonal antibodies which are being used in increasing numbers

Guidance on the Pharmaceutical Issues concerning Outpatient

Parenteral Antibiotic Therapy (OPAT) and other Outpatient IV Therapy

Services 1st Edition January 2018

The areas covered include considerations for drug stability particularly

considering the temperatures during extended infusion times. Related to this

there is guidance for patients on how to handle their infusers during storage

and during the infusion period to prevent the product being subject to

excessive temperatures.

There is also discussion on the use of buffers to stabilise certain drugs and

considerations for ensuring mixing of drug and diluent, if this is carried out

within the device.

National guidance, publications and resources

The safer management of controlled drugs: Annual update 2017

Report from CQC that makes recommendations to ensure continuing

effectiveness of the arrangements for managing controlled drugs (CDs) in

England. https://www.cqc.org.uk/sites/default/files/20180718_controlleddrugs2017_report.pdf

Clinical Pharmacists in General Practice: Pilot scheme

The report identifies the potential impact of clinical pharmacists, describes how

they are likely to affect working practices and how they may improve service

delivery related to medicines both within the medical practice and externally

with CCGs, community pharmacy and hospital pharmacy. https://www.nottingham.ac.uk/pharmacy/documents/generalpracticeyearfwdrev/clinical-pharmacists-in-

general-practice-pilot-scheme-full-report.pdf

Continuity of care for prisoners who need substance misuse treatment

This toolkit from the PHE includes: guidance on how to improve continuity of

care; how to complete a continuity of care audit and tools to support an audit

of the referral and treatment pathway. https://www.gov.uk/government/publications/continuity-of-care-for-prisoners-who-need-substance-misuse-treatment

Epistatus – midazolam prefilled syringe (PFS)

Epistatus midazolam

oromucosal solution 10mg/ml

10mg PFS is the only licensed

strength

2.5mg/5mg/7.5mg strengths are

unlicensed

Syringes are not graduated

There is also an Epistatus

unlicensed multidose bottle

Buccolam (different licensed

brand/different strength) is

midazolam oromucosal solution

10mg/2ml

Risks • Wrong strength / brand

• Used by parent/carer in emergency situation - familiarity essential

• Risk of dispensing 10mg PFS when a lower dose is intended

• Risk of overdose if licensed 10mg PFS is supplied when a lower dose (2.5mg , 5mg or 7.5mg) is intended as syringe is not graduated

National guidance, publications and resources

Patient Discharge from Hospital to General Practice: Thematic Report

2017-2018

Review from Healthcare Inspectorate Wales found that despite understanding

of issues /challenges that prevent good discharge, these issues have not been

overcome, leading to fragmented approach being taken across the country. http://hiw.org.uk/docs/hiw/reports/180808dischargeen.pdf?lang=en

Always events evaluation

Always Events are aspects of the patient experience that healthcare providers

must aim to perform consistently for every individual, every time. A programme

to implement them within the NHS has been developed and this report from

the Picker Institute focuses on an assessment of its scale up and spread. http://www.picker.org/wp-content/uploads/2018/07/P3174-Always-Events-Evaluation-Report_FINAL.pdf

The case for Medication Safety Officers (MSO)

This white paper from the ISMP discusses the role of an MSO to oversee

reporting and analysis of medication errors and coordinate improvement

efforts. Responsibilities of a medication officer include serving as a champion,

advocating for safety interventions, and helping implement system changes. https://www.ismp.org/sites/default/files/attachments/2018-08/MSOS%20White%20Paper_Final_080318_1.pdf

National guidance, publications and resources

Patient safety quarterly report (England): Quarter 2 (April - June) 2018

Report from NPA MSO showed a 64% increase in patient safety incidents from

previous quarter (includes breaches of confidentiality as a result of GDPR). Report

presents an analysis of types of incident reported and a brief descriptions of three

which led to hospital admission

https://www.npa.co.uk/wp-content/uploads/2018/08/MSO-report-Quarter-2-2018-1.pdf

This month’s papers - overview

Canham A et al. Integrating systemic accident analysis into patient safety incident

investigation practices.

Applied Ergonomics; Oct 2018; vol. 72 ; p. 1-9

Carson A et al. A comparison of medication profiles held by general practitioners and

those documented during Home Medication Reviews

Pharmacy Practice & Research; 2018: 48; 340-7

Biltoft J et al. Clinical and financial effects of smart pump-electronic medical record

interoperability at a hospital in a regional health system.

Am J Health Syst Pharm. 2018 Jul 15;75(14):1064-1068. doi: 10.2146/ajhp161058

Furmedge DS et al. Evidence and tips on the use of medication compliance aids.

BMJ 2018; 362 doi: https://doi.org/10.1136/bmj.k2801

Gomes T et al. Pregabalin and the Risk for Opioid-Related Death: A Nested Case–

Control Study. Ann Intern Med. http://annals.org/aim/article-abstract/2697572/pregabalin-

risk-opioid-related-death-nested-case-control-study

This month’s papers - details

Moriarty F et al. Fixed-dose combination antihypertensives and risk of medication

errors.

Heart. Available: https://heart.bmj.com/content/early/2018/08/02/heartjnl-2018-313492

In depth

Parekh N et al. Incidence and cost of medication harm in older adults following hospital

discharge: a multicentre prospective study in the UK

British Journal of Clinical Pharmacology; Aug 2018; vol. 84 (no. 8); p. 1789-1797

Prospective cohort study involving follow up of 1280 older adults discharged from 5 teaching

hospitals in Southern England and followed up for 8 weeks using hospital readmission data,

primary care records and patient telephone interview showed:

• 37% experienced medication related harm (556 events per 1000 discharges)

• 79% of patients with medication related harm sought healthcare support

• 81% of events were classified as serious

• 52% were classified as potentially preventable

• The incidence of medication related harm associated re-admission was 79 per 1000

discharges

• Opiates, antibiotics and benzodiazepines were most commonly implicated medicine

classes

• Estimated that post discharge medication related harm costs the NHS £396m per year of

which £243m is potentially preventable