Observatory of recent safe medication practice research ... · Summary of Product Characteristics Updates Lustral (sertraline) 50mg and 100mg film coated tablets: SSRIs may cause

UKMi Observatory

27th November 2019

Observatory of recent safe medication

practice research, reports, and publications

Presented by Jaskiran McPhail

Senior Medicines Information Pharmacist

[email protected]

Patient Safety Alert (5th November 2019): Depleted batteries in intraosseous

injectors

The intraosseous (IO) route (through bone marrow) is used to access the venous

system when intravenous access is not possible to administer medicines or fluids,

often in emergency situations, including cardiopulmonary resuscitation. The alert

asks providers to replace any battery-powered IO devices that do not have a battery

power indicator light with ones with a display that shows how much power is

remaining.

Data on patient safety alert compliance: last updated 14th November 2019

• Monthly published data on all NHS trusts who have not signed off a relevant

patient safety alert as ‘action complete’ or 'action not required' within the

designated timeframe.

• Providers are required to sign off alerts via CAS.

Recent regulator and statutory body activity

Ranitidine: numerous class 2 pharmacy level recalls

Ongoing precautionary measure due to possible contamination with NMDA,

which has genotoxic and carcinogenic potential.

• Zantac all formulations: manufactured by GlaxoSmithKline, trading as

Glaxo Welcome.

• Ranitidine Effervescent Tablets: manufactured by Teva UK.

• Ranitidine preparations manufactured by Omega Pharma: trading as

Perrigo and Galpharm International.

• Ranitidine 150mg/10ml Oral Solution: manufactured by Rosemont

Pharmaceuticals.

• Ranitidine Oral Solution 30mg/ml, Ranitidine 150mg Tablets:

manufactured by Creo Pharma and Tillomed Laboratories.

• Ranitidine 75mg Tablets, (Various Liveries): manufactured by OTC

Concepts, Relconchem, Noumed Life Sciences, and Medreich.

Recent regulator and statutory body activity

Class 2 Medicines recall: Licensed and Unlicensed Nutriflex Omega Plus

and Nutriflex Omega Special bags. B Braun recalled some batches as a

precautionary measure as these bags may not comply with required

specification throughout product shelf-life.

Class 2 Medicines recall: Omeprazole 40mg powder for solution for

infusion. Sandoz Limited recalled a batch (JS1355) due to occurrence of

degradation in some vials.

Company-led drug alert (Biogen Idec UK): Avonex 30micrograms/0.5ml.

Batches recalled due to manufacturing issue leading to potential loss of

sterility assurance and weakened glass structure of syringe with risk of

particulate matter formation.

Medical Device Alert: Syringe driver pumps – T34 3rd edition models only.

Stop using the pump until updated instructions for use and BodyCommTM

V3.0 software are released.

Recent regulator and statutory body activity

Drug Safety Updates

1. Yellow fever vaccine: stronger precautions in people with weakened

immunity and in those aged 60 years or older.

The Commission on Human Medicines has issued a series of

recommendations to strengthen measures to minimise risk with the

yellow fever vaccine (Stamaril) following very rare fatal reactions.

2. Carfilzomib (Kyprolis▼): risk of reactivation of hepatitis B virus.

Establish hepatitis B status before initiating carfilzomib and in patients

with unknown hepatitis B virus serology who are already being treated

with carfilzomib.

Recent regulator and statutory body activity

Pharmacovigilance Risk Assessment Committee

(PRAC)

New measures to minimise risk of serious side effects with Lemtrada for multiple

sclerosis

PRAC is recommending restriction of the use of Lemtrada (alemtuzumab) due to reports of rare

but serious side effects, including deaths. New measures to identify and manage the serious

side effects are also recommended, which include cardiovascular and immune-related

disorders. Lemtrada should now only be used to treat relapsing-remitting multiple sclerosis if

the disease is highly active despite treatment with at least one disease-modifying therapy or if

the disease is worsening rapidly.

Xeljanz to be used with caution in patients at high risk of blood clots

PRAC concludes that Xeljanz (tofacitinib) could increase the risk of blood clots in the lungs and

in deep veins of patients already at high risk, with specific recommendations about use in

patients with ulcerative colitis. In addition, due to increased risk of infections, patients over 65

years of age should only be treated with Xeljanz where there is no alternative treatment.

Biosimilar medicines: Overview

EMA and European Commission have developed information materials on biosimilar medicines

to improve understanding of these medicines in the EU by both healthcare professionals and

patients. An animated video and information guide is available for patients.

Direct HCP communication

Letter Oct 2019: Volibris (ambrisentan): new patient alert card and removal of

the controlled distribution system.

Requirement to use the Volibris Healthcare Professionals User Guide, Patient Booklet

and card for the partners of PAH patients has been removed. A new Patient Alert

Card has been introduced instead, which will be provided with each pack of Volibris.

Letter Oct 2019: Quadrivalent Influenza Vaccine (split virion, inactivated):

Supply of Standard Export packs Lot T3H244M.

Due to higher demand for this vaccine than anticipated, the MHRA have approved the

use of a batch available in Standard Export packs. In the UK pack the registered

tradename is ‘Quadrivalent Influenza Vaccine (split virion, inactivated)’and on the

Standard Export pack the tradename is ‘VaxigripTetra’.

Letter Oct 2019: Fentanyl 50 micrograms/ml (10ml ampoules): non-UK

marketing authorisation number on the label of batch 0112391R.

There is currently no UK-labelled Fentanyl 50 micrograms/ml Solution for Injection

(10ml ampoules) manufactured by Martindale Pharma available for distribution in the

UK. The MHRA have approved one batch of product that was labelled for distribution

in Saudi Arabia.

Summary of Product Characteristics Updates

Lustral (sertraline) 50mg and 100mg film coated tablets: SSRIs may cause

sexual dysfunction despite discontinuation.

Keppra (levetiracetam) products: Warns about possibly causing psychotic

symptoms and behavioural abnormalities; consider treatment adaptation or gradual

discontinuation.

Salofalk (mesalazine) gastro-resistant prolonged-release granules and

tablets: Advises that cases of nephrolithiasis have been reported including stones

with a 100% mesalazine content. Adequate fluid intake during treatment should be

advised.

Singulair (montelukast sodium) products: Neuropsychiatric events have been

reported in patients of all ages. Obsessive-compulsive and dysphemia added as

very rare adverse effect.

Noxafil (posaconazole) preparations: Pseudoaldosteronism has been added as a

potential adverse effect of treatment (frequency unknown).

Summary of Product Characteristics Updates

Verzenios (abemaciclib) film-coated tablets: Advises that in the event of

elevation in AST and/or ALT to >3 x upper limit of normal (ULN) with total bilirubin

>2 x ULN, in the absence of cholestasis, abemaciclib should be discontinued

Erivedge (vismodegib) capsules: Severe cutaneous adverse reactions, including

Stevens-Johnson syndrome/Toxic epidermal necrolysis (SJS/TEN), Drug reaction

with eosinophilia and systemic symptoms (DRESS) and acute generalised

exanthematous pustulosis (AGEP), have been reported.

UKMI comment: If the patient has developed any of these reactions with the use of

vismodegib, treatment with vismodegib must not be restarted in this patient at any

time.

Inlyta (axitinib) tablets: Cholecystitis has been added as a potential adverse effect

of treatment (frequency = common).

Drug shortages and discontinuations

NHS England - Guide to Managing Medicines Supply and Shortages

Aims to support NHS professionals with managing supply of medicines to patients and details

national, regional and local management and escalation processes and communication routes

for medicines supply issues to consolidate practice across industry, government and the NHS.

Supply Disruption Alert: Minims phenylephrine 2.5% and 10% w/v eye drops. Out of

stock until early January 2020. Refer to alert for management of patients using this medicine.

Supply Disruption Alert: Mitomycin-C Kyowa all strengths. All unexpired batches of

Kyowa Kirin Mitomycin-C are subject to a MHRA Class 2 recall EL (19)A/33. In addition to

this, the manufacturers will be unable to support the UK market for at least 12 months.

UKMI in conjunction with clinical experts in Oncology and Ophthalmology have produced a

memo to support local management of this supply disruption.

Supply Disruption Alert: Ongentys (opicapone) 50mg capsules. Bial Pharmaceuticals will

be out of stock of this product from mid-November to mid-January 2020. Refer to the alert for

management of patients using this medicine.

Shortage notice: Pethidine 50mg tablets. Teva anticipate resupply week commencing 2nd

December 2019 and Martindale in mid-December 2019. Unlicensed pethidine 50mg capsules

are available from Martindale.

Full list of current shortages and supply issues are available via SPS (login required)

National guidance, publications and resources

UKMI Product Safety Assessment (updated: 11th November 2019) - Insulin Glargines

This review summarises safety considerations associated with the use of high strength glargine

products and the biosimilars.

UKMI Q&A (updated: 21st October 2019) - How do you switch between tricyclic, SSRI & related

antidepressants?

UPDATE: Community Pharmacy NSAID Safety Audit 2019-20. The updated audit tool for the

2019-20 Pharmacy Quality Scheme is now available on the SPS website.

Upcoming SPS Medicines Use and Safety Network (MUSN) Webinars:

• Medicines Governance Do Once Programme - 11th December 2019

• Human Factors - 8th January 2020

New Medicines Newsletter - October 2019

Highlights recent new product launches and significant medicines regulatory changes and new

medicines monographs added to the SPS website. A new section lists new products that have

been considered for a safety assessment by the UKMi Patient Safety Working Group.

National guidance, publications and resources

Judiciary.uk publication – case of Abdeslam Benelghazi

Patient with schizophrenia, neuropathic pain and history of illicit drug use died due to combined

effects of methadone, zuclopenthixol, gabapentin and clonazepam. In particular, coroner

highlighted risk of using clonazepam with methadone, which further increased the risk of sedation,

central nervous system and respiratory depression.

Judiciary.uk publication – case of Kenneth Daly

Patient with history of chronic back pain and anxiety died after taking an overdose of multiple

opioids, pregabalin and a benzodiazepine. Coroner raised concerns about GP continuing to

prescribe dihydrocodeine alongside morphine and co-codamol (30/500 strength). In addition, the

patient was not given any written guidance regarding his pain relief, use of the medicines

prescribed and warnings about combined use of multiple opioids. This case also highlights

increased risk of respiratory depression when pregabalin or benzodiazpeines are used alongside

opioids.

In the media; Coroners inquest – case of Debbie Headspeath

Patient died from pneumonitis caused by acute pancreatitis which in turn was caused by chronic

codeine use. Coroner found patient had been obtaining codeine from her GP and via online

companies. It was concluded that she died as a result of "uncoordinated availability of codeine

from multiple suppliers"

National guidance, publications and resources

Healthcare Safety Investigation Branch (HSIB) – update on medicines related investigations

Electronic prescribing and medicines administration systems and safe discharge (October 2019):

Report completed and published identifying a significant safety risk posed by poorly implemented

electronic prescribing and medicines administration (ePMA) systems.

Ongoing investigations:

• Identifying and reducing high-risk prescribing errors in hospital

• Potential under-recognised risk of harm from the use of propranolol

• Insulin prescribing and administration in hospitals

This month’s papers - overview

1. Prevalence and Nature of Medication Errors and Preventable Adverse Drug

Events in Paediatric and Neonatal Intensive Care Settings: A Systematic Review.

Drug Saf. 2019 Dec;42(12):1423-1436. doi: 10.1007/s40264-019-00856-9.

2. Identifying risks areas related to medication administrations - text mining

analysis using free-text descriptions of incident reports. BMC Health Serv Res.

2019 Nov 4;19(1):791. doi: 10.1186/s12913-019-4597-9.

3. Effect of Electronic Prescribing Strategies on Medication Error and Harm in

Hospital: a Systematic Review and Meta-analysis. J Gen Intern Med. 2019

Oct;34(10):2210-2223. doi: 10.1007/s11606-019-05236-8.

4. Mind-Body Therapies for Opioid-Treated Pain: A Systematic Review and Meta-

analysis. JAMA Intern Med. Published online November 4, 2019.

doi:https://doi.org/10.1001/jamainternmed.2019.4917

5. Clinical oncology pharmacist: Effective contribution to patient safety. J Oncol

Pharm Pract. 2019 Oct;25(7):1665-1674. doi: 10.1177/1078155218807748.

This month’s papers - overview

6. Pharmacist-led, video-stimulated feedback to reduce prescribing errors in doctors-

in-training: A mixed methods evaluation. Br J Clin Pharmacol. 2019 Oct;85(10):2405-

2413. doi: 10.1111/bcp.14065.

7. Smart pumps improve medication safety but increase alert burden in neonatal care.

BMC Med Inform Decis Mak. 2019 Nov 7;19(1):213. doi: 10.1186/s12911-019-0945-2.

8. Reason for Use: An Opportunity to Improve Patient Safety. Stud Health Technol

Inform. 2019;257:47-52.

9. How do stakeholders experience the adoption of electronic prescribing systems in

hospitals? A systematic review and thematic synthesis of qualitative studies BMJ

Quality & Safety Dec 2019, 28 (12) 1021-1031; DOI: 10.1136/bmjqs-2018-009082

10. A deadly trend in fentanyl fatalities (England, 1998-2017). Br J Clin Pharmacol. 2019

Oct 29. doi: 10.1111/bcp.14135.

Pharmacist-led, video-stimulated feedback to reduce prescribing errors in

doctors-in-training: A mixed methods evaluation. (open access)

Br J Clin Pharmacol. 2019 Oct;85(10):2405-2413. doi: 10.1111/bcp.14065.

• Background:

Feedback can be an impactful educational intervention.

Doctors‐in‐training represent the largest group of hospital prescribers but rarely

receive feedback on prescribing.

Pharmacists, as medication experts and established members of clinical teams, are

well placed to support the development of good prescribing in doctors‐in‐training.

• Aims: To develop and evaluate a feasible, authentic pharmacist‐led prescribing

feedback intervention for doctors‐in‐training, to reduce prescribing errors.

• Methods: This was a mixed methods study. Sixteen postgraduate doctors‐in

training, rotating though the surgical assessment unit of 1 UK hospital, were filmed

taking a medication history with a patient and prescribing medications. Each doctor

reviewed their video footage and made plans to improve their prescribing, supported

by feedback from a pharmacist.

Quantitative data in the form of prescribing error prevalence data were collected on

1 day per week before, during and after the intervention period (Nov 2015-Mar

2017). Qualitative data in the form of individual semi‐structured interviews were

collected with a subset of participants, to evaluate their experience.

This month’s papers - overview

Pharmacist-led, video-stimulated feedback to reduce prescribing errors in

doctors-in-training: A mixed methods evaluation. (open access)

Br J Clin Pharmacol. 2019 Oct;85(10):2405-2413. doi: 10.1111/bcp.14065.

• Results: 923 patient drug charts were reviewed by pharmacists who identified

1219 prescribing errors overall.

Implementation of this feedback approach was associated with a statistically

significant reduction in the mean number of prescribing errors, from 19.0/d to

11.7/d (estimated to equate to 38% reduction; P < .0001).

Pharmacist‐led video‐stimulated prescribing feedback was feasible and

positively received by participants, who appreciated the reinforcement of good

practice as well as the opportunity to reflect on and improve practice.

• Conclusions: Feedback to doctors‐in‐training tends to be infrequent and often

negative, but this feasible feedback strategy significantly reduced prescribing

errors and was well received by the target audience as a supportive

developmental approach.

Such interventions need not be expensive, with time investment in giving

feedback balanced by the errors prevented.