ukmi observatory august 2018 observatory of recent safe ... · brand/different strength) is...
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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 ([email protected])
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