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Observatory Tiffany Barrett & Michele Skipp
UKMI
South West Medicines Information
Bristol
National Medication Safety Network
Slide 51 MSO Web Event 25th March 2015
National Medication Safety Network 25th March 2015
Observatory of recent safe medication practice research, reports, and publications
Presented by Tiffany Barrett
Slide 52 MSO Web Event 25th March 2015
Recent regulator and statutory body activity
U.S. Food and Drug Administration
Slide 53 MSO Web Event 25th March 2015
General practice patient safety reporting form launched
February 2015
• NHS England is making it easier than ever before for general
practice staff to report patient safety incidents.
• A new e-form is being launched today to enable general practice
staff to quickly and easily report patient safety incidents to the
National Reporting and Learning System (NRLS) – the national
patient safety incident database.
• Reports of harm or near misses to the NRLS provide NHS England
with important insight of incidents from across the country. This
enables risks to be identified and appropriate action to be taken to
prevent incidents – such as the cascading of patient safety alerts,
developing learning resources and holding workshops for NHS staff.
• The eForm is available from 26th February 2015.
Slide 54 MSO Web Event 25th March 2015
Shingles Vaccine in Pregnancy March 2015
• A number of cases of pregnant women being inadvertently
immunised with shingles vaccine (Zostavax) have been
reported to PHE, after presenting for their recommended flu
or pertussis (Boostrix-IPV) vaccine.
• It is clearly important that procedures are in place to ensure
that all vaccines are appropriately administered.
• Further to this, guidance from PHE provides information on
the safety of chickenpox, shingles and MMR vaccines
when given in pregnancy for health professionals to share
with pregnant women who have been inadvertently
vaccinated.
Slide 55 MSO Web Event 25th March 2015
• Rienso 30mg/ml solution for infusion
(Ferumoxytol). Takeda UK Ltd.
– Further to the recall of Rienso batches in January
2015, due to a change in the mode of administration
Takeda has withdrawn the MA in the EU.
– All stock of the listed batches, including any stock at
ward level and in other locations within the hospital,
should be quarantined and returned to the original
supplier for credit immediately (by 1 April 2015 at the
latest).
Medicines: company-led recalls March 2015
Slide 56 MSO Web Event 25th March 2015
Medicines: company-led recalls March 2015
• Vitaros 3mg/g cream. Takeda UK Ltd.
– Batch 511742, expiry Aug 2015 was distributed to the
UK market in error between 3 March and 11 March
2015.
– Only a small number of packs have been distributed
beyond wholesaler level.
– The batch was quarantined pending investigation of
an out of trend result for alprostadil assay reported
during stability testing.
Slide 57 MSO Web Event 25th March 2015
Drugs and Driving March 2015
• New legislation came into effect on 2nd March
which makes it illegal to drive with certain drugs
in the body above specified levels, including 8
prescription drugs:
– morphine, diazepam, clonazepam, flunitrazepam,
lorazepam, oxazepam, temazepam, methadone.
• However, if patients are taking medicines as
directed and their driving is not impaired, then
they are not breaking the law.
Slide 58 MSO Web Event 25th March 2015
Online Learning Module Launched – Steroids March 2015
• MHRA have launched an online learning module
on reducing side effects of steroid medicines.
• To help clinicians optimise the use of steroids,
and manage risks.
• Designed for doctors, nurses and pharmacists.
Slide 59 MSO Web Event 25th March 2015
Safety signals: recommendations now available in all EU languages
February 2015
• The EMA has started to translate its recommended changes to product information based on the assessment of safety signals into all official languages of the European Union (EU).
• The translations should be used by pharmaceutical companies to update the product information of their medicines.
• This initiative is expected to accelerate the implementation of changes to product information and to ensure consistency across EU countries, thus leading to better information for patients on their medicines.
Slide 60 MSO Web Event 25th March 2015
Pharmacovigilance Risk Assessment
Committee (PRAC) recommendations March 2015
• Further measures to minimise the known risk of
osteonecrosis of the jaw associated with zoledronic acid.
– Product information to be updated.
– A patient reminder card to be introduced to include the following: • The benefit of treatment of osteoporosis.
• The risk of osteonecrosis of the jaw with zoledronic acid.
• The need to highlight dental problems with doctors/nurses before starting
treatment.
• The need to ensure good dental hygiene.
• The need to inform dentist of therapy with zoledronic acid and to contact the
doctor and dentist if problems occur.
• Measures to be considered for other IV bisphosphonates
and denosumab in upcoming reviews.
Slide 61 MSO Web Event 25th March 2015
Pharmacovigilance Risk Assessment Committee (PRAC) recommendations
March 2015
• Restrictions on the use of codeine for cough and
cold in children because of risk of serious side
effects, including breathing problems.
• Contraindicated in children <12 years old.
• Not recommended 12 years – 18 years in
patients with breathing problems.
• All liquid codeine medicines should be in child-
resistant containers to avoid accidental
ingestion.
Slide 62 MSO Web Event 25th March 2015
Drug Safety Communications • FDA advises manufacturers of testosterone
products to update their product information
– to highlight the increased risk of strokes or heart
attacks
– to clarify the approved uses of these drugs. March
2015
• FDA requires label warnings to prohibit sharing of
multi-dose diabetes pen devices among patients.
– Pens and packaging containing multiple doses of
insulin and other injectable diabetic medicines must
display a warning label “For single patient use only”.
February 2015
Slide 63 MSO Web Event 25th March 2015
Drug Safety Communications March 2015
• FDA updates product information for varenicline
to include:
– a warning that varenicline can change the way people
react to alcohol.
• Some patients experienced decreased tolerance to alcohol,
including increased drunkenness, unusual or aggressive
behaviour, or they had no memory of things that happened.
– rare accounts of seizures in patients treated with
varenicline.
Slide 64 MSO Web Event 25th March 2015
In Use Product Safety Assessment Remsima® and Inflectra®
March 2015
• In Use Product Safety Assessment Report for
Remsima® and Inflectra® (infliximab biosimilars)
• Infliximab is the first monoclonal antibody for which a
biosimilar version will be available; it has been
developed by Celltrion Pharmaceuticals.
• UK marketing authorisations have been granted to two
products (both of which comprise the same biosimilar)
and this review summarises practical in-use safety
considerations associated with their introduction.
Slide 65 MSO Web Event 25th March 2015
NICE Guidance Medicines Optimisation March 2015
• Medicines optimisation: the safe and effective
use of medicines to enable the best possible
outcomes (NG5).
• Offers best practice advice on the care of people
using medicines.
– It updates and replaces recommendation 1.4.2 in the
NICE guideline on medicines adherence and replaces
PSG001 Technical patient safety solutions for
medicines reconciliation on admission to hospital
Slide 66 MSO Web Event 25th March 2015
NICE Advice [ESUOM41] March 2015
• Management of aggression, agitation and
behavioural disturbances in dementia: valproate
preparations.
– RCT evidence suggests that valproate preparations
(incl. sodium valproate and valproate semisodium) are
no more effective than placebo for treating agitation or
behavioural disturbances in people with dementia.
– Adverse effects were increased with valproate e.g.
falls, sedation, gait disturbances, tremor, muscular
weakness, thrombocytopenia, GI disorders and UTIs.
Slide 67 MSO Web Event 25th March 2015
This month’s papers • Implementation of a 24-hour pharmacy service with prospective
medication review in the emergency department. Hospital Pharmacy,
2015 Feb;50(2):134-8. doi: 10.1310/hpj5002-134.
http://www.ncbi.nlm.nih.gov/pubmed/25717209
• Pharmacist prescribing within a UK NHS hospital trust: nature and extent
of prescribing, and prevalence of errors. Eur J Hosp Pharm
doi:10.1136/ejhpharm-2014-000486.
http://ejhp.bmj.com/content/early/2014/09/04/ejhpharm-2014-
000486.abstract
• Assessment of medication errors in psychiatry practice in a tertiary care
hospital. International Journal of Pharmaceutical Sciences and Research,
2015, vol./is. 6/1(226-232). http://ijpsr.com/bft-article/assessment-of-
medication-errors-in-psychiatry-practice-in-a-tertiary-care-hospital/
• Should We Tell Parents When We’ve Made an Error? Pediatrics, January
2015, vol./is. 135/1(159-163).
http://pediatrics.aappublications.org/content/135/1/159.abstract
• High-risk medication use and patient safety. J Korean Med Assoc. 2015
Feb;58(2):105-109. http://dx.doi.org/10.5124/jkma.2015.58.2.105
Slide 68 MSO Web Event 25th March 2015
This month’s papers
• Drug-disease and drug-drug interactions: systematic examination of
recommendations in 12 UK national clinical guidelines. BMJ
2015;350:h949 . http://www.bmj.com/content/350/bmj.h949
• Hormone therapy for preventing cardiovascular disease in post-
menopausal women. Cochrane Database of Systematic Reviews 2015,
Issue 3. Art. No.: CD002229. DOI:
10.1002/14651858.CD002229.pub4.Hormone.
http://onlinelibrary.wiley.com/doi/10.1002/14651858.CD002229.pub4/full
• Paracetamol: not as safe as we thought? A systematic literature review of
observational studies. Ann Rheum Dis 2015doi:10.1136/annrheumdis-
2014-206914 http://ard.bmj.com/content/early/2015/02/09/annrheumdis-
2014-206914.full
• Increased risk of diabetes with statin treatment is associated with impaired
insulin sensitivity and insulin secretion: a 6 year follow-up study of the
METSIM cohort. Diabetologia. 2015 Mar 10. [Epub ahead of print].
http://www.ncbi.nlm.nih.gov/pubmed/25754552
Slide 69 MSO Web Event 25th March 2015
Drug-disease and drug-drug interactions: systematic examination of recommendations in
12 UK national clinical guidelines
• BMJ 2015;350:h949
• Three exemplar NICE clinical guidelines (type 2
diabetes, heart failure and depression) and nine
other guidelines for potentially comorbid
conditions selected.
• 3 clinicians reviewed each of these 12 guidelines
to identify, quantify and classify potentially serious
drug-disease and drug-drug interactions.
Slide 70 MSO Web Event 25th March 2015
Drug-disease and drug-drug interactions
• Results:
– 32 potentially serious drug-disease interactions were identified
(diabetes guideline)
• 84% of these were between the recommended drug and CKD.
– 6 potentially serious drug-disease interactions were identified
(depression guideline).
– 10 potentially serious drug-disease interactions were identified (heart
failure guideline).
– 133 drug-drug interactions were identified (diabetes guideline)
– 89 drug-drug interactions were identified (depression guideline)
– 111 drug-drug interactions were identified (heart failure guideline)
– Few of these drug-disease or drug-drug interactions were highlighted
in the guidelines for the 3 index conditions.
Slide 71 MSO Web Event 25th March 2015
Assessment of medication errors in psychiatry practice in a tertiary care hospital
• IJPSR 2015, vol./is. 6/1(226-232)
• Objective: determine the incidence, causes, patterns,
outcomes and predictors of medication errors (ME) in
psychiatric practice.
• Prospective observational study in a tertiary care
hospital over 6 months.
• Predictors were determined by bivariate non parametric
analysis.
• Variables considered were age, gender, length of stay,
and number of medications.
Slide 72 MSO Web Event 25th March 2015
Medication errors in psychiatry practice
• Results:
– 215 medication errors were identified from 166 patients
(incidence 1.3 per patient).
– Average number of ME in a patient was 2.1.
– Most common ME were:
• Dose omission (42.12%)
• Wrong technique (11.57%)
• Wrong administration (10.60%).
– Male gender and >/= 6 medications were predictors of ME.
– Factors responsible for ME:
• performance deficit of nursing staff (33.33%)
• lack of training of nursing staff (26.38%)
• knowledge deficit of physician (11.57%).
Slide 73 MSO Web Event 25th March 2015
