Download Observatory Observatory of recent safe medication

Observatory
th
28 September 2016
Observatory of recent safe medication
practice research, reports, and publications
Presented by Paula Russell
(Principal Pharmacist MI)
[email protected]
Recent regulator and statutory body activity
Restricted use of open systems for
injectable medication 07/09/2016. NHS/PSA/D/2016/008
A stage 3 alert: to stop the use of open systems for injectable medication
with the single exception of where the practice is used for embolization
procedures. Open systems include gallipots or other types of open
container such as moulded plastic procedure trays.
•
Who: All organisations providing NHS-funded care where there is potential for
an ‘open system’ to be used for injectable medication
•
When: Begin immediately and completed no later than 7 June 2017
•
Revise policies and protocols and establish systems of audit and observation
•
For embolization procedures involving embolic agents that need to be prepared
openly, develop a specific protocol or procedure to make it as safe as possible
using the advice from BSIR4 and NatSSIPs Resource Alert.
•
Circulate this alert or key messages to all relevant staff.
•
Share learning by emailing: [email protected]
Recent regulator and statutory body activity
Drug Safety Update https://www.gov.uk/drug-safety-update
 Levonorgestrel-containing emergency hormonal contraception:
 Medicines or herbal remedies that induce CYP3A4 enzymes reduce blood
levels of levonorgestrel, which may reduce efficacy. 15/09/2016
 Posaconazole (Noxafil):
 Switching from posaconazole oral solution to tablets has resulted in cases
of dose-related toxicity, whereas switching from tablets to oral solution has
resulted in underdosing and lack of efficacy. 15/09/2016
 Idelalisib (Zydelig▼):
 Updated advice as first line treatment of CLL and on risk minimisation
measures to prevent infection in all indications, with further guidance for
PJP and CMV. 15/09/2016
Letters sent to healthcare professionals in August 2016: outcome of a
review of the safety of idelalisib (Zydelig▼)
Recent regulator and statutory body activity
Drug Device Alerts and Recalls https://www.gov.uk/drug-device-alerts
 EcoLab Klerpack BD Syringe Multi-Pack (EL (16)A/13
− Sterile packaging may have small holes in the film of the pouch. Class 4.
14/09/2016
 GlucaGen HypoKit 1mg (glucagon) PL 04668/0027 (GlucaGen 1mg) PL
04668/0028 (Solvent for GlucaGen 1mg) .
− Seven batches of GlucaGen HypoKit recalled due to a small number of
needles being detached from the syringe making it unusable. Class 2.
06/09/2016
 Actilyse 20mg and 50mg powder and solvent for solution for
injection and infusion (alteplase)
− Rubber stopper may be pushed into vial during reconstitution, making the
vial unusable. Class 4. (EL (16)A/11) 24/08/2016
Recent regulator and statutory body activity
Medical Device Alert https://www.gov.uk/drug-device-alerts
 AIRVO™2 and myAIRVO™2 humidifier – risk of undetected
auditory alarm
− updated instructions to check the speaker before each use as undetected
auditory alarms could result in the patient becoming hypoxic. 02/09/ 2016
 Accu-Chek® Insight Insulin pump system: risk of over- or underinfusion of insulin
− inadequately detailed handling instructions of the 'Key Lock' function may
lead to unintentional operation of the pump. 01/09/2016
 Accu-Chek® Insight insulin pump system with NovoRapid®
PumpCart® cartridges – risk of hyperglycaemia
− Cartridges inserted incorrectly can leak insulin into the cartridge
compartment, resulting in an under-delivery of insulin.15/08/2016
Recent regulator and statutory body activity
EMA News and Events http://www.ema.europa.eu/ema/
 Pharmaceutics International Inc., US: Supply of non-critical
medicines to EU to be stopped due to manufacturing failings
(EMA/602744/2016) Committee for Medicinal Products for Human Use (CHMP) 16/09/2016
− Ammonaps (sodium phenylbutyrate), will remain available for use only where
there are no treatment alternatives.
− Dutasteride Actavis (dutasteride) and Lutigest/Lutinus (progesterone)
availability is unaffected.
 Better monitoring of biological medicines EMA 15/08/2016
− New chapter in guidelines on good pharmacovigilance practices.
− Applies to biological medicines, biosimilars and medicines which contain the
same or a closely related active substance but not authorised as biosimilars.
 EU Commission report on implementation of pharmacovigilance
legislation EU collaboration strengthens safety monitoring of medicines .EMA 08/09/16
− Covers July 2012 until July 2015
− Notes concrete pharmacovigilence achievements.
Recent regulator and statutory body activity
FDA Drug Safety Communication: warns about serious risks and death
when combining opioid pain or cough medicines with
benzodiazepines. http://www.fda.gov/Drugs/DrugSafety/ucm518473.htm
Growing combined use of opioid medicines (for cough or pain) with
benzodiazepines or other drugs that depress the CNS has resulted in serious side
effects, including slowed or difficult breathing and deaths.
 Boxed Warnings (strongest warning) added to the labelling of prescription opioid
pain and opioid cough medicines, and benzodiazepines.
 3 minute podcast www.fda.gov/Drugs/DrugSafety/DrugSafetyPodcasts/ucm076703.htm
 HCP Actions include:
− Limit prescribing opioids with benzodiazepines or other CNS depressants
to patients for whom alternative treatments are inadequate.
− If prescribed together, limit the dosages and duration of each drug to the
minimum possible while achieving the desired clinical effect.
− Warn patients and caregivers about the risks.
Drug shortages and discontinuations
 Corgard tablets (Nadalol) have been discontinued by the manufacturer
for commercial (not safety) reasons. There are unlicensed versions still
available.
 Public Health England advice on use of unlicensed BCG vaccine for
immunisation 08/09/2016
• Due to a worldwide shortage of the BCG vaccine, an unlicensed formulation
of the vaccine will be in use once current supplies expire at the end of this
month. The only formulation that is available for import is presented as a
multi-dose ampoule. PHE has issued advice and training material to support
this change in practice.
 Shortages of Medicines in Secondary Care. Some Resources to
Help. 30/08/2016
 Community Pharmacy PSNC website: Branded supply problems
• Antepsin: Supply Difficulties(Chugai) – For more information right click here
− Anticipate supply of Antepsin Oral Suspension and Antepsin Tablets will
not be resumed until Q1 of 2017.
• GSK (Dermatology): For more information right click here
Product Safety reviews
•
In use product safety assessment report for Prednisolone Dompe
1mg/mL Oral Solution 09/09/2016
– A UKMi Product Safety assessment for Prednisolone Dompe 1mg/mL
Oral Solution describes the in-use medication safety considerations
resultant from the product’s presentation or other pre-defined…
•
In use product safety assessment report for the Pevanti® (prednisolone
tablet) range 12/07/2016
– A UKMi Product Safety assessment for the Pevanti® (prednisolone
tablet) range which describes the in-use medication safety
considerations resultant from the product’s presentation or other…
•
Safety in lactation: Antidiarrhoeals 08/08/2016
– Additional information relating to breastfeeding To be used in conjunction
with individual drug entries for specific information and guidance.
Loperamide is preferred for acute diarrhoea.…
•
Safety in lactation 07/08/2016
– Safety in Lactation: Additional information relating to breastfeeding There
is no Therapeutic Group Summary relating to this medicine
NG53: Transition between inpatient mental health
settings and community or care home settings
This guideline covers the period before, during and after a person is
admitted to, and discharged from, a mental health hospital.
It aims to help people who use mental health services, their families and
their carers, to have a better experience of transition by improving the way
it’s planned and carried out.
1.2 Before hospital admission - Planning and assessment
1.2.7 Refers to the section on medicines-related communication systems when
patients move from one care setting to another and medicines reconciliation in
NICE's guideline on medicines optimisation [NG5].
1.5 Hospital discharge - Care planning to support discharge
1.5.20 Care plan should include:

details of medication (medicines-related communication systems in [NG5]

details of treatment and support plan
1.6 Follow-up support
1.6.5 If a person is being discharged to a care home, hospital and care home
practitioners should exchange information about the person refers to sharing
information about a resident's medicines in NICE's guideline on managing
medicines in care homes [SC1].
This months’ papers - overview
•
Prevalence and characteristics of adverse drug reactions at admission to
hospital: a prospective observational study. S Ling Chan, X Ang et al.. British
Journal of Clinical Pharmacology. 2016;doi: 10.1111/bcp.13081 (published early online
19/09/2016) http://onlinelibrary.wiley.com/doi/10.1111/bcp.13081/pdf
•
The impact of serious adverse drug reactions: a population-based study of a
decade of hospital admissions in New South Wales, Australia. R Walter, RO
Day et al.. British Journal of Clinical Pharmacology. 2016;doi: 10.1111/bcp.13124. (published
early online 10/09/2016) http://onlinelibrary.wiley.com/doi/10.1111/bcp.13124/abstract
•
Prevention of hospital-acquired adverse drug reactions in older people using
Screening Tool of Older Persons' Prescriptions and Screening Tool to Alert
to Right Treatment criteria: a cluster randomized controlled trial. MN O'Connor, D
O'Sullivan et al.. Journal of the American Geriatrics Society Aug 2016;64(8):1558-1566.
http://onlinelibrary.wiley.com/doi/10.1111/jgs.14312/full
•
Value of patient reporting to the pharmacovigilance system: a systematic
review. P Inacio et al.. British Journal of Clinical Pharmacology 2016;doi: 10.1111/bcp.13098
(published early online 25/08/16). http://onlinelibrary.wiley.com/doi/10.1111/bcp.13098/abstract
•
Legislation on the preparation of medicinal products in European
pharmacies and the Council of Europe Resolution. HPA Scheepers, J Langedijk et al..
European Journal of Hospital Pharmacy 2016;doi: 10.1136/ejhpharm-2016-001016
(published early online 05/09/2016). http://ejhp.bmj.com/content/early/2016/09/05/ejhpharm-2016001016
This months’ papers - overview
•
Medication errors as malpractice - a qualitative content analysis of 585
medication errors by nurses in Sweden. K Bjorksten, M Bergqvist et al.. BMC Health
Services Research 24 Aug 2016;16:431.
http://bmchealthservres.biomedcentral.com/track/pdf/10.1186/s12913-016-1695-9
•
Benzodiazepines are prescribed more frequently to patients already at risk
for benzodiazepine-related adverse events in primary care. DS Kroll et al..
Journal of General Internal Medicine. Sep 2016;31(9):1027-1034.
http://rd.springer.com/article/10.1007/s11606-016-3740-0
•
Partnered pharmacist charting on admission in the general medical and
emergency short-stay unit: a cluster-randomised controlled trial in patients
with complex medication regimens. EY Tong, C Roman et al.. Journal of Clinical
Pharmacy and Therapeutics. Aug 2016;41(4):414-418.
http://onlinelibrary.wiley.com/doi/10.1111/jcpt.12405/full
•
Evaluation of electronic health record implementation on pharmacist
interventions related to oral chemotherapy management. A Finn, C Bondarenka
et al. Journal of Oncology Pharmacy Practice 2016;doi: 10.1177/1078155216665247
(published early online 29/08/16).
http://opp.sagepub.com/content/early/2016/08/29/1078155216665247
•
An assessment of the variation in the concentration of acetylcysteine in
infusions for the treatment of paracetamol overdose. GP Bailey, DM Wood et al..
British Journal of Clinical Pharmacology 2016;doi: 10.1111/bcp.13099 (published early online
24 Aug 2016). http://onlinelibrary.wiley.com/doi/10.1111/bcp.13099/abstract
This months’ papers - details
Effect of warning symbols in combination with education on the
frequency of erroneously crushing medication in nursing homes: an
uncontrolled before and after study. van Welie S, Wijma L, Beerden T et al.
BMJ Open 2016;6:e012286. doi: 10.1136/bmjopen-2016-012286 .
•
Observed 36 nurses/nursing assistants administering medicines to 197 patients
across 18 wards in three nursing homes (Netherlands).
•
Witnessed administering 681 medications to 164 patients pre-intervention, and
636 medications to 150 patients post-intervention over 18 consecutive week days.
•
Overall, the intervention reduced the rate of wrongly crushed medicines from
3.1% (21 wrongly crushed medicines out of 681 administrations) to 0.5% (3 out of
636).
•
Also reports a decrease in ‘crushing errors’ involving patients with
swallowing difficulties (dysphagia) from 87.5% (21 wrongly crushed medicines
out of 24 medications) to 30.0% (3 out of 10).
•
Learning: need for staff to have better awareness of
– the clinical risks posed to patients from crushing tablets that should not be crushed
– the legal implications of modifying solid oral medication through crushing tablets or
opening capsules.