Observatory th 28 September 2016 Observatory of recent

Observatory th 28 September 2016 Observatory of recent safe medication practice research, reports, and publications Presented by Paula Russell (Principal Pharmacist MI) Paula. Russell@nuth. nhs. uk

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 BSIR 4 and Nat. SSIPs Resource Alert. • Circulate this alert or key messages to all relevant staff. • Share learning by emailing: patientsafety. enquiries@nhs. uk

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 CYP 3 A 4 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 § Eco. Lab 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 § Gluca. Gen Hypo. Kit 1 mg (glucagon) PL 04668/0027 (Gluca. Gen 1 mg) PL 04668/0028 (Solvent for Gluca. Gen 1 mg). − Seven batches of Gluca. Gen Hypo. Kit recalled due to a small number of needles being detached from the syringe making it unusable. Class 2. 06/09/2016 § Actilyse 20 mg and 50 mg 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 my. AIRVO™ 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 Novo. Rapid® Pump. Cart® 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/Drug. Safety/ucm 518473. 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/Drug. Safety. Podcasts/ucm 076703. 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 Q 1 of 2017. • GSK (Dermatology): For more information right click here

Product Safety reviews • In use product safety assessment report for Prednisolone Dompe 1 mg/m. L Oral Solution 09/09/2016 – A UKMi Product Safety assessment for Prednisolone Dompe 1 mg/m. L 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

NG 53: 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 [NG 5]. 1. 5 Hospital discharge - Care planning to support discharge 1. 5. 20 Care plan should include: details of medication (medicines-related communication systems in [NG 5] 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 [SC 1].

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-2016 -001016

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/s 12913 -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/s 11606 -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: e 012286. 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.