observatory 22nd february 2017 - sps...observatory 22nd february 2017 observatory of recent safe...

Observatory

22nd February 2017 Observatory of recent safe medication

practice research, reports, and publications

Presented by Sarah Cavanagh

(Acting Director East Anglia Medicines Information Service)

[email protected]

Recent regulator and statutory body activity

Class 3 Drug Alert 1 February 2017

Alka-Seltzer Original & Alka-Seltzer XS (Bayer plc)

Recall of some batches due to an issue with the blister foil

Remaining stock of affected batches should be quarantined for uplift by

Bayer

Class 3 action within 5 days (EL (17)A/03)

Bayer plc is voluntarily recalling the above batches due to an issue with the

blister foil.

This may compromise of the moisture barrier provided by the aluminium layer.

This defect as unlikely to pose a safety risk.

Recent regulator and statutory body activity News story MHRA 30 January 2017

MHRA launch 'DMAA Week of Action‘

• MHRA launched a ‘Week of Action’ 30th January to 5th February to

improve awareness of unlicensed medicines containing the

potentially dangerous ingredient DMAA (methylhexanamine)

• Aimed to improve public awareness and encourages consumers of

sports supplements to check to see if their products contain DMAA or

any alternative names of the potentially dangerous ingredient.

• Check if a supplement contains DMAA by checking the global DRO

list, by entering a sport and searching for ‘DMAA’ and looking at the

alternative names of the ingredient.

http://www.globaldro.com/UK/Search/Terms

http://www.globaldro.com/UK/Search/Terms


Guidance

updated 27 January 2017

E-cigarettes: regulations for consumer

products

Contains preliminary guidance on how to get an e-

cigarette on the market in the UK, including the

notification scheme and reporting problems with

e-cigarettes.


News story

9 February 2017

New MedRegs blog

https://medregs.blog.gov.uk/

MHRA has launched an official blog providing

expert insight into the latest regulatory thinking and

all aspects of medicines regulation.



Press Release

Dienogest / ethinylestradiol should be used for acne only after certain

other treatments have failed and use should be limited to women who

choose oral contraception.

Medicines containing dienogest and ethinylestradiol should only be used to treat

moderate acne in women who also choose oral contraception. They should only be

used when treatments applied to the skin or an antibiotic taken by mouth have not

worked.

The CHMP also recommended that women should be assessed by their doctor 3 to

6 months after starting treatment and periodically thereafter to review the need for

continuation of treatment.


Pharmacovigilance Risk Assessment Committee

(PRAC)

Canagliflozin may contribute to risk of toe amputation and this risk may

also apply to other medicines in the same class

Increase in cases of lower limb amputation, mostly affecting the toes, has been

observed in patients taking the type 2 diabetes medicine canagliflozin

compared with those taking placebo, in two ongoing clinical trials involving

patients at high risk of heart problems.

An increased risk has not been seen in studies with other medicines in the

same class, dapagliflozin and empagliflozin. However, for these medicines,

data available to date are limited and the risk may also apply to these other

medicines.

PRAC recommends that a warning on the risk of lower limb amputation, mostly

affecting the toes, should be included in the prescribing information for

canagliflozin, empagliflozin and dapagliflozin, highlighting to healthcare

professionals and patients the importance of routine preventative foot care.


(PRAC)

Uptravi: reviewing safety of pulmonary hypertension

medicine

The PRAC is reviewing the safety of Uptravi (selexipag),

following the deaths of 5 patients taking the medicine in France.

EMA advises that Uptravi may continue to be used, but use must

be in line with the current prescribing information.

The review of Uptravi is being carried out in the context of

a safety signal. A safety signals information on a new or

incompletely documented adverse event that is potentially

caused by a medicine and that warrants further investigation.


(PRAC)

Quinolone and fluoroquinolone antibiotics

persistence of side effects under review

The PRAC is reviewing systemic and inhaled quinolone

and fluoroquinolone antibiotics to evaluate the persistence

of serious side effects mainly affecting muscles, joints and

the nervous system.

The review has been started at the request of the German

medicines authority (BfArM) following reports of long-

lasting side effects in the national safety database and the

published literature.

FDA News Release

January 27, 2017

FDA confirms elevated levels of belladonna in certain homeopathic

teething products

The agency is warning consumers that homeopathic teething tablets containing

belladonna pose an unnecessary risk to infants and children and urges

consumers not to use these products.

Homeopathic teething products have not been evaluated or approved by the

FDA for safety or effectiveness. In September 2016, the FDA warned against the

use of these products after receiving adverse event reports.

Consumers should seek medical care immediately if their child experiences

seizures, difficulty breathing, lethargy, excessive sleepiness, muscle weakness,

skin flushing, constipation, difficulty urinating, or agitation after using

homeopathic teething products.


http://www.fda.gov/NewsEvents/Newsroom/PressAnnouncements/ucm523468.htm

Chlorhexidine Gluconate: Drug Safety Communication

Rare But Serious Allergic Reactions

02/02/2017

• FDA is warning that rare but serious allergic reactions have been reported

with the widely used skin antiseptic products containing chlorhexidine

gluconate.

• The FDA is requesting the manufacturers of over-the-counter (OTC)

antiseptic products containing chlorhexidine gluconate to add a warning

about this risk to the Drug Facts labels.

RECOMMENDATION:

Consider using alternative antiseptics such as povidone-iodine, alcohols,

benzalkonium chloride, benzethonium chloride, or parachlorometaxylenol when

any previous allergy to chlorhexidine gluconate is documented or suspected.


News Release

February 9, 2017

FDA approves drug to treat Duchenne

muscular dystrophy

The FDA has approved Emflaza (deflazacort) tablets and

oral suspension to treat patients age 5 years and older with

Duchenne muscular dystrophy.

Emflaza is a corticosteroid that works by decreasing

inflammation and reducing the activity of the immune

system.


News Release

February 15, 2017

FDA approves Siliq (brodalumab) to treat adults

with moderate-to-severe plaque psoriasis. Siliq is

administered as an injection.

Siliq is intended for patients who are candidates for systemic therapy or

phototherapy and have failed to respond, or have stopped responding

to other systemic therapies.

Note: because of the observed risk of suicidal ideation and behaviour,

the labelling for Siliq includes a Boxed Warning and the drug is only

available through a restricted program under a Risk Evaluation and

Mitigation Strategy (REMS)


Safety Concerns with Implantable Infusion Pumps in the Magnetic

Resonance (MR) Environment:

FDA Safety Communication January 11, 2017

The FDA is informing patients, caregivers, MR technologists, and health care providers of

important safety precautions to help patients with implantable infusion pumps safely have

an MRI exam.

Only implantable infusion pumps labelled as MR Conditional may be safely scanned, and

only under the specific conditions of safe use. Contact the implantable infusion pump

manufacturer if there are any questions about the MRI safety status of the implantable

pump system.

Be aware that the steps that must be followed before, during, and after an MRI exam may

be different for each manufacturer and model of pump. Be sure to verify that the conditions

of safe MRI use can be followed prior to scanning the patient.

http://www.fda.gov/medicaldevices/safety/alertsandnotices/ucm536518.htm




Drug shortages and discontinuations

Disulfiram Tablets 200mg shortage

Disulfiram is used in the treatment of certain patients with drinking

problems, in conjunction with appropriate supportive treatment.

Maintenance dosing should continue for as long as advised by the

physician but no longer than six months without review.

It may be out of stock until April 2017.

Alternative agents and management options are discussed in the memo which

may be downloaded from the SPS website.

www.SPS.nhs.uk

Unlicensed imports of disulfiram are currently available from abroad via the

specialist pharmaceutical importer companies. Lead time for these unlicensed

supplies may vary.

http://www.sps.nhs.uk/

This month’s papers - overview

• Medication errors associated with transition from insulin pens to insulin vials

American Journal of Health-System Pharmacy, January 2017; 74/2: 70-75

https://www.ncbi.nlm.nih.gov/pubmed/28069680

• Medication administration in hospital: Difficulties and errors

Archives of Hellenic Medicine, January 2017; 34/1:123-126

http://www.mednet.gr/archives/2017-1/123abs.html

• The impact of electronic prescriptions on medication safety in Finnish

community pharmacies: A survey of pharmacists

International Journal of Medical Informatics, April 2017; 100: 56-62

http://www.ijmijournal.com/article/S1386-5056(17)30014-X/references

• Medication safety in pediatric emergencies: Pitfalls and avoidance strategies

Monatsschrift fur Kinderheilkunde, January 2017; 1-11













This month’s papers - overview

• Comparative Safety of Morphine Delivered via Intravenous Route versus Patient-Controlled

Analgesia Device for Pediatric Inpatients

Journal of Pain and Symptom Management 2017;doi: 10.1016/j.jpainsymman.2016.12.328

http://www.sciencedirect.com/science/article/pii/S0885392416312295

• Medication-related adverse events during hospitalization: a retrospective patient record

review study in The Netherlands

Pharmacoepidemiology and Drug Safety, January 2017; 26/1 32-39


• Reliability of chemotherapy preparation processes: Evaluating independent double-

checking and computer-assisted gravimetric control

Journal of Oncology Pharmacy Practice Mar 2017;23(2):83-92

http://journals.sagepub.com/doi/pdf/10.1177/1078155215620001






http://journals.sagepub.com/doi/pdf/10.1177/1078155215620001

This month’s papers - details

Exploring the roots of unintended safety threats associated with the

introduction of hospital ePrescribing systems and candidate avoidance

and/or mitigation strategies: a qualitative study

BMJ Quality and Safety 2017;doi: 10.1136/bmjqs-2016-005879

http://qualitysafety.bmj.com/content/early/2017/02/06/bmjqs-2016-005879

Design

• longitudinal, qualitative study of the implementation and adoption of

ePrescribing systems in six English hospitals, each being

conceptualised as a case study.

• Semistructured interviews, observations of implementation meetings

and system use, and a collection of relevant documents.

• Data was analysed first within and then across the case studies.







Results

214 interviews, 24 observations and 18 documents.

Taxonomy of factors underlying unintended safety threats in:

1. suboptimal system design

lack of support for complex medication administration regimens

lack of effective integration between different systems

lack of effective automated decision support tools

2. inappropriate use of systems; too much reliance on the system and introduction of

workarounds

3. suboptimal implementation strategies; resulting from partial roll-outs/dual systems

and lack of appropriate training. We have identified a number of system and

organisational strategies that could potentially avoid or reduce these risks.


• “…one of the doctors cancelled a drug but

the nurse who administered it had not

refreshed the screen so the drug was

given…”

• “… a lot of alerts get ignored because they

come up every 5 seconds for things that are

not clinically relevant’

• “…the system went down for 2 hours – it was

a catastrophe”


Conclusions

• Imperfections in the design, implementation and

use of ePrescribing systems can give rise to

unintended consequences including safety

threats.

Hospitals and suppliers need to implement short-

and long-term strategies in terms of the technology

and organisation to minimise the unintended safety

risks.

observatory 22nd february 2017 - sps...observatory 22nd february 2017 observatory of recent safe...

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