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Medication Safety


Nearly ten years ago, I undertook a project for my Pharmacy degree, with the title “Minimising Medication Errors for Paediatric Inpatients”. The TGA’s recent alert about paracetamol dosing in addition to events in the Australian national news has led me to consider some of the newer literature on and around the issue of inpatient medication safety in children.

Bottom Line

Children experience higher rates of medication errors than adults.

Most errors are made at the prescribing stage.

The most common kind of error is an incorrect dose.

Intravenous preparations are more susceptible to errors than other routes of administration.

Neonates are particularly susceptible to medication errors

The cornerstone paper for the elective and literature review was Kaushal et al’s seminal 2001 JAMA study. This was a significant study in a major journal, and has shaped much of the research in this area;

Kaushal R, Bates DW, Landrigan C, McKenna KJ, Clapp MD, Federico F, Goldmann DA. Medication errors and adverse drug events in pediatric inpatients. JAMA. 2001 Apr 25;285(16):2114-20. PMID: 11311101

The population involved 1120 patients admitted to the paediatric wards at two academic hospitals (in 1999).

This was a prospective study as a chart review to identify medication errors, adverse drug events, and potential adverse drug events. They aimed to determine the rates, and compare them with adult patients (in previous studies).

Further analysis that looked at the features of errors and adverse drug events (ADEs) were potentially (or actually) occurring; specifically, the type of error, patient demographics, stage of medication, medication category and dosing route

What was found? 

A higher error rate in children than in previous adult studies was identified; with an error rate of 5.7% and ADE rate of 1.1% of orders. In real numbers, that means that at least one in twenty medication orders has something go wrong.

Other findings of note include;

  • Neonates in any ward, but particularly premature neonates in the NICU were vulnerable to errors.
  • The most frequent error type was dosing errors (28%); it is noted that ten-fold over and under-doses were identified.
  • Intravenous medications and fluids were the routes most susceptible to errors, accounting for more than half of errors and ADEs.

Significantly for our readership, the vast majority of errors and ADEs (74% and 79%) were at the prescribing and ordering stage. In Australia and New Zealand, this is almost solely done by doctors. Additionally, a further 10% of errors and ADEs were part of transcribing; a task done by nursing staff in the study hospitals.

One possible limitation of the study is that it was all about CPOE (computer physician order entry), that is, computer prescribing. The authors judged that 93% of the potential ADEs were potentially preventable by using computer prescribing software with decision support; and that 94% were potentially preventable with a ward-based clinical pharmacist. They highlighted the importance of decision support software, as computer medication records did not see the same high level of potential prevention.

Since the Kaushal paper, a 2009 New Zealand study by Kunac et al prospectively looked specifically at Adverse Drug Events (ADEs) in paediatric inpatients. ADEs are “actual injuries resulting from medical interventions related to a medicine”. This is a more eloquent patient-oriented outcome – it focuses on those events which have real-world consequences.

More Bottom Lines

Adverse Drug Events (ADEs) are patient-oriented outcomes.

ADEs occurred in about 1 in every 50 prescriptions.

For every hundred admissions, there are about 22 preventable ADEs or potential ADEs.

More than half of the ADEs are preventable.

ADEs are a significant drain on hospital resources.

Kunac DL, Kennedy J, Austin N, Reith D. Incidence, preventability, andimpact of Adverse Drug Events (ADEs) and potential ADEs in hospitalized children in New Zealand: a prospective observational cohort study. PaediatrDrugs. 2009;11(2):153-60. doi: 10.2165/00148581-200911020-00005. PMID19301935 (it’s paywalled, sorry!)

The authors looked at all paediatric and neonatal admissions to a tertiary hospital in Dunedin, NZ in a 12-week period. Patients admitted with overdose were excluded. A total of 520 admissions were analysed (a further ~180 were excluded as the length of stay was less than 24hrs).

Kunac et al. aimed to evaluate the incidence, preventability and seriousness of ADEs (and potential ADEs) in the paediatric inpatient setting in NZ, and their cost implications. Information was gathered via chart review, MDT attendances, parent/carer interviews and informal reporting via staff.

What was found?

67 ADEs were identified, at a rate of 2.1 per 100 prescription episodes. Of these, more than half were classified as preventable. An additional 77 potential ADEs were noted.

The numbers have also been analysed on a per-admission basis; for every 100 admissions, there were ~22 preventable occurrences that were potential or actual ADEs.

Quite correctly, the authors looked at the seriousness of the events. They classified ADEs and Potential ADEs as fatal, persistent disability, life-threatening, hospitalisation, intervention to prevent permanent impairment or not serious.

Thankfully, there were no fatal ADEs during the study period, however, three events, all in neonates resulted in ‘preventable persistent disability. Two of the events were related to ‘inadequate management’ of hyponatremia, and a third was related to the concomitant administration of vancomycin and indomethacin and increasing levels of creatinine.

A further seven further ADEs were life-threatening, and seven more as requiring intervention to prevent permanent impairment, all of which were preventable ADEs.

A few specific examples of potential ADEs given include:

  • No maximum dose on a PRN morphine prescription (potentially fatal).
  • Gentamicin dosing and frequency in neonates (persistent disability).
  • A high number of ADE reports centred around opiate medications.

I think it’s good that the authors have been specific about these events; they’re illustrative of how ADEs increase in seriousness insidiously, as though sliding through the Swiss Cheese. It’s a nice mix of the data, but with those practical stories that help this kind of research stick.

Finally, there are several paragraphs discussing the costs of ADEs, incorporating causality and costs. They are quantified as a significant expenditure. I think that as there are all kinds of volatility in repeating a dollar amount that’s more than a decade old in a small country I’ll refrain from re-posting it. It is worth noting that there’s comprehensive universal healthcare and significant Tort Law reform in New Zealand, so this cost would be about as underinflated as it gets in the developed world.

Much of the literature has not really taken into account the immediacy of prescribing. Whilst the Silva paper looked at the PICU, and Garfield et al investigated the severity of the errors, I thought we’d take a look at the pointy end of things. That is when you have a crashing patient in front of you. In this paper, Porter and her California colleagues undertook a prospective observational study of errors in Paediatric Sim training.

Porter E, Barcega B, Kim TY. Analysis of medication errors in simulated pediatric resuscitation by residents. West J Emerg Med. 2014 Jul;15(4):486-90. doi: 10.5811/westjem.2014.2.17922. PMID: 25035756

This study involved 49 first- and third-year paediatric residents taking part in the simulated resuscitation of a critically unwell child. About half of the participants were interns.

Investigators assessed the accuracy of verbal orders of medication given during the simulated resuscitation. A medication error was defined as variability from the recommended dose (references given) by greater than 20%. The investigators also analysed the presence or absence of a clinical pharmacist and the use of cognitive aids.

The sims were recorded on video and reviewed by two investigators with standardized data collection forms. Each variable was analysed separately, as well as a separate multiple logistic regression analysis on significant values. Additional information was obtained from the residents prior to the scenario.

What was found?

In the scenarios, a potential medication error rate of ~40% was identified with the initially prescribed medication. 65% of the errors were dose-related, in 40% there was an unknown dose and 5% gave an inappropriate medication. 65% of the initially prescribed errors were corrected prior to delivery, hence the final medication error rate was 26.5%.

Cognitive aids (code sheets, handheld devices, pocketbooks, calculators) were used by 12 of the 49 residents. Interns were more likely to use cognitive aids than senior residents, although the number was not significantly different.

Pharmacists were invited to join the simulations, and were present at just under half of the scenarios (due to rostering etc); they were more often present in the simulations run by interns than residents. Of the errors corrected prior to drug delivery, pharmacists corrected ~70%. Three errors were not caught prior to administration when a pharmacist was present.

The questionnaires showed that (only) a third of residents had slept more than 8 hours the previous night. In fact, the only metric that showed a statistically significant reduction in medication errors was the presence of a pharmacist at the resuscitation. The article does not state the total number of errors; all the figures are given as percentages. It’d be good to see some more raw data, including the agents used and a bit more breakdown of the errors.

My interpretation of this article is that:

Residents need a good night’s sleep – fatigue is a problem, albeit slightly outside the scope of this series.

Resuscitation of a critically ill patient is likely a time of increased risk of medication errors.

Cognitive aids are to be encouraged.

Damian Roland and Dilshad Marikar have both written previously on the risks and inaccuracies of doing maths in your head in a critical clinical situation (or any clinical situation). It’s worth noting that incorrectly estimating a patient’s weight can quite easily lead to 20% variability in dosing, the criteria used in this study.

Pharmacists may be helpful at resuscitations; although not discussed specifically, I wonder if the role of the pharmacist equates well to the question-and-answer checking system for verbal orders.

We’ve identified that kids are at a higher risk of medication errors and adverse drug events. Do parents know this? An interesting paper around this idea by Cox et Al in Wisconsin sought to identify parent perceptions of the Children’s Hospital safety climate.

Cox ED, Carayon P, Hansen KW, et al. Parent Perceptions of Children’s Hospital Safety Climate BMJ Qual Saf. 2013 August ; 22(8): 664–671. doi:10.1136/bmjqs-2012-001727.

Although parents and healthcare workers view safety differently, both these groups’ views are of value. The authors aimed to understand the potential value of parent reports of the safety climate in children’s hospitals. To do this, they undertook a survey focused on the areas of safety that were visible to parents, specifically, handovers and transitions, communication openness and overall perceptions of safety. They specifically examined the need to watch over their child’s care.

233 parents of eligible admissions were invited to take the survey; of the 194 who consented, 172 returned the survey (87% success rate). One parent per family was surveyed, and admissions with ‘stigmatizing reasons’ (child neglect, psychiatry concerns) were excluded, as were parents unable to consent (absent or sleeping during recruitment visits)

The four safety domains identified as visible to parents were:

  • The overall climate of safety
  • Handover/transitions
  • Communication openness
  • Parent communication (as a separate section),

Parental perceptions of the need to watch over care to ensure mistakes do not happen,” was identified as relevant as in a previous study, two-thirds of parents identified this concern.

The demographics of this survey revealed most parents responding to the survey were mothers, aged 35 years old, 83% white, and in “good to excellent health”. The most common reason for their child’s hospitalisation (as reported by parents) were breathing problems – 30%, stomach or intestinal problems – 20%, and fever – 17%. Nearly 60% of patients stayed one day, whilst 12% were inpatients for longer than a week.

Overall, parents found the safety climate of the institution as positive; the most positively viewed domain was parent communication.

With regard to the “need to watch over care to prevent mistakes”, this measure ran inversely proportional to the overall perception of safety, and perception of handover/transitions.

Notably, “[w]hen parents overall perceptions of safety were one point higher, the odds of needing to watch over care decreased 80%.” Likewise, for a 1-point increase in the perception of handovers/transition, the need to watch over care dropped 75%.

The need to watch over care was significantly associated with:

  • admission for breathing difficulties vs all other reasons for admission.
  • higher level of parental education.

The discussion raises some important points. They identified that survey data from staff perceptions of safety had a good fit with that obtained from parents, in the areas visible to them.

In plain language, parents and staff have a comparable awareness of the safety climate. My interpretation of this is that in those situations where there’s a disagreement between staff or the feeling that ‘something’s a bit dicey’, in a visible area, parents are aware of the tension or concern.

The authors identified that the rationale of a parent survey for patient safety appears to focus better on the frontline of care, rather than the occasional ‘high impact medical errors’ that existing systems emphasise. It is further postulated that this method holds merit because of the high rate of uptake of the parental survey.

Finally, Cox et al. suggest that the need to watch over care, and safety climate domains, suggest potential targets for improving hospital safety. The parents felt more likely to watch over care when they held less positive views of the overall safety climate and handovers & transitions. This makes good sense. Importantly, they state that

“parent[s] need to see a commitment to safety that exceeds our drive to get the work done.”

We’ve identified that paediatric inpatients are at higher risk of medication errors as ADEs than their adult counterparts. What then, can we do to reduce Medication Errors? Firstly, this 2003 article published in Pediatrics re-works the data obtained in the Kaushal prospective study. Again, remember that this data set was sponsored by one of the inventors of a prescribing software.

 Prioritizing strategies for preventing medication errors and adverse drug events in pediatric inpatients. Fortescue EB, Kaushal R, Landrigan CP, McKenna KJ, Clapp MD, Federico F, Goldmann DA, Bates DW.

In their data set (the same as Kaushal et al), the most frequent type of medication error was a dosing error; ~28% of all errors, including omissions, doses not documented and over-orders.

Fortescue et al looked at a number of possible interventions to reduce errors and ADEs (and the % of errors they’d prevent); the most successful of which were on-ward pharmacists (88.3%), computer prescribing (with and without decision support) (~75.8%) and improved communication (85.8%). The authors boldly suggest that incorporating all three of these interventions would have prevented 96.7% of potentially harmful errors.

Fortescue et al have really looked at some big-picture, big-ticket items, and they’re worth considering. At a more personal level, how can we improve safety as individuals and small teams?

As with resuscitation, medication safety is about knowing the basics and doing them really well. In much of the medication safety literature, there’s an emphasis on the “rights” of medication safety. That is,

  • right patient
  • right drug
  • right time
  • right route
  • and right dose

I’ve seen a number of different posters on the wall of medication rooms, in pharmacies et cetera with variations of the above.

On that note, the culture in nursing appears quite different to that of doctors. At the facilities I’ve worked, there have been a number of nursing-driven interventions to improve safety around medications, above what is considered the ‘general standard’. These include ‘protected time’ when preparing medications, where there’s an interruption-free zone, the preparation ‘red apron’, which clearly signals that the nurse is engaged in medication preparation and a well-upheld culture of ‘do not disturb’, around this time.

This is quite different for medical staff, for whom prescribing (and specifically initiating) is often done on the ward round, rather than a dedicated time. So, some common sense advice for prescribing:

  • Write (and re-write) prescriptions/orders without interruption
  • Consider the indications & risks vs benefits of prescribing every medication
  • Look up (confirm) the dose from a standard reference
  • Weight-based dosing is the rule for paediatrics
  • Show your work (most charts have space) – be clear about the frequency
  • Identify a review point for short-term therapies
  • Omissions – remember to prescribe all of the child’s medications!
  • Think about the rights

References commonly used Frank Shann’s Drug Doses, AMH Children’s Dosing Companion, BNF for children. Find out what your local preferred reference is and know your way around it.

In the acute setting, make use of A\algorithm chards (make sure they’re current!), Broselow tapes, Code books. Monash Children’s Hospital in Victoria recently made their Paediatric Emergency Medication Book available.

Fortescue et al mention ‘improved communication’ – on a day-to-day basis, this is something we can all improve. From letting your nursing staff know you’ve initiated or changed a new therapy to encouraging an environment where your prescribing can be queried if it ‘doesn’t seem right.’ I mention this as a key point because, certainly in the smaller Paeds wards of regional hospitals, the majority of admissions are in and out before the pharmacist gets anywhere near their chart. Being able to talk to each other adds in extra layers of Swiss cheese.

Overnight admissions can be a vulnerable time to be taking a medication history & writing a busy medication chart – consolidate your colleague’s work and medication history as soon as practicable the next morning.

One final point is regarding multiple medications; whilst our adult colleagues will readily recount the myriad of medications many of their patients take, for kids, it’s such a different situation. We less often see a child on ten or so medications. When prescribing/writing or re-writing medication orders we need to be aware of our unfamiliarity and greater potential for error.

The AAP’s 2003 position paper for those involved in the care of children. With regard to prescribers, they make twenty-five recommendations, which I’ve included here in its entirety.

Stucky ER; American Academy of Pediatrics Committee on Drugs; American Academy of Pediatrics Committee on Hospital Care. Prevention of medication errors in the pediatric inpatient setting. Pediatrics. 2003 Aug;112(2):431-6.

Prescriber Actions and Guidelines

Physician prescriptions and drug orders are a means of communicating, so they must be legible, clear, and unambiguous. The following steps help ensure that medication orders are communicated safely and effectively.

  • Confirm that the patient’s weight is correct for weight-based dosages.
  • Ensure that the weight-based dose does not exceed the recommended adult dose.
  • Ensure that calculations are correct.
  • Write the weight on each order written.
  • Include dose and volume when appropriate; specify the exact dosage strength to be used.
  • Write intravenous fluid orders clearly, ensuring that additives are quantified per litre and rates are noted per hour.
  • Identify patient drug allergies and inquire about any changes at each encounter. Note any old and new allergies on orders.
  • Write out all instructions rather than using abbreviations except for those approved by the institution.
  • Avoid vague instructions (e.g. “take as directed”); make instructions specific (e.g. “take 1 tablet each morning”).
  • Avoid the use of a terminal zero to the right of the decimal point (e.g. use 5 rather than 5.0) to minimize 10-fold dosing errors.
  • Use a zero to the left of a dose less than 1 (e.g. use 0.1 rather than .1) to avoid 10-fold dosing errors.
  • Avoid abbreviations of drug names (e.g. MS may mean morphine sulfate or magnesium sulfate).
  • Use generic medication names rather than trade names.
  • Spell out dosage units rather than using abbreviations (e.g. milligram or microgram rather than mg or microgram rather than mg or mcg; units rather than U)
  • Ensure that prescriptions and signatures are legible, and include the prescriber’s name printed next to the signature, along with a contact number.
  • Avoid the use of verbal orders whenever possible. If verbal orders are to be used, spell out common error words (e.g. fifteen vs fifty).
  • Utilize CPOE and standardized order sets when available

Prescriber Education and Communication

  • Stay current and knowledgeable concerning changes in medications and treatment of pediatric conditions.
  • Utilize pharmacist consultation if available. An example is for adjustment of dose or dosing interval for neonates or for body surface area.
  • Review the patient’s existing drug therapy, including any over-the-counter medications or herbal or dietary supplements, and inquire about old and new allergies before prescribing medications.
  • Remain familiar with individual hospital medication ordering systems.
  • Ensure that drug orders are complete, clear, unambiguous, and legible. Discuss medication changes with nursing and other appropriate staff and families.
  • When possible, speak with the patient or caregiver about the medication that is prescribed and any special precautions or observations that should be noted, such as allergic or hypersensitivity reactions. Encourage patients and families to ask questions about all medications ordered.
  • Report errors and encourage blame-free error reporting. Ensure that all staff members understand the method of reporting and are knowledgeable about JCAHO reporting rules.
  • Be aware of ongoing tracking systems and pharmacy programs and be actively involved in system development and review

Owning up to your mistake

You are the registrar of the General Paediatric Ward. As you are reviewing patients, you realise that one of your patients, 9-month-old Kayleigh, has been prescribed and given the wrong dose of paracetamol. She received one dose that was 5 x the recommended dose.

You need to speak to the family and let them know – how do you approach this?

Get the setting and intro right

It’s not easy telling a family that a mistake has happened. Be sensitive, open and honest. Make sure the setting is right – it should be in a quiet room where they can hear you and be heard themselves.

Often when it’s a difficult conversation the best thing is just to vocalise that.

There’s something I’d like to talk you about – it is a difficult thing to discuss but it’s important for me to be open and honest with you.

Right at the beginning, you should state that Kayleigh is safe and well (assuming she is) – remember throughout the whole conversation, the parent’s main concern will be Kayleigh’s health and safety, and not whether you’ve made a mistake.

Explain exactly what happened and why

Many formal complaints are due to poor communication. Make sure you explain the error fully. This will include what drug it was; how much of an overdose was given; and how it happened.

Apologise. Don’t be scared to say sorry.

Talk about possible side effects for the child

Kayleigh has had a paracetamol overdose and the side effects and management of that need to be explained.

This is not likely to be a dose that causes any serious side effects. From the scenario given it looks like Kayleigh has received 75 mg/kg and for toxicity the required dose is likely to need to be 200mg/kg.

It’s best to check a paracetamol level at 4 hours, although you would expect this to be normal. Similarly, check LFTs at the same time.

Inform the parents that:

  • The senior doctor in charge of the ward will be informed of the dosing error
  • The doctor who wrote the prescription will be made aware of the error
  • An incident form will be filled in which will go to the departmental review

Finally, let them know that if they wish to make a complaint you will get them the relevant info.

Outline the steps you will take to ensure this doesn’t happen again

Check their understanding

Tie up the conversation by checking their understanding and giving a summary of what you’ve told them.

Reiterate that Kayleigh is safe and there is a low chance of her coming to any harm from this.

See if they have any further questions and offer to come back and discuss it again with them later.

Selected References

Cox ED, Carayon P, Hansen KW, et al. Parent Perceptions of Children’s Hospital Safety Climate BMJ Qual Saf. 2013 August ; 22(8): 664–671. doi:10.1136/bmjqs-2012-001727.

Marikar D, Varshneya K, Wahid A, Apakama O. Just too many things to remember? A survey of paediatric trainees’ recall of Advanced Paediatric Life Support (APLS) weight estimation formulae. Arch Dis Child. 2013 Nov;98(11):921. doi: 10.1136/archdischild-2013-304360. Epub 2013 Aug 21. Accessed 28 Oct 2014

Roland, D. EM isn’t child’s play when it’s Emergency Maths Published 27 Aug 2014. Accessed 28 Oct 2014.

Tarini BA, Lozano P, Christakis DA. Afraid in the hospital: parental concern for errors during a child’s hospitalization. J Hosp Med. 2009; 4(9):521–7. [PubMed: 19653281]



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