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Vol 6 Issue 1 June 2014
A Medication Safety Newsletter by the Pharmaceutical
Services Division, Ministry of Health Malaysia
“Medication Safety Is Everyone’s Responsibility”
This newsletter is for circulation
to healthcare providers only
What parents think
By Chan Su Ann, Erik Tan Xi Yi, Pharmacists, Vitacare Pharmacy
˝
Parents often view a fever as an
illness that must be cured at all costs to
prevent serious consequences such as
neurological complications1. As such,
most parents treat even a minimal
increase in their child’s body
temperature vigorously.
″
According to the American Academy of Paediatrics
(AAP), about 56% of parents would administer
antipyretics for body temperatures that are within
normal range2. They are convinced that a child must
maintain a “normal” temperature at all times1. Parents
are afraid that if no steps are taken to curb the fever,
their child’s body temperature will rise to alarming
heights. Nevertheless, a fever is actually a
homeostatic process. It is tightly regulated
physiologically and very rarely, will temperatures rise
above 41.4⁰C, even in cases of severe untreated
infections2. Fevers may also be beneficial to some
extent. It serves as a physiological barrier to fight
infections within the body1.
Foundation, the U.S Food and Drug Administration
(FDA) and Centers for Disease Control and
Prevention advice against the use of aspirin by
individuals less than 19 years old3.
Even when the right antipyretic is used, the dose
may be incorrect. According to a clinical report by the
AAP, one-half of parents administer inaccurate doses
of medication while roughly 15% of parents administer
too high a dose1. The majority of parents that pick up a
bottle of paracetamol syrup over-the-counter are
unaware that a more accurate dose should be
determined by the weight of the child. Instead, they
would dose the medication according to the age of the
child as shown on the packaging. If the child does not
have the average weight for their age group, the
wrong dose of antipyretic would be administered.
˝
Caregivers usually insist on cough
syrups or antibiotics to cure their child
despite the fact that the common cough
is usually self-limiting.
″
In this day and age, many patients are armed with
a treasure-trove of information gleaned from sources
such as the internet, books and professional opinions
from their physicians or pharmacists. Despite
advances in the public’s awareness regarding various
medications and health issues, some individuals still
hold onto old practices of administering medicines.
This sentiment is particularly true for certain paediatric
medicines in the community setting. Many parents
enter the pharmacy with a pre-conceived notion on
what is best to treat their child. This article will
concentrate on two common paediatric conditions
seen in the community – fever and the common
cough.
Most of the parents do not realize that coughing is
actually a protective mechanism to clear mucus
secretions from respiratory airways4. Furthermore,
cough preparations will also
cause
severe
complications such as convulsions, decreased
consciousness and even deaths when used in children
under 2 years old5. The British Medicines and
Healthcare Products Regulatory Agency under the UK
Therefore, the goal of treatment should be to National Health Service conducted a review and found
improve the child’s overall comfort instead of no significant benefits of using cough and flu
normalising the child’s temperature1. If the child medications in children under 6 years of age6. There
seems well and active, adequate hydration and are however risks of side effects such as allergic
comfortable cooling environment for the child is reactions, sleep disturbances and hallucinations7. To
sufficient2. Antipyretics such as paracetamol or lend further credit, a study conducted by Schaefer et el
ibuprofen may also be used when required. Some showed that most adverse drug reactions from cough
parents are unaware that aspirin should not be used in and cold medicines occur in children between the ages
children due to its association with a condition known of 2 to 5 years old (64%)6.
as Reye’s Syndrome. The National Reye’s Syndrome
>> Page 4
Page 2
Medication Safety Newsletter Vol 6 Issue 1 June 2014
Editor’s
Editor’s
NOTE
Babies, infants and young children are cute and enlighten any parents
and human heart, especially their innocence. But taking good care of
their well-being especially health can be most trying. Why, because
they are different from adult.
Infants and children vary in weight, body surface areas and organ
system maturity which affect their ability to respond, metabolise and
excrete medications. But these factors can be neglected or easily
overlooked each time children are treated for illnesses and prescribed
medications, especially when few standardised dosing regimens for
children exist, not mentioning the inadequate regulation on indications
and dosing guidelines on medicines for paediatric use. It is no surprise
that a 5-year study by the US Pharmacopeia (USP) on Medication Errors
Reporting Program revealed that paediatric patients (31%) experienced
a significantly higher rate of medication error when compared with
adults (13%).
Despite the widely publicised news on the deterioration of resistance,
antibiotics are still commonly prescribed to both children and adult, or
sold indiscreetly, especially under duress from patients who believe that
antibiotic is a “cure-all” medication. The long-time popular household
remedy paracetamol can carry serious threat to health as highlighted in
the article “Paracetamol: Beware of overdose”. For all the care that
healthcare professionals can give, the cycle of medication safety is
incomplete without the involvement of family members, read what
pharmacists Chan Su Ann and Tan Xi Yi have to say on Parent’s
Perception on Paediatric Medicines in Community Setting.
Incorrect dosing, including calculation errors and dosing interval, is very
common in paediatric medicine delivery. Proper administration using
the right measuring device can help to prevent adverse drug events,
read Getting to Know MediBottle, a simple but helpful tool to ensure
better safety to children.
Is it asking too much of healthcare workers to take that extra
precaution when treating and administering medicines to infants and
children?
Getting to know
MediBottle
The Paediatric Medication
Delivery System
The MediBottle is composed of a
traditional baby bottle (filled with
breast milk or any other preferred
liquid) with the addition of an oral
dispenser (filled with medicine) (5ml)
that slides into the centre sleeve of the
bottle.
As the baby begins to drink, short
presses on the plunger jet little squirts
of medicine, displacing the familiar
liquid in the very tip of the nipple.
The baby takes in these small
amounts of medicine, which are
swallowed
and
washed
down
immediately by the familiar liquid,
giving the baby's taste buds little time
to sense the medication. The medicine
usually goes completely undetected by
the baby.
The MediBottle is easy to use and can
be operated with one hand.
The
device
delivers
a
5mL
dose of medicine in about 60 seconds.
Dispensing Medicine with the MediBottle
Allow the baby to begin
drinking the liquid from
the MediBottle.
Please let us have your feedback on our editorial contents and what you
would like us to cover in future issues.
For enquiries kindly contact:
Editorial Board
Advisors
YBhg. Dato’ Eisah A. Rahman
Dr. Salmah Bahri
Editorial Members
Che Pun Binti Bujang
Wan Mohaina Wan Mohammad
John C.P. Chang
Faridah Md. Yusof
Subasyini a/p Sivasupramaniam
Tea Ming Hui
Erik Tan Xi Yi
Yen Sze Whey
Ong Su Hua
Juliana Binti Nazlim Lim
Medication Safety Section,
Pharmaceutical Services Division,
Ministry of Health Malaysia,
P.O. Box 924, Jalan Sultan,
46790 Petaling Jaya, Selangor.
Tel: +603-78413200 / 3320
Fax: +603-79682222 / 2268
E-mail: [email protected]
Materials published in this newsletter
may be reproduced with permission.
The Pharmaceutical Services Division
(PSD) shall not be liable for any loss
or damage caused by the use of any
information obtained from this
newsletter
Press the dispenser plunger quickly to produce
a little squirt (about 5 drops) every 1-4 sips,
depending on the
baby’s eagerness to
drink from the bottle.
Adjusting to the baby’s
response will ensure that
the dilution of medication
does not occur in the
bottle. It will take about 6 squirts to deliver
each 1mL of medicine.
Amount of medicine
1mL = 6 squirts
2mL = 12 squirts
3mL = 18 squirts
4mL = 24 squirts
5mL = 30 squirts
Source: http://www.medibottle.com
Medication Safety Newsletter Vol 6 Issue 1 June 2014
Page 3
Liquid Medicines:
Is the dose RIGHT?
By Chan Su Ann, Erik Tan Xi Yi, Pharmacists, Vitacare Pharmacy
“How does one measure 5 mL of cough syrup?”
“Can I measure my medicine using a normal kitchen
spoon?”
Administration devices that comes together with medication
“How many millilitres does a teaspoon even contain?”
These are just some of the questions that might pop up
in a patient’s mind, and with good reason. Using the
wrong measuring device could result in a range of
problems that may lead to patient harm. For instance,
measuring too little of an amount might render the
medication therapeutically ineffective while measuring
too much could lead to an overdose. The results could
be catastrophic. This is especially true for paediatric
patients as they require particularly accurate doses of
medication.
“
“
Healthcare providers should
encourage patients to use the
measuring device that is provided
along with the medication or
obtain a proper one from a
pharmacy.
It falls on our shoulders, as health professionals, to
educate our patients regarding the importance of the
proper administration of their medication. As we begin
to gauge the extent of their awareness, it becomes
increasingly obvious that we have our work cut out for
us. Many patients still use a normal kitchen spoon to
measure their medications. The danger of such practice
is that the varying sizes of kitchenware available do not
provide the standardized measurement that is required.
Various measuring devices available in the market
As such, we should encourage our patients to use the
measuring device that is provided along with the
medication or obtain a proper one from a pharmacy.
Among the measuring devices that are widely available
are dosing cups, droppers, syringes and measuring
spoons.
In summary, using the right measuring device is a
simple but effective step towards medication safety.
Encourage patients or care givers to seek advice from
a doctor or pharmacist when in doubt as to what is
suitable for use.
Use measuring device provided with the medicine
Do not mix and match measuring cups from
different medicines. The cups may not be
accurate
Be sure to check the units
Follow the dose written on the prescription
Table 1: Measurement unit conversions1
1 mL
1 cc
2.5 mL
5 mL
2.5 cc
5 cc
½ teaspoon
1 teaspoon
15 mL
30 mL
15 cc
30 cc
1 tablespoon
2 tablespoon
Measure medicine at eye level
References
1)FC, Tenover, JM Hughes. Review The challenges of emerging infectious diseases. Development and spread of multiply-resistant bacterial pathogens. JAMA 1996 24-31; 275(4):300-4.
2) http://pediatrics.aappublications.org/content/119/4/698.full
3)YK Lee,BY Ong,DFS Yap H Arsal.Parental Knowledge,Attitudes&Practices(KAP) On Antibiotic Use In Children With Acute Upper Respiratory Tract Infections (URTIs).The 9th Johor Scientific Meeting 2013,(Sept 13).
Case 2
Healthcare professionals must be aware of the possibility of
errors in prescribing, dispensing and administering liquid
medicines. Examples of these errors involving alfacalcidol
drops are shown below.
Case 1
In one incident, a 4 year old boy with chronic kidney failure
was prescribed alfacalcidol drop 0.3mcg once a day. However,
the medicine with a strength of 2mcg/ml was wrongly labelled
as 1.5 mL once a day. Thus, the patient received 10 TIMES
more than the intended dose. As 1drop=0.1mcg, it should be
labelled as 3 drops once a day. Luckily, there was no harm to
the patient.
In another case, alfacalcidol drop 0.1mcg once daily was
wrongly labelled as 1mL once a day. The parents followed
instructions on the label and gave 1mL alfacalcidol drop to
the 1 month old premature baby boy. As a result, additional
monitoring was needed for patient's calcium, ALP and
phosphate level.
Case 3
The alfacalcidol drop was labelled using the label for 'ubat
mata/telinga/hidung' and 'tidak boleh diminum'. As a result,
the parents did not give the medicine to patient.
Source: Medication Error Reporting System (MERS)
Page 4
Medication Safety Newsletter Vol 6 Issue 1 June 2014
Antibiotic for Kids:
By Tea Ming Hui
Pharmacist, Sultanah Nora Ismail Hospital, Batu Pahat
The overuse of antibiotics in children is becoming a
major health problem globally1. It is estimated that
90% of the illnesses in children are viral and selflimiting e.g upper respiratory tract infections and
diarrhea where antibiotics are considered
unnecessary. Many physicians have had the
experience of parental pressure (real or perceived)
for antibiotic prescriptions.2 A recent survey
carried out by pharmacists from Hospital Enche’
Besar Hajjah Khalsom, Kluang3 on 309 parents
found that:
of the parents believed that
antibiotics should be given to all children with
fever.
of them believed that antibiotics
will make their child recover faster from flu even
though the illness may be self-limiting.
of the parents did not understand
the concept of antibiotic resistance.
would
give
their
children
antibiotics without doctor’s consultation.
of parents would sometimes
specially request an antibiotic prescription from a
doctor and 89.6% of them did not confirm with
their doctor whether the use of antibiotics is truly
necessary or not.
The complex relationship between physicians and
parents often leads to unnecessary antibiotic
administration. Significant efforts should be aimed
towards changing of prescribing patterns by
making the physicians aware of the current
evidence and guidelines for antibiotic prescribing.
It may be possible to tap into growing parental
concern by educating parents about appropriate
indications and the risks and benefits of antibiotics.
If the parents can understand the role of
antibiotics in the treatment of diseases better,
they may exert less pressure on the physicians to
dispense antibiotics inappropriately.
References
1)FC, Tenover, JM Hughes. Review The challenges of emerging infectious
diseases. Development and spread of multiply-resistant bacterial pathogens.
JAMA 1996 24-31; 275(4):300-4.
2)http://pediatrics.aappublications.org/content/119/4/698.full
3)YK Lee, BY Ong, DFS Yap, H Arsal. Parental Knowledge, Attitudes & Practices
(KAP) On Antibiotic Use In Children With Acute Upper Respiratory Tract
Infections (URTIs). The 9th Johor Scientific Meeting 2013, September 2013
>> from front page
Parents’ perception on paediatric
medicines in the community
Despite these evidences, many parents still believe that
cough preparations are beneficial to their children. A national
survey conducted in the United States revealed that 64% of
parents still considered these medicines safe or somewhat
safe and 20% of parents will continue to use cough medicines
in children under 2 years6.
Following concerns raised over the safety of cough and
cold medicines especially in children below 2 years of age,
FDA issued a public health advisory for parents and caregivers
recommending that Over the Counter (OTC) cough and cold
products should not be used to treat infants and children less
than 2 years of age. In Malaysia, the Drug Control Authority
also instructed that all products containing any of the active
ingredient(s) listed below must include the following
statements on the labels and package inserts:
a) “ Not to be used in children less than 2 years of age ”
b) “ To be used with caution and doctor’s/ pharmacist’s
advice in children 2 to 6 years of age ”
Category
Active Ingredient
Antihistamines
Brompheniramine, Chlorphenamine,
Clemastine, Dexbromopheniramine,
Diphenhydramine, Pheniramine,
Promethazine, Triprolidine
Antitussives
Dextromethorphan, Diphenhydramine
Decongestants
Ephedrine, Phenylephrine, Pseudoephedrine
Home remedies to aid with coughs in paediatric
patients recommended by AAP:
3 months – 1 year of age: Give warm, clear fluids (eg, warm
water, apple juice) 1-3 teaspoons (5-15mL) 4 times a day when
coughing. Avoid honey because it can cause infantile botulism.
If the child is younger than 3 months, the parents should
consult a doctor.
1 year and older: Use honey, ½ -1 teaspoon (2-5mL), as needed.
It thins secretions and loosens the cough. (If honey is not
available, you can use corn syrup.) Recent research has shown
that honey is better than drugstore cough syrups at reducing
the frequency and severity of night time coughing.
6 years and older: Use COUGH DROPS to coat the irritated
throat.
(If cough drops are not available, use hard candy.)
Coughing Spasms: Expose the child to warm mist from a shower.
If we all take a little extra time and effort to provide information
and care to our patients as they required, we can go a long
way in educating our patients. It is in the hope that with this
newfound awareness, less adverse events will occur and
medication safety will be maintained throughout the nation.
References
1) Sullivan JE, Farrar HC. Clinical report—fever and antipyretic use in children.
Pediatrics. 2011 Feb 28; 127 : 580 - 587.
http://pediatrics.aappublications.org/content/127/3/580.full.pdf+html
2) Adam HM. In brief fever: measuring and managing. Pediatrics in Review. 2013 Aug 1; 8:368–
370. http://pedsinreview. aappublications.org.ezproxy.library.uq.edu.au/content/34/8/368.full
3) National Reye's Syndrome Foundation. Reye's syndrome bulletin. 2005.
http://www.reyessyndrome.org/images/pdf/ BULLETIN.pdf
4) Kaslovsky R, Sadof M. Chronic cough in Children: A primary care and subspecialty
collaborative approach. Pediatrics in Review. 2013 Nov 1; 34:498-509.
http://pedsinreview.aappublications.org. ezproxy.library.uq.edu.au/content/34/11/498.full
5) OTC Cough and Cold Products: Not for Infants and Children under 2 Years of Age. U.S Food
and Drug Administration. 2008 Jan 17. http://www.fda.gov/forconsumers/
consumerupdates/ucm048682.htm
6)Schaefer MK, Shehab N, Cohen AL, Budnitz DS. Adverse Events From Cough and Cold Medications
in Children. Paediatrics. 2008 Apr 1; 4: 783-787. http://pediatrics.aappublications.org/
content/121/4/783.full.pdf
7) Overview - Risk : Benefit of OTC Cough and Cold Medicines in Children. MHRA.
http://www.mhra.gov.uk/home/groups/plp/documents/ websiteresources/con041374.pdf
8)Coughs and Colds: Medicines or Home Remedies? . American Academy of Pediatrics. [updated
2013 Nov 5]. http://www.healthychildren.org/English/health-issues/conditions/ear-nosethroat/pages/Coughs-and-Colds-Medicines-or-Home-Remedies.aspx
9)Norton S. Over-the-counter cough and cold medicines for children. United Kingdom: Medicines
Page 5
Medication Safety Newsletter Vol 6 Issue 1 June 2014
By Tea Ming Hui
Pharmacist, Sultanah Nora Ismail Hospital, Batu Pahat
: Beware of Overdose
“Oh no, my child has fever.”
“I must give him
medicines now!!”
When the little one has spiking fever, both parents
will feel anxious. They give paracetamol but as they
watch the clock and also the thermometer in
desperation, the temperature of their little one does not
seem to subside.
“This is the time most parents are tempted to give
more and more paracetamol without knowing the risks.”
said Dr Zainah Sheikh Hendra, Consultant Paediatrician
Hospital Sultanah Nora Ismail Batu Pahat.
Background
Paracetamol is both an analgesic and an antipyretic
agent. It is indicated in children for the management of
mild to moderate pain and for the symptoms of fever.
The dose for paracetamol in children older than three
months should always be based on a child’s body
weight: 15mg/kg repeated four to six hourly to a
maximum of four doses in 24 hours.1
In Malaysia, paracetamol is available in different
forms as syrups, suppositories and tablets with different
strengths. Due to its safety profile, paracetamol is easily
available not only at pharmacies but any corner shop.
“Paracetamol is so widely prescribed with a well
established safety record if taken in the recommended
doses that we have become over confident. Parents
may administer paracetamol routinely at home based
on their own dosage calculation.
Therefore, it is
essential for prescribers to ask the parents whether
medication has been given to the child. Otherwise, the
child may be at risk of paracetamol overdose,”
explained Dr Zainah.
Toxicity
Because the symptoms of paracetamol intoxication
are nonspecific, the diagnosis and treatment are more
likely to be delayed in unintentional cases of toxicity2.
According to Dr Zainah, overdose of paracetamol is
usually presented with pallor, nausea and vomiting,
followed by the late presentation of abdominal pain,
encephalophathy and jaundice heralding the onset of
established liver failure, thus making early diagnosis
difficult if an adequate history is not obtained. Be alert!
Paracetamol toxicity should be considered in the
differential diagnosis when a child previously given
paracetamol suddenly develops drowsiness and jaundice
apart from infection.
Alternative Treatment
Some of the non-pharmacological measures suggested
by Dr Zainah are removing the child’s clothing, keeping
the fan in the room on and sponging the child with tepid
water.
Another practice by some doctors eager to allay the
fears of parents about their children getting fever fits is to
prescribe
diclofenac
suppositories.
This
too
is
unnecessary, says Dr. Zainah, explaining that for such
patients, an occasional dose of ibuprofen can be
prescribed in addition to paracetamol.
Key Points
Unintentional overdose
relatively common.
with
paracetamol
is
Paracetamol can cause liver failure and death if
taken in excessive doses.
Parents should be informed about the correct
usage of paracetamol and its risks.
Optimally, written, specific information about
paracetamol should be given to the parents.
Paracetamol should be prescribed based on each
individual child’s body weight
In households with children under six, only the
lower concentration (120mg/5mL) of paracetamol
syrup should be supplied.
Because early symptoms of paracetamol toxicity
are nonspecific, health care providers are advised
to include paracetamol toxicity in the initial
diagnosis, especially those with unexplained
hepatic dysfunction.
Detailed information regarding paracetamol
therapy should be obtained.
Page 6
Medication Safety Newsletter Vol 6 Issue 1 June 2014
PPUKM’s Medication
Safety Program
Medication safety posters displayed at the lobby
have helped to attract the visitor’s attention. A talk on
medication safety was also given by Mrs Lau Chee Lan
from the Pharmacy Department, PPUKM.
By Nur Liyana Saharudin, Pharmacist, PPUKM
In support of the Ministry of Health’s efforts to
increase the quality and safety of medicines use
among the public, PPUKM had organized a Medication
Safety Program to educate patients on the importance
of proper medication use. As ‘Medication Safety is
Everyone’s Responsibility’, it is important for health
professionals to involve the patients and caregivers in
the medication use process as they do have a role to
help reduce the risk of potential adverse drug events.
The Medication Safety Program made its inaugural
presence during the Pharmacy Counselling Week
which was held from 18–20 September 2013. A
medication safety booth was set up to enable patients
to ask about their medications as well as updates on
hospital policies. The booth attracted about 118
visitors with a majority asking on drug use (34%) and
side effects of drugs (18%). Refer chart for types of
questions asked.
In addition, activities such as Return Medication
and POD (Patient On Drug), which are part of
PPUKM’s Outpatient Pharmacy innovations, were also
held. The aim of these activities is to help reduce
potential harm of taking expired drugs and double
doses while also educating patients on how to dispose
drug properly. Collaboration with Medic Alert and
National Pharmaceutical Control Bureau helped to
educate patients on how to report adverse drug
reactions while the Enforcement Unit from JKWPKL
helped to raise awareness on counterfeit medicines.
TYPES OF QUESTIONS ASKED
Medication Safety Events
Talk on Medication Error Prevention
A talk on Medication Error Prevention was held at
Hospital Angkatan Tentera Tuanku Mizan on 12
September 2013 in conjunction with the
Malaysian Patient Safety Goals Workshop.
Medication Safety Seminar 2013
Medication Safety Seminar 2013 was organized by the
Pharmaceutical Services Division, Ministry of Health at
Hotel Vistana, Kuala Lumpur on 21 September 2013.