A 6 year old boy with the history of trivial trauma presented to p
Curr Pediatr Res 2010; 14 (1): 61-62 Acute Dystonia following brand confusion: where are we heading? Ubaid Hameed Shah, Sumaiyah Yousuf, Syed M Mehdi, Varun
Department of Paediatrics and Pharmacology, J. N. Medical College, A.M.U, Aligarh Abstract A child with trivial trauma was prescribed Serronak which is a Fixed Dose Combination of serratiopeptidae (10mg) and diclofenac sodium (50mg) by a treating physican. He instead received Serenace (Haloperidol 10mg) which lead to him presenting as acute dystonia to pe- diatric emergency department. We report this preventable adverse drug reaction and high- light the importance of avoiding such prescription errors. Key woords: Dystonia, prescription, haloperidol Introduction Serenace is haloperidol, a potent antipsychotic agent,
which is known to cause extrapyramidal adverse effects
Prescription errors are quite common especially in devel-
[2]. Diagnosis of drug induced dystonia was made and
oping countries and lead to large number of adverse drug
intramuscular promethazine injection was given immedi-
reactions which can sometimes have serious conse-
ately. Reaction subsided within half an hour. Thereafter
quences. The prescription audit is virtually non existent in
no such episode was reported and no medications were
developing countries and the errors which come into no-
started for the isolated event. The patient’s guardian pro-
vided the written informed consent for publication of this
report. The case was reported to the zonal centre under
Case report
A 5 year old boy weighing 15 kg presented to the pediat-
ric out patient department with the complaint of mild dull
Discussion
aching pain in the back for one day. History revealed fall
on the back while playing at home. There was no history
The two brand names Serenace and Serronak are identical
suggestive of any trauma to the head or neck, altered sen-
orthographically (look alike) although their generic con-
sorium, vomiting, difficulty in walking or any shooting
tents are distinctly dissimilar. The illegible handwriting of
pain. On examination, there was mild tenderness over the
the physician, untrained pharmacist and functionally illit-
left side at the level of L5-L6. Signs of inflammation were
erate patient, were other contributory factors which re-
positive locally. Rest of the systemic examination was
sulted in this medication error. The patient on the receiv-
non specific. Physician prescribed him tablet Serronak
ing end suffered a potentially preventable Adverse Drug
(STEDMAN Pharma, India) half tablet thrice a day after
Reaction (ADR). Adding to the present confusion we also
food. The tablet is a Fixed Dose Combination (FDC) of
have brands Servace (Servetus, India) [3] which is rami-
serratiopeptidae (10mg) and diclofenac sodium (50mg).
pril, an antihypertensive and Seromark (Glenmark, India)
[3], a combination of diclofenac sodium, serratiopeptidase
The next day patient presented to the pediatric emergency
department with the complaint of bizarre, involuntary and
frequent abnormal movements of right upper limb. Neu-
This case report brings us to the two important issues i.e.
rological examination did not reveal any other sign. There
preventable ADR due to medication error and look-alike
was no history of seizure disorder or any such episode in
or sound-alike (LA/SA) health products. The IoM report,
the past. Family history was insignificant. The patient's
Preventing Medication Errors [4], finds that medication
medications were reviewed and it was found that the pa-
errors are surprisingly common and costly to the nation.
tient actually received Serenace 10mg (RPG life sciences,
The committee concluded that there are at least 1.5 mil-
India) half tablet thrice, instead of Serronak. Thus the
lion preventable Adverse Drug Events (ADEs) that occur
patient had ingested total of 15 mg of haloperidol in a
in United States each year. The evidence suggests that the
day. The maximum recommended dose of haloperidol in
number is likely to be under estimated and the true num-
ber may be much higher. Look-alike and sound-alike
medication names play a part in almost one quarter of all
move toward a model of health care where there is more
medication errors [5]. As for now, in Indian context, large
of a partnership between the patients and the health care
gaps exist in the knowledge about incidence and preva-
providers. One of the approaches suggested is Medication
Reconciliation. This is a process designed to prevent
medication errors at patient transition points. The simpli-
Rataboli et al [6] in an interesting study have analysed
look-alike and sound-alike brands of drugs available in
the Indian market. They have systematically divided these
• Verification (collection of medication history/list)
drugs into twelve different categories based on the nature
• Clarification (ensuring that the medications and
of the drug, the dosage form, the similarities and the
manufacturer. The classification is based on visual and
• Reconciliation (documentation of changes)
phonetic similarity. Each category listed by Rataboli et al
represents an area for potential error, although the two
In conclusion, our case throws light on how the medica-
brands mentioned above do not fall in any of the XII
tion error leads to a preventable ADR. The issue of medi-
categories graciously explained by them. Serenace and
cation error in India is extremely complex, demanding the
Serronak are look alike brands with different generic
proactive role of all the stake holders for the safe use of
names, different manufacturers and one of the brands are
the combination of two molecules. This example can be a
further extension to the category I explained by them.
References
Levenshtein distance has been used to predict error pairs
Haldol (haloperidol). Summaries of Product Character-
[5,7]. It is the number of edit operations (e.g., substitu-
istics: Janssen-Cilag Ltd Buckinghamshire UK. 2007.
tions, insertions, or deletions) needed to transform one
[Online] Available at http://emc.medicines.org.uk (last
word into another. In this particular case of Serenace and
Serronak four edit operations are required. Thus, the
Van Harten PN, Hoel HW, Kahn RS.Acute dystonia
Levenshtein distance between the two names is 4 and a
induced by drug treatment. BMJ 1999; 319:623-6.
threshold for Levenshtein distances has been proposed as
Indian Drug Review, New Delhi: Mediworld Publica-
greater than 5. Therefore this test may have predicted the
problems associated with Serenace and Serronak.
Committee on Identifying and Preventing Medication
Errors IoM, ed. Preventing Medication Errors: Quality
The implications of this case are relevant to the large pro-
Chasm Series. Washington, DC: The National Acad-emies Press; 2006.
portion of patients in India where medications are dis-
Lambert BL. Predicting look alike and sound alike
pensed mostly by the private pharmacies/chemists which
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are supposed to be manned by pharmacy trained person-
nel but the ground reality is entirely different. These
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pharmacists (mostly untrained) are known to substitute
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two drug names differ by just an alphabet, syllable, suffix
or prefix, it becomes difficult for the patient to realize that
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, et al. Systems analysis of adverse drug
brands has made the patient more vulnerable. To add to
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edge of brand names, noisy workplace and extended
working hours often confounds the problem.
Medication use is a multifaceted process that begins with
prescribing, processing of the prescription, dispensing and
monitoring the effects of medication. Each step is vulner-
able to errors. Moreover, with increasing access to medi-
Correspondence:
cal care the susceptibility to error is more common. Thus
reducing medication error is a challenging job. Analysis
of medication error suggests that prevention strategies
that target systems rather than individuals are more effec-
tive in reducing in reducing errors [8]. One of the most
effective ways to reduce medication errors, the IoM re-
port, Preventing Medication Errors [4], concluded, is to
Case Scenario 1 A 53 year old white female presented to her primary care physician with post-menopausal vaginal bleeding. The patient is not a smoker and does not use alcohol. She has no family history of malignancy. She had an endometrial biopsy that was positive for endometrial adenocarcinoma. She was sent to have a CT of the abdomen and pelvis and was found to have thickening of the uterus
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