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
A 6 year old boy with the history of trivial trauma presented to pCurr 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
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
Serenace is haloperidol, a potent antipsychotic agent, which is known to cause extrapyramidal adverse effects Prescription errors are quite common especially in devel- . 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)  which is rami- serratiopeptidae (10mg) and diclofenac sodium (50mg). pril, an antihypertensive and Seromark (Glenmark, India) , 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 , 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 . 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  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 medication errors. Am J Health Syst Pharm1997; are supposed to be manned by pharmacy trained person- nel but the ground reality is entirely different. These Rataboli PV, Garg A. Confusing brand names: Night- pharmacists (mostly untrained) are known to substitute mare of medical profession. J Postgrad Med 2005;51: prescriptions. The illiterate patient usually accepts what- ever he gets without cross-checking with the doctor. If Stephen GA. String searching algorithms. River Edge, two drug names differ by just an alphabet, syllable, suffix or prefix, it becomes difficult for the patient to realize that there is a difference. The proliferation of numerous , et al. Systems analysis of adverse drug brands has made the patient more vulnerable. To add to events. ADE Prevention Study Group. JAMA.1995; this, physician’s illegible handwriting, incomplete knowl- 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 . One of the most effective ways to reduce medication errors, the IoM re- port, Preventing Medication Errors , concluded, is to
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