Pharmaceutical Excipient Exposure in a Neonatal Intensive Care Unit
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Pharmaceutical Excipient Exposure in a Neonatal Intensive Care Unit SARA NASROLLAHI,1 NEELATHAHALLI KASTURIRANGAN MEERA1 AND SUNIL BOREGOWDA2 From Department of 1Pharmacy Practice, Visveswarapura Institute of Pharmaceutical Sciences, and 2Department of Pediatrics, KIMS Hospital and Research Centre, Bangalore, India. Correspondence to: Dr Sara Nasrollahi, Department of Pharmacy Practice, Visveswarapura Institute of Pharmaceutical Sciences, Bangalore, India. [email protected] Received: August 20, 2019; Initial review: December 30, 2019; Accepted: April 22, 2020.
Objective: To study the excipients exposure among neonates in a neonatal intensive care unit. Method: Prospective observational study was conducted from January, 2017 to June, 2019. Details of administered drugs were collected from the hospital case files. List of excipients of formulations and their quantities were collected from package insert leaflets or by contacting the manufacturers. Excipients were grouped into four categories based on available safety data. Calculated daily exposures to the excipients (mg/kg/day) were compared with adult acceptable daily intake. Results: More than half of the included 746 neonates were exposed to harmful excipients. 12.3% and 12.7% of neonates received higher than acceptable daily intake of sodium metabisulphite and sunset yellow FCF, respectively. Conclusion: There is a high risk of exposure of neonates to harmful excipients, and clinicians need to be aware of this during neonatal care. Keywords: Additives, Harm, Medications, Sodium metabisulphite.
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xcipients play a major role in converting medicinal agents to acceptable dosage forms [1]. Neonates are a vulnerable population and their drug handling, pharmacokinetic and pharmacodynamic aspects are different from older children. Neonates may be exposed to risks and unwanted effects of excipients when they are administered drug formulations. The reason could be immature physio-logical functions leading to inadequate metabolism and excretion of such excipients from body [2-4].
cines for all neonates (indication, dose, frequency, route of administration, dosage form and brand names) were recorded. Diagnoses were classified according to ICD-10 (International statistical classification of diseases and related health problems, 10th revision, 2016). Administered drugs were classified according to WHO Anatomical Therapeutic and Chemical (ATC) classification system. Lists of excipients and their quantities present in each prescribed formulation were collected by referring to package insert leaflets (PIL) of drugs or contacting the manufacturers. Excipients were categorized into four groups as per Lass, et al. [1] viz., (a) known to be harmful to neonates (adverse reactions reported in neonates); (b) potentially harmful (adverse reactions reported); (c) no safety data found (no data found in the literature on human exposure and toxicity); and (d) description of the excipient in PIL non-specific (description does not allow a specific literature search).
In the 1980s, ten
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