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Formation of Dispersible Taohong Siwu Tablets
Published on: February 3, 2023
Estimated Manipulation of Tablets and Capsules to Meet Dose Requirements for Chinese Children: A Cross-Sectional
Liwen Zhang1, Yan Hu2, Panpan Pan1
1Department of Pharmacy, The Children's Hospital, National Clinical Research Center for Child Health, Zhejiang University School of Medicine, Hangzhou, China.
Insights
Over 20% of pediatric tablet and capsule prescriptions require manipulation, with a significant portion being avoidable or inappropriate. Availability of lower-strength medications could reduce these manipulations.
Area of Science:
- Pediatric Pharmacology
- Pharmaceutical Sciences
- Drug Formulation
Background:
- Medication manipulation, including splitting tablets or opening capsules, is common in pediatric care.
- Dosage adjustments are often necessary for children due to weight-based dosing and limited availability of pediatric formulations.
- The practice of manipulation can impact drug efficacy and safety, especially for certain medications.
Purpose of the Study:
- To determine the frequency of tablet and capsule manipulation for pediatric prescriptions in a Chinese hospital.
- To evaluate the potential reduction in manipulation with the availability of lower-strength drug formulations.
- To identify the rates of avoidable and inappropriate medication manipulations.
Main Methods:
- A 1-month prospective study collected data on all prescribed tablets and capsules for children.
- Manipulation was defined as using only a portion of an intact dosage form.
- Avoidable and inappropriate manipulations were categorized based on dose rounding, alternative formulations, and contraindications.
Main Results:
- 17,123 of 78,366 pediatric prescriptions (21.9%) required manipulation.
- Common manipulations included halving, quartering, and trisecting dosage forms.
- 19% of manipulations were avoidable, and 19% involved medications with contraindications for manipulation.
- 21% of manipulations could have been avoided if lower-strength formulations were available.
Conclusions:
- A high incidence of medication manipulation, including avoidable and inappropriate practices, is observed in pediatric prescriptions.
- The availability of lower-strength formulations licensed by the Chinese National Medical Products Administration (CNMPA) could significantly reduce medication manipulation.
- Optimizing drug availability and formulation options is crucial for improving pediatric medication safety.
Abstract:
Objectives: To estimate the frequency of manipulations of all tablets and capsules prescribed for children in a teaching and tertiary children's hospital in China over the course of 1 month. Moreover, hypothetical reduction of manipulation according to the availability of low-strength tablets/capsules licensed by the Chinese National Medical Products Administration (CNMPA) was evaluated. Methods: Information on all tablets and capsules prescribed in the hospital from March 17 to April 16, 2019 was collected. It was assumed that tablets or capsules were manipulated if the prescribed dose would have required only a proportion of the intact dose form. Manipulation typically includes splitting or crushing tablets, opening capsules and dispersing in water, or combinations of these method. Moreover, we defined an "avoidable manipulation," when the dose could be rounded and/or when alternative products with a reduced strength or in liquid formulation were available in the hospital, and a "inappropriate manipulation," which involved manipulated medications with a direct contraindication for any manipulation, such as those with a narrow therapeutic index or hazardous ingredients, or modified release dosage-forms. The frequencies of total, avoidable, and inappropriate manipulation were estimated, along with the hypothetical reduction of manipulation according to the availability of CNMPA-approved drug doses. Results: A total of 17,123 prescriptions for 142 medications were identified to have required a manipulation among 78,366 prescriptions administered during the study period, with 43 different proportions of subdivisions, ranging from a 19/20 to 1/180 product strength reduction. Half, quarter, and trisection were the most common subdivisions administered. Overall, 19% of the manipulated prescriptions were determined to be avoidable, and 19% of the manipulations involved medications with a clear recommendation to not manipulate. In addition, 21% of the manipulated prescriptions could have been potentially avoided if all of the approved preparations with the lowest strength would have been available at the hospital. Any manipulations undertaken were carried out by pharmacists and family care givers. Conclusions: More than 20% of tablets and capsules prescriptions need manipulated, included a high incidence of avoidable and inappropriate manipulation.
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