A Survey from a Tertiary Care Hospital in India on Pediatric Medication Re-Dosing Practices After Patient Vomiting

Abstract

OBJECTIVE

The study was started in our institution to analyze the clinical problem and identify the benefits and drawbacks of current practices associated with drug re-dosing after vomitting. Opinions and perspectives from health care professionals from various pediatric hospitals were also gathered to build an effective and systematic protocol.

METHODS

Survey participants were recruited by using email distribution lists and forums catering to health care. Using this, 2 online surveys were carried out in the window period of 6 months.

RESULTS

Of the 14 responses from the study hospitals that were suitable for analysis, 64.2% reported pediatric patients that vomited after being administered oral medications: 7.1% faced this daily, 35.7% weekly, and 21.4% monthly. When respondents were asked to rate the importance of 8 factors potentially affecting the decision to re-dose, more than half indicated that the patient's vitals and condition (stable, unstable, or critical) were most important (57.4%), followed by time after ingestion (50%), familiarity with medication (42.8%), and formulation of medication (42.8%). Of 43 respondents from other institutions, only 11.9% had a functioning guideline for re-dosing in their institution.

CONCLUSIONS

Health care professional respondents to our surveys listed the time between ingestion and vomiting and the condition of the patient as the most important factors in their decision to re-dose the medication.

Introduction

Emesis occurs as a consequence of a wide variety of illnesses, including acute gastroenteritis and food poisoning, adverse drug reactions, acute infections, to name a few.¹ It is a common occurrence among the pediatric population, both in outpatients as well as those hospitalized. Outside of sickness, worried parents of many infants and young children might also complain of regurgitation in their children.¹ If a child vomits after administration of an oral medication, several factors need to be considered, including the nature of the symptoms and disease being treated, the therapeutic index of the medication, the drug formulation (tablet, suspension, or sustained release formulation), the pharmacokinetics of the drug, and the time between administration of the dose and emesis. However, this multifaceted issue has been dealt with very sparsely in the literature.

The available literature guideline is based on 3 newsletters: the Canadian Pharmacist's Letter,² the Nevada State Board of Pharmacy News,³ and the Department of Pharmaceutical Care at the University of Iowa Hospitals and Clinics,⁴ all of which have recommended re-dosing oral medications after vomiting. According to these sources, it is rational to readminister the medication if it is visible in the vomitus or if vomiting has occurred within 15 minutes after ingestion of the dose.^2–4 However, these expert recommendations also advise to re-dose on a case-by-case basis, taking into consideration the risk of undertreatment owing to potential therapeutic failure versus the risk of toxic effects. Thus, the therapeutic index of the medication, the drug formulation (e.g., liquid, short acting or long acting solid dose forms), and the duration of treatment (i.e., short course or long term) are important drug characteristics that need to be strongly considered.^2–4 However, these recommendations are also fragmentary because they are not specific to the pediatric community. Currently, there is no uniform algorithm in India that aids the decision-making process in suggesting what action health care professionals need to take in the setting of re-dosing for a pediatric patient vomiting following the administration of an oral medication.

The All India Institute of Medical Sciences (AIIMS; Raipur) is a tertiary care hospital involved in patient care, teaching, and research, At the time of designing this study in 2019, the Pediatric Department had no formal policies in place to direct nurses, pharmacists, or physicians in the event of patient vomiting after ingestion of an oral medication, specifically concerning whether the medication should be re-dosed. There appeared to be a consensus that medications should be readministered if emesis occurred within 30 minutes after ingestion of the dose and should not be readministered if emesis occurred more than 60 minutes after ingestion; however, individual decisions were made on a case-by-case basis. Thus we developed and employed a survey of health care professionals to determine the factors that affect (their) clinical decisions regarding the re-dosing of medications after pediatric vomiting, both in local and in the hospital environments. Additionally, the study aimed to understand the rationale behind the design of various guidelines used by different institutions. Thus, the objectives of our study were 1) to examine the extent and nature of the clinical problem, based on the results of an online survey of health care professionals, 2) to identify the current practice of medication re-dosing at AIIMS, Raipur, and 3) to collect opinions and collate directives from health care professionals from other pediatric centers regarding re-dosing following emesis of oral medications.

Methods

Current practices and opinions among physicians, nurses, and pharmacists working in pediatric wards and clinics were collected by using 2 distinct, self-administered, and voluntary online questionnaires (see Supplemental Table). The first survey was specific to the team at AIIMS, Raipur, lasting1 month. An invitation to participate in the survey along with an embedded link to a Google Form for the online survey was circulated via email, using an institutional distribution list; additionally, for convenience, WhatsApp was used. Ninety invitations were sent out using this method. The survey included questions about the current methods of practices; also included were 6 clinical scenarios in an attempt to gage their understanding of the situations and assess clinical decision-making skills. The 6 clinical scenarios (see Supplemental Table) detailed the patient's age, the medication and dosage regimen, the time to emesis, and the presence of the medication in the vomitus. One scenario served as the baseline, with 1 factor being altered in every other scenario. For every scenario, the respondents were asked whether they would readminister the medication, why they adopted the specific course of action taken, and if they had encountered a similar problem during their clinical practice.

In addition, respondents also had to rate the importance of 8 clinical factors in their order of significance to decision-making in the context of re-dosing. These included time after initial ingestion of dose, medication type, patient status, presence of medication in vomitus, health care professional's familiarity with the medication, dosage form, the volume of vomitus, and patient age. The 5-point Likert scale (where 1 = not important, 3 = somewhat important, and 5 = very important) was used for this purpose.

The second survey varied little from the first in that it was open to professionals from other parts of the country even in adult settings. The reason for including adult settings is based on a preliminary screening for pediatric management by a general physician where no trained pediatricians were available. It probed the existence of functioning guidelines in different institutions and the rationale behind using specific directives. If the respondent's hospital had a guideline in place, responses regarding its characteristics were sought. If there were no institutional directive/guideline in place, information about common practices was requested by using open-ended questions. The 8 possible clinical factors as listed above were also given to these respondents who were asked to choose which of those were not taken into account in their guidelines. Finally, references used for constructing and framing their directive were requested. The study data were collected in June 2020; permission was received from authors who conducted a similar study in British Columbia in 2012, via the authorized channels, to use their survey questionnaire.[5] General survey respondent numbers were converted to percentages and the overall rating of importance was derived as mean ± SD.

Results

Survey of Local Hospital Practitioners. A total of 14 completed responses were received from nurses and physicians at AIIMS, Raipur (Table 1): 57.1% of these were physicians and the remaining 42.9% were nurses, all of whom belonged to the Pediatrics Department. Unfortunately no pharmacists responded to our invitation to participate. Among the respondents, 35.7% reported that they never encountered the problem of patient vomiting after the administration of oral medications. The rest reported that they were faced with the problem either on a daily (7.15%), weekly (35.7%), or monthly (21.4%) basis. The demographic profile of these patients revealed that 53.8% were 1 to 4 years old, 30.8% were younger than 1 year, and 7.7% were 10 to 18 years old.

Table 1.

Characteristics of Respondents to our Survey of Health Care Professionals at AIIMS (N=14), and Practitioners Outside our Institution (N=43)

Characteristics	AIIMS	Other Facilities
Profession, n (%)
Nurse	6 (42.9)
Physician	8 (57.1)	43 (100)
Clinical Years of Experience, n (%)
<5	5 (35.7)	16 (37.2)
5–10	6 (42.9)	17 (39.5)
>10	3 (21.4)	10 (23.3)
Clinical Area Setup, n (%)
Govt. POPD	5 (35.7)	4 (9.3)
Govt. PICU	3 (21.4)	1 (2.3)
Private pediatric facility	-	13 (31)
Others	6 (42.9)	26 (60.5)

AIIMS, All India Institute of Medical Sciences Raipur; Govt. PICU, government pediatric intensive care unit; Govt. POPD, government pediatric outpatient department

^* others-General health facility

Most respondents reported that in cases of patient vomiting after oral administration of medications, they would re-dose the medication according to a general rule based on the time elapsed between ingestion and vomiting: either within 30 minutes (50%), within 15 minutes (28.6%), or within 1 hour (14.6%). Inside the institution, 53.9% and 61.5% rated the time after dose ingestion and patient status, respectively, as very important factors in the decision to re-dose (Table 2).

Table 2.

Importance of Factors Affecting Decisions Among Health Care Professionals at AIIMS and Outside the Institution to Re-dose an Oral Medication After Patient Vomiting

Factors	AIIMS, (n=13)		Other Facilities (n=43)
	Respondents Rating of Factor as Very Important*, n (%)	Overall Rating of Importance,† Mean ± SD	Respondents Rating of Factor as Very Important*, n (%)	Overall Rating of Importance,† Mean ± SD
Time after ingestion of dose	7 (53.85)	4.2 ± 3.7	20 (46.51)	3.8 ± 3.5
Medication type	5 (38.46)	3.9 ± 3.5	19 (44.19)	4.0 ± 3.6
Visible presence of medication in emesis	3 (23.08)	3.3 ± 3.0	18 (41.86)	3.7 ± 3.4
Patient clinical status	8 (61.54)	4.2 ± 3.8	17 (39.53)	3.8 ± 3.5
Dosage form	6 (46.15)	3.6 ± 3.4	15 (34.88	3.6 ± 3.3
Familiarity with medication	6 (46.15)	3.7 ± 3.5	14 (32.56)	3.2 ± 3.0
Age of patient	3 (23.08)	2.8 ± 2.8	10 (23.26)	3.0 ± 2.9
Volume of vomitus	5 (38.46)	3.2 ± 3.1	9 (20.93)	3.1 ± 2.9

AIIMS, All India Institute of Medical Sciences, Raipur

^* Important factor to be considered for redosing

^† order of importance among various factors.

Most clinical scenarios that were presented to the respondents were encountered by less than 50% except for clinical scenario 5 (see Table 3), which was faced by 57.1% in practice. For each of the 6 scenarios (outlined in Table 3), 60% to 90% of the respondents made similar clinical decisions about re-dosing the medication. Of the factors potentially affecting the decision to re-dose, time after dose ingestion was most often taken into consideration, followed by medication type. The age of the patient was the least important factor in the decision-making of all clinical scenarios. Interestingly, in case 3 (in which a 10-year-old child took a dose of oral prednisone dosed once daily and vomited the medication 30 minutes after ingestion, and part of the medication was visible in the vomitus) and case 6 (in which a 10-year-old child took a dose of oral long-acting morphine dosed twice daily post surgery and vomited the medication 30 minutes after ingestion, and medication was not visible in the vomitus), medication type was considered more important than the time since ingestion (Table 3).

Table 3.

Characteristics of and Responses to 6 Clinical Scenarios Presented in the Survey of AIIMS

Scenario					N (%) Who Would Re-dose Medication			N (%) of Respondents for Whom Factor Would Affect Clinical Decision
No.	Age, yr	Oral Medication and Regimen	Time to Emesis, min	Visible Presence of Medication in Vomitus	Yes	No	Do Not Know	Time After Dose	Patient’s Age	Medication Type
1	10	Prednisone once daily	30	None	3 (21.4)	9 (64.3)	2 (14.3)	10 (71.4)	4 (28.6)	6 (42.9)
2	10	Prednisone once daily	>60	None	-	13 (92.9)	1 (7.1)	13 (92.9)	2 (14.3)	5 (35.7)
3	10	Prednisone once daily	30	Partial	9 (64.3)	3 (21.4)	2 (14.3)	5 (38.5)	2 (15.4)	7 (53.8)
4	2	Prednisone once daily	30	None	2 (14.3)	11 (78.6)	1 (7.1)	10 (71.4)	6 (42.9)	5 (35.7)
5	10	Acetaminophen q6h PRN	30	None	-	13 (92.9)	1 (7.1)	9 (69.2)	3 (23.1)	8 (61.5)
6	10	Long-acting morphine bid	30	None	3 (21.4)	9 (64.3)	2 (14.3)	7 (58.3)	2 (16.7)	9 (75)

AIIMS, All India Institute of Medical Sciences, Paipur

Survey of Practitioners at Other Pediatric Hospitals. A total of 43 individuals from other institutions responded to our survey and all completed questions were included in the analysis (Table 1). All respondents (100%) were physicians. Though all surveys were returned not all survey questions were responded to by each respondent.

Most respondents were from the states of southern India (Tamil Nadu) and central India (Chhattisgarh). Of 42 responses, 37 (88.1%) reported that their health facility did not have any guidelines, protocols, or recommendations regarding re-dosing in the event of patient vomiting following intake of oral medication. But for the question raised on the “common practice” being followed in absence of guidelines, 39 responses were found. In this background, the most common practice followed in their health facility was to repeat the dosing within a specified time frame (76.9%), followed by decisions made by clinical judgment (48.7%). Among respondents, 20.5% reported that they would contact the prescriber, while 7.7% stated that they would not repeat the dose in such an event. Respondents rated the importance of 8 factors affecting the clinical decision to re-dose oral medications after emesis on a 5-point Likert scale, and 4 of these factors were given a rating of 5 (indicating very important) by 46.5%, 41.9%, and 44.2% of respondents outside the institute for time after dose ingestion, presence of medication in vomitus, and medication type, respectively.

Nineteen respondents indicated that their hospital had a protocol in place tailored to this situation: 84.2% was drug-specific, 21.2% was ward- or service-specific, and 10.5% was hospitalwide (Table 4).

Table 4.

Factors Addressed in Routine Practices of Other Pediatric Institutions, as Reported by Survey Respondents (n=26)

Factor	Guidelines Addressing Factors, n (%)
Time after ingestion of a dose	23 (88.5)
Visible presence of medication in the vomitus	21 (80.8)
Medication type	20 (76.9)
Patient status	18 (69.2)
Dosage form	14 (53.8)
Patient age	13 (50)
Volume of vomitus	7 (26.9)
Health care professional’s familiarity with medication	6 (23.1)

Discussion

At our home institution, AIIMS; Raipur, the problem discussed in this article was prevalent, with 35.7% and 21.4% of the respondents reporting that they had experienced the issue either on a weekly or monthly basis. However, despite encountering the issue frequently in their clinical practice, there is no evidence-based decision-making algorithm in place to assist the health care worker on the most suitable course of action. At a global level, there is an obvious lack of studies and recommendations on the issue.

One particular recommendation that was based on expert opinion stated that the tablet or capsule could be readministered if it were visible in the vomitus or if vomiting occurred within 15 minutes of ingestion. This is not only for an oral preparation of tablets or capsules but also for the liquid forms of any preparation such as syrup or suspension, where the presence of colored secretions could be noted. It also clarifies that the decision should be made on a case-by-case basis, considering the possibility of a missed dose.²

In the setting of a pediatric patient vomiting following the intake of an oral drug, the best course of action regarding re-dosing is influenced by multiple factors. In our survey of current practice at AIIMS, Raipur, the most important factors that health care professionals used to decide about re-dosing were patient status, time after dose ingestion, familiarity with medication, and dosage form (see Table 1). Medication types and the volume of vomitus were less important as was the presence of medications. The caregiver's familiarity with the medication, the dosage form, and the volume of vomitus were less important, and the visible presence of the medication and patient's age was minimally important (see Table 1). However, most of the guidelines considered time after dose ingestion followed by medication type and visible presence of medication in the vomitus.^6,7

Among the various challenges that a health care professional faces while deciding on the most appropriate course of action are the diverse nature of the patients, their illnesses, and the medications themselves being the most pertinent. Many respondents reported following a “rule of thumb” based on the time from dose administration to vomiting in deciding whether to readminister a medication, though this approach might not always be the best course of action. One such instance would be in the context of re-dosing a liquid formulation if vomiting occurred within 30 minutes of ingestion. This practice does not always hold because there is insufficient literature to accurately estimate the gastrointestinal transit time and gastric emptying time for various dosage forms in the pediatric age group. The gastric emptying time for milk varies from as little as 30 minutes to 2 hours, based on the age of the child and even the type and consistency of milk.^6,7

Clinical judgment was used by health care professionals who said they followed a general guideline based on the time of vomiting relative to dosage administration. The type of medication was ranked as the second most critical criterion in deciding whether or not to re-dose a vomited medication (Table 4).

Finally, the respondents responses regarding availability of a guideline varied widely. Thirty-seven respondents stated no guideline was available and 39 respondents simply relied on their clinical practice in the absence of a guideline; 19 responses for the availability of guidelines. These responses need to be researched in more detail. The survey participants responded to the survey by basing their answers on whatever guideline they might have generally followed in their course of practice and not necessarily during their current area of practice.

Despite the pioneering work by Kendrick et al⁵ in 2012, very few institutes have a functioning protocol for re-dosing after emesis of oral medication, let alone for pediatrics. Our study was intended to create a standard protocol for our institute, curated by the findings from our study. The published literature⁵ was used as a yardstick to quantify the measure in the setting of developing counties. In the aforementioned Canadian study,⁵ 65 responses and 53 responses from the local hospital and outside the hospital were obtained as compared with 13 responses and 43 responses in our study, respectively. The major factors influencing the decision to re-dose in our study were patient status followed by time after dose ingestion. But in the Canadian study,⁵ it was time after dose ingestion followed by medication type, marking a vast difference between the developed and the developing country setting. The simulated clinical scenarios (see Supplementary Table), we hoped, would better delve into our understanding of the practice and help elicit information regarding the various factors that influence clinical judgment. To bridge the gap in better understanding practice differences in different countries, we believe it would be prudent to pursue the perceived knowledge gaps and facilitate training, to sharpen the clinical decision-making process.

The limitations of this study include those that are intrinsic to any online survey, that is, those that are specific to the design of the survey and the distribution among the participants apart from the elemental recall bias. First, the information extracted from the participants was confined and restricted to that prompted via checkboxes, barring the free flow of thoughts as written responses. Second, the 6 scenarios that were provided, while varying somewhat from the baseline scenario, were closely related, leading many respondents to possibly answer differently from what they would have responded in clinical practice.

The survey of AIIMS, Raipur had very few respondents, which may have led to selection bias, although most of the pediatric physicians responded. The survey links were sent directly to the individual pediatrician and were posted in the WhatsApp group. We focused primarily on pediatricians whose emails were registered with the national conferences in which our hospital pediatrician, physician, or health care staff have participated, thus giving us easier access. In addition, it was posted in a general pediatric forum. Not using general pediatric nursing forums or pediatric pharmacist forums likely led to further selection bias.

A common problem of survey studies that we also encountered was some respondents did not answer all questions and answered some questions randomly. In the survey of other hospitals, respondents reported that they would typically repeat the dose within a specified time, often aided by their professional judgment. This calls for more research into understanding what would be regarded as the minimum time that should have elapsed, beyond which re-dosing can be discounted.

Conclusion

Our survey revealed that more than three-fourths of health care workers in our institution experienced situations involving vomiting of oral medication at some point in their clinical practice. This was more prevalent among infants and patients younger than 4 years. An important factor in determining whether or not to read-minister the medication was the time that had elapsed between dose ingestion and vomiting. Other important factors that were regarded as pertinent to consider before re-dosing included medication type and dosage form, patient status, and visible presence of medication in the vomitus. Among health care professionals who responded from other institutions, very few confirmed the presence of a functioning protocol in their institutions to assist decision-making in this situation. Although vomiting the medication before it can be absorbed increases the risk of therapeutic failure in the absence of readministration, it is pertinent to weigh this against the risk of toxic effects should the vomiting occur after absorption of the medication. In practice, this decision is made on a case-by-case basis. However, we believe that an algorithm, a guideline, that aids decision-making that incorporates the list of factors that need to be considered before re-dosing would be effective in guiding health care workers. As a consequence of this study, we aim to educate our professionals on this situation and provide foundational information needed to curate an algorithm that outlines the factors that would help to focus the best course of action.

ABBREVIATIONS

AIIMS

All India Institute of Medical Sciences