Hispanic Parents and Medication Administration Safety: An Educational Interventional Program. Diane E. Mosqueda. Texas Woman s University

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1 Running head: Hispanic parents and medication safety Hispanic Parents and Medication Administration Safety: An Educational Interventional Program Diane E. Mosqueda Texas Woman s University

2 Hispanic parents and medication safety 2 Abstract Medication errors are the most common form of mistakes that lead to patient injury, hospitalization and death (IOM, 2006). According to the 2006 report by the Institute to Medicine (IOM), there were approximately 1.5 million preventable adverse drug events occur each year; more than one third of these take place in outpatient settings at a cost approaching $1 billion annually (Bailey, et al., 2009). There has been much focus on the adult population and medication errors but there is less attention given to medication errors occurring in children (Bailey, et al., 2009). This is a major concern because more than half (65%) of children take one or more medications in any given week and rely upon others for their administration (Slone Epidemiology Center at Boston University, 2006). Studies that were conducted in ambulatory settings estimate that 15% of children who are prescribed a medication later suffered a medication error; most are caused by improper administration by parents or caregivers (Kaushal, Goldmann, & Keohane, 2007). The usual mistake made by the parents was failure to read or understand label instructions, leading to use of an incorrect measuring device or preparation. One parent used a teaspoon instead of the dropper for the infant solution (80mg;0.8 ml), and another used the adult regular-strength tablets (325 mg) instead of the chewable children s tablets (160 mg) (Rivera-Penera, et al., 1997). Acetaminophen is one of the most widely used antipyretic and analgesic medication. Overdose of this drug, leading to a toxic condition of the liver, remains a problem, however. According to Bond, Krenzelok & Norman (1994) found that 19,000 calls regarding childhood exposure to acetaminophen were received by 11 referral centers; 2091 of these calls were referred to a medical facility for further evaluation. There are very few studies that investigated Hispanic families and their children. This group is very vulnerable because many Hispanic parents may not be able to read or understand English. This study will be an education

3 Hispanic parents and medication safety 3 interventional study that will reduce the medication errors of Hispanic children and provide parents the opportunity to understand and demonstrate correct dose specific medication administration guidelines. It is important for parents to have specific information about medication safety to feel confident and their children to be safe from preventable medication errors.

4 Hispanic parents and medication safety 4 Statement of the problem: Medication errors are the most common form of mistakes that lead to patient injury, hospitalization and death (IOM, 2006). According to the 2006 report by the Institute to Medicine (IOM), there were approximately 1.5 million preventable adverse drug events occur each year; more than one third of these take place in outpatient settings at a cost approaching $1 billion annually (Bailey, et al., 2009). Medication errors have been defined as any preventable event that may cause or lead to inappropriate medication use or patient harm, while the medication is in the control of the healthcare professional, patient, or consumer (Conroy, et al., 2007) There has been much focus on the adult population and medication errors but there is less attention given to medication errors occurring in children (Bailey, et al., 2009). This is a major concern because more than half (65%) of children take one or more medications in any given week and rely upon others for their administration (Slone Epidemiology Center at Boston University, 2006). Studies that were conducted in ambulatory settings estimate that 15% of children who are prescribed a medication later suffered a medication error; most are caused by improper administration by parents or caregivers (Kaushal, Goldmann, & Keohane, 2007). Shone, Yin, & Wolf (2010) found that an increasing number of studies have documented problems with the safe use of prescriptions and nonprescription or over-the-counter (OTC) medicines among children and adolescents. There were reported potential errors by caretakers in administering prescription and OTC medicines to children. Children 18 years of age and younger make over 70,000 emergency visits each year for medication overdoses (Schillie, Shehab, Thomas, & Budnitz, 2009). Most of the medications that were found to be given

5 Hispanic parents and medication safety 5 incorrectly were opioids, prescription pain medicines, psychotherapeutic agents, and acetaminophen. Acetaminophen is one of the most widely used antipyretic and analgesic medications. Overdose of this drug can lead to a toxic condition of the liver. According to Bond, Krenzelok & Norman (1994) found that 19,000 calls regarding childhood exposure to acetaminophen were received by 11 referral centers; 2091 of these calls were referred to a medical facility for further evaluation. Riveria-Penera, Guig, Davis, McDiarmid, Vargas, Rosenthal, Berquist, Heyman & Ament (1997) reviewed the records of 73 pediatric patients that were admitted for acetaminophen overdose and found that twenty-eight pediatric patients (39%) had severe liver toxic effects and six of them underwent liver transplantation. Rivera-Penera, et al., (1997) found that there were multiple miscalculated overdosed given by parents and with the delay in the treatment were the major cause of overdose in children 10 years of age or younger. Children are the most vulnerable because they rely on their parents or caregiver to administer their medications. Children are at high risk for medication errors due to many factors. These factors contribute to the risk of a preventable medication error. The factors include: weight-based dosing; the need for stock medicine dilution; decreased communication abilities of children; an inability to self-administer medications; and the high vulnerability of young children who have preexisting chronic issues involving the renal and hepatic system (Kaushal, Tonushree, Walsh, Fortescue, & Bates, 2004) According to Kaushal, Tonushree, Walsh, Fortescue & Bates (2004) in ambulatory settings in pediatrics, special interventions need to target the administration stage because parents administer most medications. This process has many error-prone aspects, including parental confusion regarding the correct use of teaspoons, tablespoons, and dose cups (Kaushal, Tonushree, Walsh, Fortescue, & Bates, 2004). Dosing errors by parents were found to

6 Hispanic parents and medication safety 6 be highly prevalent with cups, compared with droppers, spoons, or syringes (Yin, et al., 2010). The authors of this study found that strategies to reduce errors should address both accurate use of dosing instruments and health literacy. Yin, et al. (2010) found that dosing cups were specifically associated with large overdosing errors. Errors involving cups were thought to arise from confusion about teaspoon versus tablespoon instructions, assumptions that the cup is the unit of measure, and assumptions that the full cup is the dose. The parents in this study also had difficulty being able to read the meniscus of the dosing correct accurately, omitting the eyelevel verification, was also associated with parental errors. Yin, et al (2010) states that redesign of dosing devices as well as instructions for their use, with a focus on standardization and consistency, has the potential to decrease mediation errors and improve safety and efficacy. Acetaminophen is a very common medication that is given to children. Parents are the caregivers responsible for administering the medication. This study is designed to assist the parents to administer acetaminophen accurately and with the correct dosing devices such as oral syringes and pediatric dosing spoon. The parents will be able to understand and read a medication label correctly and also have written instructions in Spanish to review and have available as a reference. Supplementing the often rushed information from physicians and pharmacist regarding drug administration, an educational program on medications administration safety can assist parents to feel confident about giving their child the correct dose at the correct time and for the correct reason. Goals/Objectives The overall goal of this prospectus will be to compare the ability of Hispanic parents to calculate and demonstrate the correct acetaminophen dose, interval, and frequency for their child when using product information leaflets. By developing an educational prevention program for

7 Hispanic parents and medication safety 7 Hispanic parents of children ages 1 through 13 years of age, the following objectives will be accomplished: 1. Parents will be able to state the maximum number of times per day they would administer the acetaminophen dose by the end of the educational session. 2. Parents will be able to state the shortest interval between doses in hours by the end of the educational session. 3. Parents will be able to state the appropriate reasons for administering acetaminophen to their child by the end of the educational session. 4. Parents will be able to demonstrate the recorded volume using a 5 ml oral syringe or dosing spoon by the end of the educational session. 5. Parents will be able to verbalize how to use the dosing instructions sheet for their child based on the appropriate weight of the child by the end of the educational session. 6. Parents will be able to read and state the appropriate directions from the drug label by the end of the educational session. Method This project is directed at the Hispanic community. Hispanic parents will be targeted for this educational prevention program about medication safety. The selection and recruitment of participants for this study will be composed of Hispanic parents from a predominately- Hispanic clientele at a pediatric clinic setting. Study Design A randomized control sample will be conducted. The timeline for the project will be accomplished within 2 month. Participant Selection and Setting

8 Hispanic parents and medication safety 8 All patients with their parents presenting to the pediatric clinic will be eligible to participate in the study between April 8, 2011 and April 22, The criteria for inclusion in this study are parents of Hispanic children, children age <8 years old, the parent s ability to read either English or Spanish and are willing to participate in this study. Exclusion criteria are children who are special needs or are currently taking prescribed medication. All parents must agree to an informed consent and have either a cell phone or a land line to contact them for the follow-up survey. There will be 60 parents or caregivers enrolled in the study within a 2 week period. Social and Demographic Data and Child Health Status Social and demographic data will be obtained at the beginning of the study. The caregiver s relationship to the child, marital status, country of origin, race/ethnicity, language, education, and socioeconomic status. Number of children in the household and ages of the parent and children will also be obtained. Caregivers will be categorized as having or not having a child in the household aged 8 years or younger (child aged < 8 years likely to use liquid medications). Intervention There will be 30 parents or caregivers assigned to the interventional group and 30 parents or caregivers assigned to the non-interventional group. All participants will have informed consent signed before participation in the study. The non-interventional group will receive a survey to determine their knowledge base of administering acetaminophen safely to their children. The interventional group will be surveyed about their knowledge base of administering acetaminophen safely to their children. Following the survey, the interventional group will receive a 1 hour educational program designed to cover safe

9 Hispanic parents and medication safety 9 medication administration principles and also will have instructions about drug labels. The educational program will be conducted in a classroom setting. The specific objectives for the educational program are: (1) Parents will be able to state the maximum number of times per day they would administer the acetaminophen dose by the end of the educational session. (2)Parents will be able to state the shortest interval between doses in hours by the end of the educational session:(3)parents will be able to state the appropriate reasons for administering acetaminophen to their child by the end of the educational session: (4)Parents will be able to demonstrate the recorded volume using a 5 ml oral syringe or dosing spoon by the end of the educational session: (5)Parents will be able to verbalize how to use the dosing instructions sheet for their child based on the appropriate weight of the child by the end of the educational session: (6)Parents will be able to read and state the appropriate directions from the drug label by the end of the educational session. Parents will be given an educational pamphlet that reinforces the principles of administering medications safely. Statistical Analysis Data that will be obtained from the survey results will be analyzed using the SPSS version 15.0 statistical software (SPSS inc, Chicago, Illinois). For all analysis a 2-tailed p<.05 will be considered statistically significant. A statistician will be consulted to organize and interpret the data. Evaluation/Outcome Measures After the educational program, the participants from the interventional group will be given a survey to determine the effectiveness of the program. Both groups will receive a safety medication tool kit that composes of an information instruction sheet, a dosing spoon and a safety bear button. The evaluation of the project will be determined by the pre and post

10 Hispanic parents and medication safety 10 surveys from both groups. A follow-up survey will be sent after one month following the first survey to both groups to determine if the parents continue to administer acetaminophen correctly. The interventional group will show a statistically significant difference from the non-interventional group. Budget The budget for this educational interventional study includes the direct costs for this project. The direct costs include the salary expense of the nurse practitioner, the editor and the consultant fee for the statistician. The editor will be consulted to review the study for any grammatical or spelling errors so that this study will be submitted for publication. A purchase of the SPSS 15.0 statistical package is required for the ability to analyze the data for this study. The other costs for the budget include the medication safety kit which will contain a safety bear button, and educational pamphlet, acetaminophen instructional leaflet, a dosing spoon and a dosing syringe. A computer is required to develop the educational pamphlet. The educational pamphlet publishing and printing costs are listed. The classroom rental will be for the 30 interventional group and a minimum of 3 hours is allocated for setup and cleanup. There will be drinks and snacks provided for this teaching session. Budget items Cost Frequency Budget expense Educational pamphlet educational Acetaminophen instructional leaflet pamphlets instructional leaflets Safety bear button buttons Plastic bag bags

11 Hispanic parents and medication safety 11 Dosing spoon $25.00/ dozen 2 dozens Office supplies (copy paper $ cases sheets/ream) Toner/ink $ cartridges Computer $ Statistical analysis package $ Publishing/printing costs Statistician consultant 1 (150/hr) 3hr Editor consultant 1 ( 60/hr) x 4 4hr Classroom rental 3 hr (250.00) 3 hr Nurse Practitioner 60/hr for 3 hrs 3hrs $ Consultation fee Snacks and Drinks $ Grand total 3,250 Summary By having parents administering medication safely to their children will result in saving lives and decreasing morbidity that is highly associated with medication errors. Dosing devices that parents use to administer medication to their children can be very confusing and by teaching parents how to accurately calculate and administer the medication properly has the potential to decrease medication errors and improve safety and efficacy. Reviewing medication labels and having written instructions available in Spanish will allow the parents to have an excellent resource available to continue the safe practice of administering medication in the future. This study will provide the

12 Hispanic parents and medication safety 12 education and training that is appropriate for the parents to administer medication safely to their children.

13 Hispanic parents and medication safety 13 References Bailey, S., Pandit, A., Yin, S., Federman, A., Davis, T., Parker, R., et al. (2009). Predictors of misunderstanding pediatric liquid medications instructions. Family Medicine, 41 (10): Bond, G., Krenzelok, E., & Norman, S. (1994). Acetaminophen ingestion in childhood; Cost and relative risk of alternative referral strattegies. Clinical Toxicology, Conroy, S., Sweis, D., Planner, C., Yeung, V., Collier, J., Haines, L., et al. (2007). Interventions to reduce dosing errors: A systematic review of literature. Drug Safety, Institute of Medicine. (2006). Preventing medication errors. Washington, DC: National Academy Press. Kaushal, R., Goldmann, D., & Keohane, C. (2007). Adverse drug events in pediatric outpatients. Ambulatory Pediatrics, Kaushal, R., Tonushree, J., Walsh, K., Fortescue, E., & Bates, D. (2004). Pediatric medication Errors: What do we know? What gaps remain? Ambulatory Pediatrics, Rivera-Penera, T., Gugig, R., Davis, J., McDiarmid, S., Vargas, J., Rosenthal, P., et al. (1997). outcome of acetaminophen overdose in pediatric patients and factors contributing to hepatotoxicity. The Journal of Pediatrics, 130 (2), Schillie, S., Shehab, N., Thomas, K., & Budnitz, D. (2009). Medication overdoses leading to emergency department vistis among children. American Journal Of Preventive Medicine, Shone, L., Yin, S., & Wolf, M. (2010). Medicine Safety Among Children and Adolescents. Academic Pediatrics, 10, Slone Epidemiology Center at Boston University. (2006). Patterns of medcation use in the United States. Boston: Slone Survey Report. Yin, H., Mendelsohn, A., Wolf, M., Parker, R., Fierman, A., van Schaick, L., et al. (2010). Parents' medication administration errors: Role of dosing instruments and health literacy. Archives Pediatric Adolescent Medicine,

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