Case Study Activity: Strategies to Support the Safe Use of Acetaminophen

Transcription

1 Case Study Activity: Strategies to Support the Safe Use of Acetaminophen Case 2: Educating Patients to Safely Administer Acetaminophen-Containing Products to Children Activity Preview Acetaminophen is the most commonly used medication by children in the United States. On average, 11% of children in this country receive acetaminophen each week. 1 Although safe when used as directed, acetaminophen overdose in children can lead to hepatotoxicity and death. 2 Overdose situations can occur due to either unintentional overdosage by caregivers or unsupervised ingestions by children. Unintentional overdosages can occur when multiple caregivers administer acetaminophen to a child (e.g., owing to poor communication between caregivers), when caregivers administer multiple products containing acetaminophen, or when caregivers administer inaccurate dosages. Acetaminophen is currently available in more than 600 products, and its widespread availability can contribute to therapeutic duplication. Many patients, parents, and caregivers cannot correctly identify which products contain acetaminophen. For example, in a study of 1,009 patients, 492 patients (49%) did not know if Tylenol contained acetaminophen. Furthermore, the majority (66% 90%) of patients did not know if Lortab (hydrocodone/acetaminophen), Vicodin (hydrocodone/acetaminophen), Percocet (oxycodone/acetaminophen), non-aspirin pain reliever, ibuprofen, Motrin (ibuprofen), or Advil (ibuprofen) contained acetaminophen. 3 Furthermore, many multisymptom cough-cold products contain acetaminophen, which can lead to inadvertent therapeutic duplication if a patient takes both a cough-cold product and a product for pain relief. Pediatric products may be dosed inaccurately for a number of reasons. Until recently, pediatric acetaminophen products were available in multiple concentrations, with more concentrated drops available for infants. In a survey of parents, 27% did not know there was a difference between children s acetaminophen liquid and infant acetaminophen drops, and 65% believed that the children s liquid was more concentrated than the infant drops. This situation could pose an overdose risk to children if caregivers substitute a more concentrated form of acetaminophen for another form. 4 On June 29 30, 2009, a joint meeting of the U.S. Food and Drug Administration (FDA) Drug Safety and Risk Management Advisory Committee, the Nonprescription Drugs Advisory Committee, and the Anesthetic and Life Support Drugs Advisory Committee discussed the issue

2 of over-the-counter (OTC) liquid acetaminophen concentrations. A recommendation was made during this meeting to have only one concentration of OTC pediatric liquid acetaminophen available because products with different concentrations can cause dosing confusion among parents and caregivers that may lead to unintentional overdoses in pediatric patients. In May 2011, manufacturers of children s liquid acetaminophen products announced that they would voluntarily convert all pediatric products to one concentration: 160 mg/5 ml. 5 (Before this change, liquid acetaminophen marketed for infants was only available in 80 mg/0.8 ml or 80 mg/ml concentrations. 6 ) This change in the concentration affects the amount of liquid given to an infant, and should be especially noted by caregivers accustomed to using the 80 mg/0.8 ml or 80 mg/ml concentrations of liquid acetaminophen. However, since this change is voluntary, products with the old more concentrated formulation acetaminophen marketed for infants may continue to be available. Furthermore, caregivers may still have the older concentration in their medicine cabinets. Therefore, it is crucial that health care providers verify the concentration of the liquid product a caregiver is using before providing recommendations for dosage and administration. The use of inaccurate dosing devices also contributes to inappropriate dosing. A surprising number of parents 73% in a survey conducted by Madlon-Kay and Mosch report using a kitchen teaspoon to administer medication. 7 Unfortunately, the actual volume of a kitchen teaspoon can vary widely, leading to inaccurate dosing. To address this problem, many liquid products available today are sold with a dosing device. However, parents do not always use these devices. Alternative devices, such as medication cups, cylindrical dosing spoons, oral dosing syringes, and oral droppers also are widely available, but require a fair amount of health literacy to be used properly. If a liquid product does not come with a dose-measuring device, or if the device has been lost or damaged, the health care provider should help the parent or caregiver identify an appropriate alternative and provide education about its appropriate use. 8 Educate patients to always use the medication dosing device that comes with the product. More than 60,000 young children end up in emergency departments every year because they got into medications while their parent or caregiver was not looking. 9 To reduce the risk of unsupervised ingestions, a public-private partnership of health-related organizations collaborated with the Centers for Disease Control and Prevention to develop the PROTECT Initiative. 10 In December 2011, this initiative launched the Up and Away and Out of Sight educational program ( which promotes several safety messages for parents and caregivers, including: Never leave medicine or vitamins out on a kitchen counter or at a sick child s bedside, even if you have to give another dose in a few hours. Store these products up and away and out of sight. Always relock the safety cap on a medicine bottle. If it has a locking cap that turns, twist it until you hear the click. Explain to children what medicine is and why you must be the one to give it to them. 2

3 Never tell children that medication or vitamins are candy, even if your child does not like to take his or her medicine. Sharing safe storage reminders with parents and caregivers is always a good idea. Case Study You are working the night shift at the pharmacy and receive a call around midnight from Sarah Santiago, who is seeking a recommendation for how much acetaminophen to give to her 6-yearold son, Steven. Sarah reports that Steven has had a runny nose for the past 2 days, which she has been treating with an OTC cough-cold product. Tonight, she gave him a dose of the coughcold product at 7:00 pm right before he went to bed, but he awakened at 11:00 pm with a fever of F and is pulling on his ear and crying. She gave him another dose of the cough-cold product at that time but it doesn t seem to be helping and he still is awake and crying. Sarah thinks that Steven has an ear infection, and wants to use acetaminophen to manage the pain until she can take him to the pediatrician in the morning, but she isn t sure how much acetaminophen to give him. Answer to Question 1 Before recommending an acetaminophen dosage to Sarah, what do you need to know about the cough-cold product that Sarah administered? a. What is the brand of the product? b. Does the product contain acetaminophen? c. Who recommended the product to her? d. How much of the cough-cold product did she administer? The correct answer is b. Because many multisymptom cough-cold products contain acetaminophen, it is important to determine whether the product Sarah used includes acetaminophen. Failure to do so could lead to therapeutic duplication of acetaminophen and an overdose situation. Answer a is incorrect because numerous brand and generic products contain acetaminophen. It is not possible to determine whether a product contains acetaminophen from the brand name alone. Answer c is incorrect because the person who recommended the cough-cold product is not relevant to the recommended acetaminophen dosage. Answer d is incorrect because the amount of the cough-cold product is only relevant to the acetaminophen dosage if the product contains acetaminophen. Review of proper cough-cold product usage may be appropriate, but is not crucial to determining the acetaminophen dosage. You instruct Sarah to go to her medicine cabinet where she retrieves the cough-cold product and reads the ingredients to you. Sarah gave Steven Dimetapp DM Cough & Cold Elixir, which contains the following active ingredients per 5 ml: 3

4 Brompheniramine maleate 2 mg Phenylephrine hydrochloride 5 mg Dextromethorphan hydrobromide 10 mg Sarah reports administering 5 ml of the product as directed on the product label using the measuring cup that came with the product. Because this product does not contain acetaminophen, you can rule out the risk of therapeutic duplication with acetaminophen and can proceed with providing a recommended dose of acetaminophen. Answer to Question 2 What is the most important piece of information to obtain about the acetaminophen product before providing instructions to Sarah? a. Does Sarah plan to administer a liquid product or a tablet? b. What is the labeled concentration of the product? c. Is the product brand or generic? d. What type of measuring device came with the product? The correct answer is b. The key piece of information that you need to know about the acetaminophen product is the labeled concentration. This is particularly true for liquid acetaminophen products. Although, in general, currently available products have a concentration of 160 mg/5 ml, older products with different concentrations may still be in patients medicine cabinets. It is crucial to have parents or caregivers read the concentration on the product label before making a dosing recommendation. Answer a is incorrect because although the product form may provide some information about the product s acetaminophen content, it is not the key piece of information needed to make a recommendation. Answer c is incorrect because knowing the manufacturer of the product does not provide information about its acetaminophen concentration. Answer d is incorrect. Knowledge about the dosing device will be important for providing recommendations about product administration, however it does not directly tell you the concentration. Sarah reports that she has an acetaminophen product that is labeled as containing 160 mg/5 ml. She notes the following label instructions: Weight lb (Age 6 8 years): Dose 10 ml (2 tsp) Weight lb (Age 9 10 years): Dose 12.5 ml (2.5 tsp) According to Sarah, Steven s weight is approximately 62 or 63 lb, so she is not sure whether she should follow the recommendation based on age or the recommendation based on weight. You 4

5 explain that acetaminophen can be dosed by weight, so the appropriate dosage is 12.5 ml (2.5 tsp). You ask Sarah if she still has the dosing device that came with the product to administer the medication and she reports that it is missing. Answer to Question 3 Aside from educating parents or caregivers to always save the dosing device in the future, what should you tell them if the device is missing? a. Use a kitchen teaspoon. b. Do not to administer the product and use other support measures instead. c. Come to the store and buy a new product with a new dosing device. d. Search for another administration device that has a 2.5 tsp/12.5 ml dosage clearly marked. The correct answer is d. Although it is advisable to always administer a liquid product using the dosing device that comes in the package, occasionally dosing devices are lost. If this happens, parents can be instructed to use another dosing device that has the same dosage clearly indicated. In fact, some parents specifically purchase devices for administering liquid medication dosages for their children and the use of such products is acceptable. Answer a is incorrect because kitchen teaspoons can vary widely in the amount of liquid that they hold. Answer b is incorrect because it does not address the patient s self-care need for pain relief. Answer c is incorrect because it is not practical to ask a parent to bring a sick, feverish child to the store to buy a replacement product in the middle of the night when other options are available. Finally, you educate Sarah that many acetaminophen overdosage situations in children occur when caregivers leave medicine on a table or counter after administering it to a child, because the child can reach the medicine when the caregiver is not looking. Sarah is surprised to hear this; she had thought most such poisonings occur when children access unlocked medicine cabinets. You instruct her that it is important that she closes any child safety features and puts the medication up and away after using it. Fast Facts About Acetaminophen Each year more than 25 billion doses of nonprescription acetaminophen are used in the United States. Acetaminophen is the leading cause of acute liver failure in the United States. Use of inaccurate dosing devices contributes to inappropriate dosing of liquid acetaminophen products. Although manufacturers began standardizing concentrations of liquid acetaminophen products in 2011, parents and caregivers may still have products with various concentrations in their medicine cabinets. 5

6 References 1. Vernacchio L, Kelly JP, Kaufman DW, Mitchell AA. Medication use among children <12 years of age in the United States: results from the Slone Survey. Pediatrics. 2009;124: Lavonas EJ, Reynolds KM, Dart RC. Therapeutic acetaminophen is not associated with liver injury in children: a systematic review. Pediatrics. 2010;126:e Fosnocht D, Taylor JR, Caravati EM. Emergency department patient knowledge concerning acetaminophen (paracetamol) in over-the-counter and prescription analgesics. Emerg Med J. 2008;25: Barrett TW, Norton VC. Parental knowledge of different acetaminophen concentrations for infants and children. Acad Emerg Med. 2000;7: Consumer Healthcare Products Association. OTC industry announces voluntary transition to one concentration of single-ingredient pediatric liquid acetaminophen medicines [press release]. May 4, Available at: Accessed July 2, U.S. Food and Drug Administration. FDA Drug Safety Communication: Addition of another concentration of liquid acetaminophen marketed for infants. December 22, Available at: Accessed July 2, Madlon-Kay DJ, Mosch F. Liquid medication dosing errors. J Fam Pract. 2000;49: Dlugosz CK, Chater RW, Engle JP. Appropriate use of nonprescription analgesics in pediatric patients. J Pediatr Health Care. 2006;20: Centers for Disease Control and Prevention. Up and Away and Out of Sight. Available at: Accessed July 31, Centers for Disease Control and Prevention. The PROTECT Initiative: Advancing Children s Medication Safety. Available at: Accessed July 2,