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Vol 6 Issue 1 June 2014 A Medication Safety Newsletter by the Pharmaceutical Services Division, Ministry of Health Malaysia “Medication Safety Is Everyone’s Responsibility” This newsletter is for circulation to healthcare providers only What parents think By Chan Su Ann, Erik Tan Xi Yi, Pharmacists, Vitacare Pharmacy ˝ Parents often view a fever as an illness that must be cured at all costs to prevent serious consequences such as neurological complications1. As such, most parents treat even a minimal increase in their child’s body temperature vigorously. ″ According to the American Academy of Paediatrics (AAP), about 56% of parents would administer antipyretics for body temperatures that are within normal range2. They are convinced that a child must maintain a “normal” temperature at all times1. Parents are afraid that if no steps are taken to curb the fever, their child’s body temperature will rise to alarming heights. Nevertheless, a fever is actually a homeostatic process. It is tightly regulated physiologically and very rarely, will temperatures rise above 41.4⁰C, even in cases of severe untreated infections2. Fevers may also be beneficial to some extent. It serves as a physiological barrier to fight infections within the body1. Foundation, the U.S Food and Drug Administration (FDA) and Centers for Disease Control and Prevention advice against the use of aspirin by individuals less than 19 years old3. Even when the right antipyretic is used, the dose may be incorrect. According to a clinical report by the AAP, one-half of parents administer inaccurate doses of medication while roughly 15% of parents administer too high a dose1. The majority of parents that pick up a bottle of paracetamol syrup over-the-counter are unaware that a more accurate dose should be determined by the weight of the child. Instead, they would dose the medication according to the age of the child as shown on the packaging. If the child does not have the average weight for their age group, the wrong dose of antipyretic would be administered. ˝ Caregivers usually insist on cough syrups or antibiotics to cure their child despite the fact that the common cough is usually self-limiting. ″ In this day and age, many patients are armed with a treasure-trove of information gleaned from sources such as the internet, books and professional opinions from their physicians or pharmacists. Despite advances in the public’s awareness regarding various medications and health issues, some individuals still hold onto old practices of administering medicines. This sentiment is particularly true for certain paediatric medicines in the community setting. Many parents enter the pharmacy with a pre-conceived notion on what is best to treat their child. This article will concentrate on two common paediatric conditions seen in the community – fever and the common cough. Most of the parents do not realize that coughing is actually a protective mechanism to clear mucus secretions from respiratory airways4. Furthermore, cough preparations will also cause severe complications such as convulsions, decreased consciousness and even deaths when used in children under 2 years old5. The British Medicines and Healthcare Products Regulatory Agency under the UK Therefore, the goal of treatment should be to National Health Service conducted a review and found improve the child’s overall comfort instead of no significant benefits of using cough and flu normalising the child’s temperature1. If the child medications in children under 6 years of age6. There seems well and active, adequate hydration and are however risks of side effects such as allergic comfortable cooling environment for the child is reactions, sleep disturbances and hallucinations7. To sufficient2. Antipyretics such as paracetamol or lend further credit, a study conducted by Schaefer et el ibuprofen may also be used when required. Some showed that most adverse drug reactions from cough parents are unaware that aspirin should not be used in and cold medicines occur in children between the ages children due to its association with a condition known of 2 to 5 years old (64%)6. as Reye’s Syndrome. The National Reye’s Syndrome >> Page 4 Page 2 Medication Safety Newsletter Vol 6 Issue 1 June 2014 Editor’s Editor’s NOTE Babies, infants and young children are cute and enlighten any parents and human heart, especially their innocence. But taking good care of their well-being especially health can be most trying. Why, because they are different from adult. Infants and children vary in weight, body surface areas and organ system maturity which affect their ability to respond, metabolise and excrete medications. But these factors can be neglected or easily overlooked each time children are treated for illnesses and prescribed medications, especially when few standardised dosing regimens for children exist, not mentioning the inadequate regulation on indications and dosing guidelines on medicines for paediatric use. It is no surprise that a 5-year study by the US Pharmacopeia (USP) on Medication Errors Reporting Program revealed that paediatric patients (31%) experienced a significantly higher rate of medication error when compared with adults (13%). Despite the widely publicised news on the deterioration of resistance, antibiotics are still commonly prescribed to both children and adult, or sold indiscreetly, especially under duress from patients who believe that antibiotic is a “cure-all” medication. The long-time popular household remedy paracetamol can carry serious threat to health as highlighted in the article “Paracetamol: Beware of overdose”. For all the care that healthcare professionals can give, the cycle of medication safety is incomplete without the involvement of family members, read what pharmacists Chan Su Ann and Tan Xi Yi have to say on Parent’s Perception on Paediatric Medicines in Community Setting. Incorrect dosing, including calculation errors and dosing interval, is very common in paediatric medicine delivery. Proper administration using the right measuring device can help to prevent adverse drug events, read Getting to Know MediBottle, a simple but helpful tool to ensure better safety to children. Is it asking too much of healthcare workers to take that extra precaution when treating and administering medicines to infants and children? Getting to know MediBottle The Paediatric Medication Delivery System The MediBottle is composed of a traditional baby bottle (filled with breast milk or any other preferred liquid) with the addition of an oral dispenser (filled with medicine) (5ml) that slides into the centre sleeve of the bottle. As the baby begins to drink, short presses on the plunger jet little squirts of medicine, displacing the familiar liquid in the very tip of the nipple. The baby takes in these small amounts of medicine, which are swallowed and washed down immediately by the familiar liquid, giving the baby's taste buds little time to sense the medication. The medicine usually goes completely undetected by the baby. The MediBottle is easy to use and can be operated with one hand. The device delivers a 5mL dose of medicine in about 60 seconds. Dispensing Medicine with the MediBottle Allow the baby to begin drinking the liquid from the MediBottle. Please let us have your feedback on our editorial contents and what you would like us to cover in future issues. For enquiries kindly contact: Editorial Board Advisors YBhg. Dato’ Eisah A. Rahman Dr. Salmah Bahri Editorial Members Che Pun Binti Bujang Wan Mohaina Wan Mohammad John C.P. Chang Faridah Md. Yusof Subasyini a/p Sivasupramaniam Tea Ming Hui Erik Tan Xi Yi Yen Sze Whey Ong Su Hua Juliana Binti Nazlim Lim Medication Safety Section, Pharmaceutical Services Division, Ministry of Health Malaysia, P.O. Box 924, Jalan Sultan, 46790 Petaling Jaya, Selangor. Tel: +603-78413200 / 3320 Fax: +603-79682222 / 2268 E-mail: [email protected] Materials published in this newsletter may be reproduced with permission. The Pharmaceutical Services Division (PSD) shall not be liable for any loss or damage caused by the use of any information obtained from this newsletter Press the dispenser plunger quickly to produce a little squirt (about 5 drops) every 1-4 sips, depending on the baby’s eagerness to drink from the bottle. Adjusting to the baby’s response will ensure that the dilution of medication does not occur in the bottle. It will take about 6 squirts to deliver each 1mL of medicine. Amount of medicine 1mL = 6 squirts 2mL = 12 squirts 3mL = 18 squirts 4mL = 24 squirts 5mL = 30 squirts Source: http://www.medibottle.com Medication Safety Newsletter Vol 6 Issue 1 June 2014 Page 3 Liquid Medicines: Is the dose RIGHT? By Chan Su Ann, Erik Tan Xi Yi, Pharmacists, Vitacare Pharmacy “How does one measure 5 mL of cough syrup?” “Can I measure my medicine using a normal kitchen spoon?” Administration devices that comes together with medication “How many millilitres does a teaspoon even contain?” These are just some of the questions that might pop up in a patient’s mind, and with good reason. Using the wrong measuring device could result in a range of problems that may lead to patient harm. For instance, measuring too little of an amount might render the medication therapeutically ineffective while measuring too much could lead to an overdose. The results could be catastrophic. This is especially true for paediatric patients as they require particularly accurate doses of medication. “ “ Healthcare providers should encourage patients to use the measuring device that is provided along with the medication or obtain a proper one from a pharmacy. It falls on our shoulders, as health professionals, to educate our patients regarding the importance of the proper administration of their medication. As we begin to gauge the extent of their awareness, it becomes increasingly obvious that we have our work cut out for us. Many patients still use a normal kitchen spoon to measure their medications. The danger of such practice is that the varying sizes of kitchenware available do not provide the standardized measurement that is required. Various measuring devices available in the market As such, we should encourage our patients to use the measuring device that is provided along with the medication or obtain a proper one from a pharmacy. Among the measuring devices that are widely available are dosing cups, droppers, syringes and measuring spoons. In summary, using the right measuring device is a simple but effective step towards medication safety. Encourage patients or care givers to seek advice from a doctor or pharmacist when in doubt as to what is suitable for use. Use measuring device provided with the medicine Do not mix and match measuring cups from different medicines. The cups may not be accurate Be sure to check the units Follow the dose written on the prescription Table 1: Measurement unit conversions1 1 mL 1 cc 2.5 mL 5 mL 2.5 cc 5 cc ½ teaspoon 1 teaspoon 15 mL 30 mL 15 cc 30 cc 1 tablespoon 2 tablespoon Measure medicine at eye level References 1)FC, Tenover, JM Hughes. Review The challenges of emerging infectious diseases. Development and spread of multiply-resistant bacterial pathogens. JAMA 1996 24-31; 275(4):300-4. 2) http://pediatrics.aappublications.org/content/119/4/698.full 3)YK Lee,BY Ong,DFS Yap H Arsal.Parental Knowledge,Attitudes&Practices(KAP) On Antibiotic Use In Children With Acute Upper Respiratory Tract Infections (URTIs).The 9th Johor Scientific Meeting 2013,(Sept 13). Case 2 Healthcare professionals must be aware of the possibility of errors in prescribing, dispensing and administering liquid medicines. Examples of these errors involving alfacalcidol drops are shown below. Case 1 In one incident, a 4 year old boy with chronic kidney failure was prescribed alfacalcidol drop 0.3mcg once a day. However, the medicine with a strength of 2mcg/ml was wrongly labelled as 1.5 mL once a day. Thus, the patient received 10 TIMES more than the intended dose. As 1drop=0.1mcg, it should be labelled as 3 drops once a day. Luckily, there was no harm to the patient. In another case, alfacalcidol drop 0.1mcg once daily was wrongly labelled as 1mL once a day. The parents followed instructions on the label and gave 1mL alfacalcidol drop to the 1 month old premature baby boy. As a result, additional monitoring was needed for patient's calcium, ALP and phosphate level. Case 3 The alfacalcidol drop was labelled using the label for 'ubat mata/telinga/hidung' and 'tidak boleh diminum'. As a result, the parents did not give the medicine to patient. Source: Medication Error Reporting System (MERS) Page 4 Medication Safety Newsletter Vol 6 Issue 1 June 2014 Antibiotic for Kids: By Tea Ming Hui Pharmacist, Sultanah Nora Ismail Hospital, Batu Pahat The overuse of antibiotics in children is becoming a major health problem globally1. It is estimated that 90% of the illnesses in children are viral and selflimiting e.g upper respiratory tract infections and diarrhea where antibiotics are considered unnecessary. Many physicians have had the experience of parental pressure (real or perceived) for antibiotic prescriptions.2 A recent survey carried out by pharmacists from Hospital Enche’ Besar Hajjah Khalsom, Kluang3 on 309 parents found that: of the parents believed that antibiotics should be given to all children with fever. of them believed that antibiotics will make their child recover faster from flu even though the illness may be self-limiting. of the parents did not understand the concept of antibiotic resistance. would give their children antibiotics without doctor’s consultation. of parents would sometimes specially request an antibiotic prescription from a doctor and 89.6% of them did not confirm with their doctor whether the use of antibiotics is truly necessary or not. The complex relationship between physicians and parents often leads to unnecessary antibiotic administration. Significant efforts should be aimed towards changing of prescribing patterns by making the physicians aware of the current evidence and guidelines for antibiotic prescribing. It may be possible to tap into growing parental concern by educating parents about appropriate indications and the risks and benefits of antibiotics. If the parents can understand the role of antibiotics in the treatment of diseases better, they may exert less pressure on the physicians to dispense antibiotics inappropriately. References 1)FC, Tenover, JM Hughes. Review The challenges of emerging infectious diseases. Development and spread of multiply-resistant bacterial pathogens. JAMA 1996 24-31; 275(4):300-4. 2)http://pediatrics.aappublications.org/content/119/4/698.full 3)YK Lee, BY Ong, DFS Yap, H Arsal. Parental Knowledge, Attitudes & Practices (KAP) On Antibiotic Use In Children With Acute Upper Respiratory Tract Infections (URTIs). The 9th Johor Scientific Meeting 2013, September 2013 >> from front page Parents’ perception on paediatric medicines in the community Despite these evidences, many parents still believe that cough preparations are beneficial to their children. A national survey conducted in the United States revealed that 64% of parents still considered these medicines safe or somewhat safe and 20% of parents will continue to use cough medicines in children under 2 years6. Following concerns raised over the safety of cough and cold medicines especially in children below 2 years of age, FDA issued a public health advisory for parents and caregivers recommending that Over the Counter (OTC) cough and cold products should not be used to treat infants and children less than 2 years of age. In Malaysia, the Drug Control Authority also instructed that all products containing any of the active ingredient(s) listed below must include the following statements on the labels and package inserts: a) “ Not to be used in children less than 2 years of age ” b) “ To be used with caution and doctor’s/ pharmacist’s advice in children 2 to 6 years of age ” Category Active Ingredient Antihistamines Brompheniramine, Chlorphenamine, Clemastine, Dexbromopheniramine, Diphenhydramine, Pheniramine, Promethazine, Triprolidine Antitussives Dextromethorphan, Diphenhydramine Decongestants Ephedrine, Phenylephrine, Pseudoephedrine Home remedies to aid with coughs in paediatric patients recommended by AAP: 3 months – 1 year of age: Give warm, clear fluids (eg, warm water, apple juice) 1-3 teaspoons (5-15mL) 4 times a day when coughing. Avoid honey because it can cause infantile botulism. If the child is younger than 3 months, the parents should consult a doctor. 1 year and older: Use honey, ½ -1 teaspoon (2-5mL), as needed. It thins secretions and loosens the cough. (If honey is not available, you can use corn syrup.) Recent research has shown that honey is better than drugstore cough syrups at reducing the frequency and severity of night time coughing. 6 years and older: Use COUGH DROPS to coat the irritated throat. (If cough drops are not available, use hard candy.) Coughing Spasms: Expose the child to warm mist from a shower. If we all take a little extra time and effort to provide information and care to our patients as they required, we can go a long way in educating our patients. It is in the hope that with this newfound awareness, less adverse events will occur and medication safety will be maintained throughout the nation. References 1) Sullivan JE, Farrar HC. Clinical report—fever and antipyretic use in children. Pediatrics. 2011 Feb 28; 127 : 580 - 587. http://pediatrics.aappublications.org/content/127/3/580.full.pdf+html 2) Adam HM. In brief fever: measuring and managing. Pediatrics in Review. 2013 Aug 1; 8:368– 370. http://pedsinreview. aappublications.org.ezproxy.library.uq.edu.au/content/34/8/368.full 3) National Reye's Syndrome Foundation. Reye's syndrome bulletin. 2005. http://www.reyessyndrome.org/images/pdf/ BULLETIN.pdf 4) Kaslovsky R, Sadof M. Chronic cough in Children: A primary care and subspecialty collaborative approach. Pediatrics in Review. 2013 Nov 1; 34:498-509. http://pedsinreview.aappublications.org. ezproxy.library.uq.edu.au/content/34/11/498.full 5) OTC Cough and Cold Products: Not for Infants and Children under 2 Years of Age. U.S Food and Drug Administration. 2008 Jan 17. http://www.fda.gov/forconsumers/ consumerupdates/ucm048682.htm 6)Schaefer MK, Shehab N, Cohen AL, Budnitz DS. Adverse Events From Cough and Cold Medications in Children. Paediatrics. 2008 Apr 1; 4: 783-787. http://pediatrics.aappublications.org/ content/121/4/783.full.pdf 7) Overview - Risk : Benefit of OTC Cough and Cold Medicines in Children. MHRA. http://www.mhra.gov.uk/home/groups/plp/documents/ websiteresources/con041374.pdf 8)Coughs and Colds: Medicines or Home Remedies? . American Academy of Pediatrics. [updated 2013 Nov 5]. http://www.healthychildren.org/English/health-issues/conditions/ear-nosethroat/pages/Coughs-and-Colds-Medicines-or-Home-Remedies.aspx 9)Norton S. Over-the-counter cough and cold medicines for children. United Kingdom: Medicines Page 5 Medication Safety Newsletter Vol 6 Issue 1 June 2014 By Tea Ming Hui Pharmacist, Sultanah Nora Ismail Hospital, Batu Pahat : Beware of Overdose “Oh no, my child has fever.” “I must give him medicines now!!” When the little one has spiking fever, both parents will feel anxious. They give paracetamol but as they watch the clock and also the thermometer in desperation, the temperature of their little one does not seem to subside. “This is the time most parents are tempted to give more and more paracetamol without knowing the risks.” said Dr Zainah Sheikh Hendra, Consultant Paediatrician Hospital Sultanah Nora Ismail Batu Pahat. Background Paracetamol is both an analgesic and an antipyretic agent. It is indicated in children for the management of mild to moderate pain and for the symptoms of fever. The dose for paracetamol in children older than three months should always be based on a child’s body weight: 15mg/kg repeated four to six hourly to a maximum of four doses in 24 hours.1 In Malaysia, paracetamol is available in different forms as syrups, suppositories and tablets with different strengths. Due to its safety profile, paracetamol is easily available not only at pharmacies but any corner shop. “Paracetamol is so widely prescribed with a well established safety record if taken in the recommended doses that we have become over confident. Parents may administer paracetamol routinely at home based on their own dosage calculation. Therefore, it is essential for prescribers to ask the parents whether medication has been given to the child. Otherwise, the child may be at risk of paracetamol overdose,” explained Dr Zainah. Toxicity Because the symptoms of paracetamol intoxication are nonspecific, the diagnosis and treatment are more likely to be delayed in unintentional cases of toxicity2. According to Dr Zainah, overdose of paracetamol is usually presented with pallor, nausea and vomiting, followed by the late presentation of abdominal pain, encephalophathy and jaundice heralding the onset of established liver failure, thus making early diagnosis difficult if an adequate history is not obtained. Be alert! Paracetamol toxicity should be considered in the differential diagnosis when a child previously given paracetamol suddenly develops drowsiness and jaundice apart from infection. Alternative Treatment Some of the non-pharmacological measures suggested by Dr Zainah are removing the child’s clothing, keeping the fan in the room on and sponging the child with tepid water. Another practice by some doctors eager to allay the fears of parents about their children getting fever fits is to prescribe diclofenac suppositories. This too is unnecessary, says Dr. Zainah, explaining that for such patients, an occasional dose of ibuprofen can be prescribed in addition to paracetamol. Key Points Unintentional overdose relatively common. with paracetamol is Paracetamol can cause liver failure and death if taken in excessive doses. Parents should be informed about the correct usage of paracetamol and its risks. Optimally, written, specific information about paracetamol should be given to the parents. Paracetamol should be prescribed based on each individual child’s body weight In households with children under six, only the lower concentration (120mg/5mL) of paracetamol syrup should be supplied. Because early symptoms of paracetamol toxicity are nonspecific, health care providers are advised to include paracetamol toxicity in the initial diagnosis, especially those with unexplained hepatic dysfunction. Detailed information regarding paracetamol therapy should be obtained. Page 6 Medication Safety Newsletter Vol 6 Issue 1 June 2014 PPUKM’s Medication Safety Program Medication safety posters displayed at the lobby have helped to attract the visitor’s attention. A talk on medication safety was also given by Mrs Lau Chee Lan from the Pharmacy Department, PPUKM. By Nur Liyana Saharudin, Pharmacist, PPUKM In support of the Ministry of Health’s efforts to increase the quality and safety of medicines use among the public, PPUKM had organized a Medication Safety Program to educate patients on the importance of proper medication use. As ‘Medication Safety is Everyone’s Responsibility’, it is important for health professionals to involve the patients and caregivers in the medication use process as they do have a role to help reduce the risk of potential adverse drug events. The Medication Safety Program made its inaugural presence during the Pharmacy Counselling Week which was held from 18–20 September 2013. A medication safety booth was set up to enable patients to ask about their medications as well as updates on hospital policies. The booth attracted about 118 visitors with a majority asking on drug use (34%) and side effects of drugs (18%). Refer chart for types of questions asked. In addition, activities such as Return Medication and POD (Patient On Drug), which are part of PPUKM’s Outpatient Pharmacy innovations, were also held. The aim of these activities is to help reduce potential harm of taking expired drugs and double doses while also educating patients on how to dispose drug properly. Collaboration with Medic Alert and National Pharmaceutical Control Bureau helped to educate patients on how to report adverse drug reactions while the Enforcement Unit from JKWPKL helped to raise awareness on counterfeit medicines. TYPES OF QUESTIONS ASKED Medication Safety Events Talk on Medication Error Prevention A talk on Medication Error Prevention was held at Hospital Angkatan Tentera Tuanku Mizan on 12 September 2013 in conjunction with the Malaysian Patient Safety Goals Workshop. Medication Safety Seminar 2013 Medication Safety Seminar 2013 was organized by the Pharmaceutical Services Division, Ministry of Health at Hotel Vistana, Kuala Lumpur on 21 September 2013.