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OREGON DUR BOARD NEWSLETTER
©
AN EVIDENCE BASED DRUG THERAPY RESOURCE
March 2008
Volume 10, Issue 1
http://pharmacy.oregonstate.edu/drug_policy/newsletter
© Copyright 2008 Oregon State University. All Rights Reserved Cough and Cold Products By Cydreese Aebi, PhD., RPh., OSU College of Pharmacy Reviewed by: Dr. Lyle Fagnan, Family Practice,OHSU and Dr. Ann Thomas, Medical Epidemiologist, DHS Preventative Medicine. OTC cough and cold products should not be used to treat infants and children less than 2 years of age because serious and potentially life­threatening side effects can occur from such use, according to a January 2008 FDA public health advisory (1) . The FDA is still reviewing cough/cold medication use in 2­11 yr olds and will announce those recommendations soon.This advisory comes on the heels of the FDA’s joint meeting of the Nonprescription Drugs Advisory Committee and the Pediatric Advisory Committee issued a Public Health Advisory held last October 2007. (2) From that meeting, the FDA advisory panel voted on several recommendations concerning OTC children’s medications. They based their recommendations on multiple data presented, including but not limited to: Efficacy in Children Most of these cough and cold products were approved and marketed before the mid 1970’s when efficacy and labeling regulations were not as strict. It was assumed in that day, that if these products worked in adults they would also work in children, but approval was granted with very little evidence of efficacy in this age group. Reviewing clinical trials in children between 1950 and 1991 Smith and Feldman determined no study demonstrated effectiveness of OTC cold medications in children under 6 yrs old. (3) Sharfstein, et al. reported “since 1985, the 6 randomized, placebo controlled studies on the use of cough and cold preparations in children under 12 years of age have not shown any meaningful differences between the cough and cold products used in this age group compared to placebo”. (4) Dosing in children No FDA approved dosing recommendations exist for administering OTC cough/cold products in children less than 2 years old. Historically, dosing for pediatric products was done by extrapolating adult doses downward based on the weight of the child, especially for children between 2 and 12 years old. Subsequent pharmacokinetic and pharmacodynamic knowledge leads many scientists to believe this is an inadequate approach for cough/cold preparations in this age group. (2) Marketing to parents/caregivers of children Direct­to­consumer advertising was not allowed when these products were deemed “generally safe and effective”, so direct marketing of these products since the 1990’s has resulted in exponential use and sales. (5) According to the Prescription Project, a policy­advocacy organization, companies spent more than $50 million marketing pediatric OTC cough/cold preparations in 2007. (6) Safety in children The FDA reported that between 1969 and 2006, there were 54 child deaths from decongestants and 69 from antihistamines. (2) In 2006 Center for Disease Control (CDC) and the National Association of Medical Examiners (NAME) found an estimated 1,500 children <2 years were treated in U.S. emergency departments in 2004­2005 for adverse events associated with cough/cold products, including 3 deaths. (7) Poison control centers reported more than 750,000 calls about children who were exposed to cough and cold preparations and experienced overdoses, drug interactions and other unexpected toxicities since 2000. (4) In October, 2007 manufacturers withdrew 14 pediatric products from the market. See product list at the American Academy of Pediatrics website: http://www.aap.org/new/kidcolds.htm .
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V10I1 Parents are asking about alternative therapies to use in young children. Some suggestions include (8) : * Saline nose sprays, drops. These can relieve nasal congestion and dryness. For infants, use saline drops first, then suction gently with a bulb syringe. * Cool mist humidifiers will add moisture to the air to help ease coughing and congestion. Cool mist avoids the use of hot water or steam. Replace water daily to prevent growth of bacteria/mold. * Vaporizers will also add moisture to the air. Some prefer these since you can add menthol inhalants to the steam. Replace water daily to prevent growth of bacteria/mold. * Topical eucalyptus, menthol or camphor (Vicks VaporRub, Mentholatum, etc) produces a local anesthetic sensation and opens nasal passages. Children under 2 yrs should not use camphor products for risk of systemic absorption and liver damage. Suggest Vicks BabyRub (eucalyptus, rosemary and lavender oil) for babies over 3 months. (9) In a recent study of Echinacea in children 2­11 years old there was no difference found between the Echinacea and placebo and the Echinacea group had a higher incidence of rash. (13) Safety and Efficacy in ADULTS: Ingredients used in cough and cold products have been accepted as reasonably safe and effective for symptomatic relief of cough, congestion, rhinorrhea and post nasal drip, but evidence for their efficacy in the literature is inconsistent due to variable rigor of the published studies. The American College of Chest Physicians (ACCP) published evidence based clinical practice guidelines on cough from the common cold in 2006. They recommend with “fair” level of evidence: first generation antihistamine/ decongestant combinations and/or NSAID’s (to block inflammation which stimulates cough­provoking nerves, and to help with fever, and myalgia). Nonsedating antihistamines were not found as effective, antitussives (dextromethorphan, codeine) showed mixed results. (14) The Cochrane Library’s systematic review of decongestant products concluded that topical (intranasal) and oral nasal decongestants, used up to 3 days have been shown to relieve nasal congestion. There is insufficient evidence to recommend mucolytics. (15) Despite some studies showing benefit, there is no solid evidence showing Echinacea effectively treats or prevents the common cold. Data regarding prophylactic use of vitamin C are more varied. Vitamin C prophylaxis may modestly reduce the duration and severity of the common cold in the general population and may reduce the incidence of the illness in persons exposed to physical and environmental stresses. The use of zinc has been shown to inhibit viral growth, but zinc’s role in reducing the duration of cold symptoms has not been substantiated in randomized controlled trials. (16) Effective January 24, 2008, DMAP will require Prior Authorization (PA) on single­source OTC drugs, single­source vitamins and most allergy/cold drugs. DMAP will pay for these drugs as long as the client has a prescription for a covered medical diagnosis. A limited list of allergy/cold drugs will NOT require a PA. These are: Generic Name Nasal Decongestants Pseudoephedrine/tripolidine Pseudoephedrine Expectorants: Guaifenesin Guaifenesin with codeine Guaifenesin with dextromethorphan Antihistamines: Diphenhydramine Chlorpheniramine Hydroxyzine pamoate Loratadine Promethazine Brand Name Actifed, others Sudafed Robitussin, others Robitussin AC, others Robitussin DM, others Benadryl, others Chlor­Trimeton, others Vistaril, others Claritin, others Phenergan, others
Oregon DUR Board Newsletter Produced by OSU COLLEGE of PHARMACY DRUG USE RESEARCH & MANAGEMENT DHS Division of Medical Assistance Programs ­ 500 Summer Street NE, E35, Salem, OR 97301­1079 Managing Editor: Cydreese Aebi [email protected] 503­945­6800 OREGON DUR BOARD NEWSLETTER
March 2008 Page 3
V10I1 Drug Name Confusion ­­ OTC Brand Name Extensions – OTC product ingredient changes Many OTC products have changed formulations in recent years. These brand extension products carry the same logos that are familiar to patients but may contain different ingredients than they expect. Medication errors are occurring Product Brand Name Active ingredient (17) Chloraseptic lozenges Benzocaine and menthol Dramamine Dimenhydrinate Robitussin Guaifenesin and it is important to look at the package ingredient label when purchasing these products. Listed below is a sample of the many brand name products which contain different core ingredients depending on the marketed brand name: Brand name extension products Chloraseptic Daily Defense Health Strips Dramamine Less Drowsy Formula *Robitussin Cough Long­Acting syrup Active ingredient (17) *Robitussin Cough and Allergy Relief syrup Chlorpheniramine, Dextromethorphan, Phenylephrine Menthol Chlorpheniramine and phenylephrine Loratadine Sudafed PE Phenylephrine *Robitussin cough drops Sudafed PE Sinus and Allergy Tavist Clemastine Tavist ND Allergy Vitamin C and Zinc Meclizine Dextromethorphan References: 1. FDA News. Press release dated January 17, 2008. www.fda.gov/bbs/topics/NEWS/2008/NEW01778.html 2. FDA. Nonprescription drug advisory committee meeting­ cold, cough, allergy, bronchodilator, anti­asthmatic drug products for over­the­counter human use. Oct 18­19,2007. www.fda.gov/ohrms/dockets/ac/07/briefing/2007­4323b1­00­index.htm. (Accessed 1/17/08) 3. Smith MB, Feldman W. Over­the­counter cold medications: a critical review of clinical trials between 1950 and 1991. JAMA. 1993;269:2258­63. 4 .Sharfstein, JM, et al. “Over the Counter but No Longer under the Radar­ Pediatric Cough and Cold Medications”. New England Journal of Medicine. Volume 357:2321­2324. Number 23. December 6, 2007 5. Palumbo, F, et al. ‘The Development of Direct to Consumer Prescription Drug Advertising Regulation. Food and Drug Law Journal Vol 57, No. 3, 2002 pg 423­444. 6. The Prescription Project. www.prescriptionproject.org/newscenter. (Accesssed 1/10/2008.) 7. CDC. Infant deaths associated with cough and cold medications­ two states, 2005 MMWR. January 2007 56(01);1­4. www.cdc.gov/MMWR accessed 1/10/2008. 8. Pharmacist’s Letter. Vol 24, No. 1, January 2008. 9. Foxhall, K. “Cough and cold recommendations may impact other products.” Drug Topics, Nov 19, 2007. www.drugtopics.com. Accessed 1/10/2008. 10. Hopkins AB. Chicken soup cure may not be a myth. [Review] [8 refs] [Journal Article. Review] Nurse Practitioner. 28(6):16, 2003 Jun. 11. Mayo clinic. http://www.mayoclinic.com. (Accessed 1/15/2008.) 12. Paul, Ian, et al. Effect of Honey, Dextromethorphan, and No Treatment on Nocturnal Cough and Sleep Quality for Coughing Children and Their Parents. Arch Pediatr AdolescMed. 2007;161(12):1140­1146. 13. Taylor et al. Efficacy and Safety of Echinacea in Treating Upper Respiratory Tract Infections in Children: A Randomized Controlled Trial.. JAMA 2003;290:2824­2830. 14. Pratter MR. Cough and the common cold: ACCP evidence­based clinical practice guidelines.Chest. 129(1 Suppl):72S­74S, Jan 2006. 15. Taverner D, et al. Nasal decongestants for the common cold. Cochrane Database Syst Rev 2004;(3):CD001953 16. Simasek, M, et al. Treatment of the Common Cold. Am Fam Physician 2007;75:515­520. 17. OTC product information. DrugStore.com www.drugstore.com. (Accessed 1/23/08).
Oregon DUR Board Newsletter Produced by OSU COLLEGE of PHARMACY DRUG USE RESEARCH & MANAGEMENT DHS Division of Medical Assistance Programs ­ 500 Summer Street NE, E35, Salem, OR 97301­1079 Managing Editor: Cydreese Aebi [email protected] 503­945­6800