Technician Training Tutorial: OTC Cough and Cold Products (Full update October 2011)

Transcription

1 (Page 1 of 6) Technician Training Tutorial: OTC Cough and Cold Products (Full update October 2011) Billions of dollars are spent each year on products for the treatment of cold symptoms such as coughing, sneezing, runny or stuffy nose, fever, and sore throat. Cough and cold products are generally safe and effective when used according to the directions on the label. However, the potential for problems such as accidental overdose do exist. For example, OTC cough and cold products may be used unintentionally in combination with other similar OTC or Rx products. Adding to the confusion is the fact that most cold products contain more than one ingredient. Furthermore, brand names historically associated with a certain ingredient may now contain different or extra ingredients. For example, some Sudafed (pseudoephedrine) products have been reformulated as Sudafed PE (phenylephrine). Patients may also overestimate the safety of OTC products, administering them in doses or for durations in excess of the label directions. Children s liquid medications can be sources of unintentional overdose caused by measuring errors, or by parents guessing a dose for a young child instead of contacting a health care professional. The ingredients of some cough and cold products have abuse potential (e.g., dextromethorphan) or are used in the home manufacture of substances of abuse (e.g., pseudoephedrine) and may have special record-keeping requirements. In an outpatient or community setting, technicians are often in a better position than pharmacists to see what OTC products patients are purchasing. Technicians should have a basic understanding of cough and cold product ingredients and formulations to enable them to help the pharmacist identify potential problems, and help patients use OTC products safely. Mrs. Menendez brings in the following prescription for her six year old son who has a head cold : The Rx is for B-Vex PD suspension, take one or two teaspoons twice daily, dispense 120 ml. Notice this prescriber used the less common apothecary symbol for ounce to indicate 4 ounces. (Convert ounces to ml using the conversion factor 30 ml=1 ounce: 4 ounces x 30 ml/ounce = 120 ml). Be especially alert for unfamiliar abbreviations on prescriptions for liquid medications since a small error such as accidentally substituting tablespoon for teaspoon can result in significant over- or under-dose. What are the ingredients in B-Vex PD suspension? What do they do? B-Vex PD (U.S. only) contains brompheniramine 6 mg and pseudoephedrine 30 mg per 5 ml (one teaspoon).

2 (Page 2 of 6) Brompheniramine is a first-generation antihistamine. First-generation antihistamines help dry nasal and respiratory secretions due to the common cold. They can also be used to treat allergies. Pseudoephedrine is a decongestant. Decongestants relieve nasal stuffiness by constricting blood vessels in the nose. Many Rx cough, cold, and allergy products were taken off the market in the U.S. in September 2011 because they were never approved by the FDA. B-Vex PD is one of them. The pharmacist will need to intervene to help Mrs. Menendez with product selection. What ingredients are commonly found in OTC cough and cold products? What do they do? First-generation antihistamines: Examples of first-generation antihistamines other than brompheniramine include chlorpheniramine (Chlor-Trimeton, Chlor-Tripolon [Canada]), clemastine (Tavist-1, Tavist [Canada]), and diphenhydramine (Benadryl). First-generation antihistamines often cause drowsiness, and should be avoided in patients with a certain type of glaucoma, and in men who have difficulty urinating because of an enlarged prostate. First-generation antihistamines are usually dosed every four to six hours and cost less than second-generation agents. Second-generation antihistamines: Examples include loratadine (Claritin, Alavert [U.S. only]), cetirizine (Zyrtec, Reactine [Canada]), and fexofenadine (Allegra). These are all available OTC. Desloratadine (Clarinex, Aerius [Canada-OTC]) and levocetirizine (Xyzal [U.S. only]), which are closely related to loratadine and cetirizine, respectively, are second-generation antihistamines available by prescription only in the U.S. Second-generation antihistamines are useful for treating allergies, but don t seem to help cold symptoms. Second-generation antihistamines are usually dosed once or twice daily and cost more than first-generation forms. First- or second-generation antihistamines are often included in multi-symptom cold and allergy products along with decongestants. Decongestants: Three main types of decongestants are available without a prescription: pseudoephedrine (Sudafed, etc note that some states now require a prescription for pseudoephedrine), phenylephrine (Sudafed PE, etc), and nasal spray decongestants (oxymetazoline [Afrin], etc). Pseudoephedrine is available OTC in most states, but with certain restrictions. Pseudoephedrine is an essential ingredient in the illegal manufacture of methamphetamine, a drug of abuse. For this reason, U.S. federal law requires that pseudoephedrine be kept behind the counter or in a locked cabinet. Purchasers must show identification, and the pharmacy must keep a log of names, addresses, and signatures for at least two years. This step is sometimes done electronically, by swiping the purchaser s driver s license. Purchase is limited to 120 tablets of pseudoephedrine 30 mg per day, or 300 tablets per month (i.e., 30 days). Your state may have stricter laws. Technicians are often responsible for dispensing OTC pseudoephedrine. Ask what the procedure is in your pharmacy. In Canada, products that contain pseudoephedrine as a single ingredient are Schedule II, meaning they must be kept behind the counter. However, pseudoephedrine combination products (Advil Cold and Sinus, etc) are either Schedule III (to be sold from the self-selection area of the pharmacy which is operated under the direct supervision of the pharmacist) or unscheduled depending on the province. Because of the restrictions on the sale of pseudoephedrine, many OTC products that used to contain pseudoephedrine have been reformulated to contain phenylephrine. Phenylephrine is not restricted because it is not used to make methamphetamine. However, phenylephrine probably doesn t work as well as pseudoephedrine for relieving congestion.

3 (Page 3 of 6) Clinicians may prefer that their pregnant patients use pseudoephedrine instead of phenylephrine because pseudoephedrine may be safer for the developing baby. Help patients double-check labels to ensure they re getting the product they want. For example, patients associate the brand name Sudafed with pseudoephedrine, but Sudafed PE contains phenylephrine. Explain that regular Sudafed is still available behind the counter. Nasal spray decongestants are extremely effective in reducing nasal congestion by constricting blood vessels only in the nose. Examples include oxymetazoline (Afrin), phenylephrine (Neo-Synephrine [U.S. only]), or xylometazoline (Otrivin). Nasal decongestants should only be used for three days at a time. Prolonged use can actually worsen congestion. This is often referred to as rebound congestion. Alert the pharmacist to patients buying large amounts of these products or using them chronically, since these patients may need advice about how and why to stop using nasal spray decongestants. Patients should talk to their prescriber or pharmacist before taking any decongestant if they have high blood pressure, thyroid disease, heart disease, diabetes, or trouble urinating due to an enlarged prostate. Normal saline nasal spray (Ocean nasal spray, Otrivin Saline [Canada]) is an inexpensive, safe, effective treatment for anyone with nasal congestion. Mrs. Menendez asks if Triaminic Thin Strips Cough and Runny Nose would be a good choice for her son, as an alternative to the B-Vex PD. Triaminic Thin Strips Cough and Runny Nose contain the antihistamine diphenhydramine. This is a first-generation antihistamine, just like the brompheniramine in B-Vex PD. Why do Triaminic Thin Strips for cough contain an antihistamine? In addition to its action in drying up a runny nose, first-generation antihistamines do have some minor effects as antitussives or cough suppressants, although they are not often used for this purpose in OTC products. This Triaminic product is a good example of an OTC brand name extension which has the potential for causing confusion. The brand name Triaminic has long been associated with combination cough/cold ingredients, such as a decongestant combined with a cough medicine. Patients may automatically assume that the Triaminic thin strips have the same ingredients as the liquid form, which is not true. Encourage patients to always read OTC cough/cold medicine labels carefully and consult the pharmacist if they are unsure of the right product to choose, since OTC brand names do not always reflect the assumed or logical ingredients. It may also be helpful to make sure that OTC cough and cold products are arranged on pharmacy shelves according to ingredients and not by brand name. What added safety precautions should patients take when using thin strip drug formulations? The thin strip dosage form is new and unfamiliar to most consumers. Thin strips dissolve on the tongue and are easy to use. Because they are so easy to use, it can be easy to take or administer too much. Alert the pharmacist if patients have questions about these. The pharmacist can tell patients to keep track of how many doses they have taken (or administered to their child) to avoid overdosing. Patients/parents should follow dosing instructions with thin strips carefully, and not exceed the maximum recommended daily dose. Thin strips should be kept at room temperature, out of reach of children. What OTC products are available for cough? Cough suppressants: As mentioned before, first-generation antihistamines like diphenhydramine can help suppress cough caused by minor throat and bronchial irritation that can occur with a cold.

4 (Page 4 of 6) Dextromethorphan is a common cough suppressant available in solid or liquid dosage forms, alone or in combination with other ingredients. It s available in the long-acting formulation Delsym. It is often combined with guaifenesin (Robitussin DM). Dextromethorphan has few side effects when taken as directed. But some teens take many times the recommended dose to produce a high, with effects such as euphoria, altered sense of time, paranoia, and hallucinations. Be alert for suspicious purchases or for theft of dextromethorphan-containing products in your pharmacy. Alert your pharmacist if you are concerned about a purchase. Some pharmacists keep dextromethorphan behind the counter and sell it only to adults. Find out what the policy is in your pharmacy. Mucolytics: Guaifenesin (Mucinex [U.S. only], Robitussin Chest Congestion) is a mucolytic. This means it helps thin mucus in the lungs so it s easier to cough up. Guaifenesin does not suppress cough like dextromethorphan, but instead makes the cough more productive. In many cases, drinking plenty of water and soothing the throat with a cough lozenge may provide just as much relief as an OTC cough preparation. The pharmacist recommends that Mrs. Menendez purchase pseudoephedrine liquid and diphenhydramine liquid in place of the B-Vex PD. He reminds her to avoid giving her son any other products that have diphenhydramine or pseudoephedrine. He also recommends that the child get plenty of liquids and rest. If his cough continues, or gets worse, the pharmacist recommends that Mrs. Menendez call her pediatrician for further evaluation. Later that day, another frequent pharmacy customer, Mrs. Peterson, approaches the pharmacy with a cranky and obviously uncomfortable small child. Mrs. Peterson seems frustrated. She says she is looking for a cold symptom relief product for her three-year-old daughter, and she can t seem to find one. What options are available for younger children who have cough/cold symptoms? Nonprescription infant cough and cold products were taken off the market in Labels on children s products in the U.S. now say not to use OTC cough and cold medicines in children under four years of age. Some labels also caution about use in children under six years of age. Similar products in Canada are labeled to say they should not be used in children under six years of age. The reason for the changes is that the ingredients of cough and cold products may not be safe in children younger than six years old. There have been many reports of accidental overdose with the use of these drugs. A few children have died after using them. Also, there is not good proof that cough/cold medicines work in young children, so any minor benefits from the use of these products may not be worth the possible risks. When should you refer a patient or caregiver to the pharmacist for help with OTC cough and cold medicine selection? Why is this important? Whenever a patient asks for help choosing a cough or cold product, he or she should be referred to the pharmacist. The pharmacist can help the patient determine if his or her condition requires a physician s office visit or can be self-treated. Certain patients are at high risk of complications from lung infections and may need rapid referral. Examples include infants and patients with diabetes, lung disease, or cancer. Some medical conditions can also put patients at high risk of side effects from OTC medications. In addition, the duration or characteristics of symptoms in an otherwise healthy patient may indicate the need for a doctor s visit. For example, a patient who has had a cough or congestion for over a week may

5 (Page 5 of 6) need to be evaluated for antibiotic therapy. The pharmacist will ask the patient questions about his or her symptoms and medical conditions to make sure he or she gets the right product or referral. You refer Mrs. Peterson to the pharmacist for an answer to her question. He explains that giving cough and cold meds to young kids may not be worth the risks and advises her not to use any cough/cold products for her daughter without checking with the child s health care provider first. He suggests a room humidifier for congestion, and a pain reliever like acetaminophen (Tylenol) or ibuprofen (Advil) to make the child more comfortable. He also gives Mrs. Peterson a PL Patient Handout, Cautions with Pediatric Cough and Cold Products to take home. As the pharmacist and Mrs. Peterson continue to discuss her daughter s cold symptoms, the pharmacist reminds Mrs. Peterson that if her health care provider recommends a cough/cold medicine, she should follow the dosing instructions given by the health care provider. He tells Mrs. Peterson to never use the labeled dosing instructions for older children or adults, or guess at a dose, for a younger child. What OTC pain/fever relief products for cough/cold symptoms are available? Pain or fever relief: Acetaminophen (Tylenol) and ibuprofen (Motrin, Advil) are available for children. Adults also have the option of using naproxen (Aleve) for pain associated with cough/cold symptoms. All of these products are effective at relieving pain or fever associated with the common cold. The pharmacist can help a patient choose the correct product for each situation since there are conditions in which one or the other of these pain medications should be avoided in children or adults. Although they are generally considered safe, it is important that patients and caregivers follow the product instructions when taking any OTC medicine for pain or fever relief. Parents need to be especially cautious to avoid using more than one product with the same ingredient. For example, combining children s Motrin Cold (U.S. only) with children s Sudafed would result in patients being exposed to at least twice the recommended dose of pseudoephedrine. What acetaminophen products are available for children and how are they different? Acetaminophen is available as drops for infants, liquid for toddlers, and chewable tablets for older children. The infant drops are about three times as concentrated as the liquid for toddlers. Because of the risk for overdose with the concentrated infant drops, they are being phased out in the U.S. and will be made available in the same concentration as acetaminophen liquid for children. There are also changes, such as a lower maximum dose, being made to labeling for some adult acetaminophen products in the U.S. When a caregiver purchases any children s product, it is appropriate to remind them to follow the instructions on the product carefully, and to use the enclosed measuring device, NOT a household kitchen measuring spoon. Household spoons are not accurate for the purpose of measuring medications. Alert the pharmacist if the purchaser has any questions. Also watch for ingredient duplications if more than one product is purchased, and alert the pharmacist if you notice a problem. For example, many product names do not cause you to suspect they contain acetaminophen (Robitussin Night Time Cough, Cold & Flu, etc) and should not be combined with other acetaminophen products (Tylenol, etc). We have a PL Patient Handout you can use to help patients avoid problems with acetaminophen, Safe Use of Acetaminophen (Tylenol). Mrs. Peterson decides to purchase Vicks VapoRub for her daughter.

6 (Page 6 of 6) How do topical products such as Vicks VapoRub help with cough/cold symptoms? Vicks VapoRub contains menthol, camphor, and other ingredients. It s marketed as a cough suppressant. Many parents are turning to topical rubs such as Vicks VapoRub in light of the recent warnings about cough and cold products in young children. But there s not much proof that such products relieve cough or congestion. Rubs, as well as liquids for addition to steam vaporizers, can be toxic to a child even if a small amount is ingested. It is important for patients to be reminded to keep these products out of the reach of children, and to apply them only as directed, avoiding the nostrils and broken skin. Adults should also be cautioned to use these products only as directed. Poison centers are reporting more calls about unintentional poisonings in adults from misuse. Mrs. Peterson calls the pharmacy the next day and says that she is very worried that her 18 month old son may have gotten into the jar of Vicks VapoRub she purchased in the pharmacy. There is only a little bit missing, but she can smell the cream on his hands and she is not sure how much he was exposed to. What should you tell people who call with concerns about possible overdoses with OTC medications? Recommend that patients, parents, or caregivers who are concerned about overdoses of any medication contact Poison Control, and refer their questions to the pharmacist immediately. Any accidental or suspected ingestion of a prescription or OTC medication in a child should be handled urgently in the pharmacy so that these individuals can be put in touch with the appropriate resources as soon as possible. Technicians can provide a great service to parents by ensuring they have the phone number for Poison Control ( [U.S. only]). For Canadian parents, a listing of regional poison control centres is available at The phone number for their province s poison control centre is also listed on the first page of their local telephone book. Cite this document as follows: PL Technician Training Tutorial, OTC Cough and Cold Products. Pharmacist s Letter/Pharmacy Technician s Letter. March 2009 (full update October 2011).