Ms. Weaver is a pharmacy student and Dr. Howell is an assistant professor of pharmacy practice at Lake Erie College of Osteopathic Medicine School of Pharmacy, Erie, Pennsylvania.

More than 80% of women use medications during pregnancy, most of which  are sold OTC.

 Medical and pharmacyrecords often lack documentation of nonprescription medication use, which makes it more difficult to detect an association between OTC medications and specific birth defects.

Because the teratogenic effects of most medications are unknown, many health care professionals refrain from prescribing or recommending medications for pregnant women.

 This practice could be dangerous and lead to inappropriate use of self-administered OTC medications.

The objective of this review is to provide pharmacists with the most current information on the effects of OTC medications on pregnant women and the fetus, in order to be able to advise pregnant patients on how to safely alleviate specific symptoms. Table 1 highlights treatment for specific symptoms in pregnant women.

The OTC medication most commonly used by pregnant women is acetaminophen.

 Studies have not shown an increase in birth defects associated with occasional use of acetaminophen at any time during pregnancy; however, it is important to caution all patients about using the appropriate dose only when needed, because of hepatotoxicity and, rarely, nephrotoxicity associated with overuse in the general public.

Most nonsteroidal anti-inflammatory drugs (NSAIDs), including aspirin, ibuprofen, and naproxen, are not recommended unless pain is intolerable and cannot be relieved with acetaminophen.

 NSAIDs can potentially cause premature closure of the fetal ductus arteriosus and should be avoided in the third trimester.

Cold relief products often contain several different types of medications and do not actually shorten the length of the cold; therefore, it is recommended that they are used only for serious discomfort.

 Nonpharmacologic remedies that can relieve symptoms include increasing fluid intake, using a humidifier, resting for an adequate time, and elevating the head while sleeping.

If the patient is still severely congested, pseudoephedrine is the oral decongestant drug of choice or pregnant women.

 Short-acting formulations and low doses should be recommended.

Oxymetazoline, a nasal decongestant spray, also may be recommended for up to 3 days for symptomatic congestion. It should not be used beyond the recommended period because of rebound congestion, which could lead to overuse of the medication and previously unseen teratogenic effects.

For cough and sore throat, pregnant patients may be advised to gargle with saltwater and use nonmenthol cough drops.

 If these methods do not provide adequate relief of symptoms, guaifenesin, an expectorant, and dextromethorphan, a cough suppressant, are recommended alone or in combination in the case of severe maternal discomfort.

The antihistamines chlorpheniramine and diphenhydramine are most often used for allergies in pregnant patients.

Loratadine is a newer nonsedating antihistamine that has recently switched to OTC.

 Based on evidence regarding its use as a prescription medication, it is classified as pregnancy risk category B (Table 2).

 It is recommended that it be used only when allergy symptoms cannot be relieved by first- and second-line alternatives.

Nonpharmacologic remedies are of particular importance when considering afflictions of the gastrointestinal tract. Lifestyle and dietary changes are often effective without medications. Pregnant women suffering from gastroesophagealreflux disease should eat small, frequent meals; avoid caffeine and spicy foods; avoid any food before bedtime; and elevate the head while sleeping.

 These alternatives may provide sufficient relief alone.

If medication is necessary for the relief of symptoms, aluminum, calcium, and magnesium preparations are generally recommended.

 Sodium bicarbonate is not recommended as an antacid because of sodium?s potential to cause fluid and electrolyte imbalances in both the mother and the fetus.

Antiflatulents, Laxatives, and Antidiarrheals

Constipation is common during pregnancy and may be corrected without medication through increased intake of dietary fiber and fluids and physical exercise.

 Some health care professionals believe medications for constipation and diarrhea are often futile, and, in some cases, may actually aggravate the condition.

Like NSAIDs, bismuth subsalicylate may cause premature closure of the fetal ductus arteriosus and may lead to subsequent persistent pulmonary hypertension of the newborn.

The results of several studies suggest that the antihistamines meclizine and dimenhydrinate can be used by pregnant women for the prevention or treatment of nausea or motion sickness with minimal risk to the fetus.

The imidazole agents, including clotrimazole, butoconazole, miconazole, and tioconazole, are the most commonly used OTC antifungal treatments.

 Both topical and vaginal formulations have low systemic absorption and are considered safe for use by pregnant women.

 Trials have not shown an association between birth defects and the use of these medications at any time during pregnancy.

Like the opical antifungal treatments, most other topical medications are poorly absorbed through the skin and pose little danger to the fetus. Examples of topical drugs that are considered safe for use by pregnant women include: benzoyl peroxide for acne, zinc pyrithione for dandruff, hydrocortisone for inflammation, and bacitracin and benzocaine often used in combination as an antiseptic and anesthetic.

Patient education and the development of an individualized plan are the preferred methods for smoking cessation in pregnant women. When this approach is not successful, nicotine replacement therapy should be considered as an alternative to continued smoking. Despite the risk of nicotine-induced fetal abnormalities, cigarette smoke contains >3000 chemicals, many of which are more harmful to the fetus than nicotine alone.

When recommending nicotine replacement therapy to pregnant women, immediate-release products, such as gum, spray, or inhalers, are preferred to patches, which are continuous-release. The amount of nicotine should be limited to what is absolutely necessary to stop smoking.

When recommending OTC products, pharmacists should always take certain factors into consideration, including stage of pregnancy and embryologic development, safety of the ingredients, route of administration, dose, and any other medicationsthat the patient may be taking. Products with the fewest number of safe ingredients should be chosen and administered in the lowest dose possible. It also is important to educate the patient to follow directions carefully and to use the product for the shortest duration necessary.

If possible, nonpharmacologic therapy should be the first recommendation made by a pharmacist. If symptoms can be adequately relieved, then the risk associated with medication use may be avoided.

Black RA, Hill DA. Over-the-counter medications in pregnancy. 

Conover EA. Over-the-counter products: nonprescription medications, nutraceuticals, and herbal agents. 

Werler MM, Mitchell AA, Hernandez-Diaz S, Honein MA. Use of over-the-counter medications during pregnancy. 

DiPiro JT, Posey LM, Talbert RL, Yee GC, Matzke GR, Wells BG. 

Pharmacotherapy: A Pathophysiologic Approach

. 6th ed. New York, NY: Mcgraw-Hill; 2005.

Alano MA, Ngougmna E, Ostrea EM, Konduri GG. Analysis of nonsteroidal antiinflammatory drugs in meconium and its relation to persistent pulmonary hypertension of the newborn. 

Rodriguez L, Greenfield M. Coughs and Colds in Pregnancy. Dr. Spock Web site. 2004 [cited 2007 August]. 

www.drspock.com/article/0,1510,5985,00.html

Lexi-comp Database. Lexi-Comp. Online: 2007 August.

Health Pregnancy Guide. Information for Patients: Medications and Pregnancy. Pittsburgh, PA: University of Pittsburgh Medical Center; 2003.

Articles

OTC Guide

Safety of OTC Medications in Pregnant Women

Ms. Terrie is a clinical pharmacy writer based in Haymarket, Virginia.

Statistics reveal that an estimated 95 million packages of cough and cold medications are purchased each year for use in children,

 and with the FDA advisory issued earlier this year on the use of these products in the pediatric population, many parents and caregivers will be seeking advice from their pharmacist.

Last fall the FDA assembled a joint meeting of the Pediatric Committee and the Nonprescription  Drug Advisory Committee, and this advisory panel issued recommendations on the use of cough and cold preparations in children under 6 years of age. The panel's recommendations were based on results from multiple studies that reported  a lack of effectiveness regarding pediatric cold medications and risks of potential adverse effects, especially in children younger than 2 years of age.

 Serious adverse effects have been associated with accidental overdose, unintentional misuse, and drug?drug interactions in children given standard doses.

 The panel reviewed the following categories of drugs:

FDA Advice on the Use of Cough and Cold Products (Aged 2 to 11 years)

Pending completion of the FDA?s ongoing review, parents and caregivers who choose to administer OTC cough and cold medicines to children aged 2 to 11 years should:

Follow the dosing directions on the label of any OTC medication

Understand that these drugs will not cure or shorten the duration of the common cold 

Check the Drug Facts label to learn what active ingredients are in the products because many OTC cough and cold products contain multiple active ingredients

Only use measuring spoons or cups that come with the medicine or those made specially for measuring drugs 

The FDA recommends that anyone with questions contact a physician, pharmacist, or other health care professional to discuss how to treat a child with a cough or cold

Although many medical experts may agree that the risks from pediatric cough and cold medications may be low, some experts still feel the recommendations are needed.

 On January 17, 2008, the FDA issued a public health advisory recommending that OTC cough and cold products not be used in children under 2 years of age because serious adverse effects can occur.

 The FDA also is working to complete a review on the safety of OTC cough and cold medications in children aged 2 to 11 years and plans to issue a recommendation on the use of these products in this age group once that review is completed.

 The box at right lists the FDA's current advice for children aged 2 to 11 years.

Prior to the FDA panel's recommendations, the Consumer Healthcare Products Association (CHPA) issued a press release in October stating that a number of major manufacturers voluntarily agreed to discontinue the marketing of cough and cold products for children under 2 years of age.

 The CHPA Education Foundation has a Web site (

) for parents seeking information on the use of these medicines in children.

In addition, to assist parents and caregivers in managing colds in children, the American Academy of Pediatrics recommends the following

 Administer acetaminophen or ibuprofen (not aspirin) if fever is present

Use a cool mist humidifier to relieve nasal passages

Administer saline nose drops to thin mucus

Use a suction bulb in babies to clear mucus

Given these new guidelines for the use of cough and cold products in children, pharmacists should seize every opportunity to ensure that parents and caregivers are counseled effectively about the appropriate use of these medications.

Sharfstein, JM, North, M, and Serwint, JR. Over the counter but no longer under the radar-pediatric cough and cold medications. 

Nonprescription Drug Advisory Committee Meeting. FDA Web site.  

Kid's Cold Medicines: New Guidelines. WebMD Web site. 

www.webmd.com/a-to-z-guides/kids-cold-medicines-new-guidelines

FDA Releases Recommendations Regarding Use of Over-the-Counter Cough and Cold Products [press release]. FDA Web site. 

www.fda.gov/bbs/topics/NEWS/2008/NEW01778.html

Makers of OTC Cough and Cold Medicines Announce Voluntary Withdrawal of Oral Infant Medicines [press release]. Consumer Healthcare Products Web site. 

www.chpa-info.org/~2007/10_11_07_CCMedicines.htm

Childhood Infections. American Pediatric Association Web site. 

In 2007, 36,230 acetaminophen overdoses occurred in the United States; of those, 41 individuals died from ingesting too much acetaminophen. Oklahoma, in particular, has seen acetaminophen overdoses?alone or in combination with other drugs?increase to 2078 cases in 2007, compared with 1607 cases in 2003. Lee McGoodwin, managing director of the Oklahoma Poison Center, said that 585 cases have been reported so far this year. Shannon Holcombe, education coordinator for the poison control center, said, "Read the active ingredients. Be careful of multiple medicines with the same ingredients, especially acetaminophen.Follow the directions."

Americans with cholesterol problems would be more likely to consider taking an OTC statin according to a survey of 710 Americans released by the National Consumers League. Overall, the majority of those surveyed (82%) reported that an OTC statin would be preferable to an Rx product. The respondents said that the OTC is more appealing mainly because of convenience factors. They viewed OTC statins as safer, more natural, more suitable for an individual who takes charge of his or her health, and less likely to cause side effects than Rx statins.

The American Dietetic Association recently joined 3 other groups in filing a joint citizen?s petition to the FDA regarding weight-loss claims made by the marketers of dietary supplement?containing aids. The groups want the agency to make changes in the regulation of weight-loss supplements so the manufacturers would be mandated, on the basis of valid scientific evidence, to have prior FDA approval of weight-loss claims. Normally, regulating weight-loss claims made in advertising has fallen under the Federal Trade Commission (FTC). The citizen?s petition argues that if the FDA ruled in favor that weight-loss claims are a disease state claim, the FTC would no longer have regulating authority.

Half of the individuals with back pain take Advil (ibuprofen) and Aleve (naproxen) for relief, according to a poll of 899 individuals conducted by 

. The respondents were asked which OTC pain reliever they prefer for back pain or neck pain. The poll showed that ibuprofen in general (Advil, Motrin, and Nuprin combined) accounted for 39% of the responses; 26% of the respondents said Advil is the first choice for pain relief, while 24% chose Aleve; and Tylenol (acetaminophen) was chosen by 11%.

A National Council on Patient Information and Education (NCPIE) survey showed that most adults self-medicate with OTC medicines for themselves and their children without consulting a pharmacist or other health care provider, which may put them at risk. The survey found that 76% of respondents recognizedthat self-medicating with OTC medications can pose possible risks, and more than 4 in 5 adults typically self-medicate for various health conditions that they have experienced in the past year that may be treated or relieved by OTC medications, the most common of which are colds (56%), coughs (37%), and seasonalallergies (29%).

What's New in Cough and Cold Medications for Kids?

 has been tabulating pharmacists' recommendations and publishing its Survey of Pharmacists Recommendations for 12 years. 

 began collecting data in 1997 regarding which OTC brands pharmacists recommended most frequently and how many recommendations pharmacists made per month?invaluable data for the OTC marketplace.

Why are these data so valuable? Pharmacists make more than 80 million recommendations to their patients every month, and more often than not, patients will follow these recommendations. In the Cough and Cold category alone, including adult and pediatric formulations, pharmacists make more than 15 million recommendations every month. As the most accessible health care provider, pharmacists play a key role in patients' health and have the opportunity to recommend OTC products to their patients on a daily basis.

Initially, we surveyed pharmacists' recommendations in a total of 85 therapeutic categories; we are proud to announce that the Survey of Pharmacists Recommendations has greatly expanded over the past 12 years and, this year, we surveyed a total of 142 categories. The survey has expanded from the traditional OTC categories, such as Cough andCold and Analgesics, to include new subcategories, new products, and products that have switched from Rx to OTC status. As the OTC market has grown, 

 has responded accordingly by adding new therapeutic areas to the survey. The past decade saw several "blockbuster" drugs switch from prescription to OTC status?some examplesinclude Zyrtec, Pepcid, Prilosec, and Claritin, which are all now available, in some form, over the counter. As new categories develop and the OTC marketplace continues to evolve, 

 will concurrently expand its Survey of Pharmacist Recommendations.

Thank you to the many pharmacists who contributed their input to the successful outcome of this survey.

Pharmacy Times OTC Recommendations Survey: 12 Years Strong

Every month, pharmacists make millions of recommendations from among the 1000+ OTC brands. The 2008 

 OTC Recommendations Survey asked thousands of pharmacists to declare their preferred recommendations on brands in 142 OTC categories. In the tables that follow, products are organized by category with the percentage of pharmacists' recommendations that they received. The tables also show the total number of recommendations the retail pharmacy profession makes each month.

 is an elite club made up of those products from the OTC Recommendation Survey that earned at least 50% of pharmacists' recommendations. The OTC Master's Circle features 43 products this year.

 matters. Our readers thoughtfully consider the recommendations of their peers?"Is that what I recommend?" "Should that be what I recommend?" And with billion-dollar blockbuster prescription drugs switching to OTC status, pharmacists will be called on to guide patient choices like never before.

Product manufacturers are also very interested to see what products are at the top of their respective categories. Winners in the 

?those products that received the highest percentage of pharmacist recommendations in their category?qualify to use the 

 Achievement Award logo. And Master's Circle winners?those that received 50% or more of all pharmacist recommendations in the category?qualify to use the 

OTC Master's Circle Achievement Award logo

. Winning brand managers are proud of this achievement, and these logos are frequently included in product advertising throughout the year.

 is pleased to present this year's OTC recommendations.

Pharmacy Times OTC Recommendations Survey: Why It Matters

Mr. Lamb is a freelance pharmacy writer living in Virginia Beach and president of Thorough Cursor Inc.

It is always enlightening to pick up this annual supplement and learn which OTCs are most often recommended to patients by pharmacists. This article goes a little deeper to provide some insight into why certain products are recommended.

The short answer is that pharmacists base their recommendations on a patient's symptoms, current medications, past experiences, and economic situation. This is  unsurprising, but also very beneficial for patients.

Information about OTC medications abounds. A recent breakdown of ways patients can learn about products included packaging, friends or family, store signage, manufacturers' Web sites, instore kiosks, online search engines, product review sites, and social networking sites.

As empowering as this can be, individuals are still very likely to turn to pharmacists when deciding which OTC product is best for them or their child.

 In 2006, a survey revealed that 83% of US adults commonly ask pharmacists about medications. An earlier survey found that 60% of consumers want pharmacists to advise themabout OTCs.

Asmaa Bazzi, PharmD, who manages a CVS/pharmacy in Fort Myers, Florida, estimates that between 10 and 15 patients approach her each day for help with selecting OTCs. "A lot of the people come in because their family or friends told them that I could help," Dr. Bazzi said. "Because I was able to answer all the questions for one person,they tell others that I can help them feel better."

Across the country, Tanya Scalise-Manoni, PharmD, a staff pharmacist at Target in American Fork, Utah, also consults with 10 to 20 patients each day regarding OTCs. A majority of Dr. Scalise-Manoni's patients are young parents, and she said, "All the time, I will have mothers come up to me and say, 'I can't find the yellow Triaminic [guaifenesin and phenylephrine]. My pediatrician told me I need to get the yellow Triaminic.'"

According to Dr. Scalise-Manoni, "These kinds of openings are great, because they let me dig deeper into what the medication they are looking for is going to be used for. Maybe the yellow Triaminic is not what the kid needs if she already has a runny nose."

Both Drs. Bazzi and Scalise-Manoni said that the first thing they try to determine before recommending any OTC medication is what symptoms are going to be treated. They also ask about other medications the patient is currently taking and, when the patient is a regular, check their pharmacy records for possible interactions and allergies.

The pharmacists also consider cost. Dr. Scalise-Manoni said, "I always take cost effectiveness into account. When there is no difference between the store brand and the name brand, I will ask patients to consider the store brand." She added, however, that when she hears back from patients that a generic does not work as well as its brandedequivalent, she recommends the brand. "Cost is a concern, but what really counts is that a medication makes patients feel better," she said.

Dr. Bazzi takes a slightly different approach to cost considerations. When multiple options exist, such as with combination cough and cold treatments, she will go over the benefits and possible risks of the different combinations and then mention what the products cost. "I always try to follow up with patients who buy OTCs, though, to make sure that whatever they chose worked for them."

Consumer Trend Watch 2008: Shifting Consumer Expectations Are Changing the Game. Information Resources Inc. Available at: 

us.infores.com/~TT_February_2008_Trends_to_Watch.pdf

2006 Pharmacy Satisfaction Digest. Boehringer Ingelheim Pharmaceuticals Inc. Available at: 

www.pharmacysatisfaction.com/~PharmacistServices.pdf

Troy M. Pharmacists have become OTC allies. 

findarticles.com/p/articles/mi_m3374/is_n9_v17/ai_17158292

Patients' Needs Guide OTC Recommendations

With the array of OTC products available, the selection of an appropriate product may be overwhelming and confusing for many patients and caregivers. This is especially true when choosing medications for children, because of differences in physiology and pharmacokinetics, lack of clinical data, insufficient drug labeling, and problems related to drug dosing and administration.

Pharmacists should encourage parents and caregivers to seek advice from their primary health care provider prior to using OTC products, especially in children under 2 years of age.

 Before recommending any products, pharmacists should assess the patient?s physical and medication history?as well as any allergies?to screen for possiblecontraindications.

Pharmacists should stress the importance of using products formulated especially for children and provide information about the OTC medications that are available in various therapeutic categories and formulated in different flavors and in several dosage forms, such as chewable tablets, liquids and suspensions, disintegrating and dissolvable tablets, and thin strips. Children vary in weight and size; thus, their caregivers always should read labels for dosing guidelines based upon age and weight before administering any medicine

 and, if in doubt, consult their pediatrician or pharmacist to prevent dosing errors.

When recommending any OTC products, pharmacists should ensure that parents and caregivers are counseled effectively on the appropriate use of the selected agent, including dosage, dosage intervals, route of administration, and recommended duration of use. If a liquid dosage form is recommended, pharmacists always should stress the importance of using a calibrated measuring tool to ensure accurate dosing. The American Academy of Pediatrics Committee on Drugs recommends the use of calibrated measuring devices for dosing accuracy and easy administration.

Pharmacists can be instrumental in identifying therapeutic duplications when multiple medications or combination medications are used. They should remind parents and caregivers always to read the medication labels to confirm dosage, especially because many infant formulations of analgesics are in concentrated form, and to check for active ingredients in order to avoid therapeutic duplications.

Isetts, B, Brown, L. Patient Assessment and Consultation. In: Berardi R, Kroon L, Newton G, et al, eds. 

. 15th Edition. Washington, DC: American Pharmacists Association; 2006:26-29.

Precautions with Over the Counter Drugs. Merck Manual Web site. 

www.merck.com/mmhe/sec02/ch018/ch018b.html

Patient Counseling Tips for OTC Drug Use in the Pediatric Population

Always read labels prior to administration, and check expiration date prior to use

Always adhere to dosing and administration guidelines. Never exceed recommended dose.

Always use calibrated measuring devices for liquid medications

Always consult your pediatrician or pharmacist if unsure about the use of any medication

Always keep medication out of the reach of children

Always contact a primary health care provider if the child experiences any adverse effects, the condition worsens, or shows no sign of improvement

When in doubt, ALWAYS ask your pediatrician or pharmacist

The markets for Rx-to-OTC switches could hit $5 billion in 2008 and increase by nearly 40% by 2010, according to the report, 

The Return of the Rx to OTC Switch: Market Analysis and Product Management Strategies

The report suggested that more than half of the 2008 revenues will be from allergy medications that already made the switch, such as Claritin (loratadine), Mucinex, and Zyrtec (cetirizine HCl).

The Centers for Disease Control and Prevention reported that approximately 7000 US children under the age of 11 years are treated each year in hospital emergency rooms (ERs) due to problems with cough and cold medications. The study, reported in Pediatrics (April 2008), found that children aged 2 to 5 years made up 64% of all ER visits for adverse reactions to cough and cold medications. Of these children, 80% of the problems stemmed from unsupervised ingestions.

McNeil Consumer Healthcare recently launched "Answers in the Aisles: Increasing Understanding about OTC Medications"?a Web-based portal that provides content specific to OTC medicine use from advocates including the American Pharmacists Association and the National Council on Patient Information and Education. The site (

) offers tips on choosing and administering OTC products to both adults and children, and topics include reading and understanding product labels and the importance of proper dosing.

A national survey of 500 parents with children aged 2 to 12 years old gauged how parents feel about the safety and effectiveness of cough and cold medicines and their continued availability. Among the findings: 83% of parents reported in the past 12 months they had given their child an oral OTC cough or cold medicine to relieve symptoms; 66% of parents disagreed with the FDA removing these medicines for children aged 2 to 6, while 78% disagreed with the FDA removing these medicines for children aged 2 to 11 years; and 78% agreed that medicines for children aged 2 to 12 years should remain on the store shelves but with stronger labeling about appropriate use.

June 2008

Safety of OTC Medications in Pregnant Women

What's New in Cough and Cold Medications for Kids?

Pharmacy Times OTC Recommendations Survey: 12 Years Strong

Pharmacy Times OTC Recommendations Survey: Why It Matters

Patients' Needs Guide OTC Recommendations

Choosing Wisely: Making the Right OTC Selections for Children