Over-the-counter Products Research Articles

Use of Proprietary Names by Prescribers When Prescribing Over-the-Counter (OTC) Drug Products.

To identify if proprietary names are used by health care practitioners when prescribing over-the-counter (OTC) drug products. These findings can inform evaluation of proposed proprietary names for both prescription and OTC drug products. QuintilesIMS OTC International Market Tracking (QuintilesIMS OTCIMS) was used to identify top OTC drug products sold to the consumers from US retail store outlets in year 2011. QuintilesIMS's Vector One: National (VONA) was used to identify prescribers' use of proprietary names by examining drug use data from 2003 to 2011 for the top OTC products identified from QuintilesIMS OTCIMS. Of the 29 OTC drug products that have drug utilization data available, the data showed prescribers' use of proprietary names every year from 2003 to 2011 for 24 OTC drug products, and from 2004 to 2011 for 2 OTC drug products. The drug use data showed the use of proprietary name in some years but not all years from 2003 to 2011 for the remaining 3 OTC drug products. For the OTC drug products studied, prescribers used proprietary names for OTC products when prescribing them, and the use of proprietary names on prescriptions can vary during a 9-year period. This research identified that prescribers do prescribe OTC drug products using proprietary names. This prescribing practice confirms the need for the pharmaceutical industry, industry consultants, and regulators to consider the proprietary names of OTC drug products when formulating and evaluating new proprietary names for drugs.

Prescription and Usage Pattern of Topical Corticosteroids among Out-patient Attendees with Dermatophyte Infections and Its Analysis: A Cross-sectional, Survey-based Study.

Background:There is scarce scientific data on topical corticosteroids (TCS) prescription by non-dermatologists including registered medical practitioners, ayurvedic, homeopathic practitioners, and over-the-counter (OTC) use of TCS-containing creams.Objective:The main objective of this study is to analyze the prescription and usage pattern of topical steroids among out-patient attendees with dermatophyte infection. To study health-seeking behavior of patients with dermatophyte infections.Material and Methods:An open, cross-sectional, duration-based study of 3 months. Inclusion criteria: Patients with dermatophytosis having a history of topical steroid application; either prescribed or purchased OTC and used themselves. Exclusion criteria: Patients who were not willing to give informed consent. Patient's data like socio-demographic profile, duration, frequency, site of application, contents of the topical cream used, prescriber information, and patients’ desire to continue the use of topical steroids were recorded.Results:Total of 18.40% (n = 503) patients were already using cream-containing TCS at the time of presentation to the tertiary dermatology care center. The study shows that almost half of the patients (48.90%) were using unprescribed TCS. Registered medical practitioners were the most common source of TCS creams prescription (59.92%) in the prescribed group, while 26.07% patients were prescribed TCS by dermatologists. Clobetasol propionate (47.91%), was most common steroid agent used.Conclusion:Patients are able to get “prescription-only” drugs as OTC products. Such OTC use of TCS puts patients at risk of steroid modified dermatophytosis and topical steroid damaged skin. Even dermatologists may be culprit in creating menace of steroid abuse.

Mucoactive Agents in the Therapy of Upper Respiratory Airways Infections: Fair to Describe Them Just as Mucoactive?

Background:Upper and lower respiratory tract infections are common conditions for which medical advice is sought, and their management relies on the use of prescription and over-the-counter (OTC) medicines. Ambroxol, bromhexine, carbocysteine, erdosteine, N-acetyl cysteine (NAC), and sobrerol are mucoactive agents for which clinical trials have been conducted, have been awarded well-established status by regulatory authorities, and are available as OTC or prescription products.Objective:To briefly review the evidence-based efficacy and safety of these substances in the therapy of upper respiratory airways infections.Methods:We conducted searches in MEDLINE and other databases for clinical trials and reviews done on the efficacy and safety of ambroxol, bromhexine, carbocysteine, erdosteine, NAC, and sobrerol.Results:Clinical trials have shown that these mucolytics have an important place in the relief of cough symptoms by easing the elimination of mucus. All drugs have shown comparable efficacy in the symptomatic treatment of productive cough, with some shared characteristics and some specific features.Conclusions and relevance:All mucolytics reviewed have a good safety profile, although some precautions should be taken when using ambroxol and bromhexine, and the use of NAC and carbocysteine should be monitored in special patient groups. Overall, however, the available evidence from randomised, controlled, and observational trials, as well as pragmatic, real-life experience, suggests that these products are useful in the therapy of upper respiratory airways infections, including bronchitis, sinusitis, and rhinosinusitis.

Use of over the counter products in older cardiovascular patients admitted to a tertiary care center in USA

BackgroundIn recent years there has been a substantial increase in the use of over-the-counter (OTC) products around the world. While they are assumed to be safe by consumers, they can potentially lead to adverse effects and drug interactions particularly in older adults.MethodsWe assessed the patterns of OTC products used by older adults admitted to the cardiology service in a tertiary care medical center in the USA over a three month period. We conducted a retrospective chart review where older adults with cardiovascular diseases (CVD) who were taking at least one OTC product at home were included.ResultsOut of 404 patients who were admitted to the cardiology service, 281 (69.6%) were taking OTC products. Patients were taking a total of 659 OTC products; mean of 2.35 ± 1.57 and the range varied from 1 to 9 products. The most commonly used products were vitamins (37.3%), followed by laxatives (17%), minerals (13.6%), stomach acid reducers (9%), and analgesics (3.6%). OTC users were found to be suffering from more comorbidities and received more prescription medications as compared to non-users. Gender and age did not have an impact on the use of OTC products while patients with atrial fibrillation, sleep apnea and gastro-esophageal reflux disease were more likely to use OTC products.ConclusionUse of OTC products is quite frequent in older adults with CVD in our study. Clinicians should ask about OTC product usage and counsel patients about the risks and benefits associated with their use.

Substances Involved in Suicidal Poisonings in the United States.

This study investigated specific substances most commonly involved in suicidal poisonings, causing severe clinical effects, and leading to intensive treatments. Suicidal poisoning cases for individuals ≥13years old were obtained from the National Poison Data System for 2011-2015. The most common products involved in single and multiple-product poisonings were identified. Single product cases were used to calculate substances causing the largest numbers of serious clinical effects and leading to intensive treatments. More than half of reported cases involved only a single product (54.4%), but this frequency was higher at the extremes of age (66.7% in adolescents 13-19years old and 70.5% in individuals ≥90years old) and among pregnant women (65.8%). The top three substances involved in single-product poisonings were over-the-counter (OTC) medications, while alcohol and prescription sedatives were most common in multiple-product poisonings. One OTC medication, diphenhydramine, was a frequent cause of several serious clinical effects and intensive treatments. Single product suicidal poisonings were more frequent with extremes of age and in pregnancy. OTC products were more frequently used in single product attempts. Products causing serious clinical effects can be targeted for suicide prevention efforts as well as education of health care providers.

OPTIMIZING OTC MEDICATION USE: PACKAGING, HUMAN FACTORS, PHARMACY REDESIGN

Older adults are at high risk of significant harm associated with over-the-counter (OTC) medication use. Of the estimated 2.2 million older adults who are at risk of a major adverse drug event, more than 50% of these interactions involve an OTC medication. Given the complexity and limited understanding of how older adults select and use OTC medications, different approaches are necessary to support safe OTC medication selection and use. This symposium will provide an overview of research conducted to improve OTC medication use for older adults from the perspective of three disciplines: Packaging, human factors engineering, and pharmacy. The first presentation will share results of projects that focus on the impact of OTC product labeling and packaging on older adult information processing in order to help them make safe OTC medication choices. Results of this work can inform the development of OTC medication labeling that draws attention to critical safety information. The second presentation builds on the first presentation by discussing how all older adults do not make OTC medication decisions the same way. A mobile application tool that accommodates for different decision making processes will be introduced. The third presentation will introduce an intervention that targets systems barriers in retail community pharmacies, where older adults often purchase OTC medications. Finally, the findings will be summarized by the discussant, who will discuss the presented findings in terms of patient safety implications and impact.

In vivo and in vitro assessment of the bleaching effectiveness of a brush-off patch containing 3.0% hydrogen peroxide.

To evaluate the efficacy of a brush-off patch containing 3.0% hydrogen peroxide, which is a new over-the-counter (OTC) product for tooth whitening, and determine the optimal protocol for use. We performed an in vitro study using hydroxyapatite specimens and a clinical trial involving 140 volunteers. The brush-off patch was applied to the specimens (in vitro) or the maxillary anterior teeth (in vivo; 14days) for 10min twice daily (case 10 group) or 30min once daily (case 30 group). We also included control groups in both experiments. Lightness (L*), redness (a*), and yellowness (b*) values were measured using a colorimeter. In the in vivo study, color changes were measured at baseline and 7 and 14days after the start of patch application. The overall color change (ΔE) was statistically analyzed. In the in vitro study, the color change (ΔE*) after the experiment was significantly different between the two case groups and the control group (p < 0.001). In the in vivo study, the case groups showed color changes at both 7 and 14days after patch application. In particular, the change in the case 30 group was significantly more prominent on day 14 than on day 7 (p < 0.05). Our findings suggest that brush-off patches containing 3.0% hydrogen peroxide are effective OTC products for tooth whitening. For best results, brush-off patches containing 3.0% hydrogen peroxide can be applied once daily for 30min.

Efek Penggunaan Produk Perawatan Gigi Dan Mulut Yang Dijual Bebas (Otc) Pada Mukosa Oral

Over-the-Counter (OTC) drug is a drug which is sold freely in the market and can be purchased without a prescription. Special markings on the packaging and etiquette of OTC drug is a green circle with a black edge. Over-TheCounter (OTC) Dental Care Products are dental care products sold directly to consumer without a prescription from the dentist. Nowadays, there has been a significant increase in the number of OTC products in the market for oral health such as mouth washes, breath fresheners, tooth whitening, tooth paste, denture cleaners etc. To find out the effect of inappropriate use of OTC dental care products on the oral mucosa. Many OTC dental products are freely sold, make easier for people to obtain the desired products without visiting the dentist. Besides those advantage, they may also cause undesirable effects due to the inappropriate use and indications which could actually risk the oral health of patients. Side effects that may occur in the oral cavity including altered taste, tooth staining, burning sensation, gingival irritation, desquamation, erosion, numbness and dryness of the oral mucosa. Discontinuing the use of these products usually will recover the oral mucosa conditions. The inappropriate use and indications of OTC dental care products could cause unwanted side effects.

A comparison of medication profiles held by general practitioners and those documented during Home Medication Reviews

AbstractBackgroundThe Home Medication Review (HMR) is a specialised medication management service designed to maximise medication safety and quality use of medicines.AimTo identify the type and number of discrepancies between information elicited during an HMR and information documented in general practitioner (GP) referral letters, and to determine the potential risk and clinical impact of discrepancies.MethodGP referral letters and HMR medication profiles of 60 consenting HMR recipients were compared to identify discrepancies. Discrepancies were grouped according to five types. For each discrepancy the potential clinical risk was determined relative to individual subjects and classified as minimal, moderate or severe. A case study approach was used to calculate hypothetical economic implications if discrepancies had not been detected.ResultsThere were 833 medications in the dataset and subjects took between three and 24 medications (average 10.4 per subject). Of the 247 discrepancies the greatest number were related to dose (24.6%; n = 61), followed by not taking prescribed medicines (23.1%; n = 57), taking complementary therapies (20.6%; n = 51) and prescription medicines which were not documented in the referral letter (17.4%; n = 43) and over‐the‐counter (OTC) medicines (14.2%; n = 35). Just over one‐fifth of discrepancies (55/247) had potential to cause serious clinical consequences, with dose discrepancies of prescribed medications associated with over one‐third (36.4%, 20/55).ConclusionAltered doses, patients not taking prescribed medicines, or taking complementary and alternative medicines, other prescription medicines or OTC products were common discrepancies. Serious risks were associated with taking (other) prescription medicines which were not included in the referral letter.

An open-label, randomized, four-treatment crossover study evaluating the effects of salt form, acetaminophen, and food on the pharmacokinetics of phenylephrine

Phenylephrine hydrochloride (HCl) is a decongestant available in over-the-counter (OTC) medicines. Previously marketed prescription products contained phenylephrine tannate, an extended-release salt, which allowed dosing every 8–12 h. Given the regulatory history that cold medicines marketed before 1962 had limited supporting clinical data, and with widespread replacement of pseudoephedrine by phenylephrine in OTC products over the last ten years, the need for contemporary studies grew. This exploratory crossover study evaluated effects of salt form, acetaminophen, and food on phenylephrine pharmacokinetics and metabolites in healthy adults. Test treatments were 25 mg phenylephrine tannate (equivalent to 10 mg phenylephrine HCl) combined with 200 mg guaifenesin, fasted; 10 mg phenylephrine HCl combined with 650 mg acetaminophen, fasted; and 10 mg phenylephrine HCl, fed. The reference treatment was 10 mg phenylephrine HCl, fasted. Plasma phenylephrine pharmacokinetics and urine metabolites were determined. Although the tannate salt slowed phenylephrine absorption compared with the HCl salt, terminal concentrations were similar, suggesting that products containing the tannate salt should not be dosed less frequently than those containing the HCl salt. The premise that acetaminophen increases phenylephrine bioavailability by competition for presystemic sulfation was corroborated by increased phenylephrine sulfate in urine. Food delayed phenylephrine absorption, but not the total amount absorbed.

Evaluation of reported contents in prescription and over-the-counter prenatal multivitamins

ObjectivesTo evaluate the reported amount of 14 vitamins and 10 minerals in over-the-counter (OTC) and prescription (Rx) prenatal multivitamins and minerals (PMVMs) and compare them with the Health and Medicine Division (HMD) of the National Academies recommended dietary allowances (RDAs) and tolerable upper intake levels for intake. DesignObservational convenience sample of supplemental facts labels on OTC and Rx PMVMs identified and evaluated from online retailers, grocery stores, and pharmacies. Setting and ParticipantsNot applicable. Outcome MeasuresReported vitamin and mineral amounts in PMVMs were compared with HMD RDAs to determine whether PMVMs could correct RDA deficiencies in the average pregnant woman's diet. Reported vitamin and mineral amounts were compared in OTC and Rx PMVMs and to HMD upper intake levels. ResultsOne hundred sixty-three OTC and 88 Rx PMVMs were evaluated. The average pregnant woman in the United States is deficient in many vitamins and minerals from food intake alone. Over 80% of OTC and Rx PMVMs would correct the RDA deficit for vitamin B6, folic acid, vitamin C, vitamin E, and iron. Over 90% of OTC products would correct the deficit for vitamin A and zinc; however, 47% and 74% of Rx products would correct for those deficits, respectively. Approximately 73% of OTC and 60% of Rx PMVMs corrected calcium deficit, and 33% of OTC and 24% of Rx PMVMs corrected vitamin D deficit. A minority of PMVMs corrected deficits for magnesium and choline. OTC products have significantly more of each vitamin compared with Rx, with several exceptions including: iron, folic acid, copper, and vitamin B6. ConclusionMost pregnant women take PMVMs. If pregnant women are not consuming enough essential micronutrients from diet, it is possible that PMVMs will provide adequate amounts; however, this depends on the specific vitamin or mineral. There is notable variation between Rx and OTC PMVM options.

Effect of Over-the-counter Whitening Products associated or Not with 10% Carbamide Peroxide on Color Change and Microhardness: in vitro Study

Aim: The purpose of this in vitro study was to evaluate the color and microhardness of teeth subjected to different over-the-counter (OTC) whitening products in association or not with 10% carbamide peroxide (10% CP). Materials and methods: Enamel-dentin specimens (n = 210) were obtained from bovine incisors and stained. Half of the specimens were then subjected to daily cycles of staining (5 minutes), 10% CP bleaching (8 hours) in association with OTC products, and artificial saliva storage until complete 24 hours, for 2 weeks; the other half was subjected to daily cycles of staining, OTC treatment, and storage in artificial saliva for 12 weeks. The specimens were divided into 14 groups according to the OTC: CP-Water and Water (deionized water); CP-Listerine and Listerine (whitening mouth rinse); CP-Brushing and Brushing (mechanical brushing); CP-Colgate and Colgate (conventional toothpaste), CP-ColgateW and ColgateW, CP-OralBW and OralBW, and CP-CloseUpW and CloseUpW (whitening toothpaste). After staining and whitening, color and microhardness were measured. Data were submitted to analysis of variance (ANOVA) and the Tukey's test for multiple comparisons for color analysis and the paired t-test for microhardness analysis. Results: The CP and CloseUpW groups had the largest color change (AE00). The teeth treated with Colgate increased significantly in microhardness after whitening. Conclusion: The association of 10% CP with OTC whitening agents did not increase the whitening effect or microhardness. The OTC agents containing hydrogen peroxide and abrasives had a similar effect to one another but were not as effective as the CP groups and the subgroup brushed only with blue covarine toothpaste. Clinical significance: The current study provides information about the mechanism of OTC whitening products. None of the whitening agents evaluated damaged the enamel when used according to the manufacturers' instructions. The use of toothpaste containing hydrogen peroxide or abrasives cannot provide a whitening effect similar to at-home bleaching, and this does not improve with the association with 10% CP. However, toothpaste containing blue covarine has a satisfactory whitening effect immediately after brushing. Keywords: Laboratory research, Mouthwashes, Tooth bleaching, Toothpaste.

Determination of demineralization depth in tooth enamel exposed to abusive use of whitening gel using micro-Energy Dispersive X ray Fluorescence

In this work, we present a methodology for the determination of the depth of demineralization in dental enamel caused by extended use of an Over-The-Counter (OTC) whitening product. Teeth whitening is a very common practice in Dentistry, but concerns have been raised regarding the invasiveness of the treatment, especially regarding OTC products, that can be used without medical supervision and sometimes with concentrations of active agent that exceed the allowed regulations. In this work, we studied tooth enamel samples, treated with a whitening product during an extended period of time, both directly on the enamel surface and in the cross-section. Specimens were analyzed using microbeam X-Ray Fluorescence (micro-XRF) using polycapillary optics to obtain a spot down to 25μm. Due to the relatively large spot size of our setup point analysis of the cross-sections would be inadequate. This way, line scans were performed instead, before and after whitening, and using appropriate data treatment the depth of demineralization was inferred. The used methodology indicated an average demineralization depth of 25μm, the same order of magnitude as the aprismatic enamel layer.

Effectiveness of a new non-hydrogen peroxide bleaching agent after single use - a double-blind placebo-controlled short-term study.

Tooth whitening represents perhaps the most common aesthetic procedure in dentistry worldwide. The efficacy of bleaching depends on three aspects: bleaching agent, bleaching method, and tooth color.Objective:This in vivo study aimed to examine whitening effects on frontal teeth of the upper and lower jaws using an over-the-counter (OTC) non-hydrogen peroxide bleaching agent in comparison to a placebo after one single use.Material and methods:Forty subjects (25 female; 15 male) participated in this double-blind randomized placebo-controlled trial. The subjects were randomly allocated to two groups (n=20). The test group received the OTC product (iWhite Instant) and the placebo group received an identically composed product except for the active agents. Each subject was treated with a prefilled tray containing iWhite Instant or the placebo for 20 minutes. The tooth shade of the front teeth (upper and lower jaws) was assessed before (E_0), immediately after (E_1) and 24 h after treatment (E_2), using a shade guide (VITA classical). Statistical testing was accomplished using the Mann-Whitney U test (p<0.001). The dropout rate was 0%.Results:There were no significant differences at E_0 between placebo and test groups regarding the tooth color. Differences in tooth color changes immediately after (ΔE1_0) and 24 h after treatment (ΔE2_0) were calculated for both groups. The mean values (standard deviations) of tooth color changes for ΔE1_0 were 2.26 (0.92) in the test group and 0.01 (0.21) in the placebo group. The color changes for ΔE2_0 showed mean values of 2.15 (1.10) in the test group and 0.07 (0.35) in the placebo group. For ΔE1_0 and ΔE2_0 significant differences were found between the groups.Conclusion:In this short-term study, the results showed that a non-hydrogen peroxide bleaching agent has significant whitening effects immediately and 24 h after a single-use treatment.

U.S. Congress scrutinizes over-the-counter drugs

Nearly everyone agrees that the U.S. Food & Drug Administration’s system for regulating over-the-counter (OTC) drugs is outdated and broken. Now, some members of Congress want to fix it. The current system, created 45 years ago, prevents innovative products from entering the market rapidly and hampers FDA from addressing safety issues, said witnesses at a Sept. 13 hearing in the U.S. House of Representatives. OTC products include most medicines, from pain relievers to cough syrup, found on drug store shelves that consumers can buy without a doctor’s prescription. More than 300,000 OTC products are on the U.S. market, with annual sales of $32 billion, according to FDA. Most OTC products enter the market without FDA reviewing them for safety or efficacy. If a product conforms to a set of government specifications in a document called an OTC monograph, FDA considers it to be generally recognized as safe and effective, and

LINGUISTICS-BASED PHARMACEUTICAL PRODUCT NAMING METHODS: A MORPHOLOGICAL STUDY ON OTC MEDICINE PRODUCTS IN INDONESIA

Objective: Objective of the study was to assess the linguistics-based product naming methods of some over the counter (OTC) medicine in Indonesia and their impacts to companies and consumers.Methods: The study uses qualitative descriptive method carried out among 57 data randomly taken from the lists of OTC medicine issued by some pharmaceutical companies in Indonesia. The data were classified into the morphological theory regarding the word formation methods which discusses the process of forming the words, product naming strategy and theory of OTC products taken from FDA.Results: This study shows that a proper and precise OTC medicine naming method can employ the linguistics aspect especially word formation theory to describe the kinds, characteristics, and the usage of the products. The word formation methods found in this study are blending 59.6% (34 products), clipping 1.7% (1 product), compounding 3.5% (2 products), and unknown method 35% (20 products). In the context of product naming strategies, 65% of the data employs superiority and product advantage emphasizes, usability or ability conducted by the product, and showing what can be obtained using the product. While the remains 35% does not employ the product naming strategies properly except easy to pronounce. The unknown OTC medicine naming method is not on target with the OTC medicine consumers in Indonesia since the meaning of the product names are not easily recognized from their namings.Conclusion: From the results, it can be underlined that the product naming processes should be in line with the product naming strategies to have effective and understandable names of OTC medicine. There are 59.6% using blending naming, 1.7% using clipping, 3.5% using compounding, and 35% using unknown method. In the context of product naming strategies, 65% employs superiority and product advantage emphasizes, usability or ability conducted by the product, showing what can be obtained using the product; 35% does not employ the product naming strategies properly except easy to pronounce. The ineffective and not understandable names of OTC could lead to disadvantages for both companies and consumers.

Study of consumers' perception towards pharmaceutical over-the-counter products in emerging markets – India

The study intends to study consumers' perception towards over-the-counter (OTC) products and factors that influences OTC products in India. It also aims to study the impact of demographic variables on consumers' purchase behaviour towards OTC products. The research is exploratory in nature. It is based on primary data. Primary data are collected via a questionnaire. Thirty respondents participated as a test case to understand and validate the questionnaire. The data obtained are analysed to identify the consumers' perception towards over-the-counter products. It was done in period of 1–30 October 2015. The respondents are from Mumbai – a metropolis and Nasik – a class city by population. Totally 180 respondents participated on a random basis. There were 90 respondents each from Mumbai and Nasik. Respondents were contacted on a random basis. Consumers' perception towards OTC is studied. Demographic variables are considered too for studying the perceptions between two cities. It is observed in our study that there is a significant difference in the perception for OTC based on gender and age. Doctors’ advice, brand name, pharmacist's advice, past experience, safe to use, prior awareness, friends' advise, testimonial from users are influencing factors that affect purchase behaviour of OTC products. This is the first time a study is done in emerging markets like India, compared to western countries whose market is well developed.

Investigation of advantages and disadvantages of OTC drug group

Over The Counter (OTC) drug group, which is known as over-the-counter drug, is simply defined as an over-the-counter drug. This group of medicines are medicines that the individual can provide without prescription from the pharmacy in order to provide self-treatment according to his / her own needs without physician control. In this context, the widespread use, use, advantages and disadvantages of OTC drugs, one of the most important factors affecting rational drug use in the study, are emphasized. In recent years, governments have been encouraged to put OTC forms of prescription drugs on the market because of various reasons, such as saving money on health spending, and various legal regulations are being made for this purpose. In addition to the advantages such as the widespread use of OTC products, the increased convenience of transportation and the increase in the level of disease awareness indirectly caused by the increase of OTC market, drug abuse, masking of serious symptoms, and increased cost of treatment for the patient. In summary, it is thought that drugs converted from prescription status to OTC product status will contribute to health spending, which seems to cause more health expenditure. Therefore, the implementation of a number of legal regulations to prevent the use of unreasonable drugs is thought to require pharmacists to play a more collaborative and enforcing role in the treatment process.

Understanding Current OTC Use for Heartburn and Gas: Acceptability of a New Antacid/Anti-gas Combination Product: 2016 ACG Presidential Poster Award

Introduction: Over-the-counter (OTC) medicines for heartburn and gas are accepted as safe and effective; however, lower health literacy and poor understanding of OTC product indications may increase inappropriate use. Clinical investigations of combination antacid plus simethicone for heartburn and gas are lacking. We investigated the efficacy and acceptability of a new combination OTC calcium carbonate antacid plus simethicone (CCASi) for relief of heartburn and gas symptoms. Methods: An open-label, non-randomized, single-site study evaluated subjects' self-reported efficacy and acceptability of a calcium carbonate 750 mg plus simethicone 250 mg coated chew for symptoms of heartburn and gas. Adults with self-described heartburn and gas who used >1 OTC antacid/anti-gas product within the past 30 days were enrolled. Subjects consumed 1-2 CCASi chews/day for 1 week and completed a questionnaire grading 5 symptom relief questions and 9 organoleptic attributes on 5-level Likert scales. Results were evaluated using qualitative and descriptive analyses. Results: 49 subjects (15 M, 34 F; mean age 49±16.3 yrs) completed the study. At baseline, subjects used a mean of 1.5 OTC antacid or anti-gas products; only 29% of subjects used at least 1 product in accordance with the labeled indication (Table). Pre-study heartburn and gas events/week were: 2-3 (29%); 4-5 (39%); and >6 (33%). During the study week, subjects consumed 10.7 chews/subject. Self-reported heartburn and gas events were: <1 (31%); 2-3 (22%); 4-5 (24%); and >6 (22%). The majority of subjects reported symptomatic relief from heartburn (77%) and gas (70%); time to relief was <30 minutes in 84% of subjects. Organoleptic assessment of texture attributes were: easy to chew (96%) and pleasantly chewy (92%). Assessment of taste attributes were: sweetness just right (82%) and flavor strength just right (78%). Subjects liked the taste (80%) and reported no unpleasant aftertaste (82%) or chalky taste (82%). 63% of subjects were more satisfied with CCASi than their usual product and 65% would use them in the future (Table). Conclusion: This study suggests consumers inappropriately take antacids for gas symptoms and may take multiple OTC products for relief beyond labeled indications. Subjects' acceptability of an OTC calcium carbonate 750 mg plus simethicone 250 mg coated chew for heartburn and gas was high with most preferring the new chew to their usual product. Organoleptic attributes scored higher than symptom relief.Table 1: Questionnaire Results

The power of the patient question: A secret shopper study

ObjectivesTo examine the effect of one standardized patient question on the length, number and type of new topics pharmacists addressed. To explore how community pharmacists counsel secret shoppers on two types of over-the-counter (OTC) medications—ibuprofen (IB) and emergency contraceptives (EC). Methods25 pharmacists from 7 independent, midwestern community pharmacies consented to have secret shoppers purchase an OTC medication and to have their consultations audio-recorded. Following standardized scenarios, 5 secret shoppers audio-recorded 73 encounters. At the end of 36 encounters secret shoppers asked one standard question, “What else should I know before taking this product?” Role Theory informed the study design with apriori hypotheses that topics assessed, topics discussed, and consultation length would vary by the OTC medication (IB or EC) and whether secret shoppers asked a question. Audio-recording coding had high inter-rater reliability (kappa=0.94). ResultsLength of encounter was significantly associated with patients asking the question (p<0.05), but not type of OTC medication. On average 1.22 new topics were discussed with a patient question. New topics included information about safe and efficacious use of the OTC’s. ConclusionResults highlight the importance of encouraging patients to ask pharmacists their questions about OTC products for safe use and thorough consultations.