Toll-free Number Research Articles

Pharmacovigilance Process in India: An overview

Clinical trial study of drug generally detects common Adverse Drug Reaction (ADR) but, the reaction which occurs after long duration in a specific person or population remains undetected. Pharmacovigilance (PV) is a scientific activity which keeps constant watch on the drug throughout its life cycle. In India, Indian Pharmacopoeia Commission (IPC) and National Coordination Committee (NCC) through the Central Drug Standard Control Organization (CDSCO) cordially regulate the PV activity. To build a potential PV system in India, Pharmacovilance Program of India (PvPI) have been proposed and implemented by the Indian government in 2010. The accurate detection and reporting of ADR is a heart of this system. Hence various regional, zonal and peripheral centres have been proposed for the smooth and effective reporting of ADR. Anyone can report ADR by filling the suspect ADR reporting form available online or offline to the nearest centre in suitable language. Considering Indian geographical distribution, huge population and mobile network connectivity, a toll free number and the mobile app is also provided for timely and effective reporting of ADR. The reported ADRs are collected and processed at the centres in Vigi-flow software. These centres detect signal which are reported to CDSCO and World Health Organisation (WHO) for the further regulatory action. CDSCO-WHO communicates their decision through a suitable media for the betterment of public health.

War against tobacco: Where do we stand?

India has launched war against tobacco epidemic for the past few decades but with partial success; hence, challenges are still there which need to be identified and addressed for winning the battle. Targeted approach directed at motivating smoking cessation of female smokers, frequent changing of pictorial warnings depicting variety of health consequences in cigarette packets and devoid of logos and colors in conjunction with plain packaging, and display of toll-free number for quitting are expected to dissuade tobacco consumers to quit and save themselves from the devastating health, social, environmental, and economic consequences of tobacco consumption. Online reporting system for violating legal enforcements can also be implemented easily. Moreover, guidance from success stories of countries/states who have achieved smoke-free status along with concerted efforts such as innovative anti-tobacco campaigns, involvement of religious leaders in anti-tobacco propaganda, strict legislations, and overall strong political commitment would further aid in winning the war.

3.0 AACAP Norbert and Charlotte Rieger Service Program Award for ExcellenceImproving Primary Care Access and Quality of Care for Children with Mental Health Needs: The Child and adolescent Psychiatry for Primary Care CAP PC Experience

Although child mental health problems are widespread, few get adequate treatment and there is a severe shortage of child psychiatrists. To address this public health need, many states have adopted collaborative care programs to assist primary care providers to better assess and manage pediatric mental health concerns. This report adds to the small literature on collaborative care programs and describes one large program that covers most of the state of New York. Child and Adolescent Psychiatry for Primary Care, a component program of New York State’s Office of Mental Health (OMH) Project Treatment Education Activists Combating HIV (TEACH), has provided education and consultation support to primary care providers in 90 percent of New York State since 2010. The program is a uniquely designed collaboration of five medical schools with hubs at each site that shares one toll-free number and works together to provide education and consultation support services to primary care physicians (PCPs).

Gold Award: Building the Capacity of Frontline Providers to Treat Mental and Substance Use Disorders Among Pregnant and Postpartum Women.

Gold Award: Building the Capacity of Frontline Providers to Treat Mental and Substance Use Disorders Among Pregnant and Postpartum Women.

Description of a multi-university education and collaborative care child psychiatry access program: New York State's CAP PC.

Although, child mental health problems are widespread, few get adequate treatment, and there is a severe shortage of child psychiatrists. To address this public health need many states have adopted collaborative care programs to assist primary care to better assess and manage pediatric mental health concerns. This report adds to the small literature on collaborative care programs and describes one large program that covers most of New York state. CAP PC, a component program of New York State's Office of Mental Health (OMH) Project TEACH, has provided education and consultation support to primary care providers covering most of New York state since 2010. The program is uniquely a five medical school collaboration with hubs at each that share one toll free number and work together to provide education and consultation support services to PCPs. The program developed a clinical communications record to track information about all consultations which forms the basis of much of this report. 2-week surveys following consultations, annual surveys, and pre- and post-educational program evaluations have also been used to measure the success of the program. CAP PC has grown over the 6years of the program and has provided 8013 phone consultations to over 1500 PCPs. The program synergistically provided 17,523 CME credits of educational programming to 1200 PCPs. PCP users of the program report very high levels of satisfaction and self reported growth in confidence. CAP PC demonstrates that large-scale collaborative consultation models for primary care are feasible to implement, popular with PCPs, and can be sustained. The program supports increased access to child mental health services in primary care and provides child psychiatric expertise for patients who would otherwise have none.

Effects of nurse telesupport on transition between specialized and primary care in diabetic patients: study protocol for a randomized controlled trial

BackgroundAccording to the Global Diabetes Plan, a unified health system with preventive and educational strategies is essential to proper diabetes care and primary settings should be the main site of care. In Brazil, there is limited access to outpatient hospital diabetes services, while primary-care diabetes support is underutilized. Telemedicine can be a useful adjunct to support discharge of stable patients with type 2 diabetes to the primary care setting. In this paper, we present a randomized controlled trial (RCT) protocol designed to evaluate the effects of telehealth support for stable type 2 diabetes patients discharged from hospital outpatient diabetes clinics.MethodsWe designed a RCT. Patients with stable type 2 diabetes (glycated hemoglobin < 8%) considered eligible for discharge from specialized to primary care will be included. Those with uncontrolled ischemic heart disease, severe neuropathy, and stage IV/V nephropathy will be excluded. Enrolled patients will be randomized into two groups: follow-up supported by periodic phone calls by a nurse (intervention group) plus primary care or routine primary care only (control group). The intervention group will receive regular telephone calls (every three months for one year) and will have a toll-free number to call in case of questions about disease management. The main outcome measure is a comparison of glycemic control between groups (assessed by glycated hemoglobin) at one-year follow-up.DiscussionWe plan to evaluate the effectiveness of a telephone-based intervention on glycemic control in patients with type 2 diabetes followed by primary care teams. Telemedicine can be an important adjunct in type 2 diabetes management, improving patient education and knowledge about the disease. Furthermore, it can help the healthcare system by alleviating overload in specialized care settings and supporting the stewardship role of primary care.Trial registrationClinical Trials, NCT02768480. Registered on 29 April 2016.

Direct-to-Consumer Advertising of Androgen Replacement Therapy

The Kefauver-Harris Amendment to the Food, Drug and Cosmetic Act, enacted by Congress in 1962, required pharmaceutical manufacturers to provide proof of prescription drug effectiveness as well as safety and to obtain preapproval of their marketing plans. Over the next 35 years, manufacturers promoted their products largely to physicians through ads in medical journals and in-office “detailing.” Print advertising directed toward patients was unusual and broadcast advertising was rare, owing to the US Food and Drug Administration’s (FDA’s) insistence that ads on television and radio include a brief summary of adverse reactions and contraindications—a requirement that tended to produce long, stultifying, and expensive commercials. However, 20 years ago in 1997, the FDA ruled that “adequate provision” of information about drug risks and benefits could be made by referring consumers to a toll-free telephone number, a simultaneously occurring print ad, or a website. With barriers vastly diminished, this new FDA rule unleashed a torrent of television ads

Knowledge and Attitude Toward Corneal Donation Among High School Children in Northern India.

To assess the knowledge and attitude of school-going adolescents regarding corneal donation in government and private schools in an urban area of Northern India. A school-based cross-sectional study was conducted in an urban field practice area of Post Graduate Institute of Medical Education and Research (PGIMER), Chandigarh, India. A total of 365 participants of the seventh to 10th grade were enrolled from a government school and a private school. A pretested, semistructured, self-administered, bilingual (English and Hindi) questionnaire was used to assess the sociodemographic profile and knowledge and attitude related to corneal donation. Most (87%) (confidence interval, 83.1%-90.0%) participants had heard about corneal donation. Only 2% of students answered all the knowledge-related questions correctly. None knew about the national toll-free number for corneal donation. Three-fourth (72%) supported the idea of corneal donation. Of them, only 44% (confidence interval, 41.0-47.1) were willing to pledge to donate their own eyes. Fears and myths were the persistent barriers. The government and private schools differed in both knowledge and attitude, with the latter performing better. Knowledge among the selected high school children was poor. Although many supported the idea, only a few were willing to donate. We suggest that program components be evaluated from time to time. Future studies should explore the role of strengthening Information Education and Communication (IEC) activities among high school students for motivating community members to pledge to donate for corneal donation.

The State of Emergency Medical Services (EMS) Systems in Africa.

A survey was conducted between 2013 and 2014 by distributing a detailed EMS system questionnaire to experts in paper and electronic versions. The questionnaire ascertained EMS systems' jurisdiction, operations, finance, clinical care, resources, and regulatory environment. The discovery of respondents with requisite expertise occurred in multiple phases, including snowball sampling, a review of published scientific literature, and a rigorous search of the Internet. The survey response rate was 46%, and data represented 49 of 54 (91%) African countries. Twenty-five EMS systems were identified and distributed among 16 countries (30% of African countries). There was no evidence of EMS systems in 33 (61%) countries. A total of 98,574,731 (8.7%) of the African population were serviced by at least one EMS system in 2012. The leading causes of EMS transport were (in order of decreasing frequency): injury, obstetric, respiratory, cardiovascular, and gastrointestinal complaints. Nineteen percent of African countries had government-financed EMS systems and 26% had a toll-free public access telephone number. Basic emergency medical technicians (EMTs) and Basic Life Support (BLS)-equipped ambulances were the most common cadre of provider and ambulance level, respectively (84% each). Emergency Medical Services systems exist in one-third of African countries. Injury and obstetric complaints are the leading African prehospital conditions. Only a minority (<9.0%) of Africans have coverage by an EMS system. Most systems were predominantly BLS, government operated, and fee-for-service. Mould-Millman NK , Dixon JM , Sefa N , Yancey A , Hollong BG , Hagahmed M , Ginde AA , Wallis LA . The state of Emergency Medical Services (EMS) systems in Africa. Prehosp Disaster Med. 2017;32(3):273-283.

An investigation of users' attitudes, requirements and willingness to use mobile phone-based interactive voice response systems for seeking healthcare in Ghana: a qualitative study

ObjectivesIn implementing mobile health interventions, user requirements and willingness to use are among the most crucial concerns for success of the investigation and have only rarely been examined in sub-Saharan Africa. This study aimed to specify the requirements of caregivers of children in order to use a symptom-based interactive voice response (IVR) system for seeking healthcare. This included (i) the investigation of attitudes towards mobile phone use and user experiences and (ii) the assessment of facilitators and challenges to use the IVR system. Study designThis is a population-based cross-sectional study. MethodsFour qualitative focus group discussions were conducted in peri-urban and rural towns in Shai Osudoku and Ga West district, as well as in Tema- and Accra Metropolitan Assembly. Participants included male and female caregivers of at least one child between 0 and 10 years of age. A qualitative content analysis was conducted for data analysis. ResultsParticipants showed a positive attitude towards the use of mobile phones for seeking healthcare. While no previous experience in using IVR for health information was reported, the majority of participants stated that it offers a huge advantage for improvement in health performance. Barriers to IVR use included concerns about costs, lack of familiarly with the technology, social barriers such as lack of human interaction and infrastructural challenges. The establishment of a toll-free number as well as training prior to IVR system was discussed for recommendation. ConclusionsThis study suggests that caregivers in the socio-economic environment of Ghana are interested and willing to use mobile phone-based IVR to receive health information for child healthcare. Important identified users' needs should be considered by health programme implementers and policy makers to help facilitate the development and implementation of IVR systems in the field of seeking healthcare.

Bloomex.Ca Logistics Optimization

A Canadian online floral delivery company considers whether to source more flowers from its existing growing locations and which of those would be optimal given its current market. What would be the advantages of opening a logistics facility in Miami? Students must consider the transportation costs per standard box from each origin or transshipment center to each production facility as well as data about the available supply at each origin and projected demand at each facility per week. Excerpt UVA-QA-0760 Jan. 19, 2011 Bloomex.ca Logistics Optimization Bloomex.ca was a leading Canadian floral company offering various floral and gift arrangements throughout Canada via its online computerized sending system. The website acted as a storefront that allowed consumers worldwide to place orders online for delivery in Canada, chat with a live agent, or place orders through a toll-free number. was the only floral company that offered same-day delivery to almost any location in Canada, and orders could be placed 24 hours a day and were 100% satisfaction guaranteed. Bloomex's business model was based on operating a network of small- to medium-scale warehouses and production facilities in seven major Canadian metro areas: Vancouver, Calgary, Winnipeg, Toronto, Ottawa, Montreal, and Halifax. Bloomex imported the majority of its fresh-cut flowers directly from growers in South America, Southeast Asia, and Florida as well as local growers in Ontario. It also sourced product from global wholesalers in Holland. As one of the options for optimizing Bloomex's logistics, the company's owner, Dimitri Lokhonia, was considering a possibility of opening a logistics facility in Miami. Three out of eight of Bloomex production facilities could then operate as transshipment centers: Miami (when opened), Toronto, and Vancouver. This meant these facilities could receive flowers from local growers or other growing locations and send them on to various production facilities. Exhibit 1 provides the data on the transportation costs per standard box from each origin or transshipment center to each production facility; Exhibit 1 also provides data about the available supply at each origin and projected demand at each facility per week. . . .

Effectiveness of a tailored medical support to overcome the barriers to education, treatment and good metabolic control in children with type-1 diabetes from ethnic minorities.

Aim:To analyze the effectiveness of a tailored medical support to help children from ethnic minorities to achieve the same good metabolic control of autochthonous peers with type-1 diabetes (T1D).Methods:Children <10 years of age belonging to ethnic minority (EM) families (Group 1) were compared with autochthonous peers (Group 2) who received the diagnosis of T1D in 2014-2016. The Protocol for minorities included other than the standard protocol: booklets translated in ethnic minority languages; weekly visits at home or at school; family-guides; clinic visits supported by professional interpreters. After twelve months of this approach, parents of ethnic minority children answered a short questionnaire concerning satisfaction about educational tools for diabetes management.Results:From 1st January 2014 to December 31st 2016, 72 children received the diagnosis of T1D at the University Children Hospital of Parma, Italy. Nineteen children belonged to an EM family (26.38%), and were included in the Group 1. Twenty-one autochthonous peers were randomly recruited for the Group 2. T1D was diagnosed at the same mean age in Group 1 (5.2±2.2) and in Group 2 patients (5.7±2.4). Metabolic derangements at diagnosis were more severe in Group 1 than in Group 2 patients. However, patients of both Groups showed a similar decrease in HbA1c levels during the first 3 and 6 months post diagnosis. Patients did not differ in mean insulin doses at discharge and at follow up. The calls to the emergency toll-free telephone number were more numerous from the parents from Group 1 than from the parents of Group 2. Total cost to implement the tailored protocol in Group 1 was higher of 87% compared with the standard protocol used for Group 2 patients. Great majority of parents reported to be satisfied with the provided diabetes education program.Conclusions:1The results of this study suggested that children from EM families can achieve the same good metabolic control of autochthonous peers with T1D, providing a cost-effective tailored support to their family members. (www.actabiomedica.it)

Federal suicide prevention framework underwhelms.

Four years after passing legislation to create it, the federal government has quietly tabled a [suicide prevention framework][1] as it announced plans for a national phone, text and chat service that will link existing crisis hotlines and distress centres to a single toll-free number nationwide.

Epidemiological study on cardiac emergencies in Indian states having GVK Emergency Management and Research Institute services

Abstract Background: Emergency medical service (EMS) is critical for the healthcare system as it saves lives by providing care immediately. Rapid access to medical care after a major cardiovascular event decreases morbidity and mortality. GVK Emergency Management and Research Institute (GVK EMRI) is a pioneer in emergency management services operated as a public private partnership (PPP) with various state governments. GVK EMRI coordinates medical, fire, and police-related emergencies through a single toll-free number, 108, across 15 states and 2 union territories of India. Material and Methods: This is a retrospective study of reported cases of cardiac emergencies in 2015 across 11 states with GVK EMRI services: Andhra Pradesh, Telangana, Assam, Goa, Gujarat, Karnataka, Madhya Pradesh, Meghalaya, Rajasthan, Tamil Nadu and Uttarakhand. Descriptive statistics using frequencies, proportions and means were calculated. Results and Discussion: This study aimed to describe the epidemiology of cardiac emergencies presenting to GVK EMRI across 11 states in India in 2015. There were increased cases of cardiac emergencies reported by higher age group individual across all states. The mean age was reported between 43 years to 62 years across the states. In this study, men called EMS for cardiac emergencies more often than women, except in the state of Gujarat. A higher number of cardiac emergency cases were reported by individuals living below the poverty line in Andhra Pradesh, Telangana, Assam, and Goa. Often (82.8%) people called 108 greater than six hours of symptom onset. Variation in call volume per day was minimal between the days of the week. At 48 hours, there were 2,675 reported deaths (1.1%). Conclusions: The current study stresses the scale and seriousness of the emerging challenge of cardiac emergencies, with particular emphasis on socioeconomic deprived groups in the operated states of GVK EMRI.

Access to out-of-hospital emergency care in Africa: Consensus conference recommendations.

Out-of-hospital emergency care (OHEC) should be accessible to all who require it. However, available data suggests that there are a number of barriers to such access in Africa, mainly centred around challenges in public knowledge, perception and appropriate utilisation of OHEC. Having reached consensus in 2013 on a two-tier system of African OHEC, the African Federation for Emergency Medicine (AFEM) OHEC Group sought to gain further consensus on the narrower subject of access to OHEC in Africa. The objective of this paper is to report the outputs and statements arising from the AFEM OHEC access consensus meeting held in Cape Town, South Africa in April 2015. The discussion was structured around six dimensions of access to care (i.e. awareness, availability, accessibility, accommodation, affordability and acceptability) and tackled both Tier-1 (community first responder) and Tier-2 (formal prehospital services and Emergency Medical Services) OHEC systems. In Tier-1 systems, the role of community involvement and support was emphasised, along with the importance of a first responder system acceptable to the community in which it is embedded in order to optimise access. In Tier-2 systems, the consensus group highlighted the primacy of a single toll-free emergency number, matching of Emergency Medical Services resource demand and availability through appropriate planning and the cost-free nature of Tier-2 emergency care, amongst other factors that impact accessibility. Much work is still needed in prioritising the steps and clarifying the tools and metrics that would enable the ideal of optimal access to OHEC in Africa.

Online Versus Telephone Methods to Recruit and Interview Older Gay and Bisexual Men Treated for Prostate Cancer: Findings from the Restore Study

BackgroundRecently, researchers have faced the challenge of conflicting recommendations for online versus traditional methods to recruit and interview older, sexual minority men. Older populations represent the cohort least likely to be online, necessitating the use of traditional research methods, such as telephone or in-person interviews. By contrast, gay and bisexual men represent a population of early adopters of new technology, both in general and for medical research. In a study of older gay and bisexual men with prostate cancer, we asked whether respondents preferred online versus offline methods for data collection. Given the paucity of research on how to recruit older gay and bisexual men in general, and older gay and bisexual men with prostate cancer in particular, we conducted an observational study to identify participant preferences when participating in research studies.ObjectiveTo test online versus offline recruitment demographic data collection, and interview preferences of older gay and bisexual men with prostate cancer.MethodsEmail blasts were sent from a website providing support services for gay and bisexual men with prostate cancer, supplemented with an email invitation from the web-host. All invitations provided information via the study website address and a toll-free telephone number. Study tasks included respondents being screened, giving informed consent, completing a short survey collecting demographic data, and a 60-75 minute telephone or Internet chat interview. All materials stressed that enrollees could participate in each task using either online methods or by telephone, whichever they preferred.ResultsA total of 74 men were screened into the study, and 30 were interviewed. The average age of the participants was 63 years (standard deviation 6.9, range 48-75 years), with most residing in 14 American states, and one temporarily located overseas. For screening, consent, and the collection of demographic data, 97% (29/30) of the participants completed these tasks using online methods. For the interview, 97% (29/30) chose to be interviewed by telephone, rather than Internet chat.ConclusionsOlder gay and bisexual men, when given choices, appear to prefer a mixed methods approach to qualitative investigations. For most aspects of the study, the older men chose online methods; the exception was the interview, in which case almost all preferred telephone. We speculate that a combination of the deeply personal nature of the topic (sexual effects of prostate cancer treatment), unfamiliarity with online chat, and possibly the subject burden involved in extensive typing contributed to the preference of telephone versus online chat. Recruitment of older men into this study showed good geographic diversity. We recommend that other qualitative researchers consider a mixed methods approach when recruiting older populations online.

Therapeutic Error Calls Among Older Adults Reported to a Regional Poison Control Center in Alabama.

Although Americans aged 65 years and older account for only 13.0% of the population, they consume one-third of all prescription medications each year. Increased life expectancy, age-related deterioration in health, and polypharmacy lead to a significant risk of potential medication errors. National Poison Data System studies have evaluated the older adult population and their interaction with poison centers; however, descriptive studies using regional poison center data to evaluate older adult-related medication errors, specifically in Alabama, have not been conducted. Our study assessed therapeutic errors in patients aged 65 years and older to evaluate the need for potential interventions by pharmacists and preventive education to reduce errors reported to the Regional Poison Control Center (RPCC) at Children's of Alabama. A four-year retrospective analysis was conducted by gathering call-specific data from the RPCC toxiCALL database. Calls were included if they were made to the RPCC between January 1, 2010 and December 31, 2013, involved patients aged 65 years and older, and were coded as unintentional therapeutic errors. Analysis of call data was conducted using the Centers for Disease Control and Prevention's EpiInfo version 7.0.9.7. A total of 1699 calls were evaluated for patient demographics (sex, age), call data (month, year, shift, caller site), reason for therapeutic error, clinical effects, medical outcome, management site, and reported substance details. Nearly 40.0% of the therapeutic errors were caused by patients taking or being given the same medication twice. Five of the 15 reasons for therapeutic errors accounted for nearly 82.0% of all calls reported. The reasons included taking or being given the same medication twice (37.3%), taking or being given the wrong medication (14.6%), using an incorrect dosing route (13.1%), other incorrect dosing errors (9.9%), and taking doses too close together (7.5%). The top individual substance involved in a therapeutic error was reported verbatim by callers as Spiriva inhalation capsules (10.5%). Therapeutic error calls represent a significant and increasing proportion of calls made by older adults to the RPCC. The frequent interactions between healthcare providers and patients create opportunities to prospectively prevent medication problems in older adult patients. Healthcare providers, specifically pharmacists, should encourage clients to always read the label on medications and should counsel patients carefully when dispensing a product that is not an oral preparation. In addition, although national drug take-back days are conducted biennially, patients should be encouraged to dispose of old medications and expired over-the-counter medications. The RPCC toll-free telephone number (800-222-1222) may be displayed to educate patients on its 24-hour/day availability. Current data will be used to implement programs for pharmacist interventions and to create appropriate educational material.

Tele-health: bridging the gap between the need for rapid toxicology consultation and shortage in poison control centers - a unique experience in Dammam poison control center

The development of poisons control centers (PCCs) has in general complied with the actual needs and conditions in the society. A single MOH toll-free telephone number (937) for all health services enables rapid transfer of the caller to a specialist in poison information and toxicology anywhere in the Saudi Kingdom at any time, day or night. A board-certified, qualified toxicologist can be reached within a few moments. This remarkable system is maintained by the voluntary cooperation of the 45 technical members of the Regional Dammam Poison Control Center (DPCC) since nearly three years, being the only PCC in the Kingdom offering this service till date.Objectives: The objective of the current study is to empathize and promote services delivered by PCCs as poison control, chemical safety, prevention and treatment of toxicities within the Saudi Kingdom through the single MOH toll-free telephone number (937), being the only Saudi PCC responding to this service in toxicology. It promotes toxicovigilance in the hope of decreasing the overall morbidity and minimizing mortality from poisoning.Methods: The calls received on the hotline telephone number of the DPCC directly conveying the calls from the free MOH line (937), were retrospectively studied and evaluated. Themes that emerged from the data obtained from telephone communication were statistically assessed.Results: The study showed that the Unintentional exposures (N= 4353, 85%) greatly surpassed other types of exposure. Most of the callers were Saudi (N=4198, 82%) from Eastern region (N= 1654, 32.3%). The toxicological calls (N: 2389, 87.6%) were nearly 7 folds of the non-toxicological calls (N: 337, 12.4%) in the third year of the study. The number of calls were more during the summer season.

An Empirical Examination of the FDAAA-Mandated "Toll-Free Statement" for Consumer Reporting of Side Effects in Direct-to-Consumer Television Advertisements.

We investigated how inclusion of a "toll-free statement" for reporting side effects to FDA in prescription drug direct-to-consumer (DTC) television ads affects comprehension of product risks and benefits, and comprehension of and memory for the toll-free statement itself. Participants viewed one of nine mock prescription drug television ads that varied elements of the toll-free statement, and then responded to a questionnaire. Presenting the statement in both text and audio resulted in better processing of the statement compared to only text. When shown in text alone, presenting the statement during the entire advertisement or after the statement of risks resulted in better processing of the statement compared to placement before the presentation of risk information. The placement, duration, or prominence of the statement did not affect comprehension of product risk and benefit information. Our findings suggest that the toll-free statement can be added to DTC television ads without significantly affecting comprehension of product risk and benefit information, and that select presentations are preferable for communicating the toll-free statement. The appropriate inclusion of the toll-free statement in DTC television ads may increase the visibility of the adverse event reporting system, without any apparent cost to the understanding of benefits and risks.

Who Said It Better? A Test of Wording Differences in the MedWatch "Toll-Free Statement" for Consumer Reporting of Side Effects in Direct-to-Consumer Television Advertisements.

A toll-free statement alerting consumers how to report side effects to the US Food and Drug Administration (FDA) is required for both prescription drug labeling and direct-to-consumer (DTC) print ads. Because of different regulatory requirements between these materials (the Toll-free Number for Reporting Adverse Events on Labeling for Human Drug Products Rule [TFNR] versus the FDA Amendments Act [FDAAA], respectively), the wording of this statement differs. We studied how statement wording for reporting side effects to FDA in DTC television ads affects comprehension of product risks and benefits, comprehension of and memory for the toll-free statement, and perceived statement clarity. Participants viewed 1 of 8 mock prescription drug television ads that varied the wording and placement of the toll-free statement, and then responded to a questionnaire. The FDAAA statement was more noticeable, clear, and more participants were able to recall and recognize its correct purpose. Comprehension of product risk and benefit information did not differ based on statement wording. Findings suggest that the FDAAA toll-free statement wording is superior to that of the TFNR.