Association between FDA and EMA expedited approval programs and therapeutic value of new medicines: retrospective cohort study.

OBJECTIVE: To characterize the therapeutic value of new drugs approved by the US Food and Drug Administration (FDA) and European Medicines Agency (EMA) and the association between these ratings and regulatory approval through expedited programs. DESIGN: Retrospective cohort study. SETTING: New drugs approved by the FDA and EMA between 2007 and 2017, with follow-up through 1 April 2020. DATA SOURCES: Therapeutic value was measured using ratings of new drugs by five independent organizations (Prescrire and health authorities of Canada, France, Germany, and Italy). MAIN OUTCOME MEASURES: Proportion of new drugs rated as having high therapeutic value; association between high therapeutic value rating and expedited status. RESULTS: From 2007 through 2017, the FDA and EMA approved 320 and 268 new drugs, respectively, of which 181 (57%) and 39 (15%) qualified for least one expedited program. Among 267 new drugs with a therapeutic value rating, 84 (31%) were rated as having high therapeutic value by at least one organization. Compared with non-expedited drugs, a greater proportion of expedited drugs were rated as having high therapeutic value among both FDA approvals (45% (69/153) v 13% (15/114); P<0.001) and EMA approvals (67% (18/27) v 27% (65/240); P<0.001). The sensitivity and specificity of expedited program for a drug being independently rated as having high therapeutic value were 82% (95% confidence interval 72% to 90%) and 54% (47% to 62%), respectively, for the FDA, compared with 25.3% (16.4% to 36.0%) and 90.2% (85.0% to 94.1%) for the EMA. CONCLUSIONS: Less than a third of new drugs approved by the FDA and EMA over the past decade were rated as having high therapeutic value by at least one of five independent organizations. Although expedited drugs were more likely than non-expedited drugs to be highly rated, most expedited drugs approved by the FDA but not the EMA were rated as having low therapeutic value.

Physicians' and pharmacists' perception and practice of hospital pharmacist professional role in Egypt.

OBJECTIVES: This study aimed to investigate physicians' and pharmacists' perceptions of the importance of pharmacists' role in healthcare in Egypt, and actual delivery of these roles in practice. Identifying any differences and inconsistencies between these will inform future strategies that maximize pharmacists' professional contribution to hospital practice. METHODS: A self-administered questionnaire using a 5-point Likert scale was distributed to a convenience sample of physicians (500) and pharmacists (500) practicing in selected private or public hospitals in Egypt. The main sections of the questionnaire comprised statements that pertained to physicians'/pharmacists' views on the importance of pharmacists' roles and their actual delivery in practice. KEY FINDINGS: In this study, physicians showed low scores for both the importance of and the delivery of advanced patient-facing clinical pharmacy roles such as suggesting prescription medications, and designing treatment plans. In comparison, pharmacists were more positive on both of these aspects of their roles. High mean scores were reported by the physicians for pharmacist's traditional roles such as patient counselling, assessing compliance, preventing medication errors and treating minor illnesses. Both physicians and pharmacists reported poor pharmacists practice as drug information resources despite their high perception of the importance of that role. CONCLUSION: This study suggested that in hospitals in Egypt, there are significant differences between physicians' and pharmacists' perception and practice, and pharmacists' clinical skills are underutilized in health care.

Genesis of an emergency public drug information website by the French Society of Pharmacology and Therapeutics during the COVID-19 pandemic.

On March 16, 2020, the French Society of Pharmacology and Therapeutics put online a national Question and Answer (Q&A) website, https://sfpt-fr.org/covid19 on the proper use of drugs during the COVID-19 pandemic. The working group 'Drugs and COVID-19' was composed of a scientific council, an editorial team, and experts in the field. The first questions were posted online during the first evening of home-confinement in France, March 17, 2020. Six weeks later, 140 Q&As have been posted. Questions on the controversial use of hydroxychloroquine and to a lesser extent concerning azithromycin have been the most consulted Q&As. Q&As have been consulted 226 014 times in 41 days. This large visibility was obtained through an early communication on Twitter, Facebook, traditional print, and web media. In addition, an early communication through the French Ministry of Health and the French National Agency for Medicines and Health Products Safety ANSM had a large impact in terms of daily number of views. There is a pressing need to sustain a public drug information service combining the expertise of scholarly pharmacology societies, pharmacovigilance network, and the Ministry of Health to quickly provide understandable, clear, expert answers to the general population's concerns regarding COVID-19 and drug use and to counter fake news.

Clinical pharmacist facilitators in primary care: a descriptive study of their roles and services provided in general practices of southern New Zealand.

INTRODUCTION Internationally, the inclusion of pharmacists into general practice as clinical pharmacy facilitators has improved patient outcomes. However, clinical pharmacists are relatively new to southern New Zealand general practices and their range of services has not been studied. AIMS To describe the implementation of clinical pharmacist services in general practices in the Southern region; to examine the tasks conducted by clinical pharmacy facilitators; and to determine the characteristics of patients who access this service. METHODS The establishment and development of the clinical pharmacy facilitator role was determined by documentation held within the local Primary Health Organisation. The activities performed by clinical pharmacy facilitators were collected from patient medical records for the period 31 March 2015 to 31 March 2018. To describe the characteristics of patients receiving these services, a retrospective case note review of patients seen by the facilitators was conducted. RESULTS The clinical pharmacy facilitator role was initiated with three pharmacists in three geographical locations across the region. Within 18 months, the number of facilitators was increased to eight. As a result of collaboration with the general practice team, 42% of referrals came from general practitioners directly. Overall, 2621 medicine-related problems were identified in 2195 patients. Dosage adjustment was the most common recommendation made by pharmacy facilitators. They consulted mostly older patients and patients taking five or more medicines. DISCUSSION With effective collaboration, clinical pharmacy facilitators can play a key role in optimisation of medicines therapy.

A systematic review examining the effectiveness of medicines information services for patients and the general public.

OBJECTIVES: Hospital-based patient medicines helpline services (PMHS) and medicines information services for the general public (MISGP) are available in many countries to support people with their medicines. Our aim was to examine the available evidence regarding the effectiveness of PMHS and MISGP. METHODS: Searches were conducted using Medline, EMBASE, CINAHL, Scopus and Web of Science, on 11 August 2018. Forward and backward citation searches were conducted, grey literature was searched, and study quality/risk of bias was assessed. Findings were synthesised in a narrative synthesis. Where appropriate, weighted means were calculated. KEY FINDINGS: Thirty-two studies were identified for inclusion (17 published articles, 15 conference abstracts). Eighteen studies were conducted within the United Kingdom. Mean quality assessment was moderate (51%), and risk of bias was high (63%). PMHS and MISGP are both typically perceived as positive (e.g. 94% and 91% of participants were satisfied with using a PMHS and MISGP, respectively). For PMHS, the advice received is reported to be usually followed (94%, and 66% for MISGP). For both services, users report several positive outcomes (e.g. problems resolved/avoided, feeling reassured and improved health). PMHS may also be effective for correcting medicines-related errors (up to 39% of calls may concern such errors) and for potentially avoiding medicines-related harm (48% of enquiries concerned situations that were judged to have the potential to harm patients). CONCLUSIONS: Findings suggest that both PMHS and MISGP may be beneficial sources of medicines-related support. However, the moderate quality and high risk of bias of studies highlight that more high-quality research is needed.

Development of a Drug Information Service Collaborative in Academia.

Evidence-based medicine (EBM) has been positively accepted by clinicians; however, there are barriers to practicing EBM that create gaps between EBM and current clinical practice. A pharmacist-led drug information (DI) service initiative was established to overcome common barriers to practicing EBM. The service utilizes technology and a collaborative model among otherwise independent academic DI centers to provide efficient high-quality service to health care professionals. It was piloted at a large health care system with positive user satisfaction. The unique technological collaborative has shown several benefits, including increased efficiency and peer learning among DI pharmacists.

Survey of drug information centers in the United States-2018.

PURPOSE: To provide a current directory of drug information centers (DICs) in the United States and present information about their characteristics, activities and services, and networking activities. METHODS: In February 2018, an electronic 23-question survey was delivered to 118 contacts on a distribution list compiled from previous directories of DICs, responses to listserv messages, and an Internet search. DICs, defined as formal centers dedicated to providing drug information services, including but not limited to responding to drug information requests, were asked questions about their characteristics, activities and services, drug information requests, and networking activities. RESULTS: The response rate was 79% (93 of 118 DICs). Of the 93 respondents, 82 (88%) met the definition of a DIC and were included in the directory. Of the 82 included DICs, 37 (45%) belonged to a university or college, while 36 (44%) belonged to a medical center or hospital. Seventy percent of the DICs (n = 57) had been in existence for more than 20 years. Of the 81 respondents reporting activities performed at the DICs, precepting pharmacy students (n = 79, 98%) and training pharmacy residents and/or fellows (n = 68, 84%) were most commonly reported. Nearly 90% reported that answering drug information questions was central to the DIC operations. Most DICs (n = 52, 65%) indicated receiving an average of 50 requests or less on a monthly basis. DICs reported a variety of electronic means of communicating with the DIC community, although 16 (21%) of the 77 respondents reported no need to do so. CONCLUSION: The survey identified 82 DICs that collectively provide a variety of services to their clienteles. The DIC directory published herein should facilitate networking among DICs.

Facilitators and barriers in implementing medication safety practices across hospitals within 11 European Union countries

BACKGROUND: The study was carried out as part of the European Network for Patient Safety (EUNetPas) project in 2008-2010. OBJECTIVE: To investigate facilitators and barriers in implementation process of selected medication safety practices across hospitals within European Union countries. METHODS: This was an implementation study of seven selected medication safety practices in 55 volunteering hospitals of 11 European Union (EU) member states. The selected practices were: two different versions of medicine bed dispensation; safety vest; discharge medication list for patients; medication reconciliation at patient discharge; medication reconciliation at patient admission and patient discharge, and sleep card. The participating hospitals submitted an evaluation report describing the implementation process of a chosen practice in their organisation. The reports were analysed with inductive content analysis to identify general and practice-specific facilitators and barriers to the practice implementation. RESULTS: Altogether 75 evaluation reports were submitted from 55 hospitals in 11 EU member states. Implementation of the medication safety practices was challenging and more time consuming than expected. The major reported challenge was to change the work process because of the new practice. General facilitators for successful implementation were: existence of safety culture, national guidelines and projects, expert support, sufficient resources, electronic patient records, interdisciplinary cooperation and clinical pharmacy services supporting the practice implementation. CONCLUSIONS: The key for the successful implementation of a medication safety practice is to select the right practice for the right problem, in the right setting and with sufficient resources in an organization with a safety culture

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The characteristics of drug information inquiries in an Ethiopian university hospital: A two-year observational study.

The types of drug-related information request from patients and health professionals, the extent of inquiry and capability of existing drug information centers are seldom studied in Ethiopia. This study aimed to identify the types and potential areas of drug information inquiry at the Drug Information Center (DIC) of Gondar University specialized Hospital (GUSH), Ethiopia. An observational study was employed. The drug information query was collected by distributing the drug information queries in different hospital units through two batches of graduating undergraduate pharmacy students. Descriptive statistics used to describe, characterize and classify drug related queries. Binary logistic regression test was employed to identify predictor variables to type of drug information query. A total of 781 drug related queries were collected and 697 were included in the final analysis. Near to half (45.3%) of queries comes from the pharmacists followed by general practitioners (11.3%) and nurses (10.2%). Slightly greater than half of the queries (51.9%) were focused on therapeutic information. 39.6% of drug related queries related to infectious disease case scenarios, followed by cardiovascular cases in 21.3% of queries. More than half of (53.9%) and nearly one in five (19.4%) of the queries took 5 to 30 minutes and 30 minutes to 1 hour of literature searching to answer, respectively. Pharmacists (with odds ratio of 2.474(95% CI (1.373-4.458)) and patients (with odds ratio of 4.121(1.403-12.105)) ask patient-specific questions in their drug related queries higher than other group of health professionals. Pharmacists are the primary drug information users and frequent drug related information inquirers at the DIC. Most of the queries targeted therapeutic indications, adverse drug events, infectious or cardiovascular disease related requests. This is imperative that drug information services can assist the growing role of pharmacists in addressing the patient specific drug related needs.

Information seeking behavior and awareness among physicians regarding drug information centers in Saudi Arabia

Background: The role of Drug Information Center (DIC) in a health-care setting has increased tremendously owing to the high influx of pharmaceutical molecules that pose serious challenges to physicians. DIC promotes rational prescribing behavior among physicians, leading to better patient outcome. Objectives: This study aimed to explore information-seeking behaviors and awareness of physicians regarding DIC services in the Kingdom of Saudi Arabia. Methods: A cross-sectional study was conducted among physicians working in government and private sectors between June to November 2018 by using an 18-item electronic anonymous questionnaire. Descriptive and inferential statistics were performed using IBM SPSS (Version 21). A P-value of <0.05 was taken as the level of significance between responses. Results: In total, 500 questionnaires were distributed among the included hospitals, and only 254 physicians (response rate: 50.8%), including 193 males (76%), participated in the study. The majority of participants (n = 83, 32.7%) had more than ten years of experience, and many of the respondents (n=131) worked as residents. Most of the physicians (62.9%) were aware of their institutional DIC. UpToDate was the most preferred drug information database among physicians. Regarding the improvement required in the DIC services, most of the physicians (23.6%) opined that the contact details should be available in all clinical wards. Conclusions: Only 10% of the respondents were not aware of the presence of DIC at their institution. The UpToDate online drug information database was the most frequently used database by the physicians. Our findings showed that there is a need for conducting educational programs for physicians regarding DIC services. Such an attempt can increase the frequency of drug-related queries and promote patient safety

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Implementation and evaluation of medicine and therapeutic information service by clinical pharmacists in oncology care setting.

BACKGROUND: This study was conducted to explore the role of clinical pharmacists in providing medicine and therapeutic information service in oncology care setting. METHODS: It was a prospective study conducted for a period of three years after implementation of medicine and therapeutic information service as an integral part of oncology pharmacy services. The medicine and therapeutic information queries were received during ward rounds, at ambulatory care and via telephone by clinical pharmacists. All the medicine and therapeutic information requests were reviewed and answered to the concerned requester(s). Answered medicine and therapeutic information requests were electronically documented in the hospital drug information database and analyzed further. RESULTS: A total of 484 medicine and therapeutic information requests were received by clinical pharmacists during period of August 2013 to June 2016. Majority of medicine and therapeutic information queries were requested by radiation oncologists (27.2%) followed by medical oncologists (26.4%), general physicians (14.04%), resident medical officers (11.7%), ambulatory care nurses (8.6%), in-patient nurses (5.1%) and patients and care takers (6.6%). Majority of the medicine and therapeutic information queries were asked for the purpose of improving patient care (48.3%) followed by to update knowledge (30.9%) and training sessions to nurses (6.6%). The most common categories of medicine and therapeutic information were adverse drug reactions and its management (21.4%) followed by dosage adjustments of chemotherapy and biologicals (15.5%), supportive care related (14.6%), contraindications (14%), drug-drug interactions (11.9%), management of co-morbidities (7.8%), chemotherapy selection in special populations (4.5%). CONCLUSION: The provision of medicine and therapeutic information was found to be useful in providing medicine information to improve patient care and to update knowledge of health care professionals at the study hospital.

Telepharmacy for remote hospital inpatients in north-west Queensland.

Clinical pharmacy service delivery is currently a significant challenge in remote areas. Mount Isa Base Hospital provides clinical pharmacy support to ten remote sites across an area of over 300,000 square kilometres. These sites do not have on-site pharmacists available and, due to the vast distances and unpredictable travel conditions, the outreach pharmacist from Mount Isa Base Hospital only visits sporadically. Provision of direct patient care and advice on medication safety with this model was restricted and insufficient. Telepharmacy provides an opportunity for these services to be vastly expanded. In an attempt to increase pharmacist accessibility for remote hospital sites, the Mount Isa Base Hospital pharmacy department developed an inpatient telepharmacy service. Telehealth equipment is being used to communicate directly with patients and hospital staff, review inpatient medication charts, generate patient medication lists, identify and resolve clinical interventions and provide medication-related advice and counselling. As a result of this implementation, all patients and health professionals in remote north-west Queensland hospitals now have access to a pharmacist. The number of inpatient medication reviews, clinical interventions and patient-pharmacist/clinician-pharmacist interactions occurring at each remote hospital site has increased. Since service initiation, 106 medication-related reviews have been completed via telepharmacy, including 48 patient interactions, and 111 medication-related interventions have been made. This paper outlines the process for the development of an inpatient telepharmacy service for remote hospitals and discusses the benefits and limitations associated with implementation.

Brazilian Drug Information Centre: descriptive study on the quality of information 2010-2015 / Centro Brasileño de Información sobre Medicamentos: estudio descriptivo de la calidad de la información 2010-2015

Objective: To define the activities of the Drug Information Centre of the Federal Council of Pharmacy (Cebrim/FCP), to describe the passive information and the satisfaction of its users. Method: The centre has a computerized system for recording and storing the received questions and their answers: the Sistema de Informação Farmacoterapêutica SIFAR (Pharmacotherapeutical Information System) that generates management reports; out of these, the reports from the period 2010 to 2015 were analyzed. Results: The main activity carried out by the centre was the passive information provided to pharmacists and undergraduate Pharmacy students. The most frequent subjects were: administration and way of use of medicines and indication and drug interactions, which were answered in less than 24 hours in most cases. Approximately 80% of those users who completed the satisfaction survey rated the service provided as good and optimal. Conclusion: Cebrim/FCP provides objective, updated and timely information (passive information) on medicines for pharmacists, with administration and way of use as the most recurrent subjects, and the majority of applicants were satisfied with the service (AU)

Objetivo: Caracterizar las actividades del Centro de Información sobre Medicamentos del Consejo Federal de Farmacia (Cebrim/CFF), describir la información pasiva y la satisfacción de sus usuarios. Método: El centro cuenta con un sistema informatizado de registro y almacenamiento de preguntas y respuestas recibidas (Sistema de Informação Farmacoterapêutica SIFAR), que genera informes gerenciales, del cual fueron analizados los informes del período de 2010 a 2015. Resultados: La actividad principal realizada por el centro fue la información pasiva brindada a farmacéuticos y estudiantes de pregrado de Farmacia. Los temas más frecuentes fueron administración y modo de uso de los medicamentos e indicación e interacciones medicamentosas, con respuesta en menos de 24 h, en la mayoría de los casos. Entre los usuarios que cumplimentaron la encuesta de satisfacción, aproximadamente el 80% de los usuarios clasificaron el servicio brindado como bueno y óptimo. Conclusión: Cebrim/CFF brinda información objetiva, actualizada y oportuna (información pasiva) sobre medicamentos para profesionales farmacéuticos, con administración y modo de uso como temas más recurrentes, y la gran mayoría de los solicitantes están complacidos con el servicio (AU)

Assessment and use of drug information references in Utah pharmacies

Objective: To determine which drug references Utah pharmacists use most frequently. To determine which types of drug information questions are most commonly asked, and whether Utah pharmacists have access to adequate references to respond to these questions. Methods: A 19-question survey was created using Qualtrics, LLC (Provo, Utah) software. An electronic survey link was sent to 1,431 pharmacists with a valid e-mail address listed in the Department of Professional Licensing database. Questions focused on available references in the participant’s pharmacy, how current the references are, and the participant’s use of the references. Surveys were analyzed for participants practicing in either community or hospital pharmacies in the state of Utah. Results: A total of 147 responses were included in the analysis. Approximately 44% of respondents practiced in the community, and 56% practiced in a hospital setting. The most commonly used references by Utah pharmacists are Micromedex, Lexicomp, UpToDate, Clinical Pharmacology, and Drug Facts & Comparisons. Pharmacists in the community frequently receive questions related to adverse drug reactions, drug interactions, and over-the-counter medications. Pharmacists in the hospital frequently receive questions relating to dosage and administration, drug interactions, and adverse drug reactions. About 89% of community pharmacists and 96% of hospital pharmacists feel available references are adequate to answer the questions they receive. Conclusions: Utah pharmacists generally use large reference suites to answer drug information questions. The majority of pharmacists consider the references available to them to be adequate to answer the questions they receive (AU)

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Actions in response to drug safety signals arising from a spontaneous reporting system: Retrospective study in The Netherlands.

BACKGROUND: There is limited information on actions taken in response to drug safety signals originating from a spontaneous reporting system (SRS) in pharmacovigilance. In The Netherlands the Pharmacovigilance Centre Lareb is an independent organization that works in close collaboration with the Dutch regulatory agency, the Medicines Evaluation Board (MEB). OBJECTIVE: The objective of this study is to gain insight in steps undertaken on signals originating from the SRS and disseminated by Lareb from 2008-2012. METHOD: For all signals the recommendations of Lareb and the following steps proposed by the MEB were analyzed. Secondary outcomes were prioritization of the signal, the year of dissemination and if Lareb published (inter)nationally about the signal. Pearson's Chi-square (X2) and Mantel-Haenszel statistics were used for statistical analysis. RESULTS: Of all signals disseminated by Lareb from 2008-2012, 90,7% resulted in an action: in 87% a regulatory action and in 36% an (inter)national publication. Generally, Lareb's recommendations correspond to steps undertaken by the MEB. CONCLUSION: This study found influence of signal prioritization on Lareb's recommendations but not on the steps undertaken by the MEB. Trends over time were only seen for steps undertaken by the MEB. These differences are most probably due to responsibilities of the different EU member states of various drugs.

Relationship Between Time Consumption and Quality of Responses to Drug-related Queries: A Study From Seven Drug Information Centers in Scandinavia.

PURPOSE: The aims of this study were to assess the quality of responses produced by drug information centers (DICs) in Scandinavia, and to study the association between time consumption processing queries and the quality of the responses. METHODS: We posed six identical drug-related queries to seven DICs in Scandinavia, and the time consumption required for processing them was estimated. Clinical pharmacologists (internal experts) and general practitioners (external experts) reviewed responses individually. We used mixed model linear regression analyses to study the associations between time consumption on one hand and the summarized quality scores and the overall impression of the responses on the other hand. FINDINGS: Both expert groups generally assessed the quality of the responses as "satisfactory" to "good." A few responses were criticized for being poorly synthesized and less relevant, of which none were quality-assured using co-signatures. For external experts, an increase in time consumption was statistically significantly associated with a decrease in common quality score (change in score, -0.20 per hour of work; 95% CI, -0.33 to -0.06; P = 0.004), and overall impression (change in score, -0.05 per hour of work; 95% CI, -0.08 to -0.01; P = 0.005). No such associations were found for the internal experts' assessment. IMPLICATIONS: To our knowledge, this is the first study of the association between time consumption and quality of responses to drug-related queries in DICs. The quality of responses were in general good, but time consumption and quality were only weakly associated in this setting.

Patients' views on electronic patient information leaflets

Background: Information in society and in health care is currently undergoing a transition from paper to digital formats, and the main source of information will probably be electronic in the future. Objective: To explore patients’ use and perceptions of the patient information leaflet included in the medication package, and their attitude towards a transition to an electronic version. Methods: The data was collected during October to November 2014 among individuals in South-Eastern Sweden, using a questionnaire (n=406, response rate 78%) and interviews (n=15). Results: The questionnaire showed that the majority of the respondents (52%) occasionally read the patient information leaflet, 37% always read it, and 11% never read it. Almost half of the patients (41%) were positive towards reading the patient information leaflet electronically while 32% were hesitant and 26% neutral. A majority of the patients would request to get the patient information leaflet printed at the pharmacy if it was not included in the package. There were differences in attitude related to age and gender. The interviews showed that patients had mixed views on a transition to an electronic patient information leaflet. The patients perceived several positive aspects with an electronic patient information leaflet but were concerned about elderly patients. Conclusion: Although many were positive towards reading the patient information leaflet electronically, the majority prefer the patient information leaflet in paper form. Providing appropriate and useful eHealth services for patients to access the patient information leaflet electronically, along with education, could prepare patients for a transition to electronic patient information leaflet (AU)

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Piloting social engagement on a federal agency-administered Facebook page.

OBJECTIVES: To evaluate the impact of a Federal drug information center initiating engagement with stakeholders on a Facebook Page administered by a Federal Agency. SETTING: The U.S. Food and Drug Administration (FDA) Facebook page from July 21, 2014, to October 18, 2014. PRACTICE INNOVATION: FDA's Division of Drug Information (DDI) in the Center for Drug Evaluation and Research (CDER) Office of Communications serves as a federal drug information center providing timely, accurate, and useful information on CDER initiatives and CDER-regulated products. We report a 90-day (July 21 to October 18, 2014) pilot during which DDI pharmacists monitored and moderated comments received on FDA's Facebook page to identify those warranting a reply. Once identified, DDI pharmacists replied within 2 business days. EVALUATION: Impact was measured by comparing the average number of Likes, Shares, and Reach for Facebook posts before and after the pilot. Additional metrics collected include the number of DDI replies provided to stakeholders' comments and the number of DDI replies provided on time (within 2 business days). RESULTS: During the pilot, DDI contributed 14 posts. On average, each post reached 23,582 more individuals (an increase of 187% compared with pre-pilot posts). On average, each post also received 463 more Likes (450% increase) and 130 more Shares (271% increase). DDI pharmacists replied to 3% (121/3994) and hid 0.58% (23/3994) of Facebook comments received during the 90-day period. All actions were taken within 2 business days. CONCLUSION: Initiating social engagement had a positive impact on FDA's Facebook page.