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.

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.

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.

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.

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.

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.

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.

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.

Development and feasibility of the misuse, abuse, and diversion drug event reporting system (MADDERS®).

BACKGROUND AND OBJECTIVES: Inappropriate use of analgesic drugs has become increasingly pervasive over the past decade. Currently, drug abuse potential is primarily assessed post-marketing; no validated tools are available to assess this potential in phase II and III clinical trials. This paper describes the development and feasibility testing of a Misuse, Abuse, and Diversion Drug Event Reporting System (MADDERS), which aims to identify potentially abuse-related events and classify them according to a recently developed classification scheme, allowing the quantification of these events in clinical trials. METHODS: The system was initially conceived and designed with input from experts and patients, followed by field-testing to assess its feasibility and content validity in both completed and ongoing clinical trials. RESULTS: The results suggest that MADDERS is a feasible system with initial validity. It showed higher rates of the triggering events in subjects taking medications with known abuse potential than in patients taking medications without abuse potential. Additionally, experts agreed on the classification of most abuse-related events in MADDERS. DISCUSSION AND CONCLUSIONS: MADDERS is a new systematic approach to collect information on potentially abuse-related events in clinical trials and classify them. The system has demonstrated feasibility for implementation. Additional research is ongoing to further evaluate its validity. SCIENTIFIC SIGNIFICANCE: Currently, there are no validated tools to assess drug abuse potential during clinical trials. Because of its ease of implementation, its systematic approach, and its preliminary validation results, MADDERS could provide such a tool for clinical trials. (Am J Addict 2016;25:641-651).

[The system of information concerning pharmaceuticals and its role in efficient using of medicines: opinion of medical specialists].

The issues of efficient application of pharmaceuticals by national authorities and supranational institutions are considered as important ones. The WHO recommends implementing twelve key propositions enhancing efficient application of pharmaceuticals. The development of independent information system concerning pharmaceuticals. The WHO recognizes that absence of neatly organized information system concerning pharmaceuticals information is usually spreading through different channels by manufacturers of medicines. The WHO determines admissible sources of information concerning pharmaceuticals and also requirements to content of presented information. The article presents results of survey of opinions of medical professionals about information sources concerning pharmaceuticals regulated in the Russian Federation and the WHO and also about actual information system concerning pharmaceuticals in the Russian Federation and its role in efficient application of medicines.

A comparison of the Indian Health Service counseling technique with traditional, lecture-style counseling.

OBJECTIVES: To compare the immediate postcounseling retention of important information using the traditional method with retention obtained using the Indian Health Service (IHS) interactive technique, and to compare the time required to counsel patients on new prescriptions using the traditional method with the time required using the IHS technique. DESIGN: A prospective, nonrandomized, observational study at four different local community pharmacies in Oregon. Two sites that used the traditional counseling model served as the control sites, while two other sites used the IHS counseling model. Only new prescriptions were included in this study. The pharmacists did not alter their counseling styles for new prescriptions for the purposes of this study. The duration of counseling between the pharmacist and patient was recorded. Immediately upon completion of counseling, patients met with the primary investigator for postcounseling knowledge assessment on indication of therapy, directions on how to take their medication properly, and expected adverse effects. SETTING: Four local community pharmacies in Oregon. PARTICIPANTS: Five hundred patients at four local community pharmacies in Oregon. INTERVENTION: Use of the IHS counseling technique. MAIN OUTCOME MEASURES: Immediate recall of key counseling points and time per counseling session. RESULTS: A total of 500 patients participated in the study. Seventy-one percent of patients counseled using the IHS technique answered all three questions correctly, compared with 33% of patients counseled using the traditional method (P <0.00). For patients who were counseled about adverse effects, 80% counseled using the IHS technique compared with 51.5% counseled using the traditional approach answered all three questions correctly. For indication of therapy, there was no evidence of a difference in the proportion of correct answers between counseling types on the reason for taking their medication (P = 0.06). Those who received IHS counseling had four times the odds of correctly answering when to take their medication and four times the odds of correctly answering all adverse effects questions. The duration of counseling methods differed by 53 seconds (128 s for IHS vs. 75 s for traditional). CONCLUSION: The interactive style of the IHS method of counseling provided significantly improved immediate memory recall compared with the traditional method. The IHS method also took longer than the traditional method.