Medical Information Department Research Articles

PhactMI™ Benchmarking Survey: Analysis of 27 Medical Information Departments Responses to Inquiries from Health Care Decision Makers.

The nature in which health care insurance companies have interacted with drug manufacturers has evolved over the last 50years, demanding shifts in how the pharmaceutical industry responds. The purpose of this article is to highlight how medical groups within Pharma Collaboration for Transparent Medical Information (phactMI™) member companies respond to requests from health care decision makers (HCDMs) and to understand the similarities and differences among drug manufacturers (DMs) in this evolving climate of information exchange. As health care insurance companies transition towards a managed care model and began assessments of both the clinical and economical aspects of drug products, DMs began to respond to requests from HCDMs. An anonymous 16-question survey was conducted to evaluate how 27 Medical Information departments (MIDs) respond to payer requests for information, and to identify payer needs in order to provide a better overall customer experience. The results from this survey provided insight into the overall management of payer unsolicited medical requests (PUMRs) and focused on a few different areas, including how requests are received, what materials are requested and which are sent, online availability, and availability of materials for products in the pipeline. Further discussion is recommended to ensure a focused approach in developing tools and identifying appropriate resources are available to address inquiries from HCDMs.

Pharma Collaboration for Transparent Medical Information (phactMI™) Benchmark Study: Results of Organizational Structure and Resourcing of Medical Information Services in Support of Building Departmental Strategies.

An opportunity exists to leverage the collective insights and experiences of phactMI™ member companies on current medical information (MI) services across the pharmaceutical industry. The collective insights provide considerations for refined MI strategies and enhanced MI services. The trend of organizational structure and challenge of resourcing for MI services are key areas to support efficiency and bring value to the overall organization. Between December 2017 and February 2018, all 27 phactMI™ member companies were electronically sent a 300-question survey to support the development of MI services across the pharmaceutical industry. The survey had 9 key areas of focus, including organizational structure and resourcing. All 27 companies responded to the survey. Although the 27 companies survey differed in structure and size, the MI responsibilities performed both by in-house and outsourced groups were similar with each organization. Half of the groups outsourced various responsibilities which supported the non-product roles, such as quality assurance, compliance reporting, vendor operations management, reporting/analytics, technology and digital support, content-related process work, presentation specialists, and payer and health system support. Despite the ever-changing nature of the pharmaceutical industry, most responsibilities and outsourced work by MI groups remain the same over time. These findings provide MI teams various options for organizational structuring and resource strategies for MI services. These results highlight the services and focus areas that MI departments can explore and support the development of additional MI services across the pharmaceutical industry.

PhactMI Benchmarking Survey on Content Development and Inquiry Management.

Medical information (MI) departments across pharmaceutical companies respond to medical inquiries about a company's products to healthcare providers, payors, patients, and caregivers. Responses provided are constructed to be relevant, accurate, scientifically balanced and delivered in a timely manner. Benchmarking surveys of MI groups have been conducted in the past to assess current trends and identify areas of optimization that ultimately benefit the customers. From December 2017 to February 2018, 27 U.S. pharmaceutical member companies of phactMI™, Pharma Collaboration for Transparent Medical Information, were provided a survey of 307 questions divided among nine topics to capture attributes of pharmaceutical industry medical information organizations, including inquiry management and content development. At the time of the survey, a total of 27 phactMI member companies existed and completed the survey. Detailed results are provided on the inquiry response process, including contact center services, escalation processes, use of unique delivery channels, and reported key performance indicators. The evolving nature of content formats and features, including page length, custom responses, and enhancements are addressed. Finally, resourcing and structure of these two areas are also detailed from the 27 member companies. The findings from this comprehensive benchmarking survey provide insights into the current state of inquiry response processes and content management. There continue to be opportunities to demonstrate and increase the value of MI to ensure that companies are meeting the expectations of the ever-changing needs of our customers. phactMI and the member companies continue to seek innovative ways of providing medical information in their commitment to enhancing patient care.

Evaluating Literature for Oncology Data Gaps to Improve the Quality of Standard Response Letters: A Retrospective Review

Medical information departments are responsible for maintaining standard response letters to address health care providers' inquiries. Several factors, including Food and Drug Administration regulations, insufficient diversity in clinical trials, and stringent exclusion criteria, might limit the information available to respond to unsolicited requests. However, if new data becomes available for an inquiry that was previously unanswered, it is not common practice for medical information departments to provide an updated response to health care providers. Therefore, the purpose of this study is to evaluate the impact of reviewing literature to provide an updated response to health care providers. We conducted a 1-year retrospective review of medical inquiries regarding a Bristol-Myers Squibb oncology product. We identified medical inquiry responses that were missing data via our metrics reporting software and conducted an internal and external literature search to assess if new data became available. Of 21,264 unsolicited global inquiries, data were unavailable for 531 (2.7%). The 3 most frequently observed inquiry topics were "use in special populations" (32%), "drug interactions" (27%), and "adverse events and safety" (23%). After performing an internal and external literature review, we developed standard response letters for 30% of medical inquiries that were previously unanswered. Medical information departments serve as a resource to answer product-related questions for health care providers. However, data are not always available to provide a response. On discovery of new data, if medical information departments followed up with health care providers to share new data, this could potentially increase patient safety, build stronger relationships with health care providers, and obtain insights that could influence strategies in future clinical trials and publications.

Survey of Customers Requesting Medical Information: Preferences and Information Needs of Patients and Health Care Professionals to Support Treatment Decisions.

Pharmaceutical manufacturer medical information (MI) departments play an important role in providing medical information to health care professionals (HCPs) and patients. A survey was conducted to gather insights on the utility of MI services and to understand the information needs/preferences to support therapy decisions. Patients (n=40) and HCPs (n=192) who requested medical information in a 3-month time frame from 4 companies were surveyed (15 questions for patients; 28 questions for HCPs). Patients contacted MI departments for information on concerns about side effects, efficacy information, access/insurance coverage, how to take the medicine, switching medicine, how the medicine works, comparison to another medicine, medical condition information, and participating in trials. Patients reported that the medical information received changed the perception toward the treatment in the following ways: learned something new about the treatment, provided more confidence to talk to an HCP, and were potentially more likely to start treatment. Health care professionals requested medical information related to dosing, safety, patient selection, and differentiating between therapeutic options. The HCPs used the medical information to take an action (eg, managing treatment for patients or deciding to prescribe a medicine), to support informing-type of activities (eg, help guide discussions with patients, plan to use information for future treatment decisions/ discussion, help with insurance coverage determination, or help to enroll patients into ongoing clinical trials), and to meet an education need (eg, self-education or sharing information with practice/colleagues). These results describe patients' and HCPs' information needs/preferences that provide MI departments potential areas for enhancing services.

The role of a pharmacist as a medical information specialist in the pharmaceutical industry

IntroductionThe literature has limited information on pharmacists working in the alternate career path of a medical information specialist in the pharmaceutical industry. The purpose of this study was to gather the background, functions, and skills of pharmacists working in the role of a medical information specialist (MIS) and their preparation for the role through their pharmacy education. MethodsAn electronic survey was sent to medical information departments and obtained information on educational background, prior job experience, and skills required for the MIS role. The survey also asked for suggestions on how pharmacy schools can prepare students for this role. ResultsThe survey was sent to 40 medical information departments from September to December 2017 and a total of 33 pharmacists responded. Approximately half of the responders did not complete post graduate training. The role of a MIS includes answering medical information questions and collecting adverse events and product complaints. Skills rated as important to the role as a MIS were communication skills, medical writing, and literature evaluation. Four pharmacists thought their pharmacy education definitely prepared them for role in medical information. The pharmacists suggested pharmacy curriculum focus more on drug information skills, structure of the pharmaceutical industry, and providing opportunities to improve emotional intelligence and critical thinking. ConclusionThe information collected in this survey can provide valuable insight for students interested in this career path. In addition, pharmacy schools may include more opportunities during the didactic and experiential years to help prepare students for this alternate career path.

Pharma Collaboration for Transparent Medical Information (phactMI) Benchmark Study: Trends, Drivers, Success Factors, and Value of Globalization in Medical Information.

Over the past decade, biopharmaceutical companies have been progressively establishing global frameworks across their capabilities. It is well recognized that the Medical Information (MI) department is a key externally facing function that needs to maintain a consistent focus on optimizing its capabilities of addressing product medical inquiries worldwide. In the United States, a consortium named Pharma Collaboration for Transparent Medical Information, phactMI, a collaboration of pharmaceutical company MI departments dedicated to supporting health care professionals in their commitment to provide quality patient care, has provided a forum to benchmark and share best practices across the companies. In May 2017, phactMI conducted a survey inclusive of 25 biopharmaceutical companies to gain insight into the globalization of respective MI departments and relevant trends. We found increased trends in various aspects of globalization across large, mid, and small size companies, and identified key drivers for success. Overall, 16 of the 25 companies had globalized their MI department, 5 had only partially globalized, and the remaining 4 had not globalized. The findings of this survey will further help inform the MI community as to globalization approaches for a successful outcome.

Anterior cervical spine surgical site infection and pharyngoesophageal perforation. Ten-year incidence in 1475 patients

BackgroundSurgical site infection is reputed to be infrequent in anterior cervical spine surgery. Data on pathophysiological mechanism and risk factors are sparse. The relationship between local site infection and pharyngoesophageal perforation is unclear. The present study aimed: (1) to estimate the incidence of surgical site infection in anterior cervical spine surgery, (2) estimate the incidence of associated pharyngoesophageal perforation, and (3) suggest a decision-tree for early management of this two-fold issue. HypothesisAlthough with very low incidence, anterior cervical spine surgical site infection and pharyngoesophageal perforation are frequently associated. Material and methodsA 2-center retrospective study included all anterior cervical spine surgeries between January 1, 2007 and December 31, 2016. Data were provided by the two medical information departments. Patients undergoing anterior revision surgery on the cervical spine were included. Files were analyzed to determine whether the revision surgery was secondary to surgical site infection. ResultsIn total, 1475 patients with anterior cervical spine surgery were identified: 1180 in center A (80%) and 295 in center B (20%). The rate of revision surgery for surgical site infection was 0.34% (5/1475). There were 3 cases of pharyngoesophageal perforation (0.2%). DiscussionThe incidence of revision surgery for anterior cervical spine surgical site infection was comparable to rates in the international literature (0.07–1.6%). An association between surgical site infection and pharyngoesophageal perforation was frequent, but not statistically significant. This complication is extremely serious, requiring urgent multidisciplinary management. Level of evidenceIV, retrospective study.

Evaluating Literature for Oncology Data Gaps to Improve the Quality of Standard Response Letters: A Retrospective Review

Medical information departments are responsible for maintaining standard response letters to address health care providers' inquiries. Several factors, including Food and Drug Administration regulations, insufficient diversity in clinical trials, and stringent exclusion criteria, might limit the information available to respond to unsolicited requests. However, if new data becomes available for an inquiry that was previously unanswered, it is not common practice for medical information departments to provide an updated response to health care providers. Therefore, the purpose of this study is to evaluate the impact of reviewing literature to provide an updated response to health care providers. We conducted a 1-year retrospective review of medical inquiries regarding a Bristol-Myers Squibb oncology product. We identified medical inquiry responses that were missing data via our metrics reporting software and conducted an internal and external literature search to assess if new data became available. Of 21,264 unsolicited global inquiries, data were unavailable for 531 (2.7%). The 3 most frequently observed inquiry topics were "use in special populations" (32%), "drug interactions" (27%), and "adverse events and safety" (23%). After performing an internal and external literature review, we developed standard response letters for 30% of medical inquiries that were previously unanswered. Medical information departments serve as a resource to answer product-related questions for health care providers. However, data are not always available to provide a response. On discovery of new data, if medical information departments followed up with health care providers to share new data, this could potentially increase patient safety, build stronger relationships with health care providers, and obtain insights that could influence strategies in future clinical trials and publications.

Survey of Customers Requesting Medical Information: Preferences and Information Needs of Patients and Health Care Professionals to Support Treatment Decisions

Pharmaceutical manufacturer medical information (MI) departments play an important role in providing medical information to health care professionals (HCPs) and patients. A survey was conducted to gather insights on the utility of MI services and to understand the information needs/preferences to support therapy decisions. Patients (n=40) and HCPs (n=192) who requested medical information in a 3-month time frame from 4 companies were surveyed (15 questions for patients; 28 questions for HCPs). Patients contacted MI departments for information on concerns about side effects, efficacy information, access/insurance coverage, how to take the medicine, switching medicine, how the medicine works, comparison to another medicine, medical condition information, and participating in trials. Patients reported that the medical information received changed the perception toward the treatment in the following ways: learned something new about the treatment, provided more confidence to talk to an HCP, and were potentially more likely to start treatment. Health care professionals requested medical information related to dosing, safety, patient selection, and differentiating between therapeutic options. The HCPs used the medical information to take an action (eg, managing treatment for patients or deciding to prescribe a medicine), to support informing-type of activities (eg, help guide discussions with patients, plan to use information for future treatment decisions/discussion, help with insurance coverage determination, or help to enroll patients into ongoing clinical trials), and to meet an education need (eg, self-education or sharing information with practice/colleagues). These results describe patients' and HCPs' information needs/preferences that provide MI departments potential areas for enhancing services.

Responding to Unsolicited Medical Requests from Health Care Professionals on Pharmaceutical Industry-Owned Social Media Sites: Three Pilot Studies.

BackgroundThe use of social media has risen tremendously over the past decade with usage rates spanning from 5% American adults in 2005 up to 69% in 2016. A 2011 survey of 4033 clinicians found that 65% physicians use social media for professional purposes. To meet the changing needs and preferences of their customers, medical information departments within the pharmaceutical industry must continue to assess new digital channels such as social media and evolve their medical information services.ObjectiveThe objective of the study was to pilot the use of social media as an additional channel to respond to unsolicited medical requests from health care professionals (HCP RUR) directed toward the pharmaceutical industry.MethodsFrom November 2016 to June 2017, 3 pilots were conducted during 3 professional congresses: the 2016 American College of Rheumatology Annual Meeting, the 2017 American Society of Clinical Oncology Annual Meeting, and the 2017 American Headache Society Annual Scientific Meeting. For each social media account, an identified community manager monitored the incoming account feed for proper triaging of posts. When an unsolicited medical request appeared, the community manager routed the question to the Tier One medical information contact center agents to respond. The following metrics were collected: total number of unsolicited requests directed to medical information contact center agents, total number of unsolicited requests that required escalation to Tier Two medical information associates, total number of unsolicited requests that were confirmed US HCPs, total number of unsolicited requests received after hours, and total number of unsolicited requests that were redirected to a different channel.ResultsDuring the 3 pilots, 9 unsolicited medical requests were received with request numbers ranging from 2 to 4 requests per pilot. Of these, 1 was from a confirmed US HCP that required escalation to the Tier Two medical information associates. A majority of requests (7 out of 9) came in after the scheduled monitoring hours. There were 4 requests redirected to the medical information contact center phone number. The marketing accounts received more unsolicited medical requests than the corporate accounts (7 vs 2, respectively), and the 3 Twitter accounts saw more overall engagement (ie, medical requests and other general engagement) than the LinkedIn account.ConclusionsA limited number of medical questions were asked by confirmed HCPs using social media during the 3 pilots. New innovative medical information contact center channels often take time to build awareness. Continued channel awareness is needed to fully understand the channel’s desired use. Because consumers currently make up a majority of social media engagement, companies should look into creating a combined consumer and HCP RUR strategy to provide a better experience for all customers.

Proposition d’un contenu standardisé et raisonné pour les lettres de liaison et les comptes-rendus d’hospitalisation à destination du médecin traitant

Background: Communication between general practitioners (GPs) and hospitals is a weak point of the French health system. Unfortunately, hospital discharge documents, a keypoint for healthcare safety and efficiency, tend to be poorly defined. This study aimed to propose standardised and logical templates for discharge letters (DL) and discharge summaries (DS) with particular attention to GPs’ needs.Methods: A Delphi methodology was conducted on the findings of a systematic review of the international literature. We recruited 28 experts including producers (hospital physicians and interns), recipients (GPs, head of the medical information department, patient representatives), and other professionals using discharge documents (representative of regional health administration for inspection and control, jurist, pharmacists).Results: A consensus was reached after two rounds of consultation. According to the experts, DS should ideally be available on the last day of hospitalization, but this is rarely possible. DL have therefore become the most important document for GPs. Two standardised and logical templates were submitted to the experts for validation. The templates were considered to be pertinent by the experts and were perceived as improving several key points such as writing and reading speed, communication between hospitals and community practitioners or safety of healthcare after discharge from hospital.Conclusion: DL and DS templates will be tested in pilot hospitals by an impact study.

Bilastine in allergic rhinoconjunctivitis and urticaria: a practical approach to treatment decisions based on queries received by the medical information department.

BackgroundBilastine is a safe and effective commonly prescribed non-sedating H1-antihistamine approved for symptomatic treatment in patients with allergic disorders such as rhinoconjunctivitis and urticaria. It was evaluated in many patients throughout the clinical development required for its approval, but clinical trials generally exclude many patients who will benefit in everyday clinical practice (especially those with coexisting diseases and/or being treated with concomitant drugs). Following its introduction into clinical practice, the Medical Information Specialists at Faes Farma have received many practical queries regarding the optimal use of bilastine in different circumstances.Data sources and methodsQueries received by the Medical Information Department and the responses provided to senders of these queries.ResultsThe most frequent questions received by the Medical Information Department included the potential for drug-drug interactions with bilastine and commonly used agents such as anticoagulants (including the novel oral anticoagulants), antiretrovirals, antituberculosis regimens, corticosteroids, digoxin, oral contraceptives, and proton pump inhibitors. Most of these medicines are not usually allowed in clinical trials, and so advice needs to be based upon the pharmacological profiles of the drugs involved and expert opinion. The pharmacokinetic profile of bilastine appears favourable since it undergoes negligible metabolism and is almost exclusively eliminated via renal excretion, and it neither induces nor inhibits the activity of several isoenzymes from the CYP 450 system. Consequently, bilastine does not interact with cytochrome metabolic pathways. Other queries involved specific patient groups such as subjects with renal impairment, women who are breastfeeding or who are trying to become pregnant, and patients with other concomitant diseases. Interestingly, several questions related to topics that are well covered in the Summary of Product Characteristics (SmPC), which suggests that this resource is not being well used.ConclusionsOverall, this analysis highlights gaps in our knowledge regarding the optimal use of bilastine. Expert opinion based upon an understanding of the science can help in the decision-making, but more research is needed to provide evidence-based answers in certain circumstances.

Survey of Health Care Practitioners’ Preferences for Medical Information: Collective Insights for Impacting Patient Care

Medical information (MI) departments play an integral role in providing fair and scientifically balanced MI to health care professionals, patients, and caregivers. Though there have been multiple surveys conducted to assess the value of MI, insights on what the informational needs are from the perspective of the health care professional to confidently making patient care decisions have not been addressed. A survey administered to health care professionals that collected insights and feedback on the utility of MI services across different pharmaceutical companies provided an understanding of the informational needs of different health care professionals for prescribing drug therapy with confidence. A total of 276 health care professionals who requested medical information in a 6-month time frame from 8 companies completed a 30-minute Internet-based survey (n = 260) or a 20-minute telephone survey (n = 16). Most health care professionals preferred obtaining medical information from traditional routes such as discussions with sales representatives or via the telephone, while very few preferred alternate routes such as mobile applications, video chats, or text. The type of medical information requested among practitioners included topics related to dosing, safety, patient selection, and differentiating between therapeutic options. When making patient care decisions, health care professionals identified 3 levels of evidence-prospective studies, practice guidelines, and meta-analyses-to be most important. Medical information responses were used for education purposes and provided physicians the confidence to make treatment decisions. For nurse practitioners/physician assistants, nurses, and pharmacists, the information provided by MI departments enhanced the quality of patient management. These findings provide information regarding the utility of medical information services while providing insights on the informational needs of health care professionals today. MI departments provide an important service to health care professionals that impart confidence for making treatment decisions.

Who Performs Lumbar Puncture, How Many Do They Perform, How and Why? A Retrospective Study of 6,594 Cases

Background: The number and indications of lumbar punctures (LPs) performed nowadays are unknown. The primary aim of this work was to report the number of LPs performed in each of the departments of 2 French university hospitals, their indications and the prevalence of atraumatic spinal needles used. Methods: We carried out a retrospective study of all the LPs performed in 2014. The clinical department in which the intervention was performed and the final diagnosis was made from the Medical Information Department. The type of needles (cutting or atraumatic) used during the study period was also available. Results: In 2014, 6,594 LPs were performed. Overall, 80% were performed for diagnostic purposes. Twenty percent of these LPs were performed in the Neurology Department and were usually carried out at routine check-ups. Overall, atraumatic needles were used in 8.0% of cases. Overall, 1.4 LPs per 100 hospital stays were performed and 0.8 LP for 100 Emergency department admissions. Conclusion: LP is a routine procedure for many clinicians and although neurologists perform the largest number of LPs, they are doing only one fifth of all procedures. Atraumatic needles are underused.

Queueing network model for obstetric patient flow in a hospital.

A queueing network is used to model the flow of patients in a hospital using the observed admission rate of patients and the histogram for the length of stay for patients in each ward. A complete log of orders for every movement of all patients from room to room covering two years was provided to us by the Medical Information Department of the University of Tsukuba Hospital in Japan. We focused on obstetric patients, who are generally hospitalized at random times throughout the year, and we analyzed the patient flow probabilistically. On admission, each obstetric patient is assigned to a bed in one of the two wards: one for normal delivery and the other for high-risk delivery. Then, the patient may be transferred between the two wards before discharge. We confirm Little's law of queueing theory for the patient flow in each ward. Next, we propose a new network model of M/G/ ∞ and M/M/ m queues to represent the flow of these patients, which is used to predict the probability distribution for the number of patients staying in each ward at the nightly census time. Although our model is a very rough and simplistic approximation of the real patient flow, the predicted probability distribution shows good agreement with the observed data. The proposed method can be used for capacity planning of hospital wards to predict future patient load in each ward.

A Collaborative Assessment Among 11 Pharmaceutical Companies of Misinformation in Commonly Used Online Drug Information Compendia.

Background: Online drug information compendia (ODIC) are valuable tools that health care professionals (HCPs) and consumers use to educate themselves on pharmaceutical products. Research suggests that these resources, although informative and easily accessible, may contain misinformation, posing risk for product misuse and patient harm. Objective: Evaluate drug summaries within ODIC for accuracy and completeness and identify product-specific misinformation. Methods: Between August 2014 and January 2015, medical information (MI) specialists from 11 pharmaceutical/biotechnology companies systematically evaluated 270 drug summaries within 5 commonly used ODIC for misinformation. Using a standardized approach, errors were identified; classified as inaccurate, incomplete, or omitted; and categorized per sections of the Full Prescribing Information (FPI). On review of each drug summary, content-correction requests were proposed and supported by the respective product’s FPI. Results: Across the 270 drug summaries reviewed within the 5 compendia, the median of the total number of errors identified was 782, with the greatest number of errors occurring in the categories of Dosage and Administration, Patient Education, and Warnings and Precautions. The majority of errors were classified as incomplete, followed by inaccurate and omitted. Conclusion: This analysis demonstrates that ODIC may contain misinformation. HCPs and consumers should be aware of the potential for misinformation and consider more than 1 drug information resource, including the FPI and Medication Guide as well as pharmaceutical/biotechnology companies’ MI departments, to obtain unbiased, accurate, and complete product-specific drug information to help support the safe and effective use of prescription drug products.

Study of parenteral iron use in a health facility and its impact in terms of hospital economics

Administration of parenteral iron is a mainstay of iron deficiency treatment. Evaluation and control of this element is an issue for healthcare facilities. Study of parenteral iron use is thus to be evaluated in its impact in terms of hospital economics. Parenteral iron administrations that took place on 2014in our healthcare facility were retrospectively identified by pharmacists. Following data were extracted from Pharma™ and Crossway™ softwares: indication, diagnostic coding and total dose of iron received. They were then compared to the summary of product characteristics. Of 198analyzed prescriptions, iron deficiency was known or suspected for 97% of patients. However, the total dose of iron administered was not in compliance for three quarters of prescriptions. Sixty-eight percent of patients appear under-dosed. Administration's traceability was found for two-thirds. Eighty-five hospital discharges did not have the right coding and 34stays were charged like an external act instead sessions. Financial loss for the hospital is estimated at 49,300euros. As part of improving practice, close pharmaceutical monitoring of parenteral iron prescribed dosing regimen is essential. Effective communication with the medical information department and regular awareness raising of prescribers should also allow to give more value to this act. Hospital economics is a real tool to aid decision-making.

Contrôle automatisé de l’exhaustivité du registre breton des malformations congénitales à partir des données des bases médico-administratives des établissements de santé

BackgroundExhaustiveness is required for registries. In the Breton registry of congenital abnormalities, cases are recorded at the source. We use hospital discharge data in order to verify the completeness of the registry. In this paper, we present a computerized tool for completeness assessment applied to the Breton registry. MethodsAll the medical information departments were solicited once a year, asking for infant medical stays for newborns alive at one year old and for mother's stays if not. Files were transmitted by secure messaging and data were processed on a secure server. An identity-matching algorithm was applied and a similarity score calculated. When the record was not linked automatically or manually, the medical record had to be consulted. The exhaustiveness rate was assessed using the capture recapture method and the proportion of cases matched manually was used to assess the identity matching algorithm. ResultsThe computerized tool bas been used in common practice since June 2012 by the registry investigators. The results presented concerned the years 2011 and 2012. There were 470 potential cases identified from the hospital discharge data in 2011 and 538 in 2012, 35 new cases were detected in 2011 (32 children born alive and 3 stillborn), and 33 in 2012 (children born alive). There were respectively 85 and 137 false-positive cases. The theorical exhaustiveness rate reached 91% for both years. The rate of exact matching amounted to 68%; 6% of the potential cases were linked manually. ConclusionHospital discharge databases contribute to the quality of the registry even though reports are made at the source. The implemented tool facilitates the investigator's work. In the future, use of the national identifying number, when allowed, should facilitate linkage between registry data and hospital discharge data.

Implementing a Process to Review Product-Specific Misinformation in Online Drug Information Compendia.

Health care professionals and consumers often use online drug information compendia, which are intended to be user-friendly, readily available, accurate, and up-to-date. While these resources can be valuable, it has been shown that some compendia contain inaccuracies and outdated information, motivating the Medical Services (medical information) Department at Purdue Pharma LP to implement a periodic, standardized review of select online drug information compendia. Monographs within compendia for up to 9 Purdue products were reviewed and compared to their current Full Prescribing Information, with a focus on identifying safety-related misinformation. Content correction requests for nearly 1000 errors were submitted to 7 compendia clinical editors. This surprisingly large number of errors highlights the need for compendia to better maintain accurate product monographs, as well as for pharmaceutical companies to proactively and periodically review them for misinformation. Based on these findings, an overview on how the pharmaceutical industry may implement a drug information compendia review process is provided.