Spanish Drug Database
Nguyet Edmondson
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The NDC Directory contains information on active and certified finished and unfinished drugs submitted to FDA in structured product labeling (SPL) electronic listing files by labelers. A labeler may be a manufacturer, including a repackager or relabeler, or the entity named on the product label.
Drug establishments producing active pharmaceutical ingredients are required to provide FDA with a current list of all drugs manufactured, prepared, propagated, compounded or processed in commercial distribution in the U.S. at their facilities.
The NDC unfinished drugs database contains product listing data submitted for all unfinished drugs, including active pharmaceutical ingredients, drugs for further processing and bulk drug substances for compounding.
Outsourcing facilities are required to provide FDA with a list of drugs they compounded during the previous six-month period upon initial registration and in June and December each year. The NDC Directory draws data from these product reports.
For finished drugs and unfinished drug products: Submit a new or updated product listing through SPL to add, correct or update product listing information in the NDC Directory. FDA does not submit or alter registration or listing data. Accuracy of the listing data is the responsibility of the company submitting the information to FDA. The agency monitors data accuracy and integrity through its compliance program. See the DRLS instructions for more information.
For compounded drugs: Outsourcing facilities submit product reports for compounded drugs twice a year and may update this data at any time. Outsourcing facilities should submit new or updated product reporting information through SPL to add, correct or update product reporting information that displays in the NDC Directory (see FDA guidance document on product reporting for outsourcing facilities).
ViDAL Consult is the most comprehensive web-based database covering a wide range of Latin American drug reference information in Spanish. ViDAL Consult drives hundred thousands of healthcare professionals in Latin America, Europe and Africa to confident decisions and is constantly updated with the latest drug information.
With ViDAL Consult, clinicians can quickly access the clinical properties of a drug as well as the related risk information concerning patients, helping them make the best decision when prescribing. Users can also identify foreign equivalences of a product from a list of almost 250,000 drugs referenced in 39 countries on 5 continents. Conversely, they can also find the local equivalents of a drug prescribed in another country.
ViDAL Group is a leading European healthcare informatics and information systems company. With a team of over 350 pharmacists, pharmacologists, physicians, researchers, health informaticists, database architects and application developers, ViDAL Group provides hospitals, primary care physicians, pharmacists, universities, family doctor and patients worldwide with on-line access to up-to-date drug databases and related treatment-based information.
The LactMed database contains information on drugs and other chemicals to which breastfeeding mothers may be exposed. It includes information on the levels of such substances in breast milk and infant blood, and the possible adverse effects in the nursing infant. Suggested therapeutic alternatives to those drugs are provided, where appropriate. All data are derived from the scientific literature and fully referenced. A peer review panel reviews the data to assure scientific validity and currency.
Disclaimer: Information presented in this database is not meant as a substitute for professional judgment. You should consult your healthcare provider for breastfeeding advice related to your particular situation. The U.S. government does not warrant or assume any liability or responsibility for the accuracy or completeness of the information on this Site.
Healthcare databases are very useful sources of post-marketing real-world information, generating evidence on drug use, safety and effectiveness, particularly in populations where such information may be lacking in pre-clinical studies, such as paediatric and geriatric populations. However, healthcare databases can also provide pre-marketing information by measuring the burden of disease, identifying unmet clinical needs and estimating the number of patients potentially eligible for innovative and costly treatment. Whether in a pre- or post-marketing setting, these data sources can provide regulatory agencies with evidence that can inform the development/implementation of regulatory interventions and answer questions of high, and often urgent, public health interest. In April 2019, the Italian Drug Agency (Agenzia Italiana del Farmaco) organised a workshop on the role of healthcare databases in supporting drug regulatory agencies in their pre- and post-marketing regulatory activities. The experiences of the USA, Canada, Spain and Italy in this context were presented.
The workshop brought together key experts in healthcare data networks, who presented the different legislative backgrounds in their countries as well as the different data utilisation strategies and governance approaches that were used to create such networks in close collaboration with respective regulatory agencies. The experiences of international experts can also provide insight into potential future steps for the creation of a stable database network in Italy that can provide accurate and rapid answers to public health questions. The Director General of the Italian Health Agency, Luca Li Bassi, opened the workshop, which was moderated by Francesco Trotta (Italian Medicines Agency) and Francesca Menniti-Ippolito (Italian National Health Institute). The workshop consisted of four talks, which were all given by speakers involved in the creation and use of database networks from their inception onward. Jeffrey Brown (Department of Population Medicine, Harvard Medical School and Harvard Pilgrim Health Care Institute, USA) provided a detailed overview of the origins of the Sentinel network in the USA; Samy Suissa (McGill University, Canada) introduced the Canadian Network for Observational Drug Effect Studies (CNODES), a Canadian nationwide network of claims databases; and Miguel Gil (Spanish Agency of Medicines and Medical Devices, Spain) described the BIFAP (Base de datos para la Investigacin Farmacoepidemiolgica en Atencin Primaria) general practice database. A description of these networks is found in Electronic Supplementary Material 1. Gianluca Trifir (University of Messina, Italy) provided a detailed description of the scientific contribution of the Italian European Network of Centres for Pharmacoepidemiology and Pharmacovigilance (ENCePP) node, a network of Italian data providers and experts in pharmacoepidemiology, pharmacovigilance and public health.
Dr Brown explained that the US Food and Drug Administration (FDA) Sentinel System is a distributed data system containing data on over 100 million persons, where each data partner retains their own data but converts it into a common data model, such that that each data partner can run a data analysis code that was sent to them after being developed and tested by the coordinating centre [1]. Each data partner maintains physical and operational control over their data, providing a high level of privacy for patients. Sentinel was mandated by the FDA, which was legally required to develop such a system. He noted that the Sentinel Initiative is a stable database network, i.e. it is developed as a long-term database network able to respond to a large number of FDA questions per year rather than as a specific project-based network. The Sentinel Initiative is funded via a renewable contract that is open for competition at least every 5 years. The Sentinel Operations Centre team coordinates 18 data partners who are contracted to provide a specific set of services, as well as other partners who are not contracted but can offer expertise. Partner selection was carried out through professional networks rather than a formal search for collaborators. The minimum ongoing costs of maintaining the Sentinel System are approximately $US12 million per year; however, with additional activities requested by the FDA (e.g. expansion of the common data model, methods development and query tool development), they can amount to more than $US20 million per year, depending on the number and type of queries run. The Sentinel Data Partners are willing and able to use their curated Sentinel data for other purposes through separate collaborations either directly with the Data Partners or through the Sentinel Operations Centre at Harvard Pilgrim. Several US-based networks and individual studies use the Sentinel data through agreement with the Sentinel Data Partners.
Professor Suissa described CNODES, which was founded in 2011 with the support of Health Canada, through the Drug Safety and Effectiveness Network (DSEN) and the Canadian Institutes of Health Research (CIHR), although not by act of government like Sentinel [2]. Unlike Sentinel, CNODES uses a distributed database network that currently does not employ a common data model, but where a common protocol is applied to all the claims databases in the Canadian provinces. A meta-analysis of the study results is then conducted, pooling results, not data, from each study. This approach was used because of data protection and ownership issues. Canadian provinces have their own healthcare policies, so drug availability may vary from province to province. In addition to Canadian data from each province, CNODES also uses non-Canadian data such as Clinical Practice Research Datalink (CPRD), a UK nationwide electronic health records (EHRs) database and the US MarketScan claims database (IBM Corp., Ann Arbor, MI, USA), to conduct research. The total estimated population covered by all CNODES databases is over 100 million persons. CNODES is currently piloting a common data model project across several Canadian databases to develop the possibility of more rapidly investigating drug utilisation and safety.