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2.
Int J Risk Saf Med ; 33(3): 209, 2022.
Article in English | MEDLINE | ID: mdl-35964206
3.
Int J Risk Saf Med ; 33(1): 1-3, 2022.
Article in English | MEDLINE | ID: mdl-35124577
5.
Int J Risk Saf Med ; 32(3): 159-161, 2021.
Article in English | MEDLINE | ID: mdl-34334426

Subject(s)
Deception , Humans
6.
Int J Risk Saf Med ; 32(2): 75-76, 2021.
Article in English | MEDLINE | ID: mdl-33935109
7.
Int J Risk Saf Med ; 32(1): 1-2, 2021.
Article in English | MEDLINE | ID: mdl-33459667
12.
Ther Innov Regul Sci ; 54(5): 1116-1122, 2020 09.
Article in English | MEDLINE | ID: mdl-32078733

ABSTRACT

The WHODrug medicinal information dictionary is a worldwide source of global medicinal information with the aim to facilitate the coding of medications in clinical trials as well as identification of medication-related problems when monitoring patient safety, thereby supporting the development and usage of effective and safe medications. WHODrug contains individual trade names, active ingredients and additional information such as marketing authorisation holder, country of sale, pharmaceutical form and strength. All related medications are linked using a structured WHODrug alphanumeric code, connecting trade names and variation of the ingredient with the active moiety of the ingredient. Medications in WHODrug are classified using the ATC system and clustered into Standardised Drug Groupings, to allow for grouping of medications with one or more properties in common. The built-in data structure and the classification of medications in WHODrug facilitate various ways of aggregating medications for identification and analysis of possible adverse drug reactions. The different information levels in WHODrug are used to explore the relationship between a medication or a class of medications and an adverse event. By using WHODrug in clinical trials and post-marketing safety, accurate and standardised medication information can be achieved globally and allow easy information exchange. To meet the demands of WHODrug users from the pharmaceutical industry, academia and regulatory authorities, it is relevant to keep the dictionary comprehensive, validated and constantly updated on a global scale.


Subject(s)
Drug-Related Side Effects and Adverse Reactions , Drug Industry , Humans , Marketing
13.
Int J Risk Saf Med ; 30(3): 127-128, 2019.
Article in English | MEDLINE | ID: mdl-31524183
14.
Drug Saf ; 42(6): 805, 2019 Jun.
Article in English | MEDLINE | ID: mdl-30863920

ABSTRACT

The article vigiGrade: A Tool to Identify Well-Documented Individual Case Reports and Highlight Systematic Data Quality Issues, written by Tomas Bergvall. G. Niklas Norén. Marie Lindquist, was originally published Online First without open access.

17.
Drug Saf ; 40(3): 191-199, 2017 03.
Article in English | MEDLINE | ID: mdl-28101815

ABSTRACT

The number of pharmacovigilance professionals worldwide is increasing with a high staff turnover. There is a constant stream of new colleagues with an interest or need to learn about the discipline. Consequently, there is an increasing need for training in pharmacovigilance. An important step towards this has been made through developing and publishing the World Health Organization (WHO)-International Society of Pharmacovigilance (ISoP) Pharmacovigilance Curriculum. Using the Pharmacovigilance Curriculum effectively, it should be supplemented by providing comprehensive training material from various sources, and making the Pharmacovigilance Curriculum attractive and a high-utility product. We describe a pilot of the development and initial evaluation of a crowdsourcing tool for the provision of pharmacovigilance education material. Pharmacovigilance experts shared links to their material to sections of relevance in the hierarchy and a small group of organisations conducted an initial testing. In this pilot, we have shown the usability of such a web-based tool. The strengths of this approach include the potential for a routine 'democratic' approach to sharing educational material to a wider community and an openness for access.


Subject(s)
Crowdsourcing/methods , Curriculum , Health Personnel/education , Pharmacovigilance , Access to Information , Humans , Internet , Pilot Projects , World Health Organization
18.
Lakartidningen ; 1142017 11 06.
Article in Swedish | MEDLINE | ID: mdl-29292905

ABSTRACT

Register for new drugs in cancer care provides a picture of how the drugs are used in the daily clinical practice Today, an increasing number of cancer drugs are approved before traditional well-controlled phase 3 studies have been conducted and in many registration studies there is no participation of Swedish departments. This article describes the general experience of a caregiver initiated systematic follow-up of new cancer drugs that shows the possibility of obtaining a picture of the drug's use in routine care. From the register "New Pharmaceuticals in Cancer care", registrations from Stockholm-Gotland region are reported. The structure of the registry can be used with advantage in other therapeutic areas than cancer and can be supplemented with data from national and regional registers as well as quality registers including patient experiences. The knowledge is important to many actors in health care and can contribute to an evidence based, patient-safe and equal healthcare in accordance with current guidelines.


Subject(s)
Antineoplastic Agents , Neoplasms/drug therapy , Registries , Androstenes/therapeutic use , Antineoplastic Agents/administration & dosage , Antineoplastic Agents/therapeutic use , Benzamides , Bevacizumab/therapeutic use , Breast Neoplasms/drug therapy , Breast Neoplasms/mortality , Colorectal Neoplasms/drug therapy , Colorectal Neoplasms/mortality , Drug Utilization , Humans , Ipilimumab/therapeutic use , Male , Melanoma/drug therapy , Melanoma/mortality , Neoplasms/mortality , Nitriles , Palliative Care/methods , Phenylthiohydantoin/analogs & derivatives , Phenylthiohydantoin/therapeutic use , Pilot Projects , Prostatic Neoplasms/drug therapy , Prostatic Neoplasms/mortality , Radium/therapeutic use , Survival Rate , Sweden/epidemiology , Withholding Treatment
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