scholarly journals Ability of Primary Care Health Databases to Assess Medicinal Products Discussed by the European Union Pharmacovigilance Risk Assessment Committee

2020 ◽  
Vol 107 (4) ◽  
pp. 957-965
Author(s):  
Robert Flynn ◽  
Karin Hedenmalm ◽  
Tarita Murray‐Thomas ◽  
Alexandra Pacurariu ◽  
Peter Arlett ◽  
...  
Keyword(s):  
Risk Assessment ◽  
Primary Care ◽  
European Union ◽  
The European Union ◽  
Medicinal Products ◽  
Primary Care Health ◽  
Pharmacovigilance Risk Assessment Committee ◽  
Care Health ◽  
Assessment Committee

scholarly journals Critical discussion of the current environmental risk assessment (ERA) of veterinary medicinal products (VMPs) in the European Union, considering changes in animal husbandry

2021 ◽  
Vol 33 (1) ◽  
Author(s):  
Ruth Haupt ◽  
Céline Heinemann ◽  
Jason Jeremia Hayer ◽  
Simone Magdalene Schmid ◽  
Miriam Guse ◽  
...  
Keyword(s):  
Risk Assessment ◽  
European Union ◽  
Phase I ◽  
Environmental Risk ◽  
Environmental Risk Assessment ◽  
Animal Husbandry ◽  
The European Union ◽  
Medicinal Products ◽  
The Eu ◽  
Veterinary Medicinal Products

Abstract Background Veterinary medicinal products (VMPs) administered to livestock might affect the environment. Therefore, an environmental risk assessment (ERA) is conducted during the approval process of VMPs. In the European Union (EU), the ERA, which was established approximately 10 years ago, consists of two phases. In the present review, we examined the first phase. In this phase, VMPs are subjected to a decision-making process comprising 19 questions and several tables with default values published in the “Guideline on environmental impact assessment for veterinary medicinal products in support of the VICH guidelines GL6 and GL38 (European Medicines Agency 2016).” Since a proportion of livestock husbandry systems is currently shifting toward ecological husbandry and free-range production systems, there is a lower risk of VMP consumption in general, but livestock excretions possibly containing VMPs might be directly released into the environment instead of being stored and applied as manure. In the present study, the first phase of the current ERA of VMPs in the EU was critically discussed with respect to the changes in animal husbandry. The large number of default values used in the ERA were checked for topicality. In a three-step approach, firstly trends and changes in animal husbandry in Europe that might be relevant for the ERA were collected, secondly, the interactions between Phase I and animal husbandry were evaluated and thirdly, the default values used in Phase I were verified in order to identify research gaps. Results Several default values used in the current ERA were identified as outdated. Together with the lack of valid data (e.g., on animal husbandry systems or VMP treatments), this may have an impact on the predicted environmental concentration (PEC) as the central decision threshold of the ERA. Conclusions The results of the present study indicate that an update of the ERA of VMPs in the EU is required to consider the changes in animal husbandry. Several aspects related to this issue are critically discussed.

Collaboration with primary care health providers

1995 ◽  
Author(s):  
James H. Bray
Keyword(s):  
Primary Care ◽  
Health Providers ◽  
Primary Care Health ◽  
Care Health

scholarly journals Do electronic reminders alter recorded diagnoses in primary care office-hours practices of health centers: A register-based study in a Finnish city

2021 ◽  
Vol 9 ◽  
pp. 205031212110361
Author(s):  
Mika Lehto ◽  
Kaisu Pitkälä ◽  
Ossi Rahkonen ◽  
Merja K Laine ◽  
Marko Raina ◽  
...  
Keyword(s):  
Primary Care ◽  
Primary Care Physicians ◽  
Health Centers ◽  
Health Record ◽  
Record System ◽  
Electronic Reminder ◽  
Primary Health ◽  
Primary Care Health ◽  
Before And After ◽  
Care Health

Objectives: One purpose of electronic reminders is improvement of the quality of documentation in office-hours primary care. The aim of this study was to evaluate how implementation of electronic reminders alters the rate and/or content of diagnostic data recorded by primary care physicians in office-hours practices in primary care health centers. Methods: The present work is a register-based longitudinal follow-up study with a before-and-after design. An electronic reminder was installed in the electronic health record system of the primary health care of a Finnish city to remind physicians to include the diagnosis code of the visit in the health record. The report generator of the electronic health record system provided monthly figures for the number of various recorded diagnoses by using the International Classification of Diseases, 10th edition, and the total number of visits to primary care physicians, thus allowing the calculation of the recording rate of diagnoses on a monthly basis. The distribution of diagnoses before and after implementing ERs was also compared. Results: After the introduction of the electronic reminder, the rate of diagnosis recording by primary care physicians increased clearly from 39.7% to 87.2% (p < 0.001). The intervention enhanced the recording rate of symptomatic diagnoses (group R) and some chronic diseases such as hypertension, type 2 diabetes and other soft tissue disorders. Recording rate of diagnoses related to diseases of the respiratory system (group J), injuries, poisoning and certain other consequences of external causes (group S), and diseases of single body region of the musculoskeletal system and connective tissue (group M) decreased after the implementation of electronic reminders. Conclusion: Electronic reminders may alter the contents and extent of recorded diagnosis data in office-hours practices of the primary care health centers. They were found to have an influence on the recording rates of diagnoses related to chronic diseases. Electronic reminders may be a useful tool in primary health care when attempting to change the behavior of primary care physicians.

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