scholarly journals Adverse events after Japanese encephalitis vaccination: review of post-marketing surveillance data from Japan and the United States

Vaccine ◽  
2000 ◽  
Vol 18 (26) ◽  
pp. 2963-2969 ◽  
Author(s):  
Hiroshi Takahashi ◽  
Vitali Pool ◽  
Theodore F. Tsai ◽  
Robert T. Chen
1996 ◽  
Vol 59 (2) ◽  
pp. 159-159 ◽  
Author(s):  
D.A. Spyker ◽  
R.J. Alderfer ◽  
R.A. Goetsch ◽  
G.D. Armstrong ◽  
A.W. Longmire ◽  
...  

2021 ◽  
Vol 9 (4) ◽  
pp. 46-52
Author(s):  
Dhruvi B Thakker ◽  
Kalpana G Patel

Prescription medicines, such as analgesics, stimulants, steroids, anti-depressants, psychotropics, and certain antibiotics are commonly mishandled in a variety of ways, including overdosing, abuse, diversion, and drug trafficking. Because of the considerable risk to public health, they are subject to strict regulatory oversight. The drugs possess abuse potential at specific dose and hence prone to abuse therefore they are categorized as Controlled substances. Therefore, they are subject to constant vigilance over the pharmaceutical supply chain. The complete clinical data as well as post marketing surveillance study of such drugs are critical to be in place as per the regulatory requirements. The countries have kept up with the times by constantly updating the system with regulatory laws and strategies to prevent cases of misuse. The current review will give a quick summary of how prescription medications and prohibited substances are regulated in the United States, Europe, and India. It will also emphasize current trends in drug usage, as well as the issues that these countries face and the preventive policies implemented to manage and prevent drug misuse. It will also make recommendations for new regulatory initiatives to address the current drug- misuse-related concerns. As a result, a review of the regulatory system in various countries will present current challenges and new lessons for countries around the globe.


Pain Medicine ◽  
2010 ◽  
Vol 11 (7) ◽  
pp. 1078-1091 ◽  
Author(s):  
Nabarun Dasgupta ◽  
Elise J. Bailey ◽  
Theodore Cicero ◽  
James Inciardi ◽  
Mark Parrino ◽  
...  

Author(s):  
PRATIBHA CHAUHAN ◽  
AALIA ZARREEN ◽  
MOHAMMAD KASHIF IQUBAL

Today’s medical devices are the lifesaving tool and these tools are very frequently used globally since long ago. With the increase in the number of medical devices and their uses, there is an increase in the number of adverse events related to such devices. That is why Materiovigilance is an important tool for the identification, collection, reporting, and analysis of any aversive catastrophe related to the use of medical devices and protection of a patient’s life by fending its reiteration. Post marketing surveillance of medical devices has been initiated in many countries, like the United States of America has started a program under the name Medical Device Reporting (MDR), France, Australia and the United Kingdom have also come up with their own programs. Apart from this India has also initiated the Materiovigilance program by Drug Controller General of India (DCGI) at the Indian Pharmacopoeia Commission (IPC) in Ghaziabad in 2015. In this article we have discussed about the risks associated with the use of different classes of medical devices and the need of Materiovigilance program. This article also discusses the adverse events associated with the medical devices, the reporting criteria of those adverse events and the different clinical events of the medical devices.


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