Everything related to news in the field of efficiency and safety monitoring

A total of 4 billion doses of COVID-19 vaccines have been used worldwide

2021-11-19T14:09:43+03:00

More than 4 billion doses of coronavirus vaccines have been used cumulatively worldwide since immunization programs began, MedicalXpress reports. The rate of vaccination has slowed a bit recently: the last, fourth billion doses were used in 30 days, whereas previously it took 26 days to administer the same number of doses. It took the longest [...]

A total of 4 billion doses of COVID-19 vaccines have been used worldwide2021-11-19T14:09:43+03:00

Outstaffing an qualified person for pharmacovigilance

2021-12-27T02:31:23+03:00

Our company offers such services as outstaffing of qualified persons for pharmacovigilance (QPPV/LCCPV) The main purpose of outstaffing service is to solve the issues associated with the optimization of staffing and with the operation of the company's budget, as well as reducing the risks associated with the resolution of labor disputes. All companies need [...]

Outstaffing an qualified person for pharmacovigilance2021-12-27T02:31:23+03:00

Pharmacovigilance: on the formation of periodic updated safety reports

2021-11-17T17:20:15+03:00

Currently, the development of analytical databases on the Internet makes it possible to determine the relevance of certain keywords. Among others, "pharmacovigilance, cheap" and "full range of pharmacovigilance services" occupy quite high positions. And this is a fairly new trend. So what do users who search for "pharmacovigilance, cheap" or "full-service pharmacovigilance" on Internet search [...]

Pharmacovigilance: on the formation of periodic updated safety reports2021-11-17T17:20:15+03:00

82.8% of infectious disease beds occupied for patients with COVID-19

2021-11-17T17:01:47+03:00

As of the morning of November 9, 82.8% of infectious disease beds for patients with COVID-19 were occupied in Russia, Deputy Prime Minister Tatyana Golikova said at a meeting with President Vladimir Putin. She noted that of particular concern is the continued increase in mortality among patients with coronavirus infection. Currently, there are 301.5 thousand [...]

82.8% of infectious disease beds occupied for patients with COVID-192021-11-17T17:01:47+03:00

Lizdexamfetamine dimesylate: CMDh Scientific Findings and Basis for Changes, Amendments to Product Information and Implementation Schedule — EMEA / H / N / PSR / S / 0033

2021-11-16T20:55:47+03:00

Although the overall study results provide no evidence of increased cardiovascular risk, these overall estimates are derived from the study population, in which most patients had short-term LDX exposure. In an analysis of long-term LDX use, there was a higher estimated risk of MACE among LDX users compared to what was observed in the overall [...]

Lizdexamfetamine dimesylate: CMDh Scientific Findings and Basis for Changes, Amendments to Product Information and Implementation Schedule — EMEA / H / N / PSR / S / 00332021-11-16T20:55:47+03:00

Amitriptyline, amitriptyline/amitriptyline oxide, amitriptyline oxide: CMDh Scientific Findings and Basis for Changes, Amendments to Product Information and Implementation Schedule — PSUSA / 00010374/202101

2021-11-16T20:53:27+03:00

Given the available data on interactions with duloxetine, childhood intoxication, and Brugada syndrome, PRAC considers the causal relationship between amitriptyline, amitriptyline/amitriptylinoxide, amitriptylinoxide and these risks at least a reasonable possibility. PRAC concluded that information about products containing amitriptyline, amitriptyline/amitriptylinoxide, and amitriptylinoxide should be changed accordingly. data source and details

Amitriptyline, amitriptyline/amitriptyline oxide, amitriptyline oxide: CMDh Scientific Findings and Basis for Changes, Amendments to Product Information and Implementation Schedule — PSUSA / 00010374/2021012021-11-16T20:53:27+03:00

Retrospective analysis of adverse reactions to penicillin-type antibiotics using the drug problem system method

2021-11-13T20:16:17+03:00

The results of the analysis of ADR cards revealed that amoxicillin-clavulanate and amoxicillin were the "leading" drugs in terms of the frequency of ADR development. It is worth noting the high incidence of ADR development against the background of penicillin use in pediatric patients (from 0 to 18 years) 142 cases.

Retrospective analysis of adverse reactions to penicillin-type antibiotics using the drug problem system method2021-11-13T20:16:17+03:00

Typology of problems in the Russian pharmacovigilance system

2021-11-13T20:03:11+03:00

The Russian pharmacovigilance system faces a spectrum of problems on its way to the formation, including fragmented formulation of conclusions and identification of polymorphic "targets" for subsequent adoption of appropriate management decisions in the field of pharmacovigilance. Typologization of existing problems in the field of pharmacovigilance is a method of reducing the variety of objects under study into several systematized groups for subsequent consolidated analysis of directions to optimize the mechanisms of this system and the possibilities of improving its effectiveness.

Typology of problems in the Russian pharmacovigilance system2021-11-13T20:03:11+03:00

FDA approves first drug to treat senile farsightedness

2021-11-13T19:45:33+03:00

Allergan has received FDA approval for the first therapy to treat senile hyperopia. The drug in the form of eye drops is safe and can significantly improve vision for up to six hours. Effective as soon as 15 minutes after application, these eye drops use a specialized formula that combines pilocarpine, a recognized eye therapeutic, [...]

FDA approves first drug to treat senile farsightedness2021-11-13T19:45:33+03:00

Цель Центра по фармаконадзору

Целью организации является развитие системы фармаконадзора, защита здоровья населения, мониторинг безопасности лекарственных средств, анализ, оценка риска использования лекарственных средств, медицинских изделий, развитие образования и науки в области фармаконадзора и безопасности лекарственных средств, а также содействие развитию системы фармаконадзора на территории Евразийского экономического союза.

КОНТАКТНАЯ ИНФОРМАЦИЯ

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АНО «Национальный научный центр Фармаконадзора» является резидентом инновационного фонда «Сколково» с 2018 года

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