PURPOSE: The purpose of this narrative review is to provide a comparison of several countries with different legislation and approaches to pharmacovigilance and to point out how these impact the number of adverse drug reactions (ADRs) that are reported to national competent authorities. METHODS: Legislative and statistical data regarding ADR reporting from various national competent authorities' websites, databases, and pharmacovigilance centers were used. In combination with the WHO pharmacovigilance quantitative indicator that was applied to evaluate the effectiveness of particular national pharmacovigilance systems in our scope. RESULTS: The study compared pharmacovigilance systems in six countries, focusing on ADR reporting from 2010 onwards. All countries required MAHs to report ADRs, while healthcare professionals' obligations varied. Per-capita ADR reports increased in all countries with available data, with the United States having a significantly higher reporting rate, possibly due to FDA campaigns. Despite starting later, China's per-capita reporting rate surpassed that of the Czech Republic and Japan. The study highlighted various measures taken by countries to enhance ADR reporting systems since the inception of their programs, contributing to the overall increase in reporting rates. CONCLUSIONS: ADR reporting is a global priority, with efforts made by different countries to strengthen their pharmacovigilance systems. Some success can be seen in gradually improving per-capita ADR reporting rates. The varying reporting rates and measures taken by each country may serve as a basis for further research and exchange of best practices to improve drug safety monitoring worldwide.
BACKGROUND: This research article delves into the battle against the COVID-19 pandemic, focusing on the efficacy and, particularly, the safety of the combination of nirmatrelvir with ritonavir, which is found in the pharmaceutical product Paxlovid®. This study aims to analyze the potential interactions of commonly prescribed medicinal products with Paxlovid®, shedding light on its utilization in specific medical fields. METHODS: Prescription data from the Czech Republic's Institute of Health Information and Statistics (IHIS CR) was analyzed, covering 4 million COVID-19 patients and 87.5 million medication records from September 2019 to February 2022. This study focused on potential drug interactions with Paxlovid among the 50 most frequently prescribed medications, with particular attention to four specialties: general medicine, internal medicine, infectious diseases, and diabetology. RESULTS: In this study of the 50 most commonly prescribed drugs, 56% showed no interaction with Paxlovid, 30% had a potential for interaction, and 14% were not specifically mentioned in relation to Paxlovid, with no drugs found to be contraindicated overall. However, in specific medical fields, including diabetology, infectious diseases, internal medicine, and general medicine, certain drugs had potential interactions when co-administered with Paxlovid. CONCLUSIONS: Paxlovid remains a valuable option for early COVID-19 treatment but requires a careful consideration of potential drug interactions, especially in high-risk specialties. A thorough assessment of concurrent medications is essential to optimize safety and efficacy in patients receiving Paxlovid.
- MeSH
- antivirové látky škodlivé účinky terapeutické užití MeSH
- COVID-19 epidemiologie MeSH
- farmakoterapie COVID-19 * MeSH
- fixní kombinace léků * MeSH
- lékové interakce * MeSH
- lidé MeSH
- ritonavir * terapeutické užití škodlivé účinky MeSH
- SARS-CoV-2 účinky léků MeSH
- Check Tag
- lidé MeSH
- Publikační typ
- časopisecké články MeSH
- Geografické názvy
- Česká republika MeSH
BACKGROUND: Pertussis, also known as whooping cough, is an acute respiratory illness primarily caused by Bordetella pertussis. Highly contagious, it poses significant morbidity and mortality risks, especially in infants. Despite widespread vaccination efforts, pertussis cases have recently resurged globally. This case report details possible complication in a 48-year-old woman, involving a cough-induced rib fracture and recurrent pneumothorax, highlighting the need for considering pertussis in patients with severe cough and back pain. CASE PRESENTATION: A 48-year-old female non-smoker with hypertension, treated with ACE inhibitor (perindopril), presented with a runny nose, productive cough, and back pain. Initial treatment for a common cold provided temporary relief. However, her symptoms worsened, and further examination revealed a fractured rib, pneumothorax, and subcutaneous emphysema. Laboratory tests confirmed elevated Bordetella pertussis toxin antibodies. She was treated with antibiotics, and despite recurrent symptoms, a conservative management approach was successful. Follow-up indicated resolution of symptoms, but significant anxiety related to her condition. CONCLUSION: This case emphasises the importance of considering pertussis in adults, as early symptoms resembling a common cold can lead to misdiagnosis. It also highlights the potential for significant musculoskeletal and pulmonary injuries due to intense coughing associated with pertussis. Prompt diagnosis and comprehensive management, including antibiotics and supportive care, are essential for favorable outcomes.
- MeSH
- antibakteriální látky terapeutické užití MeSH
- Bordetella pertussis izolace a purifikace MeSH
- fraktury žeber * komplikace MeSH
- kašel etiologie MeSH
- lidé středního věku MeSH
- lidé MeSH
- pertuse * komplikace farmakoterapie MeSH
- pneumotorax * etiologie MeSH
- Check Tag
- lidé středního věku MeSH
- lidé MeSH
- ženské pohlaví MeSH
- Publikační typ
- časopisecké články MeSH
- kazuistiky MeSH
Farmakovigilance je nedílnou součástí medicíny. Při užití či užívání léčivého přípravku je vždy riziko vzniku nežádoucího účinku (NÚ), který může být zcela banální, ale jsou nežádoucí účinky, které mohou být život ohrožující případně smrtelné. Farmakovigilance je obor, který by měl omezit množství či závažnost nežádoucích účinků, a to zaváděním opatření k omezení rizik vycházejících z hodnocení nasbíraných údajů o NÚ. Tento článek se zabývá nejenom obecným pojetím farmakovigilance, ale i srovnáním jednotlivých farmakovigilančních systémů různých států a regionů.
Pharmacovigilance is an integral part of medicine. There is always a risk of side effects when using medication; these can be completely trivial, but there are side effects that can be life-threatening or fatal. Pharmacovigilance practices should prevent such side effects, or at least reduce their incidence, especially by developing preventive measures that are based on adverse drug reaction (ADR) data and the evaluations of these. This article deals with the general concept of pharmacovigilance and compares individual pharmacovigilance systems of several countries and regions.
- MeSH
- farmakovigilance * MeSH
- lidé MeSH
- nežádoucí účinky léčiv MeSH
- zákonodárství jako téma MeSH
- zákonodárství lékové MeSH
- Check Tag
- lidé MeSH
- Publikační typ
- přehledy MeSH
- Geografické názvy
- Česká republika MeSH
- Čína MeSH
- Japonsko MeSH
- Kanada MeSH
- Spojené království MeSH
