The Role of European Patient Organizations in Pharmacovigilance

Matos, Cristiano; Weits, Gerda; Hunsel, Florence van

doi:10.1007/s40264-018-0748-x

Cited by 11 publications

(9 citation statements)

References 28 publications

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“…Around three in five wanted the pharmacovigilance community to provide information on drug use and adverse drug reactions that they could communicate to their members. In the same study, more than two in five patient organizations said they communicated daily with members on social media [ 8 ]. In view of this, an opportunity exists for closer collaboration between patient organizations and pharmacovigilance professionals in communicating adverse drug reaction insights.…”

Section: Introductionmentioning

confidence: 99%

Communicating Adverse Drug Reaction Insights Through Patient Organizations: Experiences from a Pilot Study in the Netherlands

Härmark

Weits

Meijer³

et al. 2020

Drug Saf

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Introduction To improve therapeutic decision making, it is crucial that information regarding adverse drug reactions reaches patients. It is not enough to disseminate such findings through regulatory and scientific channels; targeted efforts to reach patients are necessary. One possible avenue is to collaborate with patient organizations. Objectives The aim of this pilot study was to explore how adverse drug reactions can be communicated through patient organizations. Methods A text describing a signal of levothyroxine and panic attacks was tailored to patients’ needs, in terms of language, style and content, with emphasis placed on what to do when experiencing the symptoms described. The signal was communicated via the Dutch thyroid organization’s digital newsletter, social media channels, website and print magazine. Results The digital newsletter was distributed to around 5000 subscribers. On Facebook, 13,820 people viewed the message, with 2346 clicks in the message, indicating an intention to read the whole post. The interactions on social media were positive, and the tone was respectful. Conclusion Patient organizations can help enable effective communication of adverse drug reactions to a relevant audience. The social media post generated more engagement than other communications from the patient organization, indicating a strong interest in this information. The additional patient experiences that were shared in the comments on social media further strengthened the original signal and its relevance to patients, creating an interesting feedback loop. The favourable experiences in this study support further consideration and exploration of this approach to communicate adverse drug reactions to patients.

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Section: Introductionmentioning

confidence: 99%

Communicating Adverse Drug Reaction Insights Through Patient Organizations: Experiences from a Pilot Study in the Netherlands

Härmark

Weits

Meijer³

et al. 2020

Drug Saf

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“…Some authors indicate another contributing factor, i.e., the involvement of patients organizations which can encourage patients to talk to doctors or pharmacists about the suspected adverse reactions and opportunities to receive care if side effects possibly occur. The major hurdles in creating patients’ awareness of their role in pharmacovigilance include the shortage of resources, funds and insufficient involvement of competent national bodies [ 38 ]. The collaboration with other non-public organizations may create new possibilities of promotion of consumer reports, which are particularly significant as they provide additional information of drug safety independently of the data provided by sources with medical expertise.…”

Section: Resultsmentioning

confidence: 99%

The Importance of Direct Patient Reporting of Adverse Drug Reactions in the Safety Monitoring Process

Sienkiewicz

Burzyńska

Rydlewska-Liszkowska

et al. 2021

IJERPH

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All medicinal products authorized in the European Union are subjects of constant drug-safety monitoring processes. It is organized in a pharmacovigilance system that is designed to protect human health and life by the detection, analysis and prevention of adverse drug reactions (ADRs) and other drug-related problems. The main role of the aforementioned system is to collect and analyze adverse drug reaction reports. Legislation introduced several years ago allowed patients, their legal representatives and caregivers to report adverse drug reactions, which caused them to be an additional source of safety data. This paper presents the analysis of EudraVigilance data related to adverse drug reactions provided by patients, their representatives, as well as those obtained from healthcare professionals related to medicines which belong to M01A anti-inflammatory and antirheumatic products, a non-steroid group. The objective of the study was to identify the changes in the number and structure of adverse reaction reporting after the introduction of pharmacovigilance (PV) obligations in EU. A review of scientific literature was also conducted to assess the differences in adverse reactions reported by patients or their representatives and by healthcare professionals. We also identified other factors which, according to literature review, influenced the number of adverse reaction reports provided by patients. Analysis of data collected from the EudraVigilance showed that from 2011 to 2013 the number of reports made by patients and their caregivers increased by approx. 24 percentage points, and then, from 2014, it constituted around 30% of the total of reported reactions every year, so patient reporting is an important part of pharmacovigilance system and a source of drugs’ safety information throughout their use in healthcare practice. Additionally, there was no interrelationship between the seriousness of reported adverse reactions and the overall number of patient reports when compared to reports form healthcare professionals.

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“…[32][33][34] Patient reporting is seen as a useful source of information in addition to HCP reporting, not just in gaining more reports, but in receiving the patient's perspective on ADRs experienced. [35][36][37][38] Collaboration between patient organisations and national competent authorities is important to raise awareness about pharmacovigilance among the general public, 39 and can play a role in educating patients on risks related to medicine use and help involve them in pharmacovigilance.…”

Section: Introductionmentioning

confidence: 99%

“…Bringing pharmacovigilance stakeholders and patient organisations together could create a more optimal patient reporting culture. 39 The importance of the perspective of patients on public health and the impact of regulatory decisions is clear and national competent authorities have made an effort in recent years to involve patient organisations in decision making. [52][53] A study investigating the risk perception of medicines in general, found that patients have a lower risk perception for medicines used in diabetes (such as oral antidiabetics and/or insulin), in relation to other medicine groups, such as sleeping pills, tranquillisers or antidepressants.…”

Section: Introductionmentioning

confidence: 99%

“…Many organisations thought that patients could contribute to pharmacovigilance in different ways, including providing different information to that given by HCPs; aiding detection of new ADRs, their severity, and their impact on quality of life; and reporting information that was useful and based on their experience with medicines, even without medical confirmation. 39 An important number of organisations do not appear to have activities or involvement relating to pharmacovigilance. Bringing pharmacovigilance stakeholders and patient organisations together could create a more optimal patient reporting culture.…”

Section: Introductionmentioning

confidence: 99%

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Diabetes patient’s pharmacovigilance knowledge and risk perception: the influence of being part of a patient organisation

Matos

Hunsel

Ribeiro³

et al. 2020

Therapeutic Advances in Drug Safety

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Objective: The aim was to assess the perception of risk for developing adverse drug reaction (ADRs) and knowledge, attitudes and opinions regarding pharmacovigilance in diabetic patients, and to investigate the effect of being a member of a patient organisation for diabetes on these factors, in comparison with other patients. Methods: A cross-sectional study looking for patients’ risk perception of experiencing ADRs. Diabetes patients followed at the Portuguese Diabetes Association (APDP) were included, together with two comparison groups (patients with and without diabetes). Kruskal-Wallis followed by post hoc Dunn’s multiple-comparison test were used to compare patients’ groups. Results: A total of 314 patients participated in the survey (104 followed at APDP, 106 with diabetes not followed at APDP and 104 without diabetes diagnosis that used chronic medication). APDP patients presented higher risk perception scores for medicines related to their disease compared with two groups. Those patients affirmed that doctors explained possible ADRs on medication to them, and showed higher intention to report ADRs in the future if serious or unexpected. Conclusions: Patients with diabetes showed greater understanding of ADRs and higher need to report them than patients without diabetes. They would like to have more information about general ADRs related to anti-diabetic medication and present higher intention to acquire information on how and when to report compared with non-diabetic patients. Patients followed in APDP presented higher score of risk perception, which could be influenced by the presence of the diabetes disease in the patients’ life, by their previous experiences using medicines, but also by information received from the patient organisation. The two groups of patients with diabetes have different experiences of the disease, but both present higher perception of side effects related with medicines they use respectively in their diabetes type. Hence, patient organisations are well positioned to be a source where patients can obtain reliable information, changing their attitudes and perceptions about the disease and drug treatments.

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The Role of European Patient Organizations in Pharmacovigilance

Cited by 11 publications

References 28 publications

Communicating Adverse Drug Reaction Insights Through Patient Organizations: Experiences from a Pilot Study in the Netherlands

Communicating Adverse Drug Reaction Insights Through Patient Organizations: Experiences from a Pilot Study in the Netherlands

The Importance of Direct Patient Reporting of Adverse Drug Reactions in the Safety Monitoring Process

Diabetes patient’s pharmacovigilance knowledge and risk perception: the influence of being part of a patient organisation

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