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International Journal of Clinical Pharmacy

Published in:

01-08-2018 | Editorial

Overview of this issue: pharmacovigilance, what is new?

Authors: Linda Gore Martin, Yolande Hanssens, Vibhu Paudyal

Published in: International Journal of Clinical Pharmacy | Issue 4/2018

Excerpt

Pharmacovigilance, usually defined with the World Health Organization (WHO) definition of “the science and activities relating to the detection, assessment, understanding and prevention of adverse effects or any other medicine-related problems,” [1] is a mandate for the pharmaceutical industry, including Medication Authorisation Holders (MAHs), in most developed countries, but this is not the case for all countries. The International Federation Pharmaceutical Manufacturers & Associations (IFPMA) has a statement on their website regarding the importance of pharmacovigilance [2]. It should also be considered the responsibility of all governments and health care providers (HCPs) in the interest of the public’s health; a clearer role for the public is being established. This special issue of the International Journal of Clinical Pharmacy looks at the current state of pharmacovigilance from different countries and provides some insight into the future. It also explores some special patient populations. …

The links to the EMA website in some of the papers in this issue are now incorrect, possibly secondary to the move related to Brexit. The pharmacovigilance page with active links can be accessed as follows: http://www.ema.europa.eu/ema/index.jsp?curl=pages/regulation/general/general_content_000258.jsp&mid=WC0b01ac0580b18c76.

World Health Organization. The importance of pharmacovigilance—safety monitoring of medicinal products. WHO Collaborating Centre for International Drug Monitoring, Geneva, Switzerland. 2002. http://apps.who.int/medicinedocs/en/d/Js4893e/. Accessed 21 July 2018.

International Federation Pharmaceutical Manufacturers & Associations. Why is pharmacovigilance important. Geneva: IFPMA. 2015. https://www.ifpma.org/subtopics/pharmacovigiliance/. Accessed 20 July 2018.

Fornasier G, Francescon S, Leone R, Baldo P. An historical overview over pharmacovigilance. Int J Clin Pharm. 2018. https://doi.org/10.1007/s11096-018-0657-1.CrossRefPubMedPubMedCentral

Baldo P, Francescon S, Fornasier G. Pharmacovigilance workflow in Europe and Italy and pharmacovigilance terminology. Int J Clin Pharm. 2018. https://doi.org/10.1007/s11096-018-0711-z.CrossRefPubMedPubMedCentral

Behera SK, Das S, Xavier AS, Velupula S, Sandhiya S. Comparison of different methods for causality assessment of adverse drug reactions. Int J Clin Pharm. 2018. https://doi.org/10.1007/s11096-018-0694-9.CrossRefPubMed

European Medicines Agency. Pharmacovigilance. London: EMA. 2018. http://www.ema.europa.eu/ema/index.jsp?curl=pages/regulation/general/general_content_000258.jsp&mid=WC0b01ac0580b18c76. Accessed 20 July 2018.

World Health Organization. 39th annual meeting of representatives of national pharmacovigilance centres participating in the WHO Programme for International Drug Monitoring Muscat, Oman 14–17 November 2016. http://www.who.int/medicines/regulation/medicines-safety/publications/39pvnc.pdf?ua=1. Accessed 21 July 2018.

Olsson S, Harrison-Woolrich M. The role and strategy of ISoP in global pharmacovigilance. Int J Clin Pharm. 2018. https://doi.org/10.1007/s11096-018-0708-7.CrossRefPubMedPubMedCentral

Baldo P, Fornasier G, Ciolfi L, Sartor I, Francescon S. Pharmacovigilance in oncology. Int J Clin Pharm. 2018. https://doi.org/10.1007/s11096-018-0706-9.CrossRefPubMedPubMedCentral

10.

Francescon S, Fornasier G, Baldo P. EU pharmacovigilance regulatory requirements for anticancer biosimilar monoclonal antibodies. Int J Clin Pharm. 2018. https://doi.org/10.1007/s11096-018-0709-6.CrossRefPubMedPubMedCentral

11.

Al Hail M, Elkassem W, Hamad A, Abdulrouf P, Thomas B, Stewart D. Overview of pharmacovigilance practices at the largest academic healthcare system in the State of Qatar. Int J Clin Pharm. 2018. https://doi.org/10.1007/s11096-018-0629-5.CrossRefPubMed

12.

Zhao Y, Wang T, Li G, Sun S. Pharmacovigilance in China: development and challenges. Int J Clin Pharm. 2018. https://doi.org/10.1007/s11096-018-0693-x.CrossRefPubMedPubMedCentral

13.

Elshafie S, Zaghloul I, Roberti AM. Pharmacovigilance in developing countries (part I): importance and challenges. Int J Clin Pharm. 2017. https://doi.org/10.1007/s11096-017-0570-z.CrossRef

14.

Al Khaja KA, Sequeira RP, Damanhori AH. Polypharmacy associated with medical tourism: a critique on drug therapy. Int J Clin Pharm. 2011;33:61–5. https://doi.org/10.1007/s11096-010-9477-7.CrossRefPubMed

15.

Li X, Thai S, Lu W, Sun S, Tang H, Zhai S, Wang T. Traditional Chinese medicine and drug-induced anaphylaxis: data from the Beijing pharmacovigilance database. Int J Clin Pharm. 2018. https://doi.org/10.1007/s11096-018-0699-4.CrossRefPubMedPubMedCentral

16.

Chaumais M, Caroline O’Connell C, Savale L, Guignabert C, Perros F, Jaïs X, et al. Pharmacovigilance in a rare disease: example of the VIGIAPATH program in pulmonary arterial hypertension. Int J Clin Pharm. 2018. https://doi.org/10.1007/s11096-018-0712-y.CrossRefPubMed

17.

Tawde SA. Generic pharmaceuticals: is pharmacovigilance required? J Pharmacovigil. 2014;2:e124. https://doi.org/10.4172/2329-6887.1000e124.CrossRef

18.

Coulter CV. The role of the suspicious renal pharmacist in identifying unusual adverse drug reactions-why this is not a small problem. Int J Clin Pharm. 2018. https://doi.org/10.1007/s11096-018-0660-6.CrossRefPubMed

19.

Fornasier G, Taborelli M, Francescon S, Polesel J, Aliberti M, De Paoli P, Baldo P. Targeted therapies and adverse drug reactions in oncology: the role of clinical pharmacist in pharmacovigilance. Int J Clin Pharm. 2018. https://doi.org/10.1007/s11096-018-0653-5.CrossRefPubMedPubMedCentral

20.

Laven A, Schmitz K, Franzen WH. Reporting adverse drug reactions: contribution, knowledge and perception of German pharmacy professionals. Int J Clin Pharm. 2018. https://doi.org/10.1007/s11096-018-0671-3.CrossRefPubMed

21.

Li R, Curtain C, Bereznicki L, Zaidi STR. Community pharmacists’ knowledge and attitudes toward reporting adverse drug reactions in Australia: a cross-sectional survey. Int J Clin Pharm. 2018. https://doi.org/10.1007/s11096-018-0700-2.CrossRefPubMedPubMedCentral

22.

Mohammed Assen Seid M, Emagn Kasahun A, Markos Mante B, Naji Gebremariam S. Health care professionals’ knowledge, attitude, and practice toward adverse drug reaction (ADR) reporting at the health center level in Ethiopia. Int J Clin Pharm. 2018. https://doi.org/10.1007/s11096-018-0682-0.CrossRefPubMed

23.

Inácio P, Cavaco A, Airaksinen M. Current trends in pharmacovigilance: value and gaps of patient reporting. Int J Clin Pharm. 2018. https://doi.org/10.1007/s11096-018-0689-6.CrossRefPubMed

24.

Jose J, Al Hajri L. Potential negative impact of informing patients about side effects: a systematic review. Int J Clin Pharm. 2018. https://doi.org/10.1007/s11096-018-0716-7.CrossRefPubMed

25.

AlSaad D, Lee BH, Al-Obaidly S. Finasteride use during pregnancy and early neonatal outcome: a case report. Int J Clin Pharm. 2018. https://doi.org/10.1007/s11096-018-0661-5.CrossRefPubMed

26.

Lupattelli A, Spigset O, Nordeng H. Learning the effects of psychotropic drugs during pregnancy using real-world safety data: a paradigm shift toward modern pharmacovigilance. Int J Clin Pharm. 2018. https://doi.org/10.1007/s11096-018-0672-2.CrossRefPubMed

27.

Wall GC, Taylor MJ, Smith HL. Prevalence and characteristics of hospital inpatients with reported fluoroquinolone allergy. Int J Clin Pharm. 2018. https://doi.org/10.1007/s11096-018-0613-0.CrossRefPubMed

28.

Martin Arias LH, Martin Gonzales A, Sanz Fadrique R, Salgueiro E, Sainz M. Cardiovascular and gastrointestinal safety of selective cyclooxygenase-2 inhibitors: a case/non-case study. Int J Clin Pharm. 2018. https://doi.org/10.1007/s11096-018-0705-x.CrossRefPubMed

29.

World Health Organization. The WHO programme for international drug monitoring. Geneva: WHO. 2018. http://www.who.int/medicines/regulation/medicines-safety/about/drug_monitoring_prog/en/. Accessed 21 July 2018.

30.

Zhao Y, Lu H, Thai S, Li X, Hui J, Tang H, Zhai S, Sun L, Wang T. Development and validation of an algorithm to identify drug-induced anaphylaxis in the Beijing Pharmacovigilance Database. Int J Clin Pharm. 2018. https://doi.org/10.1007/s11096-018-0594-z.CrossRefPubMedPubMedCentral

31.

Bousquet C, Dahamna B, Guillemin-Lanne S, et al. The adverse drug reactions from patient reports in social media project: five major challenges to overcome to operationalize analysis and efficiently support pharmacovigilance process. JMIR Res Protoc. 2017;6(9):179. https://doi.org/10.2196/resprot.6463.CrossRef

32.

Elshafie S, Roberti AM, Zaghloul I. Pharmacovigilance in developing countries (part II): a path forward. Int J Clin Pharm. 2018. https://doi.org/10.1007/s11096-017-0588-2.CrossRefPubMed

33.

Aguiar JP, Cardoso Borges F, Murteira R, Ramos C, Gouveia E, Passos MJ, et al. Using a cancer registry to capture signals of adverse events following immune and targeted therapy for melanoma. Int J Clin Pharm. 2018. https://doi.org/10.1007/s11096-018-0665-1.CrossRefPubMed

34.

Modig S, Elmståhl S. Kidney function and use of nonsteroidal anti-inflammatory drugs among elderly people: a cross-sectional study on potential hazards for an at risk population. Int J Clin Pharm. 2018. https://doi.org/10.1007/s11096-018-0598-8.CrossRefPubMedPubMedCentral

35.

Ye JH, Ho YF, On AW, Chen WW, Huang YM, Huang WI, Tang YW. Trends in reporting drug-associated liver injuries in Taiwan: a focus on amiodarone. Int J Clin Pharm. 2018. https://doi.org/10.1007/s11096-018-0698-5.CrossRefPubMed

36.

Claus BOM. Is pharmacovigilance of biologicals cost-effective? Int J Clin Pharm. 2018. https://doi.org/10.1007/s11096-018-0695-8.CrossRefPubMed

Title: Overview of this issue: pharmacovigilance, what is new?
Authors: Linda Gore Martin
Yolande Hanssens
Vibhu Paudyal
Publication date: 01-08-2018
Publisher: Springer International Publishing
Published in: International Journal of Clinical Pharmacy / Issue 4/2018
Print ISSN: 2210-7703
Electronic ISSN: 2210-7711
DOI: https://doi.org/10.1007/s11096-018-0719-4

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Other articles of this Issue 4/2018

Finasteride use during pregnancy and early neonatal outcome: a case report

Pharmacovigilance workflow in Europe and Italy and pharmacovigilance terminology

Community pharmacists’ knowledge and perspectives of reporting adverse drug reactions in Australia: a cross-sectional survey

Using a cancer registry to capture signals of adverse events following immune and targeted therapy for melanoma

Current trends in pharmacovigilance: value and gaps of patient reporting

Comparison of different methods for causality assessment of adverse drug reactions

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Year in Review: Heart failure and cardiomyopathies

Semaglutide benefits people with type 2 diabetes and obesity-related heart failure

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