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Article ; Online: Reporting of suspected adverse drug reactions by nursing in Spain. An observational-descriptive retrospective study.

Velasco-González, Verónica / Loya-Pérez, Laura / Navarro-García, Ester / Sáinz-Gil, María

Enfermeria clinica (English Edition)

2021 Volume 31, Issue 6, Page(s) 363–370

Abstract: Objective: This study aimed to gain knowledge of the nurses' involvement in the spontaneous report of suspected adverse drug reactions (ADR) in the Spanish Pharmacovigilance System for Medicinal Products for Human Use (SEFV-H), describing the principal ... ...

Abstract	Objective: This study aimed to gain knowledge of the nurses' involvement in the spontaneous report of suspected adverse drug reactions (ADR) in the Spanish Pharmacovigilance System for Medicinal Products for Human Use (SEFV-H), describing the principal characteristics of the reported cases, identifying points of improvement. Methods: A descriptive observational retrospective study was based on the data from FEDRA, the database created by the SEFV-H. The sample taken was the spontaneous adverse drug reactions reported to SEFV-H by nurses during the first 6 months of the 2018. Results: Complete data was provided by 6,370 suspicions of ADR reported to SEFV-H by all healthcare professionals. Only 4,8% of the samples were taken by nurses, 62,7% came from medical centers. The majority of the ADR were not considered a serious disease (78%). The most frequently adverse drug reactions reported by nurses were local reactions. The patients most involved were children and vaccines were the most reported drugs (58,3%), followed by the intravenous contrast agents used in diagnostic tests. Conclusions: Nurses report very few cases to SEFV-H and are mostly related to the administration of vaccines and are sent by nurses working in the out-of-hospital setting. Most cases are not serious and usually report known adverse reactions to the suspected drug. This observed under-notification raises the need to promote increased pharmacovigilance training among these notifying nurses so that they can continue to report, and also for those who do not do so in their daily practice, so that they can begin to do so.
MeSH term(s)	Adverse Drug Reaction Reporting Systems ; Child ; Drug-Related Side Effects and Adverse Reactions/epidemiology ; Humans ; Pharmacovigilance ; Retrospective Studies ; Spain
Language	English
Publishing date	2021-03-18
Publishing country	Spain
Document type	Journal Article ; Observational Study
ISSN	2445-1479
ISSN (online)	2445-1479
DOI	10.1016/j.enfcle.2020.10.011
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Article ; Online: Reporting of suspected adverse drug reactions by nursing in Spain. An observational-descriptive retrospective study.

Velasco-González, Verónica / Loya-Pérez, Laura / Navarro-García, Ester / Sainz-Gil, María

Enfermeria clinica (English Edition)

2021

Title translation	Notificación de sospechas de reacciones adversas a medicamentos por enfermeras en España. Un estudio observacional descriptivo retrospectivo.
Abstract	Objective: This study aimed to gain knowledge of the nurses' involvement in the spontaneous report of suspected adverse drug reactions (ADR) in the Spanish Pharmacovigilance System for Medicinal Products for Human Use (SEFV-H), describing the principal characteristics of the reported cases, identifying points of improvement. Methods: A descriptive observational retrospective study was based on the data from FEDRA, the database created by the SEFV-H. The sample taken was the spontaneous adverse drug reactions reported to SEFV-H by nurses during the first 6 months of the 2018. Results: Complete data was provided by 6,370 suspicions of ADR reported to SEFV-H by all healthcare professionals. Only 4,8% of the samples were taken by nurses, 62,7% came from medical centers. The majority of the ADR were not considered a serious disease (78%). The most frequently adverse drug reactions reported by nurses were local reactions. The patients most involved were children and vaccines were the most reported drugs (58,3%), followed by the intravenous contrast agents used in diagnostic tests. Conclusions: Nurses report very few cases to SEFV-H and are mostly related to the administration of vaccines and are sent by nurses working in the out-of-hospital setting. Most cases are not serious and usually report known adverse reactions to the suspected drug. This observed under-notification raises the need to promote increased pharmacovigilance training among these notifying nurses so that they can continue to report, and also for those who do not do so in their daily practice, so that they can begin to do so.
Language	Spanish
Publishing date	2021-01-30
Publishing country	Spain
Document type	Journal Article
ISSN	2445-1479
ISSN (online)	2445-1479
DOI	10.1016/j.enfcli.2020.10.033
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Article: Thromboembolism and Oral Contraceptives During the COVID-19 Pandemic: A Disproportionality Analysis Within the Spanish Pharmacovigilance Database.

Martín, Luis H / Sainz-Gil, María / Navarro-García, Ester / Salado-Valdivieso, Inés / Sanz-Fadrique, Rosario

Drugs - real world outcomes

2022 Volume 9, Issue 2, Page(s) 211–218

Abstract: Background: Thromboembolic events (TEs) are known to be a severe complication for COVID-19. They are associated with a systemic inflammatory response syndrome with coagulation cascade activation.: Objective: The aim of this study was to determine a ... ...

Abstract	Background: Thromboembolic events (TEs) are known to be a severe complication for COVID-19. They are associated with a systemic inflammatory response syndrome with coagulation cascade activation. Objective: The aim of this study was to determine a potential association between the COVID-19 pandemic and the increment of the risk of suspected TEs in women on systemic hormonal contraceptives (SHCs). Patients and methods: This study utilised a case/non-case approach in the Spanish Pharmacovigilance Database, which includes more than 290,000 cases of suspected adverse drug reactions (ADRs). The reporting odds ratio (ROR) was calculated during an initial pandemic period in 2020 compared with a pre-pandemic period in 2019 and an additional control period in 2018. Results: While there was a decreased number of ADR notifications for any medications and for any type of ADR in patients on SHCs during the pandemic period, the TE ROR for all SHCs was higher in the 2020 pandemic period [ROR = 11.8 (5.6-24.7)] relative to the pre-pandemic period in 2019 [ROR = 6.3 (3.2-12.5)] and the additional control period in 2018 [ROR = 4.6. (2.1-9.9)]. In contrast, ROR for progestogen-only contraceptives was lower during the pandemic as compared with the two control periods. Conclusion: The reported disproportionality of TEs in women on SHCs rose during the pandemic period. This suggests a potential interaction of the drug (SHC) with COVID-19, which led to an increased risk of TEs in women exposed to both factors. This should be taken into consideration in the context of the COVID-19 pandemic.
Language	English
Publishing date	2022-02-10
Publishing country	Switzerland
Document type	Journal Article
ZDB-ID	2806600-5
ISSN	2198-9788 ; 2199-1154
ISSN (online)	2198-9788
ISSN	2199-1154
DOI	10.1007/s40801-021-00282-3
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Article: Haplotypes in the GC, CYP2R1 and CYP24A1 Genes and Biomarkers of Bone Mineral Metabolism in Older Adults

Fernández-Araque, Ana / Giaquinta-Aranda, Andrea / Moreno-Sainz, Carmelo / Martínez-Martínez, María Cruz / Velasco-González, Verónica / Sainz-Gil, María / Martín-Arias, Luis H. / Carretero-Molinero, Silvia / García-Hidalgo, Miguel / Verde, Zoraida

Nutrients. 2022 Jan. 08, v. 14, no. 2

2022

Abstract: Candidate gene studies have analyzed the effect of specific vitamin D pathway genes on vitamin D availability; however, it is not clear whether genetic variants also affect overall bone metabolism. This study evaluated the association between genetic ... ...

Abstract	Candidate gene studies have analyzed the effect of specific vitamin D pathway genes on vitamin D availability; however, it is not clear whether genetic variants also affect overall bone metabolism. This study evaluated the association between genetic polymorphisms in GC, CYP2R1 and CYP24A1 and serum levels of total 25(OH)D, iPTH and other mineral metabolism biomarkers (albumin, total calcium and phosphorus) in a sample of 273 older Spanish adults. We observed a significant difference between CYP2R1 rs10741657 codominant model and total 25(OH)D levels after adjusting them by gender (p = 0.024). In addition, the two SNPs in the GC gene (rs4588 and rs2282679) were identified significantly associated with iPTH and creatinine serum levels. In the case of phosphorus, we observed an association with GC SNPs in dominant model. We found a relationship between haplotype 2 and 25(OH)D levels, haplotype 4 and iPTH serum levels and haplotype 7 and phosphorus levels. In conclusion, genetic variants in CYP2R1 and GC could be predictive of 25(OH)D and iPTH serum levels, respectively, in older Caucasian adults. The current study confirmed the role of iPTH as one of the most sensitive biomarkers of vitamin D activity in vivo.
Keywords	albumins ; biomarkers ; blood serum ; bone metabolism ; calcium ; creatinine ; gender ; genes ; haplotypes ; mineral metabolism ; models ; phosphorus
Language	English
Dates of publication	2022-0108
Publishing place	Multidisciplinary Digital Publishing Institute
Document type	Article
ZDB-ID	2518386-2
ISSN	2072-6643
ISSN	2072-6643
DOI	10.3390/nu14020259
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Article: Effects of Antioxidants on Pain Perception in Patients with Fibromyalgia-A Systematic Review.

Fernández-Araque, Ana / Verde, Zoraida / Torres-Ortega, Clara / Sainz-Gil, Maria / Velasco-Gonzalez, Veronica / González-Bernal, Jerónimo Javier / Mielgo-Ayuso, Juan

Journal of clinical medicine

2022 Volume 11, Issue 9

Abstract: In recent years, antioxidant supplements have become popular to counteract the effects of oxidative stress in fibromyalgia and one of its most distressing symptoms, pain. The aim of this systematic review was to summarize the effects of antioxidant ... ...

Abstract	In recent years, antioxidant supplements have become popular to counteract the effects of oxidative stress in fibromyalgia and one of its most distressing symptoms, pain. The aim of this systematic review was to summarize the effects of antioxidant supplementation on pain levels perceived by patients diagnosed with fibromyalgia. The words used respected the medical search terms related to our objective including antioxidants, fibromyalgia, pain, and supplementation. Seventeen relevant articles were identified within Medline (PubMed), Scopus, Web of Science (WOS), the Cochrane Database of Systematic Review, and the Cochrane Central Register of Controlled Trials. This review found that antioxidant supplementation is efficient in reducing pain in nine of the studies reviewed. Studies with a duration of supplementation of at least 6 weeks showed a benefit on pain perception in 80% of the patients included in these studies. The benefits shown by vitamins and coenzyme Q10 are remarkable. Further research is needed to identify the effects of other types of antioxidants, such as extra virgin olive oil and turmeric. More homogeneous interventions in terms of antioxidant doses administered and duration would allow the effects on pain to be addressed more comprehensively.
Language	English
Publishing date	2022-04-27
Publishing country	Switzerland
Document type	Journal Article ; Review
ZDB-ID	2662592-1
ISSN	2077-0383
ISSN	2077-0383
DOI	10.3390/jcm11092462
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Article ; Online: Haplotypes in the

Fernández-Araque, Ana / Giaquinta-Aranda, Andrea / Moreno-Sainz, Carmelo / Martínez-Martínez, María Cruz / Velasco-González, Verónica / Sainz-Gil, María / Martín-Arias, Luis H / Carretero-Molinero, Silvia / García-Hidalgo, Miguel / Verde, Zoraida

Nutrients

2022 Volume 14, Issue 2

Abstract	Candidate gene studies have analyzed the effect of specific vitamin D pathway genes on vitamin D availability; however, it is not clear whether genetic variants also affect overall bone metabolism. This study evaluated the association between genetic polymorphisms in
MeSH term(s)	Aged ; Aged, 80 and over ; Bone Density/genetics ; Calcium/blood ; Cholestanetriol 26-Monooxygenase/genetics ; Creatinine/blood ; Cross-Sectional Studies ; Cytochrome P450 Family 2/genetics ; Female ; Haplotypes ; Humans ; Male ; Parathyroid Hormone/blood ; Phosphorus/blood ; Polymorphism, Single Nucleotide ; Serum Albumin/analysis ; Sex Factors ; Vitamin D/analogs & derivatives ; Vitamin D/blood ; Vitamin D-Binding Protein/genetics ; Vitamin D3 24-Hydroxylase/genetics ; White People
Chemical Substances	Parathyroid Hormone ; Serum Albumin ; Vitamin D-Binding Protein ; Vitamin D (1406-16-2) ; Phosphorus (27YLU75U4W) ; 25-hydroxyvitamin D (A288AR3C9H) ; Creatinine (AYI8EX34EU) ; Cytochrome P450 Family 2 (EC 1.14.14.1) ; CYP2R1 protein, human (EC 1.14.14.24) ; Cholestanetriol 26-Monooxygenase (EC 1.14.15.15) ; CYP24A1 protein, human (EC 1.14.15.16) ; Vitamin D3 24-Hydroxylase (EC 1.14.15.16) ; Calcium (SY7Q814VUP)
Language	English
Publishing date	2022-01-08
Publishing country	Switzerland
Document type	Journal Article
ZDB-ID	2518386-2
ISSN	2072-6643 ; 2072-6643
ISSN (online)	2072-6643
ISSN	2072-6643
DOI	10.3390/nu14020259
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Article ; Online: Hydroxychloroquine safety in Covid-19 vs non-Covid-19 patients: analysis of differences and potential interactions.

Sainz-Gil, María / Merino Kolly, Nieves / Velasco-González, Verónica / Verde Rello, Zoraida / Fernandez-Araque, Ana M / Sanz Fadrique, Rosario / Martín Arias, Luis H

Expert opinion on drug safety

2022 Volume 22, Issue 1, Page(s) 71–79

Abstract: Background: The use of hydroxychloroquine (HCQ) in the first COVID-19 epidemic wave raised safety concerns.: Research design and methods: Adverse reactions (ADR) suspected to be induced by HCQ and submitted to the Spanish Pharmacovigilance Database ... ...

Abstract	Background: The use of hydroxychloroquine (HCQ) in the first COVID-19 epidemic wave raised safety concerns. Research design and methods: Adverse reactions (ADR) suspected to be induced by HCQ and submitted to the Spanish Pharmacovigilance Database were studied. A disproportionality analysis was performed to determine adverse effects reported in non-Covid and Covid patients. To explore potential drug-drug interactions, Omega (Ω) statistics was calculated. Results: More severe cases were reported when used in COVID-19. Main differences in frequency were observed in hepatobiliary, skin, gastrointestinal, eye, nervous system and heart ADRs. During the COVID-19 pandemic, high disproportionality in reports was found for Torsade de Pointes/QT prolongation with a ROR (-ROR) of 132.8 (76.7); severe hepatotoxicity, 18.7 (14.7); dyslipidaemias, 12.1 (6.1); shock, 9.5 (6.9) and ischemic colitis, 8.9 (2.6). Myopathies, hemolytic disorders and suicidal behavior increased their disproportionality during the pandemic. Disproportionality was observed for neoplasms, hematopoietic cytopaenias and interstitial lung disease in the pre-COVID-19 period. Potential interactions were showed between HCQ and azithromycin, ceftriaxone, lopinavir and tocilizumab. Conclusions: The use of HCQ during the Covid-19 pandemic changed its ADRs reporting profile. Of particular concern during the pandemic were arrhythmias, hepatotoxicity, severe skin reactions and suicide, but not ocular disorders. Some signals identified would require more detailed analyses.
MeSH term(s)	Humans ; Hydroxychloroquine/adverse effects ; COVID-19 ; Pandemics ; COVID-19 Drug Treatment ; Drug-Related Side Effects and Adverse Reactions ; Chemical and Drug Induced Liver Injury
Chemical Substances	Hydroxychloroquine (4QWG6N8QKH)
Language	English
Publishing date	2022-05-19
Publishing country	England
Document type	Journal Article
ZDB-ID	2088728-0
ISSN	1744-764X ; 1474-0338
ISSN (online)	1744-764X
ISSN	1474-0338
DOI	10.1080/14740338.2022.2078303
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Article ; Online: Hydroxychloroquine and Potential Drug Interactions in Older Adults.

Velasco-González, Verónica / Fernández-Araque, Ana / Sainz-Gil, Maria / Jimeno, Natalia / Martín, Luis H / Verde, Zoraida

Archivos de bronconeumologia

2020 Volume 56, Issue 10, Page(s) 679–681

MeSH term(s)	Aged ; Antiviral Agents/therapeutic use ; COVID-19 ; Drug Interactions ; Humans ; Hydroxychloroquine
Chemical Substances	Antiviral Agents ; Hydroxychloroquine (4QWG6N8QKH)
Language	English
Publishing date	2020-10-01
Publishing country	Spain
Document type	Case Reports
ZDB-ID	2591346-3
ISSN	2173-5751 ; 2173-5751
ISSN (online)	2173-5751
ISSN	2173-5751
DOI	10.1016/j.arbr.2020.06.002
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Article: Hydrochlorothiazide use and risk of non-melanoma skin cancer in Spain: A case/non-case study.

Lecaros-Astorga, Darío A / Molina-Guarneros, Juan A / Rodríguez-Jiménez, Pedro / Martin-Arias, Luis H / Sainz-Gil, María

International journal of clinical pharmacology and therapeutics

2020 Volume 59, Issue 4, Page(s) 280–288

Abstract: Objective: In 2018, the Pharmacological Risk Assessment Committee alerted to a potential relationship between accumulated hydrochlorothiazide dosage and the risk of non-melanoma skin cancer. To study this relationship we used data from the Spanish ... ...

Abstract	Objective: In 2018, the Pharmacological Risk Assessment Committee alerted to a potential relationship between accumulated hydrochlorothiazide dosage and the risk of non-melanoma skin cancer. To study this relationship we used data from the Spanish Pharmacovigilance System for Medicinal Products of Human Use. Materials and methods: Following a case search for every thiazide potentially associated with (SMQ/MedDRA) "Malignant Skin Neoplasms and not Otherwise Specified Skin Neoplasms", a series of disproportionality analyses were conducted by estimating the reporting odds ratio (95% confidence interval). Registered adverse drug reactions and disproportionality through the reported odds ratio were the main outcome measures. Results: For basal cell carcinoma, reporting odds ratio was 4.8 (2.2 - 10.7); squamous cell carcinoma 3.2 (0.9 - 10.5); malignant melanoma, 0.8 (0.2 - 3.5). We found both disproportionality and association between hydrochlorothiazide and basal cell carcinoma, but none of these were found regarding malignant skin melanoma. In the case of squamous cell carcinoma, the lower confidence interval limit was below 1, thus the disproportionality value was not statistically significant. The accumulated hydrochlorothiazide dose was 36,714 mg for basal cell carcinoma; 98,288 mg for squamous cell carcinoma; and 38,444 mg for malignant melanoma. Conclusion: The results in Spain, where sun exposure is significant, are consistent with the data in the Pharmacological Risk Assessment Committee's alert, which were obtained in Denmark for both basal cell carcinoma and malignant melanoma. However, the results for squamous cell carcinoma did not reach statistical significance, although the reporting odds ratio value suggested a potential relationship between hydrochlorothiazide and squamous cell carcinoma.
MeSH term(s)	Carcinoma, Basal Cell/chemically induced ; Carcinoma, Basal Cell/epidemiology ; Humans ; Hydrochlorothiazide/adverse effects ; Melanoma/chemically induced ; Melanoma/epidemiology ; Risk Factors ; Skin Neoplasms/chemically induced ; Skin Neoplasms/epidemiology ; Spain/epidemiology
Chemical Substances	Hydrochlorothiazide (0J48LPH2TH)
Language	English
Publishing date	2020-12-22
Publishing country	Germany
Document type	Journal Article
ZDB-ID	124384-6
ISSN	0946-1965 ; 0340-0026 ; 0300-9718 ; 0174-4879
ISSN	0946-1965 ; 0340-0026 ; 0300-9718 ; 0174-4879
DOI	10.5414/CP203769
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Article ; Online: Bullous pemphigoid associated with the use of dipeptidil peptidase-4 inhibitors: analysis from studies based on pharmacovigilance databases.

Molina-Guarneros, Juan A / Sainz-Gil, María / Sanz-Fadrique, Rosario / García, Pilar / Rodríguez-Jiménez, Pedro / Navarro-García, Ester / Martin, Luis H

International journal of clinical pharmacy

2020 Volume 42, Issue 2, Page(s) 713–720

Abstract: Background Bullous pemphigoid has been associated to dipeptidase-4 inhibitors. Objectives Addressing the potential Bullous pemphigoid-dipeptidase-4 inhibitors association based on pharmacovigilance data currently available in Spain in order to obtain a ... ...

Abstract	Background Bullous pemphigoid has been associated to dipeptidase-4 inhibitors. Objectives Addressing the potential Bullous pemphigoid-dipeptidase-4 inhibitors association based on pharmacovigilance data currently available in Spain in order to obtain a composite disproportionality estimator from all the data generated by the case-non case studies conducted to this date. Setting The Spanish Pharmacovigilance System for Human Use Drugs database. Method Case-non case study based on the Spanish Pharmacovigilance System for Human Use Drugs notifications submitted between 2007 and 2018 (n = 169,280), using the Medical Dictionary for Regulatory Activities term (Preferred Term) 'pemphigoid' for sitagliptin, vildagliptin, saxagliptin, linagliptin, and alogliptin (n = 1952). As negative control, we used acetaminophen, while furosemide was the positive control. A pooled reported odds ratio analysis in the French, Japanese, and Spanish national pharmacovigilance databases was performed. On The Spanish Pharmacovigilance System for Human Use Drugs, we conducted a bullous pemphigoid-metformin association analysis within the period 1982-2018. Main outcome measure Adverse reaction cases in pharmacovigilance databases and the disproportionality through the reporting odds ratio. Results Within The Spanish Pharmacovigilance System for Human Use Drugs, we found 45 cases of bullous pemphigoid in dipeptidase-4 inhibitors patients. Median age was 77 years (range 72-82). The median latency period was 7 months (range 0.23-86). The Bullous pemphigoid-dipeptidase-4 inhibitors association was established with a reporting odd ratio = 70.0 (95% confidence intervals 49.1-10.1). In the combined analysis of the three aforementioned pharmacovigilance databases, the pooled reporting odd ratio was 81.0 (95% confidence intervals 69.5-94.4). Conclusion The composite estimator for the three national pharmacovigilance databases yields clear evidence of a Bullous pemphigoid-dipeptidase-4 inhibitors association, which was statistically significant for both the pharmacological class as a whole and each of the dipeptidase-4 inhibitors agents under investigation. Metformin's role in the incidence of bullous pemphigoid appeared casual rather than causal. No differences between Caucasian and Asian populations were noted.
MeSH term(s)	Age Factors ; Aged ; Aged, 80 and over ; Databases, Factual ; Dipeptidyl-Peptidase IV Inhibitors/adverse effects ; Drug-Related Side Effects and Adverse Reactions/diagnosis ; Drug-Related Side Effects and Adverse Reactions/epidemiology ; Female ; Humans ; Male ; Pemphigoid, Bullous/chemically induced ; Pemphigoid, Bullous/diagnosis ; Pemphigoid, Bullous/epidemiology ; Pharmacovigilance
Chemical Substances	Dipeptidyl-Peptidase IV Inhibitors
Language	English
Publishing date	2020-03-05
Publishing country	Netherlands
Document type	Journal Article
ZDB-ID	2601204-2
ISSN	2210-7711 ; 2210-7703 ; 0928-1231
ISSN (online)	2210-7711
ISSN	2210-7703 ; 0928-1231
DOI	10.1007/s11096-020-01003-6
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