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V Palop

Publications and source records attributed to V Palop.

At least 19 recordsLinked to original sources
PubMed2006

[Quality of the publication of adverse drug reactions in the letters to the editor section of four Spanish internal medicine and general medicine journals].

OBJECTIVE: To assess the quality and relevance of adverse drug reactions (ADRs) published as Letters to the Editor (LE) in Spanish medical journals. DESIGN: Observational study. PARTICIPANTS: LE on adverse drug reactions published over 5 years (1994-98). SETTING: Four Spanish medical journals (Medicina Clínica, Revista Clínica Española, Atención Primaria and Anales de Medicina Interna). MAIN MEASUREMENTS: Patient characteristics, drugs, ADR, causality algorithm, minimum criteria, and publication relevance. RESULTS: Out of 2244 LE, 204 (9.1%) reported ADRs, which included 235 cases. The therapeutic subgroups most commonly implicated were anticoagulants and antiplatelet drugs, antibiotics, and antineoplastic agents; 20.4% of the drugs were recently marketed. ADRs most commonly involved the nervous system (13.6%), liver (10.2%), skin and appendages (9.8%), general reactions (9.8%), and the digestive system (8.1%). The reactions were moderate in 50.2% of cases and severe/fatal in 34%. The mean causality algorithm value (5.9+/-2.2) was similar among journals. Of the ADRs, 28 (11.9%) were definitive, 182 (77%) possible or probable, and 26 (11.1%) improbable or conditional; 10.2% were unknown. There were no differences in the mean minimum publication criteria (9.5+/-1.2). Publication relevance was 3.2+/-1.6 points, and higher in Medicina Clínica. CONCLUSIONS: ADRs constitute an important part of LE in the journals studied. The causal relationship is acceptable, the documentation quality is high, with few unknown reactions and ADRs to recently marketed drugs. Relevance is generally low, although greater in Medicina Clínica.

Correspondence as Topic↗
PubMed2004

Drug utilisation in outpatient children. A comparison among Tenerife, Valencia, and Barcelona (Spain), Toulouse (France), Sofia (Bulgaria), Bratislava (Slovakia) and Smolensk (Russia).

INTRODUCTION: Scarce information about comparative diagnostic and therapeutic patterns in paediatric outpatients of different countries is found in the literature. OBJECTIVE: To describe the similarities and differences observed in diagnosis and therapeutic patterns of paediatric patients of seven locations in different countries. DESIGN: Cross-sectional, prospective, international comparative, descriptive study. PATIENTS AND METHODS: A randomly selected sample of 12,264 paediatric outpatients seen in consultation rooms of urban and rural areas and attended by paediatricians or general practitioners of the participating locations. Data on patient demographic information, diagnosis and pharmacological treatment were collected using pre-designed forms. Diagnoses were coded using the ICD-9 and drugs according to the ATC classification. RESULTS: Among the ten most common diagnoses, upper respiratory tract infections are in the first position in all locations; asthma prevalence is highest in Tenerife (8.4%). Tonsillitis, otitis, bronchitis and dermatological affections are the most common diagnoses in all locations. Pneumonia is only reported in Sofia (3.8%) and Smolensk (2.3%). The average number of drugs prescribed per child varied from 1.3 in Barcelona to 2.9 in Smolensk. There are no great differences in the profile of pharmacological groups prescribed, but a considerable range of variations in antibiotic therapy is observed: prescription of cephalosporins is low in Smolensk (0.7%) and higher in the other locations, from 16.5% (Bratislava) to 28% (Tenerife). Macrolides prescriptions range from 12.6% (Toulouse) to 24.7% (Smolensk), except in Sofia where they drop to 5.6%. Trimethoprim and its combinations are used in Smolensk (23.3%), Sofia (11.8%) and Bratislava (8.7%). Check-up consultations are not recorded in Smolensk and Bratislava, whereas in Toulouse these visits account for 16.2% of all consultations and in the other locations the percentage varies from 6.1% (Tenerife) to 1.9% (Sofia). Homeopathic treatments are registered only in Toulouse. CONCLUSION: Except in asthma prevalence, there are no great differences in diagnostic maps among locations. Significant variations in the number of drugs prescribed per child and antibiotic therapies are observed. Areas for improvement have been identified.

Bulgaria↗
PubMed2004

Pharmacological treatment of acute otitis media in children. A comparison among seven locations: Tenerife, Barcelona and Valencia (Spain), Toulouse (France), Smolensk (Russia), Bratislava (Slovakia) and Sofia (Bulgaria).

OBJECTIVE: To describe patterns observed in the treatment of acute otitis media (AOM) in several locations of five countries. PATIENTS AND METHODS: Cross-sectional, descriptive study. Random sample of 12,264 paediatric outpatients seen by paediatricians or general practitioners (GPs). Data on patient demographics, diagnoses and treatment were collected. Diagnoses were coded by ICD-9 and drugs by ATC classification. Patients diagnosed with AOM (ICD-9 codes: 381 and 382) were selected for analysis. RESULTS: Cases of AOM (873) accounted for 7.1% of the sample. There is a clear variation in the percentage of children diagnosed with AOM and treated with antibiotics in the different locations, antibiotic prescriptions being higher in Barcelona (93% of children), and lowest in Smolensk (56.4 % of children were treated without antibiotics). The antibiotics used varied widely: ampicillin use is almost limited to Smolensk (26.7%) and Bratislava (13.8%), whereas amoxicillin plus clavulanic acid is the choice in Toulouse (33.8%), Valencia (30.2%) and Barcelona (28.9%), and cephalosporins are more frequently prescribed in Tenerife (51.7%). Finally, macrolides are used in Barcelona (18.3%), Valencia (17.5%) and Tenerife (13.6%), but not prescribed in Toulouse or Sofia. Prescriptions of anti-inflammatory drugs were only relevant in Valencia (31.7%), Tenerife (27.2%) and Toulouse (17.4%) and of otological preparations in Sofia, where almost each child received ear drops (91.9%). Nasal preparations are commonly used only in Sofia (41.9%), Bratislava (65.5%) and Smolensk (68.6%). CONCLUSION: Despite the general agreement of most guidelines, wide differences in the treatment of uncomplicated AOM in children are observed. Non-antibiotic therapy for AOM and the use of first-choice antibiotics should be more actively encouraged in the primary care centres. Studies to measure prevailing rates of antibiotic resistance in these populations are needed.

Acute Disease↗
PubMed2000

Adverse drug reactions in children reported by means of the yellow card in Spain.

OBJECTIVE: To analyze the case reports concerning children (14 years or younger) in the Spanish Pharmacovigilance System over a 10-year period (1982-1991). FINDINGS: The study of 1419 reports of adverse drug reaction (9.8% of all those received) showed the most commonly involved organs and systems to be the skin, digestive tract, and nervous system (62.8%). The most commonly involved pharmacological groups were antibiotics, respiratory medications, and vaccines (69%). The absolute number of reports is higher in children between 1 and 4 years of age (37.9%). There were more reports among males than in females. Less than 5% of the reports notified directly life-threatening or fatal reactions. CONCLUSIONS: Adverse drug reaction are not common in pediatric patients, and most are mild. However, due to limitations of clinical trials in children, pharmacoepidemiological studies may be the only source of information on the benefit-risk profile of drugs received by these patients, and as such require special attention.

Adolescent↗
PubMed1999

A prospective study of adverse drug reactions in hospitalized children.

AIMS: There are few publications of adverse drug reactions (ADRs) among paediatric patients, though ADR incidence is usually stated to be higher during the first year of life and in male patients. We have carried out a prospective study to assess the extent, pattern and profile risk for ADRs in hospitalized patients between 1 and 24 months of age. METHODS: An intensive events monitoring scheme was used. A total of 512 successive admissions to two medical paediatric wards (47 beds) were analysed. The hospital records were screened daily during two periods (summer, 105 days and winter, 99 days), and adverse clinical events observed were recorded. RESULTS: A total of 282 events were detected; of these, 112 were considered to be manifestations of ADRs. The cumulative incidence was 16.6%, no differences being observed between periods. Although there were no differences between patients under and over 12 months of age, risk was found to be significantly higher among girls compared with boys (RR=1.66, 95% CI 1.03-2.52). The gastro-intestinal system was most frequently affected. The therapeutic group most commonly implicated was anti-infective drugs and vaccines (41.5%). The ADRs were mild or moderate in over 90% of cases. A consistent relationship was noted between the number of drugs administered and the incidence of ADRs. CONCLUSIONS: Hospitalized patients exhibited an ADR risk profile that included female sex and the number of drugs administered. No particular age predisposition was observed. The most commonly prescribed drugs are those most often implicated in ADRs in paediatric patients.

Child, Hospitalized↗
PubMed1999

The effects of histamine on the isolated mouse uterus.

1. A study is made of the contractile and relaxant effects, and mechanism of action, of histamine on isolated uterus from mice treated with diethylstilboestrol, employing acetylcholine and adrenaline as contractile and relaxant standard agents. 2. Concentration-response curves for histamine agonists were obtained in the absence and presence of selective histaminergic blocking drugs (clemizole, ranitidine and thioperamide) and indomethacin. A number of experiments were carried out in uterus from reserpinised mice. Concentration-response curves for acetylcholine and adrenaline were also obtained in the absence and presence of their selective antagonist (atropine and propranolol). 3. In isolated oestrogenised mouse uterus, histamine and acetylcholine produced a concentration-related contractile response. When the uterus was precontracted with KCl, histamine at lower doses produced a slight contraction, though in the presence of clemizole it induced concentration-related relaxation, reminiscent of that produced by adrenaline. Atropine and propranolol antagonised the contractile and relaxant effects of acetylcholine and adrenaline, respectively. 4. In isolated uterus from reserpinised mice, histamine and 2-pyridylethylamine, but not 4-methylhistamine, produced a concentration-related contractile response. Ranitidine potentiated the contractile effect of histamine, though clemizole--in the presence of ranitidine--competitively antagonised the contractile effect of histamine (pA2 = 10.50 +/- 0.81). The concentration-relaxant curve of histamine in the presence of clemizole was not modified by ranitidine or indomethacin, but shifted to the right with thioperamide. The same displacement was also observed in the presence of clemizole plus ranitidine. 5. In mouse isolated uterus, histamine mainly produced contraction mediated by histamine H1-receptors, though the existence of histamine H2- or H3-receptors mediating relaxation could not be excluded.

Acetylcholine↗
PubMed1998

The effects of epinine on arterial blood pressure and regional vascular resistances in anesthetized rats.

1. We carried out experiments in anesthetized rats to study the hemodynamic effects of intravenous injections of epinine. 2. Epinine (1-320 micrograms/kg) produced a biphasic effect on mean arterial blood pressure (n = 30). At doses lower than 40 micrograms/kg, arterial blood pressure decreased (by as much as 21.5 +/- 3.4%), though at higher doses it increased dose dependently (by as much as 73.2 +/- 14.5%). Epinine also produced bradicardia in a dose-dependent manner (by as much as 26.4 +/- 4.9%). Sulpiride (100 micrograms/kg) suppressed the hypotensive effect of epinine but did not change the hypertensive effect. In the presence of prazosin (1,000 micrograms/kg), arterial blood pressure remained significantly decreased at all doses of epinine. Neither sulpiride nor prazosin changed the bradycardic effect of epinine. 3. Prazosin produced a significant decrease in renal vascular resistance. Epinine (5 micrograms/kg) after prazosin reverted the effects of prazosin in renal vascular resistance, without any significant modification in the renal blood flows. However, 20 micrograms/kg epinine increased the renal vascular resistances and, moreover, produced a significant decrease in the blood flows of both kidneys. Neither prazosin nor epinine produced modifications in the intestinal vascular bed. 4. Although epinine possesses significant dopamine and alpha-adrenergic activities that are involved in the biphasic effect of the agent on mean arterial blood pressure in anesthetized rats, in the presence of prazosin, it is not possible to manifest dopaminergic activity involved in the increase in renal or mesenteric blood flow; this may be due to the low tone of the vascular wall induced by the alpha-adrenergic antagonist, though an alpha 2-activity cannot be discarded.

Anesthetics, Intravenous↗
PubMed1997

Fluoxetine-associated stomatitis.

OBJECTIVE: To describe two cases of stomatitis related to fluoxetine given for the treatment of depression that were detected in the hospital emergency department. DATA SYNTHESIS: Two women developed stomatitis after the intake of fluoxetine for the treatment of depression. One of the patients had six recurrent episodes of stomatitis without suspecting an association with fluoxetine. No other drugs were administered during these episodes. The second patient was treated concurrently with fluoxetine and bentazepam. In both patients the lesion improved upon discontinuation of fluoxetine, even though the second patient continued to take a different benzodiazepine. DISCUSSION: Stomatitis related to fluoxetine has not been previously reported in clinical trials or in the literature. According to the causal algorithm used by the Spanish Drug Surveillance Schemes, the first case constituted a defined adverse reaction and the second was probable. CONCLUSIONS: Our observations suggest that fluoxetine may be considered as a probable cause of stomatitis. The reporting of isolated cases of adverse drug reactions (ADRs) makes it possible to define the toxicity profile of recently marketed drugs such as selective serotonin-reuptake inhibitors, including fluoxetine. Emphasis is placed on the potential role played by emergency departments in detecting ADRs.

Adult↗
PubMed1996

Are the adverse drug reactions of amoxycillin and amoxycillin-clavulanic acid similar?

UNLABELLED: In an attempt to assess the relative toxicity of amoxycillin and amoxycillin-clavulanic acid, we compared the adverse drug reactions reports collected using the spontaneous reporting system of a Regional Drug Surveillance Centre of Spain for both drugs between November 1986 and December 1992. During the 7-year period 1986-92, the 247 reports of amoxycillin-clavulanic acid represent twice the number of reports of amoxycillin alone, and the number of reports related with sales received concerning the association were higher than those concerning amoxycillin alone. The adverse effects classified as severe were quantitatively and qualitatively similar for both drugs and gastrointestinal and skin are the most common system-organ affected by both drugs. With amoxycillin-clavulanic acid there is a higher proportion of stomatological reactions reported and a later onset of adverse drug reactions related with oropharyngeal lesions, and the reaction of the resistance mechanism when compared with the other organs and systems affected. The duration of the adverse drug reactions to amoxycillin-clavulanic acid is longer than for amoxycillin alone. IN CONCLUSION: (i) the adverse drug reactions profile of both drugs is different; (ii) the higher reporting rate for amoxycillin-clavulanic acid may be due to more recent marketing; and (iii) amoxycillin-clavulanic acid produces proportionately more gastrointestinal and fewer skin adverse reactions than amoxycillin alone.

Journal Article↗
PubMed1996

A prospective study of adverse drug reactions as a cause of admission to a paediatric hospital.

1. A total of 512 consecutive paediatric hospital admissions of children 2 years old or less were evaluated to assess the extent and pattern of admission caused by suspected adverse drug reactions (ADRs). the proportion of suspected ADRs related to hospital admissions was 4.3%. 2. The organ-systems most commonly implicated were the central nervous system (40.5%), digestive system (16.7%), and skin and appendages (14.3%). Together, they accounted for 71.5% of admissions attributed to ADRs. The most common clinical manifestations inducing admission were convulsions (4 cases), dizziness (4), vomiting (3), and tremor, fever, itching and apnoea (2 cases each). 3. The four classes of drugs most frequently suspected in admissions due to ADRs were respiratory drugs (35%), anti-infective agents (25%), drugs active on the central nervous system (15%) and drugs used in dermatology (10%). The most common drugs related to ADRs were a combination of chlorpheniramine, diphenhydramine, phenylephrine, guaiphenesin and salicylic acid (4 cases), followed by fenoterol, adrenaline, paracetamol, DTP vaccine and antipolio vaccine (2 cases each). 4. There were no significant differences between children older and younger than 1 year (odds ratio 0.89; 95% CI 0.37-2.17) or between the sexes as regards hospital admittance due to suspected ADRs (odds ratio 1.94; 95% CI 0.72-5.42). 5. The results of this kind of study may be influenced by patterns of drug utilization. Nevertheless, the lack of specific studies of drug effects in young children makes it desirable to carry out pharmacoepidemiological studies in this age group.

Child, Preschool↗