Any vaccine related safety issue leads to loss of parents' confidence in vaccines. This observational prospective study aimed to assess the reactogenicity and medically attended adverse events (MAEs) reported after the hexavalent vaccination (diphtheria-tetanus-pertussis toxoid, inactivated poliomyelitis virus, antigens against hepatitis B and Haemophilus influenzae type B polysaccharide). Children, vaccinated with the hexavalent vaccine in two general practitioner's offices between March 2016 and April 2017 according to the national immunization schedule from Romania, were included in the study. Reactogenicity and MAEs were assessed for 4 days post-vaccination and during 6 months post-vaccination, respectively. A total of 211 children were included in the study. The hexavalent vaccine was administered alone (Hexa alone) in 255 visits and together with other paediatric vaccines (Hexa co-ad) in 101 visits. Pain was the most frequently reported solicited local symptom regardless if the hexavalent vaccine was administered alone or co-administered with other paediatric vaccines (26.1% vs. 31.3%). Fever was more frequently reported in Hexa co-ad group as compared to Hexa alone (28.1% vs. 13.7%). Infectious diseases were the majority of reported MAEs. 13 serious AEs and no death were recorded. Overall, this study confirmed the known safety profile of the hexavalent vaccine. RezumatSiguranța vaccinurilor afectează decizia părinților de a vaccina copiii. Studiul de față a avut ca obiectiv evaluarea reactogenicității vaccinului hexavalent și evenimentelor adverse evaluate medical (EAM) raportate după vaccinare. Au fost incluși în studiu copiii vaccinați conform schemei naționale de imunizare în două cabinete de medicină de familie între martie 2016 și aprilie 2017. Reactogenitatea a fost evaluată la 4 zile și EAM timp de 6 luni după vaccinare. 211 de copii au fost incluși în studiu. 255 doze de vaccin hexavalent au fost administrate singure și 101 doze au fost co-administrate cu alte vaccinuri. Durerea a fost cea mai frecventă reacție locală raportată, indifferent dacă vaccinul hexavalent a fost administrat singur sau co-administrat cu alte vaccinuri (26.1% vs. 31.3%). Febra a fost mai frecvent raportată când vaccinul hexavalent a fost co-administrat cu altevaccinuri în comparație cu vaccinul administrat singur (28.1% vs. 13.7%). Infecțiile au fost majoritatea EAM raportate. 13 EA grave au fost raportate și niciun caz de deces. Acest studiu confirmă informațiile de siguranță ale vaccinului hexavalent.
Any vaccine safety issue affects the public confidence in vaccines. This study summarized the safety data published in randomized clinical trials from Europe on the hexavalent vaccine (diphtheria-tetanus-pertussis toxoid, inactivated poliomyelitis virus, antigens against hepatitis B and Haemophilus influenzae type B polysaccharide) administered alone or together with other paediatric vaccines, published between 2000-2016. The solicited adverse events (AEs), unsolicited AEs (uAEs) and serious AEs (SAEs) were evaluated. We included 15 studies summing up 6,618 children with the age between 2 -24 months. Grade 3 local reactions ranged between 1.1% -15.5% for redness, 0.4% -7.4% for pain and 1.4% -9.7% for swelling. Irritability and fever were the most frequently reported general symptoms. The incidence of fever ranged between 11.0% -57.3%, while grade 3 fever (> 39.5ºC) affected up to 15.9% of children. The rate of fever slightly increased when the hexavalent vaccine was co-administered with other paediatric vaccines as compared to the hexavalent vaccine alone (30.8% -76.7% vs 11.0% -57.3%). Toddlers experienced fever with a slightly increased incidence as compared to infants (31.1% -52.1% vs 9.2% -46.3%). uAEs ranged between 17.7% -51.1% for hexavalent vaccine administered alone or concomitantly with other paediatric vaccines. No vaccine-related SAEs were reported for the hexavalent vaccine administered alone, while four vaccine-related SAEs (urticaria, febrile seizure, hypotonic-hyporesponsive episode and Kawasaki disease) were reported when this was co-administered with other paediatric vaccines. The reviewed studies from Europe, published between 2000 -2016, showed that hexavalent vaccine was generally well tolerated as primary and booster vaccination. RezumatOrice informație relaționată cu siguranța vaccinurilor influențează încrederea populației în vaccinare. Acest studiu sintetizează datele de siguranță ale vaccinului hexavalent (toxoid diphtheric-tetanic-pertussis, virus poliomielitic inactivat, antigene împotriva hepatitei B și polizaharide de Haemophilus influenzae tip B) publicate în studiile clinice randomizate, efectuate în Europa și publicate în perioada 2000 -2016. Au fost incluse studii în care vaccinul hexavalent a fost administrat singur sau în asociere cu alte vaccinuri. Au fost evaluate evenimentele adverse solicitate, nesolicitate și cele grave. Au fost incluse în analiză 15 studii, cu un număr total de 6.618 de copii cu vârsta cuprinsă între 2 și 24 de luni. Reacțiile locale de gradul 3 au variat între 1,1% -15,5% pentru roșeață, 0,4% -7,4% pentru durere și 1,4% -9,7% pentru indurație. Dintre simptomele generale, cele mai frecvent raportate au fost iritabilitatea și febra. Incidența febrei a variat între 11,0% -57,3%, iar febra de gradul 3 (> 39,5ºC) a afectat până la 15,9% din copii. Frecvența febrei a fost ușor crescută atunci când vaccinul hexavalent a fost administrat împreună cu alte vaccinuri comparativ cu vaccinul hexavalent administrat singur (30,8% -76,7% vs 11,0% -57,3%). Febra a fost ...
Pharmacokinetic and pharmacodynamic changes associated with old age, along with multimorbidity and polypharmacy might lead to inappropriate prescribing and adverse reactions. Explicit criteria such as the Screening tool of older people’s prescribing (STOPP) are useful to identify potential inappropriate prescribing’s (PIPs). Our retrospective study included discharge papers from patients aged ≥65 years, from an internal medicine department in Romania (January–June 2018). A subset of the STOPP-2 criteria was used to assess the prevalence and characteristics of PIPs. Regression analysis was performed to evaluate the impact of associated risk factors (i.e., age, gender, polypharmacy and specific disease). Out of the 516 discharge papers analyzed, 417 were further assessed for PIPs. Patients’ mean age was 75 years, 61.63% were female and 55.16% had at least one PIP, with 81.30% having one or two PIPs. Antithrombotic agents in patients with significant bleeding risk was the most prevalent PIP (23.98%), followed by the use of benzodiazepines (9.11%). Polypharmacy, extreme (>10 drugs) polypharmacy, hypertension and congestive heart failure were found as independent risk factors. PIP was prevalent and increased with (extreme) polypharmacy and specific cardiac disease. Comprehensive criteria like STOPP should be regularly used in clinical practice to identify PIPs to prevent potential harm.
Antibiotics are among the most prescribed drugs in pediatric inpatients and are frequently associated with adverse drug reactions (ADRs) in children. This study aimed to assess the frequency and type of ADRs related to the use of antibiotics in pediatric inpatients through a prospective observational study, conducted over 6 months, covering the winter and spring seasons when the incidence of infections peaks in Romania. ADRs were evaluated for causality, avoidability and severity. Among the 266 included children, 25 (9.4%) experienced 30 ADRs. ADR frequency tended to be higher in ≤ 2-year-olds (13 of 25, 52.0%) than in other age categories. Gastrointestinal and hematological ADRs were most frequently observed. Diarrhea was the most common ADR associated with antibiotics (8 of 30, 26.7%). Ceftriaxone (16 of 30, 53.3%), cefuroxime, ceftazidime and azithromycin (3 of 30, 10.0% each) were most commonly responsible for ADRs. After causality assessment, 2 (6.7%) ADRs were considered definite, 12 (40.0%) probable and 16 (53.3%) possible. One ADR was classified as definitely avoidable and one as possibly avoidable. Seven children required treatment for ADRs. Antibiotic treatment was discontinued in 4 children. Antibiotics frequently caused ADRs in ≤ 2-year-olds and were commonly associated with gastrointestinal symptoms. Close monitoring of antibiotic-associated ADRs remains important in the pediatric population.
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