Abstract：
INTRODUCTION:Biological and biosimilar medicinal products have specific characteristics that call for a closer monitoring of their safety profile. Since the current legal framework stems from both European and national regulations, some gaps in the operational field may be expected. The goal of this paper is to identify these gaps and propose changes to the current information systems and pharmacovigilance regulations. MATERIAL AND METHODS:A qualitative analysis of current pharmacovigilance regulatory framework and supporting information system was conducted. RESULTS:Current pharmacovigilance system does not seem to vouch for the safe use of biologicals and biosimilar drugs. The gaps found in reviewed materials may be attributable to their lack of specificity for biopharmaceuticals. DISCUSSION:Biologicals therapy presents specific determinants related with the drugs, prescription, and traceability, without replication in any other segment of the pharmaceutical market. They are able to shape their safety profile. CONCLUSION:The existing pharmacovigilance's regulatory framework should be adjusted in order to improve the safety related with biopharmaceutical therapy. Some intervention measures are proposed. :Introdução: A monitorização da segurança associada aos medicamentos biológicos e biossimilares exige um sistema de informação alinhado com o enquadramento regulamentar. Tendo em conta que podem ocorrer descontinuidades entre a regulamentação europeia, nacional e a respetiva tradução operacional, importa pesquisar e identificar essas lacunas. Material e Métodos: Foi desenvolvida uma análise qualitativa dos suportes legais vigentes em julho de 2016 ao nível europeu e nacional, com foco na farmacovigilância. Desta análise decorreu a caracterização operacional do sistema em Portugal. Resultados: Foram identificadas zonas de descontinuidade no âmbito do sistema de farmacovigilância em Portugal, pela ausência de especificidade para os medicamentos biológicos e biossimilares. Discussão: A segurança associada à terapêutica biológica apresenta determinantes específicos relacionados com os medicamentos, prescrição e traçabilidade, que não encontram replicação nos outros segmentos do mercado farmacêutico. Conclusão: Com base nas lacunas identificadas, são apresentadas propostas de intervenção com o objetivo de incrementar a segurança associada à utilização clínica de medicamentos biológicos e biossimilares.
journal_name
Acta Med Portjournal_title
Acta medica portuguesaauthors
Portela MC,Sinogas C,Almeida FA,Baptista-Leite R,Castro-Caldas Adoi
10.20344/amp.8079subject
Has Abstractpub_date
2017-03-31 00:00:00pages
205-212issue
3eissn
0870-399Xissn
1646-0758journal_volume
30pub_type
杂志文章abstract：:The authors, using the Cancer Registry data of S. Antonio General Hospital in Oporto, selected the cancer cases from 1981 to 1993. Distribution according to age, sex, topography and morphology is presented. Seven point nine percent of the 12,124 cases mentioned in the Registry were skin cancers (n = 883). They were mo...
journal_title：Acta medica portuguesa
pub_type： 杂志文章
doi：
更新日期：1998-06-01 00:00:00
abstract：:In the literature, there are few reports of posterior cerebral artery aneurysms resulting from isolated dissections. In these cases the treatment is still a matter of discussion and includes anticoagulation, surgical intervention, endovascular techniques and conservative management. We present five cases of Posterior ...
journal_title：Acta medica portuguesa
pub_type： 杂志文章,评审
doi：
更新日期：2001-01-01 00:00:00
abstract：INTRODUCTION:The surgical management of complete ureteral duplication anomalies is not consensual. OBJECTIVE:To characterize the pediatric population who underwent surgery for complete ureteral duplication and assess the outcomes of different approaches. MATERIAL AND METHODS:Clinical records from patients treated bet...
journal_title：Acta medica portuguesa
pub_type： 杂志文章
doi：10.20344/amp.6329
更新日期：2016-04-01 00:00:00
abstract：INTRODUCTION:Accurate recognition of omental infarction has resulted in increasing supporters of non-operative approach. In order to assess the efficacy and safety of conservative management, we surveyed the cases of omental infarction treated at a single institution. MATERIAL AND METHODS:Primary omental infarction tr...
journal_title：Acta medica portuguesa
pub_type： 杂志文章
doi：10.20344/amp.4996
更新日期：2014-07-01 00:00:00
abstract：:Many studies have shown that social support is related with psychological disorders and both are high consumers of health service resources. A study was carried out by the author to identify psychological disorder relationships with social support and how they change in presence or absence of life events. An inquiry b...
journal_title：Acta medica portuguesa
pub_type： 杂志文章
doi：
更新日期：1997-12-01 00:00:00
abstract：:Allergic diseases are a major public health problem. It is essential to develop prevention strategies applied to it. A number of risk factors have been identified, but some are still under contradictory. Changing the dietary pattern of the at-risk infant may prevent food allergy. Evidence suggests that exclusive breas...
journal_title：Acta medica portuguesa
pub_type： 杂志文章,评审
doi：
更新日期：2007-05-01 00:00:00
abstract：:We reviewed all the cases of Squamous Cell Carcinoma in people under 40 years of age, diagnosed histologically at the Dermatopathology Laboratory of the Santa Maria Hospital, from January 1985 to December 1993. The 19 cases detected were analysed for age, sex, occupation, anatomical site of the tumor, evolution, smoke...
journal_title：Acta medica portuguesa
pub_type： 杂志文章
doi：
更新日期：1997-11-01 00:00:00
abstract：:The authors report the importance of not only all over the world but also in Portugal and, particularly, in Dona Estefânia Hospital. Some considerations are made about the usefulness of molecular biology methods in prenatal diagnosis. With this tool can also be do the origins and migrations of populations, which contr...
journal_title：Acta medica portuguesa
pub_type： 杂志文章
doi：
更新日期：1995-06-01 00:00:00
abstract：OBJECTIVE:The purpose of this study was to determine the safety and efficacy in the first sixteen patients operated by endoscopic third ventriculostomy for triventricular obstructive hydrocephalus in the Hospital of S. João-Porto. METHODS:Operated from December 1998 to December 1999, there were one adult, one teenager...
journal_title：Acta medica portuguesa
pub_type： 临床试验,杂志文章
doi：
更新日期：2002-09-01 00:00:00
abstract：:Two types of platelet alloantigens are considered: type I, which refers to platelet alloantigens shared by platelets and other cells; and type II, which comprises the platelet-specific alloantigens. The Human Platelet Alloantigens (HPA) System consists of five diallelic alloantigens and eleven low frequency antigens. ...
journal_title：Acta medica portuguesa
pub_type： 杂志文章
doi：
更新日期：2000-09-01 00:00:00
abstract：:Multiple sclerosis (MS) is a chronic neuroinflammatory autoimmune disease believed to arise from complex interactions of both environmental and genetic factors. As in other complex diseases with autoimmune features, a genetic association with the human leukocyte antigen (HLA) complex is well documented. Association...
journal_title：Acta medica portuguesa
pub_type： 杂志文章,评审
doi：
更新日期：2012-07-01 00:00:00
abstract：:The exercise tolerance test (ETT) is the ancillary test of choice for the evaluation of the patient with ischaemic heart disease. When faced with complaints suggestive of angina pectoris, ETT is useful in confirming or excluding such a diagnosis, frequently reproducing the complaints while recording the tell-tale elec...
journal_title：Acta medica portuguesa
pub_type： 杂志文章,评审
doi：
更新日期：1997-04-01 00:00:00
abstract：:In the medical press there are several data confirming the value of E.R.C.P. and E.E.S., in the therapeutical approach of acute lithiasic pancreatitis (A.L.P.). Nowadays it is a first line endoscopic technic on the therapeutical approach in A.L.P. permitting to clean out the biliary tree of stones, eliminating the eti...
journal_title：Acta medica portuguesa
pub_type： 杂志文章
doi：
更新日期：1995-06-01 00:00:00
abstract：:During pregnancy immunological, metabolic, hormonal and vascular changes occur, and can cause specific skin diseases. The specific dermatoses of pregnancy have undergone numerous changes in nomenclature and classification, partly due to advances in the knowledge of the pathogenesis of these skin diseases. Currently th...
journal_title：Acta medica portuguesa
pub_type： 杂志文章,评审
doi：
更新日期：2013-09-01 00:00:00
abstract：INTRODUCTION:The determination of hand grip strength is an objective method of evaluation of upper members' integrity. It is also used as a general health indicator. Data about grip strength values in healthy children is useful in the research and diagnosis of diseases that interfere with grip force. The aim of this st...
journal_title：Acta medica portuguesa
pub_type： 杂志文章
doi：
更新日期：2010-09-01 00:00:00
abstract：OBJECTIVE:To assess in diabetic nephropathy, the accuracy of estimated creatinine clearance (calculated with the Cockroft Gault formula) and the clearance of the Tc99m-DTPA, to measure the glomerular filtration rate (GFR). PATIENTS AND METHODS:We analysed the GFR measure by Tc99m-DTPA method and the estimated by the C...
journal_title：Acta medica portuguesa
pub_type： 杂志文章
doi：
更新日期：2007-03-01 00:00:00
abstract：INTRODUCTION:The percentage of citizens who were not registered with a family physician in Portugal reached 16.6% in 2011. In 2012 the Ministry of Health implemented several measures aiming at improving access to family physicians. One clear objective was that all individuals would be registered with a family physician...
journal_title：Acta medica portuguesa
pub_type： 杂志文章
doi：10.20344/amp.9873
更新日期：2018-12-28 00:00:00
abstract：INTRODUCTION:To evaluate the safety and impact on visual acuity, retinal and choroidal morphology of simultaneous cataract surgery and intravitreal anti-vascular endothelial growth factor on patients with visually significant cataracts and previously treated exudative age-related macular degeneration. MATERIAL AND MET...
journal_title：Acta medica portuguesa
pub_type： 杂志文章
doi：10.20344/amp.7850
更新日期：2017-02-27 00:00:00
abstract：INTRODUCTION:All health professionals should be aware of the importance of evaluating pain - fifth vital sign- in cancer patients. Peripheral and central acting analgesics are widely used to treat moderate to severe pain, particularly cancer pain. Many guidelines have addressed this issue. However, real life patients' ...
journal_title：Acta medica portuguesa
pub_type： 杂志文章,评审
doi：10.20344/amp.10500
更新日期：2019-05-31 00:00:00
abstract：:Twelve cases of extreme umbilical blood flow impairement (8 cases with loss of end-diastolic blood flow and 4 cases with reversed flow) found among 658 pregnancies studied by continuous Doppler between April 1st 1989 and March 31st 1990, are reported. The findings were associated to intra-uterine growth retardation (9...
journal_title：Acta medica portuguesa
pub_type： 杂志文章
doi：
更新日期：1991-05-01 00:00:00
abstract：:The isolation of nontuberculous mycobacteria was considered for many years as a result of contamination or transient colonization. The role of these bacteria in human disease was recognized only after 1950. They were present almost exclusively in patients with underlying pulmonary pathology and were rare. The prevalen...
journal_title：Acta medica portuguesa
pub_type： 杂志文章,评审
doi：
更新日期：1999-12-01 00:00:00
abstract：:Thyroid associated orbitopathy is a clinical entity with pathogenic mechanisms not fully understood, and appears in about 90% of cases in association with hyperthyroidism of Graves' disease. Its approach involves the recognition of typical features and the exclusion of other diseases in the less common presentations. ...
journal_title：Acta medica portuguesa
pub_type： 杂志文章,评审
doi：
更新日期：2011-11-01 00:00:00
abstract：:We report 3 years of experience with operative ultrasonography on 200 patients who underwent cholecystectomy for biliary lithiasis. Intraoperative ultrasonography and intraoperative cholangiography were performed on all of these patients and compared with the operative findings. The diagnostic accuracy of sonography w...
journal_title：Acta medica portuguesa
pub_type： 杂志文章
doi：
更新日期：1993-03-01 00:00:00
abstract：BACKGROUND:Abdominal trauma is a major cause of morbi-mortality all over the world which makes it essential an approach focused on rapid diagnosis and treatment. The main goals of this study are to identify global epidemiologic data of abdominal trauma in our tertiary trauma center and to study traumatic lesions, treat...
journal_title：Acta medica portuguesa
pub_type： 杂志文章
doi：
更新日期：2013-11-01 00:00:00
abstract：:Temporal arteritis is a systemic vasculitis mainly affecting large and medium sized vessels, temporal artery in particular. The authors report the case of a male who presented with large painful scalp ulcers over the temporo-parietal area, ipsilateral headache, amaurosis fugax and jaw claudication. Temporal arteries w...
journal_title：Acta medica portuguesa
pub_type： 杂志文章
doi：
更新日期：2010-03-01 00:00:00
abstract：OBJECTIVE:To assess epidemiological profile of spinal cord injury outpatients which have been participating of rehabilitation programme using neuromuscular electrical stimulation, in order to implement campaigns for preventing spinal cord trauma. METHODS:From January to April 2009, 30 patients at the spinal cord injur...
journal_title：Acta medica portuguesa
pub_type： 杂志文章
doi：
更新日期：2011-07-01 00:00:00
abstract：:The authors report a case of seronegative polyarthritis resistant to the anti-inflammatory therapy in a 16-year-old male with intermittent diarrhea. A stool examination showed the presence of cysts of Giardia lamblia and an immunological study detected a partial serum IgA deficiency, including its secretory fraction. ...
journal_title：Acta medica portuguesa
pub_type： 杂志文章,评审
doi：
更新日期：1993-12-01 00:00:00
abstract：:Sepsis is a common pathology during the neonatal period. Low-birth weight is the most important isolated risk factor. With the purpose of determining the prevalence of nosocomial infection in newborns of very low birth weight (VLBW), finding the microbial flora and the mortality of these patients, the authors retrospe...
journal_title：Acta medica portuguesa
pub_type： 杂志文章
doi：
更新日期：1996-10-01 00:00:00
abstract：:The author refer that thyroid nodule occur quite often in general population. He also mention research methods, and how they could be changed when pregnant women in concern. Therefore this prognosis must be done through cytology and ultrasounds. When related to rate of occurrence, metastasis and mortality, there are n...
journal_title：Acta medica portuguesa
pub_type： 杂志文章
doi：
更新日期：2003-09-01 00:00:00
abstract：INTRODUCTION:Severity in systemic lupus erythematosus may vary from mild to even fatal consequences. There are no biomarkers to predict the disease's prognosis. The Systemic Lupus International Collaborating Clinics/ Systemic Damage Index defines systemic lupus erythematosus disease severity and is found to predict pro...
journal_title：Acta medica portuguesa
pub_type： 杂志文章
doi：10.20344/amp.8082
更新日期：2017-05-31 00:00:00
