Medicinal products of a biological origin are approved by the EMA at a centralized level. However, there is no harmonization about their use in Europe. The current regulation referring to the safety of biological medicinal products and biosimilars in Europe has been identified. The safety associated with medicinal products of a biological origin is assured by the pharmacovigilance system, which has evolved, but doesn't yet incorporate all of the specific information from this market segment, namely that related to the identification of drugs, and its use - including the prescription and dispensing, given the possibility of interchangeability and substitution. The terminology, information systems and traceability systems aren't entirely appropriate to ensure the safety requirements for therapy with medicinal products of a biological origin. Areas covered: This article aims to identify the prescription and dispensing profiles of reference biological medicines and biosimilars in the EU, and the determinants that support their safe use. Expert opinion: The European pharmacovigilance system must evolve to ensure the safety along all of the biologicals' therapeutic cycle. It must consider the safety for each of the medicines in addition to their safety pattern related to the eventual switching procedure.

The objectives of this study are to report the contribution of pharmacists to smoking cessation and study the determinants of smoking cessation success in eight pharmacies in Portugal (south) between 2009 and 2019. A real-life study was conducted with a sample of smokers who participated in pharmacist consultations. The sample included 135 smokers (average age of 47.9 ± 1.21 years), 79 (58.5%) of whom were male. In parallel with the motivation and behavioral approach, 116 (85.9%) smokers received pharmacological therapies: 108 (80.0%) were treated with nicotine replacement products and eight (5.9%) with non-nicotine medications. The interventions resulted in 70 (51.9%) smokers complying with the quit day, of whom 59 (43.7%) were smoking-abstinent at the end of the first month. Success rates were reduced to 32.6%, 28.1%, and 20.7% at the end of the 3rd, 6th, and 12th months, respectively. Smoking cessation was more successful for the participants receiving pharmacological therapies (Fisher’s exact test, p < 0.001) and those who participated in more pharmacist consultations (χ2 = 59.994, p < 0.001) and more telephone sessions (χ2 = 17.845, p < 0.001). Pharmacists can contribute significantly to the promotion of smoking cessation. Smokers who are more thoroughly followed up by pharmacists showed increased success rates when compared with smokers having fewer sessions with pharmacists.

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. Keywords: Adverse Drug Reaction Reporting Systems; Biological Products; Biosimilar Pharmaceuticals; Drug Monitoring; Pharmacovigilance; Portugal INTRODUÇÃOOs medicamentos biológicos e biossimilares apresentam um elevado grau de complexidade e variabilidade que pode condicionar o respetivo perfil de segurança e/ou de eficácia. Estes fatores devem também ser tomados em consideração em presença de interpermutabilidade e substituição. Assim, é imperativo garantir o acompanhamento do rácio benefício risco, tendo em conta que no alinhamento entre os domínios regulamentar e operacional podem existir fronteiras de descontinuidade instrumental que urge identificar e suprir. Por ser universal, o sistema de farmacovigilância pode não estar a captar a informação específica dos medicamentos biológicos e biossimilares, que aqui se pretende identificar e caracterizar. MATERIAL E MÉTODOSFoi conduzida uma análise qualitativa, com base na legislação publicada a nível nacional e europeu, e nos documentos normativos emitidos pelas autoridades reguladoras. Recorreu-se à informação codificada disponível no sítio eletrónico da autoridade reguladora do medicamento em Portugal (INFARMED), das instituições públicas tuteladas pelo Ministério da Saúde e da Agência Europeia do

Background: According to the World Health Organisation, tobacco use is one of the most widespread public health threats in the world, making it particularly urgent to promote smoking cessation. The effectiveness of pharmacist interventions in smoking cessation has been documented in the international literature, but not sufficiently in Portugal. Objective: To report the preliminary results of study to assess the effectiveness of a smoking cessation programme delivered in Portuguese community pharmacies using an outsorcing-based regimen. Methods: Within the scope of a pharmaceutical care programme implemented in seven community pharmacies by an outsourced pharmacist, a specific consultation for smoking cessation was developed, in accordance with Portugal's General Directorate of Health's recommendations and instruments. The smokers were identified and invited to join the programme by the pharmacy staff during their daily activities. Patients that accepted signed an informed consent. Through several face-to-face and phone consultations and based on a comprehensive patient approach, personalised plans to quit tobacco were defined with the patients' agreement. The effectiveness of the service was assessed through the evaluation of quit rates at 1, 6 and 12 months. The continuous variables were expressed as mean ± standard error of the mean. Results: During approximately 5 years (between January 2009 and July 2014), 69 smokers joined the programme. Of these, 17 desisted during the first consultation. Of the remaining 52 patients, the mean age was 47.4 ± 2.11 years old and 55.8% were male. A total of 264 pharmaceutical consultations were delivered and, on average, each patient received 7.7 ± 0.81 interventions. Most interventions (60.1%) were pharmacological (e.g. nicotine replacement products), while non-pharmacological measures (e.g. motivational interviewing) represented 39.9%. Five patients were referred to a physician. At 1 month after the quit date, 37 patients were abstinent (53.6%); 6 months later the number reduced to 24 (34.8%) and, 1 year later, 16 patients remained abstinent (23.2%). Conclusions:The implementation of a smoking cessation programme in community pharmacies using an external pharmacist may contribute effectively to tobacco cessation in Portugal.

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