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Background: After primary treatment, patients with early breast cancer (EBC) are followed-up for at least 5 years. At the Helsinki University Hospital (HUS) surveillance includes appointments at 1, 3 and 5 years, and between pre-planned visits a phone call service operated by a nurse practitioner for counseling about symptoms related to side-effects or potential recurrence. In 2015 HUS launched a digital solution for cancer patients. This study was designed to find out patient preference, Health related (HR) quality of life (QOL) and satisfaction with a digital solution compared to a phone call service during the first year of follow-up., Material and Methods: Patients with EBC were randomized at the final visit of radiotherapy to surveillance by phone calls or by the digital Noona solution during the first year outside pre-planned visits. After six months the groups were crossed over to the other arm. Primary endpoint was patient preference for either follow-up method among those who had contacted the study nurse at least once by both phone service and digital solution., Results: Out of the 765 patients randomized, 142 had contacted the hospital with both methods and were eligible for inclusion in the analyses of the present study. Out of the 142 patients, 56 preferred phone calls, 43 the digital solution while 43 considered both modalities equal. Preference for the digital solution was higher among patients aged 65 or less. There were no differences in HR QoL or overall satisfaction between the modalities. However, the patients rated the timeliness of response better while using the digital solution., Conclusion: Of the patients 30% preferred the digital solution, 40% phone calls while 30% found them equal as the primary follow-up method for EBC during the first year outside pre-planned visits. There is a need to include also digital solutions in surveillance of EBC., Clinicaltrials.gov Identifier: NCT04980989.

Although the availability of generic oncology drugs allows access to contemporary care and reduces costs, there is international variability in the safety of this class of drugs. In this Series paper, we review clinical, policy, safety, and regulatory considerations for generic oncology drugs focusing on the USA, Canada, the European Union (EU), Japan, China, and India. Safety information about generic formulations is reviewed from one agent in each class, for heavy metal drugs (cisplatin), targeted agents (imatinib), and cytotoxic agents (docetaxel). We also review regulatory reports from Japan and the USA, countries with the largest pharmaceutical expenditures. Empirical studies did not identify safety concerns in the USA, Canada, the EU, and Japan, where regulations and enforcement are strong. Although manufacturing problems for generic pharmaceuticals exist in India, where 40% of all generic pharmaceuticals used in the USA are manufactured, increased inspections and communication by the US Food and Drug Administration are occurring, facilitating oversight and enforcement. No safety outbreaks among generic oncology drugs were reported in developed countries. For developing countries, oversight is less intensive, and concerns around drug safety still exist. Regulatory agencies should collaboratively develop procedures to monitor the production, shipment, storage, and post-marketing safety of generic oncology drugs. Regulatory agencies for each country should also aim towards identical definitions of bioequivalence, the cornerstone of regulatory approval., (Copyright © 2016 Elsevier Ltd. All rights reserved.)

Introduction: The introduction of recombinant human erythropoietin revolutionized the management of anemia in patients with chronic kidney disease (CKD). In order to circumvent costly recombinant DNA technology, synthetic chemistry techniques were used to manufacture peginesatide, a synthetic peptide that bore no resemblance to previous erythropoiesis-stimulating agents (ESAs), and yet was capable of stimulating erythropoiesis. Compared with other ESAs, peginesatide was deemed to have advantages related to immunogenicity, administration schedule, and cost. Marketing approval was restricted to CKD patients on dialysis because cardiovascular events were more common with peginesatide than with darbepoetin in non-dialysis CKD patients. Unfortunately, unexplained serious adverse drug reactions (sADR) led to quick withdrawal of peginesatide from the market., Areas Covered: This review describes the efficacy and safety of peginesatide in pre-approval clinical trials, sADRs after marketing approval, and lessons learned during its short life-span., Expert Opinion: The case of peginesatide illustrates the difficulties in detecting rare sADRs in trials with limited patient populations and the need for improved pharmacovigilance after marketing approval. However, the need for simpler drug production methods as a result of non-dependence on recombinant DNA techniques and mammalian cell lines remains. Lessons learned during the scientific development of peginesatide can be used in developing other drugs.

Biological oncology products are integral to cancer treatment, but their high costs pose challenges to patients, families, providers, and insurers. The introduction of biosimilar agents-molecules that are similar in structure, function, activity, immunogenicity, and safety to the original biological drugs-provide opportunities both to improve health-care access and outcomes, and to reduce costs. Several international regulatory pathways have been developed to expedite entry of biosimilars into global marketplaces. The first wave of oncology biosimilar use was in Europe and India in 2007. Oncology biosimilars are now widely marketed in several countries in Europe, and in Australia, Japan, China, Russia, India, and South Korea. Their use is emerging worldwide, with the notable exception of the USA, where several regulatory and cost barriers to biosimilar approval exist. In this Review, we discuss oncology biosimilars and summarise their regulatory frameworks, clinical experiences, and safety concerns., (Copyright © 2014 Elsevier Ltd. All rights reserved.)

Finland enacted as the first country in Europe an Act on the Status and Rights of Patients. This report deals with the experiences gained in the course of the implementation of the patient law during the past three years it has been in force. Patients' rights to information and self-determination are considered as the most central matters. Also the right to good care, the status of minor patients and patients' right to privacy protection are important matters. Patient ombudsmen have tried to convey information to the field on the law and the obligations it imposes on health care personnel. The law is considered to already have influenced practical functions within health care. However, there is still much to improve in patients' access to information and in the treatment of patients; the attitudes and the care traditions change slowly. That living wills have become more general is a manifestation of people's willingness to use their right of self-determination even when they are no more able to express their will. Complaints that are processed at the local level are frequent, and each organization has a Patient Ombudsman. The principles of this system of complaints and patient ombudsmen are considered good, but there is much room for improvement.

This study comprised all complaints submitted from 1980 to 1990 by coronary patients and their relatives to the Finnish National Board of Health (NBH). The purpose of this study was to determine the reasons for complaints and their consequences. The complaints were coded and the material was analysed using the statistical BMDP package. Only 59 of a total of 7,516 complaints dealt with coronary disease. The majority of complaints concerned professional technical competence. The NBH found negligence in ten cases and gave administrative counselling to the professionals at fault. The negligence was not deemed serious enough to warrant any penalties or the restriction of licences. Communication problems were difficult to prove and none of these complaints resulted in counselling. Treatment of coronary heart disease seldom results in a formal complaint and negligence is found only in a minority of cases. Patient dissatisfaction can well be studied by analysing complaints, but the general quality of coronary care has to be addressed with other methods.