Scholarly publishing depends on peer reviewers

The peer-review crisis is posing a risk to the scholarly peer-reviewed journal system. Journals have to ask many potential peer reviewers to obtain a minimum acceptable number of peers accepting reviewing a manuscript. Several solutions have been suggested to overcome this shortage. From reimbursing for the job, to eliminating pre-publication reviews, one cannot predict which is more dangerous for the future of scholarly publishing. And, why not acknowledging their contribution to the final version of the article published? PubMed created two categories of contributors: authors [AU] and collaborators [IR]. Why not a third category for the peer-reviewer?Scopu

Immature psychological defense mechanisms and the misrepresentations of some sex researchers

The authors reply to a quartet of recent articles in this journal. We detail certain misrepresentations and the dismissal of existing research in those articles (including attempts at denial of the repeatedly documented association of lack of vaginal orgasm with greater use of immature psychological defense mechanisms and other indices of poorer health). The authors also call for a less defensive and less doctrinaire approach to sex research, especially, but not exclusively, when the prevailing ideology in the fields of sexology might be undermining optimal health

Awareness of the implementation of the Falsified Medicines Directive among pharmaceutical companies’ professionals in the European Economic Area

Background: The Falsified Medicines Directive (FMD) is a response of the European Union to the increasing number of falsified medicines present in the legal supply chain within the Member States of the community. Effective implementation of the new regulations will depend on the effective cooperation of all parties involved in the distribution of medicinal products including the managers of pharmaceutical companies. Objective: The objective of the study was to examine awareness of the Implementation of the FMD among pharmaceutical company professionals in the European Economic Area. Methods: Sampling was conducted using a method called purposive sampling. An appropriate research tool in the form of an original questionnaire was made available to the respondents in electronic form. During the period from January 2016 to June 2016, 1,496 e-mail messages were sent. The response rate was 17.37%. Results: The study included 99 women (39.3%) and 153 men (60.7%). In the study group, 95.7% of people had heard of FMD. Doctors had rarely heard about the falsified medicine directive when compared to pharmacists (p=0.0063), people working in the pharmaceutical industry (p=0.0014), and respondents with a different professional profile (p=0.0114). In the study group, 89.6% of people were aware of the role of National Medicines Verification Organization in the process of implementing the provisions of FMD into the national system of distribution of medicinal products. The number of the respondents who knew the deadline for the implementation of FMD was significantly higher in the study population, i.e. 91.9% (p=0.0001). Both the younger respondents and those with lower level of education were less aware of the time requirements posed to national regulators (p=0.0003, p=0.0023, respectively). Conclusions: Awareness of the regulations related to the implementation of the FMD, although relatively high among pharmaceutical company professionals in the EEA, is still insufficient

The European Falsified Medicines Directive in Poland: background, implementation and potential recommendations for pharmacists

By February 2019, the Polish pharmaceutical industry, community and hospital pharmacies, wholesalers and parallel traders must all comply with the EU-wide Falsified Medicines Directive (FMD) legislation (2011/62/EU), to ensure that no medicinal product is dispensed to a patient without proper tracking and authentication. Here we describe how Poland is complying with the new EU regulations, the actions that have been taken to incorporate the FMD into Polish Pharmaceutical Law and whether or not these actions are sufficient. We found that Poland is only partially compliant with the FMD and further actions need to be undertaken to fully meet the Delegated Act (DA) requirements. Moreover, there is lack of awareness in Poland about the prevalence of falsified medication and the time scale required for implementation of the DA. Based on our findings, we suggest that a public awareness campaign should be started to raise awareness of the increased number of falsified medicines in the legal supply chain and that drug authorisation systems are implemented by Polish pharmacies to support the FMD

Hospital audit as a useful tool in the process of 2 introducing Falsified Medicines Directive (FMD) into 3 hospital pharmacy settings – a pilot study

Background: Recently, the European Union has introduced the Falsified Medicines Directive (FMD). Additionally, in early 2016, a Delegated Act (DA) related to the FMD was published. The main objective of this study was to evaluate the usefulness of external audits in the context of implementing new regulations provided by the FMD in the secondary care environment. Methods: The external, in-person workflow audits were performed by an authentication company in three Polish hospital pharmacies. Each audit consisted of a combination of supervision (non- participant observation), secondary data analysis, and expert interviews with the use of an independently designed authorial Diagnostic Questionnaire. The questionnaire included information about hospital drug distribution procedures, data concerning drug usage, IT systems, medication order systems, the processes of medication dispensing, and the preparation and administration of hazardous drugs. Data analysis included a thorough examination of hospital documentation in regards to drug management. All data were subjected to qualitative analysis, with the aim of generating meaningful information through inductive inference. Results: Only one dispensing location in the Polish hospitals studied has the potential to be a primary authentication area. In the audited hospitals, an Automated Drug Dispensing System and unit dose were not identified during the study. Hospital wards contained an enclosed place within the department dedicated to drug storage under the direct supervision of senior nursing staff. An electronic order system was not available. In the largest center, unused medications are re- dispensed to different hospital departments, or may be sold to various institutions. Additionally, in one hospital pharmacy, pharmacists prepared parenteral nutrition and chemotherapeutic drugs for patients admitted to the hospital. Conclusions: External audits might prove beneficial in the course of introducing new regulations into everyday settings. However, such action should be provided before the final implementation of authentication services. To sum up, FMD can impact several hospital departments

Hospital audit as a useful tool in the process of 2 introducing Falsified Medicines Directive (FMD) into 3 hospital pharmacy settings – a pilot study

Background: Recently, the European Union has introduced the Falsified Medicines Directive (FMD). Additionally, in early 2016, a Delegated Act (DA) related to the FMD was published. The main objective of this study was to evaluate the usefulness of external audits in the context of implementing new regulations provided by the FMD in the secondary care environment. Methods: The external, in-person workflow audits were performed by an authentication company in three Polish hospital pharmacies. Each audit consisted of a combination of supervision (non- participant observation), secondary data analysis, and expert interviews with the use of an independently designed authorial Diagnostic Questionnaire. The questionnaire included information about hospital drug distribution procedures, data concerning drug usage, IT systems, medication order systems, the processes of medication dispensing, and the preparation and administration of hazardous drugs. Data analysis included a thorough examination of hospital documentation in regards to drug management. All data were subjected to qualitative analysis, with the aim of generating meaningful information through inductive inference. Results: Only one dispensing location in the Polish hospitals studied has the potential to be a primary authentication area. In the audited hospitals, an Automated Drug Dispensing System and unit dose were not identified during the study. Hospital wards contained an enclosed place within the department dedicated to drug storage under the direct supervision of senior nursing staff. An electronic order system was not available. In the largest center, unused medications are re- dispensed to different hospital departments, or may be sold to various institutions. Additionally, in one hospital pharmacy, pharmacists prepared parenteral nutrition and chemotherapeutic drugs for patients admitted to the hospital. Conclusions: External audits might prove beneficial in the course of introducing new regulations into everyday settings. However, such action should be provided before the final implementation of authentication services. To sum up, FMD can impact several hospital departments