Biography:

Greg Koski is internationally recognized as a leader in the realm of systems thinking and technology to improve the clinical research process. He is co-founder and president of the Alliance for Clinical Research Excellence and Safety (ACRES), a global multi-sector non-profit collaborative working in the public interest to build a shared open-system to promote accountable research while enhancing quality, efficiency and safety.

Abstract:

Vigilance is the action or state of keeping careful watch for possible danger or difficulties. Conceptually and operationally, vigilance requires contemporaneous access to critical safety-relevant data or information to enable analysis and assessment of potential risks. Medicinal products provide valuable methods for diagnosis, prevention and treatment of disease, and also carry significant potential for adverse reactions resulting in injury or harm, even death. Several industries, including transportation, aerospace and nuclear power generation, have long-standing and well-developed safety systems based on systems thinking—appreciating that data flowing through critical interactions among diverse systems components generates signals that can reliably be used to effectively monitor the complex environment for indications of impending component or system failures well before a critical incidents occur with potential catastrophic results. Remarkably, the pharmaceutical and medical device industries have as yet failed to develop a comparable capability, instead relying on often out-moded, inefficient processes to support the critical function of pharmacovigilance. Through application of systems engineering principles to the drug development/clinical research process, and with effective application of information technology and informatics, it is possible to realize a system for continuous real-time pharmacovigilance, and potentially, predictive pharmacovigilance, to dramatically enhance drug and device safety. This presentation will describe a vision for such a system and proposals for its realization.

Biography:

Angela specialises in providing tailor made pharmacovigilance support, including QPPV provision and responsibility for the clients pharmacovigilance systems. Create safety data exchange agreements on behalf of our clients, database management of patient reports on adverse events related to medicinal product use, give training on basic and advanced pharmacovigilance, write periodic reports on the risk-benefit balance of pharmaceutical products by evaluating literature, case reports and all other relevant sources. Monitor the department for quality and compliance. Her research interests lie with Benefit/Risk evaluation and risk management, Off label use and Medication errors.

Abstract:

To obtain a marketing authorisation (MA), companies are expected to evaluate the safe use of their medicinal product. In the risk management plan, dedicated sections address medication errors and off-label use; two sides of the same coin: the authorized product information guidance is not followed, either inadvertently (in error) or intentionally. Several initiatives are currently taking place to monitor medication errors, e.g. to develop a medication error SMQ, and the EMA has published good practice guides on coding and reporting, and on risk minimization and prevention. The balancing line between product usage that categorizes as medication errors versus off-label use is thin, and may be drawn differently by different MAHs, also depending on the authorized indications for their specific products. How often is it clear from the reported information that the “off-label” administration indeed occurred intentionally? How to code reports where a patient intentionally takes a product for longer than is written in the product information? Also, the same active substance, usually the level on which signal detection activities occur, can be authorised for multiple indications. This means that if signalling activities occur by different stakeholders, different results will be obtained. Finally, where the concept of medication errors includes an unintended error or failure in the drug treatment process, the concept of off-label refers to an intention to not use the product according to the authorised indication. How should this be managed?

Biography:

Peter Lannon has graduated from Rhodes University in 1995 with a Bachelor of Pharmacy degree. He is a Registered Pharmacist and holds a Postgraduate Certifi cate in Pharmacovigilance and Pharmacoepidemiology from the London School of Hygiene and Tropical Medicine. He is the Director of Lanpharm Consulting, a pharmacovigilance consulting company providing advice/consulting on all areas of pharmacovigilance. He has over 17 years experience in pharmacovigilance in both small and large pharmaceutical and generic companies.

Abstract:

Submission of a new Marketing Authorization Application (MAA) requires a great deal of work and planning over many years. Much input and planning into the quality, efficacy, pre-clinical and clinical safety and numerous other areas is undertaken, however the role of the risk management plan (RMP), its production, submission and approval is oft en underestimated. It is vitally important that a clear strategy is agreed and communicated early in the development process or as soon intent to submit MAA has been taken. Although the RMP contains little new/novel data that is not present elsewhere in the submission package, the inter-relationship between the RMP and other higher level documents such as the Summary of Clinical Safety, the Clinical Overview, Pre-clinical Overview and the proposed label needs to be carefully considered. The timing of the development, production and approval of the RMP is vital as it is difficult or risky to finalize until these other high level documents have been approved for submission. The aim of this presentation is to provide some experience of a somewhat unorthodox first MAA for a new drug entity including lessons learned and to provide some practical suggestions/advice to aid a smoother regulatory submission.

Biography:

Kieran O’Donnell has over 15 years of PV and since 2006 has been leading European and Global PV operations, gaining broad experience in PV QMS; Benefit-risk management; Signal Detection & Management; PSURs & DSURs; RSI development; ICSR and SUSAR submission; Inspection (MHRA GCP & PV and FDA PV inspections; ISO 9001:2000; and responsible roles such as the RP for EudraVigilance and Deputy QPPV for Pharmacovigilance. In addition to his PgC Pharmacovigilance, he has been a member of the RQA PV Committee since 2008 and is a Fellow of PIPA. He joined TMC in June 2014.

Abstract:

The public reputation of the pharma industry has been impacted by the many examples where PV systems have failed and companies have promoted unsafe indications and dosages of approved medicines, resulting in patient deaths and severe events. However, there are some examples where tragedies and failures such as thalidomide and the lack of a structured AE reporting system eventually result in some positive outcomes e.g. approved indications for thalidomide in leprosy and cancer- all managed under the umbrella of a comprehensive risk management system. Many drugs are launched and then prescribed and/or used outside of their authorized indication, and there remain significant challenges in controlling or influencing prescriber and patient behaviour to support safe use of the product. With the introduction of the FDAAA, PDUFA, and GVP, the pharma industry has seen seismic changes to PV requirements that focus on patient protection, proactive PV, and the need for PV quality systems. But does this mitigate the possibility for pharma company ineptitude and/ or malpractice, and what should be done and what can be done by pharma to improve PV? Compliance is the minimum standard, not the gold standard. This presentation will look at some examples where the challenges of PV facing the pharma company can be proactively managed towards obtaining the right data, allow the right decisions to be made, and take the necessary actions toward safeguarding the patient.

Biography:

Alistair Coates is the UK Business Advisor for Oviya MedSafe. Current clients range from start-up companies to established pharmaceutical companies in Europe, the US and the rest of the world. He offers an independent, expert, consultancy services to the pharmaceutical, medical devices and biotechnology industries for Clinical Drug Safety and Pharmacovigilance. His career within the pharmaceutical industry spans over two decades, where he has been involved with pre-clinical pharmacology, pre-marketing Clinical Drug Safety and Clinical Data Management, post-marketing Pharmacovigilance and medical device vigilance. He holds a degree in pharmacology and he has a subsequent qualification in Pharmacovigilance.

Abstract:

EudraVigilance is a data processing network and management system for reporting and evaluating suspected ADRs during the development and following the marketing authorisation of medicinal products in the EEA. EudraVigilance is also one of the main pillars of the European Risk Management Strategy, which strengthens the conduct of pharmacovigilance in the EEA. It facilitates the process of risk management at several levels including aspects of risk detection, risk assessment, risk minimisation and risk communication. Consequently, EudraVigilance contributes to the protection and promotion of public health in the EEA. Furthermore, it provides a powerful tool for the safety monitoring of medicinal products and in minimising potential risks related to suspected ADRs

Biography:

Michelle Perry has completed her MPhil at the age of 25 from the University of Portsmouth in collaboration with the Drug Safety Research Unit, Southampton. She also has a BSc (Hons) in Applied Pharmacology from Queen Margaret University, Edinburgh and is currently a Pharmacovigilance Associate at Aspen Pharmacare Trading Limited, based in Dublin, Ireland.

Abstract:

MedDRA (Medical Dictionary for Regulatory Activities) has improved analysis of data by using agreed terms for events, making it easier to share data for products used in many countries. Standardised MedDRA queries (SMQs), a “developed tool to assist in the retrieval of cases of interest”, can be used on clinical data that are coded with preferred terms (PTs) from a single MedDRA version. Each SMQ for a medical concept comes with medical references, inclusion and exclusion criteria and includes a list of terms from various System Organ Classes (SOCs). The use of SMQs was recommended in Guidelines Volume 9A, however the advantage of using SMQs remains unclear. Defining any medical concept is difficult; two SMQs for the medical concepts acute pancreatitis and cardiac failure were chosen for this Delphi study. The agreement between eleven health professionals when rating the importance of PTs in diagnosing these medical concepts was investigated. Attribute agreement analysis (AAA) showed the Delphi method provided slight to fair overall agreement for terms ranked as very important (Fleiss’ kappa statistic (FKS) values between 0.1-0.4) on the first review. This is unsurprising due to the large number of closely related terms they were asked to assess. There was complete agreement for these terms in the second review by four of the original reviewers (FKS 1.00, p>0.0001 for cardiac failure terms, and 0.983, p>0.0001 for acute pancreatitis terms). The results show the variation in rating of terms by physicians and the requirement for further investigation into the potential use of SMQs in pharmacovigilance.

Biography:

G Furlan has a degree in chemistry and pharmaceutical technology and is a qualified pharmacist. He has about 15 years experience in the drug safety arena. He has started with processing cases in a major pharma company. Since then he has been appointed by EU and local Qualified Person Responsible for Pharmacovigilance (local QPPV), he has setup, led and developed drug safety units and merged pharmacovigilance departments. He has worked at local, European and global level in medium and big pharma and in a CRO. His experience and skills include both the operational and the medical/scientific aspects of pharmacovigilance. He has delivered presentations in major congresses and has published articles on multiple pharmacovigilance topics.

Abstract:

In the western world, at government level it is being recognized that the regulations to develop and licence a new drug are probably too demanding. In fact, the pharmaceutical industry is the most regulated and drug safety is probably the most regulated area within this industry. This not only slows down the time for developing and registering a new drug, but also increases the costs for maintaining a drug registration. In a resource constrained world, the question of whether the requirements to prepare multiple, partially overlapping, documents is in the interest of patient safety or whether it represents a risk to patient safety is not a trivial one. EU regulations require the preparation of signal detection reports, Periodic Safety Update Reports, Developmental Safety Update Reports, Risk Management Plans, addendums to the clinical overview, Investigators’ Brochures and, with the new clinical trial regulation, benefit-risk information will need to be included in the protocol and in the Investigational Medicinal Product Dossier. Furthermore, the reporting requirements diverge between ICH countries and are even more so if non-ICH countries are considered. The preparation of so many documents drains resources from the scientific evaluation of safety information simply to fulfil bureaucratic requirements. Therefore, there is a need to further harmonize pharmacovigilance requirements and to unify the many overlapping documents in one single modular drug safety master file. Furthermore, pharmaceutical companies also can improve their efficiency have to improve their efficiency: a low hanging fruit in this regard is the unification of the drug safety and clinical databases, which would have multiple benefits, such as the elimination duplicate data processing, the need for reconciliation, the expenses of validating and managing two separate databases and the duplication of queries to investigators.

Biography:

G Robert Jones graduated in Natural Sciences from the University of Cambridge, and studied respiratory enzymes in cancer for his London PhD. Working in London, Munich and the German Cancer Research Center in Heidelberg; he discovered that mitochondrial energy production provides the optimum target for cancer chemotherapy. His long and patient search for a humane, inexpensive and safe form of cancer chemotherapy is described in the book Subjugation of Cancer (2010). In 2001 he discovered that Tylenol is a major risk factor for Alzheimer’s disease.

Abstract:

Although Alzheimer’s disease (AD), initially of rare idiopathic origin and characterized by Pinel in 1800 as chronic dementia, is now a major threat to global health, the number of publications pointing to an iatrogenic case remains in single figures. In 1971 Murray associated the typical lesions of AD with high lifetime intakes of phenacetin by kidney dialysis patients. The gradual replacement of the analgesic by paracetamol, its chief metabolite, and its removal from the UK pharmacopoeia in 1974 failed to check the exponential rise in patient numbers, not until 2001 was the suggestion made that the metabolite is also a risk factor. Phenacetin first went on open sale in 1887; its nephrotoxicity was reported in the following year. Chronic dementia was rediscovered by Fischer and Alzheimer in 1901, and given a new name in 1910. Significantly, the earliest cases displayed kidney damage ranging from nephritis to organ atrophy. The cunning abilities of AD to obliterate memory and to masquerade as senility with varying degrees of success, as well as the long silent period elapsing between analgesic exposure and the overt expression of symptoms, have together contributed to the failure to recognize a pharmacological cause. There is no evidence to support the widespread belief that the rising incidence of AD is a consequence of increasing longevity. Missed opportunities will be described and discussed.

Biography:

Angela specialises in providing tailor made pharmacovigilance support, including QPPV provision and responsibility for the clients pharmacovigilance systems. Create safety data exchange agreements on behalf of our clients, database management of patient reports on adverse events related to medicinal product use, give training on basic and advanced pharmacovigilance, write periodic reports on the risk-benefit balance of pharmaceutical products by evaluating literature, case reports and all other relevant sources. Monitor the department for quality and compliance. Her research interests lie with Benefit/Risk evaluation and risk management, Off label use and Medication errors.

Abstract:

Since 2012, every new marketing authorization within the European Union (EEA) requires the inclusion of a risk management plan. With the introduction of the good pharmacovigilance practices, the template of the RMP has undergone major modifications. The current template can be found by consulting GVP module V. Depending on the type of application, certain modules can be omitted or require less information. If the RMP includes the implementation of additional PV or risk minimization measures, an implementation plan is necessary in order to be able to assess the adequate roll-out of the proposed measures and to facilitate the required assessment of effectiveness of the included measures. In this workshop, we will touch upon writing and implementation of the EU-RMP, best practices and upcoming changes and improvements.

Biography:

Greg Koski is internationally recognized as a leader in the realm of systems thinking and technology to improve the clinical research process. He is co-founder and president of the Alliance for Clinical Research Excellence and Safety (ACRES), a global multi-sector non-profit collaborative working in the public interest to build a shared open-system to promote accountable research while enhancing quality, efficiency and safety.

Abstract:

Biography:

Kriss Harris worked at GlaxoSmithKline for almost 6 years from 2005 to 2011 as a Statistician supporting drug discovery and pre-clinical development. Whilst at GSK, he developed an increasing passion for teaching and taught SAS Graphics, SAS Enterprise Guide and Discriminant Analysis to SAS Programmers, Statisticians and Scientists. Since then, he has moved on to become an independent Statistical Programmer and is now consulting at Eisai supporting late phase Oncology, which entails defining and creating ADaM datasets and using them to produce tables and figures. He has been an active participant at the SAS Global Forums and PharmaSUG Conferences and in 2010 was also awarded the title SAS Student Ambassador. At the moment he is also busy writing a book which details how SAS Graphics can be created from SDTM and ADaM data.

Abstract:

Would you like to produce Venn diagrams easily? Th is paper shows how you can produce stunning two, three, and four way Venn diagrams by using the SAS® Graph Template Language, in particular the DRAWOVAL and DRAWTEXT statements. From my experience, Venn diagrams have typically been created in the pharmaceutical industry by using Microsoft Excel and PowerPoint. Excel is used to fi rst count the numbers in each group, and PowerPoint is used to generate the two or three way Venn diagrams. Th e four-way Venn diagram is largely unheard of. When someone is brave enough to tackle it manually, then working out the numbers that should go in each of the 16 groups and inputting the right number into the right group is usually done nervously!

Biography:

Kriss Harris worked at GlaxoSmithKline for almost 6 years from 2005 to 2011 as a Statistician supporting drug discovery and pre-clinical development. Whilst at GSK, he developed an increasing passion for teaching and taught SAS Graphics, SAS Enterprise Guide and Discriminant Analysis to SAS Programmers, Statisticians and Scientists. Since then, he has moved on to become an independent Statistical Programmer and is now consulting at Eisai supporting late phase Oncology, which entails defining and creating ADaM datasets and using them to produce tables and figures. He has been an active participant at the SAS Global Forums and PharmaSUG Conferences and in 2010 was also awarded the title SAS Student Ambassador. At the moment he is also busy writing a book which details how SAS Graphics can be created from SDTM and ADaM data.

Abstract:

           Do you want to produce high quality graphs for publications or presentations? Do you want to add p-values on the graphs with annotations that show which groups are being compared? Do you want to learn more about the DPI option and how to use it? If you answered yes to any of the questions or have an interest in SAS Graphics then this paper is for you. This paper will demonstrate how to do the above plus show how to create first-rate Kaplan Meier Graphs, and Forest Plots using SAS® 9.3.

Biography:

Mangesh Bankar has completed his post graduation (MD Pharmacology) from Government Medical College, Nagpur in 2006. He has been working as an Assistant Professor in the same institute since last 8 years. He has published 10 papers in various national and international journals. He has presented research papers in three International Conferences. He is also working as a member of Institutional Ethics Committee of Shravan Hospital, Nagpur. He is reviewer and member of scientific advisory board of International Journal of Basic and Clinical Pharmacology.

Abstract:

Introduction: Off-label use of drugs refers to use of approved drugs in a situation that is not mentioned in the product information. As considerable risks are involved to the children and the extent of “off-label” drug use among children in India is largely unknown due to limited studies, this study was planned to determine the extent of off-label drug use in children admitted in a pediatric wards of a tertiary care teaching hospital. Material and Methods: This was a prospective, observational exploratory study in which data were collected from prescription records of all patients admitted between June and August 2014, in pediatric wards of Government Medical College, Nagpur. Results: Data were collected from 200 patients admitted in pediatric wards; all of them received at least two or more drugs. Of 1188 prescriptions, 524 (44.10%) were found off-label. The anatomical therapeutic chemical classes most involved in off-label prescriptions were anti-infectives for systemic use (45.03%), alimentary tract and metabolism (17.55%), Nervous system (13.74%) and Blood and blood forming organs (9.92 %). The highest rate of off-label drug prescriptions was observed in the age range of 1-30 days (36 %) followed by age range of 1-12 months (22.51%). Conclusions: The study found a high percentage of off-label use of drugs in the Pediatric inpatients. We identified inappropriate prescriptions for specific drug classes. The findings emphasize a need for further clinical studies as well as compilation of existing clinical experience and scattered evidence, particularly for drug treatment in pediatric population.

Biography:

Giannis Papadopoulos has studied Pharmacy at King's College London and then continued then his studies on International Health Management at Imperial London. He has started a PhD research on the pharmacovigilance of biotechnological medicines at Athens University. He is Pharmacy Director at Saint George Pharmacy. He has published many articles in Greek journals trying to increase the awareness of the health professionals about pharmacovigilance.

Abstract:

Introduction: Biotechnological medicines have improved the treatment of various diseases and the quality of life of patients. The administration of a drug may lead to adverse events that may or may not be documented. These events affect disease progression and health expenditures. Rheumatoid Arthritis (R.A.) is an autoimmune disease for which biotechnological medicines are prescribed. RA has serious economic impact. Especially, the annual cost of RA is 41billion Euros in the U.S.A. and 45billion Euros in Europe, which are increasing dramatically with appearance of an adverse event. Aims: To record the ADR of biotechnological drugs prescribed for R.A., to assess their possible effects on both patient & health system and to develop a tool aiming the efficient use of biological medicines. Methodology: A review of existing literature on adverse events of biotechnological medicines for RA & analysis of all available data from Eudravigiliance were conducted. The collection of adverse events data from rheumatology clinics of various hospitals will be conducted. Finally, any algorithm/tool currently utilized to guide the selection of the most appropriate treatment will be assessed. Results: 60% of patients are female aged 18-65 years. 20% of reports indicated that an infection has occurred, 15% highlighted the existence of inflammation at the site of injection and 12.5% reported a gastrointestinal disorder. The occurrence of musculoskeletal problems, hyperplasia and nervous disorder estimated at 10% of the reports and the respiratory problems approximately 8%. Conclusion: Infection or inflammation at the site of injection is the most common adverse events altering microbiological profile of patient. Possible relationships/associations between certain parameters (for example genome and the appearance of an adverse event) which will contribute to the safer and efficient use of biological drugs will be examined. In addition, the total average medical costs were reported to range from 5720$ to 5822$, while the average number of days absent from work due to a person's RA was reported to range from 2, 7 to 30 days /years. The appearance of adverse events increases dramatically the therapeutic costs.

Biography:

Princy Louis Palatty completed Post-graduation in Goa Medical College. He did PhD in Bioethics, Colombo University in 2014. Presently he is a Professor of Pharmacology at Father Muller Medical College, Visiting Professor of Bioethics at SRM Medical College, Chennai, Head of South India Unit, UNESCO Chair Bioethics at Father Muller Medical College Mangalore. He is an academician, researcher, bioethicist has over 50 research papers and reviewed 1 textbook and 22 textbook chapters.

Abstract:

In the collected data of ADR reporting among ‘in’ and ‘out’ patient, in the Pediatric department, the statistics showed low frequency of ADR reporting; (23) spontaneous and (79) tracked ADR reporting. This tertiary care centre caters to a wide variety of regions and heterogeneous composition ethnicity and genealogy. The attitude of patient and pediatrician have a tendency for claiming Dermatological Reactions, as ADR which were the commonest among spontaneous reporting, while tracked reporting showed an equal preponderance of gastrointestinal and central nervous system based reactions. ADR reflected the drug necessary to treat the prevailing illness of the population. The debatable issue of focused leading questions to elicit ADR over period of time complements ADR reporting. Various factors can modify the trend of ADR reporting. Constant surveillance of ADR would indicate vantage points for interventions and optimize therapy.

Biography:

            Born and raised in Burundi, Jean Marie Vianney moved to Russia in 2000 for his graduate and post-graduate studies. In 2006, he obtained a Master of Science in Pharmacy at the Volgograd State Medical University, in Volgograd, Russia. He then moved to The Netherlands where he obtained a Bachelor degree in Business Administration at the NHL University in Leeuwarden before continuing his life sciences research education at the Utrecht University, in a Drug Innovation Masters programme focussing on Drug Discovery, Drug Development and Regulatory Affairs. During the Drug Innovation training, he carried out research projects at the KNCV Tuberculosis Foundation in The Netherlands, the Dutch Medicines Evaluation Board and EDCTP. Since December 2010, he has been working for EDCTP as a Project Officer, managing several EDCTP-funded grants and calls for proposals. As part of his continuing professional development and academic interest, in July 2014 Jean Marie Vianney successfully defended a Master’s Thesis within the European Programme in Pharmacovigilance and Pharmacoepidemiology (Eu2P).

Abstract:

Background: This study aimed to assess the current pharmacovigilance practice and compliance with the International Committee for Harmonization Good Clinical Practice (ICH-GCP) requirements within a range of clinical trials funded by the European and Developing Countries Clinical Trials Partnership (EDCTP). Methods: A combination of a retrospective desk review of projects documentation as of June 2014 and a prospective survey among EDCTP-funded clinical trials investigators were used. Results: The overall survey response rate was 64.3%. Among the 54 trial investigators who responded to the survey, 64% are sponsored by academic institutions, 25% by public research institutions, and 6% by Product Development Partnerships (PDPs). 77% of the Sponsors are based in Europe, 17% in Africa and 6% are global-based institutions. 75% of the respondents confirmed occurrence and reporting of Serious Adverse Events (SAEs) in their trials. The primary reference document for SAEs reporting and follow up reported as % of clinical trials are clinical trial protocols (81.5%), SOPs for handling SAEs (50%) and investigator brochure (11%). The average SAE reporting time by 81% of respondents is within 24 hours, 11% within 48 hours, 4% within 7 days and 2% between 7 and 15 days. Majority (79.6%) of investigators report SAEs directly to the their trial Sponsors, 62.3% to National Ethics Committees (NECs) and Institutional Review Boards (IRBs), 33.3% to the national regulatory authorities (NRAs), 22.2% to the safety monitors, and 3.7% to the Contract Research Organisations (CROs). Combinations of these recipients were reported by several respondents. Among the 41 respondents who reported SAEs occurrence in their trial, only 22 confirmed that they are required to report to their NECs and IRBs. 85% of respondents send SAEs reports by e-mail, 27.8% by Fax mail, 11.1% by telephone and 9.3% as printed hard copies. Conclusion: A majority of respondents (75%) confirmed that SAEs have occurred in their trials; in this group, 45% of respondents did not confirm the requirement of reporting SAEs to local oversight bodies. It is important that both NECs and NRAs in all countries where clinical trials are conducted clearly make available their reporting requirements to the investigators to ensure adequate compliance with local reporting requirements. Further studies are necessary to better understand the magnitude of this problem and to strengthen capacity of local trial oversight by NECs and NRAs.

Biography:

Gopal Kumar Patidar has completed hid MD in Transfusion Medicine at the age of 28 years from Post Graduation Institute of Medical Education and Research, Chandigarh, India. Presently he is the Head of Blood Bank, Adlakha Medical Centre, Amritsar, India, a premier Transfusion Medicine Centre of the city. He has published more than 6 papers in reputed journals and has been serving as are viewer of many journals.

Abstract:

We planned this prospective study to look into donor safety aspect by studying adverse events in normal healthy plateletpheresis donors. In this study we included 500 healthy, first-time (n=301) and repeat (n=199) plateletpheresis donors after informed consent. The plateletpheresis procedures were performed on TrimaAccel (5.1 version, GAMBRO BCT) and Amicus (3.2 version FENWAL) cell separators. The adverse events during procedure were recorded and classified according to their nature. In results we found a total of 18% (n=90) adverse events were recorded in 500 plateletpheresis donors, of which 9% of were hypocalcaemia in nature followed by hematoma (7.4%), vasovagalreaction (0.8%) and kit related adverse events in (0.8%). There was significant post procedure drop in Hb, Hct, platelet count of the donors (p<0.0001) whereas WBC count showed a statistically significant rise (p<0.0001). Divalent cations (iCa+, TCa+, TMg+) also showed a statistically significant decline after donation (p<0.0001). However there were no statistically significance differences between adverse events in TrimaAccel (5.1 version, GAMBRO BCT) and Amicus (3.2 version FENWAL) cell separators. Donor reactions can adversely affect the voluntary donor recruitment strategies to increase the public awareness regarding constant need for blood and blood products. Commonly observed adverse events in plateletpheresis donors were hypocalcemia, hematoma formation and vasovagal reactions which can be prevented by pre-donationeducation of the donors and change of machine configuration.

Biography:

María Ángeles Piñero-López is graduated as a biologist, biochemist and pharmacist from University of Barcelona (Spain). She has also completed her PhD in the field of Clinical Pharmacy at University of Barcelona. She has participated in international and national conferences. At present, she is a collaborator of the Clinical Pharmacy and Pharmacotherapy Unit (Department of Pharmacy and Pharmaceutical Technology, Faculty of Pharmacy, University of Barcelona).

Abstract:

According to European Directives, the package leaflet is the leaflet containing information for the user which accompanies the medicinal product, and it must be written and designed to be understandable and clearly legible. The aim of this study was to evaluate and compare the readability levels of package leaflets of biopharmaceuticals available on line. Two samples of package leaflets of the same authorized biopharmaceuticals available on line in two years (2007 and 2010) were selected and downloaded from the European Medicines Agency (EMA). Biopharmaceuticals were sorted into 5 product categories according to their source, and into 2 groups according the year of authorization. Five out of the six entire sections of the package leaflets were studied: “1. What X is and what it is used for”, “2.What you need to know before you take (or use) X”, “3. How to take (or use) X”, “4. Possible side effects” and “5. How to store X”. Three formulas (SMOG grade, Flesh-Kincaid grade level, and Szigriszt’s perspicuity index) were used to obtain readability levels. No significant differences between readability results for the two years studied were observed (p>0.05). However, significant differences between readability package leaflet sections in both 2007 and 2010 were found (p <0.05). The most difficult section was “4”, and the less difficult was “5”. Besides, all evaluated package leaflets had a very low degree of readability. Efforts to improve readability of package leaflets of biopharmaceuticals, available from EMA website, must be done to promote patient safety.