Abstracts

 Download here Guidelines on Abstract Submission and Abstract formatting instructions

 

 

GUIDELINES ON ABSTRACT SUBMISSION

The Scientific Committee of the 13th ISoP Annual Meeting wishes to invite abstracts to be submitted for either oral or poster presentation related to the subjects of pharmacovigilance and drug safety.

Abstract submission deadline postponed to June 1st  2013

Abstracts must be submitted in English only.

All abstracts must be submitted online via the abstract submission system.

Please note that abstracts sent by mail, fax or e-mail will not be accepted.

Abstracts already published elsewhere or based on full papers that have already been published will not be considered for inclusion.

 

Abstract categories

Abstracts reporting safety data from clinical trials, observational studies, meta-analysis, signal detection analysis, evaluations of causality assessment, studies about novel methodologies for safety assessment, are all welcome. Studies investigating the mechanisms of adverse drug reactions (ADRs) in pre-clinical models will be also considered. Due to the clinical focus of the Meeting, a rigorous selection of case reports and small case series will be performed, and abstracts presenting innovative findings and interesting clinical data will be given priority.

 

Special sessions

Some sessions will be implemented with the purpose of encouraging the attendance of young scientists (< 30 years old) interested in presenting original data about drug safety. Delegates willing to take part in such sessions should indicate the age of the presenting author (poster or oral communication) at the time of abstract submission. A special French language session will be held to facilitate oral contributions by scientists from French speaking countries, with particular reference to Africa. However, all abstracts should be submitted in English language. Time frame for presentation of abstracts selected for oral communications will be 8 minutes including 2 minutes for questions and answers (flash presentation). This will allow more opportunities for the oral presentations of original data. 

 

 

Topics of special focus for this meeting include:

 

1. Safety of antidiabetes drugs

The efficacy and safety of some traditional drug therapies for type 2 diabetes mellitus (T2DM) remain a matter of intense interestby recent discussions on the cardiovascular safety of thiazolidinediones and the ongoing debate about whether a putative link exists between insulin therapy and the incidence of cancer in patients with T2DM. Among the novel therapeutic approaches, the risks and benefits of incretin-based therapies (dipeptidyl peptidase-4 inhibitors and glucagon-like peptide-1 receptor agonists), with a particular focus on cardiovascular events, pancreatitis and medullary thyroid cancer, are currently hotly debated. In this session studies on the safety of drugs to treat diabetes will be considered.

 

2. Quality defects of medicinal products – a Pharmacovigilance challenge

The increasing globalization of commerce and trade and the merging of pharmaceutical companies are internationalizing pharmaceutical production. International regulatory rules and standards for medicines are thus more important than ever before. Because medicines are relevant to the priority needs of public health, high standards of quality, safety and efficacy of medicinal products must be ensured, and reliable systems of medicine regulation and legislation must be the primary goals of health programs implemented by every Country. In this session, studies about adverse events related to quality issues of medicinal products will be considered. These include, for instance, safety of poor-quality medicinal products due to production problems, dispensing procedures (i.e. safety of drugs purchased in online pharmacies), counterfeit medications, complex medicinal products, etc.

 

3. Drug-induced adverse reactions in specific organs and systems

Drugs can produce injuries or dysfunctions in different organs and tissues. For this session, studies investigating tissue- or organ-specific adverse drug reactions (ADRs) will be considered. Although abstracts discussing all kind of drug-injuries may be acceptable, we would  recommend focussing on the following organ systems for this  conference:

a) Gastrointestinal tract

Epidemiological data about gastrointestinal (GI) adverse drug reactions (ADRs) are scarce. In the USA these ADRs represents the 20-40% of all ADRs, while studies in the European Union suggest a proportion of 9-27% over all ADRs. Both drug-induced functional adverse effects (such as constipation or diarrhoea) and organic injuries (such as lesions or ulcers) can be serious or even life-threatening.

b) Liver

Drug-induced liver-injury (DILI) account for about 6% of all adverse drug reactions (ADRs), and they are often serious. DILIs represent the most frequent cause of failure to receive appositive opinion for a marketing authorization for drugs and is one of the major causes of drug withdrawal from the market. In USA, DILIs account for about 5% of all cases of jaundice or hepatitis in outpatients as well as for 10-40% of hospitalizations due to acute liver injury (more frequent in the elderly).

c) Skin

Skin is one of the most common organs to be afflicted by adverse drug reactions (ADRs). Eruptions are observed in 0.1-1% of treated patients in post-marketing trials for many medicines. A number of drugs with high current utilization are associated with high rates of skin eruptions, such as antibiotics, gout and anticonvulsant therapies. It has been estimated that about 2% of all cutaneous ADRs can be classified as severe.

d) Cardiovascular system

Over the last decade, several drugs have been subjected to regulatory actions, including withdrawal from the market, due to cardiovascular toxicity (e.g. thiazolidinediones, rofecoxib, cisapride). Moreover, an important debate is ongoing about the respective cardiovascular safety of traditional and COX-2-selective nonsteroidal anti-inflammatory drugs (NSAIDs). Unfortunately, these reactions (and the related signals of risk) are particularly difficult to assess because of potential underlying confounding which may not be at all obvious.

e) Central nervous system

Adverse drug reactions in the central nervous system include neurologic, psychiatric and sensory disturbances. Polyneuropathies and encephalopathies following immunization are among the earliest adverse reactions described in the medical literature (1930-1940). It has been estimated that about 1-2% of neurologic admissions in neurologic care units are drug-related. The frequency of psychiatric ADR and the difficulties in the assessment of causality with exposure to drugs is currently matter of debate. Despite both neurologic and psychiatric ADRs being commonly reported spontaneously, the real scale of the causal association and public health impact are not clear for many drugs.  

 

4. Pharmacovigilance of biotechnological therapies

In the last decades the concept of what is a medicine has changed deeply and novel molecular entities have entered into clinical practice. As a consequence, traditional knowledge and methods for safety assessment need to be updated to ensure adequate protection to patients. The areas recommended for selection for the conference include:

a) Biotechnological and biosimilar drugs

The introduction of a number of biotechnology products into the market has revolutionized therapeutics in several fields of medicine. However, the patents protecting these new drugs are about to expire, particularly in the case of monoclonal antibodies, and follow-on biologic medicines, known as biosimilars, are about to invade the pharmaceutical market. There is concern about whether and how biosimilars might differ substantially from the generic copies of conventional drugs in terms of efficacy, safety and immunogenicity. An adequate awareness of such differences is essential for the appropriate prescription of biologics and biosimilars and for the safety of patients.

b) Activation immunotherapies

Immunotherapies, designed to elicit or amplify an immune response, are classified as activation immunotherapies. These therapies have taken place mainly in the treatment of several cancer diseases and to restore the immune system of patients with immune deficiencies as a result of infection or chemotherapy. For example, cytokines have been tested in clinical trials and interleukin-7 has been used in clinical trials for HIV and cancer patients. Modern anticancer vaccines (i.e. HPV vaccine) are included in this category. At present, the safety of many of these therapies remains to be assessed.

c) Cellular therapies

During the last 20 years stem cells and adult cells, derived from different tissues, such as blood, bone marrow, muscle, brain, hair, skin, etc., have been characterized, grown in culture, and tested in animals and humans for a variety of diseases. The capacity of generating different cell types from a common cell ancestor under controlled conditions and the increased understanding about how to grow cells ex-vivo, has boosted the basic research and development of potential cell products in the field of regenerative medicine. Initially the studies were aimed at replacing cells that were damaged by disease with cells grown ex-vivo. However as the field has evolved, cells are now used as secretors of factors that can ameliorate or change the course of disease. The safety of these interventions remains is a largely unexplored field.

 

5. Signal detection analysis

There is increasing interest in using disproportionality-based signal detection methodologies to support postmarketing safety surveillance activities. Many methods have been proposed with differing strengths and weaknesses but there remains lack of clarity on relative performance of approaches particularly when deployed to observational databases. Other challenges include how to best access observational databases, operational aspects of analysing multiple databases and comparing results between observational databases and spontaneous reports. Each method has its strengths and weaknesses. This session, organized as a joint symposium with the International Society for Pharmaco-Epidemiology (ISPE), will consider recent developments in this rapidly developing domain of research. Abstracts on all aspects of signal detection and analysis are welcomed.

 

6. Pharmacovigilance in special populations

Special populations includes categories of patients that are usually poorly investigated in pre-authorization trials, such as elderly, children and pregnant/lactating women. In this session, studies about ADRs in special populations will be considered, and particularly:

a) Elderly The past decades have witnessed major changes in the age demographics of Western countries, particularly because of prolonged life expectancy, with a steady increase in the proportion of elderly population. These changes have been brought about by an improved standard of life together with better medical treatments, especially drugs. However, beside the frailty of this population due to the advanced age, two peculiar features of drug therapy in the elderly continue to raise a safety concerns: chronic of therapies and polypharmacy.

b) Children: In stark contrast to adults, the use of drugs in infants, children and adolescents embodies a unique element which must be considered to ensure drug safety: namely, the impact of body development on both drug disposition and action. Despite the number of clinical trials increasing in this population recent years, uncertainties remain about the use of drugs and the assessment of ADRs in children remains. 

c) Woman’s health: following an interesting and invigorating session on Women's Medicines at the ISoP annual meeting in Istanbul, in October 2011, a group of ISoP members have continued to work in this field as the ISoP Women's Medicines Group. The members of this group have a specific interest on the safety of medicines used by women, with particular regard for contraceptive products, drugs used in pregnancy and medicines used by post-menopausal women. A particularly neglected area is the investigation of fertilization therapies in women undergoing assisted procreation. 

 

7. Pharmacovigilance of antiplatelet and anticoagulant drugs

Safety issues with both antiplatelet and anticoagulation therapy are mostly related to bleeding. New antiplatelet products have demonstrated adequate protection against thrombotic cardiovascular events with limited bleeding problems. Novel anticoagulant drugs have the potential of competing with current therapies for thromboprophylaxis and stroke prevention in atrial fibrillation. Nevertheless, the safety of both novel anticoagulant and antiplatelet drugs needs to be monitored. In this session studies about the safety of new antiplatelet and new anticoagulant drugs will be considered.

 

8. Surveillance on vaccines

Vaccine safety has gained great consideration over the last year, particularly after the development of vaccine for Human Papilloma Virus, which represents the first example of vaccine used for cancer prevention, as well as during and after the pandemic flu emergency in 2010. Vaccines are mostly administered to healthy individuals, many of whom are children. Serious (or even non-serious) adverse events following immunization are often deemed unacceptable by vaccine recipients, parents and the general public. In this session, studies concerning adverse events following immunization will be considered.

 

9. Pharmacovigilance in emergency care

Although thus far much research on adverse drug reactions (ADRs) has been focused on hospital inpatient populations, less is known about ADRs in emergency department. Two different situations can be matter of concern: the first is the burden of emergency department admission due to ADRs and the second is the safety of drugs used to treat emergency department patients, often presenting with acute clinical conditions. Previous reports have noted that patient managed in emergency departments are at high risk of drug interactions and that drug-related problems are not uncommon in these settings. However, the full scope of drug-related emergency department visits and the specific factors that put patients at risk for ADRs in emergency department remain unknown. In this session, studies about ADRs related with emergency department admission or ADR occurring in emergency department will be considered.

 

10. Communication in pharmacovigilance and perception of risk

The Internet has significantly changed the way the society manages health. We can currently look up symptoms on Wikipedia and NHS Choices, blog about illnesses, discuss conditions and side-effects on websites and discuss health issues with Facebook friends. An estimated 80% of Internet users search for health information on-line. A recent study estimated that 70% of UK patients use the Internet to search for health information, with one third deciding of not visiting their general practitioner afterwards. The explosion of user-generated content has potentially created a plethora of safety information (including information on off-label use, misuse and normal clinical practice prescription habits). Due to the lack of robust legislative frameworks, this information is currently not sufficiently verified, and therefore potentially dangerous. In this session, studies about the impact on drug safety and risk perception of new communication systems will be considered.

 

11. Pharmacogenetics of adverse drug reactions

Polymorphisms in the genes that code for drug metabolizing enzymes, transporters, receptors, ion channels and signaling pathways can affect an individual risk of having an adverse drug reaction (ADR). Mutant alleles at a single gene locus are the best studied individual risk factors for ADR, and include several genes coding for drug-metabolising enzymes. Pharmacogenomic techniques allow efficient analysis of these risk factors, and genotyping tests have the potential of avoiding ADRs in susceptible patients. In this session, studies on correlations between genotypes and ADRs will be considered.

 

12. Pharmacovigilance in oncology

Several toxicities associated with anticancer agents are frequent and expected, but can hardly be prevented (e.g., bone marrow depression, nausea, vomiting, alopecia). The oncologists are usually well aware of and report these adverse drug reactions (ADRs) during the pre-marketing phase of drug development. However, to promote ADR reporting in the post-marketing settings is a challenging task, and therefore under-reporting is recognized as the main limitation of pharmacovigilance systems, particularly in the field of oncology. On the other hand, several drugs have been reported as causative agents of tumors (e.g. biologic drugs used in rheumatology, novel agents to treat diabetic), although the performing of causality assessment is particularly challenging in these cases. In this session, studies dealing with the toxicity of drugs employed in oncologic patients will be considered.

 

13. Surveillance on complementary medicines

The term “complementary medicines” describes an array of therapeutic tools including pharmaceutical-like preparations (i.e. herbal medicines, homeopathic remedies, essential oils and dietary supplements), which are usually placed beside conventional medicine. The use of complementary medicines is a popular healthcare approach in several Countries. Patients use complementary medicines for health maintenance, for treatment or prevention of minor ailments, and also for serious, chronic illnesses. The pervasive use of complementary medicines raises several safety concerns. In this session, studies dealing with the safety of complementary medicines (case reports, case series, quality assessment studies, observational studies, signal detection analysis, causality assessment studies) will be considered.

 

14. The new EU definition of adverse drug reactions: abuse, misuse, medication error and occupational exposure

In 2012 the EMA has extended the definition of adverse drug reactions (ADRs) to include abuse, misuse, medication errors and occupational exposure among the potentially drug-related events that must be reported to the EudraVigilance network. In this session, studies investigating the frequency and nature of these peculiar ADRs will be considered.

 

 NOTIFICATION OF ABSTRACT ACCEPTANCE

Abstracts will be reviewed by the ISoP 2013 Scientific Committee, and each decision will be notified to authors by June 15th, 2013. Notification of abstract acceptance or rejection will be communicated to the presenter's e-mail address.

Scientific Committee’s decisions will be based upon evaluation of its scientific standard. The Scientific Committee will allocate each accepted abstract to the most appropriate form of presentation (oral or poster). After selection, to all presenting authors will be sent full information regarding PowerPoint preparation, poster size, style and layout, as appropriate.

Accepted abstracts, which have been received by the submission deadline, will be published in ISoP’s official journal, Drug Safety.

All accepted posters for the ISoP 2013 Annual Meeting are eligible for the poster prizes which will be awarded for the three best posters.

Please kindly note that if an abstract is accepted for presentation (oral or as poster), at least one of the authors (presenting author) must register for ISoP 2013. Registration should be done immediately after notification of abstract acceptance, and at least before June 21st. Presenting authors must attend the conference in order to present the abstract on site.

If you have any questions regarding preparing, submitting, amending or withdrawing an abstract, please contact:

 E-mail: This email address is being protected from spambots. You need JavaScript enabled to view it. ;

Phone: +39 051 300100 / Fax: +39 051 309477

 

Abstract formatting instructions

Title: In bold, title case, maximum 20 words

[New line]

Author(s): First name Initial(s) with full point followed by surname. Put each author on the same line but separate each author with a coma.

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Affiliation(s): Department, institution, city, country. If there is more than one affiliation for the authors, each one should be separated by a semicolon and preceded by a number (the same number should appear superscript after the comma after the relevant author name).

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Text: Maximum 400 words. For studies use a structured approach with bolded subheadings (background, objective/aim, methods, results, conclusion, discussion). The text should run on from the bolded subheading after a colon (also bolded).

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References: Cite in text as [x]. List on separate lines preceded by the relevant number. Use Vancouver style. A maximum of 6 references can be included.

Tables: One table can be included with each abstract and the table must not contain more than 4 columns and 10 rows. Please prepare the table in ‘table format', rather than using ‘tab' or ‘indent' commands. Do not format using word spaces. This is an example of the standard style for tables.

Table I. Table heading

Heading

Headinga

Straddle heading

subhead

subhead

Subheading

Parameter

 

 

 

Parameter

 

 

 

Subheading

Parameter

 

 

 

Parameter

 

 

 

Parameter

 

 

 

Parameter

 

 

 

a  Footnote.

Abbreviation = XXXX; abbreviation = XXXX.

 

Figures: these cannot be included.

 

For an example of a correctly formatted abstract please see below.

 

Abstract example

 

Risk Factors for Developing Serious Adverse Drug Reactions

 

N.M. Mirosevic,1 I.J. Jankovic,2 M.L. Lovrek,1 D.K. Krnic,1 V.M.S. Macolic,1 S.T. Tomic,1 C.D. Duggan,3 I.B. Bates3

 

1 Agency for Medicinal Products and Medical Devices, Zagreb, Croatia; 2 Faculty of Pharmacy and Biochemistry, University of Zagreb, Zagreb, Croatia; 3 The School of Pharmacy, University of London, London, UK

 

Introduction: Serious adverse drug reactions (ADRs) constitute major concerns in terms of both individual outcomes (e.g. deaths and hospitalizations) and public health expense. Several studies have been conducted to assess the importance and economic consequences of ADRs.[1-4] However, such work has not been previously undertaken in Croatia.

Aim: To identify risk factors associated with developing a serious ADR.

Methods:  We performed a retrospective observational study of the ADRs reported to the Croatian Agency for Medicinal Products and Medical Devices for the period from March 2005 to December 2006. All drugs were classified using the Anatomical Therapeutic Chemical (ATC) classification code system, and subsequently entered into a database. ADRs were considered serious if one of the following criteria were met according to the ICH E2A guidelines: the ADR is life threatening; it led to hospitalization/prolonged stay in hospital; caused congenital malformation; permanent disability; or, medically serious condition. Descriptive statistics and logistic regression using SPSS 14.0 were undertaken.

Results: The results showed that among all the reported ADRs (n = 898), 26.1% referred to serious ADRs (n = 234). The majority of these serious ADRs (59.4%) were caused by drugs belonging to N (25.7%), J (18.5%) and, C (15.2%) ATC groups. From this database of ADRs, polypharmacy was associated with an increased risk of experiencing a serious ADR (B = 1.226; R2 = 0.026; p < 0.005). The relationship between serious ADRs, patient demographics and drug interactions were explored as well.

Conclusions: This study has identified factors that contributed to developing serious ADRs reported to Croatian Agency for Medicinal Products and Medical Devices. These data will be used for development of national risk management plans.

References

1. Lazarou J, Pomeranz BH, Corey PN. Incidence of adverse drug reactions in hospitalized patients: a meta-analysis of prospective studies. JAMA 1998; 279: 1200-5

2. Einarson TR. Drug-related hospital admissions. Ann Pharmacother 1993; 27: 832-40

3. Bates DW, Spell N, Cullen DJ, Burdick E, Laird N, Petersen LA, et al. The costs of adverse drug events in hospitalized patients. JAMA 1997; 277: 307-11

4. Moore N, Lecointre D, Noblet C, Mabille M. Frequency and cost of serious adverse drug reactions in a department of general medicine. Br J Clin Pharmacol 1998; 45: 301-8