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Pharmacokinetic and pharmacodynamic changes associated with old age, along with multimorbidity and polypharmacy might lead to inappropriate prescribing and adverse reactions. Explicit criteria such as the Screening tool of older people’s prescribing (STOPP) are useful to identify potential inappropriate prescribing’s (PIPs). Our retrospective study included discharge papers from patients aged ≥65 years, from an internal medicine department in Romania (January–June 2018). A subset of the STOPP-2 criteria was used to assess the prevalence and characteristics of PIPs. Regression analysis was performed to evaluate the impact of associated risk factors (i.e., age, gender, polypharmacy and specific disease). Out of the 516 discharge papers analyzed, 417 were further assessed for PIPs. Patients’ mean age was 75 years, 61.63% were female and 55.16% had at least one PIP, with 81.30% having one or two PIPs. Antithrombotic agents in patients with significant bleeding risk was the most prevalent PIP (23.98%), followed by the use of benzodiazepines (9.11%). Polypharmacy, extreme (>10 drugs) polypharmacy, hypertension and congestive heart failure were found as independent risk factors. PIP was prevalent and increased with (extreme) polypharmacy and specific cardiac disease. Comprehensive criteria like STOPP should be regularly used in clinical practice to identify PIPs to prevent potential harm.

Rationale and objectives Patient counselling on medication is one of the activities that can and should be performed in community pharmacy. Patient counselling was proved to have a positive effect on clinical outcomes, quality of life, drug/disease knowledge, satisfaction and reduced health-service utilization. Our objective was to assess the degree of concordance between the responses of patient and pharmacist on the same questions regarding provided counselling. Methods Data from two questionnaires containing a common block of 14 questions regarding the counselling provided on the medications use, safety concerns, storage, validity term, disposal and disease monitoring was paired and analysed. Questionnaires were paired based on a code and Kappa Cohen coefficient (KCc) and the prevalence adjusted biased adjusted kappa (PABAK) were calculated to evaluate the degree of concordance between pharmacist versus patient responses. The values of the KCc and PABAK were interpreted as per Altman. Results For the 14 questions, data from 2047 to 2378 questionnaires collected from 520 community pharmacies in 10 of Romania's counties were analysed. The highest level of concordance ('very good') was achieved on the items regarding the counselling on the medicines' route of administration (PABAK = 0.88), time of administration (PABAK = 0.80) and dosage (PABAK = 0.82). The highest disagreement (week concordance) was found on the question regarding the counselling on the medicines adverse effects (PABAK = 0.01), where 44.8% of patients responded that they received counselling as compared to 93.1% of the pharmacists who responded that they offered counselling. For the rest of the questions, moderate concordance was found. Conclusion Overall a moderate level of concordance between patient and pharmacist responses was found on the majority of the questions, with the highest level found for drug use (dosage, route and time of administration). The highest discrepancy was found for the counselling on the medicines adverse effects.

Background and aims. The impact of fluoroquinolone (FQ)-induced long-lasting, disabling, and potentially irreversible serious adverse drug reactions (ADRs) on the overall benefit-risk balance and the need for adequate risk minimization measures has been recently assessed. The present study aims to evaluate physicians and pharmacists' awareness and knowledge of the recent safety issues communicated through a direct healthcare professional communication (DHPC), regarding FQs, at a national level, in Romania, as well as healthcare professionals (HPs) self-reported behavior regarding the management of the risk. Methods. Cross-sectional, online survey study, conducted in Romania. Results. A total of 127 participants responded to the survey. Six (4.7%) were physicians and 121 (95.3%) were pharmacists. The predominant age was 31-40 years (N=52, 40.9%), and most respondents were females (N=117, 92.1%). A majority of 101 (79.5%) were reportedly aware of the existence of the new safety issues associated with FQs, and slightly less were aware of the DHPC (N=86, 67.7%) issued in 2019. In terms of knowledge, slightly more than half of the respondents had correctly selected the responses regarding key safety messages on most important ADRs and restrictions / cautions for use. The impact of the communication on HPs self-reported behavior was high or very high in almost half of the participants (N=63, 49.6%). Conclusions. A high percentage of participants were aware of the FQ-associated safety concerns. Knowledge was relatively good for the key safety concerns among HPs. A notable impact on behavior was observed, mostly in terms of counselling of the patient and disseminating the information to colleagues.

BACKGROUND To analyse the antidiabetic medication (ADM) market trends in Romania and to describe the utilisation of the new ADMs (glucagon-like peptide-1 receptor agonists [GLP-1 RA], dipeptidyl peptidase-4 inhibitors [DPP-4i] and sodium-glucose transport protein 2 inhibitors [SGLT-2i]). METHODS We conducted an analysis of pharmacy claims data from IQVIA Romania. We analysed the reimbursed prescriptions that included at least one ADM as defined daily doses (DDDs)/1000 inhabitants/day and the number of prescriptions. RESULTS The total number of ADMs DDDs/1000/day increased by 54.33% from 2012 (48.08) to 2019 (74.20). Biguanides, sulfonylureas and insulin were the most prescribed each year, with an increasing utilisation trend. In 2019 metformin represented 37.69% of the total market share, followed by sulfonylureas (29.94%) and insulin (23.93%). The newer antidiabetics uptake was low. In 2019 the number of DDDs/1000 inhabitants/day was 2.03 for DDP-4i, 2.39 for GLP-1 RA and 1.6 for SGLT2i. CONCLUSIONS An overall trend of market increase was found for ADMs from 2012 to 2019, corresponding to the increasing prevalence of diabetes in Romania. Although the use of DPP-4i, GLP-1 RA and SGLT2i have increased steadily, the uptake remained low, with no more than 12.61% of the market share (alone or as fixed combinations with metformin or insulin) in 2019.

Recent drug safety concerns described fluoroquinolone (FQ)-induced serious musculoskeletal reactions. The objective of this study was to characterize reports with FQ-associated disabling musculoskeletal disorders, from VigiBase. The analysis included all FQ-induced musculoskeletal and connective tissue disorders adverse drug reaction (ADR) reports (up to July-2019), (disabling/incapacitating, or recovered/resolved with sequelae or fatal). We described aspects like reporter, suspected FQs, ADRs, associated corticosteroid therapy. We also looked into the disproportionality data in terms of proportional reporting ratio (PRR) and information component (IC) values. A total of 5355 reports with 13,563 ADRs and 5558 FQs were reported. The majority of reports were for patients aged 18–64 (62.67%), and the female gender prevailed (61.76%). Consumers reported almost half (45.99%), with a peak in reporting rates in 2017. Top reported ADRs were arthralgia (16.34%), tendonitis (11.04%), pain in extremity (9.98%), tendon pain (7.63%), and myalgia (7.17%). Top suspected FQs were levofloxacin (50.04%), ciprofloxacin (38.41%), moxifloxacin (5.16%), ofloxacin (3.17%) and norfloxacin (1.01%). For these, FQs-ADR association was supported by the disproportionality analysis. Corticosteroids were associated with about 7% of tendon related reports. The results augment the existing data on FQs safety concerns, specifically their potential effect on the musculoskeletal system.

Purpose To characterize acute pancreatitis (AP) related to sodium glucose co-transporter 2 inhibitors and to investigate this relationship through disproportionality analysis in an international pharmacovigilance database. Methods We analysed all AP reports for canagliflozin, dapagliflozin and/or empagliflozin from the WHOs Global adverse drug reactions database VigiBase® up to July 2019. We characterized the patients, reporters, and reactions, and we present the proportional reporting ratio (PRR) and information component (IC) for each of the gliflozins. AP cases were reports containing at least one of 11 previously selected preferred terms. Gliflozin exposure was considered for all reports with at least one gliflozin as suspected/ interacting drug. Results Of the 19 834 180 individual case safety reports in VigiBase, in 600 reports containing 618 AP group reactions, gliflozins were suspected/ interacting drugs. Men were affected in 52.3% of the cases and 59.6% of the patients were in the 45-64 age group. The reporters were in 417 cases healthcare professionals. Most of the reactions were reported for canagliflozin (59.7%), followed by empagliflozin (21%) and dapagliflozin (19.2%) and were serious (98.6%). Most of the reactions' outcomes (84% of the patients) were favorable. Ketoacidosis was frequently associated with the AP (21.3%). Significant PRR and IC were found for Pancreatitis and Pancreatitis acute for all three gliflozins, Pancreatitis necrotizing for canagliflozin and empagliflozin and Pancreatitis relapsing for empagliflozin. Conclusions Most of the AP cases were serious and with favorable outcome. We identified possible alternative causes for AP, like concomitant medication, hypertriglyceridemia, and cholelithiasis and a frequent association with ketoacidosis. We found a significant association between AP and the use of canagliflozin, dapagliflozin, and empagliflozin that would need further investigation. This article is protected by copyright. All rights reserved.

Background: The objective of this study was to characterize individual case safety reports (ICSRs) and adverse drug reactions (ADRs) related to second-generation cephalosporins and resulting in hepatobiliary disorders, in VigiBase, WHO global database. Methods: All second-generation cephalosporins hepatobiliary ADRs reported up to July 2019 were included. Characteristic of cephalosporins and ADRs, aside from disproportionality data were evaluated. Results: A total of 1343 ICSRs containing 1585 ADRs were analyzed. Cefuroxime was suspected to have caused hepatobiliary disorders in most cases—in 38% of adults and in 35% of elderly. Abnormal hepatic function was the most frequent ADR, followed by jaundice and hepatitis. For 49% of the ADRs reported in the elderly and 51% in the adult population, the outcome was favorable, with fatal outcome for 2% of the adults and 10% of the elderly. Higher proportional reporting ration (PRR) values were reported in the elderly for cefotetan-associated jaundice, cefuroxime-associated acute hepatitis and hepatitis cholestatic as well as for cefotiam and cefmetazole-associated liver disorder. Conclusion: Hepatobiliary ADRs were reported for 2nd generation cephalosporins, with over 50% of cases in adults, without gender differences. Cholestatic hepatitis was predominately reported in the elderly and this category was more prone to specific hepatic reactions.

Background and Aims: Due to the increasing number of hepatitis C virus (HCV)-infected patients being treated with direct antiviral agents (DAAs) in Romania, we aimed to conduct a pharmacovigilance study in order to comprehensively evaluate the safety profile for the ombitasvir/paritaprevir/ritonavir and dasabuvir (Om/Pa/Ri+Da) regimen. Methods: A retrospective analysis was conducted on the individual case safety reports (ICSRs), extracted from VigiBase® on 1 st February 2018, which included the Om/Pa/Ri+Da regimen as suspected for causing adverse drug reactions (ADRs). Potential drug-drug interactions (DDIs) were checked for all concomitant medication using the IBM Micromedex® tool. Results: Among the 1,102 ICSRs retrieved, 260 were serious (23.5%). Ribavirin was significantly associated with more ADRs reported per case (on average 5.1 vs. 3.2 ADRs/case, p

Important drug safety issues are evaluated through a referral procedure in the EU by the Pharmacovigilance Risk Assessment Committee (PRAC) within the European Medicines Agency. We aim to describe all safety-related referrals assessed by the PRAC by June 2019.Publicly available data on safety issues assessed through referral procedures that reached a final decision during July 2012-June 2019 were identified, analyzed and classified according to predefined criteria.Fifty-one safety issues were assessed by PRAC for 45 medicines/combinations/therapeutic classes during this timeframe. Referrals were initiated mostly by the European Commission (16) and France (8). Nine medicines were authorized in the last five years, the rest being well-established drugs. In four cases (flupirtine, hydroxyethyl-starch, valproate, codeine) PRAC re-assessed the same risks as previous recommendations have not been effective. Post-referral recommendations consisted of updates of the summary of product characteristics and package leaflet (42), Direct Healthcare Professional Communication (32), and other additional risk minimization measures (RMMs). Withdrawal was recommended for seven active substances.PRAC recommended routine or additional RMMs for most referrals. Complete withdrawal of a drug or withdrawal of certain pharmaceutical forms or concentrations was advised only when the risk could not be managed by RMMs.

Background Several drugs are available for the treatment of autoimmune rheumatic diseases; however, their effectiveness may be negatively influenced by inappropriate adherence. Low adherence and persistence rates have a significant impact on patient quality of life and are associated with health-related expenses. Purpose To provide an up-to-date narrative review on treatment adherence and persistence rates, and discuss the factors that influence them, in patients with autoimmune rheumatic diseases. Materials and methods We searched the PubMed database for studies among patients with a diagnosis of rheumatoid arthritis (RA), ankylosing spondylitis (AS), systemic lupus erythematosus (SLE), or psoriatic arthritis (PsA), published from January 2015 to February 2017. Only studies with a well-defined measurement of adherence/persistence and those that carried out an evaluation of the influencing factors were included. Results Fifteen relevant studies that evaluated adherence and/or persistence were included. Adherence rates varied between 9.3% and 94%, and persistence rates between 23% and 80%. Most of the studies used one method to evaluate adherence or persistence (different questionnaire scores, proportion of days covered, and mean treatment duration). A high concordance was found between the adherence measurements of the Medication Event Monitoring System and Visual Analog Scale. Factors of economic, demographic, and clinical nature were only moderately linked to treatment adherence or persistence. However, patient-related factors - such as positive and increased beliefs in medication necessity, strong views of the chronic nature of the diseases, and increased knowledge of the disease - were related to better treatment adherence. Conclusion Owing to the heterogeneity of the study results, we consider that the use of more than one method to assess adherence/persistence should yield more comprehensive and accurate data about patient adherence behavior. Patient-related factors should be included and analyzed more often in adherence studies as the former may be modified to improve patient adherence.

Background and aims. The success of a treatment depends on the effectiveness of the medication regimen, provided that patients take the medicines as prescribed. A low rate of adherence in chronic conditions is associated with poor outcome and decreased quality of life, which constitutes an additional burden for the healthcare systems. To correctly identify the dimension of this problem may be a challenge, as there are numerous methods, definitions, patient settings and factors, each with their specific roles. Our aim was to give an appropriate overview of the most common validated methods that can be used to identify non-adherent patients. Methods. This overview is based on an online search of PubMed database and includes the relevant articles in this field. Results. We included both direct and indirect methods for measuring treatment adherence and presented concise information that can help researchers and clinicians when choosing an appropriate method. Both subjective and objective methods have advantages and disadvantages that should be fully understood and taken into consideration. Conclusions. Choosing a simple, accurate and inexpensive method that can give supplementary information about the patterns, beliefs and barriers of adherence would be desirable. But because this perfect method to measure treatment adherence does not exist, the best solution seems to be the combined use of at least two methods.

Risk minimization measures (RMMs) represent an essential tool for preventing the occurrence of safety-related outcomes. The evaluation of RMMs effectiveness is essential to prove their success and ensure protection of public health. The aim of this qualitative review was to assess the design, process and outcome indicators used for attesting successful implementation of RMMs. We searched the EU Post-Authorization Studies Register up to 30 June 2018 for studies having the scope defined as 'effectiveness evaluation'. Study titles and objectives were screened to select the ones evaluating the effectiveness of RMMs. We described and assessed the extent to which these studies aligned with Good Pharmacovigilance Practices guidelines recommendations. Out of 360 registered studies, we identified 35 studies on evaluation of RMMs effectiveness, 29 being eligible for review. Twenty-six studies evaluated additional RMMs, employed in case routine interventions are considered insufficient. All studies assessed process indicators, five also assessing outcome indicators, thus using a dual-evidence approach as recommended by the guidelines. However, none of the latter used a pre-post design, comparing the frequency of the adverse outcome before and after the implementation of RMMs. Behaviour and knowledge were the most often assessed process indicators. Outcome indicators included occurrence of adverse reactions, pregnancy, off-label use and medication errors. Only four studies had an established threshold, all for process indicators. Stricter adherence to existing recommendations would allow for a more robust design for reaching established endpoints for RMM effectiveness evaluation. It would also infer harmonization, facilitate review and further more detailed guidance on conducting these studies.

Background and aim. Constipation is a widespread condition that requires adequate therapy. Given the large use of laxatives, it is important to know the burden of the treatment of this condition on the healthcare budget. Methods. We collected information on the number of therapeutic units (boxes) of five frequently used laxatives delivered by prescription or over the counter in 30 pharmacies randomly selected in two adjacent counties from Romania for two consecutive years. We calculated also the cost value of the laxatives delivered. Results. The total cost of laxatives in the group of pharmacies investigated was on average 62,500 euros per year. We extrapolated that the laxative consumption in Romania should be over 15 million Euro. Conclusions. To our knowledge this is the first study on the burden of constipation in this country. Although therapeutic units of laxatives are not expensive, the wide use of these drugs represents an economic burden for the patient.

Management of patients undergoing endoscopy and under treatment with the newer direct oral anticoagulants (DOACs) is a common and a complex clinical issue that gastroenterologists have to face more and more often these days. The increasing use of DOACs in patients requiring both short- and long-term anticoagulation is mostly due to the advantages these agents offer, among which the lack of monitoring requirements and the reduced need of dose adjustments are perhaps the most important ones. Managing these patients in the peri-endoscopic period implies balancing the risk for thrombosis that a certain patient carries and the bleeding risk associated with the endoscopic procedure itself. The Romanian Society of Gastroenterology and Hepatology decided to create a consensus paper to serve to practitioners and teachers. After reviewing the available published data and existing recommendations, a Delphi consensus process was carried out involving the leaders of opinion in this field. After reaching expert consensus, we provide herein guidance for a practical approach of DOACs therapy management in patients with endoscopic interventions.

Background. Muscular complaints are known side-effects of statin therapy, ranging from myalgia to clinically important myositis and rhabdomyolysis. We investigated the statin use and association with the presence and characteristics of muscular complaints. Methods. We conducted a prospective observational study in internal medicine departments. Patients with statin therapy before hospitalization were interviewed for muscular complaints. When muscular complaints were reported, information on type and severity of muscular symptoms, location and time to onset was collected. Results. We identified 85 patients with statin treatment at hospital admission out of 521 included. Nine (10.59%) patients reported muscular complaints associated with statin therapy. A cluster of symptoms (cramps, stiffness, decreased muscle power) was reported, affecting both upper and lower limbs. The severity of pain was in most of the cases moderate or severe. All patients reported that pain was intermittent. Five reported that pain was generalized. Symptoms appeared in the first month of treatment or three months after the drug initiation. Creatine kinase was raised in one patient. In two cases drug interactions were probably responsible for muscular complaints. Conclusion. In the studied set of patients muscular symptoms were a rather frequent effect of statin therapy. As this side-effect could be troublesome for patients and could lead to more severe outcomes, their timely detection and management is important.

Background Due to recent EU warnings and restrictions on the combined use of renin-angiotensin-aldosterone system (RAAS)-acting agents, and the seriousness of the associated harm, we analyzed the prescription of angiotensin-converting enzyme inhibitors (ACEIs) and angiotensin receptor blockers (ARBs) as dual therapy or associated with spironolactone. Setting An administrative claims database of a regional hospital in Romania. Methods We retrospectively included all adult patients hospitalized during 18 months in 2013–2014, discharged with a prescription of a RAAS-acting agent. Main outcome measures Counts of ACEIs and ARBs co-prescription, of ACEIs or ARBs combined with spironolactone, co-morbidities, co-medication, creatinine, and electrolytes assessment and values. Results Out of 1697 patients with a prescription of a RAAS-acting agent, 24 (1.4 %) were co-prescribed ACEIs and ARBs, and 416 (24.5 %) ACEIs or ARBs with spironolactone. Patients prescribed dual ACEI/ARB therapy and the ones with ACEI or ARB-spironolactone combination had significantly higher prevalence of increased creatinine level before discharge, compared to the ACEI and ARB monotherapy groups (48 and 31 % compared to 17 and 27 %). Subjects with diabetes, heart failure, ischaemic heart disease, or urea ≥40 mg/dL had higher odds of having ACEI or ARB-spironolactone combination compared to monotherapy, while hypertension and renal disease subjects had lower odds. Similar findings were comparing dual ACEI/ARB therapy to monotherapy except heart failure (not statistically significant). Conclusion Overall, the prevalence of use of dual therapy was low. The combined use of RAAS-acting agents was higher in patients with known risk factors for further renal function deterioration, compared to the ones without.

Introduction. The associations of drugs that may interact with the statins resulting in elevated serum concentration of the statins are an important risk factor for statin induced muscle disorders. We aimed to determine the prevalence of these associations in all hospitalized patients that had been prescribed statins before/during hospitalization and to find out how often they are associated with muscle-related side effects. Methods. This prospective, non-interventional study performed in two internal medicine departments included patients with statin therapy before/during hospitalization. Data on each patient demographic characteristics, co-morbidities and treatment was collected from medical charts and interviews. We evaluated patients’ therapy for the targeted associations using Thomson Micromedex Drug Interactions checker and we ranked the identified drug-drug interactions (DDIs) accordingly. Each patient with statin treatment before admission was additionally interviewed in order to identify muscular symptoms. Results. In 109 patients on statin treatment we found 35 potential (p) DDIs of statins in 30 (27.5%) patients, most of which were in the therapy before admission (27 pDDIs). The pDDIs were moderate (20 pDDIs) and major (15 pDDIs). Of the total number of pDDIs, 24 were targeting the muscular system. The drugs most frequently involved in the statins’ pDDIs were amiodarone and fenofibrate. Two of the patients with pDDIs reported muscle pain, both having additional risk factors for statin induced muscular effects. Conclusion. The prevalence of statins’ pDDIs was high in our study, mostly in the therapy before admission, with only a small number of pDDIs resulting in clinical outcome.

Background and aims. Patient education is a critical task that may be carried out by the pharmacists, especially in the context of contemporary pharmacists’ roles, which tend to be closer to patients and their needs. This study aimed to evaluate the counseling provided by the pharmacist in the community pharmacy, from the patient’s perspective.Patients and methods. We conducted a prospective, non-interventional study in 520 pharmacies from 10 Romanian counties across the country. The first 10 visitors of the pharmacy on a given day were asked to complete a questionnaire regarding the counseling provided by the pharmacist during the visit.Results. More than 90% of patients received advice from the pharmacist on the route of administration, use in relation to meals, dosage and length of treatment. More than 80% of the patients were counseled on the medicine contraindications and precautions, interactions with other medicines and food, side effects, additional changes in lifestyle and diet appropriate to the condition and the necessity to immediately consult a doctor/pharmacist in case of adverse drug reactions. Lower percentages were registered for advising the patient on the obligation to return to pharmacy the unused psychotropic drugs (38.04%) and the ability of the drug to modify the laboratory results (47.66).Conclusions. The results of the present study showed that the counseling activity in the community pharmacy is carried out by the pharmacists in a high proportion, according to the patients’ feedback.

Background Potential drug–drug interactions (DDIs) are frequent in drug prescription but clinically significant are the ones which can result in changes of therapeutic effect of one of the two drugs or in adverse drug reactions (ADRs). The aim of this study was to assess the potential DDIs as well as the DDIs which cause adverse drug reactions (ADRs) in an internal medicine department hospitalized patients. Methods The prospective study included all patients admitted between November 2010 and January 2011 in an internal medicine ward. Information on patients' demographics and their medication use history was obtained from each patient by interview. In addition, medical history, medication use during hospitalization, and relevant laboratory and clinical data were obtained from medical records. Potential DDIs were identified using the Thomson Micromedex program. Each patient was monitored during the hospitalization period in order to detect the ADRs resulting from DDI's if present. Results Three hundred and five patients were enrolled in this study during 3 months. Of 1279 potential DDIs, Fourteen led to 13 ADRs out of which 8 were serious and caused hospital admission or prolongation of hospitalization. There was a statistically significant association between ADRs related to DDIs and the presence of ATC (Anatomical Therapeutic Chemical) C medication during hospitalization and the length of hospital stay, in the multivariate analysis. Conclusion Awareness of the most commonly occurring DDIs should be raised by the utilization of drug–drug interaction guides in the Romanian clinical practice which can help prescribers and pharmacists prevent DDI related ADRs.

Background It is generally recognized that adverse drug reactions (ADRs) represent a major concern of health systems in terms of early recognition, proper management and prevention. The aims of this study were to identify the most frequent ADRs recognized by the attending physicians, study their nature and target these ADRs in order to take future preventive measures. Methods A prospective study was conducted over a 12-month period in an internal medicine department using stimulated spontaneous reporting for identifying ADRs. All ADRs reported by physicians were followed up to the patient's discharge and evaluated by an independent group of pharmacologists. Causality, severity and preventability were assessed. Results Of the 1854 admissions, 112 ADRs in 94 patients (5.07%) were validated from the total of 118 ADRs reported. The overall incidence of serious ADRs in the hospitalized patients was 4.7%. According to the MedDRA classification, the most frequent ADRs affected the gastrointestinal system, followed by metabolic and vascular systems. The drugs most frequently involved were cardiovascular agents, anticoagulants and NSAIDs. Drug interactions were responsible for 25.9% of ADRs. According to the selected preventability scale, 40.18% ADRs were classified as ‘potentially preventable’ and 9.82% ‘definitely preventable’. Most of the ADRs were ‘type A’ reactions and as such could have been avoided simply by adjusting the doses or by avoiding drug interactions. Conclusions Serious ADRs in hospitalized patients are common and often preventable. Preventing strategies should target drug prescription. Adequate training regarding pharmacology and optimization of drug therapy might help reduce ADRs' morbidity and mortality.

Modern therapy has changed the way diseases are controlled and has brought significant benefits. In spite of all the benefits, adverse drug reactions are a common, often preventable, cause of illness, disability and even death. Besides the intrinsic danger associated with the drug, patients might have a particular, unpredictable hypersensitivity to certain drugs, which requires careful monitoring. Different studies have shown that adverse drug reactions related hospital admissions comprise up to 10% of the total number of hospitalizations. Adverse drug reactions can be difficult and sometimes impossible to distinguish from the patient's disease as they act through the same physiological and pathological pathways. Unrecognized adverse drug reactions inflict health damage, hospital costs and may lead to prolonged hospitalization. The purpose of this paper is to review and clarify some specific terminology and to assess the likelihood that a suspected adverse drug reaction is actually due to a medicine, by outlining the information needed for recognizing an adverse drug reaction and the steps of a causality assessment of a theoretical drug-induced case of pancreatitis.