Pharmacist’s knowledge,practice and attitudes toward pharmacovigilance and adverse drug reactions reporting process

Background

Adverse drug reactions (ADRs) are a major cause of drug related morbidity and mortality. Pharmacovigilance is the science that plays an essential role in the reduction of ADRs, thus the evolution and growth of this science are critical for effective and safe clinical practice.

Objectives

This study is considered the first study in the region to evaluate pharmacist’s knowledge, practice and attitudes toward ADRs reporting after establishing the national ADRs reporting center in Jordan.

Method

A cross sectional study was used to evaluate pharmacist knowledge and attitude toward ADRs reporting. A structured validated questionnaire was developed for this purpose and a total of 208 pharmacists were recruited to participate in this study.

Results

The majority of pharmacists have insufficient awareness and lack of knowledge about pharmacovigilance and ADRs reporting. Also the rate of reporting of ADRs was extremely poor. Several factors were found to discourage pharmacists from reporting ADRs, which include inadequate information available from the patient, unavailability of pharmacist ADRs form when needed, unawareness of the existence of the national ADRs reporting system. Also pharmacists think that ADRs are unimportant or they did not know how to report them.

Conclusion

The results of this study suggest that pharmacists have insufficient knowledge about the concept of pharmacovigilance and spontaneous ADRs reporting. On the other hand, pharmacists had positive attitudes toward pharmacovigilance, despite their little experience with ADRs reporting. Educational programs are needed to increase pharmacist’s role in the reporting process, and thus to have a positive impact on the overall patient caring process.     

Patients’ role in reporting adverse drug reactions

This review discusses the involvement of patients in the reporting of adverse drug reactions (ADRs). Patients benefit from drugs but also experience their adverse effects. Since concerns about the safety of drugs are also patients’ concerns, the patient could also play a part in decreasing the risks of drug therapy. Patient interest in the safety aspects of drugs is evident. At an international level, the merits of patient reports are being considered. To date, the literature does not yet provide any actual results in relation to the detection of ADRs by patients. Different considerations regarding ADR reporting by patients are discussed. The authors conclude that we should positively value patients’ involvement in drug therapy and their concern regarding possible adverse effects. As a consequence, patients’ reports on ADRs should be accepted.     

Community pharmacists’ knowledge,behaviors and experiences about adverse drug reaction reporting in Saudi Arabia

Objective

To assess community pharmacists’ knowledge, behaviors and experiences relating to Adverse Drug Reaction (ADR) reporting in Saudi Arabia.

Methods

A cross-sectional study was conducted using a validated self-administered questionnaire. A convenience sample of 147 community pharmacists working in community pharmacies in Riyadh, Saudi Arabia.

Results

The questionnaire was distributed to 147 pharmacists, of whom 104 responded to the survey, a 70.7% response rate. The mean age of participants was 29 years. The majority (n = 101, 98.1%) had graduated with a bachelorette degree and worked in chain pharmacies (n = 68, 66.7%). Only 23 (22.1%) said they were familiar with the ADR reporting process, and only 21 (20.2%) knew that pharmacists can submit ADR reports online. The majority of the participants (n = 90, 86.5%) had never reported ADRs. Reasons for not reporting ADRs most importantly included lack of awareness about the method of reporting (n = 22, 45.9%), misconception that reporting ADRs is the duty of physician and hospital pharmacist (n = 8, 16.6%) and ADRs in community pharmacies are simple and should not be reported (n = 8, 16.6%). The most common approach perceived by community pharmacists for managing patients suffering from ADRs was to refer him/her to a physician (n = 80, 76.9%).

Conclusion

The majority of community pharmacists in Riyadh have poor knowledge of the ADR reporting process. Pharmacovigilance authorities should take necessary steps to urgently design interventional programs in order to increase the knowledge and awareness of pharmacists regarding the ADR reporting process.     

Community pharmacists’ knowledge and perspectives of reporting adverse drug reactions in Australia: a cross-sectional survey

International Journal of Clinical Pharmacy - Background Under-reporting of adverse drug reactions (ADRs) by healthcare professionals is prevalent worldwide. Community pharmacists are the most...     

Spontaneous reporting of adverse drug reactions: who reports and what?

A survey among Bordeaux pharmacovigilance centre 'users' and 'non-users' was conducted in Aquitaine, France. Two hundred physicians having reported to the centre at least one adverse drug reaction (ADR) during the past 3 years were matched to a randomly selected sample of 400 physicians who did not report. They were asked to anonymously fill out a postal questionnaire collecting data on their individual characteristics, including their practice mode, and on ADRs that they observed and reported during the past 12 months. The number of questionnaires returned was 151 (25%), of which 76 were from users (38%) and 75 from non-users (19%). The two groups had very close individual characteristics. All but three responders had observed at least one ADR during the past 12 months. For the different types of ADRs defined in terms of seriousness and labelling, more users had seen ADRs than non-users but among those who observed them, the numbers of ADRs seen were similar in both groups. In any case, the more recent the drug, the more prone to report were the physicians.     

Pharmacy students’ perceptions towards online learning in a Saudi Pharmacy School

Objectives

The aim of the study was to evaluate previous exposure to online learning and preference for learning through pre-recorded online lectures with or without live active learning among pharmacy students in their fifth year.

Community pharmacists’ views on adverse drug reactions reporting in Malaysia: a pilot study

Objectives To investigate community pharmacists’ knowledge, attitudes and views on adverse drug reaction (ADR) reporting. Setting Seven community pharmacies in Malaysia. Method Structured interviews with community pharmacists. Informed consent was obtained and interviews were audio-recorded and transcribed verbatim. Main Outcome Measures Content analysis of themes on awareness of ADR reporting, reporting activities, attitudes and views on patient reporting. Results All pharmacists claimed to have some knowledge of a reporting system but only one had submitted a report directly to the regulatory authority. Despite the low level of reporting activities, all participants agreed that it was part of their professional obligation to report an ADR. Most participants were not aware of the direct patient reporting scheme and were skeptical about its success. Lack of awareness and patients’ limited knowledge about their medications were viewed as barriers to patient reporting. Local attitudinal issues including pharmacists’ attitude towards ADR reporting were described as possible contributing factors. Conclusion Community pharmacists have an important role in reporting ADRs. Many Malaysian patients are still perceived to be ill-informed of their medications, an important determinant to the success of patient reporting. There is a need for further training about ADRs and ADR reporting for health professionals and further education for patients.     

Healthcare personnel’s experience of reporting adverse drug reactions in Baghdad city: cross-sectional study

Background Adverse drug reactions (ADRs) are undesirable effects to drugs at doses normally used in the clinical setting for diagnosis, treatment or prophylaxis of diseases. Spontaneous ADR reporting is currently considered as a critical part of ADRs detection. Objective The study aims to assess the knowledge, attitude, and practice of healthcare providers towards adverse drug reaction reporting in public and private settings within the Baghdad area. Method We follow a quantitative cross-sectional study design, using a self-administered questionnaire to collect data from the healthcare providers regarding their reporting practice. Main outcome The outcome measures include the experiences of reporting of adverse drug reactions and the available systems, in addition to the expected benefits to clinical practice. Results Among 485 respondents, 114 were able to differentiate ADRs from side effects. About half of them (47.6%) recognized the availability of reporting systems and 43.3% knew how to report adverse drug reactions. 43.7% of the respondents mentioned that ADRs should be reported only when they are life-threatening. Among the 188 respondents who encountered ADRs, 145 reported the events to the accessible local authority. Conclusion The healthcare providers working in Baghdad healthcare institutions have a good attitude toward ADR reporting. There is a relatively below-standard reporting culture of the encountered adverse reactions. The inadequate knowledge about adverse reactions and the unavailability of reporting forms played a major role in discouraging healthcare professionals to detect and report ADRs.

     

Epidemiology and characteristics of adverse drug reactions caused by drug–drug interactions

Introduction: Drug–drug interactions (DDIs) arise in numerous different ways, involving pharmacokinetic or pharmacodynamic mechanisms. Adverse drug reactions are a possible consequence of DDIs and health operators are often unaware of the clinical risks of certain drug combinations. Many papers on drug interactions have been published in recent years, but most of them focused on potential DDIs while few studies have been conducted on actual interactions.

Areas covered: This paper reviews the epidemiology of actual DDIs in outpatients as well as in hospital settings and in spontaneous reporting databases. The incidence of actual DDIs is consistently lower than that of potential DDIs. However, the absolute number of patients involved is high, representing a significant proportion of adverse drug reactions. The importance of risk factors such as age, polypharmacy and genetic polymorphisms is also evaluated. The relevance and efficacy of tools for recognizing and preventing DDIs are discussed.

Expert opinion: Potential DDIs far outnumber actual drug interactions. The potential for an adverse interaction to occur is often theoretical, and clinically important adverse effects occur only in the presence of specific risk factors. Several studies have shown the efficacy of computers in early detection of DDIs. However, a correct risk–benefit evaluation by the prescribing physician, together with a careful clinical, physiological and biochemical monitoring of patients, is essential. Future directions of drug interaction research include the increasing importance of pharmacogenetics in preventing DDIs and the evaluation of interactions with biological drugs.     

A nationwide survey of pharmacy students’ knowledge and perceptions regarding medical cannabis

ObjectiveThe primary objective of this study was to compare knowledge and perceptions of medical cannabis (MC) between pharmacy students who attended schools where MC was legal and illegal.DesignA nationwide anonymous survey regarding MC was distributed to pharmacy students. The survey consisted of the following sections: (1) demographics and personal factors, (2) knowledge assessment of indications and adverse effects of MC, and (3) perceptions assessment.Setting and participantsEqual numbers of pharmacy schools were selected and sent surveys based on geographical regions, private versus public universities, and the state’s legal status of MC for first through fourth-year pharmacy students to complete.Outcome measuresStudent knowledge of MC indications and adverse effects were treated as quizzes. Median percentage correct and whether students passed the quizzes (≥ 70%) were evaluated based on the state’s legal status. Students’ perceptions were similarly compared.ResultsA total of 629 students accessed the survey. Most students who completed the survey attended pharmacy schools where MC was illegal (55%), were female (68%), and had personally tried cannabis (53%). Overall, 91% of students believed that MC should be legalized nationally. A low number of students correctly identify approved indications with 14.8% of students in states with MC legalization scoring greater than 70% compared with 15.9% of students in states without MC legalization (P = 0.748). Similar findings were seen in the side effects quiz with only 6.1% of students in states with legal MC scoring greater than 70% compared with 7.4% of students where MC is illegal (P = 0.569) There were minimal differences in students’ perceptions of MC based on the states’ legal status.ConclusionOur study continues to highlight that pharmacy students lack knowledge and preparation to counsel and educate on MC. With increasing state legalizations, pharmacy schools need to address this knowledge gap to ensure optimal patient care.     

Do pharmacists’ reports of adverse drug reactions reflect patients’ concerns?

Aim: The aim of the present study was to investigate whether the concerns patients express to a Drug Information Line about possible adverse drug reactions (ADRs) they have experienced, are sufficiently reflected by the ADR reports submitted by pharmacists to the Netherlands Pharmacovigilance Centre Lareb with regard to the type of ADRs and the drug groups involved.Methods: ADR-related questions patients addressed to the Dutch Drugs Information Line were compared with the ADR reports pharmacists sent in to Lareb in the same period. The similarities and differences between the characteristics of the suspected ADRs and the kinds of drugs mentioned were investigated, as well as the severity of the reported ADRs. To compare the two data sets and to establish whether significant differences were present, a logistic regression analysis was conducted on the reported drugs and ADRs.Results: Analysis of the content of the phone calls yielded 1168 (14.6%) calls concerning possible experienced ADRs. The suspected ADRs pharmacists reported to the Netherlands Pharmacovigilance Centre Lareb in the same period included 1734 reports. There were only slight differences between the queries patients put to the Drug Information Line regarding possible adverse drug reactions and the reports on suspected ADRs pharmacists submitted to the pharmacovigilance centre. With respect to possible ADRs in the psychiatric spectrum and ADRs associated with the use of antidepressants, there seems to be a deficiency in the reporting by pharmacists.Conclusion: The ADRs pharmacists report to the national pharmacovigilance centre reflect patients concerns about ADRs they experience in relation to the medication they are taking.     

Healthcare professionals’ knowledge,attitude and practice towards adverse drug reaction (ADR) reporting at the health center level in Ethiopia

International Journal of Clinical Pharmacy - Background Adverse drug reactions (ADRs) are major health problems which are of global concern. Spontaneous reporting of adverse drug reactions...     

The importance of drug–drug interactions as a cause of adverse drug reactions: a pharmacovigilance study of serotoninergic reuptake inhibitors in France

Purpose  

To quantify the importance of drug–drug interactions (DDIs) in the occurrence of adverse drug reactions (ADRs) reported with serotoninergic reuptake inhibitors in a pharmacovigilance database.     

Are the adverse drug reactions of amoxycillin and amoxycillin-clavulanic acid similar?

In an attempt to assess the relative toxicity of amoxycillin and amoxycillin-clavulanic acid, we compared the adverse drug reactions reports collected using the spontaneous reporting system of a Regional Drug Surveillance Centre of Spain for both drugs between November 1986 and December 1992. During the 7-year period 1986-92, the 247 reports of amoxycillin-clavulanic acid represent twice the number of reports of amoxycillin alone, and the number of reports related with sales received concerning the association were higher than those concerning amoxycillin alone. The adverse effects classified as severe were quantitatively and qualitatively similar for both drugs and gastrointestinal and skin are the most common system-organ affected by both drugs. With amoxycillin-clavulanic acid there is a higher proportion of stomatological reactions reported and a later onset of adverse drug reactions related with oropharyngeal lesions, and the reaction of the resistance mechanism when compared with the other organs and systems affected. The duration of the adverse drug reactions to amoxycillin-clavulanic acid is longer than for amoxycillin alone. In conclusion: (i) the adverse drug reactions profile of both drugs is different; (ii) the higher reporting rate for amoxycillin-clavulanic acid may be due to more recent marketing; and (iii) amoxycillin-clavulanic acid produces proportionately more gastrointestinal and fewer skin adverse reactions than amoxycillin alone.     

Evaluation of community pharmacists’ knowledge about drug–drug interaction in Central Saudi Arabia

IntroductionAlthough all implemented and ongoing initiatives, drug-drug interactions (DDIs) are still a global problem. Most published studies about DDIs in Saudi Arabia are carried out in hospital settings. In addition, assessing the knowledge of drug interactions in Saudi Arabia is limited. The aim of our study is to evaluate the knowledge of potential common drug-drug interactions among community pharmacists particularly in Saudi Arabia.MethodologyA crosses-sectional study utilizing a self- administered questionnaire was conducted among community pharmacy in Riyadh city Saudi Arabia. DDIs' knowledge was assessed by 26 drug pairs. Community pharmacists were asked to select the DDIs as “contraindication”, “may be used together with monitoring”, “no interaction” and “not sure”.ResultsA total of 283 of community pharmacists completed the survey with response rate of 80.9%. Among the 26 drug pairs only 5 of them were identified correctly by most of the participants. To add more 3 out of the 5 pairs had a cutoff of less than 10% between the correct and wrong answer, meaning there still a majority that couldn't identify the correct answer. All the 26 pairs had a statistically significant difference between the correct and incorrect answer.ConclusionThe results of this study showed that knowledge of community pharmacists about DDIs was inadequate. Community pharmacist should have specific courses in drug interactions to cover the most possible interactions that can be seen in this setting.     

A prospective survey of knowledge and perceptions of ondansetron: what do health care workers know about this drug?

Ondansetron is a relatively new drug whose optimal use is dependent on an understanding of its characteristics and role relative to traditional antiemetics. To assess perceptions and knowledge regarding ondansetron, we conducted a prospective written survey involving 56 physicians, pharmacists, and nurses at this hospital. Pharmacists claimed to be exposed to ondansetron promotion by industry more than the other groups. Apart from industry, pharmacists were considered to be the most common source of drug information. Nurses were less aware of dosage form equivalence than the other groups (p = 0.042). Physicians were more aware of twice daily dosing efficacy than other respondents (p = 0.0006). Nurses were able to better identify the relative duration of antiemetic benefit over metoclopramide (p = 0.008); however, most participants tended to be misinformed on this issue. Pharmacists were more familiar with the side effect profile while physicians were more cognizant of oral (p = 0.001) and parenteral (p = 0.018) drug costs than other groups. Overall, survey scores for physicians and pharmacists were higher than those for nurses (p = 0.007). There is an apparent difference across health care profession disciplines in the perceptions and knowledge about ondansetron. Specific misconceptions could lead to suboptimal drug use and warrant efforts to ensure a good understanding of the attributes and relative role of this agent.     

Pharmacy education instruction: Preference and practices,Saudi students’ perception

Aim/Background

The methods of instruction in pharmacy education are crucial and meant to suit the professional development and encompass the advanced variety of services and functions provided by the pharmacists to serve individual patients. The aim of this study was to determine the students’ opinions on the adopted and preferred methods of instruction in pharmacy colleges in Kingdom of Saudi Arabia.

Methods

Opinions of Saudi pharmacy students regarding the adopted methods of learning were measured using a pretested questionnaire combined with Likert-type scales.

Results

Three hundred pharmacy students were interviewed. Direct type of lecturing was dominant (53.7%). The most frequently used language of instruction was combined English and Arabic (48.8%), that was mostly preferred by 52.5% of the students. Handouts were the most adopted post-lecture learning method (48.3%), while only 5.9% used student’s self-written notes. A cocktail of traditional and electronic aids was used as admitted by 68.7% and 59.3% of the students who preferred this lecture delivery method. Almost half (49.3%) of the students agreed of having a routine fair guidance and support when referring to their lecturers.

Conclusion

The study outcomes had revealed a practical guidance to be considered for instituting preferred modes of instruction to upgrading students’ capacities for better understanding and acquiring academic and professional skills.     

An update on adverse drug reactions related to β-lactam antibiotics

Introduction: β-lactams have been consistently associated with the majority of drug-related adverse events. Generally, these are mild under proper dosing and judicious selection.

Areas covered: Immediate hypersensitivity reactions are the most feared adverse events encountered after β-lactam administration. Emerging evidence shows that immediate reactions are not as common as previously thought. Specialist consultation and testing seems prudent before a patient is officially declared allergic to β-lactams. The risk of cross-reactions between not only members of the β-lactam super-family but also between specific classes is also lower than previously thought. Newer studies have shown that cross-reactions are not universal and pertain to specific agents with similar side chains or metabolites of the β-lactam core. The frequency of severe kidney or liver toxicity, neurotoxicity, cytopenias and Clostiridium difficile infection following β-lactam administration seem to be agent-specific.

Expert opinion: The currently available data denote that in addition to age, gender, co-morbidity, renal or liver function, and co-administered agents, the antibiotic levels rather than the dose itself seem to be associated with the emergence of adverse events. Most of them subside with time after withdrawal of the offending agent, but the number of cases resulting in chronic disabilities or even deaths in not negligible.