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1.  Public awareness, patterns of use and attitudes toward natural health products in Kuwait: a cross-sectional survey 
Background
There has been a global rise in the use of natural health products (NHPs). Proper regulation of NHPs is pivotal to ensure good quality control standards, enhance consumers' safety and facilitate their integration into modern healthcare systems. There is scarcity of published data on the prevalence of NHPs usage among the general Kuwaiti population. Hence, this study was designed to determine awareness, patterns of use, general attitude and information requirements about NHPs among the public in Kuwait.
Methods
A descriptive cross-sectional survey was performed using a pretested self-administered questionnaire on a sample of 1300 Kuwaiti individuals, selected from six governorates in Kuwait using a multistage stratified clustered sampling. Descriptive and multivariate logistic regression analysis were used in data analysis.
Results
The response rate was 90.2%. NHPs were thought to be herbal remedies by most of participants (63.5%), followed by vitamins/minerals (40.5%), traditional medicines (21.1%), probiotics (14.9%), amino acids and essential fatty acids (7.2%), and homeopathic medicines (5.6%). NHPs usage was reported by 71.4% (95% CI: 68.8-74.0%) of respondents, and mostly associated with females (OR: 1.90; 95% CI: 1.44-2.51). Herbal remedies were the most commonly used (41.3%; 95% CI: 38.5-44.2%). The most common reasons for using NHPs were to promote and maintain health and to prevent illness and build immune system. Family members and/or friends and mass media were the main sources for providing information about NHPs. About 18% of consumers have experienced a side effect due to using a NHP. Attitudes toward NHPs were generally positive; with more than 75% of participants believing that the Ministry of Health in Kuwait should regulate the claims made by the manufacturers of NHPs and it is important to talk to a medical doctor or a pharmacist prior to using NHPs. Most of the respondents showed increased interest to acquire knowledge about different types of information related to NHPs.
Conclusions
The prevalence of use of NHPs among Kuwaiti population is high. The present findings have major public health policy implications for Kuwait. Therefore, there is an apparent need to establish effective health education programs and implement better and more regulated NHPs use policies in Kuwait.
doi:10.1186/1472-6882-14-105
PMCID: PMC3999934  PMID: 24646341
Natural health products; Herbal remedies; Patterns of use; Kuwait
2.  Roles and Responsibilities of Pharmacists with Respect to Natural Health Products: Key Informant Interviews 
Background
Although many pharmacies sell natural health products (NHPs), there is no clear definition as to the roles and responsibilities (if any) of pharmacists with respect to these products.
Objective
The purpose of this study was to explore pharmacy and stakeholder leaders’ perceptions of pharmacists’ professional NHP roles and responsibilities.
Methods
Semi-structured key informant interviews were conducted with pharmacy leaders (n= 17) and stakeholder (n=18) leaders representing consumers, complementary and alternative medicine practitioners, conventional healthcare practitioners, and industry across Canada.
Results
Overwhelmingly all participants believed a main NHP responsibility for pharmacists was safety monitoring. One challenge identified in the interviews was pharmacists’ general lack of NHP knowledge. Stakeholder leaders did not expect pharmacists to be experts on NHPs, rather that pharmacists should have a basic level of knowledge about NHPs. Many pharmacy leaders appeared to be unfamiliar with current pharmacy policies and guidelines concerning NHPs.
Conclusion
Participants described pharmacists’ professional roles and responsibilities for NHPs as similar to those for over-the-counter drugs. More awareness of existing NHP-related pharmacy policies is needed. Pharmacy owners/managers should provide additional training to ensure front-line pharmacists have appropriate knowledge of NHPs sold in the pharmacy.
doi:10.1016/j.sapharm.2009.02.004
PMCID: PMC2923149  PMID: 20188329 CAMSID: cams1316
natural health products; pharmacists; professional roles and responsibilities
3.  Incidence and Economic Burden of Adverse Drug Reactions among Elderly Patients in Ontario Emergency Departments 
Drug Safety  2012;35(9):769-781.
Background: The rapid rise in the availability and use of pharmaceutical agents, and particularly polypharmacy, directly increases the risk for patients to experience adverse drug reactions (ADRs). There are few studies on the overall incidence and costs of ADRs.
Objective: The aim of this study was to estimate the incidence and costs of emergency department (ED) visits related to ADRs for patients greater than 65 years of age using administrative data, and to describe risk factors for experiencing severe ADRs.
Methods: We employed a retrospective cohort design based on population-based healthcare administrative clinical databases. Identification of ADR-related ED visits from the administrative database was based on International Classification of Diseases, 10th Revision-Canadian Enhancement (ICD-10-CA) codes for each ED visit. The incidence and costs of ADR-related ED visits and subsequent hospital admissions were estimated for all adults aged 66 years and above for the period April 2003–March 2008. Costs were standardized and reported in 2008 Canadian dollars. Logistic regression was used to detect risk factors for severe ADRs.
Results: Approximately 0.75% of total annual ED visits among adults aged 66 years and above were found to be ADR-related, and among these patients 21.6% were hospitalized. In 2007, the cost of ADR-related visits was $333 per ED visit and $7528 per hospitalization for a total annual cost of $13.6 million in Ontario, or an estimated $35.7 million in Canada. Severe ADRs were associated with sex, age, comorbid disease burden, multiple drugs, multiple pharmacies, newly prescribed drugs, recent ED visit, recent hospitalization and long-term care (LTC) residence.
Conclusions: ADRs are an important public health issue that threaten the safety of drug therapy and results in significant economic burden to the healthcare system. ED visits related to ADRs may be underestimated in retrospective studies using administrative data compared with prospective studies. Further research is needed to better understand the risk of experiencing severe ADRs among LTC residents.
doi:10.1007/BF03261973
PMCID: PMC3714138  PMID: 22823502
4.  Study of Natural Health Product Adverse Reactions (SONAR): Active Surveillance of Adverse Events Following Concurrent Natural Health Product and Prescription Drug Use in Community Pharmacies 
PLoS ONE  2012;7(9):e45196.
Background
Many consumers use natural health products (NHPs) concurrently with prescription medications. As NHP-related harms are under-reported through passive surveillance, the safety of concurrent NHP-drug use remains unknown. To conduct active surveillance in participating community pharmacies to identify adverse events related to concurrent NHP-prescription drug use.
Methodology/Principal Findings
Participating pharmacists asked individuals collecting prescription medications about (i) concurrent NHP/drug use in the previous three months and (ii) experiences of adverse events. If an adverse event was identified and if the patient provided written consent, a research pharmacist conducted a guided telephone interview to gather additional information after obtaining additional verbal consent and documenting so within the interview form. Over a total of 112 pharmacy weeks, 2615 patients were screened, of which 1037 (39.7%; 95% CI: 37.8% to 41.5%) reported concurrent NHP and prescription medication use. A total of 77 patients reported a possible AE (2.94%; 95% CI: 2.4% to 3.7%), which represents 7.4% of those using NHPs and prescription medications concurrently (95%CI: 6.0% to 9.2%). Of 15 patients available for an interview, 4 (26.7%: 95% CI: 4.3% to 49.0%) reported an AE that was determined to be “probably” due to NHP use.
Conclusions/Significance
Active surveillance markedly improves identification and reporting of adverse events associated with concurrent NHP-drug use. Although not without challenges, active surveillance is feasible and can generate adverse event data of sufficient quality to allow for meaningful adjudication to assess potential harms.
doi:10.1371/journal.pone.0045196
PMCID: PMC3461007  PMID: 23028841
5.  Pattern of adverse drug reactions reported by the community pharmacists in Nepal 
Pharmacy Practice  2010;8(3):201-207.
The pharmacovigilance program in Nepal is less than a decade old, and is hospital centered. This study highlights the findings of a community based pharmacovigilance program involving the community pharmacists.
Objectives:
To collect the demographic details of the patients experiencing adverse drug reactions (ADR) reported by the community pharmacists; to identify the common drugs causing the ADRs, the common types of ADRs; and to carry out the causality, severity and preventability assessments of the reported ADRs.
Methods:
The baseline Knowledge-Attitude-Practices (KAP) of 116 community pharmacists from Pokhara valley towards drug safety was evaluated using a validated (Cronbach alpha=0.61) KAP questionnaire having 20 questions [(knowledge 11, attitude 5 and practice 4) maximum possible score 40]. Thirty community pharmacists with high scores were selected for three training sessions, each session lasting for one to two hours, covering the basic knowledge required for the community pharmacists for ADR reporting. Pharmacist from the regional pharmacovigilance center visited the trained community pharmacists every alternate day and collected the filled ADR reporting forms.
Results:
Altogether 71 ADRs, from 71 patients (37 males) were reported. Antibiotics/ antibacterials caused 42% (n=37) of the total ADRs followed by non steroidal anti-inflammatory drugs [25% (n=22)]. Ibuprofen/paracetamol combination accounted for ten ADRs. The most common type of ADR was itching [17.2 % (n=20), followed by generalized edema [8.6 % (n=10)]. In order to manage the ADRs, the patients needed medical treatment in 69% (n=49) of the cases. Over two third (69%) of the ADRs had a ‘possible’ association with the suspected drugs and a high percentage (70.4%) were of ‘mild (level 2)’ type. Nearly two third [64.7 % (n=46)] of the ADRs were ‘definitely preventable’.
Conclusion:
The common class of drugs known to cause ADRs was antibacterial/ antibiotics. Ibuprofen/ Paracetamol combination use of the drug was responsible for more number of ADRs and the most common ADRs were related to dermatological system. Strengthening this program might improve safe use of medicines in the community.
PMCID: PMC4127056  PMID: 25126141
Adverse Drug Reaction Reporting Systems; Community Pharmacy Services; Pharmacists; Nepal
6.  Experiences from consumer reports on psychiatric adverse drug reactions with antidepressant medication: a qualitative study of reports to a consumer association 
Background
The new European pharmacovigilance legislation has been suggested as marking the beginning of a new chapter in drug safety, making patients an important part of pharmacovigilance. In Sweden since 2008 it has been possible for consumers to report adverse drug reactions (ADRs) to the Medical Products Agency (MPA), and these reports are now understood as an increasingly valuable contribution in the monitoring of safety aspects in medicines. Already in 2002 it was possible to report experiences with medicines to the non-profit and independent organization Consumer Association for Medicines and Health (KILEN) through a web-based report form with an opportunity to describe ADR experiences in free text comments. The aim of this study was to qualitatively analyze the free text comments appended to consumer reports on antidepressant medication.
Methods
All reports of suspected adverse reactions regarding antidepressant medications submitted from January 2002 to April 2009 to KILEN’s Internet-based reporting system in Sweden were analyzed according to reported narrative experience(s). Content analysis was used to interpret the content of 181 reports with free text comments.
Results
Three main categories emerged from the analyzed data material: (1) Experiences of drug treatment with subcategories (a) Severe psychiatric adverse reactions, and (b) Discontinuation symptoms; (2) Lack of communication and (3) Trust and distrust. A majority of the reports to KILEN were from patients experiencing symptoms of mental disturbances (sometimes severe) affecting them in many different ways, especially during discontinuation. Several report included narratives of patients not receiving information of potential ADRs from their doctor, but also that there were no follow-ups of the treatment. Trust was highlighted as especially important and some patients reported losing confidence in their doctor when they were not believed about the suspected ADRs they experienced, making them attempt to discontinue their antidepressant treatment on their own.
Conclusions
The present study indicates that free text comments as often contained in case reports directly submitted by patients can be of value in pharmacovigilance and provide important information on how a drug may affect the person using it and influence his or her personal life.
doi:10.1186/2050-6511-13-19
PMCID: PMC3554467  PMID: 23259410
7.  Pharmacy study of natural health product adverse reactions (SONAR): a cross-sectional study using active surveillance in community pharmacies to detect adverse events associated with natural health products and assess causality 
BMJ Open  2014;4(3):e003431.
Objectives
To investigate the rates and causality of adverse event(s) (AE) associated with natural health product (NHP) use, prescription drug use and concurrent NHP-drug use through active surveillance in community pharmacies.
Design
Cross-sectional study of screened patients.
Setting
10 community pharmacies across Alberta and British Columbia, Canada from 14 January to 30 July 2011.
Participants
The participating pharmacy staff screened consecutive patients, or agents of patients, who were dropping or picking up prescription medications.
Primary outcome measures
Patients were screened to determine the proportions of them using prescription drugs and/or NHPs, as well as their respective AE rates. All AEs reported by the screened patients who took a NHP, consented to, and were available for, a detailed telephone interview (14%) were adjudicated fully to assess for causality.
Results
Over a total of 105 pharmacy weeks and 1118 patients screened, 410 patients reported taking prescription drugs only (36.7%; 95% CI 33.9% to 39.5%), 37 reported taking NHPs only (3.3%; 95% CI 2.4% to 4.5%) and 657 reported taking prescription drugs and NHPs concurrently (58.8%; 95% CI 55.9% to 61.6%). In total, 54 patients reported an AE, representing 1.2% (95% CI 0.51% to 2.9%), 2.7% (95% CI 0.4% to 16.9%) and 7.3% (95% CI 5.6% to 9.6%) of each population, respectively. Compared with patients who reported using prescription drugs, the patients who reported using prescription drugs and NHPs concurrently were 6.4 times more likely to experience an AE (OR; 95% CI 2.52 to 16.17; p<0.001). Combined with data from Ontario, Canada, a national proportion was calculated, which found that 45.4% (95% CI 43.8% to 47.0%) of Canadians who visit community pharmacies take NHPs and prescription drugs concurrently, and of those, 7.4% (95% CI 6.3% to 8.8%) report an AE.
Conclusions
A substantial proportion of community pharmacy patients use prescription drugs and NHPs concurrently; these patients are at a greater risk of experiencing an AE. Active surveillance provides a means of detecting such AEs and collecting high-quality data on which causality assessment can be based.
doi:10.1136/bmjopen-2013-003431
PMCID: PMC3975764  PMID: 24682573
Complementary Medicine; Toxicology
8.  Nutrient- and non-nutrient-based natural health product (NHP) use in adults with mood disorders: prevalence, characteristics and potential for exposure to adverse events 
Background
To address knowledge gaps regarding natural health product (NHP) usage in mental health populations, we examined their use in adults with mood disorders, and explored the potential for adverse events.
Methods
Food and NHP intake was obtained from 97 adults with mood disorders. NHP data was used to compare prevalence with population norms (British Columbia Nutrition Survey; BCNS). Bivariate and regression analyses examined factors associated with NHP use. Assessment of potential adverse effects of NHP use was based on comparing nutrient intakes from food plus supplements with the Dietary Reference Intakes and by reviewing databases for reported adverse health effects.
Results
Two-thirds (66%; 95% CI 56 to 75) were taking at least one NHP; 58% (95% CI 47 to 68) were taking NHPs in combination with psychiatric medications. The proportion of each type of NHP used was generally higher than the BCNS (range of p’s < 0.05 to 0.0001). When intakes from food and NHP sources were combined, a small proportion exceeded any Lowest-Observed-Adverse-Effect-Levels: only for niacin (n = 17) and magnesium (n = 6), two nutrients for which the potential for adverse effects is minimal. Conversely, about 38% (95% CI 28 to 49) of the sample were taking a non-nutrient based NHP for which previous adverse events had been documented.
Conclusions
The prevalent use of NHPs in this population suggests that health care providers need to be knowledgeable about their characteristics. The efficacy and safety of NHPs in relation to mental health warrants further investigation.
doi:10.1186/1472-6882-13-80
PMCID: PMC3626531  PMID: 23570306
Natural health products; Adverse events; Mood disorders
9.  Recognition and reporting of suspected adverse drug reactions by surveyed healthcare professionals in Uganda: key determinants 
BMJ Open  2014;4(11):e005869.
Objective
To assess extent and determinants of past-month recognition of suspected adverse drug reactions (ADR) and past-year ADR reporting among healthcare professionals (HCPs) in Uganda.
Setting
Geographically diverse health facilities (public, private for-profit, private not-for-profit).
Participants
Of 2000 questionnaires distributed, 1345 were completed: return rate of 67%.
Primary and secondary outcome measures
Per cent HCPs who suspected ADR in the past month; reported ADR in the past year.
Results
Nurses were the majority (59%, 792/1345). Only half the respondents had heard about pharmacovigilance: 39% of nurses (295/763; 95% CI 35% to 42%), 70% otherwise (383/547; 95% CI 66% to 74%). One fifth (268/1289 or 21%; 95% CI 19% to 23%) had suspected an ADR in the previous 4 weeks, 111 of them were nurses; 15% (190/1296) had reported a suspected ADR in the past year, 103 of them were nurses. Past-month ADR suspicion was more likely by non-nurses (OR=1.7, 95% CI 1.16 to 2.40) and with medical research involvement (OR=1.5, 95% CI 1.05 to 2.15) but past-month receipt of patient ADR-complaint predominated (OR=19, 95% CI 14 to 28). Past-year ADR reporting was higher by hospital staff (OR=1.9, 95% CI 1.18 to 3.10), especially in medicine (OR=2.3, 95% CI 1.08 to 4.73); but lower from private for-profit health facilities (OR=0.5, 95% CI 0.28 to 0.77) and by older staff (OR=0.6, 95% CI 0.43 to 0.91); more likely by HCPs who had ever encountered a fatal ADR (OR=2.9, 95% CI 1.94 to 4.25), knew to whom to report (OR=1.7, 95% CI 1.18 to 2.46), or suggested how to improve ADR reporting (OR=1.6, 95% CI 1.04 to 2.49). Two attitudinal factors were important: diffidence and lethargy.
Conclusions
One in five HCPs suspected an ADR in the past-month and one in seven reported ADR in the previous year. Empowering patients could strengthen ADR detection and reporting in Africa.
doi:10.1136/bmjopen-2014-005869
PMCID: PMC4244492  PMID: 25421337
Pharmacoviligance; Adverse Drug Reactions; Reporting-Rates; Uganda; Healthcare Professionals
10.  Use of natural health products in children 
Canadian Family Physician  2013;59(8):e364-e371.
Abstract
Objective
To determine how common it is for parents to give natural health products (NHPs) to their children, which NHPs are being used, why they are being used, and parents’ assessments of the benefits and side effects of NHPs.
Design
Survey.
Setting
Newfoundland and Labrador.
Participants
Parents waiting in their family doctors’ offices.
Main outcome measures
Parent and child demographic characteristics; pediatric chronic medical conditions affecting the children; prescribed medications, over-the-counter medications, and NHPs used by the children; why the medications and NHPs were being used, the dose, and parents’ assessments of the effectiveness and side effects; and where parents had heard about the NHPs, whether they had told their physicians that the children were taking the products, and where they had obtained the products.
Results
A total of 202 (53.4%) of the 378 eligible adults who were approached completed the survey. This represented 333 children. Mean (SD) age of the children was 5.1 (3.3) years. Overall, 28.7% of parents reported using nonvitamin NHPs for their children. A total of 137 children (41.1%) had taken NHPs (including vitamins); 61.1% of the NHPs being used were vitamins. The remainder fell under teas (primarily chamomile and green teas), echinacea, fish or omega-3 oils, and a large category of “other” products. These NHPs were most commonly used to improve general health, improve immunity, and prevent colds and infections. Approximately half of the parents (51.7%) believed their children had benefited from taking NHPs, and 4.4% believed their children had experienced adverse side effects. Slightly less than half of the parents (45.0%) had informed their physicians that their children were taking NHPs.
Conclusion
Overall, 45.5% of parents attending physicians’ offices reported using NHPs in their children. If vitamins are not included in the definition of NHPs, this rate drops to 28.7%. Parents most commonly use NHPs to maintain the general health of their children, to prevent colds, and to boost children’s immune systems. About half of the parents believed the NHPs helped, very few had noticed any side effects, and approximately half had informed their physicians that they were giving their children NHPs.
PMCID: PMC3743713  PMID: 23946043
11.  What can we learn from consumer reports on psychiatric adverse drug reactions with antidepressant medication? Experiences from reports to a consumer association 
Background
According to the World Health Organization (WHO) the cost of adverse drug reactions (ADRs) in the general population is high and under-reporting by health professionals is a well-recognized problem. Another way to increase ADR reporting is to let the consumers themselves report directly to the authorities. In Sweden it is mandatory for prescribers to report serious ADRs to the Medical Products Agency (MPA), but there are no such regulations for consumers. The non-profit and independent organization Consumer Association for Medicines and Health, KILEN has launched the possibility for consumers to report their perceptions and experiences from their use of medicines in order to strengthen consumer rights within the health care sector. This study aimed to analyze these consumer reports.
Methods
All reports submitted from January 2002 to April 2009 to an open web site in Sweden where anyone could report their experience with the use of pharmaceuticals were analyzed with focus on common psychiatric side effects related to antidepressant usage. More than one ADR for a specific drug could be reported.
Results
In total 665 reports were made during the period. 442 reports concerned antidepressant medications and the individual antidepressant reports represented 2392 ADRs and 878 (37%) of these were psychiatric ADRs. 75% of the individual reports concerned serotonin-reuptake inhibitor (SSRI) and the rest serotonin-norepinephrine reuptake inhibitor (SNRI). Women reported more antidepressant psychiatric ADRs (71%) compared to men (24%). More potentially serious psychiatric ADRs were frequently reported to KILEN and withdrawal symptoms during discontinuation were also reported as a common issue.
Conclusions
The present study indicates that consumer reports may contribute with important information regarding more serious psychiatric ADRs following antidepressant treatment. Consumer reporting may be considered a complement to traditional ADR reporting.
doi:10.1186/1472-6904-11-16
PMCID: PMC3215951  PMID: 22026961
12.  The Prevalence of Natural Health Product Use in Patients with Acute Cardiovascular Disease 
PLoS ONE  2011;6(5):e19623.
Background
Natural health products (NHP) use may have implications with respect to adverse effects, drug interactions and adherence yet the prevalence of NHP use by patients with acute cardiovascular disease and the best method to ascertain this information is unknown.
Objective
To identify the best method to ascertain information on NHP, and the prevalence of use in a population with acute cardiovascular disease.
Methods
Structured interviews were conducted with a convenience sample of consecutive patients admitted with acute cardiovascular disease to the University of Alberta Hospital during January 2009. NHP use was explored using structured and open-ended questions based on Health Canada's definition of NHP. The medical record was reviewed, and documentation of NHP use by physicians, nurses, and pharmacists, compared against the gold-standard structured interview.
Results
88 patients were interviewed (mean age 62 years, standard deviation [SD 14]; 80% male; 41% admitted for acute coronary syndromes). Common co-morbidities included hypertension (59%), diabetes (26%) and renal impairment (19%). NHP use was common (78% of patients) and 75% of NHP users reported daily use. The category of NHP most commonly used was vitamins and minerals (73%) followed by herbal products (20%), traditional medicines including Chinese medicines (9%), homeopathic preparations (1%) and other products including amino acids, essential fatty acids and probiotics (35%). In a multivariable model, only older age was associated with increased NHP use (OR 1.5 per age decile [95%CI 1.03 to 2.2]). When compared to the interview, the highest rate of NHP documentation was the pharmacist history (41%). NHP were documented in 22% of patients by the physician and 19% by the nurse.
Conclusions
NHP use is common in patients admitted with acute cardiovascular disease. However, health professionals do not commonly identify NHP as part of the medication profile despite its potential importance. Structured interview appears to be the best method to accurately identify patient use of NHP.
doi:10.1371/journal.pone.0019623
PMCID: PMC3090400  PMID: 21573067
13.  An evaluation of knowledge, attitude and practice of Indian pharmacists towards adverse drug reaction reporting: A pilot study 
Background:
Pharmacovigilance is a useful to assure the safety of medicines and protect consumers from their harmful effects. Healthcare professionals should consider Adverse Drug Reaction (ADR) reporting as part of their professional obligation and participate in the existent pharmacovigilance programs in their countries. In India, the National PV Program was re-launched in July 2010.
Objectives:
This survey was conducted in order to assess the knowledge, attitude and practice of Indian pharmacists with the aim of exploring the pharmacists’ participation in ADR reporting system, identifying the reasons of under reporting and determining the steps that could be adopted to increase reporting rates.
Materials and Methods:
A cross-sectional survey was carried out among the pharmacists in India using a pretested questionnaire with 33 questions (10 questions on knowledge, 6 on attitude, 7 on practice, 7 on future of ADR reporting in India and 3 on benefits of reporting ADRs.). The study was conducted, over a period of 3 months from May 2012 to July 2012.
Results:
Out of the 600 participants to whom the survey was administered, a total of 400 were filled. The response rate of the survey was 67%. 95% responders were knowledgeable about ADRs. 90% participants had a positive attitude towards making ADRs reporting mandatory for practicing pharmacists. 87.5% participants were interested in participating in the National Pharmacovigilance program, in India. 47.5% respondents had observed ADRs in their practice, and 37% had reported it to the national pharmacovigilance center. 92% pharmacists believed reporting ADRs immensely helped in providing quality care to patients.
Conclusion:
The Indian pharmacists have poor knowledge, attitude, and practice (KAP) towards ADR reporting and pharmacovigilance. Pharmacists with higher qualifications such as the pharmacists with a PharmD have better KAP. With additional training on Pharmacovigilance, the Indian Pharmacists working in different sectors can become part of ADR reporting system.
doi:10.4103/2229-3485.120168
PMCID: PMC3835963  PMID: 24312887
Adverse drug reaction; adverse drug reaction reporting; knowledge; attitude; and practice; national pharmacovigilance program; pharmacists
14.  Adverse drug reactions reported by consumers for nervous system medications in Europe 2007 to 2011 
Background
Reporting of adverse drug reactions (ADRs) has traditionally been the sole province of healthcare professionals. In the European Union, more countries have allowed consumers to report ADRs directly to the regulatory agencies. The aim of this study was to characterize ADRs reported by European consumer for nervous system medications.
Methods
ADRs reported by consumers for nervous system medications (ATC group N) from 2007 to 2011 and located in the European ADR database, EudraVigilance, were analysed. Data were categorized with respect to age and sex, category and seriousness of reported ADRs and medications. The unit of analysis was one ADR.
Results
We located 4766 ADRs reported for nervous system medications, and one half of these were serious including 19 deaths. Less than 5% of ADRs were reported in children. Totally, 58% of ADRs were reported for women, 42% for men. The majority of reported ADRs were of the types “nervous system disorders” (18% of total ADRs) followed by “psychiatric disorders” (18% of total ADRs) and “general disorders” (15% of total ADRs) which also were the system organ classes in which the majority of serious ADRs were found. ADR reports encompassed medicines from the therapeutic groups: antiepileptics (ATC group N03) (36% of total ADRs), parasympathomimetics (ATC group N07) (22% of total ADRs) and antidepressants ATC group N06A (9% of total ADRs). Antiepileptics were the therapeutic group with the highest share of serious ADRs (60%) followed by antidepressants (15%). Many serious ADRs were reported for pregabalin and varenicline.
Conclusions
The majority of ADRs from nervous system mediations reported by consumers that were identified from the EudraVigilance database were serious. The value of consumer reports in pharmacovigilance still remains unclarified.
doi:10.1186/2050-6511-14-30
PMCID: PMC3685574  PMID: 23763896
Adverse drug reactions; Nervous system medications; Pharmacovigilance; Consumers; EudraVigilance
15.  Limitations and obstacles of the spontaneous adverse drugs reactions reporting: Two “challenging” case reports 
Introduction:
Nowadays, based on several epidemiological data, iatrogenic disease is an emerging public health problem, especially in industrialized countries. Adverse drugs reactions (ADRs) are extremely common and, therefore, clinically, socially, and economically worthy of attention. Spontaneous reporting system for suspected ADRs represents the cornerstone of the pharmacovigilance, because it allows rapid detection of potential alarm signals related to drugs use. However, spontaneous reporting system shows several limitations, which are mainly related to under-reporting. In this paper, we describe two particular case reports, which emphasize some reasons of under-reporting and other common criticisms of spontaneous reporting systems.
Materials and Methods:
We performed a computer-aided search of Medline, PubMed, Embase, Cochrane library databases, national and international databases of suspected ADRs reports in order to identify previous published case reports and spontaneous reports about the ADRs reviewed in this paper, and to examine the role of suspected drugs in the pathogenesis of the described adverse reactions.
Results:
First, we reported a case of tizanidine-induced hemorrhagic cystitis. In the second case report, we presented an episode of asthma exacerbation after taking bimatoprost. Through the review of these two cases, we highlighted some common criticisms of spontaneous reporting systems: under-reporting and false causality attribution.
Discussion and Conclusion:
Healthcare workers sometimes do not report ADRs because it is challenging to establish with certainty the causal relationship between drug and adverse reaction; however, according to a key principle of pharmacovigilance, it is always better to report even a suspicion to generate an alarm in the interest of protecting public health.
doi:10.4103/0976-500X.120955
PMCID: PMC3853673  PMID: 24347986
Asthma exacerbation; bimatoprost; cystitis; tizanidine; under-reporting
16.  Understanding the role of scientific evidence in consumer evaluation of natural health products for osteoarthritis an application of the means end chain approach 
Background
Over 30% of individuals use natural health products (NHPs) for osteoarthritis-related pain. The Deficit Model for the Public Understanding of Science suggests that if individuals are given more information (especially about scientific evidence) they will make better health-related decisions. In contrast, the Contextual Model argues that scientific evidence is one of many factors that explain how consumers make health-related decisions. The primary objective was to investigate how the level of scientific evidence supporting the efficacy of NHPs impacts consumer decision-making in the self-selection of NHPs by individuals with osteoarthritis.
Methods
The means-end chain approach to product evaluation was used to compare laddering interviews with two groups of community-dwelling Canadian seniors who had used NHPs to treat their osteoarthritis. Group 1 (n=13) had used only NHPs (glucosamine and/or chondroitin) with “high” scientific evidence of efficacy. Group 2 (n=12) had used NHPs (methylsulfonylmethane (MSM) and/or bromelain) with little or no scientific evidence supporting efficacy. Content analysis and generation of hierarchical value maps facilitated the identification of similarities and differences between the two groups.
Results
The dominant decision-making chains for participants in the two scientific evidence categories were similar. Scientific evidence was an important decision-making factor but not as important as the advice from health care providers, friends and family. Most participants learned about scientific evidence via indirect sources from health care providers and the media.
Conclusions
The Contextual Model of the public understanding of science helps to explain why our participants believed scientific evidence is not the most important factor in their decision to use NHPs to help manage their osteoarthritis.
doi:10.1186/1472-6882-12-198
PMCID: PMC3517436  PMID: 23107559
Natural health products; Decision-making; Means ends chain analysis; Osteoarthritis
17.  Attitudes among healthcare professionals to the reporting of adverse drug reactions in Nepal 
Background
Healthcare professional’s knowledge and attitudes to adverse drug reaction (ADR) and ADR reporting play vital role to report any cases of ADR. Positive attitudes may favour ADR reporting by healthcare professionals. This study was aimed to investigate the attitudes towards and ways to improve adverse drug reaction (ADR) reporting among healthcare professionals working at four Regional Pharmacovigilance Centres (RPCs) of Nepal.
Methods
A cross sectional study was done by survey using a self-administered structured questionnaire. The questionnaire was distributed to 450 healthcare professionals working at four RPCs.
Results
The overall response rate was 74.0%. There were 74.8% of healthcare professionals who had seen patient experiencing an ADR; however, only 20.1% had reported. Reporting form not available (48.1%) and other colleagues not reporting ADR cases (46.9%) would significantly discourage the ADR reporting among healthcare professionals working at four RPCs. Healthcare professionals perceived that seriousness of the reaction (75.6%); unusual reaction (64.6%); reaction to new product (71.2%); new reaction to existing product (70.2%); and confidence in diagnosis of ADR (60.8%) were important factors on the decision to report ADR. Awareness among healthcare professionals (85.9%), training (76.0%), collaboration (67.0%), and involve pharmacist for ADR reporting (63.1%) were mostly recognized ways to improve reporting. Regular newsletter on current awareness in drug safety (71.2%), information on new ADR (65.8%), and international drug safety information (64.0%) were the identified feedbacks they would like to receive from the Nepal pharmacovigilance programme.
Conclusion
Healthcare professionals working at four RPCs of Nepal have positive attitudes towards ADR reporting. Awareness among healthcare professionals, training and collaboration would likely improve reporting provided they would receive appropriate feedback from the national pharamcovigilance programme.
doi:10.1186/2050-6511-14-16
PMCID: PMC3599543  PMID: 23497690
Adverse drug reaction; Attitudes; Healthcare professional; Nepal
18.  Rabies in Nonhuman Primates and Potential for Transmission to Humans: A Literature Review and Examination of Selected French National Data 
Background
The nonhuman primate (NHP)-related injuries in rabies-enzootic countries is a public health problem of increasing importance. The aims of this work are to collect data concerning rabies transmission from NHPs to humans; to collate medical practices regarding rabies postexposure prophylaxis (PEP) in different countries, and to provide an evidence base to support the decision to apply rabies PEP in this context.
Methodology
To retrieve information, we conducted a literature search from 1960 to January 2013. All reports of rabies in NHPs and rabies transmission to humans by infected NHPs were included. Also included were studies of travelers seeking care for rabies PEP in various settings.
Data collected by the French National Reference Centre for Rabies concerning NHPs submitted for rabies diagnosis in France and human rabies exposure to NHPs in travelers returning to France were analyzed for the periods 1999–2012 and 1994–2011, respectively.
Principal findings
A total of 159 reports of rabies in NHPs have been retrieved from various sources in South America, Africa, and Asia, including 13 cases in animals imported to Europe and the US. 134 were laboratory confirmed cases. 25 cases of human rabies following NHP-related injuries were reported, including 20 from Brazil. Among more than 2000 international travelers from various settings, the proportion of injuries related to NHP exposures was about 31%. NHPs rank second, following dogs in most studies and first in studies conducted in travelers returning from Southeast Asia. In France, 15.6% of 1606 travelers seeking PEP for exposure to any animal were injured by monkeys.
Conclusions/significance
Although less frequently reported in published literature than human rabies, confirmed rabies cases in NHPs occur. The occurrence of documented transmission of rabies from NHPs to human suggests that rabies PEP is indicated in patients injured by NHPs in rabies-enzootic countries.
Author Summary
No international consensus or even a consensus among existing national recommendations about rabies postexposure prophylaxis (PEP) following a nonhuman primate (NHP)-related injury currently exists. Epidemiologic studies and reports collated in this review indicate that the number of rabies case reported in NHPs are rare compared with humans. This finding might be because of a lower contact rate of NHPs with rabid reservoir but also very likely because of underreporting. Nevertheless, documented cases and subsequent transmission to humans have been reported from various sources in South America, Africa, and Asia. Further, international travelers often report NHP-related injuries and NHPs can be close to humans. Little is currently known of the pathobiology of rabies virus shedding in primates, which implies that rabies PEP and administration of rabies immunoglobulin should be considered in patients with a possible exposure.
doi:10.1371/journal.pntd.0002863
PMCID: PMC4022521  PMID: 24831694
19.  Cost Effectiveness of Natural Health Products: A Systematic Review of Randomized Clinical Trials 
Health care spending in North America is consuming an ever-increasing share of Gross Domestic Product (GDP). A large proportion of alternative health care is consumed in the form of natural health products (NHPs). The question of whether or not NHPs may provide a cost-effective choice in the treatment of disease is important for patients, physicians and policy makers. The objective of this study was to conduct a systematic review of the literature in order to find, appraise and summarize high-quality studies that explore the cost effectiveness of NHPs as compared to conventional medicine. The following databases were searched independently in duplicate from inception to January 1, 2006: EMBASE, MEDLINE, CINAHL, BioethicsLine, Wilson General Science abstracts, EconLit, Cochrane Library, ABI/Inform and SciSearch. To be included in the review, trials had to be randomized, assessed for some measure of cost effectiveness and include the use of NHPs as defined by the Natural Health Products Directorate. Studies dealing with diseases due to malnutrition were excluded from appraisal. The pooled searches unveiled nine articles that fit the inclusion/exclusion criteria. The conditions assessed by the studies included three on postoperative complications, two on cardiovascular disease, two on gastrointestinal disorders, one on critically ill patients and one on urinary tract infections. Heterogeneity between the studies was too great to allow for meta-analysis of the results. The use of NHPs shows evidence of cost effectiveness in relation to postoperative surgery but not with respect to the other conditions assessed. In conclusion, NHPs may be of use in preventing complications associated with surgery. The cost effectiveness of some NHPs is encouraging in certain areas but needs confirmation from further research.
doi:10.1093/ecam/nem167
PMCID: PMC2722206  PMID: 18955290
CAM; complementary and alternative medicine; cost effectiveness; natural health products; NHPs
20.  Implementation and evaluation of adverse drug reaction monitoring system in a tertiary care teaching hospital in Mumbai, India 
Interdisciplinary Toxicology  2013;6(1):41-46.
Adverse drug reactions (ADR) are a significant cause of morbidity and mortality, often identified only post-marketingly. Improvement in current ADR reporting, including utility of underused or innovative methods, is crucial to improve patient safety and public health. Hospital-based monitoring is one of the methods used to collect data about drug prescriptions and adverse events. The aims of this study were to identify the most frequent ADRs recognized by the attending physicians, study their nature, and to target these ADRs in order to take future preventive measures. A prospective study was conducted over a 7-month period in an internal medicine department using stimulated spontaneous reporting for identifying ADRs. Out of the 254 admissions, 32 ADRs in 37 patients (14.56%) were validated from the total of 36 suspected ADRs in 41 patients. Female predominance was noted over males in case of ADRs. Fifty percent of total ADRs occurred due to multiple drug therapy. Dermatological ADRs were found to be the most frequent (68.75%), followed by respiratory, central nervous system and gastrointestinal ADRs. The drugs most frequently involved were antibiotics, anti-tubercular agents, antigout agents, and NSAIDs. The most commonly reported reactions were itching and rashes. Out of the 32 reported ADRs, 50% of the reactions were probable, 46.87% of the reactions were possible and 3.12% of the reactions were definite. The severity assessment done by using the Hartwig and Seigel scale indicated that the majority of ADRs were ‘Mild’ followed by ‘Moderate’ and ‘Severe’ reactions, respectively. Out of all, 75% of ADRs were recovered. The most potent management of ADRs was found to be drug withdrawal. Our study indicated that hospital based monitoring was a good method to detect links between drug exposure and adverse drug reactions. Adequate training regarding pharmacology and optimization of drug therapy might be helpful to reduce ADR morbidity and mortality.
doi:10.2478/intox-2013-0008
PMCID: PMC3795320  PMID: 24170978
adverse drug reaction; hospital based monitoring; pharmacovigilance; questionnaire survey
21.  Adverse drug events resulting from use of drugs with sulphonamide-containing anti-malarials and artemisinin-based ingredients: findings on incidence and household costs from three districts with routine demographic surveillance systems in rural Tanzania 
Malaria Journal  2013;12:236.
Background
Anti-malarial regimens containing sulphonamide or artemisinin ingredients are widely used in malaria-endemic countries. However, evidence of the incidence of adverse drug reactions (ADR) to these drugs is limited, especially in Africa, and there is a complete absence of information on the economic burden such ADR place on patients. This study aimed to document ADR incidence and associated household costs in three high malaria transmission districts in rural Tanzania covered by demographic surveillance systems.
Methods
Active and passive surveillance methods were used to identify ADR from sulphadoxine-pyrimethamine (SP) and artemisinin (AS) use. ADR were identified by trained clinicians at health facilities (passive surveillance) and through cross-sectional household surveys (active surveillance). Potential cases were followed up at home, where a complete history and physical examination was undertaken, and household cost data collected. Patients were classified as having ‘possible’ or ‘probable’ ADR by a physician.
Results
A total of 95 suspected ADR were identified during a two-year period, of which 79 were traced, and 67 reported use of SP and/or AS prior to ADR onset. Thirty-four cases were classified as ‘probable’ and 33 as ‘possible’ ADRs. Most (53) cases were associated with SP monotherapy, 13 with the AS/SP combination (available in one of the two areas only), and one with AS monotherapy. Annual ADR incidence per 100,000 exposures was estimated based on ‘probable’ ADR only at 5.6 for AS/SP in combination, and 25.0 and 11.6 for SP monotherapy. Median ADR treatment costs per episode ranged from US$2.23 for those making a single provider visit to US$146.93 for patients with four visits. Seventy-three per cent of patients used out-of-pocket funds or sold part of their farm harvests to pay for treatment, and 19% borrowed money.
Conclusion
Both passive and active surveillance methods proved feasible methods for anti-malarial ADR surveillance, with active surveillance being an important complement to facility-based surveillance, given the widespread practice of self-medication. Household costs associated with ADR treatment were high and potentially catastrophic. Efforts should be made to both improve pharmacovigilance across Africa and to identify strategies to reduce the economic burden endured by households suffering from ADR.
doi:10.1186/1475-2875-12-236
PMCID: PMC3710484  PMID: 23844934
Anti-malarial; Adverse drug reactions; Household costs; ACT; Sulphonamide; Tanzania
22.  The role of natural health products (NHPs) in dietetic practice: results from a survey of Canadian dietitians 
Background
Registered dietitians (RDs) play a key role in disseminating information about nutrition and intervening in nutrition-related disorders in the Canadian context. Natural health products (NHPs) are increasingly associated with nutrition in patient and health professional discussions. For this study, NHPs were divided into three categories: nutritional supplements (NS); functional foods/nutraceuticals (FF/N); and herbal preparations (HP). The objective was to explore RDs’ perceptions about their professional roles and responsibilities with respect to three categories of natural health products (NHPs).
Methods
This research consisted of an on-line survey of registered dietitians (RDs) in Ontario.
Surveys were distributed electronically to all practicing RDs in Ontario by the College of Dietitians of Ontario. There were 558 survey respondents, a response rate of 20%.
Results
The vast majority of RDs reported being consulted by clients about all product categories (98% for NS; 94% for FF/N; 91% for HP), with RDs receiving the most frequent questions about NS and the least frequent about HP. 74% of RDs believed that NS are included within the current scope of practice, compared to 59% for FF/N and 14% for HP. Even higher numbers believed that these products should be included: 97% for NS, 91% for FF/N and 47% for HP. RDs who report personally ingesting FF/N and HP were significantly more likely to report that these products should be in the dietetic scope of practice. In contrast, RDs who provide one-on-one counselling services or group-level counselling/workshops were significantly less likely to believe HP should be in the dietetic scope of practice.
Conclusions
Opinions of RDs indicated that NS and FF/N (and possibly HP) fall within, or should fall within, RDs’ scope of practice. Opportunity exists for RDs to undertake a professional role with respect to NHPs. Policy clarification regarding RD roles is needed.
doi:10.1186/1472-6882-13-156
PMCID: PMC3703453  PMID: 23819488
Dietitians; Professional roles and responsibilities; Natural health products; Dietary supplements; Nutritional supplements; Functional foods; Nutraceuticals; Herbal preparations
23.  Cost evaluation of adverse drug reactions in hospitalized patients in Taiwan: A prospective, descriptive, observational study 
Background: Adverse drug reactions (AADRs) are a leading cause of morbidity and mortality. In the United States, ADR-related morbidity and mortality costs have been estimated at US $330 billion to US $1130 billion annually.
Objectives: The aim of this study was to evaluate the incidence of ADRs in Taiwan, to identify the drug classes that are most commonly related to ADRs, and to determine the direct medical costs to hospitals associated with prolonged hospitalizations due to ADRs.
Methods: In this prospective, descriptive, observational study, patients who experienced ADRs during their hospitalization at a Taiwan teaching hospital or who were admitted due to an ADR from January 1, 2002, through December 31, 2004, were included in the study. The patients were identified actively by clinical pharmacists and passively by physicians and nurses who reported ADRs. The World Health Organization (WWHO) definition of ADR severity was adopted, and degrees of probability for each ADR were determined using the Naranjo algorithm. The direct medical costs incurred to the hospital in the treatment of ADRs that prolonged hospitalization were calculated (ie, costs of emergency department [ED] visits, intensive care unit visits, extra days of hospitalization, monitoring and laboratory studies, pharmacist dispensing fees, physician fees, room charges, ED charges).
Results: During the study period, 43 of the 142,295 hospitalized patients (00.03%)) were admitted because of an ADR. A total of 564 (00.40%)) of the hospitalized patients were verified to have ADRs. Three hundred eighteen of the patients (56.44%) with ADRs were male and the overall mean (SD) age was 66(2) years. The most common drug classes associated with the ADRs were antibiotics (219 patients [38.8% ]), analgesics (62 [11.0%]), and cardiovascular agents (56 [9.9%]). The systems most commonly involved in ADRs were cutaneous (296 patients [52.5%]), hematologic (61 [10.8%]), and cardiovascular (54 [9.66%]). The causes of the ADRs were anaphylactic (464 patients [82.3%]), drug overdose (78 [13.8%]), and drug-drug interactions (22 [3.9%]). Of the ADRs, 474 (884.0%) were idiosyncratic type B reactions (predictable). ADR-related costs, estimated at US $3489/ADR, were mostly due to prolonged length of stay. Based on the WHO definition, of the 564 ADRs, 330 (58.5%) and 40 (7.1%) were classified as moderate and severe, respectively. Two patients died of ADRs associated with allopurinol.
Conclusion: In this hospital, 0.40% of patients were identified as having ADRs that were associated with high direct costs, mostly due to extended hospitalizations.
doi:10.1016/j.curtheres.2008.04.005
PMCID: PMC3969903  PMID: 24692791
direct medical cost; adverse drug reactions
24.  Joint medicine-information and pharmacovigilance services could improve detection and communication about drug-safety problems 
Background
RELIS is a Norwegian network of four regional medicine-information and pharmacovigilance centers where pharmacists and clinical pharmacologists provide feedback to health care professionals in spontaneous drug-related questions and adverse drug-reaction (ADR) reports published in a question–answer pair (QAP) database (the RELIS database) and the Norwegian ADR database, respectively.
Objective
To describe the potential of RELIS’s dual service to improve detection and communication of drug-safety problems.
Materials and methods
We searched the RELIS database for QAPs about ADRs with use of the Norwegian ADR database as a reference. We also searched the Norwegian ADR database for reports that used the RELIS database as a reference. Both searches were limited to the years 2003–2012. We then selected the example of pregabalin and drug abuse after the marketing of Lyrica in Norway in September 2004 to illustrate RELIS’s potential to detect new drug-safety information through a limited number of QAPs and ADR reports.
Results
A total of 5,427 (26%) of 21,071 QAPs in the RELIS database concerned ADRs. QAPs from this database were used as references in 791 (4%) of a total of 22,090 reports in the Norwegian ADR database. The Norwegian ADR database was used as a reference in 363 (7%) of 5,427 QAPs that concerned ADRs. Between September 2004 and September 2008, RELIS received eleven questions and 13 ADR reports about suspicion of Lyrica (pregabalin) and different aspects of abuse.
Conclusion
RELIS processes data through two databases that facilitate communication about ADRs. Our service also has the potential to detect new drug-safety problems with a limited number of questions and ADR reports.
doi:10.2147/DHPS.S63680
PMCID: PMC4085319  PMID: 25061339
pharmacovigilance; drug safety; database; pregabalin
25.  Consequences, measurement, and evaluation of the costs associated with adverse drug reactions among hospitalized patients in China 
Background
Adverse drug reactions (ADRs) are a leading cause of morbidity in developed countries and represent a substantial burden on health-care resources. Many countries spent 15% to 20% of their hospital budgets to treat drug complications. However, few studies have measured the pharmacoeconomic effects of ADRs on hospitalized patients in China. The study estimates the costs of ADRs as identified from the spontaneous voluntary reports completed from healthcare professionals. To do so, we calculate these costs, determine the sum of Medicare payments and their proportion of total healthcare spending, and evaluate the incidence of ADRs, characteristics of hospitalized ADR patients, and outcomes of ADRs in China.
Methods
This retrospective survey studied patients who experienced ADRs during their hospitalization at a Chinese tertiary-care teaching hospital. The patients were divided into group A and group B according to general ADRs and serious ADRs in Provisions for Adverse Drug Reaction Monitoring and Reporting. The direct costs included treatment fees, inspection fees, laboratory fees, materials fees, bed charges, drug charges, nursing care, meals, and other expenses and the sunk-cost losses were calculated according to the hospital information system (HIS). Indirect costs of ADR treatment were calculated according to the human capital approach. The epidemiological characteristics of ADRs were evaluated.
Results
2739 were diagnosed with ADR during the study period, which translates to an ADR rate of 0.81%. The total socioeconomic loss from 2739 cases of ADR was estimated at ¥817401.69, consisting of direct costs of ¥603252.81 and indirect costs of ¥214148.88. On average, the costs per patient amounted to ¥196.10 in group A, ¥7032.29 in group B. The sum of medicare payment and proportion were ¥219061.13 (65.23%) and ¥105422.02 (39.42%) in group A and B. The ADR incidence in old-age patients was significantly higher than in other age groups (P < 0.0001). The most common drug class associated with ADRs represented antibiotics (957 patients, 34.94%).
Conclusions
The costs of especially severe ADRs could not be ignored, and in this hospital 0.13% of patients were diagnosed with ADRs associated with relatively higher direct costs than who suffered from mild ADRs, largely due to extended hospitalization.
doi:10.1186/1472-6963-14-73
PMCID: PMC3931293  PMID: 24533894
Adverse drug reaction; Direct medical cost; Hospitalized patients; Tertiary care teaching hospital; Pharmacoeconomic

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