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1.  Economic Impact of Adverse Drug Events – A Retrospective Population-Based Cohort Study of 4970 Adults 
PLoS ONE  2014;9(3):e92061.
Background
The aim was to estimate the direct costs caused by ADEs, including costs for dispensed drugs, primary care, other outpatient care, and inpatient care, and to relate the direct costs caused by ADEs to the societal COI (direct and indirect costs), for patients with ADEs and for the entire study population.
Methods
We conducted a population-based observational retrospective cohort study of ADEs identified from medical records. From a random sample of 5025 adults in a Swedish county council, 4970 were included in the analyses. During a three-month study period in 2008, direct and indirect costs were estimated from resource use identified in the medical records and from register data on costs for resource use.
Results
Among 596 patients with ADEs, the average direct costs per patient caused by ADEs were USD 444.9 [95% CI: 264.4 to 625.3], corresponding to USD 21 million per 100 000 adult inhabitants per year. Inpatient care accounted for 53.9% of all direct costs caused by ADEs. For patients with ADEs, the average societal cost of illness was USD 6235.0 [5442.8 to 7027.2], of which direct costs were USD 2830.1 [2260.7 to 3399.4] (45%), and indirect costs USD 3404.9 [2899.3 to 3910.4] (55%). The societal cost of illness was higher for patients with ADEs compared to other patients. ADEs caused 9.5% of all direct healthcare costs in the study population.
Conclusions
Healthcare costs for patients with ADEs are substantial across different settings; in primary care, other outpatient care and inpatient care. Hence the economic impact of ADEs will be underestimated in studies focusing on inpatient ADEs alone. Moreover, the high proportion of indirect costs in the societal COI for patients with ADEs suggests that the observed costs caused by ADEs would be even higher if including indirect costs. Additional studies are needed to identify interventions to prevent and manage ADEs.
doi:10.1371/journal.pone.0092061
PMCID: PMC3956863  PMID: 24637879
2.  Cost of illness of patient-reported adverse drug events: a population-based cross-sectional survey 
BMJ Open  2013;3(6):e002574.
Objectives
To estimate the cost of illness (COI) of individuals with self-reported adverse drug events (ADEs) from a societal perspective and to compare these estimates with the COI for individuals without ADE. Furthermore, to estimate the direct costs resulting from two ADE categories, adverse drug reactions (ADRs) and subtherapeutic effects of medication therapy (STE).
Design
Cross-sectional study.
Setting
The adult Swedish general population.
Participants
The survey was distributed to a random sample of 14 000 Swedish residents aged 18 years and older, of which 7099 responded, 1377 reported at least one ADE and 943 reported an ADR or STE.
Main outcome measures
Societal COI, including direct and indirect costs, for individuals with at least one self-reported ADE, and the direct costs for prescription drugs and healthcare use resulting from self-reported ADRs and STEs were estimated during 30 days using a bottom-up approach.
Results
The economic burden for individuals with ADEs were (95% CI) 442.7 to 599.8 international dollars (Int$), of which direct costs were Int$ 279.6 to 420.0 (67.1%) and indirect costs were Int$ 143.0 to 199.8 (32.9%). The average COI was higher among those reporting ADEs compared with other respondents (COI: Int$ 442.7 to 599.8 versus Int$ 185.8 to 231.2). The COI of respondents reporting at least one ADR or STE was Int$ 468.9 to 652.9. Direct costs resulting from ADRs or STEs were Int$ 15.0 to 48.4. The reported resource use occurred both in hospitals and outside in primary care.
Conclusions
Self-reported ADRs and STEs cause resource use both in hospitals and in primary care. Moreover, ADEs seem to be associated with high overall COI from a societal perspective when comparing respondents with and without ADEs. There is a need to further examine this relationship and to study the indirect costs resulting from ADEs.
doi:10.1136/bmjopen-2013-002574
PMCID: PMC3686161  PMID: 23794552
Epidemiology; Health Economics; Public Health
3.  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
4.  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
5.  Socioeconomic determinants of psychotropic drug utilisation among elderly: a national population-based cross-sectional study 
BMC Public Health  2010;10:118.
Background
Psychotropic drugs are commonly utilised among the elderly. This study aimed to analyse whether two socioeconomic determinants - income and marital status - are associated with differences in utilisation of psychotropic drugs and potentially inappropriate psychotropic drugs among elderly in Sweden.
Methods
All individuals aged 75 years and older who had purchased a psychotropic drug in Sweden during 2006 were included (68.7% women, n = 384712). Data was collected from national individual-based registers. Outcome measures were utilisation of three or more psychotropic drugs and utilisation of potentially inappropriate psychotropic drugs, as classified by the Swedish National Board of Health and Welfare.
Results
Individuals with low income were more likely to utilise three or more psychotropic drugs compared to those with high income; adjusted odds ratio (aOR) 1.12 (95% confidence interval [CI] 1.10-1.14). The non-married had a higher probability for utilising three or more psychotropic drugs compared to the married (aOR 1.22; CI 1.20-1.25). The highest probability was observed among the divorced and the never married. Potentially inappropriate psychotropic drugs were more common among individuals with low compared to high income (aOR 1.14; CI 1.13-1.16). Compared to the married, potentially inappropriate psychotropic drug utilisation occurred more commonly among the non-married (aOR 1.08; CI 1.06-1.10). The never married and the divorced had the highest probability.
Conclusions
There was an association between socioeconomic determinants and psychotropic drug utilisation. The probability for utilising potentially inappropriate psychotropics was higher among individuals with low income and among the non-married.
doi:10.1186/1471-2458-10-118
PMCID: PMC2845562  PMID: 20214796
6.  Are sedatives and hypnotics associated with increased suicide risk of suicide in the elderly? 
BMC Geriatrics  2009;9:20.
Background
While antidepressant-induced suicidality is a concern in younger age groups, there is mounting evidence that these drugs may reduce suicidality in the elderly. Regarding a possible association between other types of psychoactive drugs and suicide, results are inconclusive. Sedatives and hypnotics are widely prescribed to elderly persons with symptoms of depression, anxiety, and sleep disturbance. The aim of this case-control study was to determine whether specific types of psychoactive drugs were associated with suicide risk in late life, after controlling for appropriate indications.
Methods
The study area included the city of Gothenburg and two adjacent counties (total 65+ population 210 703 at the start of the study). A case controlled study of elderly (65+) suicides was performed and close informants for 85 suicide cases (46 men, 39 women mean age 75 years) were interviewed by a psychiatrist. A population based comparison group (n = 153) was created and interviewed face-to-face. Primary care and psychiatric records were reviewed for both suicide cases and comparison subjects. All available information was used to determine past-month mental disorders in accordance with DSM-IV.
Results
Antidepressants, antipsychotics, sedatives and hypnotics were associated with increased suicide risk in the crude analysis. After adjustment for affective and anxiety disorders neither antidepressants in general nor SSRIs showed an association with suicide. Antipsychotics had no association with suicide after adjustment for psychotic disorders. Sedative treatment was associated with an almost fourteen-fold increase of suicide risk in the crude analyses and remained an independent risk factor for suicide even after adjustment for any DSM-IV disorder. Having a current prescription for a hypnotic was associated with a four-fold increase in suicide risk in the adjusted model.
Conclusion
Sedatives and hypnotics were both associated with increased risk for suicide after adjustment for appropriate indications. Given the extremely high prescription rates, a careful evaluation of the suicide risk should always precede prescribing a sedative or hypnotic to an elderly individual.
doi:10.1186/1471-2318-9-20
PMCID: PMC2695460  PMID: 19497093
7.  Prescribing behaviour after the introduction of decentralized drug budgets: Is there an association with employer and type of care facility? 
Objective
To analyse whether prescribing patterns changed after introduction of drug budgets and whether there is an association between drug prescribing patterns and the type of employer and care facility.
Methods
Data analysed encompassed information on dispensed medicines, by workplaces, prescribed in the Region Västra Götaland, Sweden, for the years 2003 and 2006. Workplaces (n = 969) were categorized according to type of employer and type of care facility. Five prescribing indicators reflecting goals for cost-containing prescribing in Region Västra Götaland were assessed. Changes over time and differences between different types of employer and care facility were analysed by Mann–Whitney tests.
Results
In 2003, workplaces with a public employer had a significantly higher adherence to three of the prescribing indicators compared with private practitioners. Two of these differences remained in 2006. In 2003, none of the prescribing indicators differed between primary care and other care facilities. Three years later workplaces in primary care had a significantly higher adherence to three of the prescribing indicators than other care facilities. There was a statistically significant difference in change between 2003 and 2006 between primary care and other care facilities; there were no differences in change between workplaces with public and private employers.
Conclusions
Adherence to three of the prescribing indicators increased after the introduction of decentralized drug budgets. Workplaces with a public employer showed greater adherence to two of the prescribing indicators than private sector workplaces.
doi:10.1080/02813430902793225
PMCID: PMC3410459  PMID: 19291589
Cost containment; drug budget; physicians; prescribing patterns; Sweden
8.  Influence of mandatory generic substitution on pharmaceutical sales patterns: a national study over five years 
Background
Mandatory generic substitution was introduced in Sweden in October 2002 in order to try to curb escalating pharmaceutical expenditure. The aim of this study was to investigate how sales patterns for substitutable and non-substitutable pharmaceuticals have developed since the introduction of mandatory generic substitution; furthermore, to compare sales patterns in different groups of the population, based on patients' age and gender.
Methods
Five therapeutic groups comprising both substitutable and non-substitutable pharmaceuticals were included. The study period was from January 2000 to June 2005. National sales data were used, covering volumes of dispensed prescription medicines (expressed in defined daily doses per 1000 inhabitants and day) of each pharmacological substance in the therapeutic groups for each age and gender group. Sales patterns for substitutable and non-substitutable pharmaceuticals were compared using a descriptive approach.
Results
In most therapeutic groups there has been an increase in the volumes of substitutable pharmaceuticals sold since the introduction of the reform, ranging from one third to three times the initial volume; whereas the volumes of non-substitutable pharmaceuticals have levelled out or declined. There were few gender differences in sales patterns of substitutable and non-substitutable drugs. In three therapeutic groups, sales patterns differed across different age groups, and there was a tendency for volumes of recently introduced non-substitutable pharmaceuticals to be proportionally higher in the youngest age groups.
Conclusion
Since the introduction of the reform, there has been a proportionally larger increase in sales of substitutable pharmaceuticals compared with sales of non-substitutable pharmaceuticals. This indicates that the reform might have contributed to larger sales of less expensive pharmaceuticals.
doi:10.1186/1472-6963-8-50
PMCID: PMC2276486  PMID: 18312635
9.  Can selective serotonin inhibitor drugs in elderly patients in nursing homes be reduced? 
Objective
To investigate whether treatment with selective serotonin reuptake inhibitors (SSRIs) could be withdrawn for elderly residents who had been on treatment for at least one year and to evaluate a method for systematic drug review.
Design
Open, prospective, interventional study.
Setting
Four counties in Sweden.
Subjects
Elderly residents at 19 nursing homes, with ongoing treatment with SSRIs for more than one year.
Main outcome measures
Clinical evaluation, registration of drugs used and rating with Montgomery–Åsberg Depression Rating Scale (MADRS). A semi-structured telephone interview with 15 participating physicians and 19 nurses.
Results
About one-third of all 822 residents in the nursing homes had ongoing antidepressant treatment, predominantly with SSRIs; 75% of them had been treated with SSRIs for at least one year and 119 (60%) of these were considered eligible for the study. The intervention was judged successful in 52% of these residents of whom 88% had a MADRS rating of less than 20 points. The GPs and the nurses experienced the method as practicable.
Conclusions
Withdrawal of SSRI treatment was successful in the majority of cases. The MADRS may be a valuable addition to clinical evaluation when deciding whether to end or continue SSRI treatment.
doi:10.1080/02813430600958427
PMCID: PMC3389450  PMID: 17354152
Family practice; nursing homes; SSRI drugs; systematic drug review; withdrawal
10.  Evaluation of the quality of drug therapy among elderly patients in nursing homes 
Objective
To evaluate drug therapy quality among elderly nursing home residents. Secondary aims were to compare quality in young and old elderly and to determine whether number of prescribers affected quality of drug therapy.
Design
A cross-sectional population-based register study.
Setting
Nursing home residents in the Gothenburg area using the multi-dose system (e.g. patients who get their drugs machine dispensed into one unit for each dose occasion, a service offered by the National Corporation of Pharmacies).
Subjects
All nursing home residents aged 65 years and older.
Main outcome measures
The quality of drug therapy assessed using five quality indicators for the elderly recently introduced by the Swedish National Board of Health and Welfare; number of prescribed drugs per resident.
Results
Over 70% of residents had one or more potentially inappropriate prescription. Younger nursing home residents (65–79 years) had significantly (p < 0.001) lower quality of drug therapy than older residents (80 + ). The average number of prescribing physicians per resident was high at almost four per resident. An increasing number of prescribers per resident was associated with a higher number of drugs prescribed and a lower quality of drug therapy.
Conclusion
Computerized quality assurance systems can provide support for healthcare providers. Quality indicators should be modified to give maximum support for users.
doi:10.1080/02813430600991980
PMCID: PMC3389457  PMID: 17354153
Drugs; elderly; family practice; nursing home; prescribing; quality indicators

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