Prevalence of drug-herb and drug-supplement interactions in older adults: a cross-sectional survey.

BACKGROUND: Polypharmacy is common among older adults, with increasing numbers also using prescription drugs with herbal medicinal products (HMPs) and dietary supplements. There is no reliable evidence from the UK on concurrent use of HMPs and dietary supplements with prescription drugs in older adults. AIM: To establish prevalence of concurrent prescription drugs, HMPs, and dietary supplements among UK community-dwelling older adults and identify potential interactions. DESIGN AND SETTING: Cross-sectional survey of older adults registered at two general practices in South East England. METHOD: A questionnaire asking about prescription medications, HMPs, and sociodemographic information was posted to 400 older adults aged ≥65 years, identified as taking ≥1 prescription drug. RESULTS: In total 155 questionnaires were returned (response rate = 38.8%) and the prevalence of concurrent HMPs and dietary supplements with prescriptions was 33.6%. Females were more likely than males to be concurrent users (43.4% versus 22.5%; P = 0.009). The number of HMPs and dietary supplements ranged from 1 to 8, (mean = 3, median = 1; standard deviation = 1.65). The majority of concurrent users (78.0%) used dietary supplements with prescription drugs. The most commonly used dietary supplements were cod liver oil, glucosamine, multivitamins, and vitamin D. Others (20.0%) used only HMPs with prescription drugs. Common HMPs were evening primrose oil, valerian, and Nytol Herbal® (a combination of hops, gentian, and passion flower). Sixteen participants (32.6%) were at risk of potential adverse drug interactions. CONCLUSION: GPs should routinely ask questions regarding herbal and supplement use, to identify and manage older adults at potential risk of adverse drug interactions.

Concurrent Use of Prescription Drugs and Herbal Medicinal Products in Older Adults: A Systematic Review.

BACKGROUND: The use of herbal medicinal products (HMPs) is common among older adults; however, little is known about concurrent use with prescription drugs, as well as potential interactions associated with such combinations. OBJECTIVE: The aim of this systematic review was to identify and evaluate the literature on concurrent prescription and HMP use among older adults to assess prevalence, patterns, potential interactions and factors associated with this use. METHODS: Systematic searches were conducted in the MEDLINE, PsycINFO, EMBASE, CINAHL, AMED, Web of Science and Cochrane databases from inception to May 2017 for studies reporting concurrent use of prescription medicines with HMPs in adults ≥ 65 years of age. Quality was assessed using the Joanna Briggs Institute checklists. And the Evidence for Policy and Practice Information and Co-ordinating Centre (EPPI-Centre) three-stage approach to mixed method research was used to synthesise data. RESULTS: Twenty-two studies were included. A definition of HMPs or what was considered an HMP was frequently missing. Prevalence of concurrent use by older adults varied widely between 5.3 and 88.3%. Prescription medicines most combined with HMPs were antihypertensive drugs, ß-blockers, diuretics, antihyperlipidemic agents, anticoagulants, analgesics, antihistamines, antidiabetics, antidepressants and statins. The HMPs most frequently used were Ginkgo biloba, garlic, ginseng, St John's wort, Echinacea, saw palmetto, evening primrose oil and ginger. Potential risks of bleeding due to the use of Ginkgo biloba, garlic or ginseng with aspirin or warfarin was the most reported herb-drug interaction. Some data suggest being female, and having a lower household income and less than a high-school education were associated with concurrent use. CONCLUSION: The prevalence of concurrent prescription drugs and HMP use among older adults is substantial and potential interactions have been reported. Knowledge of the extent and manner in which older adults combine prescription drugs will aid healthcare professionals in appropriately identifying and managing patients at risk. Systematic Review Registration Number: PROSPERO 2014:CRD42014009091.

A literature-based economic evaluation of healthcare preventable adverse events in Europe.

PURPOSE: To establish from the literature, cost of preventable adverse events (PAEs) to member states of the Joint Action European Union Network for Patient Safety and Quality of Care. DATA SOURCES: We searched MEDLINE, EMBASE and CINAHL for studies in Europe estimating cost of adverse events (AEs) and PAEs (2000-March 2016). Using data from the literature, we estimated PAE costs based on national 2013 total health expenditure (THE) data reported by World Health Organization and converted to 2015 Euros. STUDY SELECTION/DATA EXTRACTION: Information on type, frequency and incremental cost per episode or estimated cost of AEs was extracted. Total annual disability-adjusted life years (DALYs) resulting from PAEs in 30 EU nations were calculated using an estimate from a published study and adjusted for the percentage of AEs considered preventable. RESULT OF DATA SYNTHESIS: Published estimates of costs of AEs and PAEs vary based on the care setting, methodology, population and year conducted. Only one study was from primary care, the majority were conducted in acute care. Nine studies estimated percentage of THE caused by AEs, 13 studies calculated attributable length of stay. We estimated the annual cost of PAEs to the 30 nations in 2015 to be in the range of 17-38 billion Euros, total DALYs lost from AEs as 3.5 million, of which 1.5 million DALYs were likely due to PAEs. CONCLUSION: The economic burden of AEs and PAEs is substantial. However, whether patient safety interventions will be 'cost saving' depends on the effectiveness and costs of the interventions.

Patient safety incidents from acupuncture treatments: a review of reports to the National Patient Safety Agency.

BACKGROUND: Acupuncture is frequently employed to treat chronic pain syndromes or other chronic conditions. Nevertheless, there is a growing literature on adverse events (AEs) from treatments including pneumothorax, cardiac tamponade and spinal cord injury. Acupuncture is provided in almost all NHS pain clinics and by an increasing number of GP's and physiotherapists. Considering acupuncture's popularity, its safety has become an important public health issue. OBJECTIVES: To evaluate the harm caused to patients through acupuncture treatments within NHS organisations. METHODS: The National Reporting and Learning System (NRLS) database was searched for incidents reported from 1st January 2009 to 31st December 2011. The free text fields of all reports received from all healthcare settings and specialties were searched for the keyword 'acupuncture'. All relevant incidents were reviewed to provide a qualitative theme of the harm to patients. RESULTS: 468 patient safety incidents were identified; 325 met our inclusion criteria for analysis. Adverse events reported include retained needles (31%), dizziness (30%), loss of consciousness/unresponsive (19%), falls (4%), Bruising or soreness at needle site (2%), Pneumothorax (1%) and other adverse reactions (12%). The majority (95%) of the incidents were categorised as low or no harm. CONCLUSIONS: A number of AEs are recorded after acupuncture treatments in the NHS but the majority is not severe. However, miscategorisation and under-reporting may distort the overall picture. Acupuncture practitioners should be aware of, and be prepared to manage, any significant harm from treatments.

Serenoa repens (saw palmetto): a systematic review of adverse events.

Serenoa repens (W. Bartram) Small, also known as saw palmetto, is one of the most widely used herbal preparations for the treatment of lower urinary tract symptoms (LUTS) and benign prostatic hyperplasia (BPH). Although a number of randomized controlled trials (RCTs) and systematic reviews of the efficacy of S. repens for the treatment of LUTS and BPH have been published, no systematic review on its drug interactions or adverse events currently exists. This review assesses all available human safety data of S. repens monopreparations. Systematic literature searches were conducted from date of inception to February 2008 in five electronic databases; reference lists and our departmental files were checked for further relevant publications. Information was requested from spontaneous reporting schemes of the WHO and national safety bodies. Twenty-four manufacturers/distributors of S. repens preparations and four herbalist organizations were contacted for additional information. No language restrictions were imposed. Only reports of adverse events in humans from monopreparations of S. repens were included. Data from all articles, regardless of study design, reporting adverse events or interactions were independently extracted by the first author and validated by the second. Forty articles (26 randomized controlled trials, 4 non-randomized controlled trials, 6 uncontrolled trials and 4 case reports/series) were included. They suggest that adverse events associated with the use of S. repens are mild and similar to those with placebo. The most frequently reported adverse events are abdominal pain, diarrhoea, nausea, fatigue, headache, decreased libido and rhinitis. More serious adverse events such as death and cerebral haemorrhage are reported in isolated case reports and data from spontaneous reporting schemes, but causality is questionable. No drug interactions were reported. Currently available data suggest that S. repens is well tolerated by most users and is not associated with serious adverse events. The majority of adverse events are mild, infrequent and reversible, and include abdominal pain, diarrhoea, nausea and fatigue, headache, decreased libido and rhinitis. We found no evidence for drug interactions with S. repens. However, higher quality reporting of adverse events is essential if safety assessments are to be improved in future.

Pelargonium sidoides for acute bronchitis: a systematic review and meta-analysis.

OBJECTIVE: To critically assess the efficacy of Pelargonium sidoides for treating acute bronchitis. DATA SOURCES: Systematic literature searches were performed in 5 electronic databases: (Medline (1950 - July 2007), Amed (1985 - July 2007), Embase (1974 - July 2007), CINAHL (1982 - July 2007), and The Cochrane Library (Issue 3, 2007) without language restrictions. Reference lists of retrieved articles were searched, and manufacturers contacted for published and unpublished materials. REVIEW METHODS: Study selection was done according to predefined criteria. All randomized clinical trials (RCTs) testing P. sidoides extracts (mono preparations) against placebo or standard treatment in patients with acute bronchitis and assessing clinically relevant outcomes were included. Two reviewers independently selected studies, extracted and validated relevant data. Methodological quality was evaluated using the Jadad score. Meta-analysis was performed using a fixed-effect model for continuous data, reported as weighted mean difference with 95% confidence intervals. RESULTS: Six RCTs met the inclusion criteria, of which 4 were suitable for statistical pooling. Methodological quality of most trials was good. One study compared an extract of P. sidoides, EPs 7630, against conventional non-antibiotic treatment (acetylcysteine); the other five studies tested EPs 7630 against placebo. All RCTs reported findings suggesting the effectiveness of P. sidoides in treating acute bronchitis. Meta-analysis of the four placebo-controlled RCTs suggested that EPs 7630 significantly reduced bronchitis symptom scores in patients with acute bronchitis by day 7. No serious adverse events were reported. CONCLUSION: There is encouraging evidence from currently available data that P. sidoides is effective compared to placebo for patients with acute bronchitis.

Methods for causality assessment of adverse drug reactions: a systematic review.

Numerous methods for causality assessment of adverse drug reactions (ADRs) have been published. The aim of this review is to provide an overview of these methods and discuss their strengths and weaknesses. We conducted electronic searches in MEDLINE (via PubMed), EMBASE and the Cochrane databases to find all assessment methods. Thirty-four different methods were found, falling into three broad categories: expert judgement/global introspection, algorithms and probabilistic methods (Bayesian approaches). Expert judgements are individual assessments based on previous knowledge and experience in the field using no standardized tool to arrive at conclusions regarding causality. Algorithms are sets of specific questions with associated scores for calculating the likelihood of a cause-effect relationship. Bayesian approaches use specific findings in a case to transform the prior estimate of probability into a posterior estimate of probability of drug causation. The prior probability is calculated from epidemiological information and the posterior probability combines this background information with the evidence in the individual case to come up with an estimate of causation. As a result of problems of reproducibility and validity, no single method is universally accepted. Different causality categories are adopted in each method, and the categories are assessed using different criteria. Because assessment methods are also not entirely devoid of individual judgements, inter-rater reliability can be low. In conclusion, there is still no method universally accepted for causality assessment of ADRs.