General practitioners' role in safeguarding patients with dementia in their use of dietary supplements. A qualitative study.

OBJECTIVE: The use of dietary supplements (DS) may cause harm through direct and indirect effects. Patients with dementia may be particularly vulnerable. This study aims to explore general practitioners' (GPs') experiences with DS use by these patients, the GPs perceived responsibilities, obstacles in taking on this responsibility, their attitudes toward DS, and suggestions for improvements to safeguard the use of DS in this patient group. DESIGN: Qualitative individual interview study conducted February - December 2019. Data were analysed using systematic text condensation. SETTING: Primary healthcare clinics in Norway. SUBJECTS: Fourteen Norwegian GPs. FINDINGS: None of the informants were dismissive of patients using DS. They were aware of the possible direct risks and had observed them in patients. Most GPs showed little awareness of potential indirect risks to patients with dementia who use DS. They acknowledged the need for caretaking of these patients. Although there were differences in practice styles, most of the GPs wished to help their patients safeguarding DS use but found it difficult due to the lack of quality assurance of product information. Furthermore, there were no effective ways for the GPs to document DS use in the patients' records. Several suggestions for improvement were given by the GPs, such as increased attention from GPs, inclusion of DS in the prescription software, and stricter regulatory systems for DS from the authorities. CONCLUSION: The GPs had initially little awareness of this safety risk, but there were differences in practice style and attitudes towards DS. The GPs did not perceive themselves as main responsible for safe use of DS in patient with dementia. The most important reason to disclaim responsibility was lack of information about the products. One suggestion for improvement was better integration of DS in patients' medical record.

Currently, little is known about general practitioners (GPs) caretaking of patients with dementia who use dietary supplements (DS). Our study showed that:The GPs in this study showed little awareness of the potential safety risk that DS use may represent for patients with dementia.Several obstacles in the treatment setting and in the regulation of DS make it difficult for the GPs to assume full responsibility for patients with dementia who use DS.Lack of evidence about DS safety and effect adds to professional uncertainty and may cause frustration or reluctance to address the issue.

Home care service employees' contribution to patient safety in clients with dementia who use dietary supplements: a Norwegian survey.

OBJECTIVE: To explore home care services (HCS) employees' professional experiences with the use of dietary supplements (DSs) in their clients with dementia. We also investigated their attributed professional responsibility concerning this use and their attitudes toward DSs in general. Differences between nurses and nurse assistants were investigated. DESIGN: A cross-sectional survey with self-administered questionnaires. SETTING: Home care services in six Norwegian municipalities in the period August-December 2016. SUBJECTS: A total of 231 (64% response rate) HCS employees; 78 nurses and 153 nurse assistants (auxiliary nurses and employees without formal education).Main outcome measures: Health care employees' experiences with patient safety in clients with dementia who use DSs. RESULTS: Fifty per cent were concerned that clients with dementia might harm their health due to DS use. Thirty-one per cent reported having intervened in order to reduce the risk. Seventy-one per cent preferred to administer DSs to clients with dementia rather than leaving this responsibility to the clients. The respondents placed the responsibility for patient safety in clients with dementia using DSs mainly with the general practitioners, while they ascribed themselves and pharmacies a medium level of responsibility. There were only minor difference between nurses and nurse assistants, and no difference in attitudes towards DSs. CONCLUSION: Employees in HCS were concerned about the DS use in clients with dementia. Moreover, almost one-third had intervened to improve clients' patient safety. The majority indicated that HCS should administer DSs rather than the clients with dementia themselves.KEY POINTSTo our knowledge, this is the first study investigating the role of home care services with regard to patient safety in clients with dementia who use dietary supplements (DSs).•Home care service employees worried about patient safety related to DS use in clients with dementia.•Home care service employees attributed to themselves medium responsibility to ensure the safe use of DSs in these clients.•Lack of knowledge was the most important reason why home care service employees did not recommend DSs to clients.

Pharmacy employees' involvement in safeguarding persons with dementia who use dietary supplements: Results from a survey of Norwegian pharmacies.

BACKGROUND: Community-dwelling persons with dementia commonly use dietary supplements (DS), often without receiving help with the administration. Patient safety is a concern, as DS-drug interactions and adverse events are potential complications. Since many persons with dementia buy their DS in pharmacies, we investigated Norwegian pharmacy employees' attitudes and professional practice behaviors related to DS. METHODS: We conducted a survey in eight Norwegian municipalities of pharmacy employees involved in the sale of DS. The questionnaire covered demographics and investigated attitudes toward DS, professional practice behaviors related to the sale of DS, experiences with customers with dementia, and perceived and attributed responsibilities with regard to patient safety. RESULTS: One hundred and five employees responded (response rate: 52%). Most employees regarded general practitioners (GPs) as primarily responsible for safeguarding the use of DS by persons with dementia and rated themselves less responsible. Thirty-seven percent of the employees reported personal use of DS (past or current use). Nine percent considered some of the DS to have symptomatic or prophylactic effects against dementia. Forty-eight percent confirmed that they informed customers about potential adverse events; 42% indicated that they did this sometimes. Sixteen percent checked regularly for DS-drug interactions, and two-thirds checked depending on the customers' health, the type of drug or the type of DS. One-quarter regularly asked about the co-use of prescription drugs (PD) when selling DS, while only 2% asked about the co-use of DS when dispensing PD. Only 25% reported access to independent scientific information on all or most DS sold in their pharmacy. Eight percent had experienced unsafe use of DS by persons with dementia. Six percent had been taught about counselling persons with dementia. Education level influenced professional practice behavior to some extent. CONCLUSION: Pharmacy employees do not see themselves as primarily responsible for the safe use of DS by persons with dementia. Moreover, they have limited experience with the unsafe use of DS by these persons. There is potential for improvement regarding tools and educational interventions for pharmacy employees to provide sufficient help to persons with dementia who use DS.

Direct and indirect risk associated with the use of dietary supplements among persons with dementia in a Norwegian memory clinic.

BACKGROUND: The use of dietary supplements (DS) is common among persons with dementia. Direct risks associated with DS use include adverse events and DS-drug interactions. A direct risk is a risk caused by the treatment itself. Indirect risks are related to the treatment setting, such as the conditions of use, and not to the treatment itself. Because dementia symptoms may reduce a person's ability to cope with the administration of DS, the use of DS may pose a threat to safety as an indirect risk. The aim of this study was to describe the extent of DS use among persons with dementia in ambulatory care and to identify some relevant direct and indirect risks related to DS use. METHODS: We conducted a survey among 151 persons with dementia attending an outpatient memory clinic in Northern Norway. Study measurements included: the participants' characteristics, cognitive functioning, functioning in the activities of daily living (ADL), and the use of DS and prescription drugs (PD). We assessed direct risks by evaluating potential DS-drug interactions and indirect risks by evaluating the conditions under which it was used. RESULTS: Forty-six percent (n = 70) of the persons with dementia used DS. Ninety-seven percent (n = 147) used PD. We found potentially clinically relevant DS-drug interactions representing a direct risk in eight persons with dementia (11% of users). While only 36% (n = 26) of the participants received assistance with the administration of DS, 73% (n = 106) received assistance with the administration of PD. Persons with dementia living alone were at risk of not receiving assistance, as home care service seldom was involved in DS administration. Data indicated that assistance with DS administration was not provided for all persons with dementia in need, representing an indirect risk to these persons. Only one-third of the persons with dementia and half of the caregivers were aware of the general risks of adverse events and interactions associated with the use of DS. CONCLUSIONS: Persons with dementia use DS frequently, yet DS use may be associated with direct and indirect risks to patient safety as potentially clinically relevant interactions were discovered and DS intake often was unsupervised.

Utilization of the tyndall effect for enhanced visual detection of particles in compatibility testing of intravenous fluids: validity and reliability.

PURPOSE: This study investigates the validity, reliability, and detection limit of a visual examination method utilizing the Tyndall effect to enhance visible detection of particles. The suitability of the method for compatibility testing of intravenous fluids in a hospital pharmacy context is discussed. METHODS: A panel of 20 inspectors examined 20 samples, with and without particles, using two light sources (halogen lightbulb in a focused desk lamp and a red pocket laser pointer). The samples contained particles of different origin (precipitate, polystyrene standards), varying size, and concentrations. Light obscuration and turbidimetric measurements were used to obtain numeric references. The samples were divided into rejection probability zones, and the validity (sensitivity, specificity, and likelihood ratios) and reliability (inter-rater agreement coefficients Fleiss' kappa and Gwet's AC1) were estimated. RESULTS: The sensitivity of the laser pointer for detecting microprecipitates was quite high; however, it also showed a high false rejection rate. The specificity was slightly higher for the focused desk lamp than the laser pointer. The likelihood ratios were not within the recommended limits of a useful test, indicating that the method could not securely confirm the presence/absence of particles in the samples. The inter-rater agreement coefficients indicated fair to moderate agreement between the inspectors. CONCLUSIONS: The validity and reliability were not satisfactory for either of the light sources. The visual detection limit seemed to be around 5 µm, although we propose that an exact detection limit is not that relevant for compatibility testing. Based on the current findings, the visual examination method cannot be recommended as the sole method for judging compatibility of parenteral nutrition and drugs, but rather in a program of several methods. In the hospital pharmacy, the method may be a resource, together with theoretical considerations, in situations where other methods are unavailable; however, use of in-line-filters is essential to protect the patient. LAY ABSTRACT: Many patients under intensive care are in need of several intravenous drugs simultaneously. These drugs cannot be given in the same infusion line unless compatibility has been documented. Incompatibilities can result in, for example, precipitation of particles. Injected particles can harm the patient and should be avoided. Visual screening of blends of drugs for possible incompatibility, using a focused light source to enhance visual detection based on the Tyndall effect, could be a quick and easy methodology to identify incompatibility. In the following study the objective was to investigate how reliable visual inspection, with the utilization of the Tyndall effect, is at detecting particles and precipitations in blends of intravenous drugs and parenteral nutrition mixtures. Twenty inspectors each examined 20 different samples with two different light sources. Some of the samples were without particles (clean), and some contained different types and degrees of particle contamination. The inspectors' judgment of the samples was recorded and validity and reliability parameters were calculated to evaluate the method's suitability. The conclusion was that because of false positive and negative findings the visual inspection method alone is not enough to securely document compatibility/incompatibility, but it is more suitable as support together with additional methods.

Menopausal hormone therapy and breast cancer risk: impact of different treatments. The European Prospective Investigation into Cancer and Nutrition.

Menopausal hormone therapy (MHT) is characterized by use of different constituents, regimens and routes of administration. We investigated the association between the use of different types of MHT and breast cancer risk in the EPIC cohort study. The analysis is based on data from 133,744 postmenopausal women. Approximately 133,744 postmenopausal women contributed to this analysis. Information on MHT was derived from country-specific self-administered questionnaires with a single baseline assessment. Incident breast cancers were identified through population cancer registries or by active follow-up (mean: 8.6 yr). Overall relative risks (RR) and 95% confidence interval (CI) were derived from country-specific Cox proportional hazard models estimates. A total of 4312 primary breast cancers were diagnosed during 1,153,747 person-years of follow-up. Compared with MHT never users, breast cancer risk was higher among current users of estrogen only (RR: 1.42, 95% CI 1.23-1.64) and higher still among current users of combined MHT (RR: 1.77, 95% CI 1.40-2.24; p = 0.02 for combined vs. estrogen-only). Continuous combined regimens conferred a 43% (95% CI: 19-72%) greater risk compared with sequential regimens. There was no significant difference between progesterone and testosterone derivatives in sequential regimens. There was no significant variation in risk linked to the estrogenic component of MHT, neither for oral vs. cutaneous administration nor for estradiol compounds vs. conjugated equine estrogens. Estrogen-only and combined MHT uses were associated with increased breast cancer risk. Continuous combined preparations were associated with the highest risk. Further studies are needed to disentangle the effects of the regimen and the progestin component.

Natural remedies in Scandinavia-authorization and sales.

OBJECTIVE OF THE STUDY: to quantify sales of authorized natural remedies (ANRs) in Norway, to compare the Norwegian authorization scheme with similar schemes in Sweden, Denmark and the EU, and to identify factors influencing the number of marketed ANRs. METHOD: descriptive statistics are used to present sales of ANRs in Norway. The ANRs are classified by indication group and assigned a recommended daily dose (RDD) according to the posology section in the Summary of Product Characteristics (SPC). Document analysis of regulation and general information concerning natural remedies is used to compare the authorization schemes for ANRs in Scandinavia and for traditional herbal medicinal products (THMs) in the EU. Four cases of herbs are described to illustrate the consequences of this regulation and identify possible influencing factors. MAIN OUTCOME MEASURE: sales, in terms of both mean consumer prices and number of RDDs, and the factors found to influence the number of marketed ANRs. RESULTS: total sales of ANRs in Norway in 2003 were 1.5 per capita (3% of the food supplement market), or 5.5 RDD/1,000/day, and the sales have tended to decline. Norway has very few ANRs compared with Sweden and Denmark. Changes in Norwegian ANR regulation in 2004 have harmonized application requirements in Scandinavia, but results have yet to be seen. THMs are subject to the same quality requirements as ANRs, and will replace the ANRs over the next 7 years. Several factors have influenced the manufacturers' application incentive, e.g., application costs, differentiated VAT rates, consumer knowledge and surveillance by health authorities. CONCLUSION: sales of authorized compared to unauthorized natural remedies in Norway are very low and the ANRs are in a weak position compared to Denmark and Sweden. Surveillance by health authorities and increased consumer knowledge of ANRs is probably more stimulating with respect to application incentive than lower application costs. Introducing THMs will hopefully increase the number of quality-controlled products on the Scandinavian market.