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Frail elderly with polypharmacy are at greater risk of preventable medication-related health damage. To improve medication safety, the healthcare field prepared, in consultation with the Dutch Health Care Inspectorate, a number of guidelines and standards containing conditions for safe prescribing. According to these standards the active involvement of patients by health care professionals is essential for good pharmacotherapeutic care. However, two studies with patients show that there is still room for improvement. According to patients, they can be (even) better informed about changes in their medication. Also the caregivers could communicate more clearly who is the central contact point and who is ultimately responsible for the medication. Patients are not sufficiently informed on this. Furthermore, there is uncertainty about how and why medication reviews are performed. More explanation to patients about this is desirable. In addition, patients experience that keeping their medication list up to date and transferring medication data between health care providers could be improved. Finally, a group of patients welcomes the opportunity to co-decide on changes in their medication. In order to prescribe safely, it is crucial that caregivers actively involve patients in pharmacotherapeutic care and really enter into conversation with them about their medication.

Farmacotherapeutische zorg voor ouderen en mensen met een psychiatrische aandoening is complex en risicovol, omdat deze groepen vaak te maken hebben met polyfarmacie, dat wil zeggen het chronisch gebruik van vijf of meer verschillende geneesmiddelen. Polyfarmacie is een risicofactor voor geneesmiddelgerelateerde ziekenhuisopnames. Voor de IGZ zijn ‘het verbeteren van zorg voor ouderen’ en ‘het verhogen van de medicatieveiligheid’ speerpunten. Om het IGZ-beleid verder vorm te geven, heeft het Rijksinstituut voor Volksgezondheid en Milieu (RIVM) onderzocht welke risico’s patienten met polyfarmacie lopen en welke maatregelen beschikbaar zijn om deze risico’s te beperken. Uit dit onderzoek bleek dat over- en onderbehandeling vaak voorkomen. Dit kan veroorzaakt worden doordat voorschrijvers soms niet van elkaar weten wat ze voorschrijven, wijzigen of stoppen. Verder bleek dat bij mensen met een psychiatrische aandoening sprake kan zijn van bijwerkingen of interacties die specifiek optreden bij psychiatrische medicatie, soms vanwege combinatie met somatische geneesmiddelen. Er zijn diverse richtlijnen die de medicatieveiligheid kunnen verbeteren, maar bij de implementatie is een aantal knelpunten gesignaleerd, niet alleen op het terrein van samenwerking, regie en medicatieoverdracht, maar ook omdat ICT onvoldoende faciliterend is en voorschrijvers nog te weinig kennis hebben over polyfarmacie bij kwetsbare groepen. Het zorgveld probeert de gesignaleerde knelpunten aan te pakken. De IGZ zal vanaf 2015 in alle domeinen van de gezondheidszorg de focus leggen op vier richtlijnen die belangrijke voorwaarden vormen voor verantwoord voorschrijven aan kwetsbare groepen met polyfarmacie.

Background: In the past years, an enormous increase in the number of available health-related applications (apps) has occurred, from approximately 5800 in 2011 to over 23,000 in 2013, in the iTunes store. However, little is still known regarding the use, possible effectiveness, and risks of these applications. In this study, we focused on apps and other e-tools related to medicine use. A large subset of the general population uses medicines and might benefit from tools that aid in the use of medicine. Objective: The aim of the present study was to gain more insight into the characteristics, possible risks, and possible benefits of health apps and e-tools related to medication use. Methods: We first made an inventory of apps and other e-tools for medication use (n=116). Tools were coded by two independent researchers, based on the information available in the app stores and websites. Subsequently, for one type of often downloaded apps (aimed at people with diabetes), we investigated users’ experiences using an online questionnaire. Results: Results of the inventory show that many apps for medication use are available and that they mainly offer simple functionalities. In line with this, the most experienced benefit by users of apps for regulating blood glucose levels in the online questionnaire was “information quick and conveniently available”. Other often experienced benefits were improving health and self-reliance. Results of the inventory show that a minority of the apps for medication use has potentially high risks and for many of the apps it is unclear whether and how personal data are stored. In contrast, online questionnaire among users of apps for blood glucose regulation indicates that they hardly ever experience problems or doubts considering reliability and/or privacy. Although, respondents do mention to experience disadvantages of use due to incomplete apps and apps with poor ease of use. Respondents not using app(s) indicate that they might use them in the future if reliability of the apps and instructions on how to use them are more clear. Conclusions: This study shows that for apps and e-tools related to medicine use a small subset of tools might involve relatively high risks. For the large group of nonmedical devices apps, risks are lower, but risks lie in the enormous availability and low levels of regulation. In addition, both users and nonusers indicated that overall quality of apps (ease of use, completeness, good functionalities) is an issue. Considering that important benefits (eg, improving health and self-reliance) are experienced by many of the respondents using apps for regulating blood glucose levels, improving reliability and quality of apps is likely to have many profits. In addition, creating better awareness regarding the existence and how to use apps will likely improve proper use by more people, enhancing the profits of these tools. [JMIR Mhealth Uhealth 2016;4(2):e34]

This March 2009 Workshop Summary Report was sponsored by Product Quality Research Institute (PQRI) based on a proposal by the Inhalation and Nasal Technology Focus Group (INTFG) of the American Association of Pharmaceutical Scientists (AAPS). Participants from the pharmaceutical industry, academia and regulatory bodies from the United States, Europe, India, and Brazil attended the workshop with the objective of presenting, reviewing, and discussing recommendations for demonstrating bioequivalence (BE) that may be considered in the development of orally inhaled drug products and regulatory guidances for new drug applications (NDAs), abbreviated NDAs (ANDAs), and postapproval changes. The workshop addressed areas related to in vitro approaches to demonstrating BE, biomarker strategies, imaging techniques, in vivo approaches to establishing local delivery equivalence and device design similarity. The workshop presented material that provided a baseline for the current understanding of orally inhaled drug products (OIPs) and identified gaps in knowledge and consensus that, if answered, might allow the design of a robust, streamlined method for the BE assessment of locally acting inhalation drugs. These included the following: (1) cascade impactor (CI) studies are not a good 2 predictor of the pulmonary dose; more detailed studies on in vitro/in vivo correlations (e.g., suitability of CI studies for assessing differences in the regional deposition) are needed; (2) there is a lack of consensus on the appropriate statistical methods for assessing in vitro results; (3) fully validated and standardized imaging methods, while capable of providing information on pulmonary dose and regional deposition, might not be applicable to the BE of inhaled products mainly due to the problems of having access to radiolabeled innovator product; (4) if alternatives to current methods for establishing local delivery BE of OIPs cannot be established, biomarkers (pharmacodynamic or clinical endpoints) with a sufficiently steep dose-response need to be identified and validated for all relevant drug classes; and (5) the utility of pharmacokinetic studies for evaluating "local pulmonary delivery" equivalence deserves more attention. A summary of action items for seminars and working groups to address these topics in the future is also presented.

The purpose of this article is to document the discussions at the 2010 European Workshop on Equivalence Determinations for Orally Inhaled Drugs for Local Action, cohosted by the International Society for Aerosols in Medicine (ISAM) and the International Pharmaceutical Consortium on Regulation and Science (IPAC-RS). The article summarizes current regulatory approaches in Europe, the United States, and Canada, and presents points of consensus as well as ongoing debate in the four major areas: in vitro testing, pharmacokinetic and pharmacodynamic studies, and device similarity. Specific issues in need of further research and discussion are also identified.

Background Proton pump inhibitors (PPIs) are prescribed to patients requiring prevention or treatment of gastric and duodenal ulcers. PPIs inhibit gastric acid secretion by specific action on proton pumps of parietal cells. The resulting pH increase is favourable for gastrointestinal pathogen survival. Indeed, PPIs are reported repeatedly as potential risk factors for infections, such as Campylobacter and Salmonella infections. The current study examined national trends in PPI use, reported campylobacteriosis cases between 2004 and 2011, and estimated the excess disease burden potentially related to PPI use. Methods In a negative-binomial regression model, annual numbers of campylobacteriosis cases were related to PPI use per capita, age (four classes: 0–25, 25–50, 50–70, and >70 years), and chicken meat consumption (an established risk factor). Annual PPI prescription data were obtained from the Foundation for Pharmaceutical Statistics for the two most frequently dispensed PPIs, omeprazole and pantoprazole. The number of reported campylobacteriosis cases was obtained from national surveillance data. Annual chicken meat consumption (fresh and frozen) was based on retail data. Annual population counts per age category were obtained from Statistics Netherlands. A counterfactual approach was used to estimate the total excess incidence due to PPI use between 2004 and 2011. The associated disease burden was quantified using an existing model for estimating the disease burden. Findings The trend and yearly fluctuations in campylobacteriosis cases were explained statistically by PPI use (p Interpretation The current study is the first to quantify the adverse effects of PPI use on gastrointestinal disease burden at the population level. Other enteric pathogens might display similar effects. A risk–benefit analysis for PPI use involving disease burden measures for multiple health outcomes is warranted. Funding Ministry of Health, Welfare and Sports, The Hague, Netherlands.