[The conversation with the patient is essential for good pharmacotherapeutic care].

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.

[Pharmacogenetics in primary health care: implementation and future expectations].

Personalised medicine is a targeted approach to the prevention, diagnosis and treatment of disorders on the basis of the specific genetic profile of the patient. Pharmacogenetics research shows that differences in the genetic profile of patients explain the interindividual differences in efficacy and side effects of medicines. Although there are high expectations of personalised medicine and pharmacogenetics in healthcare, both are only used to a limited extent to date.

[Pharmacotherapeutic care for vulnerable groups with polypharmacy has to get better].

Pharmacotherapeutic care of the elderly and psychiatric patients is complex and risky, because polypharmacy, the chronic use of five or more medications by a patient, is highly prevalent in these groups. Polypharmacy is a risk factor for medication related hospital admissions. The Dutch Health Care Inspectorate (IGZ) adopted 'improving care for the elderly' and 'improving medication safety' as spearheads.

Equivalence considerations for orally inhaled products for local action-ISAM/IPAC-RS European Workshop report.

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.

Storage instructions for inhalation capsules: consequences of incorrect storage and adherence in daily practice.

The objective was to study the influence of storage conditions on the quality of inhalation capsules and to investigate patients' knowledge and adherence to storage instructions. Inhalation capsules marketed in the Netherlands were stored at normal (20°C/60% relative humidity) and dry (20°C/25% relative humidity) conditions during 34 days and checked for brittleness. After 1 day of storage at normal conditions, no brittleness was perceived.

Demonstrating Bioequivalence of Locally Acting Orally Inhaled Drug Products (OIPs): Workshop Summary Report.

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 therapeutic index of locally acting inhaled drugs as a function of their fine particle mass and particle size distribution: a literature review.

The therapeutic index (TI) of locally acting inhaled drug products depends on a number of parameters and processes: the particle size distribution of the inhaled aerosol, the dose-efficacy response curves at the deposition sites, the amount of drug absorbed into the systemic circulation from the lung as well as the gastrointestinal (GI) tract, and the dose-effect curves for the different adverse drug reactions. In this review, we present qualitative scenarios, combining these effects and showing the possible influence of an envisaged change in the particle size distribution in the inhaled dose of a locally acting drug product on the TI. These scenarios are a valuable tool in the development of inhalation drug products.