Availability and actual use in the Belgian market of potentially inappropriate medications (PIMs) from the EU(7)-PIM list

Annex

A1: Additional information on the development and content of the EU(7)-PIM list

The EU(7)-PIM list is based on the German PRISCUS list of potentially inappropriate medications. Additionally, explicit criteria from other existing PIM lists were selected from the Beers (US), McLeods (CA), and Laroche (FR). For the content validation of each criterion, a two-round Delphi panel was constructed with experts from seven different countries (EE, NL, FI, ES, FR, SE, DE). All invited experts were selected on their experience in geriatric prescribing. The experts (n = 27) evaluated each criterion on the appropriateness of medications, dose adjustments in older adults, and gave suggestions for alternative (mostly medication) therapies. Eight experts suggested additional criteria to be added to the EU(7)-PIM list. Finally, 12 experts completed a brief final survey to decide upon issues requiring further consensus.

The EU(7)-PIM list contains 282 criteria, 275 active substances and 7 broad medication classes (defined in the Anatomical Therapeutic Chemical (ATC) classification yet without explicit enumeration of active substances within the medication classes). Criteria were predominantly medication-oriented, limited to information on the nature of the active substance, and occasionally on duration or dosage, but not on clinical data.

A2: Additional information on the Belfrail-MED cohort of oldest old (≥80 years)

The Belfrail-MED cohort (n = 503) originated from the Belfrail study, a prospective, observational population-based cohort study. General practitioners from three Belgian regions were responsible for the selection of patients. Eligible participants were at least 80 years old and had to be able to visit their GP. Further inclusion criteria were being non-institutionalised and having a medication record available. Exclusion criteria were as follows: known presence of severe dementia (Mini-Mental State Examination <15/30), in need of acute care, or being in palliative care. The general practitioners were also responsible for recording the chronic medication use (medication being used for longer than 3 months and without known stop date).

The study protocol was approved by the Biomedical Ethics Committee of the Medical School of the Université catholique de Louvain (UCL), Brussels (B40320084685, on 27/10/2008), and later by the Ethics committee of Ghent University Hospital (B670201421408, on 26/06/2014). All respondents provided informed consent.

A3: Excel file containing all identified PIM products in Belgium

• Sheet 1: All identified PIM products in Belgium, with the actual usage in the Belfrail-Med cohort

• Sheet 2: The medication classes mentioned in the EU(7)-PIM list, with all available active substances for the Belgian market

• Sheet 3: Possible omissions in the EU(7)-PIM list; all combinations of medications containing at least 1 PIM product

A4: Possible obsolete medications in Belgium, but not on the EU(7)-PIM list

The following products have been considered obsolete in Belgium by the drug information centre (BCFI): • Complex painkiller combinations (e.g. paracetamol + aspirine + cafeine) • Nasal sprays or throat pastilles with antibiotics, tilefrine (Effortil®) • Combined cough preparations with an antitussivum, mucolyticum, or expectorants (and possibly antipyretica, H1-antihistaminica, anticholinergica, bronchodilating agents, or sympathicomimetic agents) • Metamizol (Novalgine®) • Nefopam (Acupan®) • Telithromycin (Ketek®) • Oral lysate of bacteria (Broncho-vaxom® and Uro-vaxom®) Note: Some of the products may only be obsolete, but not specifically harmful for the elderly. Note: Metamizol is considered obsolete in Belgium (and Finland [2]). In the EU(7)-PIM list, it is only listed as inappropriate if not used in adequate doses (as suggested by the Spanish experts in the Delphi panel).