Potentially Inadequate Medications in the Elderly: PRISCUS 2.0
First Update of the PRISCUS List
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Background: The term potentially inadequate medication (PIM) is used to describe substances that may be unsuitable for use in the elderly and should be avoided. The PRISCUS list, published in 2010, was the first catalog of PIM designed for the German drug market to become adopted in practice. While 24% of German patients aged ≥ 65 years were prescribed at least one PIM per year in 2009, the proportion in 2019 was only 14.5%.
Methods: In a three-round Delphi process, experts from clinical practice and research evaluated whether selected substances are PIM for the elderly. The participants were provided with dedicated literature including systematic reviews carried out for the particular purposes of this project.
Results: Fifty-nine persons took part in the Delphi process and, in addition, contributed comments and therapeutic alternatives. Altogether, 187 substances were classed as PIM. One hundred thirty-three of the substances now listed were not in the original PRISCUS list: these include some oral antidiabetics, all of the selective COX-2 inhibitors, and moderately long acting benzodiazepines such as oxazepam. For some other substances, e.g., proton pump inhibitors (PPI), the advisability of treatment for more than 8 weeks was considered as potentially inappropriate, as was the use of ibuprofen in doses >1200 mg/day and for more than 1 week without PPI. Risperidone for more than 6 weeks is also PIM.
Conclusion: The new, greatly extended PRISCUS list must now be validated in epidemiological and prospective studies and its practicability in routine daily use must be verified.
Pharmacotherapy in the elderly has recently been addressed in national guidelines (1, 2). Along with attention to numerous factors such as patient preferences, compliance, and interactions, drug safety in old age can also be enhanced by avoidance of potentially inadequate medications (PIM). Many medications cause more—and sometimes different—side effects in the elderly than in younger patients, so the benefit–risk ratio may change. The substances primarily concerned are those that bring about dizziness or a rapid decrease in blood pressure, impair cognition, or increase the danger of falls (3, 4).
The PRISCUS list (Latin priscus: old, venerable) for the German drug market was published in 2010 (5) and has since found its way into textbooks and prescription software. Numerous studies have shown the association between the intake of PIM on the PRISCUS list and adverse drug events (ADE), in particular an elevated risk of hospital admission (6, 7, 8).
One challenge in evaluating the safety and tolerability of drugs in old age is the frequent lack of data from clinical research (9). For this reason, PIM lists are compiled by experts, usually in a Delphi process (5).
Nevertheless, it is advisable to substantiate an expert survey with the best available evidence. For an update of the PRISCUS list, additional systematic reviews should therefore be performed and existing reviews should be processed and presented to experts as the basis for maximally evidence-based decisions. The PRISCUS list is also in urgent need of updating because of the changes in the drugs market since 2010.
In order to facilitate preparation of a list of substances and substance classes for evaluation, the literature was searched for international PIM lists published since 2010 and a systematic literature review was conducted (eBox 1a). To narrow down the substances for assessment, prescription data from the statutory health insurance funds in Germany and Austria were analyzed, as a joint PRISCUS 2.0 list was to be compiled for use in both countries.
Moreover, substances were prioritized for analysis in systematic reviews on the basis of prescription frequency. We were also able to take advantage of existing reviews from the PRIMA-eDS study (an EU project; for details see www.prima-eds.eu) (9, 10, 11, 12, 13). Additionally, an exploratory survey was carried out to establish whether, for the remaining substances, information from other sources was sufficient for assessment by the participants (pre-Delphi; eBox 1b). The processing of the reviews’ findings was oriented on the standards for clinical practice guidelines (14, 15, 16). A detailed description can be found in eBox 1. Furthermore, the experts had access to a collection of literature with complete texts and abstracts from publications cited in Micromedex (17), for example, and the other publications used (eBox 1c).
The substances were evaluated on a consensus basis over a three-round Delphi process (18, 19). For this purpose, persons with expertise in geriatric pharmacotherapy were identified (professional bodies, the Drug Commission of the German Medical Association, participants in the compilation of the original PRISCUS list  and the Austrian PIM list [e1]) and invited to take part. The participants evaluated the substances on a five-point Likert scale, from from 1 = potentially inappropriate (= PIM) to 5 (definitely not a PIM) (eBox 2a). The rating method is explained in eBox 2b.
In addition to their ratings on the Likert scale, the participants were asked, if possible, to give the following information:
- Dose or time limit(s) from which the substance is a PIM
- More appropriate alternatives
- Monitoring of the effects if the substance is used
- Contraindicating comedication and comorbidities
- Any other comments
The participants also had the opportunity to suggest other substances for evaluation.
The results of the first Delphi round were provided to the participants as feedback (eBox 2c). Substances that were not rated unambiguously in the first round and those for which discrepancies emerged between expert evaluation and systematic reviews had to be evaluated anew in the second round. Based on the participants’ comments, some substances were evaluated in different doses and durations of use. In addition to the two Delphi rounds originally scheduled, a third round focused on one topic was added, because of inconsistencies between the evaluations and the participants’ comments with regard to the non-steroidal anti-inflammatory drugs (NSAID).
The results were available for (professional) public comment on the project website for 4 weeks in March 2021. Finally, all comments were summarized and incorporated into the complete version of PRISCUS 2.0.
We identified 24 articles that listed PIM in the elderly (5, e1, e2, e3, e4, e5, e6, e7, e8, e9, e10, e11, e12, e13, e14, e15, e16, e17, e18, e19, e20, e21, e22, e23) and eight relevant systematic reviews on ADE in older patients (20, 21, 22, 23, 24, 25, 26, 27). Evaluation of the international PIM lists, the prescription data of the German National Association of Statutory Health Insurance Fund (GKV), and the substances available for use in Austria resulted in identification of a total of 250 substances and substance classes to be considered for addition to the update of the PRISCUS list. No further substances were revealed by scrutiny of the identified systematic reviews.
Thirteen systematic reviews were carried out to provide evidence backing up the suggested additions for the update of the PRISCUS list. An overview of these reviews and their roles in the project can be found in eTable 1. Altogether, 21 GRADE summary of findings (SOF) and evidence profile tables for the results of the new and identified reviews were compiled. An example of the selected presentation can be found in Table 1.
Of 101 persons contacted with regard to the Delphi process, 70 signed a declaration that they would participate. Fifty-five persons took part in the first round, 52 in the second round, and eight in the third round. Overall 59 persons took part in at least one Delphi round, representing a broad spectrum of medical specialties (including general medicine, geriatrics, clinical pharmacy, psychiatry, internal medicine, palliative medicine, clinical pharmacology, and cardiology). The distribution of the participants across the three rounds of the Delphi process is visualized in the eFigure.
The three-round Delphi process began in March 2020. Of the 250 substances/substance classes evaluated in the first round, 158 were rated as PIM and 23 as non-PIM. On the basis of the expert comments, 13 substances were differentiated in terms of time/dose limits, two according to indication, one substance was added to the list, and two substances were reconsidered in their own right rather than as part of their class. Thus a total of 87 substances were put forward for assessment in the second Delphi round, 29 of which were classified as PIM and 13 as non-PIM. There was still no unambiguous rating for 45 substances. In a third Delphi round, none of the four substances evaluated were unambiguously classified as PIM or non-PIM. Over the course of the Delphi process, therefore, 187 substances were rated as PIM, 36 as non-PIM, and the classification of 49 substances was ambiguous, i.e., they may be PIM (eTable 4). The Delphi process is portrayed in the eFigure.
In addition to the median, mean, and 95% confidence interval, the detailed version of PRISCUS 2.0 contains the following details on each substance:
- Possible alternatives
- Information about monitoring
- Comedication/comorbidities to be avoided
- Reason for classification as PIM
- Discussion points
Substances that are no longer marketed in Germany or are not eligible for prescription are listed separately. This version is available on the project website (www.priscus2-0.de). PRISCUS 2.0 contains 177 substances/substance classes (Table 2, eTable 2).
Six substances in the original PRISCUS list were not suggested for inclusion in PRISCUS 2.0, either because they were no longer marketed (e.g., zaleplon) or because, going by the GKV prescription data, their prescription to patients aged 65 years or over had decreased to a very low level (e.g., triprolidine). Nitrofurantoin, in contrast to the original list, was no longer classified as a definite PIM. A total of 133 substances were newly classified as PIM; nine of these, however, are currently not on the market (e.g., rilmenidine) or not eligible for prescription (e.g., reboxetine).
PRISCUS 2.0, with 177 substances listed, is more than twice as long as the original PRISCUS list. In several cases (e.g., neuroleptics and NSAID), the individual substances are listed separately rather than the substance class as a whole, in order to take account of possible differences among the substances. For some indications, such as diabetes mellitus, there was previously only one single substance listed; now numerous others have been added, not only for diabetes but also in the categories of beta-blockers, muscle relaxants, and drugs for use against Parkinson’s disease.
The need to update lists of PIM regularly because recommendations for the use of certain substances change over time can be illustrated by the example of the direct oral anticoagulants (DOAC). We conducted a systematic review specifically to clarify the safety of DOAC in the elderly. Although DOAC were not evaluated at all for the first PRISCUS list, they were classified as PIM in the EU(7) list published in 2015 (e2). In the PRISCUS 2.0 process, however, they were rated as non-PIM, with the exception of dabigatran, which was categorized as a possible PIM. In the current version of the Beers list, dabigatran and rivaroxaban are mentioned as substances that should be used with caution in the elderly (e3).
In comparison with the LUTS-FORTA list (e18), it is striking that the alpha-blockers used in urology are rated in PRISCUS 2.0 as unclear (e.g., terazosin) or as non-PIM (tamsulosin), whereas LUTS-FORTA classifies them as “use with caution” (C) or “avoid” (D). A systematic review of the safety of alpha-blockers in the elderly carried out specifically for PRISCUS 2.0 did not lead to any of them being classified as PIM (28). While oral antidiabetics such as glibenclamide, glimepiride, and acarbose were categorized as PIM, the FORTA list differentiates them: glibenclamide is classified as D, glimepiride and acarbose as C. This difference is reflected somewhat in the much lower mean rating for glibenclamide than for the other substances.
Taken together, these examples clearly illustrate the discrepancies among different lists of PIM. On the one hand, this is due to the changes in available evidence over time and the different publication times of the individual lists. On the other hand, it must be remembered that the classifications of the substances considered depend on the ratings assigned by the experts involved in the process. Differences in classification of individual substances between PIM lists may be attributable to the compositions of the groups of experts recruited.
When compiling PIM lists, other lists are often used as data sources (29). In this respect, our systematic research and the development of an adapted GRADE procedure (16) represent a considerable step forward in methodology. FORTA classifies DPP-4 inhibitors as A (absolutely suitable), whereas the systematic review conducted for PRISCUS 2.0 revealed evidence of a possible elevation in mortality risk and a slightly increased risk of hypoglycemia compared with the standard treatment; however, DPP-4 were definitely superior to the sulfonylureas (30). Nevertheless, overall this class of substances was not categorized as PIM.
Since the publication of the PRISCUS list in 2010, lists of PIM have been compiled in many other countries (29). A number of studies have shown that intake of PIM is associated with adverse effects (6, 7, 8). Although there is not yet any evidence to show that discontinuation of PIM leads to reduction of morbidity and mortality (31), some analyses show a decline in the prescription of PIM in Germany (32).
Restricting the list of substances suggested for PRISCUS 2.0 to those found in the GKV prescription data means that substances which can be obtained without prescription or are not eligible for prescription were not considered sufficiently. One example is the antihistamine triprolidine.
It remains the case that elderly persons are often excluded from clinical trials, leading to paucity of data (33). For reasons of time and resources, we were able to conduct systematic reviews only for certain substances, so that data on the remainder were limited to the findings of non-systematic research. In contrast to the original intention, some of the systematic reviews were completed only in time for the second round of the Delphi process.
The third Delphi round, focusing on NSAID, featured fewer participants than the previous rounds. It is possible that the results of the third round would have been different if a higher number of experts had taken part. In view of the participants’ comments on which the third Delphi round was based, however, this is unlikely.
PIM lists specify substances that may not be suitable for use in the elderly. Prescription of a PIM may still be necessary in an individual patient, however, so the presence of a substance on a PIM list is not equivalent to a universally valid negative rating or prohibition. Individual assessment of each patient’s clinical situation and the resulting choice of appropriate medication is and will remain a central task for the treating physicians. Whether a given drug is suitable or otherwise for the person concerned can be decided only in the knowledge of the particular patient’s clinical situation, of which PRISCUS 2.0 takes no account. Although on the one hand this represents a crucial limitation, it means that PRISCUS 2.0 can also be used by persons with restricted access (or none at all) to clinical data, e.g., pharmacists, community carers, and relatives, to identify drugs that may not be appropriate. At various points in the medication process, therefore, it is possible to analyze—and potentially optimize—the patient’s pharmaceutical treatment in consultation and cooperation with the physicians involved. Furthermore, the PRISCUS list is useful for pharmacoepidemiological analyses in situations where clinical data are sparse (32, 34).
The study was supported by the German Federal Ministry for Education and Research (project no. BMBF 01KX1812) and by the Association of Austrian Social Insurance Funds (Dachverband der österreichischen Sozialversicherungsträger; project no. FA636A0504).
For their participation in the Delphi process, we thank the following: Eva Blozik, Birgit Böhmdorfer, Juliane Bolbrinker, Harald Dormann, Peter Dovjak, Corinna Drebenstedt, Günther Egidi, Gottfried Endel, Heinz Endres, Alexander Friedl, Thomas Frühwald, Gerald Ohrenberger, Markus Gosch, Athe Grafinger, Gerhard Gründer, Thomas Günnewig, Walter E. Haefeli, Ekkehard Haen, Sebastian Harder, Steffen Härterich, Siegfried Hartmann, Hans Jürgen Heppner, Walter Hewer, Christine Hofer-Dückelmann, Ulrich Jaehde, Petra Kaufmann-Kolle, Rainer Kiefmann, Michael Klock, Karin Kraft, Reinhold Kreutz, Renke Maas, Eva Mann, Werner-J. Mayet, Reli Mechtler, Guido Michels, Veselin Mitrovic, Klaus Mörike, Ursula Müller-Werdan, Beate Mussawy, Wilhelm-Bernhard Niebling, Roman Pfister, Susanne Rabady, Ina Richling, Thomas Riemer, Christoph Ritter, Martin Scherer, Guido Schmiemann, Jochen Schuler, Oliver Senn, Michael Smeikal, Isabel Waltering, Dietmar Weixler, Andreas Wiedemann, Hans Wille, Stefan Wilm, Rainer Wirth, Ursula Wolf, Joachim Zeeh, Michael Zieschang.
Für supporting our project in other ways, we thank: Tobias Dreischulte, Birol Knecht, Katja Niepraschk-von Dollen, Helmut Schröder, Carsten Telschow, Anette Zawinell.
Conflict of interest statement
The authors declare that no conflict of interest exists.
Manuscript received on 12 September 2022, revised version accepted on 9 November 2022.
Translated from the original German by David Roseveare.
Prof. Dr. med. Petra A. Thürmann
Lehrstuhl für Klinische Pharmakologie
Department für Humanmedizin
Fakultät für Gesundheit, Universität Witten/Herdecke
58455 Witten, Germany
Cite this as:
Mann NK, Mathes T, Sönnichsen A, Pieper D, Klager E, Moussa M, Thürmann PA: Potentially inadequate medications in the elderly: PRISCUS 2.0—first update of the PRISCUS list. Dtsch Arztebl Int 2023; 120: 3–10. DOI: 10.3238/arztebl.m2022.0377
eReferences, eTables, eFigure, eBoxes:
Institute of Medical Statistics, Faculty of Medicine, University of Göttingen: Prof. Dr. rer. medic. Tim Mathes
Institute of Knowledge Management in Medicine, Salzburg, Austria: Prof. Dr. med. Andreas Sönnichsen
Institute for Research in Operative Medicine, Department of Medicine, Faculty of Health, University of Witten/Herdecke: Prof. Dr. rer. medic. Dawid Pieper
Ludwig Boltzmann Institute for Digital Health and Patient Safety, Medical University of Vienna, Austria: Elisabeth Klager, M.Sc.
Department of General and Family Medicine, Center for Public Health, Medical University of Vienna, Austria: Dr. med. Mahmoud Moussa
Philipp Klee Institute of Clinical Pharmacology, Helios University Hospital, Wuppertal: Prof. Dr. med. Petra A. Thürmann
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