Evidence map›Paper›PMID 31662405›Full record

ArticleBMJ open2019

Medication safety risks to be managed in national implementation of automatic substitution of biological medicines: a qualitative study.

Hanna M Tolonen, Marja Sa Airaksinen, Päivi Ruokoniemi, Katri Hämeen-Anttila, Kenneth M Shermock, Pekka Kurki

Open access · goldAbstract read
In one paragraph

Article in BMJ open, 2019. The graph could read no effect estimate from its abstract, so it casts no vote on the map. Cited by 12 papers, 2 of them syntheses that pooled it.

0numbers the graph read from it
0cells of the map it votes in
12citing papers in PubMed, 2 pooled it
0.9field-weighted citation impact, top 26% of its field
1 · What the graph read from it

What it found

Each row is one number read from the abstract, on the scale the paper reported it, with its interval. Left of the dashed line favours the treatment, right favours the comparator. Under each row is the sentence it came from. New to these charts? A ten-minute tutorial.

The abstract states no effect estimate the extractor could read, or names no intervention and outcome on the map, so this paper lights no cell and moves no belief. It is still indexed, cited and linked below.

2 · The registry

The trial behind it

Trials whose registry record cites this paper, or whose number appears in the abstract. A trial that started after this paper was published is citing it as background, not reporting it.

Neither the registry nor the abstract names a trial number. If this is a trial report, that itself is worth knowing.

3 · Its place in the literature

Who cites it

12 citing papers in PubMed, 2 syntheses or guidelines pooled it, 17 citations in OpenAlex.

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4 · The record

Corrections and comments

PubMed lists nothing against this paper. Absence here is not a guarantee, only a check that was made.

5 · Who and what money

Authors and funding

6 authors at 3 institutions in 2 countries.

Hanna M TolonenClinical Pharmacy Group, Division of Pharmacology and Pharmacotherapy, Faculty of Pharmacy, University of Helsinki, Helsinki, Finland hanna.tolonen@hus.fi.ORCID 0000-0002-6824-7566
Marja Sa AiraksinenClinical Pharmacy Group, Division of Pharmacology and Pharmacotherapy, Faculty of Pharmacy, University of Helsinki, Helsinki, Finland.
Päivi RuokoniemiFinnish Medicines Agency Fimea, Helsinki, Finland.
Katri Hämeen-AnttilaFinnish Medicines Agency Fimea, Helsinki, Finland.
Kenneth M ShermockCenter for Medication Quality and Outcomes, The Johns Hopkins Health System, Baltimore, Maryland, USA.
Pekka KurkiUniversity of Helsinki, Helsinki, Finland.
University of Helsinki · FIFinnish Medicines Agency Fimea · FIJohns Hopkins University · US

Funding

No grant is acknowledged in the PubMed record.

6 · The paper itself

Abstract

objectivesTo explore relevant Finnish stakeholders' perceptions on the automatic substitution of biological medicines with particular focus on medication safety and issues that need to be considered to create an appropriate model for automatic biological product substitution.

designQualitative interview study.

methodsData were collected in semistructured individual (n=17), pair (n=7) and group (n=8) interviews (32 interviews, 62 participants) in 2018. Participants represented a wide range of stakeholders involved in the pharmacotherapy process: community pharmacists (n=8 interviews), authorities (n=7), prescribers (n=7), pharmaceutical industry and wholesalers (n=6), patients/customers (n=2), hospital pharmacists (n=1) and nurses (n=1). Inductive content analysis was performed.

resultsBenefits of automatic substitution were identified as cost savings, more patients receiving biological treatments and enhanced continuity of treatment. Six major risk categories were identified: (1) the patient's medication is interrupted or complicated temporarily or permanently, (2) the patient uses two products with the same active substance, (3) the traceability of the product is compromised, (4) the patient cannot get into healthcare in case of problems, (5) the patient does not receive substitution-related advice from a pharmacy and (6) the patient is distracted by the support material he/she receives. Several risk mitigation measures were commonly mentioned: medication and device counselling by pharmacists (n=23), infrequent substitution interval (n=15) and better knowledge on biosimilars among healthcare providers (n=13).

conclusionAutomatic substitution of biologics is associated with risks that should be prospectively managed before implementing the procedure. The substitution also introduces new tasks and communication needs to those involved in actual medication use process, particularly to community pharmacists who will be responsible for substitution and counselling the patients.

Indexed as

Biosimilar PharmaceuticalsPatient SafetyRisk ManagementStakeholder ParticipationAdultAttitude to HealthContinuity of Patient CareCost SavingsDrug CostsFinlandHealth PolicyHumansQualitative ResearchBiosimilar Pharmaceuticalsautomatic substitutionbiological medicinesbiosimilarsinterchangeabilitymedication safety

Identifiers

PMID31662405
PMCPMC6830661
OpenAlexW2982538146

What OpenQuestion holds

Textmetadata
LicenceCC BY-NC
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Registered trials

None linked

Read under generation 80e0d062 · epoch 390. Bibliography from PubMed, PubMed Central and OpenAlex; grants from NIH RePORTER; trial links from ClinicalTrials.gov; estimates, votes and beliefs from the OpenQuestion graph.