Instructions for clinical and biomarker monitoring in the Summary of Product Characteristics (SmPC) for psychotropic drugs: Overview and applicability in clinical practice

Abstract

The Summary of Product Characteristics (SmPC) for psychotropic drugs includes instructions for clinical and biomarker monitoring intended to optimise effectiveness and minimise harm. The present study evaluated which monitoring instructions are given in the SmPCs, and assessed whether instructions are informative enough to be applicable in clinical practice. Monitoring instructions were collected from complete SmPCs for psychotropic drugs (n=70). Reasons and requirements for monitoring were assessed and somatic parameters were distinguished from non-somatic parameters. Instructions were evaluated using the Systematic Information for Monitoring (SIM) score and considered applicable when a SIM score of ⩾3 was found. An average of 3.3 (range 0–13) instructions per drug label was found. Monitoring was primarily for safety reasons (78%). Requirement was predominantly mandatory (71%). Somatic parameters were most often mentioned (80%). Only 34% of the instructions were determined applicable. Overall, an average SIM score of 2.0 (SD=1.7) was found (out of a maximum possible score of 6). In conclusion, prescribing of psychotropic drugs is accompanied by diverse instructions aimed at improving safe use. However, most instructions on monitoring do not provide sufficient information to be applicable in clinical practice.

Keywords

Psychiatry monitoring psychotropic drugs drug safety

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References

Blier

El Mansari

(2013) Serotonin and beyond: therapeutics for major depression. Phil Trans Roy Soc Lond Ser B, Biol Sci 368(1615): 20120536.

European Commission. (2009) Guideline on Summary of Product Characteristics (SmPC). Available at: http://ec.europa.eu/health/files/eudralex/vol-2/c/smpc_guideline_rev2_en.pdf (accessed 16 June 2014).

European Medicines Agency (2001) Directive 2001/EC/83 of the European Parliament and of the Council of 6 November 2001 on the Community Code Relating to Medicinal Products for Human use. Available at: http://ec.europa.eu/health/files/eudralex/vol-1/dir_2001_83_cons2009/2001_83_cons2009_en.pdf (accessed 16 June 2014.

Ferner

Coleman

Pirmohamed

. (2005) The quality of information on monitoring for haematological adverse drug reactions. Br J Clin Pharmacol 60(4): 448–451.

Floor-Schreudering

Geerts

Aronson

. (2014) Checklist for standardized reporting of drug–drug interaction management guidelines. Eur J Clin Pharmacol 70(3): 313–318.

Geerts

De Koning

Van Solinge

. (2012) Instructions on laboratory monitoring in 200 drug labels. Clin Chem Lab Med 50(8): 1351–1358.

Gelenberg

Chesen

(2000) How fast are antidepressants? J Clin Psych 61(10): 712–721.

Gurwitz

Field

Avorn

. (2000) Incidence and preventability of adverse drug events in nursing homes. Amer J Med 109(2): 87–94.

Leendertse

Egberts

Stoker

. (2008) Frequency of and risk factors for preventable medication-related hospital admissions in the Netherlands. Arch Int Med 168(17): 1890–1896.

10.

Mitchell

(2009) Do antipsychotics cost lives or save lives? Risks versus benefits from large epidemiological studies. J Clin Psychopharmacol 29(6): 517–519.

11.

Nutt

(2006) Informed consent – a new approach to drug regulation? J Psychopharmacol 20(1): 3–4.

12.

Rougemont

Ulrich

Hiemke

. (2010) French summaries of product characteristics: content in relation to therapeutic monitoring of psychotropic drugs. Fund Clin Pharmacol 24(3): 377–384.

13.

U.S. Food and Drug Administration (2014) MedWatch: the FDA Safety Information and Adverse Event Reporting Program. Available at: http://ec.europa.eu/health/files/eudralex/vol-2/c/smpc_guideline_rev2_en.pdf (accessed 16 June 2014).

14.

Vromans

Doyle

Petak-Opel

. (2013) Shaping medicinal product information: a before and after study exploring physicians’ perspectives on the summary of product characteristics. BMJ Open 3(8): e003033–2013–003033.

15.

Warnier

Holtkamp

Rutten

. (2014) Quality of drug label information on QT interval prolongation. Int J Risk Safety Med 26(2): 89–98.

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