10th April 2014

REPORTING ADVERSE DRUG REACTIONS (ADR’s) IN IRELAND: THE PATIENT PERSPECTIVE [LMS PG UH 00173]

Project Summary:

Patients are significant stakeholders in the pharmacovigilance system and it is widely regarded that patient reporting enriches the portrayal of subjective elements of safety information. Spontaneous reporting systems are the most common methodology used for the generation and detection of previously unknown or rare signals. Moreover, it has also been suggested that patient reporting may provide a valuable and worthwhile contribution to drug safety by identifying different signals of disproportionate reporting not otherwise detected from HCP originating reports (Van Hunsel, 2012; WHO, 2012; Avery et al., 2011 & Avery et al., 2013).

There has been an increase in the number of world-wide pharmacovigilance schemes which accept adverse drug reaction reports from patients/consumer and this is set to further increase due to the enactment of recent legislative changes in pharmacovigilance in the EU. However, lack of information regarding pharmacovigilance and the importance of ADR reporting as well as poor patient-HCP communication have been identified as underlying factors for under reporting of ADR’s. Inch et al. (2012) has suggested that a significant number of ADR’s may be avoided if patients are actively encouraged to take a more proactive involvement in their care. In order to understand the extent to which patient reports positively contribute towards pharmacovigilance, a comparison needs to be drawn against reports derived from a healthcare professional (HCP) origin. (EC, 2008; Inch et al., 2012; WHO, 2007; HAI; 2010).

It is openly recognised that Ireland experiences a notable degree of under reporting of suspected ADR’s (PSI, 2009). This may be due in part to a cultural bias or perhaps through a lack of understanding of the fundamental requirements of drug safety. In Ireland, as elsewhere, low levels of ADR reporting is seen as an impediment to drug safety and an obstacle to ensuring the safety of medicines. Greater efforts need to be made to increase ADR reporting (Oireachtas, 2008).

Patient reports represent a rich and meaningful source of data and there is a missed opportunity each time an ADR occurs in a consumer/patient that is not reported. Patient reports typically provide valuable quality of life type data which is usually not found to be concisely described in HCP reports. Such reports seen from a different perspective offer an alternative viewpoint.

A fifteen-country survey & literature review by Herxheimer et al. (2010) recommended that patient and consumer organisations should be empowered to take on the responsibility for analysis of qualitative data and to invest in systems and procedures to facilitate rapid response times to reporters, extending the scope to mutual exchange of data between EU affiliate patient groups and consumer organisations. (Herxheimer et al., 2010).

During 2012, the Irish Medicines Board received a total of 2,757 suspected adverse drug reaction reports in Ireland of which, 1900 were attributed to marketing authorisation holders, 799 were attributed to healthcare professional and 55 reports were submitted from patients/consumers. A further 2744 follow up reports were also received. (IMB, 2013).

During 2011, the Irish Medicines Board received a total of 2,784 newly suspected adverse drug reaction reports occurring in Ireland, were received of which 1753 were attributed to marketing authorisation holders, 1002 were attributed to healthcare professionals and 29 reports were submitted from patients/consumers. A further 3350 follow up reports were also received. (IMB, 2012).

The total number of patient/consumer reports received directly by the IMB in 2011 and 2012 represented only 1% and 2% respectively of the total volumes. A static trend has now been observed in Ireland and therein lays a welcome opportunity to aim to identify the factors for under-reporting of ADR’s with view to exploring some possible solutions to increase patient reporting in Ireland.

Patient and consumer organisations are non-profit entities which represent the opinions and attitudes of members of the public. Collaboration between patient and consumer organisations can be key to ensuring a robust rewarding consumer reporting system is created to benefit all stakeholders. Promotion of education and awareness of pharmacovigilance and its reporting system and showing patients, consumers and their organisations that their data is valuable may encourage and stimulate patient reporting (MHRA, 2011; WHO, 2012).

The Health (Pricing and Supply of Medicinal Goods) Act 2013 was recently enacted into law in Ireland, which provided for the introduction of a system of generic substitution and reference pricing (IMB, 2013). A CMDh Report published in 2011 suggested that generic substitution can influence patient compliance to treatment such as the potential for harm to occur due to confusion with similar packaging, product names, product strengths etc. Different product labelling information can also lead to confusion. Furthermore, transparency and communication were cited as important factors from the patient’s perspective (CMDh, 2011). It is worthwhile exploring the impact this evolution is likely to have in terms of AR Reporting and whether a notable increase will be observed. Other country experiences will also be drawn upon.

References

Avery, A,J., Hazell, L., Cornelius, V., Hannaford, P. & Shakir, S. (2013). How do patients contribute to signal detection? A retrospective analysis of spontaneous reporting of adverse drug reactions in the UK’s Yellow Card Scheme. Drug Safety. 36, 199-206.

Avery, A.J., Anderson, C., Bond, C.M., Fortnum, H., Gifford, A., Hannaford, PC. et al (2011). Evaluation of patient reporting of adverse drug reactions to the UK ‘Yellow Card Scheme’: literature review, descriptive and qualitative analyses and questionnaire surveys. Health Technology Assessment, 15

CMDh (2011). Interchangeability of generics. Retrieved 16Sep2013

European Commission (2008). Directive of the European Parliament and of the Council amending, as regards pharmacovigilance, Directive 2001/83/EC on the Community code relating to medicinal products for human use; Impact assessment. Retrieved 28Oct2013.

EMA (2012). Comments received from public consultation on good pharmacovigilance practices (GVP) Annex I – definitions Retrieved 05Oct2013.References

EMA (2013). PRAC’s perspective on implementation: strengthening public health protection. 7th Stakeholders Forum.

Guideline on Good Pharmacovigilance Practices (GVP) – Module VI Management and Reporting of Adverse drug reactions to Medicinal Products (2012).

HAI Europe (2010). Managing medicine risks in Europe. Patient safety comes first. Retrieved 30Sep2013.

Herxheimer, A., Crombag, M.R. & Leonardo Alves, T. (2010). Direct patient reporting of adverse drug reactions. A fifteen-country survey and literature review. Health Action International (HAI) Europe, Jan 2010.

Herxheimer, A., Crombag, R. & Leonardo Alves, T. (2010). Direct patient reporting of adverse drug reactions. A twelve-country survey and literature review. Health Action International (HAI) Europe, May 2010.

Houses of the Oireachtas (2008). Written answers; medicinal products. Retrived 22Sep2013.

IMB (2012). Annual report; protecting public and animal health. Retrieved 04Oct2013.

IMB (2013). Annual report; protecting public and animal health. Retrieved 04Oct2013.

IMB (2013). Guide to interchangeable medicines. Retrieved 30Sep2013.

Inch, J., Watson, M. & Anakwe-Umeh, S. (2012). Patient versus Healthcare Professional Spontaneous Adverse Drug Reaction Reporting. Drug Safety, 35 (10), 807-818.

MHRA (2011). ADR Reporting and Signal Management. Retrieved 19Sep2013.

Pharmacy Society of Ireland (PSI) (2009). Pharmacy Ireland 20-20 Working Group; Interim report April 2008. Retrieved 19Sep2013.

van Hunsel, F., de Langen, J. Passier, A. et al. (2008). Adverse drug reaction reporting by patients in the Netherlands; three years of experience. Drug Safety, 31, 515-524.

van Hunsel, F., Harmark, L., Pal, S., Olsson, S. & van Grootheest, K. (2012). Experiences with adverse drug reaction reporting by patients: an 11-country survey. Drug Safety, 35 (1), 45-60.

WHO (2007). WHO: “Nine patient safety solutions” to help reduce the toll of health carerelated harm affecting millions of patients worldwide. Washington/Geneva: WHO Press. Retrieved 02Oct2013.

World Health Organisation (2012). Safety monitoring of medicinal products; Reporting system for the general public. Retrieved 13Oct2013.

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