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Section 8
Involvement of Pharmacovigilance Centres in Medication Errors Detection: Questionnaire-Based Analysis

Question 8 | Test | Table of Contents

Over the years, the scope of pharmacovigilance has been broadening to other aspects such as detection of medication errors. As David M. Benjamin [2] so rightly pointed out, caring about drug safety and rational use of drugs is not a new topic for clinician pharmacologists. They are all involved in minimizing adverse drug reactions, medication errors and increasing patient safety.

The aim of the pilot project is to develop an extended role for National Centres of Pharmacovigilance, to include collection of information on adverse incidences relating to medication error, and to enable international analysis of these data and to disseminate findings internationally. For that purpose, the first step of the pilot project is our study. The aim is to assess the ability of pharmacovigilance centres to detect medication errors before proceeding to build patient safety via their technologies and human skills, and to underline the limits for this challenge.

Methods
Design: This is an exploratory study conducted in National Pharmacovigilance Centres (PVCs) members of the World Health Organization (WHO) International Drug Monitoring network. A specifically designed questionnaire was set up.

Countries Involved: This questionnaire was sent on March 29th, 2007 to all Pharmacovigilance Centres via Vigimed [17] network. The list included 8 National Centres (Brazil, Ghana, Italy, Malaysia, Moldova, Morocco, New Zealand, and Nigeria) which volunteered to take part in this project at the Twenty-ninth WHO Annual meeting of National PVCs meeting in Lieges [16], 2006.

Vigimed network is an e-mail information exchange system, between WHO and National Pharmacovigilance Centres. Vigimed network brings together about 320 individuals in 88 countries. It is a restricted list, open only to individuals connected to the National Centre for Pharmacovigilance or to the Drug Regulatory Authority in participating countries.

Data Collection: The questionnaire is organized in three parts. The first part relates to information about pharmacovigilance centres organization, the second part concerns progress and improvement made by centres in the field of patient safety and medication errors. The third part is a retrospective study on medication errors. Twenty-one completed questionnaires were received by the end of July 2007, representing a response rate of 23.8%. Not all questions were answered and percentages refer only to completed responses.

Results
Among the 88 countries, 21 countries answered, representing a response rate of 23.8%. Amongst the 8 volunteer National Centres, we received a response from 7 countries: Brazil, Italy, Malaysia, Moldova, Morocco, Nigeria and New Zealand. Through Vigimed network we received a response from 14 countries, representing a response rate of 15.9%: Canada, Iran, Ireland, Japan, Madagascar, Netherlands, Serbia, Singapore, South Africa, Spain, Sultanate of Oman, Sweden, Switzerland and Thailand.

Discussion
The response rate to the questionnaire was low at 24%, but since the meeting in Lieges, which canvassed active interest in PS, there is an increase of almost 50% (originally 8, now 13) in countries with an interest of PS. Our study suggests that pharmacovigilance has been growing well for the last forty years, both a growing interest in detecting and preventing medication errors. The study has shown that 62% of PVCs are interested in participating in an international prospective study of detecting Medication Errors. This confirms the commitment and involvement of PVCs to build patient safety.

PVCs and PCCs may also receive reports from the patient himself. In the study conducted by the Moroccan PCC, 22.4% of MEs were reported by patients or family. Our study shows that 66.6% of PVCs receive reports from patients themselves. This method of reporting is very helpful because patients may be able to provide details that the practitioner is not aware of (for example, sometimes injuries happen after discharge from hospital). Moreover, patients who report a ME often have the desire to avoid to present the ME again for them and for others. Sometimes patient reports are very detailed and could help with the root cause analysis [20].

Conclusion
Some countries have already undertaken work on the detection of ME. Human skills are available with good outreach to HCP and collaboration with other organizations. All communication means are available in order to optimize early detection of ADEs. Patient Safety is a challenge and needs the involvement and commitment of healthcare professionals, healthcare managers and policy makers, but this study demonstrated some limitations regarding this challenge. Main concerns are the reporting system used and awareness of healthcare professionals about the possibility of MEs. The discipline of pharmacovigilance has widened over the years.

There is still the need for effective and efficient communication to healthcare professionals about the importance of reporting ADRs and ME, and for creating a culture of patient safety. There is also a need to strengthen the collaboration between PPCs and PVCs in order to improve quality of data collected leading to enhance patient safety, and the need to build a bridge between PVCs, PCCs and organizations dedicated to patient safety in order to avoid duplication and waste of workload.

Finally, to succeed in the patient safety field, communication between countries could be very useful to optimise ME detection, with a shared database leading to detect early ME [7], to identify the most successful preventive strategies for ME; and to operate the most efficient RCA method and to share prevention actions.

Personal Reflection Exercise #8
The preceding section contained information about pharmacovigilance centres in medication errors detection. Write one case study example regarding how you might use the content of this section in your practice.
Reviewed 2023

Update
Pharmacovigilance in High-Income Countries:
Current Developments and a Review of Literature

Khan, M. A. A., Hamid, S., & Babar, Z. U. (2023). Pharmacovigilance in High-Income Countries: Current Developments and a Review of Literature. Pharmacy (Basel, Switzerland), 11(1), 10. https://doi.org/10.3390/pharmacy11010010


Peer-Reviewed Journal Article References:
McGrath, R. E. (2020). What is the right amount of training? Response to Robiner et al. Clinical Psychology: Science and Practice, 27(1), Article e12315.

Robiner, W. N., Tompkins, T. L., & Hathaway, K. M. (2020). Prescriptive authority: Psychologists’ abridged training relative to other professions’ training. Clinical Psychology: Science and Practice, 27(1), Article e12309.

Shahidullah, J. D., Hostutler, C. A., & Forman, S. G. (2019). Ethical considerations in medication-related roles for pediatric primary care psychologists. Clinical Practice in Pediatric Psychology, 7(4), 405–416.

QUESTION 8
What are Clinician Pharmacologists involved in? To select and enter your answer go to Test.

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Excerpts from Bibliography referenced in this article
[2]. D.M. Benjamin, Reducing medication errors and increasing patient safety: Case studies in clinical pharmacology, Journal of Clinical Pharmacology 43 (2003), 768–783.
[7]. I.W. Hammond, T.G. Gibbs, H.A. Seifert, et al., Database size and power to detect safety signals in pharmacovigilance, Expert Opin Drug Saf 6 (2007), 713–721.
[16]. Twenty-ninth National Centres Annual Meeting of the WHO Drug Monitoring Programme, Li`eges – Belgium, 9–11 October, 2006, Available at: www.who-umc.org/dynPage.aspx?id=30794
[20]. World Health Organization draft guidelines for Adverse Event reporting and Learning Systems, From information to action, Available at: http://www.who.int/patientsafety/events/05/Reporting Guidelines.pdf