1. Risk Minimization Actions within Pharmacovigilance Centres Building a Public Health new Risk Minimization Plan ISoP Tianjin, China
G. Benabdallah, L. Alj, R. Benkirane, R. Soulaymani Bencheikh
Centre Anti Poison et de Pharmacovigilance du Maroc. Rabat, Morocco
Background Risk Management Plan (RMP) including risk minimization actions is done in specific situations to oblige Marketing Authorization Holder to put in place actions intended to prevent or reduce the probability of the occurrence of an adverse reaction associated with the exposure to a medicine or to reduce its severity should it occur1. RPM is intended to ensure patient safety. Pharmacovigilance centres and public health care settings need to put in place Risk Minimisation Plans focused on public health in order to reduce harms and to improve patient safety.
Objective Given the experience of the Moroccan Pharmacovigilance Centre (MPC) in Risk Minimisation Actions, the aim of our poster is to highlight 5 Risk Minimization Actions done by the MPC and their impact on patient safety.
Methods
It is a review of actions taken by the Moroccan Pharmacovigilance Centre.
Through the Moroccan pharmacovigilance database, 5 signals leading to alerts have
been detected. These triggered alerts concerned the Vitamin D and
nephrocalcinosis in newborn, Metoclopramide and extrapyramidal syndrome,
Methylergometrin and cardiovascular disorders, Flucloxacillin and tissular necrosis
and Paracetamol in children and hepatic troubles.
The Method used for each detected alert is the root cause analysis using the Ishikawa diagramme2 in order to look for contributing factors leading to preventable ADRs occurrence and to put in place Risk Minimisation Actions.
Contributing risk factors identified are associated to methods used as regulations, procedures and protocols, to patients and relatives, to the medicine used and to health care professionals.
Figure 1: Ishikawa Diagramme
Results
Risk Minimization Actions taken towards the triggered alerts concerned regulation actions involving the Moroccan Health Authority and Marketing Authorization Holders:
with changes in recommended doses for Vitamin D from UI to UI used for preventing rickets in newborn,
With changes in posology for Metoclopramide used in children,
With changes in the patient package insert for Vitamin D by adding the new recommended dose and by providing a patient package insert in arabic and in french , and by adding the necessary information leadding to avoid recurrence of tissular necrosis with Flucloxacillin
With changes in medicine packaging for Paracetamol by adding a child picture
With changes in the medicine formulation by withdrawing drops formulation for Methylergometrin leading to avoid
Risk Minimization Actions taken focused also on
Sensitization and information of health care professionals on rational use of these medicines
Education and trainings of patient and relatives on risk of selfmedication for metoclopramide, Vitamin D, Paracetamol and Methylergometrin
Training health Care Professionals in principles of prescribing and dispensing medicines and in principles of Good practice of injections
Following these different actions, the number of these preventable adverse drug reactions decreased.
Table 2: Risks factors identifies/Risk Minimization Actions n
Conclusion
These risk minimization actions are targeted actions done in a specific situation leading to reduce the risk of recurrence of medication errors. Actions have been done with the involvement of all concerned parties but in some cases, we were facing a lack of awareness about what could be done by pharmacovigilance centres
Pharmacovigilance centres should reinforce their roles around Patient Safety objectives and should build Risk Minimization Plan to systemize risk minimization actions for public health settings in order to complete the one done by marketing authorization Holders and then there is a need of guidance on how to do.
References 1 - Guideline on good pharmacovigilance practices (GVP) Module V(Rev 1) EMA/ /2011 Rev 1
2 - Rex, John H.; Turnbull, Joanne E.; Allen, Steven J.; Voorde, Kathryn Vande; Luther, Katharine. Systematic Root Cause Analysis of Adverse Drug Events in a Tertiary Referral Hospital. Joint Commission Journal on Quality and patient Safety. Volume 26, Number 10, October 2000, pp (13)