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GRP-077 Generic Mycophenolate Mofetil in Heart Transplant Recipients: Implementation of Active Pharmacovigilance
  1. L Calixto1,
  2. T Laranjeira1,
  3. A Mirco1,
  4. MJ Rebocho2,
  5. F Falcão1
  1. 1CHLO EPE – Hospital Santa Cruz, Hospital Pharmacy, Lisbon, Portugal
  2. 2CHLO EPE – Hospital Santa Cruz, Transplant Heart Unit, Lisbon, Portugal


Background Immunossupressant drugs have an important role in the prophylaxis of transplant rejection, so they are considered ‘critical dose drugs’. Use of a generic immunosuppressant represents a significant cost savings to the medical system. Since safety data for new medicines are always limited, post-marketing surveillance is essential to determine medicines’ safety in real life use. With the introduction of generic mycophenolate mofetil (MMF) in CHLO, EPE–HSC, the pharmaceutical services (PHS) have implemented an MMF active pharmacovigilance programme (APP) for HT recipients.

Purpose To describe and quantify suspected adverse drug reactions (ADRs) identified with an APP implemented by the PHS.

Materials and Methods Between 11/2011 and 09/2012, all adult HT recipients who switched from innovator to the generic MMF were included in the MMF APP. This substitution was made under medical supervision and the pharmacist provided the patients with all necessary explanations. Subsequent pharmaceutical assessment was done with a questionnaire (in person or telephone), which identified demographic data, concomitant treatment and suspected ADRs.

Results 55 patients were included in the MMF APP, 78% male, average age 55 ± 13 [22–76] years. 14 patients (25%) reported ADRs at MMF switch. These patients had not experienced ADRs with the innovator drug. The most common ADRs identified were diarrhoea (25%), stomach ache (12.5%) and asthenia (12.5%). All ADRs notifications were reported to the Portuguese National Pharmacovigilance Unit.

Conclusions Most suspected ADRs identified corresponded to MMF’s profile ADRs described in the summary of product characteristics. The switch to generic from innovator drug should have a surveillance strategy that includes medical monitoring, patient education and the contribution of all health professionals involved in the patient immunosuppressant regimen in order to create a system that allows adverse reactions to be detected, with the ultimate goal of maximising benefit and minimising risk by promoting safer use of medicines.

No conflict of interest.

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