PHARMACOVIGILANCE PROGRAM IN HOSPITAL UNIVERSITARIO DE LA PRINCESA – MADRID

SD Sergio Daniel, C Perez de la Campa, A Sanchez Hernandez, MD Ochoa Mazarro, F Abad Santos. Hospital Universitario de la Princesa, Madrid - 28006, Spain

OBJECTIVES: To identify and report suspected cases of Drug Induced Liver Injury (DILI) through laboratory signs in patients admitted to the Hospital Universitario de la Princesa in Madrid. Also report any suspected case of adverse drug reaction (ADR) detected spontaneously

MATERIALS AND METHODS: Through a program designed by the Computing Service of the Hospital, inpatients having an elevation of Alanine aminotransferase (ALT) ≥ 3 times the Upper Limit of Normal (ULN), Gamma-glutamyl transpeptidase (GGT) ≥ 5 ULN and Alkaline phosphatase (AP) or Total Bilirrubin (TB) ≥ 2 the ULN are identified. Subsequently, the patients were monitored or their medical records reviewed. Cases considered probable ADRs are reported electronically to the Pharmacovigilance Center of the Community of Madrid. Additionally, suspicions of ADR found by physicians at the Hospital during their practice are also notified.

RESULTS: With the start of the pharmacovigilance program from 28/09/2009, until 13/03/2012, we detected 128 probable cases of ADRs. One hundred and seven (83.59%) cases were detected through laboratory signs and 21 (16.41%) spontaneously. Patients with the highest number of ADRs are under 65 years (range 20 to 64). Through the program of laboratory signs, 2261signals were generated, after discarding those repeated in the same patient. The cases detected through laboratory signs are equivalent to 4.73% of these 2261 signals. With this program, 8 cases were different from DILI and were found incidentally. In 4 cases a patient had two different reactions, each associated with a different drug. Twenty cases (15.63%) were the cause of admission, while the remaining 107 (84.37%) were indoor patient. No case has been fatal. Adverse reactions seen and the main drugs associated are described in Tables 4 and 5. The drugs most commonly associated with DILI antibiotics and anticonvulsants. ADR suspicions were associated with a single drug in the 52.34% of cases, while two and three or more drugs in 25.78% and 21.88%, respectively (Table 6).

DISCUSSION: A hospital pharmacovigilance program significantly increases the detection of ADR. There are various methods of carrying out this program. The laboratory system signal is a useful method for detecting ADRs. This method is applicable to other types of ADR. However, it has certain disadvantages such as the need for greater availability of time and human resources to follow up cases once found the signal. As an advantage it has a greater theoretical sensitivity for finding this type of ADRs in patients who are admitted, in our experience increasing it up to 5 times. This could lead to an adequate pharmacovigilance work. Anyway, medical personnel should be encouraged to notify advADR detected spontaneously.