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Clinical pharmacy and clinical trials (including case series)
Evolution of indicators of activity related to the management of investigational drugs in a pharmacy service over a period of 10 years
  1. M. Rabuñal Alvarez,
  2. M. Calvin Lamas,
  3. E. Fernández Gabriel,
  4. I. Martín Herranz
  1. 1Complexo Hospitalario Universitario A Coruña, Servicio de Farmacia, A Coruña, Spain


Background In the last years there has been an increase in clinical trials (CT) developed in the hospital as well as in their complexity.

Purpose Describe the evolution of the indicators of activity related to the management of investigational drugs (ID) in a pharmacy service (PS).

Materials and methods Retrospective, 2001-2010, tertiary hospital. Data source: memories of PS, hospital scorecard management and applications of CT. Variables studied: number of CT, medical specialty, patients enrolled who have dispensations of CT (outpatients/inpatients), dispensations performed, phase of the CT, visits by monitors and audits. Receipts and PS-prepared dosages recorded began in PS in January/2009.

Results 496 CT have been developed. CT/years: 94 (63% phase III) in 2001, 95 (60% phase III) in 2002, 104 (59% phase III) in 2003, 97 (65% phase III) in 2004, 87 (61% phase III) in 2005, 102 (58% phase III) in 2006, 129 (53% phase III) in 2007, 163 (53% phase III) in 2008, 147 (59% phase III) in 2009 and 175 (55% phase III) in 2010. CT/medical specialty: oncology-298, rheumatology-111, urology-61, nephrology-57, pneumology-49, HIV infection-39, endocrinology-39, haematology-38, cardiology-29, dermatology-28, hepatitis-21, liver transplantation-20, laboratory haematology-17, ICU-16, others-65. 4168 patients were included (370 inpatients/3798 outpatients). 19998 dispensations were made to patients/investigator. There were 984 medication receipts (2009-530 and 2010-454). Dosages of ID in the PS: 1408 (2009) and 1599 (2010). There have been 1876 monitor's visits and 9 quality audits (without any non-compliance). Limitations: Number of dosage and medication receipts available only from 2009. Not recorded returns and type of monitor's visits.

Conclusions There has been a significant increase in the number of CT in recent years and the resulting activity. The high number of CT and their increasing complexity requires greater dedication of PS as regards the management of ID.

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