488P - Implementation of a pharmaceutical care programme for patients treated with investigational oral drugs in a clinical trials unit

Date 27 September 2014
Event ESMO 2014
Session Poster Display session
Topics Clinical Research
Translational Research
Basic Scientific Principles
Basic Principles in the Management and Treatment (of cancer)
Presenter Gisela Riu
Citation Annals of Oncology (2014) 25 (suppl_4): iv146-iv164. 10.1093/annonc/mdu331
Authors G. Riu1, I. Victoria2, L. Gaba Garcia3, G. Molas4, F. Do Pazo4, N. Creus4, B. Gomez4, L. Vidal5
  • 1Oncology Clinical Trials Unit, Hospital Clinic Barcelona, 08036 - Barcelona/ES
  • 2Medical Oncology, Hospital Clinic y Provincial de Barcelona, 08036 - Barcelona/ES
  • 3Medical Oncology, Hospital Clinic, 08036 - Barcelona/ES
  • 4Pharmacy, Hospital Clinic Barcelona, 08036 - Barcelona/ES
  • 5Medical Oncology, Hospital Clinic y Provincial de Barcelona, ES-08036 - Barcelona/ES



Oral agents provide an attractive approach to chemotherapy and its use is increasing. However, it is necessary to educate the patient to achieve a correct adherence, avoid interactions and get a correct management of adverse effects. When considering an investigational drug, the complexity increases: difficult drugs’ identification because of their presentation (packaging and labeling) which leads to an increased number of medication-related problems.

Implementing a pharmaceutical care (PC) program for oral investigational drugs in the Oncology Clinical Trials Unit of a tertiary hospital.


Prospective and descriptive intervention study conducted in cancer patients receiving oral investigational chemotherapy. The PC program was structured in interviews. Demographic data, level of patient's knowledge about the prescribed treatment and usual medication review to identify drug interactions were collected in the first visit. Subsequent follow-up interviews were aimed to assess adherence and conduct a survey of patient satisfaction.


The process of implementation of a PC program was conducted properly. Eighty-three patients were included (median age 58 years (31-80); 42 males). The 47.0% of patients admitted having doubts about the treatment. The 56.6% did not know how to take the medication in relation with food and the 77.10% what to do if they forget or vomit a dose. The overall adherence rate was 98.9%. Six interactions were detected and 23 interventions were made (13 related to drug interactions information). The reasons for non-adherence were missed doses (4 cases), voluntary decision (3 cases) and misinterpretation of the dosing regimen (2 cases). The 78.6% of patients learned something new about their treatment after the interview and 92.9% are in favor of receiving PC.


Patient's information about their investigational treatment is often incomplete. Due to the good results of adherence and patient satisfaction, individualized PC should be performed in these patients to ensure effectiveness and safety.


All authors have declared no conflicts of interest.