The Pharmaceutical Journal
Vol 268 No 7193 p506-507
13 April 2002

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European Pharmaceutical Students' Association summary

Linking pharmacoeconomics and pharmaceutical care

Observational studies provide a method of bridging the gap between pharmacoeconomics and pharmaceutical care, said ANDREA MESSORI, Italian Society of Hospital Pharmacists. The two disciplines have different objectives. Pharmacoeconomics involves an evidence-based approach, and outcome assessments are important. In general, such studies do not benefit the patients from whom the data are collected but rather construct information for future patient management. However, pharmaceutical care is aimed at the better management of patients in the study. Only a minority of pharmaceutical care interventions give priority to assessing treatment outcomes. Most aim to increase information to patients or improve drug therapy without documenting whether this is clinically beneficial.

Observational studies focus on high-cost drugs. They involve direct interaction with patients seen in everyday practice, include the assessment of outcomes and aim to generate new information about the effectiveness of a drug in a real life situation. Observational studies are not difficult to conduct, he said. For example, a simple observational study is measuring survival. "It is a small task to identify whether a patient is alive or dead. If no prescription is received, the physician should be contacted to ask if the patient has died," he suggested. The rule for conducting observational studies is to include a set of consecutive patients to avoid selection bias.

The Italian Society of Hospital Pharmacists conducts observational studies at hospitals in Italy. Findings from observational studies are compared with those from randomised controlled trials. Drug manufacturers only promote studies that are likely to show a positive result for a new drug, he said. "It is important that independent groups promote independent studies to validate whether controversial drugs are worth it."

A recent study conducted by Mr Messori's group examined the survival of 213 patients treated with temozolomide for brain tumours. "The data so far indicate that the survival pattern is worse than that reported in the randomised clinical trial for temozolomide," he said. "We will now take the results to the Ministry of Health and ask them to consider the reimbursement for this drug."

A second study looked at the use of antithrombin III in 216 patients admitted to intensive care with sepsis. The study has just been completed. BENEDETTA SANTARLASCI, also from the Italian Society of Hospital Pharmacists, explained that all patients admitted to 20 hospitals over a two-month period were included in the study. A mortality rate of 34 per cent was identified. "Our findings indicate that there is no sound proof for using this drug in critical patients who do not have a congenital deficiency of antithrombin III," she said.

Mr MESSORI added that as a result of the study, hospitals' drug and therapeutics committees were discussing whether to preclude use of antithrombin III in formularies. This observational study had both pharmacoeconomic and pharmaceutical care parts. "By saving money on this drug, there will be more to spend on drugs that do improve patients' health. This is increasing the efficiency of the system," he said. "In Europe, there are frequent introductions and approvals of expensive drugs. We must have the ability to interpret data to work out if it is worth spending money on them."