Drug treatment in pregnancy.

When considering drug therapy in pregnancy, the risk of treatment for the embryo/fetus has to be weighed against the risk to the mother and the child of carrying out no treatment. This is of particular relevance in certain conditions like diabetes, epilepsy or AIDS, where the risk of embryopathy is increased when no treatment is carried out and the available drugs are potentially teratogenic. However, carefully selected drugs and close meshed monitoring may even decrease the risk for the child. In many instances, unintentional drug exposure occurs in the period before the pregnancy has been diagnosed. This may lead to additional diagnostic measures or even abortion of an otherwise wanted child. In both situations, planned and unintentional drug exposure during pregnancy, insufficient information is available on the clinical conditions relevant here and the specific drugs involved. Identification of potential teratogenic effects of a new drug takes place during the early development phase. However, animal models may not be representative of specifically human characteristics, e.g. deficiences in enzymes. Since drug treatment is generally best avoided during pregnancy, pharmacokinetic studies in this population are rare. However, physiological changes, known to be relevant for some drugs do occur during pregnancy. In order to improve knowledge on the pharmacokinetics of drugs in pregnancy, population pharmacokinetic approaches may represent a solution. Intensive efforts to investigate the efficacy and safety of drugs during pregnancy are necessary. Since controlled clinical trials are usually not feasible due to ethical reasons, intensified collection of case reports as well as epidemiological studies are warranted to gain sufficient information for the counselling of pregnant women.

[Structure and activities of drug committees in Germany. Results of a survey of 143 hospitals. Pharmaco-economic Study Group and Rational Drug Therapy of the German Society of Clinical Pharmacology and Therapy]. / Struktur und Aktivitäten von Arzneimittelkommissionen in Deutschland. Ergebnisse einer Umfrage an 143 Krankenhäusern. Studiengruppe Pharmakoökonomie und rationale Arzneimitteltherapie der Deutschen Gesellschaft für Klinische Pharmakologie und Therapie.

BACKGROUND: To obtain information on the structure, present activities and decision making process of hospital drug committees in Germany in 1995 a questionnaire with 36 items was designed and sent to 450 hospitals in Germany with more than 400 beds. 143 returned questionnaires could be evaluated. RESULTS: According to hospital size the median value of the annual drug budget 1993 ranged between DM 2.4 Mio for hospitals with less than 500 beds and DM 30.0 Mio for university hospitals with more than 1,000 beds (including blood and blood derived products). In 53% of drug committees a pharmacist held the position of the chairman, followed by medical specialists (32%), (clinical) pharmacologists held this position only in 8% of the hospitals, but in almost 50% of the university hospitals. In most cases all clinical specialties are represented in the drug committee, the number of members ranging between 5 and 40 (median 12). The number of drugs included in the internal drug list ranging between 400 in hospitals with < 500 beds and about 700 in university hospitals was strongly correlated with the number of beds and, interestingly, with the number of drug committee members. Treatment guidelines were implemented mainly for antiinfectives (87%), infusion solutions (30%), antiemetic drugs (5-HT3-receptor antagonists, 27%) and blood and blood-derived products such as intravenous immunoglobulins (23%). However, effective control of these guidelines was only performed in about 50% of the hospitals. A drug information service was provided in most hospitals, where 95% of queries were answered by pharmacists. CONCLUSION: The results of our survey showed, that German hospital drug committees vary considerably with regard to their function and control mechanisms on drug use. Most of the responders would appreciate a more intensive exchange of current problems and treatment guidelines.

Structure and activities of hospital drug committees in Germany.

OBJECTIVES: Hospital drug committees have been established to ensure rational drug use. However, with regard to their structure and duties remarkable differences between European countries may exist, reflecting the differences in drug legislation and market. Our aim was to obtain information about the structure, present activities and decision-making processes of hospital drug committees in Germany and especially the role of clinical pharmacologists in these committees. METHODS: In 1995, a questionnaire with 36 items was designed and sent to all 450 hospitals in Germany with more than 400 beds. One hundred forty three returned questionnaires were evaluated. RESULTS: According to hospital size, the median value for the annual drug budget (including the cost of blood and blood-derived products) in 1993 ranged between DM 2.4 million for hospitals with less than 500 beds and DM 30.0 million for university hospitals with more than 1,000 beds. In 53.2% of drug committees, a pharmacist holds the position of chairman, followed by medical specialists (32%); (clinical) pharmacologists hold this position in only 7.7% of the general hospitals, but in almost 50% of the university hospitals. In most cases, all clinical specialities are represented in the drug committee the number of members ranging between 5 and 40 (median 12). The number of drugs included in the internal drug list, ranging between 400 in hospitals with < 500 beds and about 700 in university hospitals, strongly correlated with the number of beds and, interestingly, with the number of drug committee members. Treatment guidelines were implemented mainly for antiinfectives (87%), infusion solutions (30%), anti-emetic drugs (5-HT3-receptor antagonists, 27%) and blood and blood-derived products such as intravenous immunoglobulins (23%). However, effective control of these guidelines was only performed in about 50% of the hospitals. A drug information service was provided in most hospitals, where 95% of queries were answered by pharmacists. CONCLUSION: The results of our survey showed that German hospital drug committees vary considerably with regard to their function and control mechanisms of drug use. Most of the responders would appreciate a more intensive exchange of current problems and treatment guidelines. Although the process of pharmacotherapeutic decision making should be supported by clinical pharmacologists, experts in this field are often not involved in German hospital drug committees.