Application observation

In the field of medical research, application observation ( AWB ) is the term used to describe non-interventional studies that are designed to gather information on the use of approved or registered drugs . Observations of use are to be distinguished from clinical studies - and thus also in Germany from the applicability of Sections 40 to 42 of the German Medicines Act (AMG).

Concept and classification

According to § 28 para. 3 AMG, the NCA can against the pharmaceutical company by supporting order, in the interest of drug safety to conduct surveillance studies.

In § 67 para. 6 AMG, the obligation of the pharmaceutical entrepreneur is regulated, "studies that are intended to gather evidence in the application approved and registered drugs" with the competent doctors' Confederation , the Central Federal Association of Health Insurance and the competent federal authority to sign .

The Federal Institute for Drugs and Medical Devices (BfArM) defined the term as follows in its recommendations for the planning, implementation and evaluation of observational studies of November 12, 1998:

“Application observations are observational studies that are intended to collect knowledge about the use of marketable drugs. Its special characteristic is the extensive implementation of the therapy in individual cases. The aim is the observation of treatment measures in routine use by the doctor and patient. An application observation can be carried out without a comparison group, e.g. B. drug-oriented, or with two or more groups to be compared, e.g. B. indication-oriented. It is carried out with merchandise. "

In contrast to clinical studies, observational studies are therefore prospective or retrospective observational studies in the form of cohort studies . Their aim is to document a large number of individual cases and then to submit them to a special assessment. Application observations do not follow a test plan . However, there is - at least in the ideal case - a study plan that is essentially composed of an observation and an evaluation plan.

The client is not allowed to impose special therapy or diagnostic procedures or additional examinations on the attending physician beyond the patient-specific therapy, which means a reduction of the risk for the patient. During the observation period, the doctor should collect the findings according to uniform standards. Because of the non-interventional character of the post-treatment study, there is neither a legal obligation nor a practice of additional patient insurance.

There is no explicit legal definition of the term post-use monitoring in the Medicines Act .

Purpose of observation of use

Theoretically, an AWB enables the client, usually a pharmaceutical company, to gain knowledge about the risks and side effects as well as the effectiveness of the preparation for the safety of patients. Compared to the clinical trial, an AWB can observe a larger group of patients over a longer period of use. In this way it may be possible to discover drug side effects that occur relatively rarely or only over a longer period of use. In addition, it can lead to the identification of unknown, rare safety problems and recognition of risks in certain population groups (pregnant women, patients of different ages or genders). In addition to the AWB initiated by the pharmaceutical company, the competent higher federal authority can also, in accordance with Section 28 (3a) AMG, order the AWB to be carried out and submit the results of the investigation.

Implementation and frequency of AWB

For an AWB, the doctors involved enter their observations in a questionnaire or tick the appropriate boxes. Corresponding laboratory data may be attached. They receive a fee for this from the contracting company. In 2014, 10% of the approximately 17,000 resident doctors took part in an AWB. In 2019, according to the Association of Statutory Health Insurance Physicians, there were 438 AWBs on 358 medicines with 18,500 participants.

Effects of the observations

According to a study by evaluating the data of almost 7000 doctors, participants in an AWB are prescribing the corresponding drug significantly more often: the prescriptions were around 8% higher. Even one year after the end of an AWB, the prescriptions were still 7% higher than in the comparison group.

AWB can be an incentive for the doctors involved, possibly not to prescribe the best medication for the patient, but one for which there is an additional premium.

Remuneration

The range of remuneration from the pharmaceutical company for a medical doctor's participation in an AWB is between 100 and 7,000 euros per patient. According to the National Association of Statutory Health Insurance Physicians, doctors received an average of 140 euros per patient from the respective pharmaceutical company in 2019; the highest “expense allowances” paid were 1,437 euros per patient. The Allergan company, for example, paid 375 euros per patient for observations on the application of eye drops.

reception

Observations of use are criticized, both from the scientific side and from the National Association of Statutory Health Insurance Physicians and several state associations of statutory health insurance physicians. It is particularly pointed out that only a very small number of observational studies are methodologically backed up (by study plans, protocols, etc.). It is also criticized that most of the AWB is not published, although this is intended according to the Federal Institute for Drugs and Medical Devices (BfArM). The pharmaceutical companies are accused of using observational studies merely as a marketing tool to increase sales of their drugs.

It is also criticized that the federal government rejected an amendment to the ABW in 2916, although apparently essential facts seem to be unknown to it.

It is also discussed whether the participation of the doctors in the observational studies does not even constitute a criminal offense of corruption .

For Karl Lauterbach , SPD health expert, AWB are “a kind of legal corruption. ... The observations made in ABW have no scientific value. ... In this respect, ABW are nothing more than a strategy of the company to give the doctor a share of the prescriptions. That leads to false incentives. ”Doctors would have to report side effects anyway.

Web links

Individual evidence

↑ Rinke, Alexander / Tubis, Robert: The application observations in the light of the GKV-WSG - Does the collection of data during application observation violate the new regulation of § 305a sentences 4 and 5 SGB V ? , PharmaRecht, issue 09/2007, p. 375.

^ Report on the study on ABW

↑ ARD-Tagesschau: Pharma sponsoring - when doctors let themselves be seduced

↑ criticism from CORREKTIV

↑ ARD-Tagesschau on ABW

^ Report on the study on ABW

↑ KVN prescription info no. 7 Observations of use in accordance with Section 67 (6) of the German Medicines Act (AMG) Lower Saxony Association of Statutory Health Insurance Physicians, May 2003