Clinical effect of pharmaceutical products using communication tool integrated with compound of several pharmaceutical products

Abstract

A method of treating a medical condition with a combination of substances, wherein one of the substances is adalimumab, in combination with a computer program configured for: providing a patient with sets of questions adapted to the combination, to adalimumab, and to the non-adalimumab substances, wherein at least one of the sets of questions is related to perceived and/or measured therapeutic effects; subjecting the answers to the sets of questions to functions, thereby generating patient specific feedback; and adjusting a dosage of at least one substance based at least in part on the patient-specific feedback.

Description

CROSS-REFERENCE TO RELATED APPLICATIONS[0001]This application is a continuation of U.S. Ser. No. 16 / 160,519 filed Oct. 15, 2018 which was a continuation of U.S. Ser. No. 14 / 417,265 filed Jan. 26, 2015, which was a national stage application, filed under 35 U.S.C. § 371, of International Patent Application No. PCT / SE2013 / 050896 filed Jul. 12, 2013, which claims priority to SE application No. 125089-3 filed Jul. 24, 2012. Each of the previously noted applications is hereby incorporated by reference in their entirety.FIELD OF THE INVENTION[0002]The present invention relates to the field of improving the usage and clinical efficacy of pharmaceutical products in clinical practice, improving health situation of patients, where a combination of pharmaceutical products is one component in the combined product and a computer application is another.BACKGROUND[0003]Today pharmaceutical products on the market are powerful products solving health problems of the patients. However, most often the...

AI Technical Summary

Benefits of technology

[0028]According to the invention, several pharmaceutical products are integrated, in the combination product, through a QAFM, where each included pharmaceutical product in turn is integrated with an adapted question-feedback model (QFM). The specific QFM is developed and adapted based on the clinical characteristics of one single specific pharmaceutical product. The QAFM is adapted to each and multiple included QFM, and hence, each included pharmaceutical product. The QAFM is related and adapted to the combination of the included QFM:s.

[0029]One feature of the invention is that the QAFM, and the QFM:s, are developed to improve the clinical effect, the safety concerns, and the quality of life of patients, based on the clinical characteristics of the included pharmaceutical products and the circumstances and conditions of every specific patient.

[0030]According to the invention, the QAFM will enable an optimization and individualization of the different included components, such as the QFM:s, the included pharmaceutical products, the adherence and the actual dosage, based upon each specific patient's circumstances, capability and behaviour, in order to achieve an improved clinical effect, safety and quality of life. The optimization and individualization will be performed based upon the answers from each specific patient in relation to existing relevant information regarding clinical use of the actual pharmaceutical products and will be done by the QAFM and the computer program product. For example, a conclusion on such an evaluation can be that a particular patient shall increase the dosage of one pharmaceutical product and remove another. The objective is to achieve concrete increased health for each individual based upon their specific circumstances.

[0031]One aspect of the invention concerning the optimization and individualization is to continuously evaluate the health situation of each specific patient based on the input from the patient, concerning his / her behaviour and specific circumstances, in relation to the existing relevant clinical information in clinical studies or clinical practice regarding the used pharmaceutical products, the actual adherence to the pharmaceutical products, the interaction between the included pharmaceutical products, the selected dosing regimens and possible other aspects of the QAFM. Based upon this evaluation the QAFM will respond to the defined users, such as the patients themselves and the healthcare personnel, about the status of the health of the patient and recommended actions, in order to improve the clinical effect, to improve the safety or to improve the quality of life. In this way, the QAFM could, for example, respond with feedback to the relevant users that either a problem has occurred, such as an interaction between two drugs, or a positive change has happened. If a change in the used pharmaceutical products is recommended, it would most probably need to be handled by a physician.

[0032]One aspect of the invention is that the QAFM will be able to evaluate the best QFM for each specific patient based upon the specific patient's behaviour and clinical needs in relation to substance combination specific data in clinical studies and clinical practice. The type of feedback will be evaluated, as well, in order to identify and improve the feedback, given to the specific patient. The objective is to use the type of feedback achieving improved clinical effect, safety and quality of life.

[0033]One aspect of the invention is that the development of the QAFM should be dependent on each included QFM. It will be central that the QAFM will be related to the content and the characteristics of the included QFM:s and pharmaceutical products.

Problems solved by technology

However, most often they solve just a specific problem or symptom of the patient, i.e. a limited part of the patient needs; meanwhile the patient experiences a wider complex situation with several other issues and symptoms due to their illness.

A lot of drugs interact with each other often causing negative health effects for the patients and sometimes critical situations.

Today a lot of patients are forced to emergency healthcare visits due to unsuitable medication.

Today drugs on the market are thoroughly tested with regard to their clinical affect and safety during extensive clinical trials before they are approved for marketing by a national or regional Medical Products Agency, such as EMA in Europe or FDA in the U.S. In most cases, however, there are no verifications, or clinical trials, evaluating the situation of the patients in real clinical practice concerning the situation that several patients are taking a mix of multiple pharmaceuticals.

This information is often available for several different actors to utilize for researching purposes, but not effectively available directly to the individual patient using the drug.

Today drugs in clinical practice are not possible to individualize to the circumstances of each specific patient.

There is seldom any follow-up of the results of the specific patient in clinical practice, and if the patient not themselves responds in any way to the results of the medication, no action is done to improve or secure the result of the treatment.

The guidance for matching patient specific conditions to the use of pharmaceutical products is limited.

Due to the lack of adherence to medication the results of pharmaceutical treatments in clinical practice have difficulties in reaching similar results of clinical effect as the ones made in clinical trials during the development of the pharmaceutical products.

In clinical practice, however, this is difficult to achieve and the patient is mainly responsible with little or no support to accomplish it properly.

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