On 2017 Aug 06, Andrea Messori commented:

Clinical and administrative issues in the in-hospital management of innovative pharmaceuticals and medical devices

by Andrea Messori and Valeria Fadda

ESTAR, Regional Health System, via San Salvi 12, 50100 Firenze (Italy)​

Innovative treatments are increasingly being developed for a variety of disease conditions, particularly in the field of pharmaceutics and medical devices. In this scenario, two needs have clearly emerged in the past years: firstly, the activities of horizon scanning, assessment of innovation, and prediction of health-care expenditure for the new products are becoming more and more important in practical terms, thus underscoring that all the main components HTA must be strengthened to improve the governance of in-hospital innovation; secondly, in most jurisdictions of national health systems (NHS), the management of innovation includes also the administrative process of procurement, and so this mix of clinical and bureaucratic pathways further complicates the practical handling of the new products. On the other hand, optimizing the supply chain and the procurement of pharmaceuticals and/or medical devices is known to be essential for the governance of public health-care [1].

To our knowledge, the current medical literature does not comprise any real-life experience in which the management of new products for in-hospital use has been described in the context of a public NHS by examining both clinical and administrative aspects. In this brief report, we present one such experience that has been carried out in 2017 in a regional setting (the Tuscany region) of the Italian NHS.

The Tuscany region includes a total of 3.75 million inhabitants; there are 7 separate Local Health Authorities with an overall number of 27 hospitals and 11,000 beds.

Since 2014, the requests for any new pharmaceutical or medical device by the regional hospitals are submitted through a regional website. The activity carried out in May 2017 (601 requests) has been taken as an example.

If one examines separately the data for pharmaceuticals (N=436) and medical devices (N=165), the reasons for these requests were of administrative nature in 42% of cases for pharmaceuticals and in 84% of cases for devices; in more detail, administrative requests dealt with the need to extend a contract close to expiration or to run a new tender including some new products in replacement for the old tender. New products were requested in 38% and in 16% of cases for pharmaceuticals and devices, respectively, but most of these new products could not be classified as innovative (according to the criteria of our national medicines agency [2]). Overall, there were only 3 innovative products -two medical devices and one drug-, and their requests, according to our internal procedures, were transmitted to the Regional Unit responsible for HTA reports. These 3 products that met our criteria for innovation represented only 0.5% of all requests received at our website.

In conclusion, in the perspective of public hospitals, our experience shows that the management of innovation raises several practical problems because clinical and administrative aspects often co-exist and cannot be easily separated from one another. One risk in this joint management of clinical and administrative issues is that administrative criteria eventually prevail over a sound HTA assessment of the product concerned.

References

[1] Seidman G, Atun R. Do changes to supply chains and procurement processes yield cost savings and improve availability of pharmaceuticals, vaccines or health products? A system-atic review of evidence from low-income and middle-income countries. BMJ Glob Health. 2017 Apr 13;2(2):e000243.

[2] Motile D, De Ponti F, Peruzzi E, Martini N, Rossi P, Silvan MC, Vaccheri A, Montanaro N. An update on the first decade of the European centralized procedure: how many innova-tive drugs? Br J Clin Pharmacol. 2006 Nov;62(5):610-6.

On 2017 Aug 06, Andrea Messori commented:

Clinical and administrative issues in the in-hospital management of innovative pharmaceuticals and medical devices

by Andrea Messori and Valeria Fadda

ESTAR, Regional Health System, via San Salvi 12, 50100 Firenze (Italy)​

Innovative treatments are increasingly being developed for a variety of disease conditions, particularly in the field of pharmaceutics and medical devices. In this scenario, two needs have clearly emerged in the past years: firstly, the activities of horizon scanning, assessment of innovation, and prediction of health-care expenditure for the new products are becoming more and more important in practical terms, thus underscoring that all the main components HTA must be strengthened to improve the governance of in-hospital innovation; secondly, in most jurisdictions of national health systems (NHS), the management of innovation includes also the administrative process of procurement, and so this mix of clinical and bureaucratic pathways further complicates the practical handling of the new products. On the other hand, optimizing the supply chain and the procurement of pharmaceuticals and/or medical devices is known to be essential for the governance of public health-care [1].

To our knowledge, the current medical literature does not comprise any real-life experience in which the management of new products for in-hospital use has been described in the context of a public NHS by examining both clinical and administrative aspects. In this brief report, we present one such experience that has been carried out in 2017 in a regional setting (the Tuscany region) of the Italian NHS.

The Tuscany region includes a total of 3.75 million inhabitants; there are 7 separate Local Health Authorities with an overall number of 27 hospitals and 11,000 beds.

Since 2014, the requests for any new pharmaceutical or medical device by the regional hospitals are submitted through a regional website. The activity carried out in May 2017 (601 requests) has been taken as an example.

If one examines separately the data for pharmaceuticals (N=436) and medical devices (N=165), the reasons for these requests were of administrative nature in 42% of cases for pharmaceuticals and in 84% of cases for devices; in more detail, administrative requests dealt with the need to extend a contract close to expiration or to run a new tender including some new products in replacement for the old tender. New products were requested in 38% and in 16% of cases for pharmaceuticals and devices, respectively, but most of these new products could not be classified as innovative (according to the criteria of our national medicines agency [2]). Overall, there were only 3 innovative products -two medical devices and one drug-, and their requests, according to our internal procedures, were transmitted to the Regional Unit responsible for HTA reports. These 3 products that met our criteria for innovation represented only 0.5% of all requests received at our website.

In conclusion, in the perspective of public hospitals, our experience shows that the management of innovation raises several practical problems because clinical and administrative aspects often co-exist and cannot be easily separated from one another. One risk in this joint management of clinical and administrative issues is that administrative criteria eventually prevail over a sound HTA assessment of the product concerned.

References

[1] Seidman G, Atun R. Do changes to supply chains and procurement processes yield cost savings and improve availability of pharmaceuticals, vaccines or health products? A system-atic review of evidence from low-income and middle-income countries. BMJ Glob Health. 2017 Apr 13;2(2):e000243.

[2] Motile D, De Ponti F, Peruzzi E, Martini N, Rossi P, Silvan MC, Vaccheri A, Montanaro N. An update on the first decade of the European centralized procedure: how many innova-tive drugs? Br J Clin Pharmacol. 2006 Nov;62(5):610-6.