Julkaistu numerossa 4/2020

Remote inspections, a new surveillance tool

Remote inspections, a new surveillance tool

Fimea started remote inspections of pharmacies in August. The aim is to make remote inspections a permanent tool in addition to on-site inspections. 

The number of annual pharmacy inspections has risen, and Fimea has reformed the monitoring of medicines retailing. One new method is the remote inspections of pharmacies. This reform enables more extensive pharmacy inspections. 

Fimea started planning the introduction of remote inspections a year ago, before the start of the COVID-19 pandemic. At that time, inspector Päivi Luhtanen was finalizing her M.Sc. (Pharm.) studies and started to develop remote pharmacy inspections in her pro gradu thesis.

– I studied what the remote inspection process should be like. As part of the development work, we created an extensive electronic query form that forms the foundation for the remote inspections. The form was created in cooperation with Fimea’s pharmacy team which has the best expertise on the steps of pharmacy inspections, says Luhtanen. 

The COVID-19 pandemic accelerated the preparations for the remote inspection practices, and the first remote inspections were carried out in August without a pilot phase. 

– So far, we have carried out eight remote pharmacy inspections. Some of the inspections were targeted on a specific issue, such as pharmacy online services, and some remote inspections covered all aspects of the inspection, says Pirjo Rosenberg, Head of Section, Senior Pharmaceutical Inspector.

How are the remote inspections carried out? 

Remote inspections of pharmacies are conducted in the same way as regular on-site inspections. A pharmacy that is suitable for remote inspection is selected from the annual inspection plan. An example of a suitable pharmacy is a pharmacy that has undergone an on-site inspection before but has a new owner who has received her/ his first pharmacy license. 
Before the actual remote inspection, the pharmacy owner receives an extensive electronic query form in advance. The pharmacy owner is given a week or two to fill out the query and submit it to Fimea. The pharmacy owner may also be requested to send other documentation regarding the pharmacy’s operations to Fimea beforehand. Confidential material is sent by secure email. 

The actual remote inspection is usually carried out by two inspectors. On the day of the inspection, the inspectors discuss the information given in the advance query with the pharmacy owner. During the remote connection, it is possible to present documents and pharmacy premises, etc. The standard duration of an inspection is approximately five hours, including one pause. 

A final discussion takes place at an agreed time after the inspection. All findings made during the inspection are reviewed during the final discussion. If considered necessary, an on-site inspection can be decided to complement the remote inspection.  

After the final discussion, Fimea will request statements on the draft list of deficiencies, prepare an inspection record and send a copy to the pharmacy owner.  

However, everything cannot be inspected remotely. 

– For example, pharmaceutical production and new premises must be inspected on-site, explains Rosenberg. 

Remote pharmacy inspections mean more flexibility 

Experiences on both sides have been positive. Customers have given positive feedback on efficiency and the extensive query form that the inspections are based on.  

– The electronic query form has been especially well received. It has also helped pharmacies to evaluate their own performance and conduct internal audits, says Luhtanen.

Remote inspections mean more flexibility to both the inspectors and the pharmacy owners. No travel time is needed, and savings can be made because there are no travel and accommodation costs. 

– One of the benefits of the remote inspections is that we have more flexibility to invite other Fimea experts to join the remote inspection, adds Anna von Bonsdorff-Nikander, Senior Pharmaceutical Inspector.  

Remote inspections are also slightly more economical for pharmacies. At the beginning of next year, remote pharmacy inspections will be included in the Decree of the Ministry of Social Affairs and Health on fees chargeable by Fimea.  

Putting technology into better use

A new process is refined on the way, and the aim is to put technology into even better use in the future. 

– In the future, we can get even more out of technology. The pharmacy owner can, for example, show the premises and other targets of the inspection to the inspector, says von Bonsdorff-Nikander.  – In case of hospital pharmacies, for example, the inspectors must be able to see a lot of the premises, and this way remote inspections could also be used more for hospital pharmacies.

It is still difficult to evaluate how large a share of pharmacy inspections could be conducted remotely in the future but Rosenberg believes that remote inspections will be utilised a lot.

The new normal of pharmaceutical manufacturer inspections

The COVID-19 pandemic forced European authorities for medicinal products to switch to distant assessments on a tight schedule. 

The authorities for medicinal products within the EU/EEA inspect regularly pharmaceutical manufacturers within their area, as well as the manufacturers outside the EEA who import medicinal products into the EEA. In normal conditions, manufacturer inspections are carried out on the site. The COVID-19 pandemic changed the normal practice, however, and the focus shifted to distant assessments. 

–  The aim is to continue distant assessments of pharmaceutical manufacturers until the pandemic is over, says Mervi Saukkosaari, Senior Pharmaceutical Inspector, Head of Section, Fimea. 

Distant assessments of pharmaceutical manufacturers are based on risk assessment 

In the spring, the European Commission decided on flexibility of legislation during the pandemic to ensure better availability of medicinal products while continuing to supervise the pharmaceutical industry during the pandemic. One of the actions is the automatic extension of GMP certificates until the end of 2021. 

Flexibility during the pandemic also enables the authorities to assess pharmaceutical manufacturers distantly more widely than normally. For example, manufacturers of sterile medicinal products or manufacturers not supervised earlier by EEA authorities can be assessed and approved distantly during the pandemic.   

Inspectors of pharmaceutical manufacturers faced a big challenge when the pandemic made on-site inspections impossible. Pharmaceutical manufacturers may be associated with complex production and analysing technology, and inspections of large production premises and laboratories.

–  We have to consider what can be assessed distantly. Production of sterile or biological medicinal products is very challenging, for example. On the other hand, if there is a great need for a certain medicinal product in the EU, we must conduct some supervision activities, continues Saukkosaari. 

The choice and scheduling of distant assessment  targets are based on risk assessment, like the entire inspection operations. In the risk assessment, the supervisory EU inspector assesses, for example, how critical the medicinal products manufactured in the plant are for the EEA, how complex is the production and how good is the compliance history of the site.

– Based on the risk assessment, we decide if the inspection is carried out distantly or on-site. The assessment is also the basis for deciding what manufacturers can continue to operate based on the previous GMP certificate until the end of next year without a new inspection. A common risk assessment approach is applied to the entire EU, and all manufacturers are treated equally, emphasises Saukkosaari.

A decision of the inspecting authority applies to all EU/EEA countries: if a manufacturer receives a GMP certificate, medicinal products can be imported to all EEA countries.

Distant assessments a new tool for pharmaceutical manufacturer inspections?

While the push for distant assessment of pharmaceutical manufacturers came from the pandemic, Fimea had already considered them before. 

For example, pharmaceutical manufacturers with a good quality history over several years or plants operating in a narrow sector could occasionally be assessed distantly.  

In the future, distant assessments would call for a unified position of the European authorities for medicinal products. So far, distant assessment of pharmaceutical manufacturers is restricted to the duration of the pandemic.