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Frequently asked questions (COVID-19)

How are respirator masks (face masks) controlled? What authority can I contact for more information about their use and manufacture?

Authority

Product

Requirements

Further information

Finnish Safety and Chemicals Agency (Tukes)

Respirator masks intended for consumer use

Regulation on personal protective equipment (EU) 2016/425

More information on Tukes’s website

Finnish Safety and Chemicals Agency (Tukes)

Face masks intended for consumer use

Consumer Safety Act 920/2011 and Government Decree on information to be supplied in respect of consumer products and services 613/2004

General consumer goods are not CE marked.

If the product does not meet the requirements of personal protective equipment (PPE), it is not allowed to give consumers a false impression that the product is a PPE. If face masks or similar products are marketed to consumers as respirator masks, they must meet the requirements of PPEs.

The Ministry of Social Affairs and Health, Department for Work and Gender Equality

Respiratory systems intended for professional use

Regulation on personal protective equipment (EU) 2016/425

These products are subject to EU type-examination. Requirements were reduced on 31 March 2020.
See the policy of the Ministry of Social Affairs and Health.

Finnish Medicines Agency (Fimea)

Surgical face masks intended for health care professionals

Medical Device Regulation (EU) 2017/745 or directive 93/42/EEC

The products must be CE marked. Product information must include the name and address of the responsible manufacturer. If the manufacturer is located outside Europe, also the name and address of the authorised representative in Europe must be included.

The Finnish Institute of Occupational Health (FIOH)

Expert support for respirator masks and face masks intended for both professional use and consumer use.

 

The Finnish Institute of Occupational Health is an expert and researcher of respirator masks, not an authority. FIOH previously conducted testing and certification of PPEs but the testing and certification functions were sold to SGS Fimko in the autumn of 2019.

See the bulletin published by Tukes, FIOH and Fimea (in Finnish).

How should pharmacy personnel protect themselves against infections? And how are the customers protected against infections in a pharmacy?

With regard to protecting the pharmacy personnel and the customers, It is essential to consider the following in the pharmacy premises:

  • Is it possible to re-arrange customer routes and waiting areas to maintain maximum distance between the customers and between the customers and the personnel? Are customers given clear instructions on these practices?
  • Is it possible to arrange a separate pick-up point (another door or service point, etc.,) for online orders and deliveries of pharmaceuticals to health care units?
  • Is it possible to install plexiglass screens in the service points to protect against direct droplet infection?
  • Have materials handled by several customers (toys for children, plastic folders, shopping baskets, etc.) been removed from use?
  • Is it possible to avoid contact with payment equipment and the Kela card (e.g. the customers scan the Kela card themselves, use of contactless payment, etc.)?
  • Are effective measures in place to ensure general hygiene (effective and regular hand washing, protective gloves to be replaced when necessary, use of hand sanitiser, intensive cleaning of premises and goods)?

With regard to PPEs, it should be noted that a light face mask is not sufficient on its own to prevent virus infections. They are intended to protect patients from possible respiratory droplet infection caused by the health care personnel. Read more here: light face masks do not prevent virus infections (in Finnish)

Products used to protect the user from viruses and hazardous substances in the surrounding environment are referred to as personal protective equipment (PPE). They are used in health care settings during therapeutic procedures and cleaning to prevent patients with COVID-19 from infecting others. Similar PPEs are also used in several industrial sectors, e.g. in in pharmaceutical manufacturing.

More information about protection and cleaning can be found in the guidelines for employees, workers and workplaces collected by FIOH.

General information for citizens on the protection against the coronavirus can be found on the website of the Finnish National Institute for Health and Welfare (THL).

Does antimalarial medication help against the coronavirus and are they safe?

The effectiveness and safety of hydroxychloroquine and chloroquine, which are used to treat malaria and rheumatoid arthritis, in the treatment or prevention of the coronavirus has not been studied in extensive and well-designed controlled studies. Chloroquine and hydroxychloroquine have been found effective against various viruses in cell models, including the SARS-CoV-2 virus that causes COVID-19.

After the start of the COVID-19 epidemic, several countries have started clinical patient studies regarding the treatment and prevention of clinical pictures of varying severity caused by the SARS-CoV-2 coronavirus, using various doses and treatment periods.

WHO is also starting an extensive international study that will study the effectiveness of chloroquine derivatives in the treatment of COVID-19, as well as other promising therapeutic drugs. Even though research evidence is still very scattered and uncertain, the use of these drugs is already included in the clinical guidelines of some countries. On the other hand, there has been alarming information in the media about self-medication attempts with medicinal product containing chloroquine, some of which have been fatal.

Chloroquine derivatives have known adverse effects, and even a very small overdose can lead to severe adverse effects. That is why the uncontrolled use of these combinations must be avoided.

Fimea is cooperating with other national and international authority networks as well as pharmaceutical and health care operators to make chloroquine derivatives and other medicinal products that could potentially be used in the treatment of COVID-19 available, if their controlled use is sufficiently backed by the increasing body of scientific data.

In addition, Fimea encourages research communities to participate, if possible, in the international clinical drug trials on the treatment of COVID-19 that are about to start, and has committed to the rapid assessment of related trial notifications.

What clinical drug or vaccine trials or are ongoing to treat/prevent COVID-19?

(Updated on 8 April 2020)

The first clinical drug trial on the treatment of COVID-19, REMAP-CAP (trial ID 2015-002340-14), is about to start in Finland. It is a multi-national trial with more than 50 research communities around the world.

The Finnish arm of the trial will compare two approved immune response modulators (Anakinra®,  interleukin-1 receptor antagonist, and Rebif ®, interferon beta-1a) to standard treatment in the treatment of pneumonia caused by COVID-19 among patients who require intensive care.

Ongoing clinical drug trials on COVID-19 in Europe are public, and they have been listed here: Clinical trials for COVID-19.

Ongoing clinical drug trials on COVID-19 elsewhere in the world can be found in the ClinicalTrials.gov portal.

The lists are continuously updated. Fimea has committed to prioritising the assessment of drug and vaccine trials on COVID-19.

Do light face masks protect against a virus infection?

No. A light face mask is not sufficient on its own to prevent virus infections. They are intended to protect patients from possible respiratory droplet infection caused by the health care personnel. Read more: Light face masks do not prevent virus infections (in Finnish).

Do anti-inflammatory drugs worsen COVID-19?

At the moment, there is no convincing scientific evidence of an association between ibuprofen and worsening of COVID-19 infection, and discontinuation of ibuprofen can't be recommended on this ground. The Pharmacovigilance Risk Assessment Committee (PRAC) of the European Medicines Agency (EMA) is currently evaluating safety information on the use of ibuprofen and ketoprofen in severe infections. The assessment was started in the summer of 2019, based on a study conducted by the French National Agency for Medicines and Health Products Safety (ANSM). Read more: Anti-inflammatory drugs and COVID-19 (in Finnish)

Do antihypertensive drugs (e.g. ACE inhibitors or AT-II receptor blockers) worsen COVID-19?

ACE inhibitors and AT-II receptor blockers are commonly used for the treatment of hypertension (high blood pressure) and heart failure. It has been said, that these medicines could expose the user to more severe forms of the coronavirus infection. This topic is discussed because the COVID-19 virus attaches to the target molecule of these medicinal products, angiotensin-converting enzyme 2 (ACE2). There are no scientific proof on the effect of antihypertensive drugs on the susceptibility to or progress of COVID-19 virus infection. 

Antihypertensive drugs are safe to use, and there is no scientific evidence that they would increase the adverse effects related to a virus infection. 

There are risks related to self-discontinuation of cardiac, antihypertensive and antidiabetic medication  without physician's approval. The physician in charge of the case is responsible for the medication of each patient, and possible changes in the medication should be agreed with the physician. 

EMA's press release (10 June 2020)

EMA’s press release (27 March 2020)

The European Society of Cardiology (ESC) has published a position statement on the matter

The Finnish Heart has translated the position statement in Finnish

You can also find information on the subject on THL's website

Are reliable coronavirus home tests available?

According to Fimea, rapid tests to detect coronavirus infection at home have been marketed to consumers, for example online. However, Fimea is not aware of a reliable home test so far.

Read more (in finnish): Luotettavia kotitestejä koronaviruksen testaamiseen ei toistaiseksi ole saatavilla

Should I stock up on medication?

Excessive stockpiling of medicines at home ‘just in case’ is not recommended even in the special situation caused by the coronavirus; for prescription medicines, follow the Kela guidelines for the duration of the coronavirus pandemic. If a large quantity of drugs is stored at home, there is a risk that they will expire if they are not needed.

Read more: Fimea advises against overstocking medicine

Has the coronavirus epidemic affected the availability of drugs?

Based on the information supplied by pharmaceutical companies, there are no severe issues related to the availability of medicines due to the coronavirus epidemic. Finnish health care and pharmaceutical operators are constantly working in close cooperation to prevent shortages so as to avoid problems even if the situation is prolonged.

Marketing authorisation holders are responsible for the availability of the medicinal products. They must ensure that the supply chains are flexible enough to prevent disruptions of supply. Supply chain management can include, for example, keeping extra storage or alternative acquisition of products and materials. Marketing authorisation holders must notify Fimea well in advance of any shortages of supply.

Together with pharmaceutical manufacturers and importers, Fimea is constantly evaluating the impact of the COVID-19 epidemic on the production, supply chains and stocks. Fimea has also provided pharmacies with instructions for customer service situations and advised them to always check the latest information from official sources.

The authorities are actively monitoring the situation in collaboration with other operators in the sector. Information about the situation is also regularly updated between European pharmacovigilance authorities.

How has Finland prepared for shortages?

Fimea is actively monitoring the situation. Finnish health care operators are working in close collaboration,  and information about the situation is also regularly updated between European pharmacovigilance authorities.

Together with pharmaceutical manufacturers and importers, Fimea is constantly evaluating the impact of the novel coronavirus on the availability of drugs, supply chains and stocks.

In Finland, the availability of medicinal products is also ensured by maintaining obligatory reserve supplies. This obligation concerns pharmaceutical plants, importers of medicinal products, health care units and the Finnish National Institute for Health and Welfare (THL).

Does the coronavirus epidemic in China or India affect the availability of medicines?

China and India play a role in the global manufacture of raw materials, semi-finished products and active ingredients of medicinal products but medicines are also manufactured elsewhere. Fimea has required pharmaceutical operators to secure their supply chains and to prepare by mapping alternative means of acquisition, when necessary.

Setting up a new production plant or transferring a production process to a new plant requires a lot of effort and time and it might not even be possible in some cases, unless the situation has been prepared for and alternative places of production are available.