The year in overviewAn overview of the most important events in 2019.
Events
As of 1 January, the Veterinary Medicinal Products Unit of the Medicines Evaluation Board agency (MEBa) has been assigned the official task of carrying out inspections of pharmacovigilance systems of the veterinary pharmaceutical industry for veterinary medicinal products. To this end, two employees have been appointed as inspectors. With the coming into effect of the Regulation on veterinary medicinal products (2019/6) in January 2022, inspections will start playing a larger role in veterinary pharmacovigilance by the government.
In preparation for Brexit, the Medicines Evaluation Board (MEB) carried out an inventory of the medicinal products for which the Netherlands is dependent on the United Kingdom. In this inventory, the emphasis was on critical medicinal products, such as possibly life-saving medicinal products, medicinal products for which there are no alternatives or for which switching to another medicinal product is problematic. This inventory was carried out at the request of the Ministry of Health, Welfare and Sport (VWS).
Ms J.N (Janneke) Belo was sworn in as a new member of the MEB on 10 January 2019. As a general practitioner in Valkenburg, she has a lot of experience with daily care for patients. In addition, she worked at the Public Health and Primary Care Medicine of the LUMC as Head NHG Policy and Management Training until 1 September 2019.
Ton de Boer discussed current topics regarding medicinal products and explained what we do as MEB in eleven articles in 2019. These articles were published in various regional newspapers and dealt with topics such as shortages, opioids and package leaflets.
The topic of the 2019 MEB Science Day was Advanced Therapy Medicinal Products (ATMPs). Developments in science and technology provide new opportunities in the field of innovative medicinal products, such as tissue manipulation and gene and cell therapy. These advanced therapies offer many new possibilities, but there are still many challenges to overcome. This topic was discussed extensively during the Science Day 2019.
The Medicine shortages and defects notification centre published its figures in March 2019 regarding the number of notifications of possible supply problems for medicinal products in 2018. This amounted to 1,390 in 2018, compared to 536 in 2017. This increase can mainly be attributed to the fact that companies are more familiar with the notification centre, but also because the shortages of medicinal products have increased.
After earlier recalls of valsartan in 2018 due to impurities involving nitrosamines, another recall took place in March 2019 for the same reason. This time it concerns a limited number of medicinal products that contain losartan, a medicinal product that, just as valsartan, is a blood pressure reducer from the group of the ‘sartans’. A recall was also initiated in other European countries.
After a shortage of over one year, the narrow spectrum antibiotic feneticilline (Broxil) became available again. After the producers had submitted the necessary data of a new raw materials producer to the MEB, the Board was able to approve this new producer, after which the production could be resumed.
Ms A.M. (Annet) Bosch was sworn in as a new member of the MEB on 4 April 2019. As a paediatrician, she specialises in metabolic diseases. She is the head researcher of the Amsterdam UMC in this field. In addition, Ms Bosch is the coordinator of the expertise centre Metabolic Diseases AMC and AMC representative at the European Reference Network for hereditary metabolic diseases.
The composition of the thyroid medicine Euthyrox changed in 2019. In order to remove patients’ possible concerns about the new composition of this medicinal product, the MEB held consultations with various stakeholders before the introduction of this new composition. The introduction of this new composition went smoothly with the help of the Dutch Thyroid Organisation, the Dutch Pituitary Foundation, the Dutch Association for Endocrinology, the pharmacists association KNMP and the market authorisation holder.
The MEB and the Dutch National Healthcare Institute (ZIN) have joined forces to shorten the time from the registration up to and including the reimbursement of a medicinal product. We do this in the pilot ‘Parallel Procedures MEB-ZIN', in collaboration with parties including the Innovative Medicines Association and HollandBIO.
The contraceptive pill supply has stabilised again as from the end of May 2019. Most companies that supply the contraceptive pill were able to produce sufficient pills and meet the demand. Therefore, the MEB cancelled the advice to pharmacist to provide the contraceptive pill for a maximum period of three months.
The theme of the MEB Board Day 2019 was confidence in medicinal products. Various aspects of this topic were examined and discussed in several plenary sessions and parallel workshops. However, other topics were also touched on: from pharmacovigilance to the proper use of opioids and from risk-based quality tests to herbal products. Before the Board Day, the Nivel had carried out an inventory, at the request of the MEB, of the confidence of Dutch people in medicinal products.
An extensive list of patient-friendly translations of medical terms and a list of sample sentences, which have both been tested extensively. These are resources that can be used by anyone who wants to provide good quality information about medicinal products and their usage. The MEB programme ‘Better Use’ launched the ‘Toolkit for an understandable package leaflet’ in July 2019, in collaboration with expertise centre Pharos and other parties.
The combination of herbals and medicinal products can sometimes be detrimental to a person's health. However, not everybody is aware of this. In the campaign, the MEB asked attention for the use of medicinal products in combination with herbal products that are often used. The aim is to increase awareness among the users of medicinal products and care providers that herbal products can have an influence on the effect of (other) medicinal products.
The Veterinary Medicinal Products Unit of the MEBa held a stakeholders day on Monday 23 September 2019 at Ouwehands Zoo in Rhenen. The main topic was the implementation of the new regulation on veterinary medicinal products and the regulation on medicated feeds. Various speakers from the Netherlands and Europe discussed the ramifications of the implementation of the new regulations from their own perspective.
All marketing authority holders must test their medicinal products for possible nitrosamine impurities. This precautionary measure was imposed by the European Medicines Agency (EMA) in consultation with all national medicine authorities, including the MEB.
A large share of the ranitidine on the Dutch market was recalled in connection with possible NDMA impurities. This took place following the decision of the market authorisation holders in question in consultation with the MEB and the Dutch Healthcare and Youth Care Inspectorate (IGJ). Ranitidine is an antacid which is available both on prescription and over the counter.
After years of preparation, an important amendment of an international directive for medicinal products research will be implemented. As a result, hundreds of thousands fewer test animals will be needed than is currently the case. The MEB was closely involved in the amendment of this directive. The now amended directive concerns research into the harmfulness of medicinal products during pregnancy.
The guide ‘Zó werkt de geneesmiddelenzorg’ [This is how medicinal products care works] was published on 18 November. This publication from the ‘Platform Zó werkt de Zorg’, provides an overview of the system of Dutch medicinal products care: from development to assessment, reimbursement and distribution. Many parties that play a role in the medicinal products care, including the MEB, collaborated to produce this book.
The international Adverse Events Week started on 25 November 2019. This is an annual campaign in which 57 countries participated in the past year. In the Netherlands, the MEB and the Netherlands Pharmacovigilance Centre Lareb participated in this campaign. The aim of this week is to create awareness among the users of medicinal products and care providers of the importance of reporting adverse reactions, certainly when a person uses several medicinal products at the same time.
