It became clear in 2016, that the process for reporting a possible shortage of a medicine had to be improved in order to put an end to the unclear situation for medicine manufacturers and to ensure that patients are confronted with medicine shortages less often. Therefore, the MEB took a number of measures in 2017. The taking into use of the ‘Medicine shortages and defects notification centre’ was an important step.
The notification centre was launched on 1 January 2017 at the request of the Ministry of Health, Welfare and Sport (VWS). The coordination is in the hands of the MEB and the Dutch Health and Youth Care Inspectorate (IGJ, previously IGZ). For the first time, there is now one point of contact with a standardised reporting form. Manufactures are required to report shortages to the notification centre and they are also required to report the introduction of a new medicine.
The notification centre has ended the unclear situation regarding the reporting of shortages. Up to 2017, manufacturers were required to report expected shortages to the MEB and unexpected shortages to the Netherlands Health Care Inspectorate. As a consequence of this unclear situation, manufactures often did not report anything because they did not know whether and where they were supposed to report a shortage.
“Market authorisation holders are legally obliged to report a shortage two months before a possible shortage occurs. And now we have set it up in such a manner that they only have to report this to one central point. Depending on the type of notification, it is either sent on to the MEB or to the Health and Youth Care Inspectorate (IGJ) or to both organisations. The manufacturer no longer has to think about this,” Sandra Kruger explains. Up to the end of 2017, she was secretary of the MEB Board and member of the Working Group Medicine Shortages.
The Notification Centre gives the MEB and IGJ more room to act: “We now have a complete picture and we do not have to ask the manufacturer all sorts of questions, we can start working on finding the best solution directly. In addition, we also examined what we asked of manufacturers. What the consequences were when we asked company B to supply more when there was a shortage at company A. The medicine market is a competitive market. The government should intervene as little as possible in this market. It simply happens that when company A is out of the market, company B jumps in. However, as soon as company A can start supplying again, company A will then ask the IGJ to enforce against company B, so that company B is forced out of the market.”
In order to handle the report of a threatening medicine shortage, the MEB and IGJ use a ‘Roadmap’ . When reporting a shortage, the Roadmap provides for transparency and predictability of the actions that are to be taken. The Roadmap was drawn up the Working Group Medicine Shortages with input from the lessons learned in the Thyrax shortage in 2016 and other medicine shortages. Kruger: “When we drew up the Roadmap, in the Working Group on Medicine Shortages, we sat down at the table with all parties involved - doctors, pharmacists, patients, health insurers, big and small firms, generic and innovative. We examined the different types of shortages, the possible solutions and what applies in any case. This helps when handling reports. If we only had the notification centre without the Roadmap, then we would not have been able to take such big steps. The Roadmap is public, so it also gives companies an idea of the possible solutions beforehand. We also see now that when manufacturers report a shortage, sometimes they already ask of their own accord whether they may use a different packaging because they still have stocks in another country.”
The Roadmap specifies various possible solutions: look for an alternative medicine, change an existing marketing authorisation, redistribute stocks or limit treatments. Each route also details how the compensation takes place.
In the event of a temporary medicine shortage, IGJ can allow manufacturers, wholesalers and pharmacists to obtain comparable medicines from other countries since 1 January 2018. And that saves the prescribing doctor, pharmacists and other parties involved a lot of time.
Number of notifications in 2017
The Notification centre received a total of 985 notifications in 2017. Of these notifications, 301 concerned medicines that were being marketed for the first time or again. 87 medicines were definitely withdrawn from the market. A quality defect was reported for 61 medicines.
It was reported 536 times that medicines were temporarily not available or available less often. Of these, there were 391 reports that could possibly have consequences for patients, as it is unknown whether there are sufficient alternatives or if a possible shortage could occur of the medicine in question. A notification does not mean a shortage also actually occurred. What is more, a good alternative was available in most cases.
A production delay was the main reason referred to for the temporary discontinuation of marketing of a medicine (492 reports). There were substantially fewer shortages as a consequence of quality defects (29 reports), or for business economic reasons (15 reports).
The notification centre and the Roadmap together form the infrastructure to avoid and solve shortages. After a year, the MEB sees that manufactures have no trouble in finding their way to the notification centre.
A major gain, because the earlier that manufacturers report possible shortages, the earlier the MEB and/or IGJ can take action to help avoid problems from occurring. Even before a problem could arise for the patient. The MEB Board Members are an important link with the practice in this case; they work daily as pharmacists and doctors (in hospitals). The MEB can ask them questions confidentially or verify solutions. If necessary, the MEB also contacts patient organisations and professional organisations for healthcare providers.
In addition, it has been made clear that marketing authorisation holders must immediately report it when they suspect that a shortage of a medicine could occur within a specific period of time because, for instance, a certain pharmaceutical ingredient is not available. They do not have to wait until the statutory minimum period of two months before the shortage occurs. And it works, according to Kruger: “Companies report earlier. We are able to identify potential shortages earlier. We also involve the members of the Working Group Medicine Shortages earlier with the question whether they are willing to help us find solutions if we are unable to solve the problem together with the marketing authorisation holder. We did not do that in the past. You can see that this results in good solutions, for example, by obtaining a product from another country via parallel import. In the event of a shortage that only lasts for a short period of two to three weeks, a solution could be requesting pharmacists to provide the medicines to the patient for a shorter period. This is a very elegant solution; the patient may have to go to the pharmacy more often, but everyone does receive their own medicine.”
Concerns about disappearance of antibiotics: MEB letter to the Ministry
The MEB is regularly confronted with market authorisation holders that wish to withdraw certain types of antibiotics from the market. The MEB wants existing antibiotics to remain available because of the resistance issue and the absence of good alternatives. And also that the authorisation dossiers remain available if a product is withdrawn from the market. Because it is often easier to start production again with an existing marketing authorisation than it is to submit a whole new application. Nevertheless, the MEB cannot prevent a marketing authorisation from disappearing.
At present, it appears to be less interesting for manufacturers to develop new antibiotics or to maintain licences. The consequence: the range of antibiotics and narrow-spectrum penicillins is becoming smaller and smaller, whereas there is a need for this. In the meantime, pipram, cedax and penidural are no longer available and fewer antibiotics are also available in other countries. An undesirable situation according to the MEB. In March 2017, the MEB sent a letter to the Ministry of Health, Welfare and Sport about this. A signal, because something had to be done.
From the reaction of the Ministry of Health, Welfare and Sport, the MEB understood that the Ministry is looking into possibilities to prevent the termination of the production of old antibiotics and into how authorisation dossiers can be maintained. The Ministry is also going to look into the situation with regard to actions for maintaining existing antibiotics in other countries.
Continuation of monitoring shortages
The MEB continues to strive for the availability of antibiotics. In addition, the MEB continues to work on improving the notification centre and the Roadmap together with the stakeholders. For instance, the MEB is examining whether the number of actions required to complete a notification could be reduced.
Working Group on Medicine Shortages
The Working Group on Medicine Shortages is an initiative of the Ministry of Health, Welfare and Sport. Manufacturers, (hospital) pharmacists, healthcare insurers, wholesalers, medical specialists, patients, the MEB, IGJ and the Ministry of Health, Welfare and Sport are represented in the working group. They work together to avoid medicine shortages, and if shortages do occur, to solve these. The Medicine shortages and defects notification centre is an initiative of the working group. The working group examined and elaborated around twenty possible measures in 2017 and entered into agreements to ensure that patients are impacted as little as possible by shortages and the consequences of shortages. The working group sent its report to the Dutch House of Representatives in May 2017.
The Working Group on Medicine Shortages convenes twice a year. If necessary, this frequency can be increased.