Pilar G. has 58 years old, and still remembers “as if it were yesterday” the morning of the summer of 2014 in which he suffered his first tachycardia. “I thought I was dying. It scared Me so much that since then I live in fear”, he confesses in the waiting room of the primary care centre Maragall, Barcelona. To the problems of your ailment, Pillar, has joined in recent months the stock of the flecainide, the drug is indicated to treat their arrhythmias. “First we ran out of Apocard [the commercial brand most used], then the generic. It is a medicine very delicate and may not cambiártelo the pharmacist has to do it the doctor. Every time I say I do not have it, I have anxiety. Is already the third time that I come for this,” he laments.
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As a Pillar, more than 400,000 patients suffer in Spain the scarcity of the flecainide. And there are millions that have been affected by the lack of supply of hundreds of drugs, a problem on the rise. If in 2015 the Spanish Agency of Medicines and Health Products (AEMPS) recorded 700 notifications for this reason, in the past year were 900. And at this point 2018, the number already reached a thousand, though several of them have already been solved the problem. The number of drugs sales in Spain is around 17.500.
The discomfort can be banal in the beginning, as with the Dalsy (ibuprofen for children) or the Patient (acetylsalicylic acid), of which there are dozens of alternatives in the pharmacy. But often, as with the Apocard, the lack of the best-known brand brings the pressure to the generic. In the end, the entire health system is stressed when a drug is at the limit of disappearing in all their presentations.
“we have Not reached the point of putting at risk the health of the population, but the disorders are enormous”, says Teodomiro Hidalgo, member of the General Council of the Colleges of Pharmacy. “The pharmacists we spent the day searching among the wholesalers. The doctors, changing dozens of treatments. And the patients suffer, because nobody likes to run out of the medicine that you trust,” adds Hidalgo.
The AEMPS has taken in the last few months severe measures to mitigate the problem. Some are not new, but in exceptional have gone to almost everyday. One is the controlled distribution of scarce available stock. The other, the restriction of exports to retain in Spain all the possible units. It is also authorized laboratories to manufacturing or marketing of exceptional drugs in principle intended for other markets or purposes. In extreme cases, is given the green light to imports of medicines not authorised in Spain. Also the sale of drugs in phase precaducidad (in the last six months of life).
The summary of the measures adopted consists in a report published by the AEMPS the past day 8. This is the first time that the agency makes public a document of these characteristics, which analyzes the 518 notifications of problems of supply recorded in the first half of the year and divides them by its impact. Four out of every five fall into the categories of “null” or “minor”, which are those that the patient or get to notice (and are resolved before they affect the pharmacy) or the solution passes through the change on the part of the pharmacist of a drug to another identical one.
In 33 cases (5.7% of total), the problem of supply had a “medium impact” that forced the patient to go to your Betvole doctor to receive “an alternative treatment”. And in the 81 remaining cases (13.9%), “the impact of care was important, as there do not exist therapeutic alternatives”. It is in these cases when the AEMPS resorted to measures such as the importation of “medicines not authorised in Spain”. These drugs contain active principles different, but with indications similar to, and under medical supervision in order to overcome a shortage on time.
The AEMPS regrets that the supply problems causing “a huge consumption of resources professionals to its management” and “discomfort for the patients.” And in a veiled rebuke to some pharmaceutical notes that the “problems are concentrated in a relatively limited number of laboratories”, which requires “as a responsible past of the drug [...] make the necessary efforts and to develop plans preventive to comply with its obligation to continued supply”.
THE COUNTRY has obtained the release of eight of the nine laboratories, in which most problems of supply have suffered this year in Spain and of Farmaindustria, the association that groups them. “We are facing a global phenomenon which also occurs in Spain”, says Emili Esteve, of Farmaindustria. This does not consider that a single cause to explain the phenomenon. “The sector is working as a large network of interrelated and a problem at one point affects the whole. And here come many things, such as works in a factory that reduce the production, the poor harvest of raw materials, failures at other providers, upticks in demand...”, adds Esteve.
Boehringer Inhelgeim the lab is authorized to sell the Nolotil. The active principle (metamizol magnesium), however, it does not manufactures it, but buy it to Sanofi, which in turn is the pharmaceutical with more incidents. “We've had supply problems of the active principle,” says a spokesperson for Boehringer. “We are one of the companies with a portfolio of drugs that are more wide and we sell to more than 100 countries. This makes it very complex to predict the needs of each product in each country, and we are subject to more risks,” he defends his time Sanofi.
Another example is the Bayer, the owner of the Patient. The multinational concentrates global production of the active principle in the rough at its plant in Asturias, and sends him to Leverkusen for their handling and packaging. The multinational is attributed to the works of “modernization” of its facilities in Germany “temporary interruptions of supply”.
All the labs you remember, with words that are very similar, which work under a “scheme of planning very complex in a highly regulated industry” and insist on showing their “full commitment” with the guidelines laid down by the AEMPS.
The shadow of the low prices of a reference
Spain has a system of reference prices for medicines, the heir of the policies to contain pharmaceutical expenditure, which puts the cost of medicines among the cheapest in Europe. Many industry sources are pointing “at these prices” as another of the causes that underlie the problem.
Aualthough all the actors deny that it can be claimed that the laboratories prefer to sell to countries with more expensive prices rather than in Spain. “In a highly regulated industry, where companies are required to comply with its commitments with the Government in a market as important as Spain, there is that possibility,” says Farmaindustria. To industry sources that asked for anonymity share this vision, but they admit that “the incentives for laboratories to make their schedules themselves can be influenced by the system of prices”.
Neither the wholesalers incur in this practice, according to the sector itself. Exports parallel, these distrubuidores may legally be sold to third countries (with higher prices) medications, in principle, intended for the Spanish market, were years ago a source of controversy. “That's not the case,” says Miguel Valdés, director general of Fedifar, the association that groups to the wholesalers who sell the 97% of drugs in Spain. “Spain has become one of the main exporters for this concept to be a practice almost residual,” says Valdés. This attributes the reduction to the agreements “reached that arrived over a decade ago, laboratories, and wholesalers to avoid this”.
Sources from the Ministry of Health reject also that the reference prices can be identified as guilty of the problems of supply. "Spain is an important market and the prices are adjusted to our reality," according to these sources. "It is true that each time a problem arises, it is suggested to do this, but it seems more an attempt to pressure the stakeholders with an interest to sell at a higher price than a reality", concluded these sources.