Spanish pharmacies and hospitals have experienced a significant increase in drug supply problems over the past year. According to the latest six-month report of the Spanish Agency for Medicines and Health Products (AEMPS), a total of 1,105 drug presentations suffered some kind of incident between January and June this year. This figure means that one in 30 of the more than 32,000 drugs on the market – some are different versions of the same molecule – have been affected, an increase of 38% compared to the first half of 2021.
“We are facing a growing problem because the upward trend has been maintained since last year and our data shows us that it has continued to grow over the summer,” explains the vice president of the General Council of Pharmaceutical Associations, Juan Pedro Riskes. This organization has a platform called CISMED that collects information on the orders of 10,000 of more than 22,000 Spanish pharmacies. “This allows us to have up-to-date data, even more precise and up-to-date than the agency’s, but the results are constant. The years 2018 and 2019 were complicated, then the situation improved and now we are back to an alarming scenario,” added Riskes.
The production of medicines forms a huge network that is highly interconnected at the international level, in which it is customary, from the first steps of the production of the active ingredient to the packaging of the final product, that medicines pass through several countries and companies. This means that a problem in a factory, changes in a logistics center or an increase in costs at one point in the chain have a significant impact on the whole. Also that the sector is very sensitive to the international context, which has been affected in the last year by factors such as inflation, political tensions and changes in international trade.
“The complexity of the system means that the causes of these problems are different and each affects a particular drug or country differently, without it being easy to pinpoint the severity of each. But it is true that there is huge anxiety in the sector due to the increase in the cost of energy and international transport [los precios de los fletes sufrieron una gran subida en 2021 y principios de año]. The difference between medicines and other goods is that the final price intervenes, you cannot transfer these increases and this may have particularly affected some segments of the sector, “says Emily Esteve, director of the technical department of the employers’ association Farmaindustria .
According to AEMPS data, 25.3% of reported issues were caused by “production issues” not related to quality, 24.6% by “plant capacity” related issues, 22% due to “increased demand “, which the manufacturer cannot handle, in 8% of cases the problem is the lack of active ingredients and in 7.5% the quality of the final product. Incidents related to the coronavirus pandemic barely account for 3% of the total.
The data included in the AEMPS report offers some clues about what happened over the past year, according to the sources consulted. The growth from 801 problems reported in the first half of 2021 to 1,105 this year is concentrated in those presentations with less added value and with more alternatives in the market, mainly among generic drugs that operate at lower margins.
AEMPS distinguishes four levels of problems according to severity. Minors are those considered to have “zero impact” on the patient, as their short duration allows demand to be met with the drugs available in the supply chain. This type of incident has increased by 61% in the last year to 437. The second level has a “lesser” impact because “as there are other drugs on the market with the same active ingredient and the same route of administration”, the pharmacist can replace at time of sale. These problems have increased since 2021 by 30%, to 545.
“Medium impact” incidents occur when there are other options on the market, but they are not quite the same, and the patient needs to see a doctor to “determine the choice of alternative treatments.” In this case, the affected drugs increased from 88 to 57 in one year, a drop of 35%.
According to the AEMPS report, the most serious problems arise when “a drug shortage generates a significant health impact due to the lack of therapeutic alternatives for any or all of its indications.” This requires special measures that range from the suspension of the export of available treatments to the retention in Spain of the maximum number of doses, “controlled distribution” practically box by box to ensure that they reach the patients who need them, a special importation of certain drugs or the development of specific measures with manufacturers to accelerate the production of therapeutic alternatives. In the event that none of these measures succeeds, the worst-case scenario arises: a “temporary shortage”. In total, the highest-impact issues occurred in 66 cases in the first half of the year, 5% more than the same period in 2021. In three cases, the Agency opened criminal cases against the responsible laboratories, considering that they had unduly failed to fulfill their legal obligation to ensure the supply of medicines.
Jaume Sellares, family doctor and director of the Sardinia Primary Care Center (Barcelona), explains how even problems with an impact considered average can sometimes have a significant impact on care. “This happened with Tromalyt, a drug that contains acetylsalicylic acid, the popular aspirin, but with a single dose of 150 milligrams. It is a widely used drug that is usually taken by people with other underlying pathologies and treatments. Available presentations were 100 or 200 milligrams. All of this forces you to review many patients’ medications on a case-by-case basis and make a special effort to explain the changes well to them to avoid the risk of confusion or misuse,” he states.
The list of pharmaceutical companies with the biggest supply problems is dominated by companies with many products on the market. Among the laboratories that produce patented drugs, Sanofi is the one that takes first place with 108 incidents. The company claims that the sector “faces an increase in drug shortages worldwide, which has a multifactorial cause, as it involves all agents that intervene in the supply chain: suppliers of raw materials (and shortages of the same), manufacturers, transport , distributors, distribution points, health authorities…”. Sanofi chose “several large projects to minimize these situations, such as the EUROAPI initiative, an independent company that produces active ingredients with six main drug production centers in five European countries.”
In the generic sector, the most affected by the problems, the company that tops the list is Kern Pharma, with 65. The company and employers in the sector, the Spanish Association of Generic Medicines (AESEG), declined to answer questions for this newspaper. AEMPS has also done what its report provides as another possible reason for the increase in reported problems, which would be “greater awareness and reporting of problems by industry and detection capacity by authorities”.