2023-08-02 18:41:16
Almost 900 presentations of medicines of the 33,149 authorized to be marketed in Spain present supply problems, 2.7% of the total; 0.33% of these drugs cannot be replaced by others, but also in these cases there are formulas so that no patient is left without treatment.
Pharmacies and hospitals have been accusing continuous incidents with medicines that, in their vast majority, have an alternative for two years; In addition to the 888 active supply problems to date, another 963 have been resolved in the last six months, according to the Drug Information Center (CIMA), which updates its data several times a day.
At this time, and according to information from the Spanish Agency for Medicines and Health Products (Aemps), these problems have been a growing constant: in the second half of 2022, obstacles in the distribution of drugs rose by 9.7 % compared to the previous semester, when in turn they had shot up 31% over the first six months of 2021.
Anti-infectives, analgesics and antidepressants
Amoxicillin -which is once again in short supply in its presentation in 500 mg sachets-, paracetamol, the well-known ozempic pens… These well-known crises have recently been joined by other lesser-known drugs that, unlike these, have no replacement.
It has happened with Hydrea, indicated for diseases such as chronic myeloid leukemia, which began to be lacking in April due to the lack of aluminum to manufacture the blister pack of the pills and it was not until last week that it returned to normal distribution.
In fact, in the United States, the cancer sector is on alert due to the shortage of 14 cancer drugs, which has forced the industry to encourage domestic production and imports.
In Spain there are 15,490 authorized medicines and 33,149 presentations; those most affected are those from the group of anti-infectives (for systemic, not local use) and those related to the nervous system (analgesics, antidepressants, antiepileptics…), explains Antonio Blanes, director of Pharmaceutical Services of the General Council of Pharmaceutical Colleges to EFE ( CGCOF).
PHOTO EFE/André Coelho
90% are resolved in a pharmacy
Depending on the impact it has on the patient, Aemps makes a triple classification of supply problems.
Most of the time it is nil or less; They are very short problems that you hardly notice thanks to the drugs that are in the distribution channel or because there are therapeutic alternatives, they tell EFE from the agency under the Ministry of Health.
With few exceptions, adds Blanes, the legislation allows the pharmacist to replace the unavailable drug with another of the same composition, pharmaceutical form, route of administration and dosage; nine out of ten problems are solved in the pharmacy.
If you do not have it at that time, you can use Farmahelp, a platform of the College Pharmaceutical Organization with which the professional can contact nearby offices to help the patient find their medicine.
Who assumes the cost difference? The casuistry can be varied, explains the Aemps, because it depends on different factors -type of substitution needed, state of financing, price…-. When the patient receives the treatment charged to the SNS, the costs are those that would correspond according to the regimen in which they are found.
Prioritization of patients or purchases abroad
Medium-level problems appear when it must be the doctor who decides which is the most appropriate alternative based on the clinical history.
Already in the third are those with the greatest impact because they have no substitute. They represent 0.33% of the total.
For them, the Aemps has various mechanisms: a controlled distribution to prioritize people without alternative treatment, exceptional marketing authorizations or exceptional manufacturing or export or import stops of foreign medicines.
With Hydrea, for example, the agency authorized its exceptional commercialization of other EU markets. These foreign drugs are distributed to communities through the agency’s specialty drug enforcement.
What’s going on?
The origin of these fluctuations is multifactorial and very complex and, in some cases, global in scope: delays with a raw material, quality incidents, problems in a plant -such as those that a tornado left a few days ago at a Pfizer facility in North Carolina-, increased demand…
The Aemps is aware of potential incidents from the laboratories themselves on 90% of the occasions, which facilitates the adoption of measures to prevent them from occurring or, if they do, to mitigate their impact.
They can also reach you through communities or health professionals, hospitals or the Cismed system, managed by CGCOF, although in this case they barely account for 1%.
In addition, the Artemis project that is being developed with the Federation of Pharmaceutical Distributors (Fedifar) analyzes a large number of supply data for different essential medicines in order to find patterns with which to detect problems at the wholesale distribution level early.
Supply of essential medicines
The shortage of drugs, and very specifically of antibiotics, is causing great concern in Europe: a few days ago, the Executive Steering Group on Medicines Shortages and Safety (MSSG), to which the amempsdeveloped a series of recommendations to avoid another crisis of pediatric amoxicillin like the one last winter, when adult pills had to be broken up to give them to children.
Which are summarized in increasing the production of essential antibiotics, monitoring supply and demand and assuming public awareness and prudent use, with public awareness campaigns if necessary.
At the same time, the European authorities are developing a list of essential medicines -strategic drugs that are considered necessary to meet the basic needs of the population-, the first version of which will be made public at the end of 2023.
At Aemps they are aware of the importance of guaranteeing the supply of medicines, and they ensure that all the agents involved are working to detect, prevent or, if necessary, alleviate them.
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