2024-08-11 08:00:00
New alert messages flash on the website of the National Agency for the Safety of Medicines and Healthcare products (ANSM) almost every day. Summer is no exception. This Thursday, August 8th, communiqué For example, the agency noted that supplies of Anapen epinephrine auto-injector pens (Bioprojet Laboratories) were disrupted. The plan is to make this vital emergency treatment – used to treat life-threatening allergic reactions (anaphylactic shock) – fully available by the first quarter of 2025. Transfer prescriptions to other pens where handling is not necessarily the same. This depends on the patient’s adaptability.
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More than 30% of reports within one year
A shortage of medicines that has been criticized for years is poisoning French life. Reports of inventory shortages or risk of inventory shortages even increased by more than 30% in 2023, with nearly 5,000 reports submitted to ANSM. All classes of drugs are affected. Among the main therapeutic drugs (MITM), cardiovascular drugs, neurological drugs, anti-cancer drugs and anti-infective drugs are represented. In 40% of cases, the authorities had to take measures: quantitative or qualitative quotas (such as stockpiling for certain indications) or the import of similar medicines from other countries. As the school year begins, things don’t seem to be getting any better. ANSM just announced that it is preparing the next “ winter plan » Attempt to limit damage.
“Anti-narcotics”
Recently marketed drugs may also be missing. Charles, 63, a resident of the Lille area, knows something about this. To treat his diabetes, he gives himself weekly injections of Ozempic. But before that happens, he does a “drug hunt,” which, he quipped, is a walk around the pharmacy when it’s time to renew a prescription. Pharmacists warn that it is not possible to order in advance and you will have to find the right dose yourself. “It’s stressful sometimes. When you travel a lot, it’s hard to make sure you have enough stuff to take with you,” he laments. Ozempic comes in the form of an injection pen, produced exclusively by Danish laboratory Novo Nordisk. Its action is based on an innovative and highly anticipated molecule (semaglutide), which is also used in Wegovy, a new treatment sold by the same laboratory to obese people to help them lose weight. The problem is, Denmark doesn’t produce enough to satisfy the global craze for these treatments.
Ration tickets
Be aware that the laboratory does not put all continents into the same system. If France and Europe as a whole are experiencing a diet, America is experiencing affluence. On the other side of the Atlantic, according to statistics, sales “increased 48% in the past six months to 5.1 billion euros, while sales in the Europe, Africa and Middle East (EMEA) region increased only 8% to 1 billion euros.” echo. Ozempic’s sales in this segment even fell by 2% in the second quarter compared with the second quarter of 2023.
In the face of less than expected growth, should we see commercial arbitration, or rather a very drawn-out production event? Questioner focusNovo Nordisk did not issue an official comment. However, Dr. Jean-François Thebaut, Vice Chairman of the French Diabetes Federation, explained in one sentence: “Industrialists prefer to supply countries with the best-selling and most expensive drugs.” The doctor recalled, “From September 2022, academic The groups and ANSM recommend limiting initiation of Ozempic treatment to high-risk patients.” In other words, admission tickets are no longer distributed to all diabetic patients who could benefit from them because of the lack of sufficient low-dose boxes, which are essential at the beginning of treatment. “Yet the prescribers continued to prescribe it, simply because it was an effective drug,” recalled Jean-François Tabault.
Impact on 44% of diabetic patients
Therefore, in December 2023, ANSM issued a new press release: “Novo Nordisk Laboratories informed us that in order to allow continued production of Ozempic to continue the care of patients already receiving treatment, it is suspending the supply of Ozempic 0.25 mg (starting dose) […] Supply is expected to be tight in 2024. » Subsequently, low-dose pen syringes will disappear entirely from pharmacies so that laboratories can fully fill syringes for patients already receiving treatment.
Like a game of dominoes, the middle doses gradually start to run out. In fact, some patients will switch to a higher-dose pen, inject themselves about halfway, count the turns of the dial, and then carefully store the remaining medication in the refrigerator for the next week. Others decided to space out their injections slightly, waiting two to three days before stocks ran out. “This is sometimes the biggest challenge,” admits Dr. Jean-François Thebaut, citing a study conducted in March 2023 that showed that for nearly 44% of diabetic patients surveyed, the shortage had an impact on their disease. For mental health effects, the proportions are similar. The only information Novo Nordisk provided was: “A gradual resumption of Ozempic treatment is planned in September. »
Another form of monopoly was responsible for the shortage that began last April. Pegasys (peginterferon alfa-2a) from Cheplapharm Laboratories, used to treat certain cancers and blood disorders. In an open letter published in June 2024, the presidents of the French associations Vivre avec une NMP and LMC rebuke A “double penalty for patients” is the lack of reference drugs and the lack of access to potential alternative drugs. In fact, unlike its neighbors, France only authorizes one form of treatment, effectively creating a local monopoly. Under pressure from patients, ANSM finally approved “special and transitional import” of Besremi (ropeginterferon alfa-2b) on August 7. Tensions are expected to last until March 2025.
Antibiotics are also missing
“Such a situation would have been completely unimaginable twenty years ago. Today, we are used to empty cupboards. Every morning we open the door and find with our own eyes that this or that molecule is not on the shelf. Every week we It took hours to resolve the problem of not being able to get a prescription, said Sylvain Diamantis. focustitled: “When drug shortages cost us expensive practices and encourage the development of antibiotic resistance. »
Together with other infectious disease experts, including Dr. Véronique Mondain, director of the Paca Regional Reference Center for Antibiotic Therapy, the doctor denounced the consequences of the severe shortage of amoxicillin, a well-known antibiotic used in Europe, in 2022 and 2023. Since 1970, some patients have been treated with very expensive antibiotics (€2,250 for 15 days of treatment) and extensive treatment due to the inability to obtain this molecule, which costs 1 or 2 euros a day and does not carry a high risk of bacterial resistance. Spectrum, which means it does not target specific bacteria. “This is completely contrary to what has been recommended for many years to limit antibiotic resistance,” infectious disease experts worry.
If tensions over amoxicillin have eased for now, then it’s the turn of the other two antibiotics that are seriously lacking. The first is rifampicin, which is essential in the treatment of tuberculosis and also in the prevention of nosocomial infections associated with prosthetic fitting. The second, azatan, is indicated for patients allergic to all antibiotics. “We deal with paperwork and the urgent needs of our team every day. The risk of treatment failure is real.
The price of the drug involved
No exceptions. Innovative drugs with high prices or cheap old drugs will be affected. “On the one hand, production cannot keep up due to the surge in demand, and on the other hand, the industrial logic of just-in-time movement is to avoid costly accumulation of inventory,” explains Antoine Flahault, director of the Institute for Global Health in Geneva. Frequently, low drug prices in France are responsible for drug shortages, “but the same difficulties are faced in Switzerland, where prices are surprisingly high,” the doctor points out simply.
Over the years, successive health ministers have tried to restore some order to mobility. Therefore, since 2012, laboratories selling medicines of significant therapeutic interest (MITM) must maintain a minimum safety stock of two months for patients receiving treatment on French territory. Among them, the deadline for 422 companies has even been extended to 4 months from 2022. Relocation plans have already begun for some flagship products such as Doliprane. But “we will not be able to stop this phenomenon without very profound reforms of production and distribution systems on a regional and even global scale,” insists Antoine Flahaut.
For its part, anticipating that returning to school will be as difficult as before, the ANSM is planning a new rule: pharmacies will now be required to no longer place orders directly with laboratories, but instead rely entirely on wholesalers for their treatment. Key antibiotics. The measure aims to ensure better distribution of medicine boxes between pharmacies. “We remember that this winter program is first and foremost a collective commitment,” the agency said soberly. […]everyone must take responsibility for ensuring that patient needs are met. » Everyone is in the same boat, but we are still rowing in the same direction.
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