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The stockpile of Ozempic breaks equity and leaves diabetics without treatment, pharmaceutical wholesalers warn


Highlights: Ozempic, a drug indicated for diabetes, is being massively used to lose weight. “The Ozempic stockpile breaks equity in patients' access to the treatment they need,” warned Matilde Sánchez Reyes, president of the Federation of Pharmaceutical Distributors. The Spanish Medicines Agency admits that the use of the drug in private weight loss clinics aggravates the shortage . The pharmacy network works in Spain as a high-precision mechanism, with 22,220 open offices and 33,000 medications on market.

The Spanish Medicines Agency admits that the use of the drug in private weight loss clinics aggravates the shortage

The pharmacy network works in Spain as a high-precision mechanism.

With 22,220 open offices and 33,000 medications on the market, ensuring that each one is capable of meeting the needs of its patients is a colossal logistical challenge.

The way to successfully overcome it is through careful management of stocks in each establishment and the daily distribution of drugs by wholesalers—also urgent, when necessary.

A system that has proven capable of resisting a pandemic, but that now also shows some weaknesses in the face of two of the biggest phenomena that threaten the sector: the recurring problems of drug supply and the

Ozempic revolution,

the drug indicated for diabetes. which, on the other hand, is being massively used to lose weight.

“The Ozempic stockpile breaks equity in patients' access to the treatment they need,” warned Matilde Sánchez Reyes, president of the Federation of Pharmaceutical Distributors (Fedifar)—the association of wholesalers in the sector—, in the recent National Congress. Pharmacist held in Valencia.

With this statement, Sánchez Reyes put on the table in a debate with representatives of the sector and the administrations a problem that he explains in writing in more detail to EL PAÍS: “There is an unequal” and “not equitable” distribution, which “makes some pharmacies have certain quantities of the medicine that is in shortage and others do not”, which leaves thousands of diabetics without the treatment they need.

José Jodar, 70 years old, is one of them.

“The problems started last year.

But then, if your pharmacy didn't have the medicine, you could get it in a few hours or a day.

But since this Christmas, things have gotten much worse.

There is no way to get it anymore.

First I tried to solve the problem with my family doctor, but in the end I had to make an appointment with my endocrinologist at the hospital to change my treatment," complains this retired printer who lives in Seville and was diagnosed a decade ago. type II diabetes.

He had been taking Ozempic for almost two years.

The difficulties of the Danish pharmaceutical company Novo Nordisk in facing the enormous demand for Ozempic are the main cause of the problem, from which all the others are triggered, explain the sources consulted.

The first variable that aggravates the problem is, paradoxically, the willingness of each pharmacy to free its patients from it.

By ordering the doses they will need, plus a few more just in case, all together they end up increasing pressure on an already weakened supply chain.

“These situations tend to occur when there is intermittent supply.

If you see that there is a product today, but that there was not yesterday and that tomorrow you do not know if there will be one, and you have patients who need the drug, you place an order in anticipation of what may happen," explains Juan Pedro Rísquez, vice president of the General Council of Pharmaceutical Colleges.

A second variable that triggers demand is the use of the drug outside its indication, often when it is prescribed in private clinics to patients who are looking to lose weight, specialists warn.

“Ozempic is a treatment indicated for diabetes.

And these patients are being left without treatment because the doses end up being used by other people to lose weight.

"This, in situations of shortage like the one we are experiencing, is something that should be avoided by the administrations," says Cristóbal Morales, member of the Spanish Diabetes Society (SED) and endocrinologist at the Virgen de la Macarena and Vithas hospitals (both in Seville).

A pharmacist shows a box of Ozempic in an office in Valencia. Mònica Torres

The Spanish Agency for Medicines and Health Products (AEMPS) has published to date “several informative notes recommending that health professionals stick to the indications included in the technical sheet” and “prioritize” the use of the medication for diabetics, explains a spokesperson.

To this end, “consultations have been made with the autonomous communities to verify that there are control and supervision mechanisms in the prescription.”

The Agency itself, however, admits that the results are not as expected: “We have detected that a high percentage of this medicine has been transferred to private prescriptions (around 42% in 2023).

This, in addition to being unusual (in the indication of diabetes mellitus), makes it very difficult to monitor to check whether the prioritization of these patients with diabetes is being done effectively.”

A third variable that explains the unequal distribution of the few available doses of Ozempic is the organization of pharmaceutical distribution.

In the sector, there is a small group of large wholesalers – grouped together in the Fedifar employer association – that carry the majority of the sector.

These distributors serve all pharmacies with any type of drug, which is why they are called “full range wholesalers.”

But there are other actors, such as other smaller distributors or distributors specialized in some products, or the pharmaceutical companies themselves, which can sell medications directly to some pharmacies (usually those with the highest sales volume).

According to Fedifar, in shortage situations like the current one, this multiplicity of actors aggravates the unequal distribution of the few existing doses.

“The fact that some pharmacies have a certain amount of a medicine that is in short supply and others do not have that product can only be attributed to a non-responsible supply made by operators who are not full-range pharmaceutical distributors,” explains the entity.

This occurs when “commercial aspects are prioritized over health aspects” with strategies such as selling the medicine in a situation of shortage “in exchange for buying other products.”

This employer's association recalls that "in France, for example, there have been times when, in situations of shortage of some medicine, direct supply by laboratories has been prohibited and its distribution has been reserved exclusively for full-range wholesalers. ”.

The objective of this measure is to “guarantee the equitable supply of medicines”, something that large wholesalers defend that they can offer as they are the only ones that already distribute to all pharmacies and, therefore, know their needs well.

Asked about Ozempic's supply problems, Novo Nordisk assures that it is “doing everything possible to stabilize the supply situation as soon as possible” and to increase production.

The company is in the process of investing nearly 7.7 billion euros in plants in Denmark and France, to which another 10.2 billion must be added due to the recent acquisition of the company Catalent, which has three factories in the United States, Belgium and Italy.

Regarding the channels used by the pharmaceutical company to sell its products, it states that “mainly” they are wholesalers and hospital pharmacy services in health centers.

Located at the end of the long supply chains now interrupted and oblivious to these problems in the sector, José Jodar feels lucky because Cristóbal Morales, who is his endocrinologist, has been able to prescribe him another drug called Rybelsus despite all the problems suffered.

These pills, also from Novo Nordisk, have the same active ingredient as Ozempic, semaglutide, and for now they do not suffer from serious shortage problems.

“Rybelsus is an important innovation because it allows the oral intake of molecules such as semaglutide, which had to be administered through subcutaneous injections because gastric juices degrade them.

And, for now, it is being of great help to Spanish diabetics to alleviate the serious shortage of Ozempic,” concludes Morales.

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Source: elparis

All life articles on 2024-02-20

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