The portal tv3.lt has received complaints from worried patients that for some time now they have to look for the medicine “Ozempic” with a light, which doctors prescribe for patients with type 2 diabetes.
It also goes to Poland
Head of the Diabetology Department of the Endocrinology Clinic of Kaunas Clinics, Endocrinologist Assoc. According to Evalda Danytė, the situation today is paradoxical. Although there is a lack of this medicine for patients, it is even brought from Poland by those who want to lose weight.
“There is a lot of information on the Internet and social networks that this drug, although it is not intended for this purpose, helps to lose weight, and for those who are sick and need to regulate their blood sugar, we are running out of it. The logistics have been disrupted for a long time, there are so-called introductory doses, they haven’t been available for half a year or more,” said the doctor and warned that if you decide to use this preparation at your own discretion, you can get bad consequences.
Abuse if the drug is prescribed for other purposes
Speaking about the mentioned medication, the head of the Outpatient Department of the Endocrinology Clinic of Kaunas Clinics, the vice-president of the Lithuanian Society of Endocrinologists, prof. Džilda Veličkienė pointed out that GLP-1 receptor analogues (GLP-1 RA) are a group of drugs that are currently prescribed to patients in several specific cases.
“This class of drugs is prescribed to a subset of patients diagnosed with certain cardiovascular conditions in type 2 diabetes, and in other cases when other measures fail to achieve good diabetes control with 2 or 3 oral antidiabetic medications,” she explained.
The doctor emphasized that, like other medications, the prescription of this group of medications with PSDF funds is strictly regulated by the procedure defined by the Minister of Health. However, no such preparation available in the country has an indication for weight loss.
“Yes, it is sad to hear that there are cases of abuse where the medicine is prescribed outside of the indications, but I cannot comment on how this happens. If this happens en masse, it can certainly contribute to drug shortages for individuals who need this drug class the most.
A prescription for any drug in this group can be issued by both family doctors and endocrinologists only for people with type 2 diabetes according to the indications I defined earlier, if the treatment is provided with funds from the PSDF fund,” she explained.
The doctor added that according to the current legislation, it is possible to use medicines outside of the approved therapeutic indications only if the council of doctors of a personal health care institution has made such a decision to allow a specific patient to be prescribed a specific medicinal product according to therapeutic indications that are not specified in the summary of the medicinal product, but are scientifically based.
Are there any substitutes for diabetics?
When asked if, in the absence of the necessary drug, there is something to replace it for those suffering from diabetes, Dž. Veličkienė indicated that this group of drugs also includes medications from other suppliers. It is true that there are also disruptions in their logistics.
“These groups are several representatives of different manufacturers and different forms of release (injected under the skin 1 time per day or 1 time per week, orally) and certainly there are currently disruptions in the supply of some representatives of this class. However, some patients find it easier, others more difficult, that is, they have devoted more effort to the search for a drug, they can purchase one or another representative of this class of drugs”, said the professor.
“There is a lot of information on the Internet and social networks that this drug, although it is not intended for this purpose, helps to lose weight, and for those who are sick and need to regulate their blood sugar, we are running out,” says E. Danytė.
The doctor confirmed that, in terms of the effect on reducing glycemia, the effectiveness of all representatives of this class is more or less similar.
“The glycemic-lowering effect is achieved for most patients with any drug in this class, usually in combination with other drugs. Here it is very important to understand the course of type 2 diabetes and the fact that certain medications for the treatment of diabetes can reduce glycemia only at a certain stage of the disease and will not work if prescribed to the “wrong” patient, that is, in the wrong phase of the disease, for example, a patient whose pancreas the endocrine function has already been exhausted, drugs that stimulate insulin secretion from the pancreas will not be effective”, explained Dž. Velickiene
The effect is similar, but not everything is so simple
In addition, she emphasized that the glycemic-lowering effect of any representative of the class also depends on the level of diabetes compensation, and also that each patient’s response to treatment is individual.
“Therefore, it cannot be said that when the same drug is administered to all patients, a specifically defined effect will be observed, that is, for one patient any representative of the same drug class will be very effective, and for another, none of them may work.
Another issue is that within the GLP-1 RA class, different members of the class have varying evidence of additional benefits in addition to the hypoglycemic effect, such as cardiovascular risk reduction or weight loss effects, so depending on the patient’s level of compensation for type 2 diabetes, a specialist in comorbidities may sometimes recommend different members of the same class for different patients.
But the legal act “Description of the procedure for the outpatient treatment of diabetes mellitus with compensable drugs” does not regulate that choice within the class and allows prescribing any GLP-1RA analogue in the presence of relevant indications for prescribing the drug,” she explained the complex process of drug selection.
When is the earliest the new batch could reach?
The State Medicines and Control Service (VVKT) indicated that supply disruptions of the diabetes drugs “Trulicity” and “Ozempic” (1mg) are being faced on a European scale.
“Therefore, both preparations have been supplied in limited quantities in Lithuania for some time. Trulicity’s newly declared disruption is until May 27th, and Ozempic’s 0.25mg disruption is until June 30th. However, the registrant of this medicine imports about 150-170 packages every month”, commented VVKT representative Aistė Tautvydienė.
She reminded that disruptions in the supply of medicines occur regularly and are usually related to production problems, such as shortages of active ingredients or other substances.
“The supply of medicines can also be disrupted due to logistical problems, increased demand for medicines, as well as for commercial reasons. Drug supply disruptions are often resolved quickly. For example, if a disruption in the supply of a medicine is caused by logistical problems, it happens that the population does not even feel this shortage, because the existing drug residues are sufficient.
Also, there are fewer problems if there are enough other preparations of the same active substance on the market – in this case, the drug is easily replaced by another. Those cases where the production of a certain active substance is disrupted are more complicated. In such cases, the drug is in short supply on the market of more than one country”, said the representative of VVKT.
New drugs to treat obesity are also waiting
When asked if, as a representative of the community of endocrinologists, she does not see the need to strictly regulate the prescription of the drug in question, Dž. Veličkienė agreed that it was necessary.
“We see that the demand for GLP-1RA is greater than the supply, but to answer whether this is largely due to disruptions in the supply of manufacturers, or whether it is due to greater demand, with the emergence of better opportunities for prescribing drugs under PSDF funds from 2022. valid description of the procedure, or because a large number of patients purchase somehow illegally, we cannot answer. This should probably be done by other institutions, but not endocrinologists.
The legislation, in my opinion, is good at regulating the indications for prescribing a drug, and if there is evidence of abuse, I think there are other means of disciplining abuse by individual doctors or other professionals, because tightening the prescription may reduce the possibility of prescribing for those patients for whom this drug is prescribed. class is the most necessary,” explained the doctor.
She added that endocrinologists are very hopeful that in the coming years, not only will the supply of GLP-1RA to patients with type 2 diabetes improve, but also new drugs for the treatment of obesity will be available, which will also belong to the GLP-1RA or GLP-1RA/GIP classes.
“At least that’s what many drug manufacturers are promising, saying that they are finishing the construction of large-capacity factories in other countries to meet the increased demand for these drugs in the world,” added Dž. Velickiene
