WARSAW, 6 Dec (APM) - Poland's Ministry of Health (MoH) has recommended patients and doctors do not change diabetes treatment with metformin after the European Medicine Agency’s (EMA) recent discovery that some batches could be contaminated with a probable carcinogen.
The news was reported on Thursday by Dziennik Gazeta Prawna (pA1, pA3), Gazeta Wyborcza (p1-2) and Rzeczpospolita (pA2, pA5), and by Rzeczpospolita (pA6) on Friday. Metformin is a type 2 diabetes drug used by 1.8 million diabetics and 300,000 patients with insulin resistance and polycystic ovary syndrome in Poland.
The EMA recently announced that the Health Science Authority in Singapore had discovered contamination with the carcinogen N-Nitrosodimethylamine (NDMA) in diabetes drugs. The regulatory is now asking pharma companies to thoroughly assess the contamination levels of their products and will continue to monitor the situation, reported all the newspapers on Thursday.
Neither the EMA nor the MoH have recommended stopping metformin use, as failing to treat diabetes and other illnesses poses a greater health risk than the harmful effects of possibly consuming NDMA.
According to the minister of health, Łukasz Szumowski, there is a chance that the NDMA found in metformin could be a side effect of synthesis and is not a direct contamination. Other experts claim that NDMA may come from the packaging of the drug.
If this proves to be true, it would resolve the problem without interfering with the production processes and lines, nor will it require lengthy processes of acquiring drug distribution licences on EU markets.
Nevertheless, news of possible contamination has caused huge concerns, especially among elderly patients. People whose parents or grandparents are refusing to take metformin because of the risk of being poisoned have been calling doctors for advice.
This problem reopens the subject of the high level of dependence of Polish and European drug producers on active pharmaceutical ingredients (API) imported from the Asian and Indian pharma factories, according to reports.
Around 60-80% of APIs are produced in Asia because of price, but the reports highlighted dubious production conditions that are almost impossible to check and interruptions in the supply of APIs and drugs.
Polish and European patients are currently struggling to find the drugs they need in pharmacies and, without moving API production to the EU, the problem will continue, reported all the newspapers on Thursday.
Poland readying for launch of extensive 10-year cancer plan
A team of experts under the Ministry of Health (MoH) have prepared an extensive 10-year oncology plan to reduce the cancer mortality rate by 10 percentage points, which is expected to be legalised by the Government this month, reported Dziennik Gazeta Prawna (pA1, pA4) on Monday.
The 60-page document covers the subjects of oncology staff, primary and secondary prophylaxis, investment and research. One of the main areas of focus is prophylaxis, which includes compulsory and free human papillomavirus (HPV) vaccinations for both girls and boys.
It also lays out financing plans for research into innovative oncology treatments to be conducted within a future network of clinical research facilities located beside large hospitals, research institutes and scientific facilities. The programme aims to significantly increase the amount of these research projects, for which only 10 are currently being conducted in Poland.
The establishment of such a network is estimated to cost 100 million zlotys (€23.25 million), a part of which could be covered by EU grants.
Polish OTC drugs are increasingly the source of illicit Czech meth production ingredients
Poland is a growing supplier of pseudoephedrine from popular OTC drugs, used for the illicit production on methamphetamine in the Czech Republic, Tuesday's Dziennik Gazeta Prawna (pA5) reported, citing the European Monitoring Centre for Drugs and Drug Addiction (EMCDDA) and Europol.
Even though Polish Border Guards and the Czech authorities caught an organised criminal group that is said to have produced 60 kg of methamphetamine worth 7 million zlotys (€1.6 million) up to the end of November, there are increasingly more advanced production plants not only in the Czech Republic, but also in Poland, according to the report.
Experts say this may be because Poland has no system of monitoring or preventing bulk purchases of OTC drugs containing pseudoephedrine. Even if one person cannot buy more than one packet in one pharmacy, they can visit numerous pharmacies or buy thousands of packets from wholesalers.
The regulations also need amendment as, although it is prohibited to carry pseudoephedrine drugs across borders, purchasing and owning huge amounts is not, they said.
Anti-vax communities criticise local HPV vaccination programmes
HPV vaccinations - almost unavailable today to individual patients in Poland - have been included in local authority vaccination programmes for 13-year-old boys and girls, but are under attack from anti-vaxxers, Gazeta Wyborcza (p13) reported in its Warszawa supplement on Monday.
If the vaccine is applied before sexual initiation, it can almost completely prevent anal, throat and larynx cancers. Warsaw’s local authority plans to spend 13 million zlotys (€3 million) in three years on the vaccination programme, vaccinating around 9,000 13-year-old boys and girls each year.
Despite the global trend of making the vaccination compulsory, it is still optional in Poland, so vaccination costs patients approximately 350-450 zlotys (€80-105) per shot, with the need to take two or three shots. Even if a patient does decides to buy the vaccine, they are still currently almost unavailable.
The only HPV vaccine that can still be obtained on the Polish market is Cervarix, which protects against HPV strains 16 and 18, but the more complex 4 and 10-valent vaccines are unobtainable.
Nevertheless, the Polish Ministry of Health (MoH) is considering including HPV vaccinations in the compulsory vaccination programme as primary cancer prevention. According to Professor Piotr Rutkowski, one of the authors of the National Oncology Strategy, HPV vaccines will be included in the compulsory vaccination programme in 2024.
Paper prescriptions will still be accepted after e-prescriptions become compulsory - newspaper
Though it will be compulsory for every prescription written out in Poland from 8 January to be electronic, paper prescriptions will still be accepted in pharmacies, Rzeczpospolita (pA26) reported on Wednesday.
The news follows concerns raised by Polish doctors, who questioned whether they would be able to write traditional prescriptions in case of a system failure for e-prescriptions.
Polish pharmacies are already accepting e-prescriptions, of which 42 million have been written by 50,000 doctors since the start of 2019. Deputy Health Minister Janusz Cieszyński said the e-prescription programme has proved to be a great success, especially compared to the U.S., where e-prescriptions were introduced over an eight to 10 year period.
The system still has areas for improvement, such as fixing formal errors in the rates of reimbursement, although such mistakes will be paid for by the National Health Fund (NHF). The NHF has reserved 100 million zlotys (€23.3 million) for the computerisation of Polish healthcare in 2020.
Polish diabetes patients gain access to more innovative therapies
Flozines - a group of long-awaited and effective therapies for patients suffering from type 2 diabetes and cardiovascular diseases - were included in Poland's reimbursement lists in November, Rzeczpospolita (pA11) reported on Tuesday.
Patients must have been treated with at least two oral hypoglycaemic agents with at least 8% glycated haemoglobin and must be in the very high cardiovascular risk category to be eligible for full reimbursement.