WARSAW, Feb 9 (APM) - The Chief Pharmaceutical Inspectorate (GIF) has discovered that doctors in numerous outpatient clinics throughout Poland have been knowingly administering vaccines to children that should have been disposed of because of improper storage conditions, reported Dziennik Gazeta Prawna on Monday (pA1 & pA8) and Tuesday (pA1 - A3).
The GIF says outpatient clinics frequently do not report that they have vaccines which have been stored in improper conditions, for example after power cuts and the consequent interruption in the cold supply chain. Some pharmaceutical inspectors claim this has been going for years and the authorities have been keeping it quiet so as not to give anti-vaccination organisations additional arguments against vaccinating children.
Additionally, many doctors believe the storage requirements imposed by manufacturers are very strict and no harm is done if they are not fully met, reported the newspaper.
The GIF says the practice could be dangerous and lead to complications in patients vaccinated with these products. Further, in such cases, manufacturers are not required to compensate patients for adverse effects caused by the vaccines and the responsibility is transferred to the state, the newspaper reported.
Poland’s health ministry confirmed the issue on Monday and the prosecutor general ordered a detailed investigation. All doctors who have been knowingly administering vaccines that should have been disposed of could face disciplinary action, reported the newspaper on Tuesday.
Barbara Trabszys, a lawyer from the KRK Kieszkowska Rutkowska Kolasinski law firm, said parents of children who received the vaccines can file for compensation, theoretically even if no visible complications arose.
She added that deputy health minister Marcin Czech’s claims that the storage requirements are too strict and the irregularities that took place were minor are out of order, as drugs and vaccines are a special category of products and institutions responsible for dispensing them must observe the standards specified by the manufacturers.
She concluded that this is not the first time such a situation has taken place and irregularities on a smaller scale are reported reasonably frequently, the newspaper reported on Thursday.
Experts say the way the authorities handle this issue and the reaction of Polish patients could lead to the strengthening of anti-vaccination organisations throughout Europe. Polish organisations have already filed a request with the MoH to suspend the vaccination programme until the investigation is complete, the newspaper reports on Friday.
The problem mainly applies to vaccines stored between October 2017 and January 2018 in outpatient clinics in the Lublin, Pomeranian and Lower Silesian voivodships, which were the regions exposed to extended periods of power cuts due to poor weather conditions. The full list of potentially affected vaccines includes ACT-Hib, BCG, Bexsero, Boostrix, Clodivac, DTP, Dultavax, Euvax B, FSME-immun 0.25 junior, FSME-immun 0.5ml, Hepavax-Gene, Infanrix Hexa, Infanrix IPV+ Hib, Nimenrix, Pentaxim, Poliorix, Prevenar, Priorix, Rotarix, Silgard, Synflorix, Tetana, Tetraxim, Typhim VI, Varilrix and Verorab, the newspaper reported on Tuesday.
Access to innovative prostate cancer drugs restricted
Polish patients and health experts are complaining that access to innovative prostate cancer drugs is restricted because the health ministry disagrees with the reimbursement of sequential treatment, reported Rzeczpospolita (pA6) on Wednesday.
The problem applies to patients with prostate cancer that cannot be surgically removed. These patients are first treated with abiraterone then, when the drug is no longer effective, they undergo radiotherapy. After these treatment options are exhausted, doctors usually recommend enzalutamide, but administrative barriers mean that patients cannot have the drug reimbursed and are forced to pay between 8,000 and 14,000 zlotys per month because, according to the MoH, only one of the drugs may be financed by the state.
Many patients cannot afford such expensive therapy and are left with no alternatives.
Prostate cancer is the second most common cancer in Poland, with 10,000 new cases every year.
Access to paediatric post-transplant drug remains restricted
The Polish health minister has not fulfilled his promise of January 24 that the only post-transplant drug in the form of a suspension will be available to children for free and its administration will not require visits to hospitals, reports Rzeczpospolita (pA17) on Friday.
Parents complain that the drug, which had a price hike last year from 316 zlotys (76 euros) to 817 zlotys (196 euros), is only available to patients for free when administered in hospitals, and specialists say this requirement poses a risk to children after transplants because of widespread hospital-acquired infections.
Healthcare institutions say they have not received any legally binding instructions from the health ministry and are not allowed to dispense the drug to parents until the authorities give them the legal grounds to do it.
Innovative cancer vaccine could soon be tested on humans
Scientists from Stanford University in the U.S. have announced that they have developed an innovative cancer vaccine which is extremely effective in destroying cancer cells in mice, reports Gazeta Wyborcza (Tylko Zdrowie supplement, p3) on Friday.
The vaccine consists of two particles, CPG oligonucleotide and an antibody which stimulates T lymphocytes to attack cancer cells. The therapy proved extremely effective in lymphoma, nipple, bowel cancer and melanoma.
The scientists are now preparing to test the vaccine on 15 patients diagnosed with early-stage lymphoma.