WARSAW, 12 Apr (APM) - The introduction of the e-prescription, the verification of drug authenticity and medicinal product sales monitoring systems this year, are removing a substantial burden from the under-staffed pharmaceutical inspectorates and is helping track pharmacy and wholesaler malpractice in Poland, reported Rzeczpospolita (pA15) on Wednesday.
Poland currently has around 130 pharmaceutical inspectors only, which means they cannot properly supervise 14,400 pharmacies and dispensaries, as well as 360,000 other outlets selling various OTC drugs.
According to an audit conducted by the Ministry of Health in March, based on the analysis of the e-prescription system log, 54% of 156 audited pharmacies were defaulting on the requirement of having a pharmacy manager on site at all times.
The audit was the effect of an incident in November 2018, when an unsupervised pharmacy technician made a mistake and gave a patient a very high dose of morphine, 10 times higher than that prescribed, resulting in the patient’s death.
The officials and the Supreme Pharmaceutical Council (NRA) are satisfied with the way the new systems are working together. Marek Tomkow from the NRA said while the introduction of the e-prescription system on 1 January, the drug authenticity verification system on 9 February and the medicinal product sales monitoring system on 1 April initially caused some inconvenience, it was a change for the better and should improve patient safety.
Reimbursement of a new cardiac drug could improve situation of many patients
Organisations and experts supporting patients with cardiac insufficiencies want officials to reimburse a new sacubitril/valsartan drug, reported Rzeczpospolita (pA11) on Tuesday.
Agnieszka Pawlak from the Central Clinical Hospital of the Ministry of the Interior and Administration in Warsaw said sacubitril/valsartan is the first drug with greater and more effective application than the currently used ace-1 inhibitors.
The drug was registered in the EU in 2015 and is reimbursed in 14 member states, including the Czech Republic, Bulgaria, Slovakia and Portugal, where GDP per capita is comparable to Poland’s.
Sacubitril/valsartan therapy has also been recommended by the Polish HTA Agency, but the officials are still refusing to reimburse the drug. Pawlak said opening access to the drug could reduce the risk of hospitalisation for patients suffering from cardiac failure by 21% and the risk of death by 20%, compared with current therapies.
An average of 164 Poles die every day from cardiac failure and 94% of the entire budget on treating the disease is consumed by hospitalisations.
Possible blackmailing of medical cannabis importer
Spectrum Cannabis, the only importer of medical cannabis in Poland, is receiving e-mails with claims that the quality of its products is non-uniform and demands for compensation, reported Dziennik Gazeta Prawna (pA11) on Monday.
Spectrum Cannabis’ country manager, Tomasz Witkowski, said the company is certain about the high quality of products it distributes and will not yield to any demands. He added that the company is treating the situation as a potential blackmail attempt.
The Wolne Konopie organisation, which supports patients who require cannabis treatment and operates a store with cannabis-based products, admits it became interested in the matter after receiving over 30 complaints from patients about the quality of medical cannabis distributed in Poland. Although the organisation ordered laboratory tests which supposedly confirmed inconsistency in the quality of medical cannabis from pharmacies throughout Poland, Spectrum Cannabis claims the much more complex and expensive tests which it ordered itself did not reveal any quality-related issues.
Wolne Konopie claims its objective is not to discredit Spectrum Cannabis, but to ensure that patients receive high-quality products, which is why the organisation has not been widely publicising the results of the tests it had ordered.
The Chief Pharmaceutical Inspectorate announced that it had not received any official complaints about medical cannabis distributed in Poland to date.
Nine more companies are already attempting to obtain licences to import and distribute medical cannabis in Poland, which means the current price of 65-70 zlotys (€15.2-16.3) per gram of the product could soon be driven down by competition.
Pharmena to transfer to Warsaw Stock Exchange
Polish biotech Pharmena is to transfer from the parallel market, NewConnect, to the Warsaw Stock Exchange on Friday, reported Parkiet Gazeta Gieldy (p6) on Thursday.
The move is supposed to make the company more recognisable and attract the attention of new investors.
Pharmena is currently expanding on the dietary supplements market and intends to increase its portfolio from one to eight products by the year end. The company is also working on a new drug containing the 1MNA particle it developed, as well as a line of dermocosmetics.
Pharmena’s market capitalisation is 55 million zlotys (€12.9 million).