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Electronic monitoring of essential
medicines haven't "acclimation"
Health Reporter Wang lemin
March 31 is the implementation deadline of the wide variety of electronic monitoring of essential medicines. According to the documentation requirements, starting on April 1 this year, included in the essential medicines list of varieties, and does not use electronic monitoring of medicines is not network code logo enterprise, must not participate in the bidding and procurement of essential medicines.
According to reports, to 307 basic drugs include drugs of electronic supervision network, manufacturers more than more than 3,500 involves preparation, preparation production enterprises in China accounted for 70% of the total. At present, the country has more than more than 1550 essential drug manufacturers do the access procedure, get the keys. At the end of 2010, Beijing, Anhui, Jiangxi, Gansu, Ningxia and other provinces (autonomous regions and municipalities) production rates of corporate network has reached 100%.
"But in some areas, even some economically developed provinces there is a lack of confidence, the progress of the work is not very satisfactory. Net rate of less than 40% the 8 provinces, there are 4 provinces now without even a progress report. "In response, the State food and Drug Administration Commissioner SHAO Ming lap at the end of January 13, 2011 National Conference on food and Drug Administration has repeatedly emphasized that implementation of basic drug electronic monitoring is not just surveillance authorities or pharmaceutical company, is an overall situation, cannot be passive watching.
Businesses complained of increasing cost pressures
To reduce the burden on enterprises as far as possible, and mobilize the enthusiasm of pharmaceutical companies, the State food and Drug Administration has introduced relevant documents, clear pharmaceutical enterprises to join electronic supervision network costs borne by the State. State food and Drug Administration has applied to special funds for the Central Government transfer payments, is equipped with a digital certificate for the production of essential medicines enterprises and training.
Electron promotion in the process of regulatory codes, enterprise has reflected a number of questions remained to be resolved, despite the Government's burden of the cost of network, hardware and manpower costs also require companies to take. Manufacturers on different types of packages you want to assign codes, you need to join the pharmaceutical electronic supervision network, purchase equipment, increase staff assigned codes. According to estimates, after electronic regulatory codes, minimal package of each drug cost 4 min ~5 cents. For a low profit of essential drugs, and increased cost 1 penny is unbearable. One corporate official, they complete renovation spent millions of dollars.
During this process, distribution enterprises need to do more work. It is understood that due to the operation of many varieties, business processes, and electronic monitoring code and cannot be done with existing barcode management system, businesses must be involved electronic monitoring code product needs, such as inbound and outbound, unlikely chailing increase in the work of new professionals, efficiency will be greatly reduced, and increased cost is astronomical. A major medical business company official said, in full compliance, increased costs could reach $ 50 million.
Hospitals and pharmacies are blind
State food and Drug Administration Deputy Commissioner bian zhenjia, electronic monitoring of implementation of basic drugs, is beneficial to multiple win-win initiatives. At present, China has achieved on narcotic drugs, psychotropic drugs one or two classes, blood products, vaccines, injections of electronic supervision. Therefore, the implementation of electronic monitoring is not a new idea of essential medicines. Have been previously accumulated more experienced and successful experience.
Bian zhenjia said that electronic monitoring of essential medicines through the means of information technology, essential medicines for the patients get in the hands of each cartridge with all electronic bar code, namely drug "electronic identity cards" to achieve the regulator electronic production of essential medicines to the circulation and to use monitored. Code can protect their intellectual property rights of pharmaceutical companies using electronic supervision, achieve products anti-counterfeiting of drugs, quality traceability, issue recalls, counterfeiting law enforcement, accountability. The public also by electronic monitoring code in a Web query to a specific drug information, to identify the authenticity of the drug.
However, the company believes that current electronic regulation only covers the production, circulation, mastering 80% medical institution is not included in the scope of regulation of pharmaceutical sales, this system did not grasp the medical use of drugs. Issues relating to regulation and for a huge number of pharmacies throughout the country, has not been settled. Enterprises are looking to spend are posted on the regulatory code, and finally to really play a regulatory effect.
All over the touched stone River
On October 25, 2010, Beijing pilot enterprises first assigning codes to essential medicines – Nimodipine formal referrals, which is national essential drugs of pre-assigned codes. And drug administration in Beijing congluoluo, the Secretary said, as of now, the city covered basic normal when it comes to production of the drug companies have all been developed an implementation plan, login State drug electronic supervision network, determined Integrator; already has 32 production companies to complete a one-way transformation of electronic assigned codes, 12 was formally put into production use.
According to him, in Beijing to promote electronic monitoring of essential medicines do "base clear and stated that". Essential drugs in the city when it comes to enterprise 78, approval number 861, reconstruction of production enterprises in the city a total of 194 production lines, an average of every production line reconstruction needs to invest $ 288,000, overall is expected to need 48.127 million Yuan. Assigned codes manually remolding the lowest cost about $ 50,000, assign a code line for transformation of the highest costs nearly $ 2 million.
He said, to the progressive implementation of electronic regulatory codes, Beijing has developed 3 milestones. As at October 31, 2010, the pilot production line for all aspects of operating a pilot production, 100% all through, the first products were officially assigned codes BTL; until December 31, 2010, all essential drug production and distribution enterprises 100% determined Integrator, completed contract start modification; until March 31, 2011, all essential drug production and distribution enterprises 100% complete transformation. Government, society, technology, Enterprise square linkage operation, push forward the work carried out.
Anhui Province has launched the "undertaking" System. The Province provides that joined electronic supervision network companies must submit a letter of commitment. Commitments should be made clear in the book to buy, debugging, and running electronic monitoring system of official Internet time. Where an enterprise determines not to join the electronic supervision network clearly does not operate, must be submitted not to participate in the electronic monitoring varieties tendering undertaking of such content. It is understood that, in order to grasp the pharmaceutical wholesale business of drug electronic monitoring work progress in the implementation, in Anhui Province food and drug administration requirements, effective December 1, 2010 weekly electronic monitoring system, wait, slow progress of enterprises to focus on supervision.
Jiangxi province food and Drug Administration has issued electronic monitoring of essential medicines in Jiangxi province of the job responsibilities and the evaluation criteria, support the implementation process in terms of monitoring and evaluation. As of December 31, 2010, a total network of pharmaceutical enterprises in Jiangxi province, 219 70 has signed a contract for pharmaceutical production enterprises. In addition, this year will also be developed in Jiangxi province and docking state food and drug administration and covers 11 districts and cities, and electronic monitoring platform in 100 counties.
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