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Drug Information Bulletin

Drug Information Centre (DIC) Indian Pharmaceutical Association

Bengal Branch Tele fax: 033 24612776, E-mail: Web Site: Contact: 09830136291



Volume: 05

Number: 39

7th January 2012

Minnesota Hospital assigns pharmacists to check patient discharge orders FDA announces restrictions on Cephalosporin use in Farm Animals Health ministry's 2nd delegation to China for inspection of sites to begin from Feb 12 Kerala DC registers 20 cases of DMRO violation in state wide crackdown for misleading ads Planning Commission recommends NPPA to be under health ministry Forthcoming Event


Minnesota Hospital pharmacists to check discharge orders

assigns patient

contact the physician and straighten it out." FDA announces restrictions on Cephalosporin use in Farm Animals The New York Times reports that the FDA "announced on Wednesday that farmers and ranchers must restrict their use of a critical class of antibiotics," cephalosporins, "in cattle, pigs, chickens and turkeys because such practices may have contributed to the growing threat in people of bacterial infections that are resistant to treatment." The medicines "are among the most common antibiotics prescribed to treat pneumonia, strep throat, and skin and urinary tract infections." Michael R. Taylor, deputy commissioner for foods at the FDA, said, "We believe this is an imperative step in preserving the effectiveness of this class of important antimicrobials that takes into account the need to protect the health of both humans and animals."

The Minneapolis Star Tribune reports in Minnesota that after "a kidney transplant patient left Hennepin County Medical Center with instructions for the wrong dose of antibiotics" and "another patient, who was treated for a pulmonary embolism, was discharged without a needed blood thinner," Bruce Thompson, the center's pharmacy services director, "decided to do a spot-check of 37 patients who were discharged from the hospital to nursing homes over three months in 2008 and 2009." He found a 92% "rate of medication errors," with only three of 37 cases without error. "The most common problems: Hospital physicians had prescribed the wrong doses, duplicate medications or omitted medications." Following Thompson's spot-check, "the hospital assigned pharmacists to check the discharge orders before patients are released. Now, if they spot a mistake, they

2 The AP reports, "In a statement on the FDA website, the agency said the announcement is 'among a number of ongoing FDA activities and initiatives intended to address concerns about the use of antimicrobial drugs in animal agriculture.'" These "include increased monitoring and voluntary guidelines for producers on how to use the drugs judiciously." The Wall Street Journal reports the FDA said that in 2010, US farm animals were given roughly 54,000 pounds of cephalosporins, although altogether, the animals consumed more than 29 million pounds of antibiotics. The Washington Post reports, "The antibiotics can no longer be used to prevent diseases in livestock starting April 5, though they can still be used to treat illnesses, the FDA said." Although "consumer advocates support the FDA's decision," they contend that "the move is long overdue and deals with only one small part of a much larger public health issue tied to the overuse of antibiotics in animals." The Chicago Tribune reports that US Rep. Louise Slaughter (D-NY) said, "This is a modest first step by the FDA," although "we're really just looking at the tip of the iceberg. We don't have time for the FDA to ploddingly take half-measures." According to Slaughter, "We are staring at a massive public health threat in the rise of antibioticresistant super bugs." The Los Angeles Times "Booster Shots" blog reports that Slaughter also said, "With over 1 million Salmonella cases in the US each year, at least 30,000 Americans will contract cephalosporin-resistant bacteria every year. I'm glad the FDA is finally acting but how many Americans have needlessly been sickened in the meantime?" CQ reports, "American Academy of Pediatrics President Robert Block also praised the decision, noting that cephalosporin drugs are often used to treat several serious childhood infections and have no warnings for pediatric use." According to Block, "Pediatricians are already limited in the number and types of antibiotics that we can use to treat ill children, and when one type of antibiotic is found to be resistant to a strain of an infection, some of our sickest young patients are left without life-saving treatment options." The National Journal reports, "The comment period on the new order closes on March 6." The agency "first proposed the rule in 2008 and has been tweaking it ever since because of objections from a range of groups." Bloomberg News reports, "The FDA and Agriculture Department have made 'limited progress' in addressing antibiotic use in food animals, the Government Accountability Office said in a September report. The agencies should identify ways to collect detailed data on veterinary uses, and obtain better statistics on resistance trends, said the GAO, the investigative arm of Congress." Health ministry's second delegation to China for inspection of sites to begin from Feb 12 The Union health ministry's second delegation to China for auditing and inspection of manufacturing plants will commence from February 12 and the three-member delegation will inspect six manufacturing units there. The delegation will be there in China till February 19. The three-member delegation of the Central Drugs Standard Control Organization (CDSCO) consists of Dr S Eshwar Reddy, Assistant Drug Controller, B Kumar, Assistant Drugs controller, CDSCO sub-zonal office (Chandigarh) and Dr C Sokhey, senior scientist at National Institute of Biologicals (Noida).

3 According to sources, during the second visit, inspections will be carried out in China only and the plans to inspect manufacturing plants in Italy has once again been deferred. Earlier, the ministry had elaborate plans to start the new practice with one country each in Europe and Asia --- Italy in Europe and China in Asia. But in the pilot project, the ministry sent the delegation to China only. The ministry has made plans to extend the auditing and inspection of all the manufacturing sites in all the foreign countries once the pilot programmes are successful. As per the earlier plan, a three-member CDSCO delegation was to leave for China on November 20. But, the visit has been postponed to the fourth quarter of this financial year as the financial allocation of the ministry for the third quarter had finished. Now, the delegation will be going to China in the fourth quarter. The health ministry had early last year started the process of auditing and inspection of manufacturing plants outside India as part of its efforts to ensure that only quality products are sourced by Indian companies from abroad. The first delegation was sent to China in May last year in which the delegation had inspected five pharma companies in China. The introduction of auditing and inspection of foreign manufacturing facilities by the Indian drug regulators was a long awaited plan, especially in the wake of the fact that even though the government had made registration of imports of drugs and pharmaceuticals into India mandatory way back in 2003, it failed to bring the desired results as the inflow of inferior raw materials into the country refused to subside. It was under these circumstances the ministry decided to introduce the system of inspection facilities. of foreign manufacturing

Kerala DC registers 20 cases of DMRO violation in state wide crackdown for misleading ads In a state wide crackdown on misleading advertisements for certain pharmaceutical products, including Ayurveda and herbal, by some manufacturing companies using print and electronic media, the drugs control department of Kerala has registered 20 cases of violation of the Drugs & Magic Remedies (Objectionable Advertisements) Act 1954. The cases have been registered after confiscating drugs from the store houses and manufacturing units of traders and manufacturers in surprise raids conducted by the officials of the department. Majority of the cases of violations were reported in the central zone of Ernakulam where 11 cases have been registered. According to C S Satheesh Kumar, drugs controller of Kerala, this crackdown drive on misleading advertisers is being initiated following the instruction of the drugs controller general of India who had sent circulars to all the states for strict action against the violators of the act. He said the drive will continue till January 31. He said all the confiscated items were produced in the respective magistrate courts and FIRs will be filed against some more companies for advertising drugs related to impotency, hair fall, fairness, and body fat under sections 3 & 4 of DMROA Act. According to him the advertisements usually mislead the public and they buy these products which are harmful to the human body.

4 The special team has taken four cases in Thiruvananthapuram, five cases in Kozhikodu and 11 cases in Ernakulam. However, the inspectors have deliberately avoided raids in popular companies of branded products which have markets in India and abroad. The whip came down on only small and unknown companies. Some NGOs have alleged that the departments action is only a farce as it is giving green signal to 'big sharks'. P V Shaji, Assistant Drugs Controller at Thiruvananthapurma said recently the issue of misleading advertisements for ayurvedic and other herbals products has become an agenda in the state assembly for discussion and many members had raised questions on the actions taken by the department. He said the initiative by the new DC will clean the market soon.

loopholes are used by companies to escape price control, the panel said. Prescriptions must be made in INN name which could play a crucial role in removing incentives for doctors to prescribe the most expensive brands of generic drugs. The drug regulatory authority (CDCSO) should be linked to IP delays generic competition. Patent matters must continue to be firmly delinked from the drug licensing process for clinical research, manufacture and marketing approval, the report said. Ministry of Health shall identify and issue compulsory licenses for patented expensive drugs required for public health programmes and take steps to make them affordable, the report added. If the recommendation of the Planning Commission is accepted, it can trigger a controversy since the Department of Pharmaceuticals (DoP) was specially created under the chemicals ministry a couple of years back as the administrative department for the pharma sector. The Department which now controls the NPPA has been pushing the proposal to bring also the CDSCO under its control. Forthcoming Event:

Planning Commission recommends NPPA to be under health ministry The Planning Commission has recommended that National Pharmaceuticals Pricing Authority (NPPA) be placed under the Union ministry of health and family welfare. A working committee under the Planning Commission to help prepare the plan for the next period has called for linking the National List of Essential Medicines to the Drug Price Control Order (DPCO), apart from a number of policy and legal measures by the health ministry. All drug pricing related matters should be under one ministry and not be divided between the health ministry and the chemicals and fertilizers ministry. Particularly the health ministry should be the nodal ministry for NPPA. Review of the DPCO be taken up to determine which

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