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FDA Recommends Gardasil Recipients Sit, Lie Down After Receiving Vaccination
In a posting aimed at health care professionals, FDA on its Web site on Wednesday said that recipients of Merck"s human papillomavirus vaccine, Gardasil, should be closely observed afterward for 15 minutes while they remain seated or lying down to avoid the possibility of fainting, the Wall Street Journal reports. FDA said that since October 2007, Gardasil"s labeling for both health care providers and patients has included a discussion about fainting. The agency said the strengthened recommendation comes in response to reports of "traumatic injuries" among some recipients who experienced fainting (Corbett Dooren, Wall Street Journal, 6/10). Gardasil protects against the strains of HPV that cause most cases of cervical cancer and genital warts. The Centers for Disease Control and Prevention recommends that girls ages 11 and 12 receive the three-dose vaccine before they are sexually active. Girls and women ages 13 to 26 who have not been vaccinated or completed the vaccine series also should receive the vaccine (CDC fact sheet, June 2008). On Wednesday, FDA also approved changes to Gardasil materials that place warnings about fainting in a more prominent place on drug labels and handouts. The agency said that the new recommendations are intended to "prevent falls and injuries" (Wall Street Journal, 6/10).
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Use Of Adipose Stem Cells And Polylactide Discs For Tissue Engineering Of The Temporomandibular Joint Disc
There is currently no suitable replacement for the irreversibly damaged temporomandibular joint (TMJ) discs after discectomy. In this study, we designed a TMJ disc shaped scaffold of biodegradable polylactide and combined it with adipose stem cells (ASCs).
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Study Demonstrates Internet Risks For Teen Girls
A new study demonstrates why parents need to know how their teenage girls present themselves online.
Cardiovascular

Society Calls For Clarification Of Responsible Pharmacist Regulations

The Royal Pharmaceutical Society has called for clarification of the responsible pharmacist requirements but will not be asking the Department of Health to amend the commencement date of the regulations. The Society"s Council debated the responsible pharmacist requirements in the light of concerns amongst community and hospital pharmacists about their implementation. President Steve Churton said: "Some of the concerns relate to existing problems that have been brought into sharper focus as a result of the introduction of the regulations. These include concerns about the relationship with employers, and being properly supported to take professional decisions. Council agreed that these must be addressed regardless of when the responsible pharmacist requirements are implemented". There are a number of operational issues related to the responsible pharmacist requirements which need clarification for the profession. These include: - The definition of operation of a pharmacy which seems to run counter to the government"s proposals around the greater use of skill mix in pharmacy - Requirements to remain contactable during an absence from the pharmacy for a rest break - Whether a responsible pharmacist should read all the standard operating procedures prior to commencement as a responsible pharmacist "The Society will undertake urgent work, in conjunction with other bodies, to provide further clarification, guidance and support to members and pharmacy owners to enable them to fulfil their obligations under the new regulations. This clarification will be produced prior to the introduction of the responsible pharmacist requirements," continued Mr Churton. "The Society has also decided not to request a delay of the implementation date of the responsible pharmacist requirements. The regulations were published a year ago following a fairly lengthy period of consultation and discussion in the profession and a number of organisations and employers have produced support material or plan to deliver training in the lead up to that date. "The responsibilities of the responsible pharmacist are not significantly different to the current responsibilities of the pharmacist in personal control. Indeed, the responsible pharmacist changes make explicit some of the implicit requirements of the Medicines Act. "The views of a number of leading hospital pharmacists also informed our thinking and they stated the implementation of the responsible pharmacist requirements should not be delayed as clear guidance would be available for hospital pharmacy shortly." Royal Pharmaceutical Society of Great Britain


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