Safety promotion guidelines

Both ACC and SOCMA have programs to promote good practices among their member companies in the area of chemical process safety.59 In 1989, ACC developed the Responsible Care Process Safety Code60 to prevent fires, explosions, and accidental chemical releases. The code and its accompanying resource guidelines include a series of recommended management practices. 

In its report ( 3) issued in 1972, the Task Force acknowledged the potential human and animal health hazard of drug resistant bacteria and made a number of recommendations. In addition to basic research to better understand the nature of the problem, the Task Force recommended that restrictions be placed on the use of antibacterial agents in feeds which fail to meet guidelines established by the Task Force in regard to safety and/or efficacy. Agents that do not meet these standards would be prohibited from growth promotion and any subtherapeutic use in animals but could continue to be used at therapeutic levels for short-term treatment on the order of licensed veterinarians. 

Phase IV clinical trials and prospective observational cohort studies have been criticised as no more than promotional devices used by aggressive pharmaceutical companies. The fact that misuse has sometimes happened should not be allowed to obscure the greatly more important needs of safety evaluation and the further development of new and improved therapies. A set of guidelines has been published in the United Kingdom which are specifically intended to provide the high standards of study design and methodology necessary for observational cohort studies. It is to be hoped that similar procedures will be adopted internationally. 

The Medicines Act, together with the associated EU legislation and EU and ICH guidelines, should ensure that the safety of drugs made to the highest quality, the acceptability of their risk/benefit ratio and the promotion of correct information to the prescribers and consumers are the dominant features of the controls that operate today. 

Attention is drawn to the Guidelines for Company Sponsored Safety Assessment of Marketed Medicines (SAMM) which have been produced jointly by the ABPI, the British Medical Association, the Committee on Safety of Medicines, the Medicines and Healthcare products Regulatory Agency and the Royal College of General Practitioners. These state that SAMM studies should not be undertaken for the purposes of promotion. 

This coalition of businesses, business groups, and individuals promotes efforts to reduce drug and alcohol abuse in the workplace in order to protect the health and safety of workers as well as business productivity. It also supports drug-testing programs when done under proper guidelines to protect employees rights. 

International Conference on Harmonization Guideline on Data Elements for Transmission of Individual Case Safety Reports. This document s efforts focus on quality control/quality assurance endeavors to ensure accuracy and to promote validation in the handling of case safety reports for both preapproval and postapproval periods. It covers both adverse drug reaction and adverse event reports. 

Anonymous. 2004. Medicinal plants - guidelines to promote patient safety and plant conservation for a US 60 billion industry. World Med. J. 50 78-79. 

In light of current policies that are unevenly evoked to ensure safety and efficacy, reliance on promotional information, no matter how skillfully executed, this is folly unless authoritative scientific evaluations are well known to back up any claims of worth and parameters of use. There is little meaning in the belief that natural is safe, any more than one can expect the same for a pharmaceutically derived product. The following guidelines for rational herb use follow many recommendations already outlined by Murphy (1999) and Drew and Myers (1997) (Table IX). 

World Health Organization. 2004. Medicinal Plants—Guidelines to Promote Patient Safety and Plant Conservation for a US 60 Billion Industry , pp. 1-2. World Health Organization, Geneva, Switzerland. 

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