Most type B reactions are uncommon, occurring at a frequency of one in every 5, patients treated or less, and may not be acknowledged until many thousands of patients have been treated. Examples of type B reactions are argyria and leucopenia in patients receiving silver sulfadiazine for wound care.
During that time, a new medicine will be the subject of post-marketing surveillance, allowing a more accurate estimate of the incidence of adverse effects to be made. An example is acute renal failure due to medullar toxicity induced by topical silver sulfadiazine. In modern wound care provision, clinical practice needs to be refined in the light of emerging evidence of effectiveness as well as consider aspects of efficiency and safety from the perspective of the individual patient and carers in the wider community.
A new therapy can be licensed if evidence determines pharmaceutical quality, efficacy but not necessarily more so than comparators , and safety. The question of cost is explicitly excluded from consideration. However, almost all hospitals have a Drug, Technology and Therapeutics Committee, often serving not only the hospital s but also family physicians and their local communities. Cost-effectiveness is one of the parameters these committees will attempt to include in their decision regarding the inclusion or exclusion of a medicine in their local formulary, informed by work undertaken by drug information pharmacists and their nationwide network.
The issue of economic aspects of a therapy is complex because the boundaries to evaluating costs and benefits are artificial and the results are strongly dependent on where the boundaries are drawn. Modern therapies can be costly and yet still save money. One example is negative pressure wound therapy, which is more expensive than routine dressings in the treatment of diabetic foot ulcers and traumatic and postsurgical wounds, but randomized controlled trials suggest that appropriate usage can lead to savings through fewer surgical procedures, less-frequent monitoring, and fewer outpatient treatment visits.
Cost-effectiveness studies are the best examples of how efficacy and effectiveness studies differ in generalizability and relevance to policy. Interventions with demonstrated benefit in efficacy studies need to be transported into the cost-effectiveness arena. Integrating cost-effectiveness models within efficacy studies yields results that are relevant both to policy and to clinical care. But even with such techniques, contextual and human factors, such as clinic prescribing practices and staff training, cannot affect care decisions.
The prescription of any wound therapy represents a form of therapeutic experiment with the object of maximizing the benefit to the patient while minimizing risks. With that information, the evidence base can be applied. For example, a level 2 study 56 demonstrated that most small traumatic lacerations in young people do not need antibiotics and level 5 evidence 44 showed it would be unwise to give silver sulfadiazine to a pregnant patient for prophylaxis of infection in burn wounds. Provided the probable benefits of therapy are greater than those of alternatives and outweigh any potential risks, additional patient characteristics would need to be considered in the choice and length of administration of the therapy to be prescribed.
The presence of disease affecting the metabolism or elimination of drugs and treatment with drugs that can interact are obvious problems. Patient age is another important factor. Relatively few drugs have been adequately studied in children and some, such as silver sulfadiazine, have been found to be potentially dangerous.
Driven by the development of technologically innovative products and rising incidences of chronic wounds as well as an increasing aging population, the wound care market is forecast to grow by 7. Like all therapeutic interventions, the choice of wound care products should be based on the evidence base for clinical safety, efficacy, cost, and patient suitability. Wound care professionals are encouraged to participate in conducting well-designed and controlled clinical studies of wound dressings and to resist the routine use of new dressings that are usually more expensive in the absence of good quality clinical evidence for their benefit over existing products.
In order to make an informed decision on wound management, wound care professionals need to have a good knowledge of the types of dressings available and the properties of individual dressings along with a sound understanding of wound healing. General factors such as safety, comfort, pain management, and convenience must be considered when deciding which dressing is the best for individual patients, given that dressings should be cost- as well as clinically effective. Although high costs and widespread use would indicate that modern dressings have a clinical advantage over conventional ones, this is not always the case.
Wound care professionals should consider whether the routine use of expensive modern wound dressings is justified on the basis of safety and patient preference. It is recommended that large-scale, local and individual health economies work together to develop local wound formularies to improve consistency in prescribing and maximize cost efficiency. Increasing use of evidence-based medicine can contribute to a more efficient wound care system. The adoption of evidence-based medicine by individual healthcare professionals may help facilitate efficient distribution of resources, perhaps translating into more people receiving better wound care and having better health.
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