Embedded Files
continual evaluation or phase IV study . Prescribers are required to report any untoward or unexpected adverse effects associated with drugs they are using to the MHRA. The MHRA continually evaluates this information. Some drugs cause unexpected effects that are not seen until wide distribution occurs. Sometimes, those effects are therapeutic. For example, patients taking the antiparkinsonism drug amantadine were found to have fewer cases of infl uenza than other patients, leading to the discovery that amantadine is an effective antiviral agent. In other instances, the unexpected effects are dangerous. In 1997, the diet drug dexfenfl uramine was withdrawn from the market only months after its release because patients taking it developed serious heart problems. In 1998, the antihypertensive drug mibefradil was removed from the market not long after its release because patients taking it were found to have more cardiac morbidity. These problems were not seen in any of the premarket studies. Licensed and Unlicensed Drugs There are occasions when an unlicensed drug, that is a drug which has not completed the entire clinical trials programme, is used to treat a patient. For example, an unlicensed drug may be used as drug treatment as part of a clinical trial. Alternatively, the doctor may consider that the patient will benefi t from the new treatment because other treatment approaches have failed. The doctor must apply to the pharmaceutical company to use the drug on what is known as a ‘named patient’ basis. The doctor takes responsibility for the unlicensed drug treatment and the patient must be made aware of the potential risks associated with the drug. Drugs that have successfully passed through clinical testing are granted a product licence by the MHRA. This licence permits the pharmaceutical company to market this drug for the treatment of specifi c diseases or medical needs covered by the license. If it becomes apparent that the new drug could be useful in another clinical situation, for example to treat another form of cancer, the pharmaceutical company will need to conduct further clinical trials and obtain another license for the second condition. In the meantime, doctors can use this unlicensed form of the drug to treat a patient for an indication that is not covered by the original license. This is known as ‘off-label’ use. The National Institute for Health and Clinical Excellence The National Institute for Health and Clinical Excellence (NICE) was established in 1999 to provide guidance to health care professionals and also members of the public through the sharing of best practise. This organization provides information on three key areas: (1) promotion of good health and prevention of ill health; (2) new and existing medicines, treatments and procedures available within the National Health Service (NHS); and (3) the most suitable treatment for patients with specifi c diseases and conditions (NICE, 2008) to maximize resources by evaluating the cost to the NHS against the benefi ts to the patient. NICE uses current published evidence about the intervention to evaluate whether or not it would be cost effective for the NHS to use a particular medical intervention (e.g. the use of inhaled corticosteroids in the treatment of asthma for adults). When NICE recommends a specifi c medicine or treatment, the NHS is legally obliged to provide the funding. 1-(4-Chlorophenyl)-5- isopropylbiguanide hydrochloride Trade names Beconase BOX 1.1 Generic, Chemical and Trade Names of Drugs SAMPLE es. can be names are only the generic the generic ufacturers to use rers to use nproprietary Name ary Name y cases, the rINN was d Name (BAN). Wherever AN was changed to the rINN. was changed to the rINN. to this general rule: adrenaline s general rule: adrenaline he BANs, whereas epinephrine and hereas epinephrine and he rINNs. In this text, the BAN names text, the BAN names radrenaline are used as does the British ulary . Continual Evaluation Evaluation a drug is approved for marketing, it enters a phase approved for marketing, it enters a phase tinual evaluation or inual evaluation or phase IV study . Prescrib required to report any untoward or unexpecte effects associated with drugs they are using to
Report abuse