Licensed medicines

In this section, a brief summary of the nature, frequency, and consequences of adverse drug reactions (ADRs) in two clinical situations is presented. There are ADRs experienced by healthy volunteers and patients participating in clinical studies with potential new medicines and those experienced by patients who are prescribed licensed medicines. A review of these two situations points to areas of success with the current practices for non-clinical safety pharmacology testing but also identifies some areas where further research might lead to new or better safety pharmacology tests. Prior to reviewing the literature, some... 

Post-marketing trials of recently licensed medicines have been used as an opportunity for a pharmaceutical company to familiarise a doctor with a new product. Such studies have more to do with the marketing department of the pharmaceutical company than with serious research. Although regulatory authorities do not encourage such studies, there are undoubtedly several therapeutic issues, particularly related to safety, that remain to be answered at the... 

The Scottish Medicines Consortium (SMC) was established in 2001 with the remit to provide advice to NHS Boards and their Area Drug and Therapeutics Committees across Scotland about the status of all newly licensed medicines, all new formulations of existing medicines and any major new indications for established products. The SMC process (full details of which are available on their website http //www.scottishmedicines.org.uk/) requires pharmaceutical companies to complete a new product submission form. The aim is to make a recommendation soon after the launch... 

There is a general lack of pharmacokinetic (PK) and other clinical information to support the administration of many medicinal products to children which leads to a lack of appropriate dosage recommendations in this population. As a consequence, there is frequent off-label use of licensed medicines in children. 

The industry knows that it has to learn to live with restrictions of some kinds and one of the means of restriction is the formulary, a list of formulations of medicines with varying amounts of added information. A formulary may list all nationally licensed medicines prescribable by health professionals, or list only preferred drugs. 

It will be obvious from the account that follows that drug development is an extremely arduous, highly technical and enormously expensive operation. Successful developments (1% of compounds that proceed to full test eventually become licensed medicines) must carry the cost of the failures (99%). It is also obvious that such programmes are likely to be carried to completion only when the organisations and the individuals within them are motivated overall by the challenge to succeed and to serve society, as well as to make money. 

List of documents necessary for a registration of licensed medicinal products ... 

The DDX scheme is a notification procedure for a doctor or dentist plcinning to conduct a clinical trial independently of a commercially interested party and entirely on his or her own responsibility, using an unlicensed medicine or a licensed medicine supplied other them in response to a prescription. The scheme allows a... 

Nurse independent prescribers are able to prescribe any licensed medicinal product including some controlled drugs. Pharmacist independent prescribers have similar prescribing rights however, currently they may not prescribe any controlled drugs (although this may change in the future). 

The black triangle symbol (T) is used within the British National Formulary to indicate drugs or certain preparations of drugs that are under closer monitoring by the Medicines and Healthcare products Regulatory Agency (MHRA). These may be, for example, a newly licensed medicine or an established medicine being used for a new condition or administered via a new route. 

In the United Kingdom, the post-licensing division of the MHRA deals with all reclassification requests. By law, all medicines are P unless they meet the criteria for POM or GSL. Pack size restrictions for GSL products are listed in the Medicines (Sale or Supply) (Miscellaneous provisions) Regulations 1980. For all licensed medicines, legal status is ultimately determined by the MA. 

The sponsor of an IMP or the MA holder in the case of a clinical trial using a licensed medicine is responsible for the ongoing safety assessment, compliance with reporting timelines and distribution of reports to all concerned parties. Furthermore, the sponsor of a trial now also has the responsibility to report serious adverse drug reactions occurring in the use of active comparator products, even if the sponsor of the trial is not its MA holder. The guidelines recommend that the sponsor also inform the MA holder about the reported case. 

In Germany, a fully licensed medicinal product contaiiting a special extract of P. sidoides root is now among the most widely bonght self-medication products. EPs 7630 (Umckaloabo ), showed in vitro antibacterial, antiviral, and immunomodnlatory properties in several stndies. These activities seem to account for its therapentic effect in patients snffering from acute bronchitis, tonsillopharyngitis, sinnsitis and symptoms of the common cold. Efficacy and safety have been proved in numerons cliiucal trials. 

No preparations of agnus castus are available as licensed medicines, but there are products marketed as food supplements. 

Extended formulary nurse prescribing was discontinued in 2006 and replaced by qualified nurse independent prescribing. Nurses can now prescribe any licensed medicine, including some controlled drugs, if they are qualified to do so. At the same time, pharmacists became eligible to train as pharmacist independent prescribers, being able to prescribe all licensed medicines but, as yet, no controlled drugs. 

Nurses, midwives and pharmacists can now train to prescribe any licensed medicine as independent prescribers to patients. 

Table 3.2 Proportion of single enantiomer chiral drugs in development and in licensed medicines...

In Germany, eucalyptol is a licensed medicinal product sold in gut-soluble capsules and is reported to be well tolerated at a dose of 600 mg daily. Instructions for use indicate that this product should be taken with cold water about 20 minutes prior to eating to prevent epigastric pain (Juergens et al. 2003). 

However, pharmacy prepared products are not subject to the same levels of scrutiny with respect to quality assurance and efficacy as licensed medicines therefore prescribers and pharmacists cannot make the same assumptions of quality, safety and efficacy about these products as they do for licensed medicines. 

The same principles apply for reviewing prescriptions for pharmacy preparations as for licensed medicinal products. 

Use of a (licensed) medicine which is then administered by an alternative route or method e.g. use of a soluble or dispersible product or indeed rectal product in patients who have difficulty swallowing whole tablets. 

The pharmacist should consult the prescriber if it is possible or more appropriate to use a different medicine. A licensed medicinal product should be used in preference to a pharmacy preparation, if an appropriate product is available. 

The pharmacokinetic and pharmacodynamic changes usually become clinically more relevant over the 75th year of life. There are however large intra- and interindividual differences in aging of organ functions. Therefore, it is difficult to predict the exact pharmacological response of a given elderly patient. As with licensed medicines, it may be necessary to adjust doses of pharmacy prepared medicines carefully and cautiously in elderly patients. 

In Europe the German Homeopathic Pharmacopoeia is available for the regulation of the quality of these medicines. If prescribed it usually is a licensed medicine but occasionally - mainly in cases of non-availability - a pharmacy... 

Information about medical devices is not as accessible as about licensed medicines. If a pharmacist has to decide about a medical device being used in a way that is not included in the instructions for use, he has to contact the manufacturer. 

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