Prescribers, authorised

E 951, E 952, E 954, E 957 and E 959 are intensely sweet substances and conditions of use are imposed, with maximum limits prescribed in certain foods for each sweetener. A few examples of authorised uses of these sweeteners are stated in Table 2.3. 

As required by Directive 89/107/EEC, criteria of purity have been drawn up for all the listed food additives (with a couple of exceptions). Purity criteria for all the permitted sweeteners have been prescribed in Directive 95/31/EC,6 as amended, and criteria for all the permitted colours are contained in Directive 95/ 45/EC,7 as amended. Directives that prescribe purity criteria for all the additives authorised under Directive 95/2/EC have been drawn up in stages. Directive 96/ 77/EC8 containing purity criteria for antioxidants and preservatives is amended by Directives 98/86/EC which lays down purity criteria for emulsifiers, stabilisers and thickeners and 2000/63/EC which contains purity criteria for most additives numbered E 500 and above, and for certain other additives not covered in the earlier directives. Purity criteria for most of the few remaining permitted miscellaneous additives are contained in Directive 2001/30/EC however, purity criteria for E 1201 polyvinylpyrrolidone and E 1202 polyvinylpolypyrrolidone are still being considered by the Scientific Committee on Food. Some methods of analysis for verifying prescribed purity criteria have been developed at EU level these are contained in Directive 81/712/EEC.9... 

The plan will eventually prescribe a likely filing date for a marketing authorisation application (MAA) (product hcence). This date is vital and when the plan becomes public information, any slippage in the date is likely to impact on the share price of the company. Accordingly, senior members of the company must be confident that the date can be met. There will always be pressure to bring the date forward but this has a cost in resources, and risks damaging credibility with investors if the accelerated timelines cannot be met. 

This is the name of what we used to know simply as the data sheet, or colloquially as the package insert. The SPC is the document that must be submitted in draft by companies to the MHRA/Reference Member State/European Medicines Evaluation Agency upon application for a marketing authorisation and, once approved, must then be provided to prescribers or suppliers of medicines, either with the product or at the time of promotion or within the previous 15 months of promotion of the product, written or verbal. The SPC includes the prescribing information for the product and represents the product licence approval for the medicine (see Section 12.2.1.1). It is the definitive statement between the competent authority and the company and, more importantly, is becoming the common basis of communication between the... 

The UK MEIRA has recently drawn special attention to several areas of interest and have highlighted adverse reactions in children and the elderly. Children pose a particular problem because they are seldom studied in clinical trials that form the basis of marketing authorisation submissions. The consequence of this is that children are prescribed medicines which are not licensed for that age group and little experience of possible adverse effects is available. The elderly are also under-represented in pre-marketing clinical trials and are also subject to diminished metabolic activity in respect of numerous commonly used drugs. 

An application for a marketing authorisation must be accompanied, among other items, by specified pharmaceutical, preclinical and clinical particulars and documents (the dossier ). Three important summary documents in the dossier are the SPC, a Package or Patient Information Leaflet (PIL), and the sales presentation of the product (label). The SPC has a formally prescribed structure (Box 17.1), and forms the basis for authorised chnical prescribing of the medicinal product concerned. 

Another avenue for limited access to an unapproved medicine is through the Authorised Prescriber provisions of the Act. A few specified medical practitioners are authorised by the TGA to prescribe a specific unapproved therapeutic good or class of unapproved therapeutic goods, to specified recipients or classes of recipients (identified by their medical condition) in their immediate care, without further approval from the TGA. The authorised prescriber must also have the endorsement of an appropriate HREC to supply the product. 

A pharmaceutical company is not obliged to supply an imapproved product under the authorised prescriber provisions. If it does supply the specified product, the company must provide reports every six months of the amount of product supplied to authorised prescribers. 

Adverse event and ADR reporting requirements are similar to those for clinical trials, with greater emphasis on the authorised prescriber being responsible for reporting any ADR to the TGA, the sponsor and HREC as the sponsor will not normally be actively monitoring the use of the product. 

If the decision is favourable, the drug is granted a marketing authorisation (for 5 years renewable), which allows it to be marketed for specified therapeutic uses. The authority must satisfy itself of the adequacy of the information to be provided to prescribers in a Summary of Product Characteristics (SPC) and also a Patient Information Leaflet (PIL). 

If the medicine is prescribed for certciin designated diseases zmd if necessary to be imported on the responsibility of an individual medical professional, he ensures the safety and efficacy assuming scientific awareness and presenting real benefit. The authorisation is granted for a limited period of time with a preliminary agreement. The authorisation may be suspended if the prescribed conditions are not met. For such medicines, the authorisation may be dependent on conditions mentioned in the protocol of therapeutic use and gathering of information. 

The conditions set out in the above paragraph refer specifically to the term of the authorisation, the need for or exemption from new trials, the particular prescribing conditions, a possible restriction to certain specialist fields such as hospital use, the need for prior diagnosis, the undertaking of complementary studies and the special procedure for reporting adverse reactions. 

Prescription-only medicines (POMs) (see Section 1.3.3) are usually obtained on the authorisation of a valid prescription form (either an NHS or a private prescription form) written by a recognised prescriber registered in the UK and presented at a registered pharmacy (although exceptions to this do exist, for example, dispensing doctors (see Section 2.3.1), in-patient hospital supply (see Section 4.2.1) and emergency supply at the request of a patient (see Sections 7.2 and 7.3)). 

To allow the pilots for electronic transmission of prescriptions (ETP) to go ahead in England, the Prescription Only Medicines Order was amended to allow authorised prescribers who were participating in the pilot schemes to sign prescription forms digitally in place of ink signatures. 

All medicinal products may be prescribed on an NHS prescription form (providing that the pre-scriber is authorised to prescribe that item - see Section 3.2) and that the item is not subject to any specific restrictions. For details of the different restrictions, see Section 2.6. 

Doctors may prescribe any licensed (i.e. products with a UK marketing authorisation) or unlicensed medicinal product on an NHS prescription form (unless the item is specifically prohibited by the relevant Drug Tariff - see Section 2.6). In addition they may prescribe any licensed or unlicensed product on a private prescription form (see Section 5.1). NHS prescriptions written by doctors for dispensing in the community will usually either be written by general practitioners (GPs) or (less commonly) by hospital doctors. Prescriptions for patients written by hospital doctors that are to be dispensed within the hospital are written on hospital-specific forms (see Section 4.2). 

Bonuses or gifts In the context of the promotion of medicinal products to people authorised to prescribe or dispense them, it is forbidden to give, offer or promise a bonus, financial benefit or any type of benefit, including as part of a competitive game, except if they are of little value or related to the practice of medicine and/or pharmacy. 

The people authorised to prescribe or to supply medicinal products cannot accept gifts for their personal benefit (i.e. tickets for entertainment events, etc.). 

With the reservation of the previous paragraphs of the present article, any other grant, offer or promise of any kind in exchange, monetary donation or benefit to people authorised to prescribe medicinal products is absolutely prohibited. 

The request form must be fully completed by the healthcare professional before being passed on to authorised company personnel prescribing information must be supplied to the healthcare professional. This must be shared with the patient. 

Free samples can only be given to persons authorised to prescribe or dispense medicines in internal pharmacies upon their request. 

Marketing authorisation holders must maintain adequate records of the samples of medicinal products provided by them and of the prescribing practitioners to whom they have furnished the samples, as well as the quantities involved. These records must be retained for 5 years. 

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