Patient information leaflet

Please provide an appropriate patient information leaflet providing a full explanation of the nature, purpose, procedures and risks associated with the study and consent form. 

The DRA in Venezuela allows prescription drugs to be advertised in the press on a onetime basis as an announcement that the dmg is now registered in Venezuela. Information presented in the promotion and advertising materials must be based on the product information, as specified in the summary of product characteristics (SPC), approved at the time of registration. In all countries except Australia, patient information leaflets and labels are also subject to approval. In Australia, although approval is not needed, the information must not conflict with the approved product information. 

Perhaps it is not without reason that in Italy a patient information leaflet is sometimes called a bugiardino - literally, little liar . 

The Risk Assessment model comprises (1) prediction of the concentration that will reach the enviromnent (PEC), (2) prediction of the no-effect concentration (PNEC) on a small selection of organisms (3 species), and (3) propose possible minimization measures which will be inserted, in form of standard sentences, in summary of product characteristics (SPC) and/or patient information leaflet of respective Medicinal Product [125]. 

Patient information leaflets are intended to provide information about the medicine to the patient. The leaflets are produced for many medicines whether presented as original packs or patient packs. For medicines presented in bulk dispensing packs, the manufacturer may supply additional copies of the leaflet. Within the European Union, Directive 92/27/EEC outlines the contents of patient information leaflets and the use of the rINN is required. 

Identify the essential information which the patient will want to know and which the patient needs to know and prepare a patient information leaflet. 

In the United States, the FDA had first required patient information leaflets in 1970. Following consultations with the Pharmaceutical Society, the ABPI, BMA, Health Council and other bodies, regulations on leaflets (SI 1977/1055) were introduced to make sure that the public had greater information on the medicines they were prescribed. 

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. 

Part I was a summary of the information presented in the whole dossier and included the application forms and administrative particulars on fees, various declarations and the t)rpe of application as well as particulars of the marketing authorisation (lA), proposed SPC (IBl), proposals for packaging, labels and package or patient information leaflets (IB2), and any SPCs already approved in the Member State(s) for the particular product (IB3). Also included were separate Expert Reports on chemical and pharmaceutical (ICl), pharmacotoxicological (preclinical) (IC2), and chnical documentations (IC3), as... 

The prices of generic medicines must inevitably rise in the near future as manufacturers move to produce patient packs, which will be required to contain patient information leaflets. Under EC legislation, bulk containers will almost inevitably be phased out of production (except perhaps for hospital use). 

Kerry had a one-year history of heroin use before undergoing a straightforward community detoxification with lofexidine and symptomatic medication. She was keen to go on naltrexone, and we supervised the first half-tablet dose, eight days after her last use of heroin. Her mother had helped her through the detoxification at home, and was also going to make sure that Kerry had her naltrexone each day. They were given a patient information leaflet, and a medical warning card for Kerry to carry with her at all times. 

GlaxoSmithKline. (2003, June 18). Dear Healthcare Professional. GlaxoSmithKline would like to warn you of changes to the Patient Information Leaflet (PIL) for Seroxat (paroxetine). Uxbridge, Middlesex, UK. 

Possible adverse effects Ciclosporin has many adverse effects. It would be prudent to discuss the most significant effects and offer to return when she has had the opportunity to read through a patient information leaflet. 

Electronic Medicines Compendium (2008) Patient information leaflet for Hydrea. Available at http //www.emc.medicines.org.uk/ [Accessed 4 July 2008],... 

As well as ensuring that the prescriber is aware of the unlicensed use of the medication it is important to bring this to the attention of the patient. This should be done without undermining the patient s confidence in either the prescriber or the prescribed medicine. This is also necessary because the patient information leaflet which you are supplying with the medication will not include anything to suggest that the product can be used in sickle cell anaemia. 

Medicine containers. Reclosable child-resistant containers and blister packs are increasingly used, as is dispensing in manufacturers original sealed packs containing a patient information leaflet. These add to immediate cost but may save money in the end (increased efficiency of use, and safety). 

The application for a licence for general use (marketing application) should include a draft Summary of Product Characteristics for prescribers. A Patient Information Leaflet must be submitted. These should include information on the form of the product (e.g. tablet, capsule, sustained-release, liquid), its uses, dosage (adults, children, elderly where appropriate), contraindications (strong recommendation), warnings and precautions (less strong), side-effects/ adverse reactions, overdose and how to treat it. 

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). 

Further cases of congenital malformations were reported in 1994 due to lax control of thalidomide use (Lancet 343 433 and 344 196). Thalidomide is available in the UK on a named-patient basis only, with a detailed patient information leaflet and with signed patient consent. 

The Patient Information Leaflet (PIL), different from the Summary of Product Characteristics (SPC), was introduced as early as the mid-1970s in Hungary. A detailed NIP Guideline was issued in 1990,2 years earlier that the corresponding 92/ 27/EEC Directive (Paal 1996c). However, there were only minor differences in their content. In Hungary, for example, label texts should not be repeated on the PIL and not all excipients, only those that may have an adverse effect on certain patients, should be listed, the address of the MA holder were not necessarily to be specified, etc. 

Evaluation of Physician Leaflet and Patient Information Leaflet... 

Packaging materieils—drcift or printer s artwork copies of the product s inner label, outer carton, package insert (PI) (for prescription-only products) or patient information leaflet (PIL) (for pharmacy-only and general sales list products). 

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