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    Compounding For Paediatric Patients

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    Carlos Moreno
    This document summarizes compounding for paediatric patients in Portugal. It discusses that 30% of compounded preparations in Portugal are for paediatric patients. The most common therapeutic classes for paediatric compounded preparations are dermatological (15%), cardiovascular (18%), and anti-inflammatory (15%). The document outlines the objectives to understand paediatric compounded preparations in Portugal, develop validated oral dosage forms with stability studies, and provide patient information leaflets. It also describes the methodology used to develop the Portuguese Galenic Formulary including identifying needs, evaluating compounds, selecting preparations, and obtaining approvals. The conclusions state that compounding addresses clinical situations and safety is important when following good preparation practices.

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    Compounding For Paediatric Patients

    Uploaded by

    Carlos Moreno
    195 views1 page
    This document summarizes compounding for paediatric patients in Portugal. It discusses that 30% of compounded preparations in Portugal are for paediatric patients. The most common therapeutic classes for paediatric compounded preparations are dermatological (15%), cardiovascular (18%), and anti-inflammatory (15%). The document outlines the objectives to understand paediatric compounded preparations in Portugal, develop validated oral dosage forms with stability studies, and provide patient information leaflets. It also describes the methodology used to develop the Portuguese Galenic Formulary including identifying needs, evaluating compounds, selecting preparations, and obtaining approvals. The conclusions state that compounding addresses clinical situations and safety is important when following good preparation practices.

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    Compounding for paediatric patients

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    This document summarizes compounding for paediatric patients in Portugal. It discusses that 30% of compounded preparations in Portugal are for paediatric patients. The most common therapeutic classes for paediatric compounded preparations are dermatological (15%), cardiovascular (18%), and anti-inflammatory (15%). The document outlines the objectives to understand paediatric compounded preparations in Portugal, develop validated oral dosage forms with stability studies, and provide patient information leaflets. It also describes the methodology used to develop the Portuguese Galenic Formulary including identifying needs, evaluating compounds, selecting preparations, and obtaining approvals. The conclusions state that compounding addresses clinical situations and safety is important when following good preparation practices.

    Copyright:

    Attribution Non-Commercial (BY-NC)
    Download as PDF, TXT or read online from Scribd
    Download as pdf or txt
    195 views1 page

    Compounding For Paediatric Patients

    Uploaded by

    Carlos Moreno
    This document summarizes compounding for paediatric patients in Portugal. It discusses that 30% of compounded preparations in Portugal are for paediatric patients. The most common therapeutic classes for paediatric compounded preparations are dermatological (15%), cardiovascular (18%), and anti-inflammatory (15%). The document outlines the objectives to understand paediatric compounded preparations in Portugal, develop validated oral dosage forms with stability studies, and provide patient information leaflets. It also describes the methodology used to develop the Portuguese Galenic Formulary including identifying needs, evaluating compounds, selecting preparations, and obtaining approvals. The conclusions state that compounding addresses clinical situations and safety is important when following good preparation practices.

    Copyright:

    Attribution Non-Commercial (BY-NC)
    Download as PDF, TXT or read online from Scribd
    Download as pdf or txt
    of 1

    Whats happening in Portugal

    Compounding for Paediatric Patients


    Tavares, Paula

    Departamento de Medicamentos Manipulados

    LEF, Instituto de Formao e Inovao em Sade, Barcarena, Portugal;Tel(+351) 214278610; Fax (+351) 214278639; [email protected]

    Introduction
    Treating a paeditric patient presents a therapeutic challenge when the safest and most effective agent is not available in a suitable dose or an acceptable dosage form. Most marketed products that are mostly used in adults have not been studied in children. The market for paeditric products is small compared to the adult market because children are generally healthy and are a smaller part of the population. A compounded medication that is formulated to meet the unique needs of the paeditric patient and that can be quickly adjusted to more effectively address a childs changing medical needs can be essential to a successful therapeutic outcome. In fact paediatric compounded preparations allow the choice of the most suitable dosage form, the adjustment of the doses to the pharmaco-therapy of peadiatric sub-groups, the selection of excipients and the customization of the medicines to respond to some peculiarities such as pharmacokinetic properties, biological maturity and intolerances.

    Resultados
    1. Replies to the inquiry target to community and hospital pharmacies and the analysis of the requests made to PCIC show that, in Portugal, 30% of compounded preparations are paediatrics. 15% of PCP are dermatological, 18% are for cardiovascular diseases and 15% are anti-inflammatories. Powder packets represent 10%, capsulas 5%, oral liquid 61%, topical liquids 10% and semisolids 14%. 2. PGF inclued 218 paediatric compounded preparations (PCP) corresponding to 90 active substances. The cardiovascular PCP represents 17%, dermatological 21%,and anti-inflammatories 13% . PCP adressed to the CNS, endocrine and metabolism, nutrition and gastrointestinal disorders represent 7% to 9%, each. 66% of PCP included in the PGF are oral liquid. Vehicles of different viscosities are composed of different sweeteners (sucrose or saccharin).
    AI
    Mineral Tar Zinc Oxide Iodine Hydroquinone Ictamol Salicylic acid Choramphenycol Boric acid Eosin Azelaic acid Glicolic acid Ditranol+ Salic. Resorcinol + Salic Chlorhexidine Fluorouracil Metronidazole Benzoyl peroxide Podophyllin Tretinoin+Hydroqu inone+Cogic ac.

    Objectives
    1. Knowledge of the paediatric compounded preparations (PCP) in Portugal 2. Development and validation of oral pharmaceutical forms, establishing the galenic formula, the preparation procedure and the term of use supported with stability studies . 3. Availability of the pharmacotherapeutic information ( package information leaflet -PIL ) for informed hand over and suitable use of the PCP.

    AII
    Boric acid Acetic acid Sodium bicarbonate Urea peroxide

    AIII
    Metronidazole benzoate Trimethoprim Nitrofurantoin kecotonazole Ciprofloxacin Dapsone Griseofulvin Hydroxychloroquine Itraconazole Pyrazinamide Rifampicin Tetracycline Ethambutol

    AIV
    Testosterona prop

    AV
    Hydrocortisone Potassium iodide Cortisone acetate Dexamethasone Prednisolone Prednisone Propylthiouracil

    AVI
    Methadone Phenobarbital Amitriptlyline Caffeine Carbamazepine Lamotrigine

    AVII
    Spironolactone Propanolol Hydrochlorothiazide Captopril Atenolol Clonidine Diltiazem Dipirydamole Enalapril Furosemide Labetalol Minoxidil Nifedipine Pentoxyfilline Verapamil Flecainide Digoxin

    AVIII
    Triamcinolone Ranitidine Famotidine Cimetidine Nitroglycerine +Cinchocaine Ursodeoxycholic Omeprazole

    AIX
    Sodium citrate Citric acid Potassium Chloride Sodium phosphate

    Design & Methods


    1. Inquiry targeted to Community and Hospital pharmacies asking about the active substance, dosage, dosage form, excipients, indications for use and posology. Evaluation of the requests settled to the PCIC (2006 2009) by query of a dedicated database. The information was treated by classification of the content Question & Answer in the following items: active substance / dosage form / dosage / disease / target group / query frequency to PCIC. 2. Edition of the Portuguese Galenic Formulary (PGF) according to the following method:

    Auscultation needs

    Evaluation

    PCP Selection

    FGP

    AX
    Acetazolamide

    AXI
    Allopurinol Indomethacin Methotrexate Capsaicin

    AXIII
    Riboflavin Zinz acetate pyridoxiune Sodium benzoate Biotin Arginine

    AXIV
    Folic acid Phytomenadione

    Pharmaceutical development Pharmaceutical characterization Inquiry PCIC Data SPP/WHO/EMA Target group : Paediatric Dosage form Route of administration PCP proposal Consultive Commission approval Period of use Monograph Preparation record Label / PIL

    AI Drugs used in skin disorders; AII Drugs used in otorhinolaryngological disorders; AIII Anti-Infectives drugs; AIV Drugs used to treat genitourinary disorders; AV Hormones and Drugs used to treat endocrine disorders; AVI Drugs used to treat Central nervous system disorders; AVII - Drugs used to treat cardiovascular disorders; AVIII - Drugs used to treat gastrointestinal disorders; AIX Correctives of blood volume and electrolytes; AX - Drugs used to treat ocular diseases; AXI - Drugs used to treat locomotor disorders; AXIII - Drugs used to treat nutritional disorders; AXIV - Drugs used to treat blood disorders

    3. Package information leaflet is clear and simply organized. Recommendations on the dosage, posology and indication for the therapeutic use are given for all PCP. All the information is given using patient comprehensive language. Information included in the PIL is based inscientific literature (Taketomo CK, Hodding JH, Kraus DM. Pediatric dosage handbook 2001 and DRUGDEX, 2006).

    The criteria for the PPC proposal were: a) highest frequency of use; b) therapeutic need; c) trouble in the formulation or stability of the compound. 3. The package information leaflet -PIL follow current legislation and includ the subjects: 1) What ____ is and what is used for; 2) Before take ____ 3) How to take ____
    Disease / Dosage / range takes

    CONCLUSES
    Pharmaceutical compounding settle clinical situations and, in fact, are extremely important since they allow the adjustment of the medicine to the intended patient. Pharmaceutical quality and safety are underlying for a suitable use of these medicines that obey to Good Preparation Practices (GPP) procedures. The identification of the pharmaceutical compounding needs and the decision on which will be included in this category is urgent. Then, it would be appropriate the harmonization of pharmaceutical compound in the EEA, as well as a quality system applied to the pharmaceutical compounding characteristics that show a personalization to the patient as an added value. In Pediatrics, it is central to comply with a judicious selection of excipients, not only for safety reasons but also for adherence to therapy. An informative platform, managed by the different countries in concert, would minister a more safe and efficacious use of these medicines. Pharmacovigilance programs and efficacy monitoring should be developed and implemented.

    4) Possible side effects 5) How to store ___ 6) Further information

    Bibliography
    Diverse challenges in pediatric compounding, IJPC Vol14 Jan/Feb 2010 2 Lack of commercial oral drug formulations for Children, IJPC Vol12 July / Aug 2008 3 Safety of inert additives or excipients in paediatric medicines, Arch Dis Child Fetal Neonatal, Vol 94 Nov 2009 4 Poor Formulation in published pediatrics drug trials, Pediatrics Vol116 n4 Oct 2005 5 Inappropriate oral formulation and information in paediatric trials, Arch Dis Child, July 2010
    1

    21

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    to 22nd September 2010

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