Klin Farmakol Farm. 2007;21(3):145-150

Risk management system and drug safety examples

Jozef Kolář1, Milan Kriška2,3
1 Ústav aplikované farmacie, Farmaceutická fakulta VFU, Brno
2 Farmakologický ústav Lekárskej fakulty UK, Bratislava
3 Nemocnica s poliklinikou Považská Bystrica

A risk management system is a set of pharmacovigilance activities and interventions designed to identify, characterise, prevent or minimise risks relating to medicinal products, including the assessment of the effectiveness of those interventions. The prescription and distribution of some drugs are subject to restrictions and limitations. The authors describe several the most famous programs like TOUCH (natalizumab, Tysabri), S.T.E.P.S. a PRMP (thalidomide, Thalomid), RevAssist (lenalidomide, Revlimid), SMART, iPLEDGE (isotretinoin, Accutane), CPMS (clozapine, Clozaril), T.I.P.S. (dofetilide, Tykosin). Particular attention is paid to the systems alert about counterfeit drugs, e.g. SafeMeds Alert.

Keywords: risk management system, pharmacovigilance, programs

Published: January 1, 2008  Show citation

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Kolář J, Kriška M. Risk management system and drug safety examples. Klin Farmakol Farm. 2007;21(3):145-150.
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    References

    1. Zákon č. 79/1997 Sb. o léčivech a o změnách a doplnění některých souvisejících zákonů.
    2. Slovník pojmov. http://www.udzs.sk/buxus/docs/MU_7_2006_priloha4_slovnik_25.10.06.pdf
    3. Filipová L, Svobodová Z. Farmakovigilance: bděle a ostražitě. PharmBusiness Mag 2006 (říjen/listopad): 8-10.
    4. Zákon č. 140/1998 Z. z. o liekoch a zdravotníckych pomôckach v platném znění.
    5. Kolář J, Kriška M. Preventívne programy vo farmakovigilancii. Kurz komunikácie pri riziku liekov II. A - používanie NSAIDs z hľadiska nových poznatkov vo farmakovigilancii. Bratislava 29. 11. 2006.
    6. Guideline on Risk Management Systems for Medicinal Products for Human Use. London 14 November 2005; Doc. Ref. EMEA/CHMP/96268/2005
    7. Palágyi M. Pharmacovigilance (farmakobdelosť) - prostriedok na získanie novších poznatkov o bezpečnosti liekov. Lekárnik 2007; 12, 1: 54-55.
    8. Creation of a better medication safety culture in Europe: Building up safe medication practices. Report Expert Group on Safe Medication Practices (P-SP-PH/SAFE) 274. Zdroj: Council of Europe On 19 March 2007.
    9. EMEA template to help companies prepare risk-management plans. Scrip 2006, č. 3201, 3.
    10. Bateman S. RiskMAPs: A route to drug safety. GCPj 12, 2005, č. 9, s. 15-17.
    11. EMEA group calls for new approach to risk-benefit evaluations. Scrip 2007, č. 3247, 4.
    12. Evropská veřejná zpráva o hodnocení (EPAR) TYSABRI. Souhrn zprávy EPAR určený pro veřejnost. EMEA/H/C/603. Tento souhrn byl naposledy aktualizován v 05-2006. TysabriEPARsummary-cs.pdf
    13. Tysabri - fact sheet. http://www.mstrust.org.uk/publications/factsheets/tysabri.jsp (4. 7. 2006)
    14. Biogen wins US approval to return Tysabri to the market. Scrip 2006; 3164: 23.
    15. Tysabri marketing allowed resume. U. S. Pharmacist 2006; 31, 6: 72.
    16. Traynor K. Tysabri´s return draws cautious optimism. Amer J Health-Syst Pharm 2006; 63: 1388, 1392. Go to original source... Go to PubMed...
    17. Krasner J. What' s in a name? At times, danger Biogen Idec retools after FDA clears drug but not its moniker. Boston Globe December 20, 2004 http://www.boston.com/yourlife/health/diseases/articles/2004/12/20/whats_in_a_name_at_times_danger/
    18. Kolář J. Znovuzavedení léčiv na farmaceutický trh. Čas čes Lék 2003; 75, 3: 20-21. Go to original source...
    19. Thalidomide to be funded by Australia. Scrip 2006; 3126: 18.
    20. Thalomid finally available in the US for multiple myeloma. Scrip 2006; 3161/62: 26.
    21. Addition of Thalidomide to Standard Therapy Improves Overall Survival in Newly Diagnosed Multiple Myeloma. http://www.prnewswire.co.uk/cgi/news/release?id=172469
    22. Seznam specifických léčebných programů schválených MZ ČR v období od 30. 4. 2004 do 31. 5. 2004. Věstník SÚKL 2004; 6: 75-76.
    23. Revlimid. http://www.revlimid.com/mds_important.aspx (29. 9. 2006)
    24. Accutane(R) (isotretinoin). System to Manage Accutane Related TeratogenicityTM S.M.A.R.T. TM Guide to Best Practices. Roche Pharmaceuticals.
    25. Upozornění pro lékaře předepisující léčivý přípravek Roaccutane. www.sukl.cz (30. 1. 2006)
    26. Isotretinoin iPLEDGE programme requirements eased for some US patients. Scrip 2006; 3200: 14.
    27. Huber P. The lawyers versus the homeless. Forbes, July 9, 1990, 92. http://www.overlawyered.com/articles/huber/clozaril.html (30. 11. 2006)
    28. Notice of Decision for Xyrem(R). http://www.hc-sc.gc.ca/dhp-mps/prodpharma/sbd-smd/phase1-decision/drug-med/nd_ad_2005_xyrem_088659_e.html (26. 9. 2006)
    29. Tikosyn (dofetilide). http://www.tikosyn.com/tikosyn_faq.asp (14. 12. 2006)
    30. Counterfeit Medicines: The Silent Epidemic. http://www.who.int/mediacentre/news/releases/2006/pr09/en/index.html (17. 1. 2007)
    31. http://www.rednova.com/news/display/?id=155685&source=r_health (30. 10. 2005)
    32. Besinque KH, Downing DF. Emergency contraception: A guide to over-the-counter availability. US Pharmacist 31, 2006, č. 12, Suppl.
    33. Raine TR, Harper CC, Rocca CH, Fischer R, Padian N, Klausner JD, Darney PD. Direct Access to Emergency Contraception Through Pharmacies and Effect on Unintended Pregnancy and STIs. A Randomized Controlled Trial. JAMA 293, 2005; 1: 54-62, 98-99. Go to original source... Go to PubMed...
    34. FDA Approves Nexavar (Sorafenib) for Treatment of Patients with Advanced Kidney Cancer. http://www.pslgroup.com/dg/256136.htm (12. 11. 2006).

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