3rd annual Pharma Packaging and Labelling Forum Global Conferences, Vienna
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1 Joint recommendations for the avoidance of confusion concerning the primary packaging and labelling of several pharmaceutical dosage forms the swiss way Dr. pharm. Enea Martinelli; Head of Pharmacy Head of the working-group look alike sound alike (Science Industries, Interpharma, Intergenerika, Patient Safety foundation, GSASA) 3rd annual Pharma Packaging and Labelling Forum Global Conferences, Vienna spitäler frutigen meiringen interlaken ag, weissenaustrasse 27, ch-3800 unterseen, 1
2 Policy and requirements Challenges Actions and achievements 2
3 Lieferant Verwaltung Apotheke Pflege Arzt Patient The medication process in hospitals KG A 1 Visite Essen Pflege Betreuung Blutentnahme Untersuchungsvorber. 9 Medikamente verabreichen Spezialist nein med. Therapie ja später zu A Kardex Kurven Labor C Kontrolle Stationsapotheke Medi- Bestellung für Lager / lauf. Therpie Listen-Medi ja nein ja 2 Verordnung Rücksprache Station/Arzt Grund / Ersatz? Ersatz B Einlagerung Stationsapotheke Wareneingangskontrolle Medi- Transport nein 3 3 Verordnung in Kardex abschreiben Verabreichungszeiten festlegen Medi abbolen Medi bereitstellen KMT IPS OHC Chir 3 Pflegehandlungen, Dokumentation Verordnung übertragen: Kardex/ Verlaufsblatt 3 4 Abschreiben für Medi- Zubereitung Medi vorrätig Medi-Best. in Apotheke Listen-Medi ja nein nein Rücksprache Station/Arzt ja ja Grund / Ersatz? Ersatz Medi abbolen nein 8 Zubereitung der Medi nach abgeschr. Verordnung Medi abbolen Medi bereitstellen Wareneingangskontrolle Verlaufsblatt / Cardex: Abgabe eintragen Medikamentenverrechnung: teurer Medi auf Leistungsblatt Medi bereitstellen Medi bestellen Rechnungskontrolle 5 Medi bereitstellen Medi bestellen 6 Rechnungskontrolle Rechnungskontrolle / Zahlungsfreigabe Rechnungskontrolle / Zahlungsfreigabe Statistik / Verrechnung Medi bereitstellen 7 Medi bereitstellen Dr. J. Götte; Diplomarbeit NDS Wirtschaft 10/1999 3
4 Medication process Optimised pharmacotherapy Right medication / form Right dosage Right patient Right quality Right time real pharmacotherapy Wrong medication (form) Contraindication not considered Interaction not considered Wrong order entry, transcription error Wrong dosage (too much/ not enough) Wrong order entry, transcription error Error of calculation (Calculation error) Wrong Patient Bad (Poor?) communication Wrong application Incorrect handling Wrong preparation Wrong time Late delivery (supply chain) Wrong order entry, transcription error Fido Möll 2008
5 Medication errors Kind of error Share (Occurrence?) Country Source: author (year) Perscription errors 14.4% NL Van den Bemt (2000) 39% UK, US Leape (1999) 48% US Pepper (2006) 15-21% US MedMarx (2004) Transcription errors 11% US Leape, Bates (1995) 23-26% US MedMarx (2004) Dispensing errors 12.5% US Kistner (1994) 14% US Leape, Bates (1995) 21-22% US MedMarx (2004) Errors of use (including preparation) 3% 38% UK US Taxis (2003) Leape, Bates (1995) 33-37% US Medmarx (2004) 5 Fido Möll 2008
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7 How often do medication errors occur? In 5-10% of all medication applications there is an error (Data from 29 studies) Krähenbühl A, Schlienger R, Lampert M et al. Drug Safety 2007; 30 (5): Fido Möll 2008
8 Medication errors and consequences 5-10% of all applications are errors Approx. 3-5% of the errors led to adverse drug reactions. many near misses Importance of CIRS In approx. 5-10% of all hospital patients ADR s can be found Approx. 0.3% of all ADR lead to death Approx. 60% of all ADR are perventable! - Classen DC.; Adverse drug events and medication errors : the scientific perspective. In: Proceedings of Enhancing Patient Safety Foundation; 1998: Oertle M., Schweizerische Aerztezeitung 84, 41 (2003) Fido Möll Leape LL et al.; N Engl J Med 24, 6 (1991)
9 Impact of these errors in over 5% of all applications in a hospital a medication error is found In an average hospitalisation of 7 days and a treatment with 7 drugs = approx. 50 applications per hospitalisation 2 medication errors / hospitalisation Empirical data show that 6% of all patients have an ADR during hospitalisation. 3-5% of all medications lead to a ADR every patient (5-10%) is exposed to an ADR 3% of ADR lead to death % of all medication errors are fatal 1 ADR costs Ø $4000 and prolongs hospital stay Ø 3 days. With patients/ year this results in errors a year (Basis = 3 sources) 3% of the equal 420 ADR s / year. 60% are preventable = 250 UAW s / Jahr 420 x Fr. = 1.7 Mio Fr. extra cost with patients / year
10 Packaging and medication errors Packaging is not the only problem in the process, there are many more to work on Packaging is one of the solutions for improving the process (or one of the problems leading to many errors). 10
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14 Tree of breakdowns Experimentally generated results Dispensing errors 3% Picking errors 2% Diluting errors 3% Errors in calculation 10% Performance of double-checks 85%
15 Slides presented with the kind permission of Prof. P. Bonnabry, Head of Pharmacy, University-hospital Geneva
16 Slides presented with the kind permission of Prof. P. Bonnabry, Head of Pharmacy, University-hospital Geneva
17 Slides presented with the kind permission of Prof. P. Bonnabry, Head of Pharmacy, University-hospital Geneva
18 Slides presented with the kind permission of Prof. P. Bonnabry, Head of Pharmacy, University-hospital Geneva
19 which one would you choose? 19
20 250 or 500 mg per pill? 20
21 9 in 11 nurses judged that the content of one pill is 250 mg Valacyclovir. In fact it s 500 mg per pill... 21
22 the easy solution 22
23 Multiple step preparation dilute in x ml Aqua, mix the solution with normal saline 95% of all dilutions are made by normal saline. Find easy solutions for the exceptions! 23
24 Actions and achievements Working group look alike sound alike : Interpharma, Intergenerika, SGCI, VIPS, ASSGP, GSASA Worked first on parenterals -> Adopted in 2010 Guidelines on look alike and sound alike were definitively adopted in November Guidelines are published on : 24
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33 the ideal packaging 33
34 before after 34
35 before after 35
36 House of horrors... 36
37 Conclusions Packaging is one of the risk factors in the medication process not only in hopsitals, but everywhere where a third party is prepearing medications for patients. -> hospitals, homes, home care With a good packaging concept many errors can be prevented Your good ideas may be good, but also may bring new risks Ask the professionals in the medication use process BEFORE you launch a medication. 37
38 Thank you for your attention! Bilder : Interlaken Tourismus
Drug shortages frequent and ongoing trouble reasons and measures
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