Climate Change Impacts on Terrestrial and Aquatic Ecosystems.pptx
Poster hosp. med gas management luisetto m global chemistry congress rome 2019
1. POSTER PRESENTATION
AUTHOR MAURO LUISETTO
TITLE : HOSPITAL MEDICINE GAS MANAGEMENT SYSTEM: THE PHARMACIST ROLE IN
A PHARMACEUTICAL- CHEMISTRY SETTING RESULTS OF A PRACTICAL EXPERIENCE
KEYWORDS : MEDICINAL GASES , HOSPITAL PHARMACY, PHARMACIST COMPETENCIES ,
CHEMISTRY COMPETENCIES
Abstract
Aim of this work is analyse actual normative rules ( Italy, Europe) and
produce a global description of an practical experience related hospital
pharmacist management in med. Gases field.
Introduction
Related actual European and Italian normative rule hospital medicinal
gases management is a official responsibility of hospital pharmacist.
Medicinal gases like therapeutic oxigen are classified as medicinal
drugs officially registered , and pharmacist is involved in all Logistic
2. and clinical pharmacist role in the management of this healthcare
products .
Other gases managed are : medical air , azote protoxide , co2 , other
specific mixtures required by the clinicians .
Some gases are classified as medical devices ( argon ) , liquid azote .
Technical gas for chemistry lab in example for GC.
Different uses of the different gases : oxigeno-therapy, cryosurgery,
sample conservation ( blood bank ) , diagnostic use and other
Medical gases in hospital settings are inside centralize implant in
tanks or in mobile container like mobile tanks and all this are
classified as MEDICAL DEVICES .
The hospital pharmacist manage all MEDICAL DEVICE and so is responsible
also for MED. DEV. IN MEDICINAL GASES settings .
Often other gases are produced inside the hospital structure like
medicinal air in a sort of magistral –galenic production central : even
in this cases the pharmacist provide guaranty regarding quality of
production under the PHARMACOPEA in use.
Other pharmacist responsabilities are required by law : the quality
control of gases from implants and from tanks for the patients safety (
under pharmacopeia prevision ).
A complex systems of quality control is annually performed whit certified
control laboratory using officially chemical methods .( precision,
sensibility accurancy, repeatability ) .
In cases of out of control of analized sample a rapid information is
gived to hospital medical direction and to clinicinas and Techincal
engineer to rapid find a solution ( provide other oxygen tanks, excluding
parts of the implants and so on ).
Other pharmacist competencies is related to the pharmaco-vigilance and
medical devices vigilance as request by normative rule also in med gases
settings.
Hospital pharmacist are involved in the healthcare professional training
in med gas uses and in periodic wards inspection related detection of
mobile tanks.
3. Hospital pharmacist is permanent member of teams local (or regional)
(according a responsibility matrix)involved in writing the official
procedure as request by accreditation institution and by total quality
management or involved in central buying procedure like gases, medical
devices , service related et other .
( procedure like recall of tanks, quality control, tanks stokes ,
emergency, stokes management, management and many other documents like
DGO doc. Operative management, risk evaluation ).
According Italian rules other roles can be played by hospital pharmacist
: DIRECTOR OF EXECUTION OF MEDICINAL GASES CONTRACT. (DEC)
This role is substantially a project management function with
responsabilities in manage quality, risk, costs and time of contract
execution.
Many managerial instrument are daily managed by hospital pharmacist in
this field like : time management,
GANTT , root causes analysis , benchmarking, communicative abilities and
many other .
Dec make possible to facilitate the role played by different hospital
office like TECHNICAL OFFICE, PREVENTION AND PROTECTION OFFICE, FARMACY,
EXTERNAL PROVIDER OF MED GASES, BUYING OFFICE,REGIONAL BUYING CENTRE ,
AND MEDICAL AND INFERMIERISTIC HOSPITAL DIRECTION, CLINICAL INGENEERING
SERVICE .
To do this is needed a deep knowledge in medicinal and non medicinal
gases , pharmaceutical technique,Pharmacology, Toxicology, and chemists
competencies to adequately manage this complex world.
This is an example also of the chemists competencies required today also
to pharmacist.
In recent time normative rules make possible to pharmaceutical degree (
pharmacy and medicinal chemistry course ) to participate in official
statal- public examination for the access to the chemistry profession
and this fact show the chemistry competencies of pharmaceutical degree.
In this kind of course many chemistry examination ( organic, inorganic,
analitic: qualitative and quantitative , physical chemistry , physical
methods in organic chemistry ,laboratories, physics , mathematics and
other course like pharmaceutical industry implants propose to the
student a deep chemical knowledge usefull in today working world.
Recent normative rules have euiparated old university title in pharmacy
and in medicinal chemistry to the new magistral laurea in pharmacy and
industrial pharmacy .
4. And in DPR 328/2001 art 37 italian law for statal examination to access to the A sections of
chemistry register for chemistry profession is reported :
1. L'iscrizione nella sezione A è subordinata al superamento di apposito esame di Stato.
2. Per l'ammissione all'esame di Stato è richiesto il possesso della laurea specialistica in una delle
seguenti classi:
a) Classe 62/S - Scienze Chimiche;
b) Classe 81/S - Scienze e Tecnologie della Chimica industriale;
c) Classe 14/S - Farmacia e Farmacia Industriale.
The gases management in Italy in example in an not recent normative
rules ( REGIO DECRETO 1927 regarding toxic gases management ) required
also the degree in chemistry and pharmacy in the title required for
responsibility in this field.
Physical properties of gases are present in many chemistry course of
pharmaceutical sectors and Deep knowledge in pharmacology, toxicology,
pharmaceutical techinque , pharmaceutical medicine are studied.
Also course of medicinal chemistry implants are inside curriculum
studiorum of pharmaceutical degrees.
Material methods
After an initial review related normative ruled in Italian and European
setting we analyze the result of a specific practical experience in order
to produce a complexive conclusion related pharmaceutical-chemist
competencies played by hospital pharmacist in actual time in the global
management in hospital gas service. ( therapeutic, diagnostic,
laboratoristic ).
A Practical experience :
Geographic location: PC AREA 29121
Time of observation: from 2013 to 2018 November 28, 2018
5. Position observed : Public hospital manager involved in : QUALITY
CONTROL FUNCTION MEDICAL GASES ( title of hosp. pharmacist manager ,
applied pharmacologist, European specialist laboratory medicine EC 4
registered , clinical pharmacist, director of contract execution
hospital gas med, departmental pharmacist of all hospital laboratory ,
blood bank, Imaging dep., molecular biology, pathological anatomy ,
microbiology, clinical chemistry and other.
DIRECTOR OF EXECUTION CONTRACT HOSPITAL MED. GASES ( from 2014),
assigned an engineer as assistant of DEC director of execution for the
implant competencies .
Hospital pharmacist involved in med gases hosp. management : from 2008
( uditor in official Regional updating courses organized by RER ).
Results :
in the period considered the medicinal gases , technical and laboratory
gases have been correctly managed, no incident or other relevant facts (
near miss events ) , or relevant side effect involving health of
patients.
No any risk involving hospital med gas workers ( implants et other )
The execution of the med gases contract in the time considered was
correctly performed under profile of Costs, quality, risk, and time as
request by pharmacopea ( Italian and European ) , the European community
rules in field of drugs and medical devices.
No any notify of relevant problems from all the official subject involved
in gas management (different office, external provider, healthcare org.et
other ).
Discussion conclusion
Related the normative rules and the results of the practical experiences
cited in this work is clear a chemist- pharmaceutical competencies played
by hospital pharmacist in field of global management of medicinal and not
medicinal hospital gases ( also laboratory and other technical gases ).
Even if pharmaceutical professional are not engineer to adequately
manage the hospital medicinal gases System are required deep chemistry-
6. pharmaceutical and managerial competencies as request by actual
normative rule. ( risk management, project management, total quality
management , clinical risk ,Clinical pharmacist management, logistic
managements , HR managements , ICT management, time management ).
Knowledge regarding physical – chemistry of gases ( pressure, quality
specifics, analytical properties, Accuracy and sensibility in analysis
methods, concentration title , impurity level, safe stoking modality,
wharehouse , technical and safety information, fire safety procedure and
risks )and also managerial deep knowledge and skills.
REFERENCES AND SOME NORMATIVE RULES ( OLD OR IN FORCE )
1 ) R.D. 9 gennaio 1927, n. 147
2) direttiva 2001/83/CE, direttiva 2003/94/CE and modifications
3) UNI EN ISO 7396-1:2013 and modifications and other related updating
rules
4) Luisetto M, Cabianca L, Sahu R (2016) Management Instrument in
Pharmaceutical Care and Clinical Pharmacy. Int J Econ Manag Sci 5: 373.
doi: 10.4172/2162-6359.1000373
5) https://www.slideshare.net/MLuisettoWebsiteFARM/request-to-miur-for-
official-opinion-related-some-chemists-competencies-an-historical-
normative-review-1928-2009-pharmaceutical-university-course-mluisetto-m-
fidani
6) https://www.slideshare.net/MLuisettoWebsiteFARM/esami-di-stato-parere-
miur-prot-2100-del-6-62012
7) www.CodiceAppalti.it DECRETO LEGISLATIVO 18 APRILE 2016, N. 50
Codice dei contratti pubblici. (GU n.91 del 19‐4‐2016 – s.o. n.10) and
modifications
8) PMBOK Guide and Standards
9) legge 81/08 sulla sicurezza sul lavoro( workers security ) and
modifications
10 ) italian official pharmacopea XII edit.
11) european pharmacopea
12) art 19 R.D. 1 marzo 1928 n. 842 LAUREA CHIMICA E FARMACIA: (ammessa
per Esame di Stato Professione di Chimico e per Farmacista) vedi TABELLA
L allegata al R.D. n. 1592 1933.
7. Laurea in C.T.F. V.O. Tabella XXVII BIS introdotta con Legge nel 1967
n.1037
(e successive modificazioni ) relativo alla istituzione del corso di
laurea CTF presso Universita' di Pavia. Non ammessa a Esame di Stato per
Chimico
Laurea in Farmacia V.O. Tabella XXVII allegata a Regio Decreto Istruzione
Superiore del 1938 : Solo accesso a Esame di Stato per Farmacista
13)Decreto 16 maggio 96 n. 413 Regolamento concernente la disciplina
degli esami di idoneita' nazionale all'esercizio delle funzioni di
direzione. (GU n.185 del 8-8-1996 - Suppl. Ordinario n. 132 ) cita i
laureati in Chimica Farmaceutica oltre ai laureati in Chimica e
Tecnologie Farmaceutiche per discipline chimica analitica e
biochimica clinica.
Pubblicata nella Gazz. Uff. 20 ottobre 1982, n. 289.
Ammissione dei laureati in chimica e tecnologia farmaceutiche ai concorsi
per
i quali sia prescritta la laurea in chimica e farmacia o farmacia.
14)La Tabella L allegata all’ Art. 173 del R.D. 31 Agosto 1933, n. 1592
(Pubblicata nellaGazz. Uff. 7 Dicembre 1933, n. 283.) prevede l’ accesso
ai laureati in CHIMICA E FARMACIA all’ Esame di Stato per Chimico
15)Decreto Interministeriale 5 Maggio 2004 and modifications
Pubblicato nella Gazzetta Ufficiale del 21 agosto 2004 n. 196
Equiparazioni dei diplomi di laurea (DL) secondo il vecchio ordinamento
alle nuove classi delle lauree specialistiche (LS), ai fini della
partecipazione ai concorsi pubblici.
16) Decreto Interministeriale 9 Luglio 2009 and modifications
Pubblicato nella Gazzetta Ufficiale del 7 ottobre 2009 n. 233
Art. 3: Il presente decreto sostituisce il decreto interministeriale 5
maggio 2004 e successive modificazioni ed integrazioni.
Equiparazioni dei diplomi di laurea (DL) secondo il vecchio ordinamento
alle
nuove classi delle lauree specialistiche (LS), e alle lauree magistrali
(LM) ai
8. fini della partecipazione ai concorsi pubblici.
17)Decreto del Presidente della Repubblica 5 giugno 2001,
n.328 and modifications
Pubblicato nella Gazzetta Ufficiale 17 Agosto 2001 n.190 - Supplemento
Ordinario n.212/L
Modifiche ed integrazioni della disciplina dei requisiti per l'ammissione
all'esame di Stato e delle relative prove per l'esercizio di talune
professioni,
nonchè della disciplina dei relativi ordinamenti
18) DPR 328/2001 art 37
19) REGOLAMENTO (UE) 2017/745 DEL PARLAMENTO EUROPEO E DEL CONSIGLIO del
5 aprile 2017
20) GMP OF MEDICNAL GASES
21) DIREZIONE GENERALE SANITÀ E POLITICHE SOCIALI LINEE DI INDIRIZZO IN
MATERIA DI GESTIONE DEI GAS MEDICINALI: SISTEMA ORGANIZZATIVO E
CONTROLLI RER 2011 .
22) Elementi di supporto per la redazione del “Documento di Gestione
Operativa dei Gas Medicali” aspetti della gestione in sicurezza (2015)
RER
9. MAURO LUISETTO European specialist lab medicine EC4 registered Applied
pharmacologist Clinical pharmacist Public hospital pharmacist manager
Director execution hospital medicinal gas Piacenza area Turin and Pavia
UNIV. CURR STUD. Independent researcher 29121 Italy Maurolu65@gmail.com
Biography
Dr. Mauro luisetto university curriculum studiorum in Turin university
and Pavia university Pharm.d., applied pharmacology university
specialization, advanced university course clinical pharmacist. European
specialist in laboratory medicine , EC4 registered, public hospital
pharmacist manager (8 EQF LEVEL ) Several course in management field(
project, strategic, change management, total quality m., knowledge manag.
, Healthcare mang .Human resource manag.) Author of many publications in
field of: pharmaceutical care, clinical pharmacy, pharmacology ,pathology
Infectious disease , surgery ,immunology , neuroscience, management ,
economics. Execution contract DIRECTOR med gas public hospital Italy
Antidothes stokes responsible for provincial hospital ,Editor in chief or
editorial board member in many scientific journal Global clinical
pharmacy academy member since 2013 Officially invited in many
international scientific congress.