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POSTER ABSTRACT National Seminar on Recent Trends in Radiopharmaceuticals in Drug Discovery -Quality, Safetyand Regulatory
Perspectiveat Himachal Pharmacy College | 12-13th September 2019
AUTHOR :
luisetto mauro , applied pharmacologist, European specialist lab.Medicine , hospital pharmacist manager , IMA ACADEMY pharmacy and
pharmacology branch, medicine laboratory branch , PC AREA 29121 italy
dep. Pharm. Cal maurolu65@gmail.com
Title : Imaging , contrast agents ,radiopharmaceuticals and the clinical pharmacist role in 2019
Abstract
Related actual therapy strategy ( molecular targeting, MABS in oncology, )and related needto correctly set the disease stadium ( in oncology or
other field ) imaging techniques play a crucial role.
Imaging use often contrast agent ( nuclear medicine or PET, TC, MR and other ) and the clinical pharmacist is considereduniversally as the
Expert for excellence of drugs.
For this reason in this work is verified the global contribute that the pharmacist in hospital settingcan provide in patient healthcare.
Keywords :IMAGING, CONTRAST AGENT ,RADIOPHARMACEUTICALS, NUCLEAR MEDICINE, CLINICAL PHARMACY ,
RADIOPHARMACEUTICALS
Introduction
Actually the high level of imaging procedurelike PET , magnetic resonance, TC but also in the classic diagnostic procedure like radiology and
ecography are oftenusedspecific contrast agent to improve the quality and information for diagnostic use.
The clinical pharmacist is universally considered the expert for excellence of drugs andmany imagingcontrast agent are classified and registered
as drugs.
The same the efficacy of therapy imply a deep use of the results of medicine lab. Tests, imaging and other in strumental objectivedataand also
clinical pharmacy in their daily activity must have access also to this patient datain monitoringof the therapy , in helping the physicians in choosing
the most efficacy molecule
interactions, side effects , pharmaco-vigilance , documentation and so on.
Also medical device used in the subministration of the contrast agent are under the control and management by hospital pharmacist ( logistics,
technical characteristics, budget analisys andmany other ).
Material and methods :
In order to produce a global response related the efficacy of clinical pharmacist in the management of contrast agent or radi o drugs
Is evalued an practical experience and some relevant ( in our opinion ) biomedical literature.
Practical experience :
Location : PC AREA
Time of observation : 2008-2018
Position observed: hospital clinical-logistic pharmacist manager, applied pharmacologist
n. beds: about 700
results : during this periods it was observed a great collaboration between the hospital pharmacist involved
– responsible for imaging logistic and with the functionof departmental pharmacist for imaging .
All imaging procedure involvingcontrast agent was correctly performed.
No official notify from general medical office regarding problems with contrast agent logistics
(No death or other really relevant with permanent patient damages) .
Imaging medical equip was adequately informed relatedcontrast agent characteristics andother pharmaceutical information if request to the
pharmacy .
Right relationship with pharmaceutical industries related informations , technical schedeof the product andrelated up -dating course.
Pharmaco-vigilance was correctly performedrelated also radio-drugs and contrast agent registered as drugs .
Results
According article “Steps and Impacts of Pharmaceutical Care and Clinical Pharmacy Development on Clinical Outcomes 2016 :A Historical
Analysis Comparedwith Results”:
“During the periods of 1928 to 2016 a progressive and trendy development of clinical pharmacy and pharmaceutical care was developed, as a new
discipline.
This approach was observednot only in hospital settings, but also in community pharmacy in different ways, although with the same philosophy
(patient-oriented pharmaceutical discipline)
It was also observed a tendency of clinical pharmacist in field of medicine laboratory and imaging for when they were related to the therapy and its
monitoring.
Clinical pharmacists today are employed to reduce therapy errors and contain medicationcost burdens. In additionto that what we have observed
was a “general positive influence of the pharmacist’s presenceas a part of the medical team, on public health as well as in various clinical
outcomes”; this accordingto clinical studies as systematic reviews, clinical trials and meta-analysis.” (1)
In 1994 Shaw M. wrote: “pharmacists, not only specialists, must be knowledgeable of the role diagnostic imaging plays in pharmaceutical care;
diagnostic imaging is utilized to follow the course of therapy; i.e. determiningtherapeutic outcomes “(2)
According Luisetto, Nili b. in “ an open letter to all clinical pharmacists: 2016 pharmaceutical care, medical laboratory an dimaging
“for the sake of patient's safety and healthas well as cost reduction and for clinical pharmaceutical care purposes , it is incumbent upon the
hospital to engageand demand an activerole from clinical pharmacists not only limited to but especially in field such as me dical laboratory and
imaging
Today, we are not dealing only with ordinary drug molecules with traditional dosage forms, anymore. Today, the world of medicationis much more
complex, because thenumber of classes of products is much wider. Even for small molecules, a clinical pharmacist activeinte raction with patient
could have saved lives.
We are dealing with immune-globulins, genes, enzymes, nanoparticles, and many other innovative forms that many things can go wrong, if there
won’t be an active and interactivepatient compliance with a medical team.It makes very difficult, if not impossible, for one professionalone,
namely physician to control surprises that may leave un-repairabledamages. These systems are not as simple as small molecules, they interact
with cells and tissues by mechanisms that are not simple hydrophilic-hydrophobic partition, crossing barriers basedon simple conjugation to
receptors etc, therefore a vigilant presence with an easy access would be a real safeguarding of patient health.“(3)
And according editorial : An Open Letter to all Pharmacists, 2016: Pharmaceutical Care, Medical Laboratory and Imaging:
“Clinical pharmacy, clinical pharmaceutical care, MTM, ward pharmacy, and consultant service can be helpful instruments in today cognitive
services filed involved in the therapy decision making
systems. The pharmacist presence in multidisciplinary medical equip improves some clinical andeconomic outcomes as demonisterd by many
scientific works.
This gives an opportunity for medical authorities’ patients and insurance to efficiently containcosts (drugs, medical devices, costs involved in
therapy errors) with the increase of new drugs, medical
and new diagnostic procedures added to more complex pharmacological therapies and poly-therapy there is a real need of clinical pharmacist
service. In order to create an efficient team, the pharmacists must update
their knowledgeand skills, so they will be preparedto use the data provided by imaging, medical laboratory, biochemistry, toxicology, molecular
biology, genetic assay, andimmunohistochemistry
departments.”(4)
according Callahan RJ et al:
“As nuclear medicine evolved from an obscure research tool to a mainstream clinical diagnostic and therapeutic modality, so h as the role of the
practice of pharmacy in nuclear medicine also evolved.A similar evolution is unfolding today in the practiceof positronemission tomography (PET).
The skills of many diverse professionals, including pharmacists, are essential for the safe andefficient operationof a modern PET facility. The
importance of the role of pharmacists in PET has been increasing as the use of PET radiopharmaceuticals has matured from rese arch to clinical to
commercial arenas. While it is clear that pharmacists can contribute clinical and technical skills to the operationof a PET center, perhaps one of
the most important factors influencing the increased role of pharmacists in PET is their expertise and experience in the drug regulatory process.
The commercial distributionof PET radiopharmaceuticals, primarily [18F]2-fluorodeoxyglucose (FDG), is currently being performedby a variety of
corporate andinstitutional facility partnerships, with the likelihoodof several new players entering themarketplace in the near future. This factor has
served to dramatically increase the role for nuclear pharmacy in PET. The practiceof nuclear pharmacy is a well-establishedcomponent of PET.
The role of nuclear pharmacists in PET is complementary to the many other professionals currently practicing in this specialty.With the rapidly
increasing clinical demandfor FDG imaging, it is likely that the number of facilities and institutions entering into the commercial distribution of PET
radiopharmaceuticals will also increase. Such growth will also serve to solidify and expand the role for the practice of nuclear pharmacy in PET.”
(5)
And from book DIAGNOSTIC IMAGING FOR PHARMACIST :
“with the first covering the role of the pharmacist in diagnostic imaging and focusing on the process of medication therapy management, thenan
introduction to the physics of ionizing radiation. The next 10 chapters review the imaging procedures, adjunct agents, and ra diopharmaceuticals
used in
radiography, computedtomography, nuclear medicine, positron emissiontomography, magnetic resonance imaging, and ultrasonography.The final
chapter reviews regulations in the UnitedStates associatedwith the use of ionizing radiation.
These chapters provide adequate detail for understanding how the various imaging techniques function, with useful information on dosing,
administration, contraindications, adverse effects, andmedication therapy management issues for the various agents applicable to each imaging
modality.
Overall, this book provides a solid foundation for pharmacists who want to improve their understanding of medical imaging,with sufficient detail
about the associatedpharmaceuticals to facilitate better monitoring of their effects. Theonly major limitation, in my opinion, is the lack of a section
on the application of medical imaging in assessing other drug therapies.
Appreciating that many drugs have beneficial and adverse effects that can be monitored with imagingand that most pharmacists have limited
training in the use of these tools, such an addition
would greatly expand thepotential audiencefor the book.That said, information on theapplication of medical imaging for pharmacists would likely
require a whole separatevolume, given
the potential amount of information to be covered (6)
Discussion conclusion
Related the results of a practical experience and the literaturereported is clear the crucial function played by clinical ph armacist in hospital settings
involving contrasts agent.
In actual medicine with molecular targetingtherapy, MABS and other precision medicine is relevant to use imaging methods ( PET, TC, MR ,
SPECT, radiology , ecography , nuclear medicine ) and in this methods are currently used contrast agent. ( in example to set the cancer stadium –
linpho-node involvement, lymphoma stadiation for MABS therapy , heart diseaselike IMA and nuclear medicine technique , pulmonary
functionality in pulmonary embolia , thyroid metabolic disease and many other ).
The clinical pharmacist must play a relevant role not only in logistics, or in laboratory to produce radiodrugs for nuclear medicine but also in clinical
activities in medical team to add their specific competencein
Pharmaceutical pharmacology and toxicological field with the general scopeto improve clinical outcomes, reduce in toxicology andcost
contaniment.
Conflicts of interests : NO
Clarifications
This work is produced without any diagnostic or therapeutic intent and under a pharmaceutical-pharmacological point of view.
References
1) M. Luisetto, B. Nili-Ahmadabadi, L. Cabianca, M. Ibne Mokbul, Steps and Impacts of Pharmaceutical Care and Clinical Pharmacy
Development on Clinical Outcomes 2016: A Historical Analysis Compared with Results, Clinicians Teamwork, 2016, 1:4-8
2) S Shaw, Diagnostic Imaging and Pharmaceutical Care, AmericanJ. of Pharmaceutical Education, 1994, 58, 2
3) M. Luisetto, B. Nili-Ahmadabadi, An Open Letter to all Pharmacists, 2016: Pharmaceutical Care, Medical Laboratory and Imaging, Clinicians
Teamwork, 2016, 1:1-4
4) Luisetto M (2016) Clinical Pharmaceutical Care, Medical Laboratory Imaging, Nuclear Medicine: A Synergy to Improve Clinical
Outcomes and Reducing Costs. J App Pharm 8: e112. doi:10.4172/1920-4159.1000e112
5) Clin Positron Imaging. 1999 Jul;2(4):211-216.
The Role of the Practice of Nuclear Pharmacy in PositronEmission Tomography.
Callahan RJ1, Dragotakes SC
6) Diagnostic Imaging for Pharmacists Smith BT, Weatherman KD, editors. American Pharmacists
Association, Washington, DC, 2012. 273 pages, softcover. ISBN 978-1-58212-153-6. US$74.95 ($60 for APhA members).

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Poster abstract 2019 national seminar on recent trends in radiopharmaceuticals in drug discovery quality safety and regulatory perspective at himachal pharmacy college

  • 1. POSTER ABSTRACT National Seminar on Recent Trends in Radiopharmaceuticals in Drug Discovery -Quality, Safetyand Regulatory Perspectiveat Himachal Pharmacy College | 12-13th September 2019 AUTHOR : luisetto mauro , applied pharmacologist, European specialist lab.Medicine , hospital pharmacist manager , IMA ACADEMY pharmacy and pharmacology branch, medicine laboratory branch , PC AREA 29121 italy dep. Pharm. Cal maurolu65@gmail.com Title : Imaging , contrast agents ,radiopharmaceuticals and the clinical pharmacist role in 2019 Abstract Related actual therapy strategy ( molecular targeting, MABS in oncology, )and related needto correctly set the disease stadium ( in oncology or other field ) imaging techniques play a crucial role. Imaging use often contrast agent ( nuclear medicine or PET, TC, MR and other ) and the clinical pharmacist is considereduniversally as the Expert for excellence of drugs. For this reason in this work is verified the global contribute that the pharmacist in hospital settingcan provide in patient healthcare. Keywords :IMAGING, CONTRAST AGENT ,RADIOPHARMACEUTICALS, NUCLEAR MEDICINE, CLINICAL PHARMACY , RADIOPHARMACEUTICALS
  • 2. Introduction Actually the high level of imaging procedurelike PET , magnetic resonance, TC but also in the classic diagnostic procedure like radiology and ecography are oftenusedspecific contrast agent to improve the quality and information for diagnostic use. The clinical pharmacist is universally considered the expert for excellence of drugs andmany imagingcontrast agent are classified and registered as drugs. The same the efficacy of therapy imply a deep use of the results of medicine lab. Tests, imaging and other in strumental objectivedataand also clinical pharmacy in their daily activity must have access also to this patient datain monitoringof the therapy , in helping the physicians in choosing the most efficacy molecule interactions, side effects , pharmaco-vigilance , documentation and so on. Also medical device used in the subministration of the contrast agent are under the control and management by hospital pharmacist ( logistics, technical characteristics, budget analisys andmany other ). Material and methods : In order to produce a global response related the efficacy of clinical pharmacist in the management of contrast agent or radi o drugs Is evalued an practical experience and some relevant ( in our opinion ) biomedical literature. Practical experience : Location : PC AREA Time of observation : 2008-2018 Position observed: hospital clinical-logistic pharmacist manager, applied pharmacologist n. beds: about 700 results : during this periods it was observed a great collaboration between the hospital pharmacist involved – responsible for imaging logistic and with the functionof departmental pharmacist for imaging . All imaging procedure involvingcontrast agent was correctly performed. No official notify from general medical office regarding problems with contrast agent logistics (No death or other really relevant with permanent patient damages) .
  • 3. Imaging medical equip was adequately informed relatedcontrast agent characteristics andother pharmaceutical information if request to the pharmacy . Right relationship with pharmaceutical industries related informations , technical schedeof the product andrelated up -dating course. Pharmaco-vigilance was correctly performedrelated also radio-drugs and contrast agent registered as drugs . Results According article “Steps and Impacts of Pharmaceutical Care and Clinical Pharmacy Development on Clinical Outcomes 2016 :A Historical Analysis Comparedwith Results”: “During the periods of 1928 to 2016 a progressive and trendy development of clinical pharmacy and pharmaceutical care was developed, as a new discipline. This approach was observednot only in hospital settings, but also in community pharmacy in different ways, although with the same philosophy (patient-oriented pharmaceutical discipline) It was also observed a tendency of clinical pharmacist in field of medicine laboratory and imaging for when they were related to the therapy and its monitoring. Clinical pharmacists today are employed to reduce therapy errors and contain medicationcost burdens. In additionto that what we have observed was a “general positive influence of the pharmacist’s presenceas a part of the medical team, on public health as well as in various clinical outcomes”; this accordingto clinical studies as systematic reviews, clinical trials and meta-analysis.” (1) In 1994 Shaw M. wrote: “pharmacists, not only specialists, must be knowledgeable of the role diagnostic imaging plays in pharmaceutical care; diagnostic imaging is utilized to follow the course of therapy; i.e. determiningtherapeutic outcomes “(2) According Luisetto, Nili b. in “ an open letter to all clinical pharmacists: 2016 pharmaceutical care, medical laboratory an dimaging “for the sake of patient's safety and healthas well as cost reduction and for clinical pharmaceutical care purposes , it is incumbent upon the hospital to engageand demand an activerole from clinical pharmacists not only limited to but especially in field such as me dical laboratory and imaging Today, we are not dealing only with ordinary drug molecules with traditional dosage forms, anymore. Today, the world of medicationis much more complex, because thenumber of classes of products is much wider. Even for small molecules, a clinical pharmacist activeinte raction with patient could have saved lives. We are dealing with immune-globulins, genes, enzymes, nanoparticles, and many other innovative forms that many things can go wrong, if there won’t be an active and interactivepatient compliance with a medical team.It makes very difficult, if not impossible, for one professionalone, namely physician to control surprises that may leave un-repairabledamages. These systems are not as simple as small molecules, they interact with cells and tissues by mechanisms that are not simple hydrophilic-hydrophobic partition, crossing barriers basedon simple conjugation to receptors etc, therefore a vigilant presence with an easy access would be a real safeguarding of patient health.“(3) And according editorial : An Open Letter to all Pharmacists, 2016: Pharmaceutical Care, Medical Laboratory and Imaging:
  • 4. “Clinical pharmacy, clinical pharmaceutical care, MTM, ward pharmacy, and consultant service can be helpful instruments in today cognitive services filed involved in the therapy decision making systems. The pharmacist presence in multidisciplinary medical equip improves some clinical andeconomic outcomes as demonisterd by many scientific works. This gives an opportunity for medical authorities’ patients and insurance to efficiently containcosts (drugs, medical devices, costs involved in therapy errors) with the increase of new drugs, medical and new diagnostic procedures added to more complex pharmacological therapies and poly-therapy there is a real need of clinical pharmacist service. In order to create an efficient team, the pharmacists must update their knowledgeand skills, so they will be preparedto use the data provided by imaging, medical laboratory, biochemistry, toxicology, molecular biology, genetic assay, andimmunohistochemistry departments.”(4) according Callahan RJ et al: “As nuclear medicine evolved from an obscure research tool to a mainstream clinical diagnostic and therapeutic modality, so h as the role of the practice of pharmacy in nuclear medicine also evolved.A similar evolution is unfolding today in the practiceof positronemission tomography (PET). The skills of many diverse professionals, including pharmacists, are essential for the safe andefficient operationof a modern PET facility. The importance of the role of pharmacists in PET has been increasing as the use of PET radiopharmaceuticals has matured from rese arch to clinical to commercial arenas. While it is clear that pharmacists can contribute clinical and technical skills to the operationof a PET center, perhaps one of the most important factors influencing the increased role of pharmacists in PET is their expertise and experience in the drug regulatory process. The commercial distributionof PET radiopharmaceuticals, primarily [18F]2-fluorodeoxyglucose (FDG), is currently being performedby a variety of corporate andinstitutional facility partnerships, with the likelihoodof several new players entering themarketplace in the near future. This factor has served to dramatically increase the role for nuclear pharmacy in PET. The practiceof nuclear pharmacy is a well-establishedcomponent of PET. The role of nuclear pharmacists in PET is complementary to the many other professionals currently practicing in this specialty.With the rapidly increasing clinical demandfor FDG imaging, it is likely that the number of facilities and institutions entering into the commercial distribution of PET radiopharmaceuticals will also increase. Such growth will also serve to solidify and expand the role for the practice of nuclear pharmacy in PET.” (5) And from book DIAGNOSTIC IMAGING FOR PHARMACIST : “with the first covering the role of the pharmacist in diagnostic imaging and focusing on the process of medication therapy management, thenan introduction to the physics of ionizing radiation. The next 10 chapters review the imaging procedures, adjunct agents, and ra diopharmaceuticals used in radiography, computedtomography, nuclear medicine, positron emissiontomography, magnetic resonance imaging, and ultrasonography.The final chapter reviews regulations in the UnitedStates associatedwith the use of ionizing radiation. These chapters provide adequate detail for understanding how the various imaging techniques function, with useful information on dosing, administration, contraindications, adverse effects, andmedication therapy management issues for the various agents applicable to each imaging modality. Overall, this book provides a solid foundation for pharmacists who want to improve their understanding of medical imaging,with sufficient detail about the associatedpharmaceuticals to facilitate better monitoring of their effects. Theonly major limitation, in my opinion, is the lack of a section on the application of medical imaging in assessing other drug therapies.
  • 5. Appreciating that many drugs have beneficial and adverse effects that can be monitored with imagingand that most pharmacists have limited training in the use of these tools, such an addition would greatly expand thepotential audiencefor the book.That said, information on theapplication of medical imaging for pharmacists would likely require a whole separatevolume, given the potential amount of information to be covered (6) Discussion conclusion Related the results of a practical experience and the literaturereported is clear the crucial function played by clinical ph armacist in hospital settings involving contrasts agent. In actual medicine with molecular targetingtherapy, MABS and other precision medicine is relevant to use imaging methods ( PET, TC, MR , SPECT, radiology , ecography , nuclear medicine ) and in this methods are currently used contrast agent. ( in example to set the cancer stadium – linpho-node involvement, lymphoma stadiation for MABS therapy , heart diseaselike IMA and nuclear medicine technique , pulmonary functionality in pulmonary embolia , thyroid metabolic disease and many other ). The clinical pharmacist must play a relevant role not only in logistics, or in laboratory to produce radiodrugs for nuclear medicine but also in clinical activities in medical team to add their specific competencein Pharmaceutical pharmacology and toxicological field with the general scopeto improve clinical outcomes, reduce in toxicology andcost contaniment. Conflicts of interests : NO Clarifications This work is produced without any diagnostic or therapeutic intent and under a pharmaceutical-pharmacological point of view. References 1) M. Luisetto, B. Nili-Ahmadabadi, L. Cabianca, M. Ibne Mokbul, Steps and Impacts of Pharmaceutical Care and Clinical Pharmacy
  • 6. Development on Clinical Outcomes 2016: A Historical Analysis Compared with Results, Clinicians Teamwork, 2016, 1:4-8 2) S Shaw, Diagnostic Imaging and Pharmaceutical Care, AmericanJ. of Pharmaceutical Education, 1994, 58, 2 3) M. Luisetto, B. Nili-Ahmadabadi, An Open Letter to all Pharmacists, 2016: Pharmaceutical Care, Medical Laboratory and Imaging, Clinicians Teamwork, 2016, 1:1-4 4) Luisetto M (2016) Clinical Pharmaceutical Care, Medical Laboratory Imaging, Nuclear Medicine: A Synergy to Improve Clinical Outcomes and Reducing Costs. J App Pharm 8: e112. doi:10.4172/1920-4159.1000e112 5) Clin Positron Imaging. 1999 Jul;2(4):211-216. The Role of the Practice of Nuclear Pharmacy in PositronEmission Tomography. Callahan RJ1, Dragotakes SC 6) Diagnostic Imaging for Pharmacists Smith BT, Weatherman KD, editors. American Pharmacists Association, Washington, DC, 2012. 273 pages, softcover. ISBN 978-1-58212-153-6. US$74.95 ($60 for APhA members).