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RIPER PDIC Bulletin, April
2012, Volume 3, Issue 21
R I P E R P o i s o n & D r u g I n f o r m a t i o n C e n t e r ( P D I C ) , R D T H O S P I T A L ,
B a t h a l a p a l l i , A . P. & R a g h a v e n d r a I n s t i t u t e o f P h a r m a c e u t i c a l
E d u c a t i o n a n d R e s e a r c h ( R I P E R )
2 RIPER PDIC Bulletin, April 2012, Volume 3, Issue 21 [ISSN 2230-8741]
RIPER PDIC Bulletin R I P E R P o i s o n & D r u g I n f o r m a t i o n C e n t e r ( P D I C ) ,
R D T H O S P I T A L , B a t h a l a p a l l i , A . P . &
Raghavendra Institute of Pharmaceutical Education and Research
((((RIPERIPERIPERIPERRRR))))
VOLUME 3, ISSUE 21VOLUME 3, ISSUE 21VOLUME 3, ISSUE 21VOLUME 3, ISSUE 21
APRILAPRILAPRILAPRIL 2012201220122012
Editorial team Page 03
Contents Page 05
Editorial Page 06
Articles Page 07
Drug news Page 21
Instruction to authors Page 23
‘RIPER’ is the premier educational institution promoted by Raghavendra Educational & Rural
Development Society. The institution is established in 2002 under the leadership of four pharmacy
graduates including Dr. Y. Padmanabha Reddy and Dr. J. Ravindra Reddy. Now the institution
is offering; M. Pharm, B. Pharm, D. Pharm, Pharm D and PharmD (PB) courses approved by AICTE, PCI
and Govt. of AP. The college is affiliated to JNT University, Anantapur (JNTUA) / SBTET, AP.
3 RIPER PDIC Bulletin, April 2012, Volume 3, Issue 21 [ISSN 2230-8741]
EDITORIAL BOARDEDITORIAL BOARDEDITORIAL BOARDEDITORIAL BOARD CHIEF EDITORCHIEF EDITORCHIEF EDITORCHIEF EDITOR
Dr. Y. Padmanabha Reddy, Principal, RIPER
EDITOREDITOREDITOREDITOR
Mr. Dixon Thomas, Head, Dept. of Pharmacy Practice, RIPER ASSOCIATE EDITORSASSOCIATE EDITORSASSOCIATE EDITORSASSOCIATE EDITORS
Dr. Adepu Ramesh, Professor, JSS University, Mysore Dr. Gerardo Alvarez-Uria, Head, Dept. of Infectious Diseases, RDT Hospital Dr. C. Sowmya, Professor, RIPER Dr. P. Ramalingam, Professor, RIPER Dr. Jyothi MV, Professor, RIPER Mrs. Seeba Zachariah, Assoc Professor, RIPER Dr. S. Sriram, Professor, SRIPMS, Coimbatore Dr. Roger Walker, Chief Pharmaceutical Officer, Wales, U.K. Dr. Chris Wisniewski, MUSC Drug Information Center, USA Ms. Atefa Noorain, Associate Research analyst, Thomson Reuters, Hyderabad EDITORIAL ADVISORY BOARDEDITORIAL ADVISORY BOARDEDITORIAL ADVISORY BOARDEDITORIAL ADVISORY BOARD
Dr. M.S. Kannan, Medical Director, RDT Hospital Dr. A.N. Nagappa, Professor, Manipal University, Karnataka Dr. G.P. Mohanta, Professor, Annamalai Univeristy, T.N. Dr. Gayathri Palat, Program Director, Palliative Access (PAX) Programme, India Dr. C. Vijaya Raghavan, Vice-Principal, PSG College of Pharmacy, T.N. Dr. Subhash C. Mandal, Vice President, IPA-Bengal Branch Dr. Sunil K Jain, Chief Pharmacist, AIIMS, New Delhi Dr. B. J. Mahendra Kumar, Prof, JDT, Kerala Dr. Gunasakaran, Clinical Head, Azidus Laboratory Ltd, T.N. Dr. S.S. Rao, Pharmacist, Canada Mr. Ali Dulfikkar, Pharmacist, Dubai Prof. M.N. Femi Oyewo, Olabisi Onabanjo University, Nigeria Dr. Ugochi Nyere Ogudu, Lagos Island Maternity Hospital, Nigeria Dr. Azubike Okwor, President, Pharmaceutical Association of Nigeria Dr. Cheikh Saad, Univeristy of Thies, Senegal Dr. Stein Lyftingsmo, Pharmacist, Norway Dr. M.K. Unnikrishnan, Professor, Manipal University, Karnataka Mr. Sonal Sekhar, Sr. Lecturer, Manipal University, Karnataka Dr. Hari Hara Nadha Sarma, Medical Superintendent, RDT Hospital, Bathalapalli Dr. H. Harish, Head, Dept. of Anesthesia RDT Hospital, Bathalapalli Dr. Tadepalli Durgesh, Head, Children’s Hospital, RDT Hospital, Bathalapalli Dr. K. Sudheer Kumar, Head, Dept. of Surgery, RDT Hospital, Bathalapalli Dr. Alexander Daniel Sunad, Surgeon, RDT Hospital Mr. K. Thejomoorthy, Chief Pharmacist, RDT Hospital Mr. Prasanth Kumar, Data Manager, Novartis Healthcare Pvt. Ltd. Mr. Tapan Kumar Shah, Clinical Operations, Boehringer Ingelheim India Pvt. Ltd Mr. Tarun Wadhwa, Asst Professor, KLE College of Pharmacy, Belgaum
4 RIPER PDIC Bulletin, April 2012, Volume 3, Issue 21 [ISSN 2230-8741]
PUBLICATION COMMITTEEPUBLICATION COMMITTEEPUBLICATION COMMITTEEPUBLICATION COMMITTEE
CHAIRMANCHAIRMANCHAIRMANCHAIRMAN
Dr. J. Ravindra Reddy, Correspondent, RIPER
MANAGING EDITORSMANAGING EDITORSMANAGING EDITORSMANAGING EDITORS
Mr. Vigneshwaran, Asst Professor, RIPER Mr. G. Narayana, Asst Professor, RIPER Dr. Mohan Raj, Asst Professor, RIPER
REGULATORY NEWSREGULATORY NEWSREGULATORY NEWSREGULATORY NEWS
Rohit Bhavsar
D. Giri Rajasekhar
PROOF READINGPROOF READINGPROOF READINGPROOF READING
K. Balaji, Asst Professor, RIPER
S.K.R. Sowmya
N. Sreelalitha
A. Srinadh
INDEXIINDEXIINDEXIINDEXING & DISTRIBUTIONNG & DISTRIBUTIONNG & DISTRIBUTIONNG & DISTRIBUTION
Mr. M. Jaffar, Asst Professor, RIPER Seetharam C Vinay Pawar
K H Ushadevi
V. N. HariKiran
WEBSITE ADMINISTRATIONWEBSITE ADMINISTRATIONWEBSITE ADMINISTRATIONWEBSITE ADMINISTRATION
D. K. Sudheer Naik
RIPER PDIC Bulletin
Raghavendra Institute of Pharmaceutical Education and Research (RIPER)
Chiyyedu Post, Anantapur 515721, AP, India
Phone: 91-8978541693
[email protected], www.riper.ac.in, www.riperjournals.org
Notice: For healthcare professionals only. View of authors are independent to that of
editorial team, it is highly advised for consulting other drug information sources also for
your specific needs. Publisher, editorial team or authors are not responsible for any damage
happens due to the information provided. RIPER PDIC Bulletin Published by the Principal,
RIPER, Anantapur— 515721, A.P
5 RIPER PDIC Bulletin, April 2012, Volume 3, Issue 21 [ISSN 2230-8741]
RIPER PDIC Bulletin
CONTENTSCONTENTSCONTENTSCONTENTS
1 Editorial Page 06
2 Medication Therapy Management-how pharmacy
practice is evolving - Paul J. Oesterman
Page 07
3 Good Pharmacy Practice as a tool for transformation
of pharmacies to healthcare facilities - Raj Vaidya,
Seeba Zachariah & BJ Mahendra Kumar
Page 10
4 Inhalation chemotherapy - Bhupinder Singh Sekhon Page 13
5 Drug news Page 21
6 Instruction to the authors Page 23
6 RIPER PDIC Bulletin, April 2012, Volume 3, Issue 21 [ISSN 2230-8741]
Editorial
Clinical training – student exchange programs
From the guest editorial of Paul in this issue of the bulletin, it is clear that
there is at least 3 phases of clinical training for Pharmacy students,
Introductory, advanced and residency. In advanced training it is essential that
the Pharm.D students need to undergo training in different health care
setting. As per the current guidelines of Pharm.D education, students have to
complete all the formal training in same institution except an allowed 5 % transfer. There
are high amount of attention and need is arising to have training in different healthcare
settings while the students are in advanced phase of their clinical training (especially in
clerkship and internship). The major variation in clinical practice happens with the basic
policy of the hospital, i.e., either charity or for profit. Also there are variations between
teaching & non-teaching hospitals, urban and rural hospitals, public, trust and private
hospitals and depending on specialty or super-specialty hospitals. Student exchange
programs are one of the key aspects of pharmacy practice education to orient students
towards different clinical settings. I appreciate all organizations who believe that the
student exchange could make a difference in clinical pharmacy or Pharm.D education.
Sincerely yours,
Dr. Y. Padmanabha Reddy, M.Pharm, PhD, FIC
Principal, RIPER & Chief Editor, RIPER PDIC Bulletin
Poison and drug Information services
With the advent of newer electronic devises, poison or drug information
services are available with the practitioner while they practice. But of course
those services will not answer all clinical questions or it may take long time to
get what is required by using those devises. Here the question is that the
practitioner should spend their time to find the answer or contact a poison or
drug information specialist to find the possible answer and dedicate their time
to clinical practice. If complete confidentiality is maintained by the poison or
drug information specialist, I believe there is scope for the service of a poison or drug
information specialist in all hospitals.
I invite the poison or drug information specialists to give a short note on the potential
services they provide and how it is helpful to the healthcare. We could include those
experiences in the upcoming issues of the bulletin to strengthen the services of poison or
drug information specialists.
Best Regards,
Mr. Dixon Thomas, M.Pharm, M.S., M.Sc.
HOD, Pharmacy Practice, RIPER & Editor, RIPER PDIC Bulletin
7 RIPER PDIC Bulletin, April 2012, Volume 3, Issue 21 [ISSN 2230-8741]
Medication Therapy Management - how pharmacy practice is evolving
Paul J. Oesterman
Associate Professor Pharmacy Practice, Roseman University of Health Sciences, Nevada, USA
Introduction
Questions about next steps were raised
following the Inaugural Quality Pharmacy
Practice Module- Advanced Learning
Series. While the practice of pharmacy in
the United States is considerably different
from how it is currently being practiced in
India, there is a mobilization to increase
the clinical knowledge and expand the
scope of pharmacy practice through
Medication Therapy Management (MTM)
in India. This evolution is one that
requires careful thought and planning to
assure the successful implementation of
the clinical model.
Educational Paradigm Shift
While much of the required disease state
education and training will take place in
the academic institutions, there are three
critical initial components that need to be
concurrently incorporated to allow for
successful implementation of clinical
pharmacy and MTM. The first critical
component is associated with the law and
recognition of the roles that clinically
trained pharmacists play, the second
relates to the role of technology, and the
third significant piece is the clinical
training.
Legal Perspective
It is imperative that the laws governing
the practice of pharmacy be relevant to
how pharmacy is being currently practiced
and that compliance is carefully
monitored by the respective regulatory
agencies. Collaborative efforts through
the Indian Association of Colleges of
Pharmacy (IACP) can assist with
development of practice guidelines.
Careful designation of the duties that can
be performed by technicians versus those
that can be performed by clinically trained
pharmacists must be clearly delineated
and strictly enforced.
Technological Perspective
The current technology available to
pharmacists needs to be maximized.
A
good starting point for the community
pharmacy practitioner will be the creation
of patient profiles. These profiles can be
either paper format or stored
electronically, with the latter being
preferred. The profile should include
select patient demographics including
name, address, phone, and date of
birth/age, height and weight, known drug
allergies, medical providers, list of current
medical conditions and current
medications (prescription and non-
prescription). In addition to the patient
demographics, the profile can be used to
assist with assurance of patient adherence
to their medical regimens.
Clinical Perspective
The clinical training is going to require
that pharmacy students spend time in
experiential sites where they are able to
8 RIPER PDIC Bulletin, April 2012, Volume 3, Issue 21 [ISSN 2230-8741]
place their didactic teachings into the real
world of healthcare. Most students in the
United States spend a minimum of 2000
hours divided between introductory
Pharmacy Practice Experiences (IPPEs)
and Advanced Pharmacy Practice
Experiences (APPEs). The IPPEs can be
completed in a variety of pharmacy
settings including both community and
institutional pharmacies and are generally
started early in the educational program.
The goal of the IPPE is to permit the
student pharmacist to actively see, learn,
and practice the technical components of
prescription dispensing under the
guidance of a mentor preceptor
pharmacist.
Student pharmacists are
assessed by their preceptors. While
students are at their experiential sites,
they incorporate their didactic training
and contribute to the health of the
patients and the knowledge of their
preceptors. The APPEs generally consist
of a series of 6 to 8 week rotations at
various practice sites where the students
spend more time applying their didactic
knowledge as it relates to disease state
management and “Clinical Pharmacy”.
Students complete 4 required rotations
including: Adult Acute Care, Advanced
Community, and Ambulatory Care &
Health System Pharmacy. They may also
complete additional rotations in direct
patient care areas such as pediatrics,
oncology, and diabetes. Following
graduation with their Pharm.D degree,
many students continue their education in
a focused area completing a Pharmacy
Residency where they specialize in a
focused area of pharmacy practice. Other
pharmacists will obtain accreditation or
certification in specialty programs like
immunizations, diabetes, hypertension,
lipid management.
Conclusions
While the Inaugural program was
designed to give a brief overview of MTM
and select disease states, there are many
tools available and the steps to successful
implementation must be carefully
navigated to avoid some of the pitfalls
that others have experienced.
References/Resources:
1. American Pharmacists Association.
Integrating Medication Therapy
Management (MTM) Into the
Curricula of Schools and Colleges
of Pharmacy. March 2012, pg 1-8.
2. McMahan R. Operationalizing
MTM through the use of health
information technology. J Manag
Care Pharm. 2008, 14(2)(suppl S-
a):S18-21.
3. Posey LM. Early experiences link
students, MTM, patients.
Pharmacy Today. 2009, 15(1):48.
4. Farnstrom B. MTM mentor and
practitioner. Pharmacy Today.
2009, 15(12):29-31.
5. Spooner JJ. Medication therapy
management programs: When will
the outcomes come out? J Manag
Care Pharm. 2007, 13:276-7.
6. Culhane N, Brooks A, Cohen V,
Couchenour R, Ferreri S, et al.
Medication therapy management
services: Application of the core
elements in ambulatory settings.
ACCP Board of Regents. January
23, 2007.
9 RIPER PDIC Bulletin, April 2012, Volume 3, Issue 21 [ISSN 2230-8741]
7. Barnett MJ, Frank J, Wehring H,
Newland B, VonMuenster S, et al.
Analysis of pharmacist-provided
medication therapy management
(MTM) services in community
pharmacies over 7 years. J Manag
Care Pharm. 2009, 15(1):18-31.
8. Cahill JA, Manasse HR. Medication
therapy management programs:
To optimize pharmacy outcomes. J
Manag Care Pharm. 2005, 11:179-
86.
9. MacIntosh C, Weiser C, Wassimi A,
Reddick J, Scovis N, et al. Attitudes
toward and factors affecting
implementation of medication
therapy management services by
community pharmacists. J Am
Pharm Assoc. 2009, 49:26-30.
10. McDonough R. Focusing on the
nitty-gritty of MTM. Pharmacy
Today. 2009, 15(1):49.
11. Patel J. Bringing student
pharmacists into the patient care
process. Pharmacy Today. 2008,
14(6):32.
10 RIPER PDIC Bulletin, April 2012, Volume 3, Issue 21 [ISSN 2230-8741]
Good Pharmacy Practice as a tool for transformation of pharmacies to
healthcare facilities
Raj Vaidya1, Seeba Zachariah
2 & BJ Mahendra Kumar
3
1Immediate - Past Vice-President, Indian Pharmaceutical Association &/or Community
Pharmacist, Hindu Pharmacy, Panaji 2Assoc Prof, RIPER, Anantapur, A.P
3Director, PG Studies, JDT Islam College of Pharmacy, Calicut, Kerala
In 2011, the Pharmacy Council of India has
mandated that all pharmacy practice
departments in teaching hospitals to
implement and adhere to Good pharmacy
practice (GPP), and that curriculum of
D.Pharm, B.Pharm and Pharm.D should
include aspects and components of GPP.
GPP has been a standard for guiding the
pharmacies around the globe for
achieving their quality in operation. Many
countries make their national GPP with a
regulatory vision to reciprocate standard
practices of pharmacy in the country. For
the hospitals or the proprietors it could be
used as a management tool and for the
pharmacists, GPP works with a moral
vision. Other so called ‘good’ practice
guidelines are Good Manufacturing
Practice (GMP), Good Laboratory Practice
(GLP) and Good Clinical Practice (GCP).
There are also some other GPPs in use;
such as Good Pharmacovigilance Practice,
Good Pharmaco-epidemiological Practice
and Good Publishing Practice.
The International Pharmaceutical
Federation (FIP) first released GPP
Guidelines in 1992, and this was then
endorsed by the WHO in 1997. In 2002,
the Indian Pharmaceutical Association
prepared GPP Guidelines for Community
Pharmacy in India, and followed it up in
2005, by preparing a GPP Training Manual
for community in collaboration with the
Central Drugs Standard Control
Organization and World Health
Organization (WHO) India Country Office.
The GPP Training Manual has 6 Modules,
and a set of SOPs.
Module I: Regulatory Affairs
Module II: Procurement and Inventory
Management
Module III: Storage and Stock
Management
Module IV: Dispensing
Module V: Patient Information
Module VI: Rational Use of Medicines.
These modules were prepared based on
the GPP Guidelines, the drug laws in the
country, and took into consideration the
ground realities and situation in
community pharmacy in India. The
Modules have been prepared in an easy
to understand language with simple
illustrations, charts, and examples, to
guide community pharmacies across the
country, in every nook and corner, to
11 RIPER PDIC Bulletin, April 2012, Volume 3, Issue 21 [ISSN 2230-8741]
adapt GPP and upgrade their pharmacies
and practice.
The module “Regulatory Affairs” is largely
dealing with the compliance of regulatory
requirements to operate pharmacies in
India. There is lots of room for regulatory
reform in India to make the Indian
pharmacies to work for health screening
and pharmaceutical care. The leading
pharmaceutical associations in the
country such as Indian Pharmaceutical
Association (IPA) have to work with
regulatory bodies to improve the legal
priorities to expand the healthcare
practices of pharmacists in the country. As
in some of the developed countries, if the
pharmacist is licensed to administer
selected immunization or do some lab
tests and other health screening
techniques like measuring the lean body
mass, etc., the pharmacies will have a
facelift to a healthcare facility in the
society. The regulation should allow
limited but essential patient management
rights to the pharmacies especially when
considering rural India with access to
medical care, and where a pharmacy
could cater the basic health care needs
and referral services to the rural public.
The Module II and III are largely
concerning with choosing, managing,
handling and storage of the product in
pharmacies.
The Module on “Dispensing”, the core
activity of a pharmacy deals with the
various aspects of every step of
dispensing, right from receiving the client
and the prescription to handing over the
medicines, in a very lucid, systematic
manner, with ample illustrations. The
Module on “Patient Information” deals
with various means of providing
information to the patient, both written
and verbal (through patient instructions
and counseling) and how pharmacies
should go about it, to increase their
professional outlook as well as increase
compliance amongst the patients, a very
important component of providing
pharmaceutical care. The last Module is a
policy aspect to take the responsibility
that the medicines are used rationally at
the prescriber, pharmacist, nurse and
patient levels. Rational use not only
benefits the patient but also has national
priority when it comes to prevention and
management of drug resistance, misuse of
medicines, reducing adverse reactions,
and effective management of medical
resource and economy.
With the evolution of a more patient
focused approach by the pharmacies, the
Patient Information Modules needs to be
further expanded to include finer aspects
of pharmaceutical care, an important
organ of pharmacy. In pharmaceutical
care or medical therapy management (as
it is called in USA) or medication action
plan (as it is called in Australia) the sub
areas to be established well in pharmacies
are;
• Health Screening Services and
Immunization
• Drug Interaction Screening and
Management
• Adverse drug reaction monitoring
• Medication error prevention and
management
12 RIPER PDIC Bulletin, April 2012, Volume 3, Issue 21 [ISSN 2230-8741]
• Health Information Services and
referral services
• Pharmacoeconomic Services
It is understood that because of patient
load, during the dispensing process it is
not possible to provide pharmaceutical
care services. Besides, dispensing is a full
time, full attention responsibility.
Therefore, there should be and additional
pharmacist in the pharmacy, who could
provide the other healthcare services and
charge for the consultation. There should
be legal permission for collecting this
charge and the insurance companies
should agree to pay for the pharmacy
consultation. In many developed counties,
pharmacies are legally permitted to
provide certain healthcare services and
charge for it. Most of the insurance
companies including the government
health insurance recognize the
importance of pharmacy consultation and
how it reduces the number of
hospitalizations and other healthcare
costs.
So, we hope the usefulness of GPP as a
tool for making pharmacies into
healthcare facilities is fairly explained. If
you have a point to add, please feel free
to contact: Raj [email protected]
Further reading:
WHO India, GPP – training manuel,
http://whoindia.org/en/Section2/Section
5/Section403.htm
13 RIPER PDIC Bulletin, April 2012, Volume 3, Issue 21 [ISSN 2230-8741]
Inhalation chemotherapy
Bhupinder Singh Sekhon
PCTE Institute of Pharmacy, near Baddowal Cantt, Ludhiana-142 021, India.
e-mail:[email protected]
Abstract
Certain medicinal agents are more effectively delivered to the body by vaporizing them and
inhaling them. Inhalation therapies are considered safe and effective methods for treating
lung disease as well as a variety of other health conditions. Inhalation chemotherapy focus
on targeting chemotherapy that it goes selectively to the lungs and has much lower
concentrations in the blood stream (minimizes side effects).
Keywords: Inhalation, lung cancer, insulin, glutathione, asthma.
Introduction
Advances in drug formulation and
inhalation device design are creating new
opportunities for inhaled drug delivery.
Inhaled medicines are the first choice and
are an important part of controlling and
treating asthma and chronic obstructive
pulmonary disease. These medicines
begin to work within few minutes and
have fewer side effects. Moreover, the
medicine goes right to the lungs and does
not easily go into the rest of the body.
There are a number of devices that deliver
medicine directly to the airways.
Metered-dose inhalers, dry powder
inhalers and nebulizers are currently
available with different medicines.
Inhalational chemotherapy was first
reported in 1968.1 Inhaled steroids, also
known as inhaled corticosteroids have
become the mainstay of asthma
treatment for persistent asthma in
children and adults. The use of inhaled
steroids leads to: better asthma control,
fewer symptoms and flare-ups and
reduced need for hospitalization.2 Many
brands of inhaled corticosteroids are
available such as: Fluticasone (Flovent),
Budesonide (Pulmicort), Triamcinolone
(Azmacort), Flunisolide (Aerobid),
Beclomethasone (Qvar).3 Almost all COPD
medications are inhaled including inhaled
corticosteroids. Inhalation marijuana is an
effective therapy for the treatment of
nausea and vomiting due to cancer
chemotherapy.4
Inhalant chemotherapy using paclitaxel or
doxorubicin has been investigated in dogs
with primary and metastatic lung tumors.5
Inhaled fluticasone propionate decreased
the incidence of delayed pulmonary
toxicity syndrome and decline in
pulmonary function in breast cancer
patients undergoing high-dose
chemotherapy with the conditioning
regimen of cyclophosphamide, cisplatin,
and carmustine followed by autologous
stem cell transplantation.6 Air hunger, or
dyspnea, is a frequent and devastating
symptom in patients with advanced
cancer. Nebulized morphine has the
potential to act more quickly, is relatively
easy to administer, and could sidestep the
sedating side effects that occur with
injections.7
14 RIPER PDIC Bulletin, April 2012, Volume 3, Issue 21 [ISSN 2230-8741]
Inhalation of nebulized furosemide seems
to be an effective and useful treatment
for dyspnea in terminal cancer patients.
Dyspnea dramatically improved and could
be controlled for weeks. Moreover, no
noticeable side effects were observed.8 A
variety of opioids have been administered
for inhalation dyspnea.9 The rationale of
drug delivery by the inhalational route, its
technical challenges, preclinical and
clinical experiences, limitations, and
promise have been reported.10
Scientists have successfully used pet dog
cancer models to evaluate the delivery of
cytotoxic chemotherapy and cytokines by
aerosol for the treatment of primary
cancers of the lung and cancers
metastatic to the lung.11
Asthma
treatment by inhaled drugs began in
earnest in the 1950s, and now targeted
treatment with inhaled drugs is actively
considered for treating many other lung
diseases. The first such product to be
marketed was Exubera (first inhaled
insulin product).12,13
In October
2007,Pfizer discontinued the production
of Exubera due to poor sales.14
Currently,
major advances have led to increasing
interest in systemic delivery of drugs by
inhalation. In this direction, small
molecules can be delivered with very
rapid action, low metabolism and high
bioavailability; and macromolecules can
be delivered without injections.
Reduced glutathione or simply glutathione
(γ-glutamylcysteinylglycine; GSH) is found
in the cytosol of most cells of the body.
GSH in the epithelial lining fluid of the
lower respiratory tract is thought to be
the first line of defense against oxidative
stress. Inhalation (nebulized or
aerosolized) is the only known method
that increases GSH's levels in the
epithelial lining fluid. The clinical
effectiveness of inhaled glutathione as a
treatment for various pulmonary diseases
and respiratory-related conditions has
been reported. Reasons for inhaled GSH's
effectiveness include its role as a potent
antioxidant, and possibly improved
oxygenation and host defenses. Inhaled
glutathione was found effective for
treating lung diseases, including idiopathic
pulmonary fibrosis, cystic fibrosis, and
lung disease in people with HIV disease.15
One of the primary side effects of existing
methods of drug delivery is kidney
damage. Damage to the kidneys could be
avoided with the administering of drugs
by inhalation. Some companies are
developing inhaled forms of the drug to
reduce the need for daily injections
among diabetics. Aerogen in Galway,
Ireland and Dance Pharmaceuticals in San
Francisco, California have announced a
drug-delivery partnership for the
production of inhaled insulin in January
2011.16
It was announced in September
2011 that a form of inhalable insulin,
aerosolized insulin, applied deep into the
nostrils may delay the onset of
Alzheimer.17
A new delivery technology
developed by the Aradigm Corp.,
Hayward, Calif., has been tested in about
100 patients to deliver aerosolized
morphine directly into the lung for acute
or breakthrough pain.18
Inhalation chemotherapy in lung cancer
Inhalation therapy is being explored as a
way to deliver chemotherapy drugs
directly to the lungs, either for a primary
cancer or cancer that has spread to the
lungs. Osteosarcoma is a rare childhood
bone cancer that can be fatal because it
spreads to the lungs. Lung cancer and
mesothelioma, a cancer of the lining of
the lung, take large number of lives each
year and affects both smokers and non-
15 RIPER PDIC Bulletin, April 2012, Volume 3, Issue 21 [ISSN 2230-8741]
smokers, killing more than half of the
people who get it within five years.19
Lung
cancer is histologically separated into
either small-cell lung cancer (SCLC) or
nonsmall-cell lung cancer (NSCLC). NSCLC
is much more common, and can occur in
the periphery (adenocarcinomas) or
central airways (squamous cell
carcinomas). It is argued that inhalation of
chemotherapy as an adjuvant in Stage II
NSCLC and inhalation of chemopreventive
agents in Stage I adenocarcinomas are
direct paths to improve lung cancer
therapy as well as demonstrate the ultility
of inhalation therapy.
Regional chemotherapy has been
proposed as a treatment modality in a
number of cancer settings. In case of
primary or metastatic lung cancer,
administration of chemotherapy via
inhalation could increase exposure of lung
tumour to the drug, while minimizing
systemic side effects. Several studies in
animal models of metastatic or primary
lung cancer have demonstrated the
safety, pharmacokinetic advantage, and
antitumor effect of aerosol administration
of several chemotherapeutic agents
including doxorubicin, gemcitabine and
liposome-encapsulated formulations of
paclitaxel and 9-nitrocamptothecin.
Recent phase I studies have demonstrated
the feasibility of aerosol delivery of
doxorubicin and liposomal formulations of
9-nitrocamptothecin and cisplatin in
patients with primary and metastatic lung
cancer with a limited pharmacokinetic
profile consistent with the observed low
systemic toxicity.20
Researchers hypothesized that a
substantial enhancement in the efficiency
of lung cancer treatment is possible by (i)
local delivery of chemotherapeutic
agent(s) by inhalation and (ii)
simultaneous suppression of at least
major mechanisms of lung cancer cell
resistance. A variety of chemotherapeutic
agents including cisplatin, mitomycin, and
5-fluorouracil administered by inhalation
have been evaluated in preclinical models.
Researchers have tested the
administration of 5-fluorouracil by
inhalation in dogs and found high levels of
the drug in the trachea, hilar bronchi, and
regional nodes. Subsequently, the same
authors treated 10 patients with
inoperable lung tumors with 5-fluorouracil
administered via supersonic nebulizer at a
dose of 250 mg twice daily for 2 to 3 days
per week. There was antitumor efficacy
with two complete and four partial
responses observed.21
In addition to administration of inhaled
chemotherapeutic agents, Huland et al.
administered interleukin-2 (IL-2) by
inhalation with concomitant IFN-α
administered subcutaneous to 15 patients
with metastatic renal carcinoma. There
seemed to be improved response in lung
compared with non-lung metastases,
suggesting that inhalational IL-2 displayed
enhanced antitumor efficacy in pulmonary
lesions.22
Nebulized IL-2 in combination
with systemic IL-2 has also been evaluated
in patients with renal cancer.23
More
recent studies have been done using
formulations of cisplatin, camptothecins,
and alternative biological response agents
with exciting early results.24-27
Researchers have shown the safety of
delivering doxorubicin using a novel
inhalational delivery device.28
The efficacy
of inhaled doxorubicin HCl when given in
combination with intravenous docetaxel
and cisplatin in patients with NSCLC have
been reported.29
Research is currently underway to address
issues of local versus systemic toxicity,
optimal drug delivery and selection of
optimal drugs and schedules including
outpatient aerosol therapy.30
Paediatric
16 RIPER PDIC Bulletin, April 2012, Volume 3, Issue 21 [ISSN 2230-8741]
cancer specialists investigated inhalation
chemotherapy with the potential to treat
children with a deadly bone cancer that
has spread to their lungs.31
One of the most widely used cancer-
fighting drugs, cisplatin, was administered
in a vaporized form, enabling medical
professionals to get the drug to the
cancerous cells while avoiding damage to
healthy cells nearby. Damage caused to
healthy cells can be especially debilitating
to patients suffering from mesothelioma.
In other words, delivery of vaporized
cisplatin by means of inhalation would
help mesothelioma patients live longer
and enjoy a higher quality of life.32
Development of cancer cell resistance,
low accumulation of therapeutic drug in
the lungs, and severe adverse treatment
side effects represent main obstacles to
efficient chemotherapy of lung cancer. To
overcome these difficulties, scientists
have reported inhalation local delivery of
anticancer drugs in combination with
suppressors of pump and non-pump
cellular resistance. Nanoscale-based
delivery systems containing doxorubicin
as a cell death inducer, antisense
oligonucleotides targeted to MRP1 mRNA
as a suppressor of pump resistance and to
BCL2 mRNA as a suppressor of non-pump
resistance, were developed and examined
on an orthotopic murine model of human
lung carcinoma. The experimental results
showed high antitumor activity and low
adverse side effects of proposed complex
inhalatory treatment that cannot be
achieved by individual components
applied separately.33
Mesothelioma is a rare and deadly disease
that affects the mesothelium, or the lining
of organs such as the lungs, abdominal
organs, and heart. In the case of pleural
mesothelioma, the disease affects the
pleura, the lining of the lungs. Inhaled
chemotherapy was found useful to pleural
mesothelioma patients because it targets
only the cancerous cells in the lungs, while
injected chemotherapy affects any
healthy cells it comes into contact with.34
Inhaled chemotherapy is still under
examination as an alternative therapeutic
modality for NSCLC treatment regarding
to respiratory function side effects.
Researchers showed that patients in
partial inhaled chemotherapy have a
statistically significant survival benefit
without any side effect in respiratory
function.35
A tumour targeted mesoporous silica
nanoparticles (MSN)-based drug delivery
system (DDS) was developed for
inhalation treatment of lung cancer. The
system was capable of effectively
delivering inside cancer cells; anticancer
drugs (doxorubicin and cisplatin)
combined with two types of siRNA
targeted to MRP1 and BCL2 mRNA for
suppression of pump and non-pump
cellular resistance in non-small cell lung
carcinoma, respectively. Researchers
achieved targeting of MSN to cancer cells
by the conjugation of LHRH peptide on
the surface of MSN via (polyethylene
glycol) spacer. The delivered anticancer
drugs and siRNA preserved their specific
activity leading to the cell death induction
and inhibition of targeted mRNA.
Suppression of cellular resistance by
siRNA effectively delivered inside cancer
cells and substantially enhanced the
cytotoxicity of anticancer drugs. Local
delivery of MSN by inhalation led to the
preferential accumulation of
nanoparticles in the mouse lungs,
prevented the escape of MSN into the
systemic circulation, and limited their
accumulation in other organs. The
experimental data confirmed that the
developed DDS satisfies the major
17 RIPER PDIC Bulletin, April 2012, Volume 3, Issue 21 [ISSN 2230-8741]
prerequisites for effective treatment of
non-small cell lung carcinoma. In view of
above, the proposed cancer-targeted
MSN-based system for complex delivery
of drugs and siRNA has high potential in
the effective treatment of lung cancer.36
The safety and efficacy of inhaled
antineoplastic drugs, using pet dogs with
spontaneously arising primary and
metastatic lung cancers (including
sarcoma, carcinoma, and malignant
melanoma) as a model was reported.
Dogs received new formulations of either
paclitaxel or doxorubicin by the inhalation
route every 2 weeks using a specially
designed aerosol device avoided systemic
toxicity while delivering efficacious local
drug levels by the inhalation route.37
Regional chemotherapy to the lung
parenchyma for lung cancer was found
feasible and efficient. However, safety
depends on the chemotherapy agent
delivered to the lungs and is dose-
dependent and time-dependent.38,39
Clinical trials are on track to develop
pulmonary marinol that would be
delivered with a pressurized metered
dose inhaler .This method has shown
immediate and rapid systemic absorption,
however FDA approval is still awaited. In
the meantime, Sativex, an oral cannabis
spray consisting of natural cannabinoid
extracts has already been approved for
use in Canada, New Zealand and eight
other European countries, and hopes to
gain FDA approval for use by US patients
by 2013. Just as inhaling cigarette smoke
can cause lung cancer, inhaling
medication may treat it. National
Institutes of Health and the National
Cancer Institute funded the research
project that involves inhaling a drug called
5-azacytidine to target the bronchial
epithelium. 5-azacytidine is a
demethylating agent, meaning it strips off
methyl groups that have bound to genes
and rendered them inactive. Since
removing methyl groups can reactivate
genes that suppress tumors, drugs such as
5-azacytidine can potentially treat a
number of different types of cancers.
Chemotherapy plays a significant role
both as primary and as supportive care for
lung cancer treatment. The majority of
currently available anticancer agents are
administrated intravenously, causing side
effects due to the systemic drug
distribution. Alternatively, the
bioavailability of orally administrated
anticancer agents is usually compromised
by the first-pass metabolism. Pulmonary
administration may be a potential route
for anticancer drug delivery to treat lung
tumors, due to its site specific delivery,
avoidance of first-pass metabolism,
possibility of fewer side effects, and
improved comfort for cancer patients
using a needle-free delivery device.
However, to attain an effective
inhalational delivery, there is a
requirement to design a formulation with
appropriate aerodynamic properties with
well-suited excipients. This review article
explores work to date related to the
formulations developed for pulmonary
delivery of small molecule antineoplastic
agents to treat primary and metastatic
lung carcinomas. Ultimately, it highlights
the importance of formulation design to
define the role of inhalational
chemotherapy.40
More research is
required regarding inhaled chemotherapy
delivery method. Experts are of the
opinion that inhaled chemotherapy could
one day be administered at home with
fewer systemic adverse effects. It is also
hoped that inhaled chemotherapy
discovery will lead to other less invasive
drug delivery systems for other types of
mesothelioma and asbestos diseases.
18 RIPER PDIC Bulletin, April 2012, Volume 3, Issue 21 [ISSN 2230-8741]
Conclusions
The concept of delivering drugs by
inhalation for the treatment of cancers in
the lung is attractive. Researchers have
showed that much higher local drug
exposure can be achieved with total doses
considerably lower than those required
for systemic administration, resulting in
lower exposure of non-respiratory tract
tissues to potentially toxic drugs.
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9. Ferrarest V. Inhaled opioids for the
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13. McMahon GT, Arky RA. Inhaled insulin
for diabetes mellitus. N Engl J Med
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14. Simons J (19 October 2007). "How the
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(Nebulized or Aerosolized)
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25. Markovic SN, Suman VJ, Nevala WK,
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26. Wittgen BP,Kunst PW, van der Born K,
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27. Verschraegen CF,Gilbert BE, Loyer E,
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28. Otterson GA, Villalona-Calero MA,
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29. Otterson GA, Villalona-Calero MA,
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30. Rao RD, Markovic SN, Anderson
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33. Garbuzenko O, Saad M, Pozharov V,
Reuhl K, Mainelis G, Minko T.
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34. New drug delivery system brings hope
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35. Zarogoulidis P, Eleftheriadou E,
Zarogoulidou V, Sapardanis I,
Kontakiotis T, Sichletidis L,
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36. Taratula O, Garbuzenko OB, Chen AM,
Minko T. Innovative strategy for
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37. Hershey AE, Kurzman ID, Forrest LJ,
Bohling CA, Stonerook M, Placke ME,
Imondi AR, Vail DM. Inhalation
chemotherapy for macroscopic
primary or metastatic lung tumors:
proof of principle using dogs with
spontaneously occurring tumors as a
model. Clin Cancer Res. 1999; 5(9):
2653-2659.
38. Zarogoulidis P, Chatzaki E, Porpodis K,
Domvri K, Hohenforst-Schmidt W,
Goldberg EP, Karamanos N,
Zarogoulidis K. Inhaled chemotherapy
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2012:7:1551 – 1572.
39. Inhalation SLIT Cisplatin for the
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80.
21 RIPER PDIC Bulletin, April 2012, Volume 3, Issue 21 [ISSN 2230-8741]
Drug news
Collected by Giri Rajasekhar
Aliskiren combinations in diabetes and
renal impairment
Aliskiren is a renin inhibitor used to treat
high blood pressure (hypertension) by
lowering blood pressure.
FDA notified healthcare professionals of
possible risks when using blood pressure
medicines containing aliskiren with other
drugs called angiotensin converting
enzyme inhibitors (ACEIs) and angiotensin
receptor blockers (ARBs) in patients with
diabetes or kidney (renal) impairment.
These drug combinations should not be
used (are contraindicated) in patients with
diabetes. In addition, avoid use of
aliskiren with ARBs or ACEIs in patients
with moderate to severe renal
impairment (i.e., where glomerular
filtration rate [GFR] < 60 mL/min).
Stopping aliskiren suddenly is not advised
without taking other measures to control
blood pressure.
Reference:
http://www.fda.gov/Safety/MedWatch/S
afetyInformation/SafetyAlertsforHumanM
edicalProducts/ucm301120.htm
Use of statins and HIV Drugs could
increases Risk of Muscle Injury
Statins are a class of prescription drugs
used together with diet and exercise to
reduce blood levels of low-density
lipoprotein (LDL) cholesterol (“bad
cholesterol”). HIV protease inhibitors are
a class of prescription anti-viral drugs used
to treat HIV.
FDA notified healthcare professionals of
updates to the prescribing information
concerning interactions between protease
inhibitors and certain statin drugs.
Protease inhibitors and statins taken
together may raise the blood levels of
statins and increase the risk for muscle
injury (myopathy). The most serious form
of myopathy, called rhabdomyolysis, can
damage the kidneys and lead to kidney
failure, which can be fatal.
Reference:
http://www.fda.gov/Safety/MedWatch/S
afetyInformation/SafetyAlertsforHumanM
edicalProducts/ucm294294.htm
Measles outbreak in 2011 highest in last
15 years in USA
There were 222 cases and 17 outbreaks of
the measles in the United States in 2011it
was the highest in last 15 years," said Dr.
Anne Schuchat, director of the National
Center for Immunization and Respiratory
Disease at the U.S. Centers for Disease
Control and Prevention.
In the prior decade, an average of 60
cases and four outbreaks were reported
annually.
The highly infectious illness seems to be
making an unexpected comeback.
Measles was declared eliminated in 2000
after public health measures successfully
interrupted the transmission of disease
from person-to-person in the United
States. The disease is still endemic in
many other parts of the world, however.
And most of the outbreaks resulted from
foreign travel.
Reference: Medlineplus:
http://www.nlm.nih.gov/medlineplus/ne
ws/fullstory_124281.html
22 RIPER PDIC Bulletin, April 2012, Volume 3, Issue 21 [ISSN 2230-8741]
Summer temperature fluctuations risk
old people with chronic diseases
People generally adapt to the
temperatures where they live. But drastic
fluctuations in temperature are known to
increase chances of health risks. Those
who are very old, very young, overweight
or infirm are especially vulnerable. There
are also seasonal variations in some sort
of infections also.
Dr. Antonella Zanobetti of the Harvard
School of Public Health led a research
team to study the long-term impact of
summer temperature variability in 135
U.S. cities. The scientists analyzed
Medicare data on more than 3.7 million
at-risk people, ages 65 and older. The
study populations were released after
hospitalization for chronic obstructive
pulmonary disease (COPD), congestive
heart failure, diabetes or a heart attack.
Some patients were followed up even up
to 21 years. The results shows that
greater the summer temperature
variation, greater was the risk on life.
Reference: NIH Research Matters:
http://www.nih.gov/researchmatters/apri
l2012/04162012summer.htm
23 RIPER PDIC Bulletin, April 2012, Volume 3, Issue 21 [ISSN 2230-8741]
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