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H.P. STATE
COUNCIL
DRUG AND THERAPYBULLETIN
Toll Free 18001210443
DRUG INFORMATION CENTERHIMACHAL PRADESH STATE
PHARMACY COUNCIL
Contents | Editorial | Drug Updates | Medical News
Local News | Importance of blood donation |
Which kind of queries can be asked from Drug Information Center?
Issue: 5 ● Volume: 2 ● Feb 2018
LAUREATE INSTITUTE OF PHARMACY, KATHOG. DISTT. KANGRA. HP. 177101,Toll Free 18001210443 Phone: 09218428042, 9459220253. E-mail: hpspcdic@gmail.com, dic@hpspc.in
DRUG INFORMATION CENTER HIMACHAL PRADESH STATE PHARMACY COUNCIL LAUREATE INSTITUTE OF PHARMACY, KATHOG. DISTT. KANGRA. HP. 177101,
Toll Free 18001210443 Phone: 09218428042, 9459220253. E-mail: hpspcdic@gmail.com, dic@hpspc.in
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DRUG AND THERAPY BULLETIN
Content
EDITORIAL
Patron
Mr. Gopal Krishan Sharma and Dr. Ran Singh
Editor-in-chief
Dr. Kamlesh Naik and Dr. M.S. Ashawat
Co-Editors
Dr. Vinay Pandit and Mr. Ankush Sharma
Advisory Board
Dr. Navneet Marwah, Mr. Sanjeev Pandit, Dr. Manoj Kumar, Dr. Ranjit Singh, Prof. CPS Verma, Dr. Poonam
Sandhu, Dr. Rajender Guleria, Mr. Arvind Kumar, Mr. Bihari Lal Gupta, Mr, Hemant Sharma, Mr. Rakesh
Chandel, Mr. Praveen Upadhya, Mr. Kamashwar Chauhan, Mr. Lokesh Kumar, Mr. Vishal Kumar,
Mr. Y.S.Chandel, Mr. Birbal Sharma, Mr. Manoj Kumar, Mr. Yogesh Verma, Mr. Surender Nadda, Dr. Parshuram
Drug Updates. . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 3
Medical News . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 5
Local News . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 6
Importance of blood donation . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 7
Which kind of queries can be asked from Drug Information Center? . . . . . . . . . . . . . . . . . . . . . . 8
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DRUG UPDATES
DRUG INFORMATION CENTER HIMACHAL PRADESH STATE PHARMACY COUNCIL LAUREATE INSTITUTE OF PHARMACY, KATHOG. DISTT. KANGRA. HP. 177101,
Toll Free 18001210443 Phone: 09218428042, 9459220253. E-mail: hpspcdic@gmail.com, dic@hpspc.in
Makena sub-Q Auto injector
On February 14, 2018, the US FDA approved
Makena(R) (hydroxyprogesterone caproate) as a
subcutaneous auto-injector, making it the second route
of administration for this product. Makena, already
marketed as an IM injection, is approved to reduce the
risk of preterm birth in women pregnant with a singleton
and who spontaneously delivered 1 preterm baby in the
past.
Pr e s c r i b i n g i n f o rma t i on can be f ound a t :
https://www.accessdata.fda.gov/drugsatfda_docs/label/
2018/021945s012lbl.pdf.
Erleada for NM-CRPC
On February 14, 2018, the US FDA approved
Erleada(TM) (apalutamide) oral tablets to treat patients
with non-metastatic castration-resistant prostate cancer
(NM-CRPC). In the SPARTAN clinical trial, Erleada, a
next-generation androgen receptor inhibitor, showed a
risk reduction of distant metastasis or death as well as an
increase of 2 or more years in median metastasis-free
survival.
Prescribing information can be found at: https://
www.accessdata.fda.gov/drugsatfda_docs/label/2018/
210951s000lbl.pdf.
Symdeko for CF
On February 12, 2018, the US FDA approved
Symdeko(TM) (tezacaftor/ivacaftor and ivacaftor) oral kit
to treat the underlying cause of cystic fibrosis (CF) in
patients 12 years of age or older who have 2 copies of the
F508del mutation in the cystic fibrosis transmembrane
conductance regulator (CFTR) gene or who have at least
1 mutation that is responsive to tezacaftor/ivacaftor.
Some CF mutations result in CFTR protein that does not
reach the cell surface due to it not being processed or
folded normally within the cell. Tezacaftor works in
addressing the processing CFTR protein defect which
allows it to reach the cell surface. Then, ivacaftor can
increase the amount of time the protein stays open.
Prescribing information can be found at: https://
www.accessdata.fda.gov/drugsatfda_docs/label/2018/
210491lbl.pdf.
Feraheme for all IDA
On Feb 5, 2018, the US FDA approved an expanded
indication for Feraheme(R) (ferumoxytol) IV injection to
include all eligible adult patients with iron deficiency
anemia (IDA) who have intolerance to oral iron or have
had inadequate response to oral iron. Feraheme was
previously approved only for IDA in adult patients with
chronic kidney disease. The boxed warning now states
that Feraheme should be administered as an IV infusion
over at least 15 minutes.
Pr e s c r i b i n g i n f o rma t i on can be f ound a t :
http://www.feraheme.com/pdfs/Feraheme-Prescribing-
Information.pdf.
Avicaz for HABP/VABP
On February 1, 2018, the US FDA approved a new
indication for Avycaz(R) (ceftazidime/avibactam) IV
injection to include the treatment of adult patients with
hospital-acquired bacterial pneumonia and ventilator-
associated bacterial pneumonia (HABP/VABP) caused
by the fo l lowing suscept ib le Gram-negat ive
microorganisms: Klebsiella pneumoniae, Enterobacter
cloacae, Escherichia coli, Serratia marcescens, Proteus
mirabilis, Pseudomonas aeruginosa, and Haemophilus
influenzae in patients. In a clinical trial, Avycaz was
shown to be non-inferior to meropenem for 28-day all-
cause mortality.
DRUG INFORMATION CENTER HIMACHAL PRADESH STATE PHARMACY COUNCIL LAUREATE INSTITUTE OF PHARMACY, KATHOG. DISTT. KANGRA. HP. 177101,
Toll Free 18001210443 Phone: 09218428042, 9459220253. E-mail: hpspcdic@gmail.com, dic@hpspc.in
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DRUG AND THERAPY BULLETIN
Pre s c r i b i n g i n f o rma t i on can be f ound a t :
http://www.allergan.com/assets/pdf/avycaz_pi
Zomacton for adult GHD
On January 31, 2018, the US FDA approved a new
indication for Zomacton(R) (somatropin, e-coli derived)
5-mg and 10-mg subQ injection to replace growth
hormone in adult patients with growth hormone
deficiency (GHD). Zomacton is also approved to treat
pediatric patients who have growth failure due to an
inadequate secretion of endogenous growth hormone.
Prescribing information can be found at: www.
ferringusa.com/pi/zomacton
Frivanq for CDAD colitis
On January 29, 2018, the US FDA approved
Firvanq(TM) (vancomycin hydrochloride) powder for oral
solution to treat clostridium difficile associated diarrhea
(CDAD) and enterocolitis cause by Staphylococcus
aureus, including methicillin-resistant strains. Firvanq
could provide improved patient access and ease
pharmacists' workload as they will no longer have to
compound vancomycin oral liquid formulations.
Prescribing information can be found at: https://www.
accessdata.fda.gov/drugsatfda_docs/label/2018/2089
10s000lbl.pdf.
Trisenox with Tretinoin for APL
On January 15, 2018, the US FDA approved a new
indication for Trisenox(R) (arsenic trioxide) IV injection
for the first-line treatment of adult patients with newly-
diagnosed low-risk acute promyelocytic leukemia (APL)
in combination with tretinoin. Trisenox, which is already
approved for relapsed or refractory APL, carries a boxed
warning for differentiation syndrome and cardiac
conduction abnormalities.
PI can be found at: www.trisenox.com/trisenox-
prescribing- information.pdf.
Lynparza now for breast cancer
On January 12, 2018, the US FDA approved a new
indication for Lynparza(R) (olaparib) oral tablets for use
in patients with deleterious or suspected deleterious
gBRCAm, HER2-negative metastatic breast cancer, who
have been treated with chemotherapy in the
neoadjuvant, adjuvant, or metastatic setting. The FDA
also approved a complementary diagnostic test for
olaparib to assess the presence of deleterious or
suspected deleterious gBRCA-mutations. Lynparza is the
first PARP inhibitor to gain approval for the treatment of
breast cancer.
PI can be found at: https://www.accessdata.fda.gov/
drugsatfda_docs/label/2018/208558s001lbl.pdf
Opioid Cough/cold Meds for adults only
On January 11, 2018, the US FDA issued a safety
communication to limit the use of prescription cough and
cold medications containing codeine or hydrocodone to
adult patients 18 years of age or older. Because the risks
of misuse, abuse, addiction, overdose, and death
outweigh the benefits, these products are no longer
indicated for use in pediatric patients younger than 18
years of age. The FDA is requiring safety labeling updates
for all prescription codeine- or hydrocodone-containing
cough and cold medications.
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DRUG INFORMATION CENTER HIMACHAL PRADESH STATE PHARMACY COUNCIL LAUREATE INSTITUTE OF PHARMACY, KATHOG. DISTT. KANGRA. HP. 177101,
Toll Free 18001210443 Phone: 09218428042, 9459220253. E-mail: hpspcdic@gmail.com, dic@hpspc.in
USFDA: olanzapine may cause DRESS
The United States Food and Drug Administration recently
issued a safety communication about the possible, rare
but serious skin reaction linked with Olanzapine use.
According to the warning, Olanzapine-containing
formulations may cause Drug Reaction with Eosinophilia
and Systemic Symptoms (DRESS) that can affect all over
the body.
Balcoltra: latest in birth control
Balcoltra (levonorgestrel and ethinyl estradiol tablets,
USP, and ferrous bisglycinate tablets) provides an oral
contraceptive regimen consisting of 21 orange active
tablets and 7 blue inactive tablets. Balcoltra is indicated
for use by females of reproductive potential to prevent
pregnancy.
Maha FDA asks CDSCO to notify bodies, officers and labs to implement compliance of new Medical Device Rules
In order to implement the newly notified Medical Device
Rules 2017 which is effective from January 1, 2018 in a
proper manner, the Maharashtra Food and Drug
Administration (FDA) has asked the Central Drugs
Standard Control Organization (CDSCO) to notify the
bodies, officers and labs designated for the purpose of
overseeing the compliance of new Medical Device Rules,
2017.
CDSCO Approves Macitentan for The Tr e a t m e n t O f Pu l m o n a r y A r t e r i a l Hypertension (PAH)
On December 07, 2017, CDSCO approved Macitentan
Bulk/Tablets 10 mg, which is indicated for the treatment
of Pulmonary Arterial Hypertension (PAH, World Health
Organization (WHO) group I) to delay disease
progression1. The manufacture and marketing approval
for Macitentan Tablet was granted to MSN laboratories
Private Limited. The Subject Expert Committee (SEC) of
Cardiovascular & Renal, CDSCO, after detailed
deliberation has recommended grant of manufacturing
and marketing permission with local clinical trial (Phase
IV) waiver and submission of Bioequivalence (BE) study
data.
CDSCO issues draft Clinical Trials Rules, 2018
The Central Drugs Standard Control Organization
(CDSCO) has issued the draft Clinical Trials Rules, 2018.
It applies to all new drugs, investigational new drugs for
human use, clinical trial, bioequivalence study,
bioavailability study and Ethics Committee. It will come
in to force after its final publication in the Official Gazette.
This will be under Part XA and Schedule Y of the Drugs
and Cosmetics Rules, 1945, and section 12 and 33 of
the Drugs and Cosmetics Act, 1940. The new
regulations clearly defines features of an academic study,
role of central licensing authority, trial protocol,
biomedical and health research.
Dr Reddy’s recalls over 80,000 bottles of Atorvastatin from US
Dr Reddy’s Laboratories has initiated voluntary recall of
over 80,000 bottles of its drug Atorvastatin Calcium
Tablets 10mg, 20mg and 40mg from the US market due
to quality concerns. Atorvastatin is a drug that blocks the
production of cholesterol and reduces its level in the
blood. According to the USFDA, the reason for the recall
was, “Failed Impurities/Degradations specifications; out-
of-specification results observed for Total Degradation
Impurities during stability.” The product was
manufactured at the drug maker’s Srikakulam plant in
MEDICAL NEWS MEDICALnews
DRUG INFORMATION CENTER HIMACHAL PRADESH STATE PHARMACY COUNCIL LAUREATE INSTITUTE OF PHARMACY, KATHOG. DISTT. KANGRA. HP. 177101,
Toll Free 18001210443 Phone: 09218428042, 9459220253. E-mail: hpspcdic@gmail.com, dic@hpspc.in
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DRUG AND THERAPY BULLETIN
Mukhya Mantri Kshaya Rog Niwaran Yojna
(MMKRNY)
Himachal Pradesh govt. has implemented MMKRNY to
eliminate tuberculosis from state by 2021. The major
objectives of the scheme will be to detect all cases of
tuberculosis and ensure an early action for the treatment
of tuberculosis through DETECT- TREAT- PREVENT-
BUILD mode.
INSPIRE at Laureate
5 days INSPIRE (Innovation in Science Persuit for
Inspired Research) internship program was organized at
laureate Institute of Pharmacy (Jwalamukhi), from 22nd
January to 26th January 2018. Different professors from
different national universities share the knowledge with
students of different schools of Himachal Pradesh and
introduce the students with the future scope of technical
education. MD of Institute Dr. Ran Singh and Principal
Dr. M.S. Ashawat were also present in the program.
National Conference at Laureate
Laureate Institute of Pharmacy (Jwalamukhi) organised
the ICMR and HPTU sponsored National Conference of
two days on topic 'Phytoconstituents: An Advances in
Noval Drug Delivery System' on 30th-31st Jan 2018.
Differnet scientists from different areas of India share
their knowledge as well as their research papers with
s tuden t s and in t r oduce the s tuden t s w i th
phytoconstituents based noval drug delivery systems.
National Seminar at HIPER
Himachal institute of Pharmaceutical education and
Research (HIPER) at Nadaun (Distt. Hamirpur,HP)
organizing ICMR and HPTU sponsored a national
seminar on topic “current status and future scope for
nanomaterials and nanotechnology in drug discovery
and drug development on 23-24 Feb. 2018, aims to
bring together academicians, industrialists, researchers,
and scholars from different regions on a common
plat form to discuss advances and emerging
opportunities in Pharmaceutical sciences.
LOCAL NEWS
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DRUG INFORMATION CENTER HIMACHAL PRADESH STATE PHARMACY COUNCIL LAUREATE INSTITUTE OF PHARMACY, KATHOG. DISTT. KANGRA. HP. 177101,
Toll Free 18001210443 Phone: 09218428042, 9459220253. E-mail: hpspcdic@gmail.com, dic@hpspc.in
IMPORTANCE OF BLOOD DONATION
Blood donation is definitely a noble act. Many clinics
and hospitals constantly require blood for several
purposes. This makes the idea of blood donation a
noble gesture as it provides life-saving help to people
and patients. On an average, human body contains
approximately 4 to 5 liters blood that can be donated
after every third month for men and every 4 months
for women. Many people believe that blood donation is
harmful for their body, however, this is untrue.
A person can donate blood if
between age group of 18-65 years.
weight is 45 kg or more.
haemoglobin is 12.5 gm% minimum.
last blood donation was 3 months earlier.
healthy and have not suffered from malaria, typhoid
or other transmissible disease in the recent past.
A person cannot donate blood if
old / fever in the past 1 week.
under treatment with antibiotics or any other
medication.
cardiac problems, hypertension, epilepsy, diabetes
(on insulin therapy), history of cancer, chronic
kidney or liver disease, bleeding tendencies,
venereal disease etc.
major surgery in the last 6 months.
vaccination in the last 24 hours.
had a miscarriage in the last 6 months or have been
pregnant / lactating in the last one year.
had fainting attacks during last donation.
have regularly received treatment with blood
products.
been tested positive for antibodies to HIV.
Pregnancy and Menstrual Cycle
Females should not donate blood during pregnancy.
They can donate after 6 weeks following a normal
delivery and when they are not breast feeding.
Females should not donate blood if they are having
heavy menstrual flow or menstrual cramps.
Benefits of blood donation
Lower Iron Levels: High iron levels in your blood can
lead to an increased risk of cardiovascular disease and
damaged arteries. Every time you give blood it lowers
your body's iron levels, which lowers your risk of
developing heart disease.
Reduced Risk of Cancer: It is safe to donate blood
every three months for men and every four months for
women. Consistent donations will actually drop your
cancer risk levels each time you donate. Donating
blood has been associated with a lower risk of liver,
lung, colon, stomach, and throat cancers in regular
donors.
Reduced Risk of Heart Attack: Years of regular blood
donation can lower your risk of heart attack by 88%,
as well as reduce your risk of stroke and other
cardiovascular events by 33%.
Replenish Blood: Your body naturally restores and
replenishes blood supplies in the event of blood loss.
Such replenishment can help your body work more
efficiently and stay healthy.
DRUG INFORMATION CENTER HIMACHAL PRADESH STATE PHARMACY COUNCIL LAUREATE INSTITUTE OF PHARMACY, KATHOG. DISTT. KANGRA. HP. 177101,
Toll Free 18001210443 Phone: 09218428042, 9459220253. E-mail: hpspcdic@gmail.com, dic@hpspc.in
8
DRUG AND THERAPY BULLETIN
Which kind of queries can be asked from Drug
Information Center?
It is the matter of pride for all the population of Himachal
Pradesh that there is drug information center (DIC) in the
state which is giving the services to promote the rational
drug use. Maximum population of state knows that there is
DIC, but they are unaware about the services of the DIC.
They all are confused that which kind of queries they can ask.
There is no any restriction to take the drug query
information by any one. Any person (physician, pharmacist,
nurse, patient, people of community, old persons, students,
researchers etc.) can come in or call in the DIC office to take
drug information.
Following kinds of queries regarding drugs can be asked
from DIC:
Ÿ If patient is administering two medicines at the same
time then he/she before administering the medicine,
can confirm from DIC that this combination is safe or not
safe. If combination will be not safe then it may also be
life threatening.
Ÿ If patient is administering a medicine then he/she can
confirm which kinds of foods have to be avoided.
Ÿ Someone can confirm that use of any specific medicine
in particular condition (like as pregnancy/lactation) is
safe or not safe.
Ÿ General information about drug identification can also
be taken from the DIC, like as use and side/adverse
effects , t ime of administrat ion, durat ion of
administration, dose in different age groups etc. about
any drug.
Ÿ Information about substituted drugs with different
prices can also be provided by DIC.
Ÿ Any updation about medicines can be confirmed from
DIC.
DIC will provide the accurate information on request
without any fear and favor. In short, we can say that DIC can
provide any kind of information about any medicine to
anyone without any cost. Personnel can assess directly, can
call in the DIC office, sent the query by post, by E-mail
Toll Free 18001210443, Phone: 09218428042, 9459220253
Scan this Quick Response (QR)
code to know more
You may download any QR code scanner from
Play Store/iTunes
Personnel can assess directly, can call in the DIC office, sent the query by post, by E-mail on following address.
Note: If any want to publish his/her article in the monthly bulletin of Drug Information Center regarding Pharma updates, they can send their articles with their full address and professional status on the following reference before 25th of every month.
Toll Free 18001210443
DRUG INFORMATION CENTER
HIMACHAL PRADESH STATE PHARMACY COUNCIL
Laureate Institute of Pharmacy, Kathog, Jwala Ji, Distt. Kangra HP 177101
Website: www.hpspc.in | Mail ID: hpspcdic@gmail.com, dic@hpspc.in
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