+ All Categories
Home > Documents > DRUG AND THERAPY BULLETIN · (CVP) chemotherapy. Truxima, which is the first biosimilar to...

DRUG AND THERAPY BULLETIN · (CVP) chemotherapy. Truxima, which is the first biosimilar to...

Date post: 09-Aug-2020
Category:
Upload: others
View: 5 times
Download: 0 times
Share this document with a friend
16
H.P. STATE COUNCIL DRUG AND THERAPY BULLETIN HIMACHAL PRADESH STATE PHARMACY COUNCIL Toll Free 18001210443 DRUG INFORMATION CENTER LAUREATE INSTITUTE OF PHARMACY, KATHOG. DISTT. KANGRA. HP. 177101, Toll Free 18001210443 Phone: 09218428042, 9459220253. E-mail: [email protected], [email protected] Contents | Drug Updates Pharma News Pharma Jobs Continuing Pharmacy Education Program Local News Which kind of queries can be asked from Drug Information Center? Issue: 15 Volume: 2 Dec 2018
Transcript
Page 1: DRUG AND THERAPY BULLETIN · (CVP) chemotherapy. Truxima, which is the first biosimilar to Rituxan(R) (rituximab) to gain FDA approval, was approved based on pharmacokinetic, clinical

H.P. STATE

COUNCIL

DRUG AND THERAPYBULLETIN

HIMACHAL PRADESH STATE PHARMACY COUNCIL

Toll Free 18001210443

DRUG INFORMATION CENTER

LAUREATE INSTITUTE OF PHARMACY, KATHOG. DISTT. KANGRA. HP. 177101,Toll Free 18001210443 Phone: 09218428042, 9459220253. E-mail: [email protected], [email protected]

Contents |Drug UpdatesPharma NewsPharma Jobs

Continuing Pharmacy Education ProgramLocal News

Which kind of queries can be asked from Drug Information Center?

Issue: 15 ● Volume: 2 ● Dec 2018

Page 2: DRUG AND THERAPY BULLETIN · (CVP) chemotherapy. Truxima, which is the first biosimilar to Rituxan(R) (rituximab) to gain FDA approval, was approved based on pharmacokinetic, clinical

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: [email protected], [email protected]

2

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

Dextenza for Post-op ocular pain ...........................................................................................................4

Xospata for AML for FL T3 mutation ......................................................................................................4

Truxima: First rituxan Biosimilar ............................................................................................................4

stVitrakvi: 1 TRK inhibitor for advanced tumor.........................................................................................4

Venclexta with chemo for AML ..............................................................................................................5

Daurismo with LDAC for AML ...............................................................................................................5

Adcetris with chemotherapy for PTCL.....................................................................................................5

Aemcolo for Traveller’s Diarrhea ............................................................................................................5

Keytruda now approved for HCC............................................................................................................5

stYupelri: 1 Nebulized bronchodilator for COPD .......................................................................................6

New Emplicicti for combo for MM .........................................................................................................6

Page 3: DRUG AND THERAPY BULLETIN · (CVP) chemotherapy. Truxima, which is the first biosimilar to Rituxan(R) (rituximab) to gain FDA approval, was approved based on pharmacokinetic, clinical

3

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: [email protected], [email protected]

Udenyca: Second neulasta biosimilar .....................................................................................................6

PHARMA NEWS

Chandigarh: Government suspends license of 1,000 chemists in 10 months ..............................................7

Jan Aushadhi shops can replace branded drugs with generics ...................................................................7

Future of Homeopathy lies in standardization ..........................................................................................7

Government plans database of drugs to prevent use of similar brand names ...............................................8

Probiotics not beneficial for young kids with stomach virus .......................................................................8

Antibiotic resistance kills over 50,000 children in India annually...............................................................9

Weightlifting may be good for your heart: Study ......................................................................................9

Disabling and potentially permanent side effects lead to suspension or restrictions of quinolone and

fluoroquinolone antibiotics: EMA ...........................................................................................................9

MoU signed on India-UK Cancer Research Initiative for Affordable Approaches to Cancer...........................10

PHARMA JOBS

Walk in interview for Research Associate at IHBT ..................................................................................11

CSIR Project(s): “Bioprospection of Microbiome from Himalayan Niches.” ................................................11

CSIR Project(s): “Conservation and sustainable resource generation of high altitude bioresources

at CSIR-Centre for High Altitude Biology (NCP)" ....................................................................................11

CONTINUING PHARMACY EDUCATION PROGRAMME

Continuing Pharmacy Education Programme (CPE) for Pharmacy Teachers...............................................12

Continuing Pharmacy Education Programme.........................................................................................12

LOCAL NEWS

Newspaper – Amar Ujala, 30-11-2018................................................................................................13

Newspaper – Amar Ujala, 28-11-2018................................................................................................13

Newspaper – Amar Ujala, 21-11-2018................................................................................................14

Content (Continued)

Page 4: DRUG AND THERAPY BULLETIN · (CVP) chemotherapy. Truxima, which is the first biosimilar to Rituxan(R) (rituximab) to gain FDA approval, was approved based on pharmacokinetic, clinical

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: [email protected], [email protected]

4

DRUG AND THERAPY BULLETIN

DRUG UPDATES

Dextenza for Post-op ocular pain

On December 3, 2018, the US FDA approved

®Dextenza (dexamethasone) ophthalmic extended-

release implant for intracanalicular use indicated for the

treatment of ocular pain following ophthalmic surgery.

Dextenza, which is the first intracanalicular implant to

gain FDA approval, delivers dexamethasone for up to 30

days following a single administration.

Prescribing information can be found at: http://www.

dextenza.com/wp-content /uploads/2018/12/

DEXTENZA-Final-Label-12.1.18.pdf.

Xospata for AML for FL T3 mutation

On November 28, 2018, the US FDA approved

®Xospata (gilteritinib) oral tablets indicated to treat adult

patients who have relapsed or refractory acute myeloid

leukemia (AML) with a FLT3 mutation as detected by an

FDA-approved test. Xospata, which was granted fast

track, priority review, and orphan drug designations, was

approved based on a clinical trial demonstrating a

significant rate of complete remission or complete

remission with partial hematologic recovery in patients

treated with gilteritinib.

Prescribing information can be found at: https://www.

accessdata.fda.gov/drugsatfda_docs/label/2018/2113

49s000lbl.pdf.

Truxima: First rituxan Biosimilar

On November 28, 2018, the US FDA approved

®Truxima (rituximab-abbs) IV injection indicated to treat

adult patients with: 1) relapsed or refractory, low-grade

or follicular, CD20-positive, B-cell non-Hodgkin

lymphoma (NHL) as a single agent; 2) previously

untreated follicular, CD20-positive, B-cell NHL in

combination with first line chemotherapy and, in

patients achieving a complete or partial response to a

rituximab product in combination with chemotherapy, as

single-agent maintenance therapy; and 3) non-

progressing (including stable disease), low-grade,

CD20-positive, B-cell NHL as a single agent after first-

line cyclophosphamide, vincristine, and prednisone

(CVP) chemotherapy. Truxima, which is the first

biosimilar to Rituxan(R) (rituximab) to gain FDA

approval, was approved based on pharmacokinetic,

clinical immunogenicity, and other clinical data

demonstrating that rituximab-abbs is biosimilar to

rituximab.

Prescribing information can be found at: https://www.

accessdata.fda.gov/drugsatfda_docs/label/2018/7610

88s000lbl.pdf.

stVitrakvi: 1 TRK inhibitor for advanced tumor

On November 26, 2018, the US FDA approved

®Vitrakvi (larotrectinib) oral capsules and oral solution

indicated to treat adult and pediatric patients with solid

tumors that have a neurotrophic receptor tyrosine kinase

(NTRK) gene fusion without a known acquired resistance

mutation, are metastatic or where surgical resection is

likely to result in severe morbidity, and have no

satisfactory alternative treatments or that have

progressed following treatment. Vitrakvi, which is the

first tyrosine receptor kinase (TRK) inhibitor to gain FDA

approval, was approved based on pooled data from 3

clinical trials in which larotrectinib demonstrated a 75%

overall response rate across different types of solid

tumors.

Prescribing information can be found at: https://www.

accessdata.fda.gov/drugsatfda_docs/label/2018/2108

61s000lbl.pdf.

Page 5: DRUG AND THERAPY BULLETIN · (CVP) chemotherapy. Truxima, which is the first biosimilar to Rituxan(R) (rituximab) to gain FDA approval, was approved based on pharmacokinetic, clinical

5

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: [email protected], [email protected]

Venclexta with chemo for AML

On November 21, 2018, the US FDA approved a new

®indication for Venclexta (venetoclax) oral tablets in

combination with azacitidine or decitabine or low-dose

cytarabine for the treatment of newly-diagnosed acute

myeloid leukemia (AML) in adults who are 75 years of

age or older, or who have comorbidities that preclude use

of intensive induction chemotherapy. Venclexta, which

was approved under priority review for this indication,

demonstrated efficacy based on the rate and duration of

complete remission in 2 clinical trials.

Prescribing information can be found at : https://www.

accessdata.fda.gov/drugsatfda_docs/label/2018/2085

73s009lbl.pdf.

Daurismo with LDAC for AML

On November 21, 2018, the US FDA approved TMDaurismo (glasdegib) oral tablets in combination with

low-dose cytarabine (LDAC), for the treatment of newly-

diagnosed acute myeloid leukemia (AML) in adult

patients who are 75 years of age or older or who have

comorbidities that preclude use of intensive induction

chemotherapy. In a clinical trial, patients treated with

glasdegib plus LDAC demonstrated a significantly

greater improvement in overall survival compared with

those treated with LDAC alone. Daurismo carries a boxed

warning regarding the potential for embyro-fetal toxicity,

including embryo-fetal death and severe birth defects.

Prescribing information can be found at https://www.

accessdata.fda.gov/drugsatfda_docs/label/2018/2106

56s000lbl.pdf.

Adcetris with chemotherapy for PTCL

On November 16, 2018, the US FDA approved a new

®indication for Adcetris (brentuximab vedotin) IV

injection to treat adult patients with previously untreated

systemic anaplastic large cell lymphoma (sALCL) or

other CD30-expressing peripheral T-cell lymphomas

(PTCL), including angioimmunoblastic T-cell lymphoma

and PTCL not otherwise specified, in combination with

cyclophosphamide, doxorubicin, and prednisone.

Adcetris, which was granted breakthrough therapy and

priority review designations by the FDA, was approved

for this indication based on data from the Echelon-2

clinical trial. This marks the first FDA approval for

treatment of newly diagnosed PTCL.

Prescribing information can be found at : https://www.

adcetrispro.com/pi.

Aemcolo for Traveller’s Diarrhea

On November 16, 2018, the US FDA approved TMAemcolo (rifamycin) oral delayed-release tablets to

treat adult patients with travelers' diarrhea caused by

noninvasive strains of Escherichia coli, not complicated

by fever or blood in the stool. Aemcolo, which was

granted the Qualified Infectious Disease Product

designation by the FDA, demonstrated efficacy in a

clinical trial in which rifamycin significantly reduced

symptoms of travelers' diarrhea compared with placebo.

Prescribing information can be found at http://www.

ariespharma.com/wp-content/ uploads/2018/11/1-

AEM18176-NDA-210910-Approved-PI-11-16-18.pdf.

Keytruda now approved for HCC

On November 9, 2018, the US FDA approved

®Keytruda (pembrolizumab) IV injection indicated to

treat patients with hepatocellular carcinoma (HCC) who

have been previously treated with sorafenib. Keytruda,

which was granted accelerated approval for this

indication, demonstrated efficacy with a significant

overall response rate following treatment with

pembrolizumab in the KEYNOTE-224 trial.

Page 6: DRUG AND THERAPY BULLETIN · (CVP) chemotherapy. Truxima, which is the first biosimilar to Rituxan(R) (rituximab) to gain FDA approval, was approved based on pharmacokinetic, clinical

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: [email protected], [email protected]

6

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 :

https://www.accessdata.fda.gov/drugsatfda_docs/label/

2018/125514s042lbl.pdf.

stYupelri: 1 Nebulized bronchodilator for COPD

TMOn November 9, 2018, the US FDA approved Yupelri

(revefenacin) inhalation solution indicated for the

maintenance treatment of patients with chronic

obstructive pulmonary disease (COPD). Yupelri, which is

the first once-daily bronchodilator to gain approval for

COPD, demonstrated efficacy in a clinical trial in which

patients treated with revefenacin had significant

improvements in trough forced expiratory volume

compared with those treated with placebo.

Prescribing information can be found at: https://www.

accessdata.fda.gov/drugsatfda_docs/label/2018/2105

98s000lbl.pdf.

New Emplicicti for combo for MM

®On November 6, 2018, the US FDA approved Empliciti

(elotuzumab) IV injection for use in combination with

pomalidomide and dexamethasone for the treatment of

adult patients with multiple myeloma (MM) who have

received at least 2 prior therapies, including

lenalidomide and a proteasome inhibitor. Following

priority review, Empliciti was approved for this indication

based on clinical trials in which patients treated with

elotuzumab in combination with pomalidomide and

dexamethasone experienced significantly reduced

disease progression compared with those treated with

pomalidomide and dexamethasone.

Prescribing information can be found at: http://

packageinserts.bms.com/pi/pi_empliciti.pdf.

Udenyca: Second neulasta biosimilar

On November 2, 2018, the US FDA approved TMUdenyca (pegfilgrastim-cbqv) subQ injection indicated

to decrease the incidence of infection, as manifested by

febrile neutropenia, in patients with non-myeloid

malignancies receiving myelosuppressive anti-cancer

drugs associated with a clinically significant incidence of

febrile neutropenia. Udenyca, which is the second

biosimilar to Neulasta(R) (pegfilgrastim) to gain FDA

approval, was approved based on similarity to the

reference drug and pharmacokinetic, pharmaco-

dynamic, and immunogenicity studies.

Prescribing information can be found at: https://www.

accessdata.fda.gov/drugsatfda_docs/label/2018/7610

39s000lbl.pdf

Reference: www.micromedex.com

Page 7: DRUG AND THERAPY BULLETIN · (CVP) chemotherapy. Truxima, which is the first biosimilar to Rituxan(R) (rituximab) to gain FDA approval, was approved based on pharmacokinetic, clinical

7

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: [email protected], [email protected]

PHARMA NEWS

Chandigarh: Government sus-

pends license of 1,000 chemists in 10 months

In its fight against drugs, the Punjab government has

tightened the noose around chemists indulging in

malpractices by suspending licenses of nearly 1,000

shops in the last 10 months. There are nearly 16,000

retail and 8,000 wholesale chemists across the state. A

large number of them have come up in recent years,

especially in rural areas. And these reportedly indulge in

illegal activities such as sale of habit-forming drugs.

From January to October, 8,024 inspections were

conducted and actions against the violators were

initiated under the provisions of the Drugs and Cosmetics

Act, 1940 / Rules 1945. Ninety licenses were

suspended and 12 cancelled due to contraventions

relating to habit-forming drugs. While remaining licenses

were suspended due to general violation, which include

non-availability of pharmacist. According to the drugs

and cosmetic rules, every chemist must have a

pharmacist. However, throwing norms to the winds, a

large number of these shops operate without a

pharmacist. Many were found without proper records

too.

Ref: www.healtheconomics.indiatimes.com

Jan Aushadhi shops can replace branded

drugs with generics

To promote low-cost generic medicines, the

government's top drug regulatory board has allowed Jan

Aushadhi Kendras — which are like fair price shops for

medicines under the Pradhan Mantri Bhartiya

Janaushadhi Pariyojana — to substitute doctor's

prescription with a generic brand. The Drugs Technical

Advisory Board cleared a proposal to amend a rule under

the drugs law. “This proposal asking permission for

chemists to substitute brands prescribed by doctors with

other brands was pending for a very long time. For the

time being, we have allowed only Jan Aushadhi stores to

do so because we want to watch it on a trial basis,” an

official said. So far, chemists were legally not allowed to

replace the brand or the medicine prescribed by a doctor.

The official said allowing all retailers to substitute

medicine brands may open up the market to corruption

as chemists may push brands with higher margin. The

move is also likely to promote Jan Aushadhi stores which

have failed to take off as well as intended in the last few

years. At present, there are over 4,000 Jan Aushadhi

stores.

Ref: www.healtheconomics.indiatimes.com

Future of Homeopathy lies in standardization

Homeopathy has survived the last 200 years despite

opposition from many quarters and is slowly emerging as

the largest system of medicine patronized by

governments and people alike due to safety, efficacy and

standardization of homeopathic practices. From being an

alternative system of medicine, homeopathy has become

a complementary system of medicine and a primary

healthcare choice to treat both acute and chronic

medical conditions. People including allopathic doctors

Page 8: DRUG AND THERAPY BULLETIN · (CVP) chemotherapy. Truxima, which is the first biosimilar to Rituxan(R) (rituximab) to gain FDA approval, was approved based on pharmacokinetic, clinical

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: [email protected], [email protected]

8

DRUG AND THERAPY BULLETIN

are accepting homeopathy like never before. From a

humble beginning with just 200 drugs during

Hahnemann's time, today there are more than

2,000clinically-tested homeopathic medicines in

practice. Its growing popularity can be gauged from the

fact that World Health Organization has recognized it as

the second largest system of medicine in the world. For

the past 250 years, this system of medicine has made a

remarkable journey and has a bright future across the

world. There are multiple factors that have lead to a

resurgence of homeopathy globally. First, thanks to

standardization that is happening at a rapid pace in

developed countries, homeopathy is coming on par with

allopathic medicines. Homeopathy drugs are now pre

medicated, prepackaged, sealed, and labeled which is

proving to be a boon for patients. New packaging tubes

are made of food grade plastic and dispensing has

become hygienic and easier using modern technology.

The trend has just begun and is rapidly catching up.

Ref: www.healtheconomics.indiatimes.com

Government plans database of drugs to

prevent use of similar brand names

The government is considering a databank for all

medicine brands to prevent pharmaceutical companies

from using the same or similar looking and sounding

brand names for drugs, especially those used to treat

different conditions, senior officials close to the

development said. The Drugs Technical Advisory Board

(DTAB), the country's highest drug advisory body, will

discuss a mechanism to this effect at its meeting because

the problem is extensive and spread across the country.

Ref: www.healtheconomics.indiatimes.com

Probiotics not beneficial for young kids with

stomach virus

Children with stomach viruses are often given probiotics

to ease symptoms of vomiting and diarrhea. However, a

new study has found that commonly used probiotic is not

effective in improving symptoms in young patients

with gastroenteritis. The study was led by Washington

University School of Medicine in St. Louis and the

results were published in The New England Journal of

Medicine.

"Probiotics have become an increasingly popular way to

treat children experiencing acute gastroenteritis. Some

smaller studies have indicated that probiotics may help,

however, such studies had a number of limitations. We

sought to provide independent and conclusive evidence

for or against probiotic use in infants and toddlers with

acute gastroenteritis," said the study author David

Schnadower.

“Probiotics had no effect on the children. Parents are

better off saving their money and using it to buy more

fresh fruits and vegetables for their children,” said US

study co-author Phillip I. Tarr. There are no treatments for

pediatric acute gastroenteritis other than giving children

fluids to prevent dehydration and, sometimes,

medication to relieve nausea. The lack of options has

prompted some physicians and parents to give ill

children probiotics.

Probiotics generally are considered safe. However, the

Food and Drug Administration (FDA) does not regulate

Page 9: DRUG AND THERAPY BULLETIN · (CVP) chemotherapy. Truxima, which is the first biosimilar to Rituxan(R) (rituximab) to gain FDA approval, was approved based on pharmacokinetic, clinical

9

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: [email protected], [email protected]

dietary supplements such as probiotics as stringently as

it does prescription and over-the-counter drugs.

"Because of the popularity of probiotics, it was important

to make sure their use is worth the cost. In this instance,

probiotics added no measurable benefit, and, therefore,

they are not worth the added cost," said Schnadower.

Ref: www.healtheconomics.indiatimes.com

Antibiotic resistance kills over 50,000

children in India annually

Antibiotic-resistant infections are spreading wings in

India, killing over 58,000 children every year, while

uncontrolled dumping of untreated urban waste into

water bodies is affecting aquatic life and environment.

With some of the highest antibiotic resistant bacteria

that commonly cause infections in the community and

healthcare facilities, India suffers severely, reminds

Centre for Disease Dynamics Economics and Policy

(CDDEP), as World Antibiotic Awareness Week 2018.

"Every year globally, almost 700,000 lives are lost. More

than 58,000 children die every year in India alone, from

antibiotic-resistant infections," said CDDEP. The

antibiotic resistance is the ability of disease-causing

bacteria and micro-organisms to resist the antibiotics or

medicine due to adaptation.

Ref: www.healtheconomics.indiatimes.com

Weightlifting may be good for your heart: Study

Lifting weights for less than an hour a week may reduce

your risk for a heart attack or stroke by 40 to 70 per cent,

a study has found. The research by Iowa State University

(ISU) in the US also showed that spending more than an

hour in the weight room did not yield any additional

benefit. "People may think they need to spend a lot of

time lifting weights, but just two sets of bench presses

that take less than 5 minutes could be effective," said

Duck-chul Lee, associate professor at Iowa State

University (ISU). You do not have to meet the

recommended guidelines for aerobic physical activity to

lower your risk; weight training alone is enough.

Ref: www.healtheconomics.indiatimes.com

Disabling and potentially permanent side

effects lead to suspension or restrictions of

quinolone and fluoroquinolone antibiotics: EMA

EMA has reviewed serious, disabling and potentially

permanent s ide ef fects wi th quinolone and

fluoroquinolone antibiotics given by mouth, injection or

Page 10: DRUG AND THERAPY BULLETIN · (CVP) chemotherapy. Truxima, which is the first biosimilar to Rituxan(R) (rituximab) to gain FDA approval, was approved based on pharmacokinetic, clinical

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: [email protected], [email protected]

DRUG AND THERAPY BULLETIN

10

inhalation. The review incorporated the views of

patients, healthcare professionals and academics

presented at EMA's public hearing on fluoroquinolone

and quinolone antibiotics in June 2018. EMA's human

medicines committee (CHMP) has endorsed the

recommendations of EMA's safety committee (PRAC)

and concluded that the marketing authorisation of

medicines containing cinoxacin, flumequine, nalidixic

acid, and pipemidic acid should be suspended.

The CHMP confirmed that the use of the remaining

fluoroquinolone antibiotics should be restricted. In

addition, the prescribing information for healthcare

professionals and information for patients will describe

the disabling and potentially permanent side effects and

advise patients to stop treatment with a fluoroquinolone

antibiotic at the first sign of a side effect involving

muscles, tendons or joints and the nervous system.

Ref: www.pharmatutor.org

MoU signed on India-UK Cancer Research

Initiative for Affordable Approaches to Cancer

A Memorandum of Understanding (MoU) for the

partnership between Department of Biotechnology and

Cancer Research UK for the India-UK India-UK Cancer

Research Initiative was signed in New Delhi.

The India-UK Cancer Research Initiative is a

collaborative 5-year bilateral research initiative by the

Department of Biotechnology, Ministry of Science &

Technology, India and Cancer Research UK (CRUK) that

will focus on affordable approaches to cancer. Both

CRUK and DBT will invest £5m each in this 5-year pilot,

and seek further investment from other potential funding

partners.

The India-UK Cancer Research Initiative will identify a

core set of research challenges that address issues of

affordability, prevention and care of cancer by bringing

together leading Indian and UK experts across clinical

research, demographic research, new technologies and

physical sciences. The initiative will provide funding to

develop new research alliances and undertake impactful

research to enable significant progress against cancer

outcomes.

Ref: www.pharmatutor.org

Reference: www.micromedex.com

Page 11: DRUG AND THERAPY BULLETIN · (CVP) chemotherapy. Truxima, which is the first biosimilar to Rituxan(R) (rituximab) to gain FDA approval, was approved based on pharmacokinetic, clinical

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: [email protected], [email protected]

11

PHARMA JOBS

Walk in interview for Research Associate at IHBT

Eligible candidates may appear for “Walk-in-interview(s)” on the dates, time and place mentioned below along with

an application on prescribed format which is available on the CSIR-IHBT website ihbt.res.in along with attested

photocopies of their testimonials of age, educational qualifications, experience, reserved category etc. at the time of

interview. The positions are purely temporary and co-terminus with the duration of the project. There will be no

right implicit or explicit for regular position or any post in CSIR-IHBT, whatsoever. Candidates must also bring with

them original certificates of testimonials at the time of appearing for the interview failing which he/she will not be

allowed to appear for interview. No TA will be paid for attending the interview.

CSIR Project(s): “Bioprospection of Microbiome from Himalayan Niches.”

Research Associate – 01 post

Maximum Age(As on date of interview): 35 years as on 14-12-2018

Stipend (Per Month) [Consolidated]: Rs. 38,000/- p.m. + HRA

Educational Qualification(s) Essential:

Ph.D. in Biotechnology / Microbiology with two years working experience in the area of Microbial genomics.

Tenure of the Project(s): 31-03-2020

CSIR Project(s): “Conservation and sustainable resource generation of high altitude bio-

resources at CSIR-Centre for High Altitude Biology (NCP)"

Research Associate – 04 posts

Maximum Age (As on date of interview): 35 years as on 14-12-2018

Stipend (Per Month) [Consolidated]: Rs. 36,000/- p.m. + HRA

Educational Qualification(s) Essential:

Ph.D. in Biotechnology / Forestry / Botany.

Tenure of the Project(s): 31-03-2020

Page 12: DRUG AND THERAPY BULLETIN · (CVP) chemotherapy. Truxima, which is the first biosimilar to Rituxan(R) (rituximab) to gain FDA approval, was approved based on pharmacokinetic, clinical

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: [email protected], [email protected]

DRUG AND THERAPY BULLETIN

12

Continuing Pharmacy Education Programme

Himachal Pradesh State Pharmacy Council is organinzing first ‘Continuing Pharmacy Education Programme’ for

the registered pharmacist of District Bilaspur (2018-2022) at Shiva Institute of Engineering and Technology,

Chandpur, Bilaspur on 16th December 2018. All the pharmacists of District Bilaspur are informed to participate in

the said programme.

CPE Programme

Continuing Pharmacy Education Programme (CPE) for Pharmacy Teachers

First PCI sponsored CPE of Himachal Pradesh, for Pharmacy teachers, is organizing at Laureate Institute of

Pharmacy Kathog, Jwalamukhi, HP from 6th to 8th January 2019. Thirty (30) participants from different PCI

approved pharmacy institutions and University departments of this region (Himachal Pradesh, Punjab, Haryana,

Chandigah and Rajasthan) can participate in this CPE. Interested members can fill the registration form which

can be downloaded from the web site www.laureateinstitutes.in before 20-12-2018. Registration will be on first

come first serve basis.

Page 13: DRUG AND THERAPY BULLETIN · (CVP) chemotherapy. Truxima, which is the first biosimilar to Rituxan(R) (rituximab) to gain FDA approval, was approved based on pharmacokinetic, clinical

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: [email protected], [email protected]

13

LOCAL NEWSPAPERS

Reference:

Amar Ujala, 30-11-2018

Reference:

Amar Ujala, 28-11-2018

Page 14: DRUG AND THERAPY BULLETIN · (CVP) chemotherapy. Truxima, which is the first biosimilar to Rituxan(R) (rituximab) to gain FDA approval, was approved based on pharmacokinetic, clinical

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: [email protected], [email protected]

DRUG AND THERAPY BULLETIN

14

Reference:

Amar Ujala, 21-11-2018

Page 15: DRUG AND THERAPY BULLETIN · (CVP) chemotherapy. Truxima, which is the first biosimilar to Rituxan(R) (rituximab) to gain FDA approval, was approved based on pharmacokinetic, clinical

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

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: [email protected], [email protected]

15

Page 16: DRUG AND THERAPY BULLETIN · (CVP) chemotherapy. Truxima, which is the first biosimilar to Rituxan(R) (rituximab) to gain FDA approval, was approved based on pharmacokinetic, clinical

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: [email protected], [email protected]


Recommended