drug and therapy bulletin - hpspc.in · drug and therapy bulletin himachal pradesh state pharmacy...

DRUG AND THERAPYBULLETIN

HIMACHALPRADESHSTATEPHARMACYCOUNCIL

DRUGINFORMATIONCENTER

LAUREATE INSTITUTE OF PHARMACY, KATHOG, DISTT. KANGRA, HP - 177101

Toll Free : 18001210443 |Phone: 9218428042/9459220253|E-mail: [email protected]/[email protected]

Toll Free: 18001210443

Issue 18|Volume 3|March 2019

ContentsDrug Updates

Pharma News

Pharmacist Result

Local News

Noble Prize in Physiology or Medicine, 2018

1

DRUG AND THERAPY BULLETIN

Content

EDITORIAL

AdvisoryBoard

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.RakeshChandel,Mr.PraveenUpadhya,Mr.KamashwarChauhan,Mr.LokeshKumar,Mr.VishalKumar,

Mr.Y.S.Chandel,Mr.BirbalSharma,Mr.ManojKumar,Mr.YogeshVerma,Mr.SurenderNadda,Dr.Parshuram

Patron

Mr.GopalKrishanSharmaandDr.RanSingh

Editor-in-Chief

Dr.KamleshNaikandDr.M.S.Ashawat

Co-Editors

Dr.VinayPanditandMr.AnkushSharma

Drug Updates

FDA:UloricCVdeathBBW...........................................................................................................................................................3

EsperoctforHemophiliaA...........................................................................................................................................................3

Keytruda:AdjuvantforMelanoma............................................................................................................................................3

Egatenforfascioliasis............................................................................................................................................................................................3

Darzalex:Newsplitdosingregimen........................................................................................................................................3

CabliviforaTTP.................................................................................................................................................................................4

Pharma News

Governmentbrings42non-scheduledcancerdrugsunderpricecontrol.................................................................4

FDAadvancesnewproposedregulationtomakesurethatsunscreensaresafeandeffective.....................4

DRUG INFORMATION CENTER HIMACHAL PRADESH STATE PHARMACY COUNCIL

Laureate Institute of Pharmacy, Kathog, Distt Kangra, HP - 177101


2

Content (Continued)SCexemptspainkillerSaridonfromthebannedlistinIndia........................................................................................5

MinistryofAYUSHintroducednewCentralSectorschemeforpromotingPharmacovigilanceofAYUSH

Drugs.....................................................................................................................................................................................................5

FDAauthorizes�irstinteroperableinsulinpumpintendedtoallowpatientstocustomizetreatment

throughtheirindividualdiabetesmanagementdevices................................................................................................6

PharmacistResult

PharmacistResult..................................................................................................................................................7,8,9,10,11,12

LocalNews

LocalNews................................................................................................................................................................................14,15




NoblePrizeinPhysiologyorMedicine,2018

NoblePrizeinPhysiologyorMedicine,2018..............................................................................................................13,14

3

Drug Updates

FDA:UloricCVdeathBBW

OnFebruary21,2019,theUSFDAhasconcluded

thatthereisanincreasedriskofdeathwithUloric

(febuxostat) oral tablets compared with

allopurinol, another gout drug. In the CARE

clinical trial, therewas a signi�icant increase in

cardiovascular(CV)deathandoverallmortalityin

patientstreatedwithUloriccomparedwiththose

treatedwithallopurinol.Asaresult,theFDAhas

required an update to the Uloric prescribing

informationtorequireablackboxwarning(BBW)

andanewpatientmedicationguide.Inaddition,

the approved use of Uloric is being limited to

certainpatientswhoarenottreatedeffectivelyor

experienceseveresideeffectswithallopurinol.

P re s c r i b i n g i n f o rma t i on c an b e f o und a t :

http://general.takedapharm.com/content/�ile/pi.pdf ?�

iletypecode=ULORICPI.




EsperoctforHemophiliaA

On February 19, 2019, the US FDA approved

Esperoct(R) (antihemophilic factor (recombinant),

glycopegylated-exei) IV injection for the treatment of

adult and pediatric patients with hemophilia A

(congenital factor VIII deficiency) for routine

prophylaxis to reduce the frequency of bleeding

episodes, on-demand treatment and control of

bleeding episodes, and perioperative management

of bleeding. Approval was based on a clinical trial in

which Esperoct provided effective routine prophylaxis

in patients with severe hemophilia A and showed

efficacy in the treatment of bleeding episodes and

perioperative management. Esperoct has an

extended half-life in adult and pediatric patients

compared with standard factor VIII products.

P r e s c r i b i n g i n f o r m a t i o n c a n b e f o u n d

at:https://www.fda.gov/downloads/BiologicsBloodVac

cines/UCM631602.pdf.


Keytruda(R)(pembrolizumab)IVinjectionforthe

adjuvant treatment of patients with melanoma

with involvement of lymph node(s) following

complete resection. Keytruda, which is already

approved for 3 other melanoma indications,

demonstrated signi�icant recurrence-free

surviva l compared with p lacebo in the

EORTC1325/KEYNOTE-054trial.

Prescribinginformationcanbefoundat:

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

l/2019/125514s040lbl.pdf.

Keytruda:AdjuvantforMelanoma

Egatenforfascioliasis


Egaten(R)(triclabendazole)oraltabletstoforthe

treatment of fascioliasis in adult and pediatric

patients6yearsofageorolder.Egatenistheonly

FDA-approved drug and the on ly drug

recommended by World Health Organization

(WHO)forfascioliasis,commonlyknownasliver

�lukeinfestation.



l/2019/208711s000lbl.pdf.

4




Darzalex:Newsplitdosingregimen

On February 12, 2019, the US FDA approved a

s p l i t - do s i n g re g imen fo r Da r z a l ex (R )

(daratumumab) IV injection for patients with

multiplemyeloma.Thisnewdosingregimenfor

Darzalex, which provides an option to split the

�irstdoseover2consecutivedays,wasapproved

basedondatafromthePhase1bEQUULEUStrial

in which daratumumab concentrations were

similarafterweeklydosingwhengivenasasingle

�irstinfusionorsplitinfusion.



l/2019/761036s016lbl.pdf.

CabliviforaTTP


Cablivi(R) (caplacizumab-yhdp) IV or subQ

injection indicated for the treatment of adult

p a t i e n t s w i t h a c q u i r e d t h r om b o t i c

t h rombocy topen i c purpura ( aTTP) , i n

combination with plasma exchange and

immunosuppressivetherapy.Cablivi,whichisthe

�irst targeted treatment that inhibits blood clot

formation,demonstratedef�icacyinaclinicaltrial

inwhichplateletcountsimprovedmorequicklyin

patients treated with caplacizumab-yhdp

comparedwiththosetreatedwithplacebo.

P re s c r i b i n g i n f o rma t i o n c an b e f o und a t :


l/2019/761112s000lbl.pdf.

Ref:www.micromedexsolutions.com

Pharma News

The government said it has brought 42 non-

scheduledanti-cancerdrugsunderpricecontrol,

cappingtrademarginat30percent,whichwould

reducetheirretailpricesbyupto85percent.The

National Pharmaceutical Pricing Authority

(NPPA) has invoked extraordinary powers in

publicinterest,underPara19oftheDrugs(Prices

Control)Order,2013tobring42non-scheduled

anti-cancer drugs under price control through

trade margin rationalisation, an of�icial release

said.

"Invoking paragraph 19 of DPCO, 2013, the

governmentherebyputsacapontrademarginof

30percentanddirectsmanufacturersto�ixtheir

retailpricebasedonpriceat�irstpointofsaleof

product... of the non-scheduled formulations

containinganyofthe42drugs,"theDepartmentof

Pharmaceuticals (DOP)said inanoti�ication.As

per data availablewith NPPA, theMRP for 105

brandswillbereducedupto85percententailing

minimumsavingofRs105croretoconsumers,it

added.Currently,57anti-cancerdrugsareunder

pricecontrolasscheduledformulations.Now42

non-scheduledanti-cancermedicineshavebeen

selectedforpriceregulationbyrestrictingtrade

marginon the sellingprice (MRP)up to30per

cent,thenoti�icationsaid.

Ref:www.health.economictimes.indiatimes.com

Governmentbrings42non-scheduledcancer

drugsunderpricecontrol

FDAadvancesnewproposedregulationtomakesurethatsunscreensaresafeandeffective

TheU.S.FoodandDrugAdministration issueda

5




proposed rule that would update regulatory

requirementsformostsunscreenproductsinthe

UnitedStates.

This signi�icant action is aimed at bringing

nonprescription, over-the-counter (OTC)

sunscreens that are marketed without FDA-

approvedapplicationsuptodatewiththelatest

sciencetobetterensureconsumershaveaccessto

safeandeffectivepreventativesuncareoptions.

Among its provisions, the proposal addresses

sunscreenactiveingredientsafety,dosageforms,

and sun protection factor (SPF) and broad-

spectrumrequirements.Italsoproposesupdates

tohowproductsarelabeledtomakeiteasierfor

consumerstoidentifykeyproductinformation.

SCexemptspainkillerSaridonfromthebannedlistinIndia

In a major relief for Piramal Enterprises, the

SupremeCourtexemptedpainkillerSaridonfrom

t h e l i s t o f b a nn ed FDC s ( F i xe d D o s e

Combinations)inIndia.

Thehealthministryhadbannedthemanufacture,

sale and distribution of 328 � ixed dose

combinations(FDCs)ofdrugsinSeptemberlast

year. The ban included popular drugs like

painkiller Saridon, skin cream Panderm,

combination diabetes drug Gluconorm PG,

antibioticLupidicloxandantibacterialTaximAZ.

Severalpopularcoughsyrups,painkillersandcold

medicinesarecombinationdrugs,containingtwo

ormoretherapeuticingredientsinasingledose.

Saridon is marketed by Piramal to treat

headaches. The tablet is the largest selling

painkiller in India with sales of nearly Rs 100

crore.

Ref:www.health.economictimes.indiatimes.com

MinistryofAYUSHintroducednewCentralSectorschemeforpromotingPharmacovigilanceofAYUSHDrugs

MinistryofAYUSHintroducednewcentralSector

scheme for promoting pharmacovigilance of

Ayurveda, Siddha, Unani and Homoeopathy

(ASU&H)Drugs.Primeobjectiveoftheschemeis

to develop the culture of documenting adverse

effects and undertake safety monitoring of

Ayurveda,Siddha,UnaniandHomoeopathydrugs

and surveillance of misleading advertisements

appearingintheprintandelectronicmedia.The

Standing Finance Committee (SFC) chaired by

Secretary (AYUSH) approved the schemeon1st

November,2017andthereafteritwasrolledout

forimplementationinthecountryneartheendof

�inancialyear2017-18.

Theschemeintendstofacilitatetheestablishment

o f t h r e e - t i e r n e t w o r k o f N a t i o n a l

PharmacovigilanceCentre(NPvCC),Intermediary

Pharmacovigilance Centres (IPvCCs) and

Peripheral Pharmacovigilance Centres (PPvCC).

All India Institute of Ayurveda, New Delhi, an

autonomousbodyundertheMinistryofAYUSH,

h a s b e e n d e s i g n a t e d a s N a t i o n a l

Pharmacovigilance Centre for coordinating

various activities of the initiative. In the initial

phase of implementation, �ive (05) National

Institutes of AYUSH are designated as the

Intermediary Pharmacovigilance Centres and

forty two (42) institutions of AYUSH having

6




clinical facilities as Peripheral Pharmacovigilance Centres to take up the work of reporting,

documentation,analysis,causalityassessmentoftheadversereactionsandeventsassociatedwiththe

consumption ofAyurveda,Unani, Siddha andHomoeopathydrugs. It is intended to havemore such

centresacrossthecountryandachievethetargetof100peripheralpharmacovigilancecentresby2020.

Ref:www.pharmatutor.org

TheU.S.FoodandDrugAdministration permittedmarketingoftheTandemDiabetesCaret:SlimX2

insulinpumpwithinteroperabletechnology(interoperablet:SlimX2)fordeliveringinsulinunderthe

skinforchildrenandadultswithdiabetes.Thisnewtypeofinsulinpump,referredtoasanalternate

controllerenabled(ACE)infusionpump,orACEinsulinpump,isthe�irstinteroperablepump,meaningit

canbeusedwithdifferentcomponentsthatmakeupdiabetestherapysystems,allowingpatientstotailor

theirdiabetesmanagement to their individualdevicepreferences.Diabetes therapy systemsmaybe

comprisedofanACEinsulinpumpandothercompatiblemedicaldevices,includingautomatedinsulin

dosing(AID)systems,continuousglucosemonitors(CGMs),bloodglucosemetersorotherelectronic

devicesusedfordiabetesmanagement.

Ref:www.pharmatutor.org

FDAauthorizes�irstinteroperableinsulinpumpintendedtoallowpatientstocustomizetreatmentthroughtheirindividualdiabetesmanagementdevices

7




Pharmacist Result

HimachalPradeshStaffSelectionCommissionhascompiledthe�inalresultof142postsofPharmacist

(Allopathy)(oncontractbasis)PostCode-586onthebasisofthemarksobtainedinwrittenobjectivetype

screeningtestandevaluationprocess.ThecandidatesbearingthefollowingRollNumbers have been

declaredsuccessful:-

Sr. No. Roll No. Name Total Marks

1

2

3

4

5

6

7

8

9

10

11

12

13

14

15

16

17

18

586000016

586000049

586000101

586000155

586000169

586000170

586000212

586000275

586000465

586000531

586000594

586000611

586000627

586000661

586000671

586000725

586000740

586000764

SUSHMA

PRATIBHAKUMARI

SUMANKUMAR

SUNILKUMAR

ANJULKUMAR

KISHORILAL

SHALINIKUMARI

NEERAJ

SANDEEPSHANDIL

KANHIEYASHARMA

ANJALISHARMA

AJAYSINGH

TILAKRAJ

DEEPIKARANI

MONIKABHARDWAJ

AMITKUMAR

50.92

46.22

55.14

56.71

54.82

46.64

46.1

52.16

46.03

43.88

50.61

46.62

46.99

53.38

50.25

45.62

52.15

49.52

ASHWANIKUMAR

RANBIRSINGH

8




19

20

21

22

23

24

25

26

27

28

29

30

31

32

33

34

35

36

37

38

39

40

41

42

AKHILESHKUMAR

ANUPRIYA

VINAYKUMAR

KARAMJEETSINGH

SWATISHARMA

CHANDERREKHA

NIKHLESHSINGH

47.57

44.45

45.22

53.7

54.42

53.58

67.02

586000786

586000986

586000997

586001058

586001081

586001083

586001092

586001123

586001177

586001274

586001283

586001288

586001352

586001355

586001521

586001539

586001542

586001627

586001661

586001663

586001686

586001695

586001728

586001785

MONIKADEVI

BOBYJASWAL

SURINDERKUMAR

KUMARIRANIDEVI

VINODKUMAR

LALITGULERIA

DIPIMACHAUDHARY

DEEPMALA

JYOTIKAUDAL

SAVITADEVI

UMESHKUMAR

DEEPSHIKHASHARMA

ANKAJKAUNDAL

REETIKADADIAL

RAGHAVDOGRA

ARCHANAKASHYAP

ANJU

53.05

46.03

55.67

43.98

46.17

61.43

48.43

48.84

44.29

44.75

45.93

53.21

50.76

47.3

53.54

44.32

46.81

9




43

44

45

46

47

48

49

50

51

52

53

54

55

56

57

58

59

60

61

62

63

64

65

66

586001811

586001821

586001823

586001883

586001908

586001918

586001936

586001955

586002028

586002067

586002122

586002138

586002152

586002198

586002281

586002283

586002345

586002347

586002350

586002508

586002617

586002671

586002920

586003013

ISHABHARTI

ANITARANI

SUDHIRKUMAR

AMANSINGH

MAMTAPALIA

SHIKHACHOUDHARY

AJAYKUMAR

SWATI

GOPAL

BHUPINDERSINGH

RAHULSHARMA

SUNNYRANA

NEHADHIMAN

SAMRIDHIBUGWAN

POOJARANI

GOVILSHARMA

KUSHMADEVI

SHAILJA

NITINDHIMAN

BALKRISHAN

RAJEEVBHARTI

TANZINDOLKER

BHIMIKUMARI

AJAYKUMAR

56.37

51.67

45.72

45.7

43.25

51.97

49.52

46.62

46.33

52.66

63.42

54.57

46.68

57.97

51.04

55.74

52.22

46.77

42.13

45.67

46.41

44.96

50.3

46.59

10




67

68

69

70

71

72

73

74

75

76

77

78

79

80

81

82

83

84

85

86

87

88

89

90

586003048

586003079

586003122

586003172

586003193

586003225

586003242

586003286

586003380

586003482

586003489

586003509

586003512

586003549

586003582

586003594

586003596

586003602

586003614

586003741

586003766

586003777

586003802

586003811

CHANDRIKAKUMARI

ANJANAKUMARI

OMPRAKASH

VINAYKUMAR

RAVISINGH

ASHOKKUMAR

LUDERMANI

CHATTARSINGH

CHATTERSINGH

NEELAMRAJ

RAKESHKUMAR

TAPENDERKUMAR

RAVIKUMAR

ANILKUMAR

VANDANASHARMA

POOJADEVI

VINAYDHATWALIA

BHIMSINGH

REENAKUMARI

BABITADEVI

PRAJJUALMAKHAIK

SOHANLAL

MANOJKUMAR

SHASHIBALA

55.56

54.49

54.79

60.04

44.75

45.76

53.4

47.35

54.17

54.77

47.8

49.94

40.92

58.15

45.26

56.35

53.92

54.47

56.03

61.37

57.42

54.01

45.93

46.75

11




91

92

93

94

95

96

97

98

99

100

101

102

103

104

105

106

107

108

109

110

111

112

113

114

586003860

586003921

586003934

586003945

586003984

586004032

586004312

586004469

586004540

586004559

586004628

586004692

586004729

586004785

586004850

586004878

586004887

586004915

586004919

586004956

586004962

586004979

586005046

586005049

ROHIT

AARTI

RAVINDERSINGH

PREETI

RUCHIMISTA

DEEPASHARMA

BALDEVSINGH

SHIVANIDEVI

KANCHANSHARMA

RAKESHKUMAR

ARCHANATHAKUR

CHETNAJHAGTA

SAMMIKUMAR

PRAMODKUMAR

RAMANKUMAR

VEENA

RUPINDERKAUR

VISHALCHAUHAN

DAISYBANSAL

DALEEPKUMAR

SANDEEPKUMAR

UDAYVEERSINGHTHAKUR

NAVEJANSARI

BHUMIKAMANGLA

46.14

56.43

56.08

54.93

41.35

57.12

45.18

46.36

52.26

60.73

54.91

53.37

56.99

46.48

42.08

47.89

44.31

52.12

52.81

45.98

47.16

55.03

56.26

58.43

12




115

116

117

118

119

120

121

122

123

124

125

126

127

128

129

130

131

132

133

134

135

136

137

138

139

586005210

586005247

586005373

586005414

586005433

586005440

586005476

586005532

586005669

586005720

586005795

586005821

586005916

586005969

586006000

586006017

586006020

586006083

586006322

586006367

586006386

586006416

586006469

586006562

586006630

BINDIA

CHIRAG

MEENADEVI

MANJEETSINGH

RANJANATHAKUR

SHIVANI

RUCHIKASHARMA

POONAMJINTA

DINESHKUMAR

NITIKAKASHYAP

NEHA

RAJESHKUMAR

NISHA

PREETI

POONAMNEGI

JYOTI

VEENITKUMAR

RAJATKUMAR

POOJARANI

INDUBALA

AKANKSHARATTAN

MOHAMMADTAHIR

NIKITADEVI

POONAMKUMARI

SANDEEPSINGH

47.33

62.54

63.75

49.97

52.36

54.72

46.3

51.75

41.28

50.86

48.4

46.07

55.99

53.85

48.44

43.97

53.42

49.1

48.87

44.81

47.77

48.26

45.62

55.82

44.58

13




Total:139Candidates.

03posts{OBC(WFF)=02&SC(WFF)=01}categoryhavebeenremainedvacantduetononavailability

ofcandidates.

Theresultisalsoavailableontheof�icialwebsiteoftheHPSSC,Hamirpur.(http://www.hpsssb.hp.gov.in).

Noble Prize in Physiology or Medicine, 2018

The2018NobelPrizeinPhysiologyorMedicinewasawardedtoJamesP.AllisonandTasukuHonjofor

discoveriesthathaveledtonewmedicinesthatactivatetheimmunesystemanddriveitto�ightcancers.

Thesetherapiescandefeateventhedeadliestmalignancies.Todate,ourbest tools for treatingaggressivecancers thathavespreadbeyondtherangeofcurative

surgeryhavebeenradiationtherapyandsystemicchemotherapyagents.Tounderstandthesigni�icance

ofAllisonandHonjo’sdiscoveries,onemustappreciateresearchershavebeentryingtorallyapowerful

immuneresponseagainsttumorcellsforthepastcentury.PriortoAllisonandHonjo’swork,researchers

believed that aggressive cancers grewunchecked because the immune responsewas tooweak. The

consensuswasthatifonecouldstimulatetheimmunesystem,itwouldrespondanddestroytheinvasive

tumorcells.AllisonandHonjo,however,madeacriticalleapwhentheycharacterizedtwoveryimportant

andpotentpathways–called“immunecheckpoints”–thatcanshutdowntheimmuneresponse.These

pathways inhibitTcells–whitebloodcells thatarechargedwithdestroyingvirus-infectedcellsand

tumorcells–andpreventthemfrom“seeing”andattackingthetumor.AllisonandHonjoidenti�iedand

characterizedtwodifferentproteins,calledCTLA-4andPD-1,respectively,thatsitonthesurfaceofT-

cells.Whentheseproteinsinteractwithmatchingproteinsontumorcellsorotherimmunecells–theway

akey�itsalock–theT-cellsfallinto“sleepmode”anddon’tattackthetumor.Inmanypatientswithcancer,theseCTLA-4andPD-1pathwaysshutdownanti-tumorimmuneactivity.

Withoutimmunesurveillance,thetumorsgrowandspread.Thismeantthatourearlyattemptstoactivate

14




theimmunesystemwereliketryingtodriveacarwiththebrakepedalpressedtothe�loor.Nomatterhow

wetried,orsteppedonthegas,thebrakesthwartedanyprogress.ButAllisonandHonjo’sresearchledto

the development of a new type of drug:monoclonal antibodies that block the regulatory pathways

controlledbyCTLA-4andPD-1.Thesedrugs,calledimmunecheckpointinhibitors,basicallyattachtothe

CTLA-4andPD-1proteinsandpreventthemfromswitchingofftheT-cells.Thesenewantibody-drugs

haveledtodramatictumorregressions.TheresultsaresoimpressivethattheFDAhasapprovedtheiruse

foravarietyof advancedcancers suchas:metastaticmelanoma, lungcancer,kidneycancer,bladder

cancer,headandneckcancers,andothertumors.

Ref:www.google.com

Local News

Ref: Amar Ujala, 14-02-2019

15




Ref:AmarUjala,20-02-2019

Ref:AmarUjala,28-02-2019

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