Vol. 1 Issue. 1August – November 2015

Contents

Vision :"We care..... God cures......."

Mission :To work towards aknowledge society with a lifein abundance, throughscience and technology,improving health care of ourimmediate community, state,country and the world atlarge.

H.G. Rev. Dr. Thomas Mar KoorilosMetropolitan Archbishop of TiruvallaCatholic Archdiocese of Tiruvalla

Our Patron1. Article by

Dr. Manu Krishnan

2. Article byM.Surulivelrajan

3. Article byMs. Sissy Aloysia

4. Article byMs. Jancy Kuruvila

5. Article byMrs.Rani Manju

6. Drugs Banned inIndia

7. Department News

H.E. Rev. Dr. Philipose Mar Stephanos(Auxiliary Bishop of Tiruvalla)

Vice President

CEO's MESSAGEIam extremely delighted to know thatPushpagiri College of Pharmacy isreleasing a special newsletter oriented onClinical Pharmacy practice services. Thisnewsletter is a product of an excellentteam work with dedication, determination

and discipline. Wishing you a grand success.

FROM THE DIRECTORIam very happy to know that PushpagiriCollege of pharmacy is bringing out anewsletter from the department ofPharmacy Practice which highlights theclinical pharmacy oriented services.

Rev. Fr. Mathew Vadakkekuttu(Director Medicity)

FROM THE DIRECTOR OF ACADEMICSI take this opportunity to congratulateall the devoted hands who worked behindthis endeavor and I wish all the successto Clinical Pharma Practice News Echo.

Rev. Dr. Mathew MazhavancherilChief Advisor & Director- Academics & Research

Rev. Dr. Shaji Mathews Vazhayil(Chairman & Chief Executive)

FROM THE PRINCIPAL’S DESKFrom the depth of my heartIam very contended to declarethat the Pharmacy practicedepartment of our college isreleasing the first issue ofClinical Pharma Practice NewsEcho. Heartful congratulations

and appreciation for the teammembers for putting this forward.

Prof. Dr. Mathew George,Principal

FROM THE EDITORIAL ADVISORY BOARD

It’s my immense pleasure tocongratulate the editorial teammembers for releasing theClinical Pharma Practice NewsEcho which reflects the

Pharmacy practice activities inenhancing better pharmaceuticalcare to the society.

Prof. Dr. Lincy Joseph, HOD(Department of Pharmaceutical

Chemistry)

An official publication of the Department of Pharmacy Practice, Pushpagiri College of Pharmacy, Thiruvalla, Pathanamthitta (Dist.) KeralaPh: 0469-2645450 Email: pcppharmacypracticenewsletter@gmail.com

EDITOR’S DESKWe, the editorial committee have great privilege on releasing the first issue of our Clinical Pharmacy Practice news letter of PushpagiriCollege of Pharmacy. This news letter covers the information related to the clinical practice activities and achievements in department ofPharmacy Practice. Clinical pharmacy is concerned with the science and practice of rational medication use. The practice of clinicalpharmacy embraces the philosophy of pharmaceutical care; it blends a caring orientation with specialized therapeutic knowledge,experience, and judgment for the purpose of ensuring optimal patient outcomes. The overall goal of clinical pharmacy activities is topromote the correct and appropriate use of medicinal products and devices. We extend our sincere thanks to all the devoted handsworked behind this venture. Please drop your valuable suggestions and feedback at: pcppharmacypracticenewsletter@gmail.com.

Advisory Board

Rev. Dr. Mathew MazhavancherilChief Advisor &Director of Academics & Research

Rev. Fr. Mathew VadakkekuttuDirector, Medicity

Prof. Dr. Mathew GeorgePrincipal

Prof. Dr. Lincy JosephHOD. Dept of Pharm. Chemistry

Dr. K. Sujith

Chief EditorMrs. Rani Manju

22

There are increases in glomerular capillary pressure(Intraglomerular hypertension) in alterations in renalstructure and function. Direct effects ofhyperglycemia on the actin cytoskeleton of renalmesangial and vascular smooth-muscle cells as wellas diabetes-associated changes in circulating factorssuch as atrial natriuretic factor, angiotensin II, andinsulin-like growth factor (IGF) may account for this.

Dr. Manu KrishnanMBBS, MD, DM

Diabetic Nephropathy

It is the single most common cause of chronic renalfailure in the United States.

The thickening of the Glomerular basementmembrane (GBM) is a sensitive indicator for thepresence of diabetes but correlates poorly with thepresence or absence of clinically significantnephropathy. Composition of the GBM is alterednotably with a loss of heparan sulfate moieties thatform the negatively charged filtration barrier.

All are true regarding Diabetic Nephropathy except that thethickening of the GBM correlates well with the presence or absence of

clinically significant nephropathy.

Polyol Pathway - The role of polyols indiabetic complicationsThis has been assessed with aldose reductaseinhibitors, such as sorbinil, tolrestat, and ponalrestat.They have shown promise in preventing diabeticcataracts and improving or stabilizing diabeticneuropathy.Hexosamine PathwayThis pathway enhances transcription of keymediators, such as TGF-â1 and plasminogen activatorinhibitor. The Glucosamine-mediated modificationof the enzyme Akt/PKB reduces expression ofendothelial NOS and promotes apoptosis of cells.Protein Kinase C (PKC) PathwayIn this pathway, hyperglycemia have been attributedto activation of PKC, a family of serine - threoninekinases that regulate diverse vascular functions. PKCwas detected in almost all types of cells and tissuesin the body. The activation of PKC is involved in thesignal regulation of many physiological andpathological processes. PKC-â–selective inhibitorameliorated glomerular hyperfiltration,albuminuria, and renal TGF-â overexpression as wellas extracellular matrix accumulation. Recent findingssuggest that isoform-specific PKC inhibitors arepotentially beneficial to the prevention or treatmentof some common diseases, including cancers anddiabetic vascular complications. Safety and efficacystudies of the PKC inhibitors will be requiredthrough large-scale long-term clinical trials.

2

Protein Kinase C (PKC) Pathway

Many of the adverse effects of hyperglycemia havebeen attributed to activation of PKC. The activity ofPKC, especially the membrane-bound form, isincreased in the retina, aorta, and heart.

The goals of treatment for diabetic nephropathy areaimed to slow the progression of kidney damage andcontrol related complications. Diabetic nephropathyis the most common cause of end-stage kidney disease,which may require hemodialysis or even kidneytransplantation. It is associated with an increased riskof death in general, particularly from cardiovasculardisease. It is expected that the number of people withdiabetes and consequently diabetic nephropathy willrise substantially by the year 2050.

Evolving RolE of CliniCal PhaRmaCist inthE Changing hEalth CaRE sCEnaRio

M.Surulivelrajan, M.Pharm, PhDAssociate Professor, Deparmtment of Pharmacy Practice,Manipal College of pharmaceutical Sciences,Manipal University, Karnataka

Clinical Pharmacy concept is established well inwestern countries. In the Indian context, this conceptis gaining attention in the past decade. Postgraduatelevel education in pharmacy practice is establisheda decade back and Pharm.D curriculum isintroduced a few years back. But the hospitals andhealth care centres are reluctant to appoint clinicalpharmacists. Most of the graduates either left togreener pastures abroad or got into jobs in theindustrial sector.

In the recent past, few positive changes arehappening in the health care sectors. For any healthcare setting to grow in the present day scenario thereis a need to go for national and international levelaccreditations. In the national level NABH is themajor accreditation body. In the international levelJAC is the major body. Hospitals having theseaccreditations are well placed to receive patientsreferred by various insurance companies and as wellas international patients. So, many of the largecorporate hospitals are taking steps to get accreditedby these agencies.

These accrediting bodies have focus on the qualityof service delivery. One of their main focus will beon the medication management and safety. They are

expecting the hospitals to have medication reviewprocess and document safety issues. They stress onthe adverse event documentation systems, medicationerror documentation, and methods to reducemedication errors. They expect documentation andprevention of dispensing errors in the pharmacy.

The requirements of accrediting agencies in the areaof medication related issues have opened an avenuefor clinical pharmacists. Many of the hospitals arelooking for suitable candidates to take care of theseroles as required by the agencies. Aspiring clinicalpharmacists should be aware of the evolving scenarioand get trained adequately in these areas. This will helpthem getting a place inside the health care setting.Such an entry will pave the way for professional growthof clinical pharmacy in future. Let us all hope, thisevolving scenario shall unfold for the benefit of ourprofession.

44

RECENTLY APPROVED DRUGS BY FDA

The U.S. Food and Drug Administration approvedUnituxin (dinutuximab) as part of first-line therapyfor pediatric patients with high-risk neuroblastoma, atype of cancer that most often occurs in youngchildren. Neuroblastoma is a rare cancer that formsfrom immature nerve cells. It usually begins in theadrenal glands but may also develop in the abdomen,chest or in nerve tissue near the spine. Neuroblastomatypically occurs in children younger than five years ofage. According to the National Cancer Institute,neuroblastoma occurs in approximately one out of100,000 children and is slightly more common inboys. Patients with high-risk neuroblastoma have a40 to 50 percent chance of long term survival despiteaggressive therapy.MECHANISM OF ACTION

Unituxin (dinutuximab) binds to the glycolipidGD2. This glycolipid is expressed on neuroblastomacells and on normal cells of neuroectodermal origin,including the central nervous system and peripheralnerves. Dinutuximab binds to cell surface GD2 andinduces cell lysis of GD2- expressing cells throughantibody-dependent cell-mediated cytotoxicity(ADCC) and complement-dependent cytotoxicity(CDC).

RECOMMENDED DOSEThe recommended dose of Unituxin is 17.5 mg/

m2 /day administered as an intravenous infusion over10 to 20 hours for 4 consecutive days for a maximumof 5 cycles.

Unituxin carries a Boxed Warning alerting patientsand health care professionals that Unituxin irritatesnerve cells, causing severe pain that requirestreatment with intravenous narcotics and can alsocause nerve damage and life-threatening infusionreactions, including upper airway swelling, difficultyin breathing during or shortly following completionof the infusion.

Unituxin may also cause other serious side effectsincluding

· Pain· Pyrexia· Thrombocytopenia· Lymphopenia· Infusion reactions· Hypotension· Hyponatremia· Increased alanine aminotransferase· Anemia· Vomiting· Diarrhea· Hypokalemia & Hypoalbuminemia· Capillary leak syndrome· Neutropenia· Urticaria· Increased aspartate

aminotransferase· Hypocalcemia

Unituxin is contraindicated in patients withhistory of anaphylaxis to Dinutuximab.

Ms. Sissy AloysiaAsst.Professor, Department of Pharmacy Practice

NEWS ROOM

FDA approves first therapyfor high-risk Neuroblastoma

INDICATION

Type 2 Diabetes mellitus

Hyperlipidemia

Schizophrenia & bipolardisorder

Hereditary orotic aciduria

Metastatic colorectal cancer

COPD

DRUGS NAME

Synjardy (Empagliflozin & metformin

hydrochloride)

Repatha (Evolocumab)

Vraylar (Cariprazine)

Xuriden (Uridine triacetate)

Lonsurf (Trifluridine & tipiracil)

Glycopyrrolate Inhalation Powder

SL.NO

1

2

3

4

5

6

DATE OF APPROVALAugust 2015

August 2015

September 2015

September 2015

September 2015

October 2015

4

Brain death is the complete and irreversible lossof brain function (including involuntary activitynecessary to sustain life). Brain death is used as anindicator of legal death in many jurisdictions.

Brain death occurs when a critically ill patient diessometime after being placed on life support. Thissituation can occur after, for example, a heart attackor stroke. A person is confirmed as being dead whentheir brain stem function is permanently lost. Thebrain stem is the lower part of the brain that’sconnected to the spinal cord. The brain stem isresponsible for regulating mostof the body’s automaticfunctions that are essential forlife. These include:

· Breathing· Heartbeat· Blood pressure· Swallowing

The brain stem also relaysinformation to and from thebrain to the rest of the body,so it plays an important role inthe brain’s core functions, suchas consciousness, awarenessand movement. After brain death, it’s not possiblefor someone to remain conscious, combined withthe inability to breathe or maintain bodily functions,this constitutes the death of a person.How brain death occurs

Brain death can occur when the blood and/oroxygen supply to the brain is stopped. This can becaused by:· Cardiac arrest – when the heart stops beating

and the brain is starved of oxygen.

BRAIN DEATHMs. Jancy kuruvilaAsst. Professor, Department of Pharmacy Practice

· Heart attack – a serious medical emergencythat occurs when the blood supply to the heartis suddenly blocked.

· Stroke – a serious medical emergency thatoccurs when the blood supply to the brain isblocked or interrupted.

· Blood clot – a blockage in a blood vessel thatdisturbs or blocks the flow of blood aroundyour body.

Brain death can also occur as a result of:· Severe head injury· Brain haemorrhage· Infections, such as encephalitis · Brain tumour

Brain death is not the same ascoma; coma is similar to deepsleep, except that no amount ofexternal stimuli can prompt thebrain to become awake and alert.However, the person is alive andrecovery is possible. Brain deathis often confused with apersistent vegetative state, butthese conditions are not the sameeither.

A persistent vegetative statemeans the person has lost higherbrain functions, but theirundamaged brain stem still

allows essential functions like heart rate and respirationto continue. A person in a vegetative state is alive andmay recover to some degree within a given time. Braindeath means the person has died.

In some cases, a person who is brain dead may be acandidate for organ donation. Patients classified asbrain-dead can have their organs surgically removedfor organ donation.

The heart is a part of the autonomic nervous systemand thus has the ability to beat independently of the

INDICATIONDRUGS NAMESL.NO

7

8

9

10

DATE OF APPROVAL

Buprenorphine Hydrochloride

Patiromer Oral Suspension

Necitumumab

Mepolizumab

Chronic Pain Management

Hyperkalemia

Non-Small Cell Lung Cancer

Maintenance Treatment of Asthmain Paediatrics

October 2015

October 2015

November 2015

November 2015

66

brain as long as it has oxygen. The heart will eventuallystop beating as all bodily systems begin to stop workingshortly after brain death. Once this process has begun,it cannot be reversed. At the time a physician declaresbrain death, the patient is dead.

Mechanical support (a breathing machine) keepsoxygen going to the organs until they can be recoveredfor transplant. The machine is not keeping the patientalive; it is merely keeping the organs viable until theycan be recovered. The legal time of death is the dateand time that doctors determine that all brain activityhas ceased. This is the time that is noted on the patient’sdeath certificate.Signs of brain death

Some of the signs of brain death include:· The pupils don’t respond to light.

· The person shows no reaction to pain.· The eyes don’t blink when the eye surface is

touched (corneal reflex).· The eyes don’t move when the head is moved

(oculocephalic reflex).· The eyes don’t move when ice water is poured

into the ear (oculo-vestibular reflex).· There is no gagging reflex when the back of

the throat is touched.· The person doesn’t breathe when the ventilator

is switched off.· An electroencephalogram test shows no brain

activity at all.

There are two sides to rice: the grain that feeds halfthe world and the primary carcinogenic source ofinorganic arsenic in our diet.

Arsenic is a naturally occurring element that isubiquitous in the environment. It is present primarilyas inorganic arsenic, which is highly toxic. Thechemical gets into the rice as a result of industrialcontaminants and pesticides that were used in the pastand can remain in the flooded paddy fields where therice is grown for decades.

What sets rice apart is that it is the only major cropthat is grown under flooded conditions of paddy fields.It is this flooding that releases inorganic arsenic,normally locked up in soil minerals, which makes itavailable for the plant to uptake. Rice has, typically,ten times more inorganic arsenic than other foods asreported by the European Food Standards Authority.

Chronic exposure can cause a wide range of healthproblems including developmental problems, heartdisease, diabetes and nervous system damage.However, most distressing are lung and bladdercancers.

The first food that most people eat is rice porridge,thought suitable for weaning as rice is low in allergens,

Can rice give you cancer?

Mrs.Rani ManjuAsst.Professor,Department of Pharmacy Practice

has good textural properties and tastes bland. Asbabies are rapidly growing they are at a sensitive stageof development and are known to be moresusceptible to inorganic arsenic than adults. Babiesand young children under five also eat around threetimes more food on a body weight basis than adults,which means that, relatively, they have three timesgreater exposures to inorganic arsenic from the samefood item. The rice product market for youngchildren, which includes biscuit crackers and cereals,is booming. If the child is gluten intolerant then ricebreads and rice milks can be added to this list. Glutenintolerant adults are also high rice consumers, as arethose people of South-East Asian origin.

Rice contains more of the carcinogen arsenic thanother grains, but researchers at Queen’s UniversityBelfast, UK found that cooking rice in a simple coffeepot removed about half the arsenic (85%). Themethod of rice cooking to optimize the removal ofinorganic arsenic and that by using percolatingtechnology, where cooking water is continuallypassed through rice in a constant flow, we couldmaximize removal of arsenic.

The World Health Organisation and the Food andAgriculture Organisation of the UN have justannounced guidelines for inorganic arsenic in rice:200 parts per billion for white rice and 400 parts perbillion (ppb) for brown rice. Brown rice is higher ininorganic arsenic than white as arsenic isconcentrated in the bran that is removed by millingto produce white rice.

6

A number of individual drugs as well as fixed dose combinationsare banned in India. The adverse effects are detected througha process of regular monitoring after the drug is released to themarket called pharmacovigilance. If the adverse effects aresevere or the risks of using the drug outweigh the benefits, orif the drug is ineffective, the country may ban the drug or thedrug company may itself voluntarily withdraw the drug. Somedrugs may cause adverse effects only when combined withparticular drugs.

In such cases, only the fixed dose combination is banned andnot the individual drugs.

A number of single drugs as well as fixed dose combinationshave been banned for manufacture, marketing and distributionin India. Some drugs banned in India are mentioned below:

Drugs Banned in India

DRUGFenfluramine anddexfenfluramine

Rimonabant

SibutramineAstemizole andterfinadine

RosiglitazoneGatifloxacinTegaserod

INDICATIONUsed to treat obesity

Weight loss pill

Weight loss pillUsed to treat allergies

Anti-diabetic drugAntibioticIrritable bowel syndrome withpredominantly constipation.

WHY BANNEDWithdrawn due to reports of diseases of heartvalves, fibrosis of the heart and pulmonaryhypertension.Withdrawn due to serious side effects likedepression, suicidal tendencies and seizures.Caused heart related side effects.Polymorphic ventricular tachycardia and evendeath when used in high doses or with drugslike erythromycin, clarithromycin andketoconazole.Increased risk of heart attacks.Due to its risk for severe hyperglycemiaIncreased incidence of heart attack and stroke.

CONDUCTED NSS MEDICAL CAMPThe National service scheme unit of

Pushpagiri College of Pharmacy organized a freemedical camp on 30th May, 2015 at PushpagiriMedicity Campus. The camp was inauguratedby Adv. Mathew T Thomas, MLA, Thiruvalla. Inthe medical camp, the service of eminentconsultants from the departments of GeneralMedicine, Orthopedics, Gynecology, Pediatrics,Ophthalmology and Dermatology were arrangedfrom Pushpagiri Medical College Hospital. Freelab services and medicine samples were alsodistributed as part of this venture.

DEPARTMENT NEWS

88

INTERNATIONAL SEMINARThe Indian association of college of pharmacy hadjointly presented an international certification seminar“PHARMACY PRACTICE MODULE” during 6th to8th August, 2015 at Pushpagiri College of Pharmacy.The seminar focused on new trends in cardiovasculardiseases. The seminar was led by Dr. Krishna Kumar,Prof. of Biopharmaceutics and Pharmacokinetics,Howard University College of Pharmacy, WashingtonDC, USA; Dr. J. Christopher Lynch, PharmD, BCACP,Southern Illinois University, USA & Dr. DouglasJennings, Pharm D, AACC BCPS-AQ Cardiology,Clinical Pharmacy Manager, Presbyterian ColumbiaUniversity Medical Centre, New York.

CLINICAL PHARMACY PRACTICE DEPARTMENT ACTIVITIES DURING APRIL-JULY 2015

SL.NO12345

ACTIVITIESNo: of Patients CounseledNo: of Queries AnsweredAdverse Drug ReactionPharmacist InterventionsMedication History Interview

NO: OF ACTIVITIES102512058140

Our M.Pharm pharmacy practice, Pharm.D regular and Pharm D P.B students are involved invarious patient care activities such as;

Patient counselling Drug information Medication history interview Bedside counselling Ward round participation ( General medicine, Cardiology,Pulmonary, Nephrology, Neurology, Pediatrics )