Editorial, Jan March 2018

Editorial

Al Shifa College of Pharmacy, Perinthalmanna  is at 51st rank among pharmacy institutions nationally and is the lone one to figure in the top 75. Alshifa college of Pharmacy stood 1^st in Kerala IHRM ranking and indeed it was a proud moment for the management staff and students at Alshifa. Continuous commitment and persistent efforts of the Shifa Management lead Alshifa College of Pharmacy to achieve greater heights and to become one of the premier institute of Kerala.

          In 2018, we are gearing up for our new tie up with the University of AIMST, PENANG, MALAYSIA. This tie up will open up new Internship opportunities for our Pharm.D students and Faculties. This relationship will help us to share knowledge and grow further in the field of pharmacy practice. Few Years back, our pharm.D students received training from National Health group Pharmacy and Tantock hospital, Singapore. Collaboration and research is the only way forward, since the advancement of clinical practice truly depends on evidence based research outcomes. Exploring new horizons of teaching and learning experiences further strengthens the core values, thus helping the ideology of each candidate undergoing education in our institution. New research outcomes and new learning practices make the foundation strong and give a new dimension to clinical practice.

 Department of Pharmacy practice has always been in the forefront in sensitizing the public about the various diseases that exist today. A massive rally followed by awareness class was organized at kizhattur village in view of world AIDS day. Politicians, Stake holders, Health care providers actively participated in the programme. Faculty Mr. Linu Mohan delivered an awareness class for cancer patients at Valancherry town, Malappuram, which had a fruitful outcome.  Our first year M. Pharm students conducted a medical screening associated with the cancer awareness programme .One day seminar on ‘Rational Use of Antibiotics’ was carried out by the department during the World Antibiotic Week. Dr. Hamza koya, Additional Director, National Center for Disease Control, inaugurated the programme and delivered a talk that turned out to be an eye opener for many. This issue of our newsletter includes the highlights from our 2 days National Seminar, 2 days International Conference, Convocation day of second batch Pharm.D students and Christmas day celebration followed by orphanage visit by our second year Pharm.D students.

Hala Jawad, a community Pharmacist from United Kingdom, has shared her experiences and I am sure it would be an interesting read for many aspiring students. Dr. Mohanta, Linu Mohan, Shinu, Anas and Levin have turned up with their regular columns, which has made this issue content rich.

Dilip.C

Editor in Chief

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Dept activities

With P. Unneen, Managing trustee,SIMS,Hamza P, CEO, Suhail Hamza, General Manager, and speakers Dr Hamza koya, Dr Muhammad Yahya, Dr Murali, Dr Cijo Oommen... Organized by 4 th batch Pharm D and 5 th PB..

A life lived for others is worthwhile...
There are merciful hearts among the teens..
7 the batch Pharm D with Asst Profs Shinu and Basheera at Rahma Special School Melatur during Christmas celebrations

Sparsham- Cancer awareness class and screening Programme at valanchery grama panchayat, Malappuram, organised by 9th and 10 the batches of M.Pharm pharmacy Practice.

World aids day , awareness class followed by rally ,jointly organised by dept of pharmacy practice,( second and third Pharm.D) NSS unit, Acp and keezhatur grama panchayat at primary health centre , poonthavanam , perinthalmanna .

 

the Revival of Intravenous Fosfomycin therapy in critically ill patients infected with with Colistin Resistant Enterobacteriacae

The Revival of Int ravenous Fosfomycin therapy in critically ill patients infected with with Colistin Resistant Enterobacteriacae

Dr Anas.M

Clinical Pharmacist

KIMS AL-SHIFA Super Speciality Hospital.

Carbapenem resistant enterobacteriacae (CRE) emerged in recent years as one of the most challenging group of antibiotic resistant pathogens. Polymyxins are considered as the last resort for the treatment of infections with Carbapenem resistant gram bacilli (GNB). Inadequate or extensive use of Colistin leads to emergence of Colistin resistance, jeopardizing treatment options in Intensive Care Units (ICU), potentially increasing mortality and morbidity and necessitating prudent use of alternative antibiotics.  Selective pressure by the increased use of Colistin and clonal expansion through horizontal transmission have generated clusters of cases infected with multi-resistant klebsiella pneumonia strains.

Fosfomycin is a bactericidal antibiotic that interferes with cell wall synthesis in both Gram –Positive and Gram negative bacteria by inhibiting the initial step involving phosphoenolpyruvate synthetase. Its unique mechanism of action may provide a synergistic effect to other antibiotic including beta –lactams, Aminoglycosides and fluoroquinolones. Fosfomycin penetrates sufficiently into various tissues and CSF.

Fosfomycin may be considered an alternative for the treatment of infection due to Carbapenem-resistant bacteria in adult due to its unique mechanism of action and its protective effect against nephrotoxicity induced aminoglycosides or Colistin. Fosfomycin has regained attention because of its in Vivo activity against ESBL –producing Enterobacteriacae and MDR p aeruginosa.

Fosfomycin is a bactericidal agents showing low level of toxicity as well as low level of cross-resistance with other antibiotics. Fosfomycin tromethamine is an oral formulation approved for the treatment of uncomplicated urinary tract infection (UTI), caused by Multi Drug Resistant bacteria. Fosfomycin is also available as sodium/disodium formulations for intravenous use, which is showing promising result against MDR/PDR pathogens

Fosfomycin disodium is given intravenously and on rare occasion intramuscularly. Daily dose ranges from 12-16 g on average, administered in 2-4 infusions. Dose should be reduced if the creatinine clearance is less than 50ml/min. Intravenous administration of fosfomycin is associated with a low incidence adverse effects. The most significant adverse effect related to the administration of fosfomycin disodium is a high sodium intake, which could be a limitation in patients with heart and renal failure. It should be emphasized that 1g of intravenous fosfomycin brings 0.33g (14.4 mEq) of Sodium.

References

1.      The International Journal of Infectious Diseases: The revival of fosfomycin, 732-739, November 2011.

2.      American Journal of Emegency Medicine:Newly Approved antibiotics and antibiotics reserved for resistant infections:Implications for emergency medicine-Vol 35, page 154-158, 2017

3.      Open Journal of Medical Microbiology: Synergistic Combination of Carbapenems and Colistin against P.Aaeruginosa  and A.baumannii, 2013,13,253-258

Tides of Indian pharma

Tides of Indian pharma by Levin thomas

Analysis of New Drugs approved by CDSCO for use in humans in 2017 by ATC Classification.

In the year 2017 (from 06-01-2017 to 07-12-2017), there were 37 new drugs approved by CDSCO for use in humans and for veterinary use. The current article analyses the new drugs approved for use in humans into various pharmacological categories using the globally accepted ATC classification of drugs.

As shown in graph 1, it can be analyzed that the maximum number of new drugs approved were anticancer and antiinfectives. No new drugs for musculoskeletal system, antiparasites, insecticides and repellants were approved last year.

Graph 1: No. of new drugs approved in each ATC pharmacological category in 2017.

The new drugs approved in each ATC category with their indication are as follows:

A.      Alimentary tract and metabolism

1.      Dexlansoprazole Delayed Release Capsule 30/60mg & Bulk (erosive esophagitis & GERD)

2.      Prucalopride 1mg/2mg Tablet (chronic idiopathic constipation)

3.      Eliglustat 84mg Capsules ( Gaucher disease type 1 )

B.     Blood and blood forming organs

1.      Argatroban Hydrate Bulk & Injection 250 mg/2.5 ml (Heparin induced thrombocytopenia (HIT))

C.     Cardiovascular system

1.      Efonidipine Hydrochloride Ethanolate Bulk & Tablets 10 mg/20mg/40mg (Hypertension & Angina)

2.      Macitentan Bulk and Tablets 10 mg (Pulmonary arterial hypertension (PAH)

D.      Dermatologicals

1.      Apremilast bulk & film coated tablets 10 mg/20 mg/30 mg (Psoriasis)

  G. Genito urinary system and sex hormones

1.      Mirabegron Prolonged Release Tablet 25 mg /50 mg (Urinary incontinence/ Urgency)

2.      Etonogestrel 68 mg implant (For use by women to prevent pregnancy)

3.      Dienogest 2mg Tablets  (For the management of Pelvic pain associated with Endometriosis )

H. Systemic hormonal preparations, excl. sex hormones and insulins

1.      Pasireotide long-acting release 20/40/60mg powder (Acromegaly )

J. Antiinfectives for systemic use

1.      Delamanid 50 mg tablet (MDR TB)

2.      Arbekacin bulk & Injection 200mg/4ml (Methicillin resistant Staphylococcus aureus (MRSA) infections)

3.      Arteolane Maleate and Piperaquine phosphate Dispersible tablets (37.5 mg +187.5 mg (Plasmodium falciparum malaria infection)

4.      Sofosbuvir 400 mg +Velpatasvir 100 mg Tablet (Chronic Hepatitis C )

5.      Tenofovir Alafenamide Fumarate bulk & 25 mg capsules (Chronic Hepatitis B virus infection)

L. Antineoplastic and immunomodulating agents

1.      Carfilzomib Sterile Lyophilized Powder for Injection 60mg/vial (50ml vial) ( Multiple myeloma)

2.      Dabrafenib 50mg/75mg Capsules (Metastatic melanoma)

3.      Trametinib 0.5mg/2mg Tablets (Metastatic melanoma)

4.      Alectinib 150mg Capsules (metastatic non-small cell lung cancer (NSCLC))

5.      Osimertinib 40 mg/80 mg Film coated Tablets (non-small cell lung cancer (NSCLC))

6.      Ribociclib 200 mg Film coated Tablets (Metastatic breast cancer)

7.      Midostaurin 25 mg Capsules (AML)

8.      Teriflunomide  14 mg tablets (Multiple sclerosis)

9.      Pomalidomide 1mg/2mg/3mg/4mg Capsules (Multiple myeloma)

10.  Treosulfan Bulk & injection 5g/vial (Haematopoetic stem-cell transplantation)

  M. Musculo-skeletal system: Nil

   N. Nervous system

1.      Brivaracetam Film Coated Tablets 50mg/75mg/100mg (Epilepsy)

  P. Antiparasitic products, insecticides and repellents : Nil

  R. Respiratory system

1.      Fluticasone Furoate (100 mg mcg) and Vilanterol Trifenatate (25 mcg) powder for inhalation (COPD)

2.      Bepotastine Besilate 10 mg Tablets (Allergic rhinitis)

  S. Sensory organs

1.      Bepotastine Besilate 1.5 %w/v Ophthalmic solution (Allergic conjunctivitis)        

  V. Various: Nil

NEW SKIN CLOSURE SYSTEM FOR WOUNDS

Pharma pulse by Linu mohan

NEW SKIN CLOSURE SYSTEM FOR WOUNDS

A surgical incision is a cut made through the skin and soft tissue to facilitate an operation or procedure. It is made as small and unobtrusive as possible to promote safe surgical conditions. Once the operation is over, surgical excisions are closed by sutures, staples, steri-strips, tissue glue, or a combination of these agents. For proper healing, the wound have to cover in a protective dressing and kept dry for a few days.

Wound dehiscence is one of the most common complications of surgical incisions. This may cause the breaking open of the surgical incision along the suture. It may be a result of poor surgical techniques such as improper suturing, over-tightened sutures or inappropriate type of sutures. When it occurs, the edges of the wound starts to separate and reopens instead of healing.

Recently scientists has come forward with new skin closure system known as  surgical adhesives, which can be utilized as an alternative or as an adjunct to conventional suture closures to help, achieve good wound tension. It consist of a self-adhering flexible mesh strip, mesh anchors and a fast-curing 2-octyl cyanoacrylate topical adhesive to quickly close and seal large incisions while forming an immediate microbial barrier to protect against infections.

The self-adhering mesh and anchor system allows for easy application and enables surgeons to close incisions faster than sutures. This will help the surgeon to handle large wounds easily. The waterproof microbial barrier reduces the risk infection, allows them to shower immediately after surgery, and the innovative anchor system improves comfort during removal. This adhesive based medical skin closure can be used in all common type of surgeries and enhances the patient comfort after the procedure and prevents surgical site infections.

 

“LIQUID BIOPSY TEST” FOR EARLY CANCER DETECTION 

Cancer, also called malignancy, is an abnormal growth of cells. There are different types of cancer, including breast cancer, skin cancer, lung cancer, colon cancer, prostate cancer, and lymphoma.  For the optimum treatment of cancer the basic aim must be its recognition at a stage so early that it can be destroyed or excised before it has time to spread to a distant structure.

The existing best method for detecting cancer is a biopsy, which means cutting out a small piece of the tumour tissue for lab analysis. But biopsies are often painful and invasive. For biopsy procedure either a developed tumor or a suspect tumor is required to collect the cell for analysis.

Recently the researchers have developed a new blood test which can  identify colorectal, breast, lung, and ovarian cancers at their earliest stages which will be useful for screening people who have an increased risk of developing cancer.

The mechanism behind the test is detection of cell free circulating tumor DNA released in to the blood as small fragments from dying tumor cells. Normally tumor cells have somatic mutations that are acquired during a person's lifetime. These mutations are present only in tumor DNA. This helps to identify whether the cell free DNA fragment is from a cancer cell.

This test will be a non-invasive test for screening and monitoring cancer, with potential to save lives by detecting cancers at their earliest and most treatable stages without any need of tumour tissue samples.

Increased risk of serious pancreatitis with Eluxadoline in patients without a gallbladder

ADR Bulletin, by Shinu.C

Increased risk of serious pancreatitis with Eluxadoline in patients without a gallbladder

Eluxadoline is approved for use in adults for the treatment of irritable bowel syndrome with diarrhea (IBSD). It is a tablet taken by mouth twice a day with food. It works by activating opioid receptors in the gut to decrease bowel contractions, which leads to less diarrhea. It can also help to ease stomach-area or abdomen pain and improve stool consistency. It is a controlled substance (CIV) and may be abused or lead to drug dependence. Alcohol and other diarrhea medicines should be avoided while taking the drug. Use the drug along with lifestyle changes, such as limiting foods that aggravate your symptoms, eating more slowly and not overeating, and avoiding carbonated drinks, which can lead to gas and cramping. Common side effects of the medicine include constipation, nausea, and stomach-area or abdomen pain.

FDA is warning that eluxadoline should not be used in patients who do not have a gallbladder. An FDA review found these patients have an increased risk of developing serious pancreatitis that could result in hospitalization or death. Pancreatitis may be caused by spasm of a certain digestive system muscle in the small intestine. Eluxadoline is a prescription medicine used to treat irritable bowel syndrome in adults when the main symptom is diarrhea (IBS-D). IBS-D affects the large intestine and causes cramping, stomacharea or abdomen pain, bloating, gas, and diarrhea. The cause of IBS-D is not known. It works by decreasing bowel contractions, which leads to less diarrhea. In patients with IBS-D, the drug  can help ease stomach-area or abdomen pain and improve stool consistency.

Studies from May 2015 to February 2017, FDA received 120 reports of serious cases of pancreatitis or death. Among the 68 patients who reported their gallbladder status, 56 of them did not have a gallbladder and received the currently recommended dosage of drug. Seventy-six patients were hospitalized, of which two patients died. These two patients did not have a gallbladder. Some cases of serious pancreatitis or death also reported sphincter of Oddi spasm (n=6) or abdomen pain (n=16)

ADDITIONAL INFORMATION TO PATIENTS •Patients who do not have a gallbladder should not take eluxadoline. •Patients who do not have a gallbladder who are taking eluxadoline have an increased risk of developing new or worsening stomach-area or abdomen pain due to pancreatitis with or without sphincter of Oddi spasm. •Hospitalizations related to pancreatitis, including deaths, have been reported with eluxadoline in patients who do not have a gallbladder. •Stop taking the drug right away and get emergency medical care if you develop new or worsening stomach-area or abdomen pain, or pain in the upper right side of your stomach-area or abdomen that may move to your back or shoulder, with or without nausea and vomiting. •Talk to your health care professional before you take any over-the-counter (OTC) medicines to treat diarrhea, constipation, or other problems with your bowels or colon, can cause severe constipation. •Before starting treatment with eluxadoline, patients should tell their health care professional if they: •Have no gallbladder •Have or may have had a blockage in your gallbladder or a sphincter of Oddi problem •Have had inflammation of your pancreas

•Have serious liver problems •Have a history of chronic constipation •Have or may have had a bowel blockage •Have a habit of drinking more than three alcoholic beverages a day •Lifestyle changes, such as limiting foods that aggravate your symptoms, eating more slowly and not overeating, and avoiding carbonated drinks which can lead to gas and cramping, can help reduce the symptoms of IBS-D. •Report side effects from the drug.

ADDITIONAL INFORMATION TO HEALTH CARE PROFESSIONAL •Pancreatitis with and without sphincter of Oddi spasm can occur even after the first or second dose of drug, independent of gallbladder status. •Do not use the drug in the following patients: •Who do not have a gallbladder •Have or may have had a blockage of the gallbladder or a sphincter of Oddi problem •Have had pancreatitis or other pancreas problems, including a blockage of the pancreas •History of serious liver problems •History of chronic or severe constipation •Have or may have had intestinal obstruction •History of alcohol abuse, alcohol addiction, or drinks more than three alcoholic beverages a day •Counsel patients on managing stress and making changes in diet and lifestyle to help control symptoms of IBS-D. •Tell patients to talk with a health care professional before taking any anti-diarrhea medicine, including over-the-counter medicines. •Report adverse events of eluxadoline.