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Rabu, 09 Mei 2012

ADVERSE DRUG REACTION CASE REPORTS IN ELDERS

Ciprofloxacin Delirium and myoclonus in an elderly patient: case report
An 85 year old man received oral ciprofloxacin 500mg daily for an infected right hip joint. On the seventh day he experienced generalized myoclonic jerks, hallucination and delirium which improved with a small dose of clonazepam. Ciprofloxacin was permanently withdrawn after his symptoms recurred twice following re-administration. No further episodes of delirium myoclonic jerks occurred.
Jayathissa S. Eet al. Myoclonus and delirium associated with ciprofloxacin. Age and Ageing 39: 762, No. 6, Nov 2010.

Metformin Lactic acidiosis and vision loss in an elderly patient: case report 
A 67 year old woman developed lactic acidiosis and transient vision loss during treatment with metformin for type 2 diabetes mellitus. The woman, who had a history of coronary disease, hypertension and osteoarthritis, and who had been receiving metformin (dosage, route and duration of treatment not stated), presented to an emergency department with acute bilateral vision loss. Her vision loss had started the previous afternoon. Examination revealed a rectal temperature of 32.3o, a HR 55 beats/min, a BP of 117/94mm Hg, a respiratory rate of 34 breaths/min and a pulse oximeter reading of 98%. She was awake and alert but her visual acuity and fields were not intact and she had mid-sized pupils that were slow to react. Laboratory tests showed a pH OF 6.65 and a lactate level of 10.9mmol/L. Her creatinine level was 7.0 mg/dL from a baseline of 1.3 mg/dL and her serum metformin concentration was 28 microgram/mL. She also had hyperkalaemia with a potassium level of 7.1mmol/L. The woman was treated with calcium gluconate, insulin and glucose for hyperkalaemia and sodium bicarbonate for her metabolic acidiosis. Following a lack of response, emergency haemodialysis was initiated. Her vision returned 10 hours after admission with an acuity of 20/30 bilaterally. Her blood pH increased to 7.48, her hypothermia resolved and her laboratory values normalized. She was discharged without metformin therapy. Author comment: ‘’This patient’s metabolic acidiosis resulted from long-term metformin use in the setting of an elevated creatinine, which ultimately caused decreased excretion of the drug. Her presenting complaint was vision loss’’.
Kreshak AA, et al. Transient vision loss in a patient with metformin-associated lactic acidiosis. American Journal of Emergency Medicines 28: 1059e5-1059e7, No.9, Nov 2010.

Corticosteroids/methotrexate Kaposi’s sarcoma in an elderly patient: case report
A 65-year old man developed kaposi’s sarcoma with colonic and skin lesions, following treatment with methotrexate and corticosteroids, including prednisone for ulcerative colitis(UC).
Following a diagnosis of left sided UC and spondyloarthropathy in November 1993, immunomodulatory therapy with mercaptopurine and azathioprine was initiated; treatment was subsequently withdrawn due to gastrointestinal intolerance. In June 2001, methotrexate (dosage and route not stated) was introduced but was suspended in November 2007 to prevent potential drug-related toxicities; prednisone 5mg/day (route not stated) was administered continuously throughout this period. In August 2008, he was admitted for IV steroid therapy (details not stated) following an acute disease episode. During admission he developed violaceous reddish-brown nodules on both legs (time to reaction onset not clearly stated). Investigation revealed active UC with multiple reddish elevated lesions in the last 25cm of the colon, and thickening of the rectum and sigmoid colon walls. Skin histology showed a small, non-encapsulated dermal lesion composed of dilated, irregular and spiculated blood vessels, lined by few prominent endothelial cells; lymphocytes and macrophages comprised an associated infiltrate. Immunohistochemistry with CD34 and CD31 were positive; staining for human herpes virus 8 (HHV-8) showed moderate and focal nuclear positivity. Colonic kaposi’s sarcoma was the preliminary diagnosis. Anti-HHV-8 serology demonstrated an IgG antibody titre of 1/40. A protocolectomy was performed, confirming the presence of multiple nodular lesions of the sigmoid colon and rectum. Labelling for HHV-8 was positive. Multifocal kaposi’s sarcoma of the colon was the final diagnosis. The man’s skin lesions resolved after surgery and steroid withdrawal. At 12 months follow-up, he had no symptoms and no recurrence of skin lesions.
Rodriguez-Pelaez M, et al. kaposi’s sarcoma: An opportunistic infection by human herpesvirus-8 in ulcerative colitis. Journal of Crohn’s and colitis 4: 586-590, No.5, Nov 2010.

Influenza virus vaccine/influenza A virus vaccine H1N1 Guillain-Barre syndrome in an elderly patient: case report
A 75 year old man, with severe chronic obstructive pulmonary disease and dyspnoea, was hospitalized with worsening dyspnoea, cough and purulent expectoration. He reported a progressive debility in his lower limbs for the past week. Neurological examinations revealed grade 4/5 debility in his lower limbs and loss of osteotendinous reflexes. He had received a seasonal influenza virus vaccine 8 weeks earlier and an influenza A viral vaccine, H1N1 vaccine 2 weeks before the onset of the symptoms (route and doses not stated ). A lumber puncture and an electromyogram revealed albumino-cytological dissociation and acute demyelinating neuropathy affecting his lower limbs, respectively. Guillain-Barre syndrome secondary to influenza vaccine was suspected. He received immunoglobulins and rehabilitation. The weakness in his extremities and his respiratory process improved markedly; he was discharged and monitored. Author comment: There was casual effect between the vaccinations and Guillain-Barre syndrome, although it was not possible to determine which of the two was supposed to be responsible, whether it was the result of a sum of probabilities or a cumulative effect of antigen stimulation. Nieto ML, et al. Gullain-Barre syndrome secondary to H1N1 influenza vaccine.
Revista Clinica Espanola 210: 485-486, No. 9, Oct 2010.
by
Akshaya Srikanth
Pharm.D Resident
Hyderabad, India

Minggu, 26 Februari 2012

DIA to organize 2-day conference on pharmacovigilance in Bengaluru on March 3 & 4


Drug Information Association (DIA) is organizing a two-day Pharmacovigilance conference in Bengaluru on March 3 and 4, 2012  The event will be held at The Park hotel. The theme of the event is  “Future Perspectives in Pharmacovigilance.’
The key objective of the event is to explain the current global safety reporting requirements for prescription and over the counter drugs.
There is also need to discuss the new pragmatic approaches to pharmacovigilance as proposed in the Council for International Organizations of Medical Sciences (CIOMS) working group. Over the two days, experts will deliberate and provide inspection program of regulatory agencies in the area of clinical safety from US and Europe, stated Kaushik Desai, director DIA India.
The key note speakers are from India and abroad. They are Dr YK Gupta, department of clinical pharmacology, All India Institute of Medical Sciences, Moin Don, executive director PVCON, Pharmacovigilance Consulting Services, Stewart Geary, vice president, and deputy director of Corporate Regulatory Compliance, Safety & QA, Eisai Co. Ltd and Dr Vivek Ahuja, director, Pharmacovigilance, Asia Pacific, Baxter Healthcare.
While Programme co-chairs are Moin Don and Dr Ahuja, the programme committee members constitute Dr BR Jagashetty, Karnataka drugs controller, Dr Gupta, Prof. Parathasarthy Gurumurthy, professor and head of the department of clinical pharmacy, JSS College of Pharmacy Medical College Hospital, Mysore, RK Giridhar, vice president, BPO Pharma Services, Accenture, Dr Chitra Lele, chief scientific officer, Sciformix Corp.
International speakers panel covers Dr Sidney Kahn, principal scientist, Sciformix Pharmacovigilance Services, Dr Sumit Munjal, consultant, (oncology), Global Medical Safety, Johnson & Johnson, a division of Janseen-Cilag Ltd., Johnson & Johnson, UK and Angela Pitwood, VP, Pharmacovigilance, Indipharm Inc. US.
Some of the topics are safety and management during early drug development programme, US &EU safety regulations upsides-New FDA Rule/ DSURs, safety and regulatory writing, medical device vigilance, panel discussion on Schedule Y and Empowerment to Ethics Committees(ECs) and Institutional Review Boards (IRBs), India: as pharmacovigilance outsourcing destination, safety during clinical trials through medical monitoring, integrating pharmacovigilance in medical and para medical curriculum., Utility of Cloud Computing in pharmacovigilance data base domain.
The organizers recommend that the conference should be attended by those from clinical research, risk management, compliance, medical information, regulatory affairs, academia and pharmacology.

Selasa, 07 Februari 2012

USFDA & EU Essentials of Drug Safety and Pharmacovigilance - India Seminar 2012 at Mumbai

Global Compliance Panel, MUMBAI,INDIA
This training course is designed to give pharmaceutical and biologic companies operating in the U.S.
EU an understanding of product safety and regulatory compliance.The course will include case studies of adverse events to illustrate the decision-making process and reasoning needed behind when and how to properly report incidents to regulatory authorities.
Product safety makes headlines every day - and the impact on a company’s image, consumer confidence, and Wall Street’s opinion is profound. While good safety data has historically been a prerequisite for product approval, recent media attention has intensified public and Congressional scrutiny and resulted in regulations such as the FDA Amendment Act and its strengthened requirements for monitoring post-marketing safety.
Agenda:
  • Overview of Pharmacovigilance
  • Assessing Adverse Event Cases
  • Reporting Adverse Events
  • Global Regulatory Requirements
  • Inspections and Audits
  • Pharmacovigilance Best Practices
  • Preparing for an Inspection
  • Case Studies with Real-Life Inspection Findings
  • Background to Signal Detection
  • Signaling Exercises
  • Data Mining Exercises
  • Pharmacovigilance and Risk Management Process
Who will benefit: 
  • Drug safety and Pharmacovigilance
  • Regulatory affairs
  • Clinical development
  • Executives (including C-Level) with any Legal responsibility for drug safety
  • Clinical safety staff
  • Pharmacovigilance specialists
  • Regulatory affairs professionals
  • Quality management specialists
  • Management involved in clinical oversight
  • Pharmacovigilance
  • Pharmacoepidemiology
  • Regulatory affairs
DATE AND VENUE:
March 5th, 6th and 7th, 2012
at Mumbai, INDIA
Conference Timings: 9:00 am - 6:00 pm

Jumat, 03 Februari 2012

5th ISCR Annual Conference receives overwhelming response from industry

Dr Prem Kumar Reddy inaugurating the conference

The fifth annual conference of Indian Society for Clinical Research (ISCR) was recently held at Taj Krishna in Hyderabad. The theme for this year's conference was ‘Beyond Efficiency to Excellence’ and was attended by over 400 delegates from India and abroad.
Dr Prem Kumar Reddy, a leading authority on cancer research, inaugurated the conference and delivered the keynote address. This was followed by a welcome address by Dr Krathish Bopanna, President, ISCR. Bindhya Cariappa, Chairperson, Scientific Committee presented an overview of the conference, which was followed by a vote of thanks by Dr Radhika Bobba, Chairperson, Local Organising Committee. 
A panel discussion in progress

In synchrony to ISCR's objective of ensuring that the conference serves as a platform for the best minds in clinical research to share innovative views and best practices in clinical research, this year’s sessions focussed on excellence in line with the conference theme. The two-day conference had two clinical research tracks that touched upon each aspect of clinical development and covered early development, regulatory affairs, medical writing, clinical research technology, ethics, investigator site perspectives, project management, data management, quality assurance, pharmacovigilance, biostatistics and a discussion on the perception of clinical trials in India.  
Delegates attended Akshaya, Mandar Kelkar,
 Dr.Parthasarathi, Anand Harugery
The conference was preceded by four workshops on study management, medical writing, statistics and pharmacovigilance. Unique to this conference was also the young clinical research debate conducted at the end of day one of the conference. The conference was concluded by a valedictory speech by Dr PM Bhargava, scientist and recipient of Padma Bhushan and a vote of thanks to delegates, speakers, sponsors, organisers and volunteers. 
Participants at the conference
Speakers who attended the conference were Dr Rajesh Karan, Novartis; Dr Julius Vaz, Dr Reddy's Laboratories; Dr Shreemanta K Parida, Dept of Biotechnology; Dr Deven Parmar, Wockhardt; Dr Sudhakar Mairpadi, Phillips; Shenaz Vakharia, Theraverity; Dr Shashidhar Rao, Novartis; Dr Sanjay A Pai, Columbia Asia; Dr Roopa, Basrur, Parexel; Dr Graham Bunn, Medidata Solutions; Gunjan Jain, Oracle; Dr SD Rajendran, Sristek; Dr Ajay Parker, SIRO Clinpharm; Carol Isaacson Barash, Genetics, Ethics and Policy Consulting; Dr Gauri Gholap, Optra Systems; Sudip Sinha, CliniRx; Dr Mubarak Naqvi, Sanofi Aventis; Dr Aamir Shaikh, Assansa; Dr Ajoy Roy, Parexel; Dhiren Joshi, Voisin Life Sciences; Vivek Ahuja, Baxter; Dr Manish Kumar Shah, Pfizer; Narasimha Kumar, Parexel; Dr Sneha Limaye, CRF; Dr Milind Antani, Nishith Desai Associates; Gourav Kumar, Apollo Hospitals; Dr Vishwanath Iyer, Novartis; Dr Chitra Lele, Sciformix; Tommy Pedersen, Quintiles; Bindhya Cariappa, ClinTec international; Dr Rupam, KIMS; PV Rao, eminent media person; Dr Suresh Menon, Novartis; Professor Sarma, NALSAR; Dr Nimita Limaye, Siro Clinpharm; Dr Hema Bajaj, Sanofi Aventis; Mark Aubrey, Daiichi Sankyo; Dr Raghunatha Rao, NIMS; Dr Purvish Parikh, Americares and Dr Senthil Rajappa, Indo-American Cancer Hospital. The resounding success of the conference has raised the bar for the sixth annual conference to be held in Mumbai next year.
Source:ExpressPharma
by
Akshaya Srikanth
Pharm.D Intern