Pharmaceutical legislation changes in Europe

 
Preparations are underway at the European Medicines Agency together with European Member States and the European Commission, for the introduction of the new pharmacovigilance legislation in July this year. The new legislation will represent the biggest change to the legal framework since The Agency was founded in 1995. The Agency is finalizing their preparations for the inaugural meeting of the new Pharmacovigilance Risk Assessment Committee (PRAC), which is scheduled for 19 July 2012. 

Stakeholders are kept up-to-date on the ongoing implementation process through The Agency's website and stakeholder meetings, including information on transitional arrangements for the pharmaceutical industry, consultations and guidance on new or revised processes, and information on ways in which patients and healthcare professionals can get involved in identifying and managing safety issues in European Member States. This information will be supplementary to the finalization of the implementing measures by the European Commission. 

Adjunct to the establishment of PRAC, the mandate of the existing Co-ordination Group for Mutual Recognition and Decentralized Procedures - Human (CMDh) has also been revised to reinforce its role in pharmacovigilance, with meetings commencing as of September 2012 that will focus on its newly assigned responsibilities. 

According to The Agency, the new urgent Union procedure for safety issues with regard to nationally and centrally authorized medicines in 2012 will be starting to operate, and it will implement the procedure for protocol approval of post-marketing safety studies and results management, however, at first these will apply only for centrally authorized medicines. Furthermore, The Agency will develop a revised process for the coordination of pharmacovigilance inspections during the year starting from July 2012 with the revised process for signal detection for centrally authorized medicines with support from The European Member States for nationally authorized products providing additional data. 

Any patient in European Member States will be able to report suspected adverse drug reactions to his or her national medicines authority under the new legislation, a right that already exists in some Member States. Both, The Agency and Member States will cooperate to provide patients with information on direct reporting during 2012. 

The Agency's and European Member States' transparency of all their pharmacovigilance activities will be raised substantially under the new pharmacovivgilance legislation, with the Agency increasing transparency of its processes and procedures through the publication of its agendas, recommendations, opinions and minutes from its scientific committees, which include the PRAC, the CMDh and the Committee for Medicinal Products for Human Use (CHMP). The Agency will also organize public hearings on request of the PRAC that will enable the public to openly discuss safety issues with the Agency. This will reinforce the Agency's current responsibility in ensuring the exchange of coherent and consistent messages on safety issues across Europe. 

The Agency had a consultation with European industry associates in a workshop held on the 30 January 2012, and will subsequently publish details on the revised implementation of the electronic submission of information on all medicines for human use authorized or registered in the European Union (also known as Article 57 requirements) in February 2012. 

The Agency will also publish its concept paper on the structure of good pharmacovigilance practice (GVP) in February, releasing the first wave of GVP modules for public consultation, and has just published a new implementation plan that provides detailed activities of the new pharmacovigilance legislation scheduled to be implemented in 2012 together with those activities that will be a key issue beyond 2012. 

The highest priority will be assigned to activities that contribute to public health, followed by activities that increase transparency and improve communication, after which come those that simplify processes. 

Starting in February, the Agency and its stakeholders will be communicating closely on development issues regarding the implementation of the new legislation.

Center yet to disburse funds for state's 18 PV at Govt. Medical College Hospitals

The Union government is yet to provide the funding, staff and infrastructure to commission the 18 Centres for Pharmacovigilance at government medical college hospitals in Karnataka.

Pharmacovigilance prevents adverse drug reactions. The Centres will monitor and evaluate the information from hospitals on Adverse Drug Reactions (ADRs) besides identifying information on drug hazards to ensure the safety of patients.

In early 2010, following the need to open up pharmacovigilance across the country, the erstwhile Drugs Control General of India (DCGI) Dr Surinder Singh was working to approve the Centre for Pharmacovigilance at  government hospitals attached to the medical colleges.

This led the Karnataka health and family welfare department to identify 16 locations which covers 12 government medical colleges hospitals  and six   government independent hospitals to establish the Centre for Pharmacovigilance. The state had also sent a letter of intent to these institutions.

The 12 colleges from the 10 districts are Bangalore Medical College and Research Institute, Government Dental College and Hospital, Bangalore,  Mysore Medical College and Research Institute (MMC&RI), Bellary Medical College now renamed as Vijayanagara Institute of Medical Sciences, Government Dental College and Research Institute, Bellary, Mandya Institute of Medical Sciences, Karnataka Institute of Medical Sciences, Hubli  which is attached to the Kempegowda Institute of Medical Sciences, Belgaum Institute of Medical Sciences (BIMS), Shimoga Institute of Medical Sciences(SIMS), Bidar Institute of Medical Sciences(BRIMS), Raichur Institute of Medical Sciences(RIMS), Hassan Institute of Medical Sciences (HIMS). The four hospitals are Jayadeva Institute of Cardiology, Indira Gandhi Institute of Child Health, Kidwai Memorial Institute of Oncology, Rajiv Gandhi Institute of Chest Diseases and SDS Sanatorium, Karnataka Institute of Diabetology, Karnataka Institute of Nephrology.

In fact in 2004, the  Director General Health Services (DGHS), Ministry of Health and Family Welfare received grant from the World Bank to start a  National Pharmacovigilance Programme for which Central Drugs Standard Control Organization (CDSCO) was the coordinator. Under the programme, 21 pharmacovigilance centres were opened with two zonal centres While  All India Institute of Medical Sciences, New Delhi covered North and East, the  KEM Hospital at Mumbai monitored southern and western regions in the country. There were five regional pharmacovigilance centres at Kolkata, Pondicherry (JIPMER), Nagpur and Mumbai with two centres. There were several periphery centres including Bangalore at the Victoria Hospital, Goa, and Mysore within JSS College of Pharmacy.

There are already a couple of similar centres run by pharmacy colleges in Karnataka which include the Drug Information Centre at Victoria Hospital supported by the Al Ameen College of Pharmacy.

“Since pharmacovigilance is now viewed as a critical component in patient care, we had  proposed to the DCGI on the need to set-up centres across healthcare providers in the state,” stated Dr BR Jagashetty, Karnataka drugs controller.

With India now recognized as a hub for human drug studies, an efficient pharmacovigilance programme is a must as stringent safety pharmacology  studies also help to prevent fatality and serious injuries of volunteers and patients who are part of the clinical trials, he added.

Source: PB

DIA organised 2 day conference on PV in Bengaluru

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.

career options for those with a degree in Pharmacy

Most of us think of pharmacists as the persons who are behind the counter when we go to a drug store with a prescription. While retail pharmacy is a common career choice for pharmacists, there are many other options available to those who have completed their Pharm.D degree and the necessary licensure requirements. Although there are a variety of practice settings, compensation remains relatively consisitent across all of these employment options with minor variations according to hours of work and call.

Here are the some career options in this field:

Retail Pharmacy/ Chemists 

A pharmacist in medical retail store prepares and dispenses drugs on prescription to the general consumer. With the growing availability of pre-packaged doses, the pharmacists now monitor the drug sale on the basis of prescriptions and dosage and give over-the-counter advice on how to use the prescribed drugs.

In the retail sector pharmacists run chemist's shops. As medical representatives, they inform and educate medical practitioners about the potential uses of the drug or health product and its administration along with the side effects or precautions for its use. The job entails regular visits to medical practitioners, hospitals, clinics, nursing homes, health centres. There is usually a lot of touring to be done in this case.

Hospital Pharmacy

The primary role of a hospital pharmacist is to provide medication and medication management services to patients who are hospitalised or are visiting hospital-based clinics, and to provide medication services to health professionals who care for patients in the hospital set up.

Hospital pharmacists have exposure to many complicated and unique therapy needs, including intravenous medication therapy, nutrition, and the specific needs of newborns and the elderly. Pharmacists in the practice find working with other health professionals, work variety and focused clinical care opportunity rewarding. This is the second most common practice area.

Industrial Pharmacy 

While most firms are involved in the production of pre-formulated preparations, a growing number of firms are developing new formulations through autonomous research work. Industrial pharmacists carry out clinical trials, where drugs are tested for safety and effectiveness work in research and development to develop new formulations the production job entails management and supervision of the production process, packaging, storage and delivery work in marketing, sales and quality control.

In addition to the many opportunities for graduates in the many areas of pharmacy practice there are increasing numbers of opportunities within the pharmaceutical industry in advanced and specialised areas, as the depth and breadth of education in pharmacy increases opportunities in industry. This includes the promotion of pharmaceuticals to health professionals, marketing, development of new drugs and dosage forms, clinical studies in patients, monitoring pharmaceutical use on a population scale, and managing regulatory and legal issues.

Government Services

Pharmacists are hired within the central and state government departments - the Health Protection Branch of the Department of Health and Welfare, the Pest Control Division of Agriculture, the Department of National Defense, Provincial Research Councils, and the Provincial Departments of Agriculture or Environment. There are employment opportunities available also within the food and cosmetic industries or within any other industry that requires an assurance that new products are as safe and effective as possible. In government departments, a pharmacist maintains proper records according to various Acts governing the profession.

Pharmaceutical Education 

Many pharmacists work as faculty in colleges of pharmacy. These pharmacists enjoy influencing the future of pharmacy by educating future pharmacists and may participate in direct patient care and/or scientific research as well. Academic pharmacist practice has its rewards in disseminating and discovering new ideas that change medication use, pharmacist practices and healthcare policy. Career as a teacher is satisfying as it allows interaction with people, especially students, and provides them with the flexibility to pursue their own ideas in the field.

Nuclear Pharmacy 

Nuclear pharmacists are responsible for measuring and delivering radioactive materials which are used in digital imaging (MRI, CT, etc) and other procedures in medical offices and hospitals. Due to the nature of the radioactive materials and how they are handled, nuclear pharmacists are typically required to start each work day very early, sometimes pre-dawn, as the radioactive materials must be delivered within a few hours of their use, or they lose their effectiveness

Clinical Research

Recently, Clinical research has also opened its door for B.Pharma graduates as medical underwriter, CRO, data validation associate, clinical research associate etc. A clinical research associate plays an important role in monitoring and overseeing the conduct of clinical trials, which are conducted on healthy human volunteers. They have to see that the trials meet the international guidelines and the national regulatory requirements.

Community pharmacy

The primary role of a community pharmacist is to provide medication and medication related services to patients. In most settings, pharmacists provide prescription drug services to their community of patients, working with the patients and a broad spectrum of healthcare providers to achieve the best possible healthcare outcome of medication.

Quality Control & analysis

A pharmacy graduate can play a crucial role in controlling product quality as an analytical chemist or a quality control manager. The Drug and the Cosmetics Act (1945), Rules 71(1) and 76(1) says that the manufacturing activity should be taken up under the supervision of a technical man whose qualification should be B PharmA, B Sc, B Tech or medicine with Bio-Chemistry.

Research and Development

New and expanding knowledge in healthcare and biomedical sciences provides tremendous opportunities for the pursuit of research careers for pharmacists. Graduates with Pharm.D degree can pursue a research career directly or go in for additional education either in the form of residency and fellowship training or in formal graduate programmes leading to the M.S. and Ph.D. degrees.

With a clinical focus one can be involved in the conduct and analysis of large-scale human drug studies in academic, industrial, and governmental settings. Pharmacists are also highly qualified to pursue additional training in business, public health, or pharmaceutical socioeconomics in order to become involved in research in drug utilisation, healthcare outcomes, and the provision of pharmacy services.

Sales and Marketing

Ambitious achievers with pleasant personality and good communication skills can opt for the job of Medical Sales Representative. Companies prefer pharmacy graduates for this job, as they have a good knowledge about the drug molecules, their therapeutic effects and the drug -drug interactions.

GOD

why one should consider Pharm D programme?

Different people have different career dreams. Just like any other career, pharmacy is not as easy as it seems. This is especially considering the fact that you will have to work really hard first before you can get your degree. Nevertheless, it is correct to say that every moment of it is worth your effort. This is because pharmacy offers you a wide range of career opportunities in the different health sectors.

Pharm.D simply refers to a six year doctorate program in pharmacy. Different countries have different policies and in some countries this is considered as a first professional doctorate degree in pharmacy and the grandaunts can be given the license to exercise their profession. The health care industry is very vital. A doctor of pharmacy is intended to prepare the students for different responsibilities as pharmaceutical care, research, pharmaceutical science and health policy and management among others.

With the many job opportunities contracted for this career, it is correct to say that the Pharm.D programs are one of the most marketable syllabuses globally. Positions are usually available in research facilities in different universities, hospitals, pharmaceutical companies, government agencies and advisory boards among many other places. Such programs will usually differ from the regular PhD which is usually theoretical to a research based degree.

You can get your doctorate in pharmacy from the different universities across the globe. While a simply degree in pharmacy is acceptable, today, more and more people would prefer to graduate with a Doctors in pharmacy especially due to the tight competition in the career opportunities available.

A Pharm.D degree is intended to equip you with all the knowledge necessary for any pharmaceutical field of practice. What is more, students are also endowed with the necessary health care skills which are going to come in handy once they start practicing.