Friday, 20 December 2013

Changing Trends in Global Pharmacy Workforce

INTRODUCTION
Increased demand for health services and increasing expectations to service delivery have a significant effect in shaping work dynamics.Contemporary issues surrounding the global pharmacy workforce identified from the literature's include the importance of working conditions and job satisfaction, wide range of supply and demand factors affecting the workforce and migrations.To support growth in the establishment of pharmacy practice and its aspiration for increased patient focused care, work force needs another trends will need to be factored into pharmaceutical service development plans.
Global Policy Context
The world’s health workforce is facing significant challenges with a shortage of more than FOUR million health workers worldwide. The global health workers crisis is possibly the greatest health system constraint on countries seeking to meet their 2015 millennium development goals (MDGs). Increased demand for health services and increasing expectations for service delivery has changed the health workforce issues have generated huge interest and international action to bring about change. -World health report 2006
In order to meet the MDGs, had laid revolutionary change in every sector of healthcare system in accelerating, delivering and planning the future health care professional not only to national needs but also to global health innovations.
In many countries, pharmacists are the most accessible of all health care workers and a such play a key role in the delivery of health care services, particularly the safe distribution of medicines at all levels. In an era of rapidly accelerating change in health care delivery, the roles of pharmacists are constantly being redefined, as roles, competency, and training requirements change.Thus, understanding the current workforce and the factors that influence it are key components to human resource planning in pharmacy. As the recent report from the Office of The Chief Pharmacist of US, a health system improvement that is well supported by the evidence-base is to maximize the expertise and scope of pharmacists in minimize expansion barriers for an already existing and successful upgrading the health care delivery models in USA, Canada, Australia and Great Britain. There is also a need for countries to model their workforce needs based on predicted future provision of services and care, roles and responsibilities of the pharmacy support workforce, increased use of technology, the advancement of biotechnology and personalized medicine, demographic changes, and future patterns of working all while ensuring there is a sustainable academic workforce to maintain the supply of suitably trained pharmacists. 
Work Condition & Job Satisfaction
The level of job satisfaction among pharmacy personnel is an important indicator of staff turnover and retention. A number of studies found female pharmacists hold high levels of job satisfaction compared with their male counterparts.Other factors identified as increasing pharmacist retention were good remuneration, good relationships with co-workers, and flexible schedules. Factors increasing staff turnover included high stress, insufficient or unqualified staff, and poor salary.Evidence also suggests that pharmacists engaged in shift work might present unique characteristics, which has implications for labour supply and pharmacy services delivery.
Workforce development: Education, training, & leadership
Continuing professional development (CPD) has the potential to be useful in pharmacy workforce revalidation. Pharmacy professionals on the whole agreed with the principle of engaging with CPD, but there was little evidence to suggest widespread and wholehearted acceptance and uptake of CPD, essential for revalidation.Direct experience of effective CPD in the absence of perceived barriers could impact personal and professional development and patient benefit, thus strengthening personal beliefs in the value of CPD.
Supply and demand issues: Current status & future directions Increased demand and limited supply of pharmacists constrains the ability of the workforce to expand. Many different supply and demand factors that influence the pharmacy profession were identified, the majority of which were common to most countries.
Supply and demand issues: Current status & future directions The most common factors increasing demand for pharmacists were increased feminisation, increased clinical governance measures through continually reviewing and improving the quality of patient care, increased numbers of prescriptions, and increased complexity of medication therapy. The most common factors mitigating demand for pharmacists included increased use of technology, expansion in the numbers and roles of pharmacy technicians, and increased numbers of pharmacy graduates. 
Pharmacy workforce migration
There is greater migration from less-developed countries to more-developed countries. The pharmacist workforce from African and Asian countries was disproportionately affected by migration. Significant number of pharmacists from developing countries migrate to the developed world; however, the extent of such migration was not properly captured. Postulated reasons for migration include better remuneration, joining or supporting family, political and social instability, poor living conditions, poor working conditions and management, unsafe environment, further training and qualifications, and job opportunities and satisfaction.
Conclusion
The current challenges affecting the global pharmacy workforce in ensuring equitable access and responsible use of safe, effective and quality medicines. The present status states that there is a huge paradigm shift from the past to current Pharmacy profession leading in the developed countries for more advancement and the developing countries upgrading for the better services with new branches in managing future needs in delivering of the health services.  But still many skillful pharmacists are needed to strengthen the workforce in the Global Pharmacy.
Source: Global workforce Report 2012

Pharm D the No. 1 employer in Medical Research !!!

The pharmacy community contributes to biomedicine at multiple levels including education, scholarly activity, and service through patient care. Pharm.D have a broad base of knowledge in pharmacology, including pharmacokinetics, pharmacodynamics, pharmacogenetics, pharmacotherapy, pharmacoepidemiological and pharmacoeconomics, as well as a strong understanding of human metabolism, transport, and elimination. Because of significant interest in clinical research questions related to drug development and therapeutics, the field of pharmacy is in a unique position to conduct research toward achieving the goal of individualized prescription drug therapy. With the ability to envision translational endpoints, Pharm.D is a valuable component of the current biomedical research enterprise.  
Pharmaceutical scientists can offer unique perspectives to clinical and translational research, such as introducing and integrating pharmacogenomic approaches and methods to clinical trials in various disease areas. In addition, Pharm.D researchers can play an important bridging role between clinical investigators who may not otherwise find each other. Broad training in physiology and drug metabolism enables Pharm.D scientists to pursue research interests in a range of therapeutic areas, including but not limited to oncology, cardiology, HIV/AIDS, liver disease, and health services research. Pharmaceutical scientists that are currently conducting studies in these areas provided brief accounts of their research, described their own career paths, and offered suggestions on strengthening the Indian Pharm.D researcher pipeline.
Despite a wide range of individual career trajectories, these successful pharmaceutical researchers all viewed certain characteristics of their training as pivotal to their becoming productive, independent scientists. These include i) high-quality mentoring, ii) grant-writing education and experience, iii) exposure to rigorous research, and iv) clinical acumen acquired through practice experience. 
Leading pharmaceutical scientists have followed diverse paths to yield successful research careers
Historically, most of the trailblazers in pharmacy research discovered their interest and compatibility with scientific investigation relatively late in the game. Most reported that they turned to research after realizing that manufacturing & dispensing alone was not sufficient to hold their interest. Many also were dissatisfied with the lack of a literature basis for pharmacy practice. Once these investigators chose to pursue a research career, a common thread to their eventual success was the significant value of mentoring (occasionally from outside the profession). Whether on-site or from a distance, mentoring is an essential component of the professional development of junior investigators. Through continual nurturing from experienced investigators, junior scientists acquire the necessary professional skills for succeeding in research, such as grant-writing and manuscript preparation. Mentoring Pharm.D students from current level should also include a focus on raising awareness about clinical research opportunities and play their role in interpreting the research. 
Pharm.D aspirants have a wide range of research exposure and career interests in academia and industry
Some students plan to pursue Ph.D. after earning their Pharm.D degree, whereas others obtain research experience through some type of post graduate diploma in research after receiving a Pharm.D degree. There is some debate about the value of each type of training approach in our country, but general consensus exists that when it comes to training, one size does not fit all. Speakers agreed that a solid basic science education and meaningful clinical experience were both important ingredients of a successful pharmacy researcher. 
For those students who focus on research, individual preference as well as research interest and skills will influence whether that graduate suits his employment in academia, industry, or other venues such as the government. One reality is money: Every graduate who had the thought to accumulate into the industry after his Pharm.D degree will find a high-paying position in industry in future. It is also important to recognize that emerging Pharm.D graduates will surely draw their importance and contribution to industry irrespective of other concerns. Pharm.D's had the opportunity to play key leadership roles in contract research organizations (CROs), pharmacovigilance, health policy makers, pharmaceutical firms, and biotechnology companies in their careers.

USFDA and 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

Regulatory Framework for Medical Devices in India

India has emerged as one of the leading markets for pharmaceutical products. Increase in the private healthcare infrastructure, widening rural markets, and inclusion of newer technologies have placed healthcare as an independent sector in India. With privatization of healthcare, the medical devices sector is growing too.
In order to regulate the import, manufacture, distribution and sale of drugs and cosmetics, the Drugs and Cosmetics Act, 1940 (“D&C, Act”) was introduced in India in 1940. However, no separate legislation/regulation has been enacted for regulating the import, manufacture, distribution or sale of medical devices in India till date by the Government of India.
The Central Drugs Standard Control Organization (CDSCO) is the key medical regulatory organization in India. Since 2006, both the Indian Department of Science and Technology and the Ministry of Health and Family Welfare have sought to completely restructure the regulations for the medical devices. Till date, neither of these attempts has been successful. Medical device market is quite diverse which includes medical and diagnostic equipment; medical implants like heart valve and cardiac stents, pacemakers, cannulae, knee joints; and lower end plastic disposables, blood bags, IV sets, syringes etc. In light of its widespread applicability, overall medical device market is experiencing reasonable growth.
Historically, most Indians had very limited access to any type of modern medical service. Today, however, the situation is much improved. There is a growing awareness about health issues within India, an increasing demand for quality care at affordable prices, further the Indian Healthcare industry is in a steady growth trajectory and is expected to grow in the next few years.
The Indian economy is worth about US$1,243 billion and rapidly getting bigger. The GDP growth reached 9% in the year to March 2008. The 2010-11 budget extended the coverage to another 20% of the Indian population covered by the National Rural employment Guarantee Act (NREGA) programmes, who have worked for more than 15 days during the preceding financial year.Budget 2010-11 also allocated US$ 2,920 million under the National Rural Health Mission (NRHM), an increase of 15% over the previous year.
Regulations on Medical Devices in India
 Undoubtedly, the medical devices and surgical instruments are currently not covered under the regulatory framework in India. However, any device which is intended for internal or external use in the diagnosis, treatment, mitigation or prevention of disease or disorder in human beings or animals, as may be specified by the Central Government by notification in the Official Gazette would be considered as a drug under the D&C Act and provisions of D&C Act and Rules made therein would be applicable on such device. From time to time, Ministry of Health and Family Welfare, Government of India vide gazette notifications has notified certain medical devices as drugs under the D&C Act.
 Prior to 2005, only medical devices such as disposable hypodermic syringes, tubal rings, condoms, metered dose inhalers, were required to be registered in India. In 2005, the Ministry of Health and Family Welfare (MOHFW) vide gazette notification dated 6 October 2005 further notified 10 sterile devices (“Notified Medical Devices”) to be considered as drugs and consequently regulated their import, sale and manufacture under Section 3(b) (iv) (defined below) of the D&C Act.
Regulating Authority for Notified Medical devices
In India, the Central Drugs Standard Control Organization (‘CDSCO’) is the main regulatory body currently regulating import, sale and manufacture of medical devices which have been notified as drugs by virtue of Section 3(b) (iv) of the D&C Act.The CDSCO lays down standards of drugs, cosmetics, diagnostics and devices and issues licenses to drug manufacturers and importers. It also lays down regulatory measures, amendments to Acts and Rules and regulates market authorization of new drugs, clinical research in India and standards of imported drugs etc. The CDSCO has setup a separate division which is called Medical Device Division in order to facilitate mattes related to Notified Medical Devices.
New Proposed Medical Devices Regulation Bill
 In 2006, the Medical Devices Regulation Bill (MDRB) was proposed by the Ministry of Science and Technology. The MDRB was designed to consolidate laws related to medical devices and establish the Medical Device Regulatory Authority of India (MDRA). This proposal was aimed at establishing and maintaining a national system of controls for the quality, safety and availability of medical devices in India. If enacted, the MDRB will govern all medical devices throughout India. Companies wishing to import devices into India or manufacture products locally will have to comply with the design, manufacturing, packaging, labeling, import, sale, use, and disposal requirements of the MDRB. Also the bill will expand the list of products requiring registration.
 The Bill provides for the creation of a Medical Device Regulatory Authority which has been empowered with extensive powers relating to fining and imprisoning defaulters. Besides looking to harmonize the standards in accordance with the global norms to push the export potentials, the Bill also seeks to lay down concrete norms on import of devices and their conformity with the Indian standards. Standards notified by the Bureau of Indian Standards or other international standards making bodies like International Organization for Standardization (ISO), may be incorporated for harmonization. The Bill seeks to regulate the design, manufacture, packaging, labelling, import, sale, usage and disposal of medical devices in India.
 With a view to raise the level of control on Medical Devices, the Drug Technical Advisory Board (DTAB) in India has submitted the final draft of the guidelines on medical devices and has recommended strict implementation of Indian Conformity Assessment Certificate (ICAC) for the medical devices manufactured, imported and marketed on Indian market under Schedule M III of Drugs & Cosmetics Rules 1945. The Medical Devices have been classified into Class A, B, C & D as per their level and intended use. It is provided that all Medical Devices sold in India (except for custom made devices, meant for a particular patient use) should, as a general rule, bear the Indian Conformity Assessment Certificate mark (ICAC) to indicate their conformity with the provisions of this schedule.
Proposed New Clinical Trial Regulations 
Additionally, the MDRB discusses clinical trials and Clinical Research Organizations (CROs) in India. If the bill is approved, some high-risk medical devices will require local clinical trials in India in addition to foreign clinical data. In general, more-stringent regulations will apply to CROs and clinical trials.
My Comment:
The Indian medical devices and supplies market is at a nascent stage and was estimated at US$2.75 billion in 2008. This is about 1.25% of the global medical devices and supplies market of around US$220 billion in 2008. By 2012, India’s medical devices market is expected to nearly double to around US$5 billion.The production of low value medical supplies and disposables is dominated by domestic manufacturers, whereas the high end medical equipment is generally imported. In the future, due to the huge market opportunity in India, more and more foreign medical device companies are expected to explore Indian market for their products.
With an evolving regulatory situation, medical device companies are required to stay up-to-date in order to achieve success in India. The Indian government is working on a comprehensive regulatory framework for the medical device sector. India’s health authorities plan to issue a set of guidelines to define and regulate medical devices as a separate category.
 The growth of Indian medical devices industry is driven by a host of factors and is sure to see exponential growth in the coming years. Some market drivers for this industry are:
  1. An increase in the Gross Domestic Product growth of the Indian economy
  2. Increase in the Healthcare Expenditure
  3. Improvement of overall health status
  4. Changing of demand pattern for medical devices in India due to a rise of lifestyle-related diseases such as diabetes, cardiovascular disease etc.
  5. Increasing of Medical Tourists
  6. Increasing of medical infrastructures like hospitals, specialized diagnostic centers, laboratories
In a nutshell, continued flow of investment in private sector infrastructure has resulted in a steady increase in the market for medical equipments and supplies. It is estimated that the market will continue to grow. Further, the recent liberalization of trade and investment laws makes India one of the most promising markets for medical device manufacturers. It is predicted that India will be the most populous country in the world by 2050. India will make its mark as a growing market, potential partner in manufacturing and R&D, and as a preferred destination for clinical trials.

Source: CDSCO

drugs and cosmetic act ammendment 2007 review

The Central Drug Authority of India (CDAI) is the principle for the licensing for drugs and cosmetics. 
The Drugs and Cosmetics (Amendment) Bill, 2007 seeks to replace the Drugs Technical Advisory Boards for allopathic and Indian systems of medicine with the Central Drugs Authority (CDA). Drug consultative committees may be established to advise the CDA and central and state governments.
The CDA shall be the licensing authority for the manufacturing, distribution, sale, import and export of drugs and cosmetics. It shall also recommend to the central government standards for drugs and cosmetics, measures to regulate clinical trials, etc.
The 2007 Bill expands the definition of “drugs” to include medical devices. It also defines “clinical trial”, states that all clinical trials require the approval of the CDA, and prescribes penalties for any person violating this provision.
The Standing Committee has submitted its recommendations on the 2005 Bill. It recommended enhanced penalties for spurious and adulterated drugs that lead to prolonged illness. It also suggested separate courts for trying offences under the Act.
The CDA shall be the licensing authority for the manufacture, sale or stocking of drugs and cosmetics. Currently, these functions are delegated to state governments.
The 2007 Bill does not mandate medical and scientific experts in the CDA. A member can be any person with special knowledge of and a minimum of 15 years professional experience in the pharmaceutical industry, public administration, finance or law.
Based on the above Amendment, Recently on the RajSabha T.V had called for the panel discussion of the expert committee. Dr.Sunil Kumar Jain, Chief Pharmacist, AIIMS, Vice-President IPA, New Delhi and R.Narayaswamy, Former Deputy Drug Controller of India, President of IPA, Tamil Nadu.

list of ADR monitoring centers under Pharmacovigilance programme of India (PVPI)


S.No.
Address
Coordinators
Email Address
National Coordinating Centre (NCC)
1
Department of Pharmacology,
 All India Institute of Medical Sciences, New Delhi.
Dr. Y.K. Gupta
National Coordinator
ADR Monitoring Centres (AMC)

  1.  
Department of Pharmacology,                                                        
 Therapeutics & Toxicology,
Govt. Medical College, Bakshi Nagar, Jammu.
Dr. Vishal Tandon

  1.  
Department of Pharmacology,
PGIMER, Chandigarh
Dr. Bikash Medhi

  1.  
Department of Pharmacology,
 R.G. Kar Medical College, Kolkatta
Dr. Anjan Adhikari

  1.  
Department of Pharmacology,
Lady Hardinge Medical College, New Delhi
Dr. H.S. Rehan

  1.  
Department of Clinical Pharmacology,
  Seth GS Medical College & KEM Hospital, Parel, Mumbai
Dr. Urmila Thatte

  1.  
Department of Clinical & Experimental Pharmacology,
 School of Tropical Medicine, Chittaranjan Avenue, Kolkata
Dr. Santanu Tripathi

  1.  
Department of Pharmacology,
JIPMER, Pondicherry
Dr. C Adithan

  1.  
Department of Clinical Pharmacy,
JSS Medical College Hospital, Karnataka
Dr. Parthasarathi G

  1.  
Department of Pharmacology ,
Medical College, Guwahati. Assam
Dr. Mangala Lahkar

  1.  
Institute of Pharmacology,
 Madras Medical College, Chennai
Dr. R Nandini

  1.  
Department of Pharmacology,
SAIMS Medical College, Indore-Ujjain
Dr. Chhaya goyal

  1.  
Department of Pharmacology,
 GSVM Medical College, Swaroop Nagar, Kanpur, U.P.
Dr SP Singh

  1.  
Department of Pharmacology,
Pandit Bhagwat Dayal Sharma, Post Graduate Institute of Medical Sciences,
Rohtak, Haryana.
Dr MC Gupta
dr_mcgupta@yahoo.co.in,
dr.mcgupta57@gmail.com

  1.  
Department of Pharmacology,
Dayanand Medical College and Hospital, Ludhiana, Punjab
Dr. Sandeep Kaushal

  1.  
Department of Clinical Pharmacology,
Sher-i-Kashmir Institute of Medical Sciences, Srinagar, J&K. 
Dr. ZA Wafai

  1.  
Himalayan Institute of Medical Sciences, Dehradun, Uttrakhand
Dr. DC Dhasmana

  1.  
Department of Pharmacology,
Santosh Medical University, Santosh Nagar, Ghaziabad
Dr VC Chopra

  1.  
Department of Pharmacology,
SMS Medical College, Jaipur
Dr. Mukul Mathur
coordpvpimsjp@rediffmail.com

  1.  
Department of Clinical Pharmacology, Christian Medical College,Vellore, Tamil Nadu
Dr. Sujith chandy

Pharm D focuses on the Healthcare- The Hindu