Business Environment and Job Opportunities in USA

By Darshan Jamindar PhD IIP Indore

Contents
Overview Courses offered USA Drug Pharmacy Act USFDA Pharmacy Management Scope

What is Pharmacy?

Branch of science.
Study of chemistry of drugs, origin.

Procedures for drug development.

Their preparation, dispensing, their effects. Use for prevention and treatment of disease.

Courses Offered

Diploma in Pharmacy- 2 yrs. Pharmacy Technician 1 year. Baccalaureate in Pharmacy- 4 yrs. Master of Pharmacy- 2 yrs. (Pharmaceutics, Pharmachemistry, Pharmacognosy) Pharm. D- 6 yrs.( Integrated course, USA) MS PhD- 4-6 yrs, ( India, USA) D.Phil 4 yrs. UK. B.Pharm MBA.

Universities in USA
GMAT TOEFL/IELTS www.usc.edu www.stjohns.edu www.umkc.edu www.licester.edu www.sdsu.edu www.aaps.edu www.columbia.edu www.auburn.edu www.usc.edu
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From: SK Gershon, JM Cultice, KK Knapp, How Many Pharmacists are in our Future. www.hhs.gov/pharmacy/phpharm/howmany.html presented at ASHP June 5, 2000

Pharmacy Graduates in USA in 2020

Scope and Work environment

Hospitals Colleges and universities Community pharmacies Health maintenance organizations Clinics Military Pharmaceutical industry Public health departments Retail drug chains (CVS , Walgreens)

Diploma in Pharmacy
Govt./Semi Govt./Private Hospitals. Own Medical Store.

Retail
Retail pharmacists In medical retail stores, the pharmacist prepares and dispenses drugs on prescription to the general consumer . The pharmacist monitors the drug sale on the basis of prescriptions and dosages, and gives over the counter advice.

Bachelor in Pharmacy
Medical representative- medical detailing man, Marketing Managers -Sales Manager. Drug Inspectors. Drug Controllers. Graduate Pharmacist. Chief Pharmacist. As Lecturers for D.Pharm.

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What is USFDA
Federal Agency of US Department of Health and Human Services. Responsible for protecting public health by assuring safety, efficacy and security of human and veterinary drugs,biological products, medical devices, food supply, cosmetics and products that emit radiation. Responsible for making medicines more effective, safer,and affordable. Helping public to get science based information to use medicines and foods to maintain and improve their health.

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USFDA
Responsible for regulating the manufacturing ,marketing and distribution of tobacco products to protect the public health and to reduce tobacco use by minors FDA plays significant role in counterterrorism capability Ensures the security of the food supply Development of medical products Responding to naturally emerging public health threats.

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FDA Regulation
Drugs Product approvals OTC and prescription drug labeling Drug manufacturing standards Cosmetics Safety Labeling Biologics Product and manufacturing establishment licensing Safety of the nations blood supply Research to establish product standard and develop improved testing methods

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Foods Labeling Safety of all food products Bottled water Medical Devices Pre-market approval of new devices Manufacturing and performance standards Tracking reports of device malfunctioning and serious adverse reaction Radiation Emitting Electronic Products Radiation safety performance standards for microwave owens, television receivers, diagnostic X-ray equipment ,cabinet X-rays laser products, ultrasonic therapy equipment ,mercury vapor lamps and sunlamps. Veterinary Products Livestock feed Pet foods Veterinary drugs and devices.
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What FDA doesnt regulate

Advertising Federal Trade Commision Presciption drugs and medical devices

Alcohol- Department of justice bureau of alcohol, tobacco firearms and explosive.

Consumer products Consumer product safety commission Drugs of abuse- Drug Enforcement Agency Health Insurance-Center for Medicare and Medicaid Services Pesticides-Environment protection agency Water-Environment protection Agency.

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Careers in USFDA
Student Intern Programs Summer student Research Program at National Center for Toxicological research Visiting pediatric Pharmacology fellows rotation at center for drug evaluation and research International scientist exchange program NCTR Medical device fellowship program Pharmacy student experiantial program Faculty research program NCTR Federal career intern program Office of policy and planning internship program

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Hospital Pharmacy
Procure, stock, prepare and dispense medicines. Medical accessories. Responsibility for stock control, storage, placing orders, labeling and financial budgeting and account-keeping for the dispensary. The pharmacists are expected to meet patients, doctors and nurses to discuss the supply of medicines and the appropriate form of drugs for administration.

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Sales and Marketing

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Prescription Drug Marketing Act 1988

To ensure that prescription drug products purchased by consumers would be safe and effective To avoid an unacceptable risk that counterfeit, adulterated , misbranded, or expired drugs were being sold to public .

Amendments: 2000 21CFR parts 203 and 205. It requires that certain wholesalers provide a statement prior to each wholesale distribution of prescription drugs. State licensing of wholesale distributors

Prohibits the sale of or offer to sell prescription drugs that have been purchased
by a hospital or that have been donated or supplied to a charitable organization.

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Pharmaceutical Management
Pharmaceutical management represents whole set of activities aimed at ensuring the timely availability and appropriate use of safe, effective quality medicines and related products.

Bid: Document prepared in response to an expression of procurement needs. Cold Chain: Distribution system used for the storage and transport of medicines that require refrigeration. Essential medicines: The World Health Organization (WHO) defines essential medicines as the limited number of medicines that satisfy the needs of the majority of the population and that should be available at all times. Countries often publish a national essential medicines list (NEML) that identifies the medicines considered to be most important and relevant for the public health needs of that population.

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Distribution System
Push/pull systems: Push and pull are two types of distribution systems In push systems, quantities of supplies and the schedule for their delivery to facilities are determined at a higher (usually central) level with little to no input from lower levels. In pull systems, facilities provide information on actual consumption and needs estimates to higher levels.

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Trace Product List

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How Does Pharmaceutical Management Work?

Set of practices aimed at ensuring the timely availability and appropriate use of safe, effective, quality medicines, health products, and services in any health care setting. These activities are organized according to functional components of a cycle or system and may take place at various levels of the health system according to the design of the health system.

The components are the same for all sectors although procedures and activities within each component may differ.
Activities in the pharmaceutical management system are related to the selection of products that are to circulate in the supply system and to their procurement, distribution, and use

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Source Management Science for Health

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The pharmaceutical management cycle operates within and is affected by apolitical, legal, and regulatory framework. This framework defines health priorities that have an impact on the following The types of products and services that can or should be offered at different types of facilities. The types of personnel needed and required qualifications for carrying out various responsibilities related to the functioning of the cycle. Quality assurance standards and financial requirements to be met. This cycle applies to the public and private sectors. The capacity to carry out these activities is mediated by the level of management support that is available. Management support includes information systems, human resource capacity, and financial resources.
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Overall Health system Profile

What is the participation of various levels of care in the public healthcare system? o Primary level of care (e.g., health post or clinic) o Secondary level of care (e.g., district hospital) o Tertiary level of care (e.g., specialized hospital) What has been the countrys experience with health sector reform? (e.g.decentralization, privatization)

Are NGOs present in the country? What is their role?

What are the prevalence and incidence of major health problems? What role do donors play in managing and providing pharmaceuticals? What trade issues apply, including the influence of global and regional trade agreements or initiatives (e.g., North American Free Trade Agreement, Central American Free Trade Agreement, Economic Community of West African States, Association of Southeast Asian Nations, World Trade Organization. )

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Main areas of Pharmaceutical Management

A. Pharmaceutical Policy, Laws, and Regulations B. Selection of Pharmaceuticals C. Procurement. D. Storage and Distribution E. Appropriate Use F. Availability G. Access to Quality Products and Services H. Financing Pharmaceuticals

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Pharmaceutical Management flow

Source Management Sciences for Health

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Direct Delivery Model

Source Management Sciences for Health

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Selection Cycle

Source Management Sciences for Health

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Pharmaceutical Procurement Cycle

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The Distribution Cycle

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Procurement
The primary purpose of procurement is to provide regular delivery of adequate quantities of high-quality supplies at the lowest cost, down to the facility level. Some steps of the procurement process may be centralized whereas others take place at the local level. Understanding where the various steps of procurement take place is critical. It will contribute to identifying the appropriate stakeholders to interview. For example Centralized system: Procurement is conducted at central level by a national procurement unit. Decentralized system: Procurement is conducted by subnational entities, including regional or provincial authorities and facilities. Mixed systems: In some systems that have decentralized as a result of health sector reform, pharmaceutical systems have been redesigned to maintain economies of scale at the central level, so prices may be tendered or negotiated at the central level and actual purchases from approved suppliers at approved prices are made at the local level by budgetary units.

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Storage and Distribution

The storage and distribution topical area includes all activities related to managing an inventory.

Ordering, receiving, storing, issuing, and reordering supplies. These activities may take place at various levels of the system.

The goals of inventory management are to protect stored items from loss, damage, theft, or wastage, and to manage the reliable movement of supplies from source to user in the least expensive way.

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Appropriate Use
The aim of any pharmaceutical management system is to deliver the correct product to the client/patient who needs it. The steps of selection, procurement, and distribution are necessary precursors to the rational use of medicines. The rational use of medicines means that client/patients are prescribed and dispensed the full amount of the appropriate, high-quality medicine.

That clients/patients take the medicines correctly and without interruption.

The appropriate use of pharmaceuticals and should be explored for both the public and private sectors.

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Availability
Physical availability is defined by the relationship between the location, time, type, and quantity of product or service needed and the location, time, type, and quantity of the product or service provided. Pharmaceutical management system should be measured repeatedly over a period . Sufficient to cover at least one procurement cycle, preferably three. It should be measured at all relevant points in the distribution system (central, regional, and municipal medical stores; health facilities; and pharmacies) and in all relevant sectors (public, private, and NGO). To measure and to keep focused on priority issues, a sample list of tracer products should be used

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Financing Pharmaceuticals
Because pharmaceuticals save lives and improve health, financing systems must help ensure access to essential medicines for all segments of the population.

Most countries rely on a diverse set of financing mechanisms for pharmaceuticals.

Sources of funding may include public financing based on national budgets, donor contributions, and direct private spending or indirect spending through insurance programs.

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Summary of Findings

MSH and WHO (Management Sciences for Health and World Health Organization). 1997. Managing Drug Supply. 2nd ed. West Hartford, CT: Kumarian Press.

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NMP:National Medicine Policy MOH: Ministry of Health

Industrial Pharmacy

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Industrial pharmacists
While most firms are involved in the production of preformulated preparations, a growing number of firms are developing new formulations through autonomous research work. Industrial pharmacists carry out clinical trials. 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.

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Research and development

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 Basic research Clinical Research Phase I,II,III and IV trials Drug development

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Clinical Trials

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Research clinical trials

Clinical Research Scientist Monitor clinical trials Drug inventory Liason

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Regulatory Affairs
FDA interaction New product information Government affairs Promotional regulatory affairs. New Drug Applications Approval for new product

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Scientific information

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Medical Information scientist Market Development scientist Medical Marketing scientist Marketing strategy executives Clinical research associates

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Academics
Lecturers for pharmacy Colleges. Basic degree for Ph.D., Research Assistant or Research Associate. Pharmacy teachers with B.Pharm having 5 years of teaching experience.

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Why Pharmacy
A very noble and respected profession. Involves helping the Peoples health. Excellent employment opportunities . Involves variety of task to be performed.

A vital part of health care team

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Why Pharmacy Excellent earning potential Provides continues learning opportunities Outstanding career opportunities. Makes you independent. You can take your pharmaceutical skills any where in country or for that matter world

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