Industrial Pharmacy

Pharmacy benefit manager (PBM) is a third-party administrator of prescription drug programs. PBMs are primarily responsible for developing and maintaining the formulary, contracting with pharmacies, negotiating discounts and rebates with drug manufacturers, and processing and paying prescription drug claims. PBMs also offer programs that provide value and flexibility to participants to help control prescription costs. Some of these areas include information about tablet splitting, lower-cost therapeutic alternatives, and tiered trial of specific medications in a therapeutic class, evaluating clinical programs for large populations, medication therapy management programs, and mail order service.

Specialty drugs are prescribed to treat complex conditions such as cancer, HIV and inflammatory diseases. While these drugs fulfil the promise of modern medicine by enriching and often extending a patient’s quality of life Specialty pharmaceutical spending is on the rise and is expected to increase from approximately $55 billion in 2005 to $1.7 trillion in 2030, according to the Pharmaceutical Care Management Association Specialty drugs are frequently administered by medical professionals at higher-cost treatment sites such as hospitals, infusion centres and physician offices. These drugs also require special handling, administration, patient education, and clinical support -- all of which further drive up their cost Pharmaceutical management teaches how to provide the correct drugs in the correct amount to individuals.

Drug design, sometimes referred to as rational drug design or simply rational design, is the inventive process of finding new medications based on the knowledge of a biological target. Major type of drug designing is ligand-based drug design and the second, is structure-based drug design. Packaging can be defined as an economical means of providing presentation, protection, identification information, containment, convenience and compliance for a product during storage, carriage, display and until the product is consumed. Pharmaceutical packaging has to be carried out for the purpose of Protecting the product from the environment, providing all necessary information for identification of the medicine, enabling accurate dosing and compliance, Ensuring supply-chain integrity of the medicine. Many drug development companies will do all their packaging within a contamination free environment or Cleanroom. Some common pharmaceutical packaging techniques include foil and heat sealing; polyester and olefin package printing; polyethylene and polypropylene printing; and flatbed die cutting. A Pharmacy Benefits Manager, or PBM, is an organization that provides programs and services designed to help maximize drug effectiveness and contain drug expenditures by appropriately influencing the behaviours of prescribing physicians, pharmacists and members. PBM serve as intermediaries between employers and wholesalers, contracting with a network of pharmacies, Developing and managing formularies and prior authorization programs, Operating mail order pharmacies and mail order claims etc.

Pharmacy drugs (A prescription drug, prescription medication or prescription medicine) is a pharmaceutical drug that legally requires a medical prescription to be dispensed. In contrast, over-the-counter drugs can be obtained without a prescription. "Rx" is often used as a short form for prescription drug. He reason for this difference in substance control is the potential scope of misuse, from drug abuse to practicing medicine without a license and without sufficient education. Pharmaceutical marketing, sometimes called medico-marketing or pharma marketing is the business of advertising or otherwise promoting the sale of pharmaceuticals or drugs. Activities conducted as part of pharmaceutical marketing and promotion is an important component of educating and informing consumers and health care professionals about new treatments. Pharmaceutical sales representatives provide doctors with important information about new treatment options that is factored into prescribing, but studies find that many other factors, including insurers’ policies, affect prescribing decisions, often with greater impact. Online pharmacies, also called as online pharmacy, or Mail Order Pharmacies are pharmacies that operate over the Internet and send the orders to customers through the mail or shipping companies. Online or internet pharmacies include Pharmacy benefit manager, A large administrator of corporate prescription drug plans, Legitimate internet pharmacy in the same country as the person ordering etc.

The stages of drug development are Discovery, Product characterization, Formulation, Delivery, Packaging Development, Pharmacokinetics and drug deposition, Preclinical Toxicology Examination and IND Application, Bio analytical Testing, Clinical Trials.

Computational drug discovery is an effective strategy for accelerating and economizing drug discovery and development process. Because of the dramatic rise in the availability of biological macromolecule and small molecule information, the applicability of computational drug discovery has been extended and broadly applied to nearly every stage in the drug discovery and development workflow, including target identification and validation, lead discovery and optimization and preclinical tests. Formulation development is the process in which different chemical substances, including the active drug, are mixed to produce a final medicinal product. Formulation studies involve developing a preparation of the drug which is both stable and acceptable to the patient. Reformulation involves the characterization of a drug's physical, chemical, and mechanical properties in order to choose what other ingredients (excipients) should be used in the preparation. Formulation studies consider factors such as particle size, polymorphism, pH, and solubility, as all of these can influence bioavailability and hence the activity of a drug. Drug design, sometimes referred to as rational drug design or simply rational design, is the inventive process of discovering new medications based on the knowledge of a biological target. The drug is most commonly an organic small molecule that activates or inhibits the function of a biomolecule such as a protein, which in turn results in a therapeutic benefit to the patient. In the most basic sense, drug design and discovery involves the design of molecules that are complementary in shape and charge to the bimolecular target with which they interact and therefore will bind to it. Drug design frequently but not necessarily relies on computer modelling techniques. This type of modelling is often referred to as computer-aided drug design. Finally, drug design that relies on the knowledge of the three-dimensional structure of the bimolecular target is known as structure-based drug design. Major type of drug designing is ligand-based drug design and the second, is structure-based drug design. Pharmaceutical research and development begins with the drug discovery phase. Typically, at this stage, chemical compounds — either naturally occurring (called biologics) or synthetic — are investigated in laboratory settings for their potential to bind. Once promising candidates are identified, preclinical trials begins. In this stage, actual drug development begins and pharmacological studies are carried out. Basically that research focuses on how the drug candidates react when delivered to the body. Then clinical trials are carried out. Candidate drug must pass through before it can be considered for market approval. Accerlated pharmacy programs will also be conducted.

Drug discovery is the process by which new medications are originated.  Historically, drug discovery and development was done through identifying the active ingredient from traditional remedies or by serendipitous discovery. Modern drug discovery process involves the identification of conceal hits, medicinal chemistry and optimization of those hits to increase the affinity, selectivity, efficacy/potency, metabolic stability, and oral bioavailability. Drug design through computer, is a very effective technique in modern arena. Now a days Computer Aided Drug Design (CADD) technologies are used in nanotechnology, biochemistry etc. The main benefit of the CADD is cost effective in research and drug development. There are wide ranges of software’s are used in CADD, are Grid computing, window based general PBPK/PD modelling software etc.  Computer aided drug design is applicable in Cancer disease (anticancer drug discovery), transit of drug to specific site in body, data collections and storages of organics and biologicals. Cancer is the second leading cause of death in Europe and North America. A cancer vaccine is that either treats existing cancer or prevents development of cancer.  Vaccine that treats existing cancer is called as therapeutic cancer vaccines. There does not exist any vaccines which are able to prevent all cancers as of now.

Pharmacists are medication experts who use their detailed knowledge of medicines to help inmates get well. Services include dispensing medications, assuring the safety and appropriateness of the prescribed therapy, monitoring patient health and progress, partnering with consumers and patients to provide education and advice on the use of medications. They also collaborate with physicians, nurses, and other health care team members to provide expertise on drug decisions and improve pharmacy health, patient outcomes, providing knowledge about the composition of drugs and safeguard drug purity and strength. Compounding pharmacists prepare customized prescription medications to meet individual patient needs. They also prepare, mix, assemble, package and label drugs and devices. Overseas pharmacy is nothing but online pharmacy where the pharmacist operates over the Internet and sends the orders to customers through the mail or shipping companies. Risk concern with overseas pharmacy is that some Illegal or unethical pharmacies sometimes send outdated, substituted, or counterfeit medications, Minors or children can order controlled substances without adult supervision, Other concerns include potential lack of confidentiality, improper packaging, inability to check for drug interactions, and several other issues. A community pharmacy is a healthcare facility that emphasizes providing pharmaceutical services to a specific community health. It dispenses pharmacy medication and typically involves a registered pharmacist. Community pharmacists are the health professionals most accessible to the public. They supply medicines in accordance with a prescription or, when legally permitted, sell them without a prescription. In addition to ensuring an accurate supply of appropriate products, their professional activities also cover counselling of patients at the time of dispensing of prescription and non-prescription medicine, drug information to health professionals, patients and the general public, and participation in health-promotion programmes. They maintain links with other health professional in primary health care.

 Compounding pharmacy is the art and science of preparing personalized medications for patients. In general, compounding is a practice in which a licensed pharmacist, a licensed physician, or, in the case of an outsourcing facility, a person under the supervision of a licensed pharmacist, combines, mixes, or alters ingredients of a drug to create a medication tailored to the needs of an individual patient. The traditional role of compounding pharmacies is to make drugs prescribed by doctors for specific patients with needs that can't be met by commercially available drugs.

Clinical trial is a research study that prospectively assigns human participants or groups of humans to one or more health-related interventions to evaluate the effects on health outcomes. Pre-clinical research and conduct of clinical trial is also named as preclinical trials and nonclinical trials is a stage of research that begins before clinical trials, and during which important feasibility, iterative testing and drug safety database is collected. The main goals of pre-clinical trials are to determine the safe dose for First-in-man study and start to assess product's safety profile. A clinical trial is a type of clinical research that follows a pre-defined plan or protocol. Clinical trials are typically conducted in four phases, each phase is considered as separate trial and, after completion of a phase, investigators are required to submit their data for approval from the FDA before continuing to the next phase. The process of identification, analysis and either acceptance or mitigation of uncertainty in investment decision-making  Essentially, risk management occurs anytime an investor or fund manager analyses and attempts to quantify the potential for losses in an investment and then takes the appropriate action given their investment objectives and risk tolerance. Inadequate risk management and data outsourcing can result in severe consequences for companies as well as individuals. Clinical research raises profound ethical and safety questions. The protection of participants in a clinical trial is of paramount importance. With the increasing challenges associated with bringing a medical product to market, and skyrocketing R&D costs, there has been a shift in biopharmaceutical commercialization and clinical trial strategies in order to minimize risk and maximize success.  Moreover, market saturation in many disease modalities is also forcing biopharmaceutical enterprises to focus their efforts on accessing patients with orphan/rare diseases. The future of clinical trials illustrated as follows. Access and engage the patient online – Attract patients to the trial – Consent patients & convert to subjects – Remotely manage subjects & collect data.

Waste by definition is something that the producer no longer requires and therefore discards. In many industries the waste has been to dispose of it as cheaply as possible without much concern as to what happens. Now this altitude is changing as greater environmental safety is reflected. Fly tipped waste can poison and injure children and animals, carelessly disposed of liquid waste such as solvents can leach into ground water and contaminate drinking water supplies, poorly planned and landfills will create significant neighbourhood nuisance. Biomedical waste means “any solid and/or liquid waste including its container and any intermediate product, which is generated during the diagnosis, treatment or immunization of human beings or animals. Biomedical waste poses hazard due to infectivity and other toxicity. biomedical waste consist of Human anatomical waste like tissues, organs and body parts, Animal wastes generated during research from veterinary hospitals, Waste sharps like hypodermic needles, syringes, scalpels and broken glass.

Pharmaceuticals are an important part of maintaining human health, but many pharmaceuticals contain toxic chemicals that can pollute the environment if they are not properly managed and disposed of. Pharmaceutical waste is potentially generated through a wide variety of activities in a healthcare facility. Hazardous waste is waste that is dangerous or potentially harmful to our health or the environment. Hazardous wastes can be liquids, solids, gases, or sludge’s. They can be discarded commercial products, like cleaning fluids or pesticides, or the by-products of manufacturing processes. Toxic wastes are poisons, even in very small or trace amounts. They may have acute effects, causing death or violent illness. Several options are available for hazardous-waste management. The most desirable is to reduce the quantity of waste at its source or to recycle the materials for some other productive use. Environmental responsibility and stewardship is the key to any industrial Waste Disposal program. Some of the best waste management practices include Reduce unused pharmaceuticals by reviewing purchasing practices, using limited dose or unit dose dispensing, replacing pharmaceutical samples with vouchers, and performing on-going inventory control and stock rotation. Segregate waste for disposal to ensure regulations are met and to reduce costs (e.g., non-hazardous pharmaceutical waste disposal in a solid waste landfill may be less expensive than disposal via hazardous waste hauler).

Good Manufacturing Practices is the aspect of quality assurance that ensures that medicinal products are consistently produced and controlled to the quality standards appropriate to their intended use and as required by the product specification. GMP defines quality measures for both production and quality control and defines general measures to ensure that processes necessary for production and testing are clearly defined, validated, reviewed, and documented, and that the personnel, premises and materials are suitable for the production of pharmaceuticals and biologicals including vaccines. GMP Quality Audits are necessary for assessment of self-inspection in the regulatory aspects of GLP/GCP interface. Roles of pharmaceutical inspection convention and co-operation scheme (PIC/S) are to improve co-operation in the field of Good Manufacturing Practices between regulatory authorities and the pharmaceutical industry.EU-GMP guidelines are needed to maintain the quality which is stricter when compared to WHO-GMP guidelines.CGMP (Current good manufacturing practice guidelines) Quality Principles for Biologics and Medical Devices are required to maintain product compliance.

Good Clinical Practice (GCP) is an international ethical and scientific quality standard for designing, conducting, recording and reporting trials that involve the participation of human subjects. The GLP Principles describe requirements for and provide general guidance on the conduct of all nonclinical health and environmental safety studies, including invitro studies. Good laboratory practice should be followed for pre-clinical trials. The role of Quality Impact Assessment & effectiveness checks is an essential operation of the pharmaceutical industry. Quality Control Technicians are responsible for assuring quality of the product through all day-to-day operations. They assist the bio manufacturing plant by evaluating raw materials, other supplies and the finished, packaged product. They ensure compliance to common Good Manufacturing Practices. Quality control also plays a major role in analytical method development. General Quality Management is very important for pharmaceutical industries to produce the better product and ensure the maximum safety of healthcare system and also protect waste of money for both government & individual consumers Quality assurance testing is done by using software called Quality Metrics.

Regulatory Affairs is a profession which has developed from the desire of governments to protect public health, by controlling the safety and efficacy of healthcare products in areas including pharmaceuticals, veterinary medicines, medical devices, pesticides, agrochemicals, cosmetics and complementary medicines. The Regulatory professional's roles and responsibilities typically begin within the analysis and development phases, going in clinical trials and lengthening through premarket approvals, producing, labelling and advertising and postmarked police work best in both Biologics and biotechnology products. The novel Regulatory aspects include Novel Drug Discovery Systems, Medical Affairs, Active Pharmaceutical Ingredients, and Licensing in pharmaceutical production, packaging materials and pharmaceutical excipients. Licensing in pharmaceutical production is mandatory step for pharmaceutical products (regulatory requirement for pharmaceutical products). Principal ideas of Intellectual Property Management (IPM) and its importance as a spur to human power and therefore the advancement of economic and social development. It additionally provides rationalization on the event Associate in implementation of an IPM strategy together with the management of material possession. Patents in the pharmaceutical industry include both legal and ethical issues. As outlined in WHO's Guiding Principles for Small National Drug Regulatory Authorities (1) an important task for a drug regulatory authority (DRA) is to institute a system which subjects all pharmaceutical products to premarketing evaluation, marketing authorization and post marketing review to ensure that they conform to required standards of quality, safety and efficacy. Quality of beginning materials, instrumentality labelling, pharmacology, medical specialty and clinical information, Product data, Interchange ability, issue of written marketing authorizations variations, community Code on medicinal products, periodic reviews, suspension and revocation of selling authorization must be checked in marketing authorization.

Veterinary science is vital to study and protection of livestock. The Global veterinary healthcare market, estimated at $24.8 Billion in 2014, is set to reach $34.39 Billion by 2019. Veterinary healthcare market is gaining importance as a result of manufacturers focus on production of products with specialized formulations and specialized manufacturing processes. The research and marketing of veterinary medicines are, therefore, more complicated compared to human medicines. Animal breeding and genetics provide advance breeding technology and testing services such as DNA typing, genetic trait tests, and genetic disease tests. The animal genetics market is segmented by products, testing services, and by geography. Based on type of product, the market is mainly segmented into live animals and genetic material. The global dairy herd management market was valued at $823.65 million in 2013 and is expected to reach $1,511.91 million by 2018, at a CAGR of 12.92% between 2013 and 2018. Dairy cattle management products are rapidly gaining widespread acceptance in the dairy industry primarily due to the increased demand for dairy products. The U.S. poultry production industry is the world's largest producer, its second-largest exporter of poultry meat, and a major egg producer. The poultry and egg industry is a major user of feed grains. Animal testing, also known as animal experimentation, animal research, and in vivo testing, is the use of non-human animals in experiments. The Animal Biotechnology industry has experienced strong growth during the past five years. Since 2010, industry revenue is expected to rise at an average annual rate of 5.0% to $8.7 billion.

A natural product is a compound or substance produced by a living organism that is, found in nature. In the broadest sense, natural products include any substance originated by life. The products contain complex mixture of many medicinal plant metabolites, such as Natural products: Alkaloids, steroids, flavonoids, and triterpinoids.Phytochemistry is nothing but the branch of chemistry concerned with plants and plant products. .Exposure of skin to sunlight and other atmospheric conditions causes the production of reactive oxygen species, which can react with DNA, proteins, and fatty acids, causing oxidative damage and impairment of antioxidant by using different system. Chromatography and powerful tool of detection of Phytoconstituents of their helpful instruments like Identification: UV, IR, NMR, Mass spectroscopy. The dominant separation technique High-performance liquid chromatography is a technique in analytical chemistry used to separate the components in a mixture, to identify each component, and to quantify each component-Ray diffraction is a tool used for identifying the atomic and molecular structure of a crystal.

The art or practice of using herbs and herbal preparations to maintain health and to prevent, or cure disease and a plant or plant part or an extract or mixture of these used in herbal medicine by the Extraction method of drug formulation. A pharmacological study of Herbal drugs is a method of using natural herbs and plants to promote physical, emotional, and spiritual health. Recent efforts into the research and development of Natural products as markers for new drug discovery of anti-cancer drugs have led to the identification of a variety of Terpenoids that inhibit cancer cell proliferation and metastasis via various mechanisms.  Phytochemical evaluation of plant drug Now day’s pharmaceutical companies start processing of medicinal and aromatic plants in their formulation by using extraction of active components there are several processes like distillation, effleurage, maceration, expression, solvent extraction and fluid extraction are available for extraction of plant component and which includes Moisture content, total ash, acid insoluble ash, water soluble ash, water soluble Extractive value, alcohol soluble Extractive value, Phytochemical screening, and further isolation and identification of phytoconstituents.Natural products can also be prepared by chemical synthesis (both semisynthesis and total synthesis) and have played a crucial role in the development of the field of organic chemistry by providing challenging synthetic targets. Identity, purity, and quality of Crude drugs is a Standardization of drugs means confirmation of its identity, determination of its quality, purity and detection of nature of adulterant by various parameters like morphological, microscopically, physical, chemical and biological evaluations. Plant tissue culture is widely used to produce clones of a plant in a method known as micro propagation. Plant biotechnology may be defined as the application of knowledge obtained from study of the life sciences to create technological improvements in plant species.

Industrial pharmacists research drug compounds and flourish new medications based on research. They test medicines for efficiency and security, oversee the manufacturing process to ensure medications are produced accurately, and they engage marketing and promoting new drugs to consumers, hospitals and doctors' offices. An industrial pharmacist may also be pledged for conducting clinical trials and evaluating the outcome of these trials to gauge a drug’s effectiveness and to determine potential risks or side effects. As part of a clinical drug trial, industrial pharmacists collaborate with other pharmaceutical companies, local and federal governments, and a variety of health care professionals to ensure trials are conducted safety and within federal or state guidelines for drug testing. Pharmacists must have a Doctor of Pharmacy degree from an accredited college or university. To gain admission to a doctorate program in pharmacy, applicants must complete course work in anatomy and physiology, general biology, general chemistry, microbiology, organic chemistry, physics, immunology research, biochemistry, statistics, calculus, economics and the liberal arts. Pharmacists must be licensed by the state in which they intend to practice. Licensing requires successfully passing two comprehensive exams.