Pharmacists practice in a variety of areas including community pharmacies, infusion pharmacies, hospitals, clinics, insurance companies, medical communication companies, research facilities, pharmaceutical companies, extended care facilities, psychiatric hospitals, and regulatory agencies. Pharmacists themselves may have expertise in a  medical specialty .


A  pharmacy  (also known as a  chemist  in  Australia ,  New Zealand  and the  British Isles ; or  drugstore  in  North America ;  retail pharmacy  in industry terminology; or  apothecary , historically) is where most pharmacists practice the profession of pharmacy. It is the community pharmacy in which the dichotomy of the profession exists; health professionals who are also retailers.


Community pharmacies usually consist of a retail storefront with a dispensary, where medications are stored and dispensed. According to Sharif Kaf al-Ghazal, the opening of the first drugstores are recorded by  Muslim  pharmacists in  Baghdad  in 754 AD. [ 11 ] [ 19 ]


Pharmacies within  hospitals  differ considerably from community pharmacies. Some pharmacists in hospital pharmacies may have more complex clinical medication management issues, and pharmacists in community pharmacies often have more complex business and customer relations issues.


Because of the complexity of medications including specific indications, effectiveness of treatment regimens, safety of medications (i.e., drug interactions) and  patient compliance  issues (in the hospital and at home), many pharmacists practicing in hospitals gain more education and training after pharmacy school through a pharmacy practice residency, sometimes followed by another residency in a specific area. Those pharmacists are often referred to as clinical pharmacists and they often specialize in various disciplines of pharmacy.


For example, there are pharmacists who specialize in hematology/oncology, HIV/AIDS, infectious disease, critical care,  emergency medicine , toxicology, nuclear pharmacy, pain management, psychiatry, anti-coagulation clinics,  herbal medicine , neurology/epilepsy management, pediatrics, neonatal pharmacists and more.


Hospital pharmacies can often be found within the premises of the hospital. Hospital pharmacies usually stock a larger range of medications, including more specialized medications, than would be feasible in the community setting. Most hospital medications are unit-dose, or a single dose of medicine.  Hospital pharmacists and trained pharmacy technicians compound sterile products for patients including  total parenteral nutrition  (TPN), and other medications are given intravenously. That is a complex process that requires adequate training of personnel,  quality assurance  of products, and adequate facilities.


Several hospital pharmacies have decided to  outsource  high-risk preparations and some other compounding functions to companies who specialize in compounding. The high cost of medications and drug-related technology and the potential impact of medications and pharmacy services on patient-care outcomes and patient safety require hospital pharmacies to perform at the highest level possible.


Pharmacists  provide direct patient care services that optimize the use of medication and promotes health, wellness, and disease prevention. [ 20 ]   Clinical pharmacists  care for patients in all  health care  settings, but the clinical pharmacy movement initially began inside  hospitals  and  clinics . Clinical pharmacists often collaborate with  physicians  and other healthcare professionals to improve pharmaceutical care. Clinical pharmacists are now an integral part of the interdisciplinary approach to patient care. They often participate in patient care rounds for drug product selection. In the UK clinical pharmacists can also prescribe some medications for patients on the NHS or privately, after completing a non-medical prescribers course to become an Independent Prescriber. [ 21 ]


The clinical pharmacist's role involves creating a comprehensive drug therapy plan for patient-specific problems, identifying goals of therapy, and reviewing all prescribed medications prior to dispensing and administration to the patient. The review process often involves an evaluation of the appropriateness of drug therapy (e.g., drug choice, dose, route, frequency, and duration of therapy) and its efficacy. Research shows that pharmacist led strategies reduce errors related to medication use. [ 22 ]   The pharmacist must also consider potential drug interactions, adverse drug reactions, and patient drug allergies while they design and initiate a drug therapy plan. [ 23 ]


Since the emergence of modern clinical pharmacy, ambulatory care pharmacy practice has emerged as a unique pharmacy practice setting. Ambulatory care pharmacy is based primarily on pharmacotherapy services that a pharmacist provides in a clinic. Pharmacists in this setting often do not dispense drugs, but rather see patients in-office visits to manage chronic disease states.


In the U.S. federal health care system (including the VA, the Indian Health Service, and NIH) ambulatory care pharmacists are given full independent prescribing authority. In some states, such as  North Carolina  and  New Mexico , these pharmacist clinicians are given collaborative prescriptive and diagnostic authority. [ 24 ]  In 2011 the board of Pharmaceutical Specialties approved ambulatory care pharmacy practice as a separate board certification. The official designation for pharmacists who pass the ambulatory care pharmacy specialty certification exam will be Board Certified Ambulatory Care Pharmacist and these pharmacists will carry the initials BCACP. [ 25 ]


Compounding involves preparing drugs in forms that are different from the generic prescription standard. This may include altering the strength, ingredients, or dosage form. [ 26 ]  Compounding is a way to create custom drugs for patients who may not be able to take the medication in its standard form, such as due to an allergy or difficulty swallowing. Compounding is necessary for these patients to still be able to properly get the prescriptions they need.


One area of compounding is preparing drugs in new dosage forms. For example, if a drug manufacturer only provides a drug as a tablet, a compounding pharmacist might make a medicated  lollipop  that contains the drug. Patients who have difficulty swallowing the tablet may prefer to suck the medicated lollipop instead.


Another form of compounding is by mixing different strengths (g, mg, mcg) of capsules or tablets to yield the desired amount of medication indicated by the  physician ,  physician assistant ,  nurse practitioner , or  clinical pharmacist practitioner . This form of compounding is found at community or hospital pharmacies or in-home administration therapy.


Compounding pharmacies specialize in compounding, although many also dispense the same non-compounded drugs that patients can obtain from community pharmacies.


Consultant pharmacy practice focuses more on medication regimen review (i.e. "cognitive services") than on actual dispensing of drugs. Consultant pharmacists most typically work in  nursing homes , but are increasingly branching into other institutions and non-institutional settings. [ 27 ]  Traditionally [ where? ]  consultant pharmacists were usually independent business owners, though in the United States many now work for a large pharmacy management company such as  Omnicare ,  Kindred Healthcare  or  PharMerica . This trend may be gradually reversing [ citation needed ]  as consultant pharmacists begin to work directly with patients, primarily because many elderly people are now taking numerous medications but continue to live outside of institutional settings. Some community pharmacies employ consultant pharmacists and/or provide consulting services.


The main principle of consultant pharmacy is developed by Hepler and Strand in 1990. [ 28 ] [ 29 ]


Veterinary pharmacies, sometimes called  animal pharmacies , may fall in the category of hospital pharmacy, retail pharmacy or mail-order pharmacy. Veterinary pharmacies stock different varieties and different strengths of medications to fulfill the pharmaceutical needs of animals.  Because the needs of animals, as well as the regulations on  veterinary medicine , are often very different from those related to people, in some jurisdictions veterinary pharmacy may be  kept separate from regular pharmacies.


Nuclear pharmacy focuses on preparing radioactive materials for diagnostic tests and for treating certain diseases. Nuclear pharmacists undergo additional training specific to handling radioactive materials, and unlike in community and hospital pharmacies, nuclear pharmacists typically do not interact directly with patients.


Military pharmacy is a different working environment to civilian practise because military pharmacy technicians perform duties such as evaluating medication orders, preparing medication orders, and dispensing medications. This would be illegal in civilian pharmacies because these duties are required to be performed by a licensed registered pharmacist. [ 30 ]  In the US military, state laws that prevent technicians from counseling patients or doing the final medication check prior to dispensing to patients (rather than a pharmacist solely responsible for these duties) do not apply.


Pharmacy informatics is the combination of pharmacy practice science and applied information science. [ 31 ]  Pharmacy informaticists work in many practice areas of pharmacy, however, they may also work in information technology departments or for  healthcare information technology  vendor companies.  As a practice area and specialist domain, pharmacy informatics is growing quickly to meet the needs of major national and international patient information projects and health system interoperability goals. Pharmacists in this area are trained to participate in medication management system development, deployment, and optimization.


Specialty pharmacies supply high-cost injectable, oral, infused, or inhaled medications that are used for chronic and complex disease states such as cancer, hepatitis, and rheumatoid arthritis. [ 32 ]  Unlike a traditional community pharmacy where prescriptions for any common medication can be brought in and filled, specialty pharmacies carry novel medications that need to be properly stored, administered, carefully monitored, and clinically managed. [ 33 ]  In addition to supplying these drugs, specialty pharmacies also provide lab monitoring, adherence counseling, and assist patients with cost-containment strategies needed to obtain their expensive specialty drugs. [ 34 ]  In the US, it is currently the fastest-growing sector of the pharmaceutical industry with 19 of 28 newly FDA approved medications in 2013 being specialty drugs. [ 35 ]


Due to the demand for clinicians who can properly manage these specific patient populations, the Specialty Pharmacy Certification Board has developed a new certification exam to certify specialty pharmacists. Along with the 100 questions computerized multiple-choice exam, pharmacists must also complete 3,000 hours of specialty pharmacy practice within the past three years as well as 30 hours of specialty pharmacist continuing education within the past two years. [ 36 ]


The pharmaceutical sciences are a group of  interdisciplinary  areas of study concerned with the  design ,  manufacturing ,  action ,  delivery , and  classification  of  drugs . They apply knowledge from  chemistry  ( inorganic ,  physical ,  biochemical  and  analytical ),  biology  ( anatomy ,  physiology ,  biochemistry ,  cell biology , and  molecular biology ),  epidemiology ,  statistics ,  chemometrics ,  mathematics ,  physics , and  chemical engineering . [ 37 ]


The pharmaceutical sciences are further subdivided into several specific  specialties , with four main branches:


As new discoveries advance and extend the pharmaceutical sciences, subspecialties continue to be added to this list. Importantly, as  knowledge  advances, boundaries between these specialty areas of pharmaceutical sciences are beginning to blur. Many fundamental concepts are common to all pharmaceutical sciences. These shared fundamental concepts further the understanding of their applicability to all aspects of  pharmaceutical research  and  drug therapy .


Pharmacocybernetics  (also known as pharma-cybernetics, cybernetic pharmacy, and cyber pharmacy) is an emerging field that describes the science of supporting drugs and medications use through the application and evaluation of informatics and internet technologies, so as to improve the  pharmaceutical care  of patients. [ 43 ]


The word  pharmacy  is derived from  Old French   farmacie  "substance, such as a food or in the form of a medicine which has a laxative effect" from  Medieval Latin   pharmacia  from  Greek   pharmakeia  ( Ancient Greek :  φαρμακεία ) "a medicine", which itself derives from  pharmakon  ( φάρμακον ), meaning "drug,  poison ,  spell " [ 44 ] [ 45 ] [ a ]  (which is etymologically related to  pharmakos ).


Separation of prescribing and dispensing, also called dispensing separation, is a practice in  medicine  and pharmacy in which the  physician  who provides a  medical prescription  is independent from the  pharmacist  who provides the  prescription drug .


In the  Western world  there are centuries of tradition for separating pharmacists from physicians. In Asian countries, it is traditional for physicians to also provide drugs.


In contemporary time researchers and health policy analysts have more deeply considered these traditions and their effects. Advocates for separation and advocates for combining make similar claims for each of their conflicting perspectives, saying that separating or combining reduces  conflict of interest in the healthcare industry ,  unnecessary health care , and lowers costs, while the opposite causes those things. Research in various places reports mixed outcomes in different circumstances.


In 2022 the  Organisation for Economic Co-operation and Development  proposed that pharmaceutical companies should be required to collect and destroy unused or expired medicines that they have put on the market in order to reduce public health risks around the misuse of medicines obtained from waste bins, the development of antimicrobial resistant bacteria from the discharge of antibiotics into environmental systems and "economic losses" from wasted healthcare resources.  Potentially harmful concentrations of pharmaceutical waste has been detected  in more than a quarter of water samples taken from 258 rivers around the world.  OECD recommend that medicines should be collected separately from household waste and that  "marketplaces and redistribution platforms for unused close-to-expiry-date medicines" should be set up.  Such extended producer responsibility schemes are already running in France, Spain and Portugal. [ 47 ]


In the coming decades, pharmacists are expected to become more integral within the  health care system . Rather than simply dispensing medication, pharmacists are increasingly expected to be compensated for their patient care skills. [ 48 ]  In particular,  Medication Therapy Management  (MTM) includes the clinical services that pharmacists can provide for their patients.  Such services include a thorough analysis of all medication ( prescription , non-prescription, and herbals) currently being taken by an individual.  The result is a reconciliation of medication and patient education resulting in increased patient health outcomes and decreased costs to the health care system. [ 49 ] [ unreliable source? ]


This shift has already commenced in some countries; for instance, pharmacists in  Australia  receive remuneration from the  Australian Government  for conducting comprehensive Home Medicines Reviews. In Canada, pharmacists in certain provinces have limited prescribing rights (as in Alberta and British Columbia) or are remunerated by their provincial government for expanded services such as medications reviews (Medschecks in Ontario). In the United Kingdom, pharmacists who undertake additional training are obtaining prescribing rights and this is because of  pharmacy education . They are also being paid for by the government for  medicine use reviews . In Scotland, the pharmacist can write prescriptions for Scottish registered patients of their regular medications, for the majority of drugs, except for controlled drugs, when the patient is unable to see their doctor, as could happen if they are away from home or the doctor is unavailable. In the United States, pharmaceutical care or  clinical pharmacy  has had an evolving influence on the practice of pharmacy. [ 50 ]  Moreover, the  Doctor of Pharmacy  (Pharm. D.) degree is now required before entering practice and some pharmacists now complete one or two years of residency or fellowship training following graduation.  In addition,  consultant pharmacists , who traditionally operated primarily in  nursing homes , are now expanding into direct consultation with patients, under the banner of "senior care pharmacy". [ 51 ]


In addition to patient care, pharmacies will be a focal point for medical adherence initiatives. There is enough evidence to show that integrated pharmacy based initiatives significantly impact adherence for chronic patients. For example, a study published in NIH shows "pharmacy based interventions improved patients' medication adherence rates by 2.1 percent and increased physicians' initiation rates by 38 percent, compared to the control group". [ 52 ]


The  symbols  most commonly associated with pharmacy are the  mortar and pestle  (North America) and the ℞ ( medical prescription ) character, which is often written as "Rx" in typed text; the green  Greek cross  in  France ,  Argentina , the  United Kingdom ,  Belgium ,  Ireland ,  Italy ,  Spain , and  India ; the  Bowl of Hygieia  (only) often used in the  Netherlands  but may be seen combined with other symbols elsewhere. Other common symbols include  conical measures , and (in the US)  caduceuses , in their  logos .  A red stylized letter A in used  Germany  and  Austria  (from  Apotheke , the  German  word for pharmacy, from the same  Greek  root as the  English  word " apothecary "). The  show globe  was used in the US until the early 20th century; the  Gaper  in the Netherlands is increasingly rare.


A  pharmacist , also known as a  chemist  in  Commonwealth English , is a  healthcare professional  who is knowledgeable about preparation, mechanism of action, clinical usage and legislation of  medications  in order to dispense them safely to the public and to provide consultancy services. [ 1 ] [ 2 ]  A pharmacist also often serves as a  primary care  provider in the community and offers services, such as health screenings and immunizations.


Pharmacists undergo university or graduate-level education to understand the biochemical mechanisms and actions of drugs, drug uses, therapeutic roles, side effects, potential  drug interactions , and monitoring parameters. This is mated to  anatomy ,  physiology , and  pathophysiology . Pharmacists interpret and communicate this specialized knowledge to patients,  physicians , and other health care providers.


Among other licensing requirements, different countries require pharmacists to hold either a  Bachelor of Pharmacy ,  Master of Pharmacy , or a  Doctor of Pharmacy  degree.


The most common pharmacist positions are that of a  community pharmacist  (also referred to as a  retail pharmacist ,  first-line pharmacist  or  dispensing chemist ), or a  hospital pharmacist , where they instruct and counsel on the proper use and adverse effects of medically prescribed drugs and medicines. [ 3 ] [ 4 ]  In most countries, the profession is subject to professional regulation. Depending on the legal  scope of practice , pharmacists may contribute to prescribing (also referred to as " pharmacist prescribers ") and administering certain medications (e.g., immunizations) in some jurisdictions. Pharmacists may also practice in a variety of other settings, including industry, wholesaling, research, academia, formulary management, military, and government.


Historically, the fundamental role of pharmacists as a healthcare practitioner was to check and distribute drugs to doctors for medication that had been prescribed to patients. In more modern times, pharmacists advise patients and health care providers on the selection, dosages, interactions, and side effects of medications, and act as a  learned intermediary  between a prescriber and a patient. Pharmacists monitor the health and progress of patients to ensure the safe and effective use of medication. Pharmacists may practice  compounding ; however, many medicines are now produced by pharmaceutical companies in a standard dosage and drug delivery form. In some jurisdictions, pharmacists have  prescriptive authority  to either independently prescribe under their own authority or in collaboration with a  primary care physician  through an agreed upon protocol called a  collaborative practice agreement . [ 5 ]


Increased numbers of  drug therapies , aging but more knowledgeable and demanding populations, and deficiencies in other areas of the health care system seem to be driving increased demand for the clinical counseling skills of the pharmacist. [ 1 ]  One of the most important roles that pharmacists are currently taking on is one of pharmaceutical care. [ 6 ]  Pharmaceutical care involves taking direct responsibility for patients and their disease states, medications, and management of each to improve outcomes. Pharmaceutical care has many benefits that may include but are not limited to: decreased  medication errors ; increased  patient compliance  in medication regimen; better  chronic disease  state management, including hypertension and other cardiovascular disease risk factors; [ 7 ]  strong pharmacist–patient relationship; and decreased long-term costs of medical care.


Pharmacists are often the first point-of-contact for patients with health inquiries. Thus pharmacists have a significant role in assessing medication management in patients, and in  referring  patients to physicians. These roles may include, but are not limited to:


The role of pharmacy education, pharmacist licensing, and  continuing education  vary from country to country and between regions/localities within countries. In most countries, pharmacists must obtain a university degree at a  pharmacy school  or related institution, and/or satisfy other national/local credentialing requirements. In many contexts, students must first complete pre-professional (undergraduate) coursework, followed by about four years of professional academic studies to obtain a degree in pharmacy (such as  Doctorate of Pharmacy ). In the European Union, pharmacists are required to hold a Masters of Pharmacy, which allows them to practice in any other E.U. country, pending professional examinations and language tests in the country in which they want to practice. Pharmacists are educated in  pharmacology ,  pharmacognosy ,  chemistry ,  organic chemistry ,  biochemistry ,  pharmaceutical chemistry ,  microbiology ,  pharmacy practice  (including  drug interactions , medicine monitoring, medication management),  pharmaceutics , pharmacy law, pathophysiology,  physiology ,  anatomy , drug delivery, pharmaceutical care,  nephrology ,  hepatology , and compounding of medications. Additional curriculum may cover diagnosis with emphasis on laboratory tests, disease state management, therapeutics and prescribing (selecting the most appropriate medication for a given patient).


Upon graduation, pharmacists are licensed, either nationally or regionally, to dispense medication of various types in the areas they have trained for.


Some may undergo further specialized training, such as in cardiology or oncology or long-term care. Specialties include: [ citation needed ]


The Ministry of Education and Ministry of Health oversee pharmacy school accreditation in  Armenia . Pharmacists are expected to have competency in the  WHO Model List of Essential Medicines  (EML), the use of Standard Treatment Guidelines, drug information, clinical pharmacy, and medicine supply management. There are currently no laws requiring pharmacists to be registered, but all pharmacies must have a license to conduct business. According to a  World Health Organization  (WHO) report from 2010, there are 0.53 licensed pharmacists and 7.82 licensed pharmacies per 10,000 people in Armenia. Pharmacists are able to substitute for generic equivalents at point of dispensing. [ 11 ]


The Australian Pharmacy Council is the independent accreditation agency for Australian pharmacists. [ 12 ]  The accreditation standards for Australian pharmacy degrees include compulsory clinical placements. [ 13 ]  with an emphasis on encouraging rural experiences to develop a rural workforce. [ 14 ] [ 15 ]  It conducts a written examination on behalf of the Pharmacy Board of Australia towards eligibility for registration. The Pharmacy Board of Australia conducts an oral examination at the end of the intern year as the last hurdle prior to registration.  The Pharmaceutical Society of Australia provides continuing education programs for pharmacists. The number of full-time equivalent pharmacists working in Australia over the past decade has remained stable. [ 16 ]  Pharmacy practice is described by the practice standards  [ 17 ]  and guidelines including those from the Pharmaceutical Society of Australia. [ 18 ] [ 19 ] [ 20 ] [ 21 ]


The Australian Pharmacy Council is developing accreditation standards for pharmacists to prescribe and for pharmacists to work in aged care.  The aged care accreditation standards are being developed in preparation for pharmacists working in residential aged care settings to ensure that they are adequately prepared. [ 22 ]


There is a shortage of pharmacists at present leaving many jobs unfilled. Despite many pharmacists leaving the profession, pharmacists remain optimistic about their profession. [ 23 ]  Contract and casual work is becoming more common. A contract pharmacist is self-employed and often called a locum; these pharmacists may be hired for one shift or for a longer period of time. The number of pharmacists has stayed stable over a number of years. [ 16 ]


The  Canadian Pharmacists Association  (CPhA) is the national professional organization for pharmacists in  Canada . Specific requirements for practice vary across provinces, but generally include a bachelor's (BSc Pharm) or  Doctor of Pharmacy (PharmD)  degree from one of  10 Canadian universities  offering a pharmacy program, successful completion of a national board examination through the  Pharmacy Examining Board of Canada  (PEBC) (Quebec being the exception), practical experience through an apprenticeship/internship program, and fluency in French or English. [ 24 ]  International pharmacy graduates can begin their journey of becoming licensed to practice in Canada by enrolling with the National Association of Pharmacy Regulatory Authorities (NAPRA) Pharmacists' Gateway Canada. [ 24 ] [ 25 ]  The vast majority (~70%) of Canada's licensed pharmacists work in community pharmacies, another 15% work in hospital, and the remainder work in other settings such as industry, government, or universities. [ 26 ] [ 27 ] [ 28 ]  Pharmacists' scope of practice varies widely among the 13 provinces and territories and continues to evolve with time. [ 29 ] [ 30 ]   As a result of pharmacists' expanding scope and knowledge application, there has been a purposeful effort to transition the professional programs in Canadian pharmacy schools to offer doctors of pharmacy over baccalaureate curriculums to ensure graduates have the most up to date level of training to match the increasing practice requirements. [ 31 ] [ 32 ]


The pharmacist qualification in the  European Union  is regulated by the  Directive 2005/36/EC , [ 33 ]  where Section 7 Article 44(2) mandates at least five years of training including "four years of full-time theoretical and practical training" and "six-month  traineeship  in a pharmacy which is open to the public or in a hospital, under the supervision of that hospital's pharmaceutical department". The training of pharmacist must include at least: "Plant and animal  biology ,  Physics , General and  inorganic chemistry ,  Organic chemistry ,  Analytical chemistry ,  Pharmaceutical chemistry , including analysis of medicinal products, General and applied  biochemistry  (medical),  Anatomy  and  physiology ;  medical terminology ,  Microbiology ,  Pharmacology  and  pharmacotherapy ,  Pharmaceutical technology ,  Toxicology ,  Pharmacognosy ,  Legislation  and, where appropriate,  professional ethics ", which can be adapted to "scientific and technical  progress " according to procedure in Directive 2005/36/EC. [ 33 ]


In Germany, the education and training is divided into three sections, each ending with a state examination:


After the third state examination a person must become licensed as an RPh ("registered pharmacist") for a licence to practice pharmacy.
Today, many pharmacists work as employees in public pharmacies. They will be paid according to the labour agreement of  Adexa  and employer associations. [ citation needed ]


Polish pharmacists have to complete a  5 + 1 ⁄ 2 -year Master of Pharmacy Programme at medical university and obtain the right to practice as a pharmacist in Poland from District Pharmaceutical Council. The Programme includes 6 months of pharmacy training. The Polish name for the Master of Pharmacy Degree (M.Pharm.) is  magister farmacji  (mgr farm). Not only pharmacists, but also pharmaceutical technicians are allowed to dispense prescription medicines, except for narcotics, psychotropics and very potent medicines. Pharmacists approve prescriptions fulfilled by pharmaceutical technicians subsequently. Pharmaceutical technicians have to complete 2 years of post-secondary occupational school and 2 years of pharmacy training afterwards. Pharmacists are eligible to prescribe medicines in exceptional circumstances. All Polish pharmacies are obliged to produce compound medicines. Most pharmacists in Poland are pharmacy managers and are responsible for pharmacy marketing in addition to traditional activities. To become a pharmacy manager in Poland, a pharmacist is expected to have at least 5 years of professional experience. All pharmacists in Poland have to maintain an adequate knowledge level by participating in various university- and industry-based courses and arrangements or by undergoing postgraduate specialization. [ 34 ]


In  Sweden , the national board of health and welfare regulates the practice of all legislated health care professionals, and is also responsible for registration of pharmacists in the country. The education to become a licensed pharmacist is regulated by the  European Union , and states that minimum educational requirements are five years of university studies in a pharmacy program, of which six months must be a pharmacy internship. To be admitted to pharmacy studies, students must complete a minimum of three years of gymnasium, similar to high school (school for about 15–20-year-old students) program in natural science after elementary school (6–16-year-olds). Only three universities in the whole of Sweden offer a pharmacy education,  Uppsala University , where the Faculty of Pharmacy is located, the  University of Gothenburg , and  Umeå University . In Sweden, pharmacists are called  Apotekare . At pharmacies in Sweden, pharmacists work together with another class of legislated health care professionals called  Receptarier , in English so-called  prescriptionists , who have completed studies equal to a Bachelor of Science in pharmacy, i.e., three years of university. Prescriptionists also have dispensing rights in Sweden, Norway, Finland and Iceland. The majority of the staff in a pharmacy are  Apotekstekniker  or "pharmacy technicians" with a three -semester education at a vocational college. [ citation needed ]  Pharmacy technicians do not have dispensing rights in Sweden but are allowed to advise on and sell over-the-counter medicines.


In ancient Japan, the men who fulfilled roles similar to pharmacists were respected. The place of pharmacists in society was settled in the  Taihō Code  (701) and re-stated in the  Yōrō Code  (718). Ranked positions in the pre- Heian  Imperial court were established; and this organizational structure remained largely intact until the  Meiji Restoration  (1868). In this highly stable hierarchy, the pharmacists — and even  pharmacist assistants  — were assigned status superior to all others in health-related fields such as physicians and acupuncturists. In the Imperial household, the pharmacist was even ranked above the two personal physicians of the Emperor. [ 35 ]


As of 1997, 46 universities of pharmacy in Japan graduated about 8000 students annually. [ 36 ]  Contemporary practice of clinical pharmacists in Japan (as evaluated in September 2000) focuses on dispensing of drugs, consultation with patients, supplying drug information, advising on prescription changes and amending prescriptions. These practices have been linked to decreases in the average number of drugs in prescriptions, drug costs and incidence of  adverse drug events . [ 37 ]


Training to become a registered pharmacist in Nigeria involves a five-year course after six years of secondary/high school or four years after eight years of secondary/high school (i.e. after 2 years of Advanced-level studies in  accredited Universities). The degree awarded by most pharmacy schools is a  Bachelor of Pharmacy Degree (B.Pharm.) However, in the near future, [ when? ]  all schools will offer a 6-year first Degree course leading to the award of a Pharm.D (Doctor of Pharmacy Degree). The  University of Benin  has started the Pharm.D programme with other pharmacy schools planning to start soon. The Pharmacy Degree in Nigeria is unclassified i.e. awarded without first class, second class upper, etc., however graduates could be awarded Pass with Distinctions in specific fields such as Pharmaceutics, Pharmacology, medicinal chemistry etc. Pharmacy Graduates are required to undergo 1 year of Tutelage under the supervision of an already Registered Pharmacist(a preceptor) in a recognized and designated Institution before they can become Registered Pharmacists. The Profession is Regulated by a Government Statutory body called the  Pharmacists Council of Nigeria . The West African Post Graduate College of Pharmacy runs post-registration courses on advanced-level practice in various fields of pharmacy. It is a college jointly  funded by a number of Countries in the West Africa sub-region. There are thousands of Nigerian-trained pharmacists registered and practicing in countries such as the US, the UK, Canada etc., due to the relatively poor public sector salaries in Nigeria. [ citation needed ]


In  Pakistan , the Pharm.D. (Doctor of Pharmacy) degree is a graduate-level professional doctorate degree. Twenty-one universities are registered with the  Pharmacy Council of Pakistan  for imparting Pharmacy courses. In 2004 the  Higher Education Commission  of Pakistan and the Pharmacy Council of Pakistan revised the syllabus and changed the 4-year B.Pharmacy (Bachelor of Pharmacy) Program to a 5-year Pharm.D. (Doctor of Pharmacy) program. All 21 universities have started the 5-year Pharm.D Program. In 2011 the Pharmacy Council of Pakistan approved the awarding of a Doctor of Pharmacy degree, a five-year programme at the Department of Pharmacy,  University of Peshawar . [ citation needed ]


In Switzerland, the federal office of public health regulates pharmacy practice. Four Swiss universities offer a major in pharmaceutical studies, the  University of Basel , the  University of Geneva , the  University of Lausanne  and the  ETH Zurich . To major in pharmaceutical studies takes at least five years. Students spend their last year as interns in a pharmacy combined with courses at the university, with focus on the validation of prescriptions and the manufacturing of pharmaceutical formulations. Since all public health professions are regulated by the government it is also necessary to acquire a federal diploma in order to work in a pharmacy. It is not unusual for pharmaceutical studies majors to work in other fields such as the pharmaceutical industry or in hospitals. Pharmacists work alongside  pharma assistants , an apprenticeship that takes three years to complete. Pharmacists can further specialize in various fields; this is organized by  PharmaSuisse , the pharmacists' association of Switzerland. [ citation needed ]


In  Tanzania , pharmacy practice is regulated by the national Pharmacy Board, which is also responsible for registration of pharmacists in the country. By international standards, the density of pharmacists is very low, with a mean of 0.18 per 10,000 population. The majority of pharmacists are found in urban areas, with some underserved regions having only 2 pharmacists per region. According to 2007–2009 data, the largest group of pharmacists was employed in the public sector (44%). Those working in private retail pharmacies were 23%, and the rest were mostly working for private wholesalers, pharmaceutical manufacturers, in academia/teaching, or with faith-based or non-governmental facilities. The salaries of pharmacists varied significantly depending on the place of work. Those who worked in the academia were the highest paid followed by those who worked in the multilateral non-governmental organizations. The public sector including public retail pharmacies and faith based organizations paid much less. The  Ministry of Health  salary scale for medical doctors was considerably higher than that of pharmacists despite having a difference of only one year of training. [ 38 ]


In  Trinidad and Tobago , pharmacy practice is regulated by the Pharmacy Board of Trinidad and Tobago, which is responsible for the registration of pharmacists in the twin islands.  The  University of the West Indies  in St. Augustine offers a 4-year Bachelor of Science in Pharmacy as the sole practicing degree of pharmacy.  Graduates undertake a 6-month internship, known as pre-registration, under the supervision of a registered pharmacist, at a pharmacy of their choosing, whether community or institutional.  After completion of the required pre-registration period, the graduate can then apply to the Pharmacy Board to become a registered pharmacist.  After working 1 calendar year as a registered pharmacist, the individual can become a registered, responsible pharmacist.  Being a registered, responsible pharmacist allows the individual to license a pharmacy and be a pharmacist-in-charge.


In  British English  (and to some extent  Australian English ), the professional title known as "pharmacist" is also known as  "dispensing chemist"  or, more commonly,  "chemist" . A dispensing chemist usually operates from a pharmacy or chemist's shop, and is allowed to fulfil  medical prescriptions  and sell  over-the-counter drugs  and other health-related goods. Pharmacists can undertake additional training to allow them to prescribe medicines for specific conditions. [ 39 ]


In the United Kingdom, most pharmacists working in the  National Health Service  practice in  hospital pharmacy  or  community pharmacy . The  Royal Commission on the National Health Service  in 1979 reported that there were nearly 3,000 pharmacists employed in the hospital and community health service in the UK at that time.  They were enthusiastic about the idea that pharmacists might develop their role of giving advice to the public. [ 40 ]


The new professional role for pharmacist as prescriber has been recognized in the UK since May 2006, called the " Pharmacist Independent Prescriber ". Once qualified, a pharmacist independent prescriber can prescribe any licensed medicine for any medical condition within their competence. This includes controlled drugs except schedule 1 and prescribing certain drugs for the treatment of addiction ( cocaine ,  diamorphine  and  dipipanone ). [ 41 ]


Pharmacists,  pharmacy technicians  and pharmacy premises in the  United Kingdom  are regulated by the  General Pharmaceutical Council (GPhC)  for  England ,  Scotland  and  Wales  and by the  Pharmaceutical Society of Northern Ireland  for  Northern Ireland . The role of regulatory and professional body on the  mainland  was previously carried out by the  Royal Pharmaceutical Society of Great Britain , which remained as a professional body after handing over the regulatory role to the GPhC in 2010. [ 42 ]


The following criteria must be met for qualification as a pharmacist in the United Kingdom (the Northern Irish body and the GPhC operate separately but have broadly similar registration requirements): [ 43 ]


In 2014 the United States Bureau of Labor Statistics revealed that there were 297,100 American pharmacist jobs. By 2024 that number is projected to grow by 3%. [ 44 ]  The majority (65%) of those pharmacists work in retail settings, mostly as salaried employees but some as self-employed owners. About 22% work in hospitals, and the rest mainly in mail-order or  Internet pharmacies , pharmaceutical wholesalers, practices of physicians, and the Federal Government. [ 4 ]


All graduating pharmacists must now obtain the  Doctor of Pharmacy  (Pharm.D.) degree before they are eligible to sit for the North American Pharmacist Licensure Examination ( NAPLEX ) to enter into pharmacy practice. [ 45 ]  In addition, pharmacists are subject to state-level jurisprudence exams in order to practice from state to state. [ 46 ]


The  Accreditation Council for Pharmacy Education  (ACPE) has operated since 1932 as the accrediting body for schools of pharmacy in the United States. [ 47 ]  The mission of ACPE is "To assure and advance excellence in education for the profession of pharmacy". [ 47 ]   ACPE is recognized for the accreditation of professional degree programs by the  United States Department of Education  (USDE) and the  Council for Higher Education Accreditation  (CHEA). [ 48 ]  Since 1975, ACPE has also been the accrediting body for continuing pharmacy education. The ACPE board of directors are appointed by the  American Association of Colleges of Pharmacy  (AACP), the  American Pharmacists Association  (APhA), the  National Association of Boards of Pharmacy  (NABP) (three appointments each), and the  American Council on Education  (one appointment). To obtain licensure in the United States, applicants for the North American Pharmacist Licensure Examination (NAPLEX) must graduate from an ACPE accredited school of pharmacy. ACPE publishes standards that schools of pharmacy must comply with to gain accreditation. [ 49 ]


A  Pharmacy school  pursuing accreditation must first apply and be granted Pre-candidate status. [ 48 ]  These schools have met all the requirements for accreditation, but have not yet enrolled any students. This status indicates that the school of pharmacy has developed its program in accordance with the ACPE standards and guidelines. Once a school has enrolled students, but has not yet had a graduating class, they may be granted Candidate status. The expectations of a Candidate program are that they continue to mature in accordance with stated plans. The graduates of a Candidate program are the same as those of fully accredited programs. Full accreditation is granted to a program once they have demonstrated they comply with the standards set forth by ACPE.


The customary review cycle for established accredited programs is six years, whereas for programs achieving their initial accreditation this cycle is two years. These are comprehensive on-site evaluations of the programs. Additional evaluations may be conducted at the discretion of ACPE in the interim between comprehensive evaluations.


Acceptance into a doctorate of pharmacy program depends upon completing specific prerequisites or obtaining a transferable bachelor's degree.  Pharmacy school  is four years of graduate school (accelerated Pharmacy Schools go January to January and are only 3 years), which include at least one year of practical experience. Graduates receive a Doctorate of Pharmacy ( PharmD ) upon graduation. Most schools require students to take a Pharmacy College Admissions Test  PCAT  and complete 90 credit hours of university coursework in the sciences, mathematics, composition, and humanities before entry into the  PharmD  program. Due to the large admittance requirements and highly competitive nature of the field, most pharmacy students complete a bachelor's degree before entry to pharmacy school.


Possible prerequisites:


Besides taking classes, additional requirements before graduating may include a certain number of hours for community service, e.g., working in hospitals, clinics, and retail.


Estimated timeline: 4 years undergraduate + 4 years doctorate + 1–2 years residency + 1–3 years fellowship = 8–13 years


A doctorate of pharmacy (except non-traditional, i.e. transferring a license from another country) is the only degree accepted by the National Associate of Boards of Pharmacy  NABP  to be eligible to "sit" for the North American Pharmacist Licensure Examination ( NAPLEX ). Previously the United States had a 5-year bachelor's degree in pharmacy. For BS Pharmacy graduates currently licensed in US, there are 10 Universities offering non-traditional doctorate degree programs via part-time, weekend or on-line programs. These are programs fully accredited by Accreditation Council for Pharmacy Education ( ACPE ) but only available to current BS Pharmacy graduates with a license to practice pharmacy. Some institutions still offer 6 year accelerated  PharmD  programs.


The current Pharm.D. degree curriculum is considerably different from that of the prior BS in pharmacy. It now includes extensive didactic clinical preparation, a full year of hands-on practice experience in a wider array of healthcare settings, and a greater emphasis on clinical pharmacy practice pertaining to pharmacotherapy optimization. Legal requirements in the US to becoming a pharmacist include: graduating from an accredited  PharmD  program, conducting a specified number of internship hours under a licensed pharmacist (i.e. 1800 hours in some states), passing the  NAPLEX , and passing a Multi-state Pharmacy Jurisprudence Exam  MPJE .  Arkansas, California, and Virginia have their own exams instead of the MPJE;  in those states, pharmacists must pass the Arkansas Jurisprudence Exam, the California Jurisprudence Exam, or the Virginia Pharmacy Law Exam. [ 50 ] [ 51 ] [ 52 ]


Residency is an option for post-graduates that is typically 1–2 years in length. A residency gives licensed pharmacists decades of clinical experience in an extremely condensed timeframe of only a few short years. In order for new graduates to remain competitive, employers generally favor residency trained applicants for clinical positions. The profession is moving toward resident-trained pharmacists who wish to provide direct patient care clinical services. In 1990, the American Association of Colleges of Pharmacy ( AACP ) required the new professional degree. Graduates from a  PharmD  program may also elect to do a fellowship that is geared toward research. Fellowships can varying in length but last 1–3 years depending on the program and usually require 1 year of residency at minimum.


American pharmacists can become certified in recognized specialty practice areas by passing an examination administered by one of several credentialing boards.


As of 2016, all 50 states and the District of Columbia permit pharmacists to provide vaccination services, but specific protocols vary between states. [ 56 ] [ 57 ] [ 58 ]


All licensed California pharmacists can perform the following:


The passage of Assembly Bill 1535 (2014) authorizes pharmacists in California to furnish naloxone without a physician's prescription. [ 61 ]


With the passage of Senate Bill 159 in 2019, pharmacists in California are authorized to furnish  pre-exposure prophylaxis  (PrEP) and  post-exposure prophylaxis  (PEP) to patients without a physician's prescription. [ 62 ]  In order to be eligible to dispense, a pharmacists must first "complete a training program approved by the" California State Board of Pharmacy. [ 62 ]


California pharmacists can apply for Advanced Practice Pharmacist (APh) licenses from the California State Board of Pharmacy. Senate Bill 493, written by Senator Ed Hernandez, established a section on the Advanced Practice Pharmacist and outlines the definition, scope of practice, qualifications, and regulations of those holding this license. [ 63 ]  An APh can:


To qualify for an advanced practice pharmacist license in California, the applicant must be in good standing with the State Board of pharmacy, have an active pharmacist license, and fulfill two of three requirements, including certification in their area clinical practice. [ 64 ]  The license must be renewed every 2 years, and the APh applying for renewal must complete 10 hours of continuing education in at least one area relevant to their clinical practice. [ 64 ]


According to a 2010  PharmacyWeek  survey, pharmacists were paid the following average annual salaries, depending on their positions: [ 65 ]


The  American Pharmacy Journal of Education  in 2014 reported the average salary around $112,160. [ 66 ]


According to the US Bureau of Labor Statistics'  Occupational Outlook Handbook, 2016–17 Edition , Median annual wages of wage and salary pharmacists in May 2015 were $121,500. [ 44 ]


In 2020  US News and World Report  noted that the median pharmacist salary was $128,710. The top 25 percent of pharmacist earners made $147,690 that year, while the lowest 25 percent made $112,690. [ 67 ]


School students must take a national exam to enter a university of pharmacy or the pharmacy department of a university of medicine and pharmacy. About 5–7% of students can pass the exam. There are 3 aspects to the exam. These are on math, chemistry, and physics or biology. After being trained at the university for 5 years, successful students receive a bachelor's degree in pharmacy. Or they are university pharmacists (university pharmacist to discriminate between college pharmacist or vocational pharmacist in some countries of the world these trainee pharmacists are called pharmacist assistants). An alternative method of obtaining a bachelor's degree is as follows. School pupils study at a college of pharmacy or a vocational school of pharmacy. After attending the school or college they go to work in a pharmacy, and with two years of practice they could take an exam to enter university of pharmacy or the pharmacy department of a university of medicine and pharmacy. This exam is easier than the national one. Passing the exam they continue studying to gain 3-year bachelor's degrees or 4-year bachelor's degrees. This degree is considered equivalent to a 5-year bachelor's degree. [ citation needed ]


This article incorporates  public domain material  from websites or documents of the  United States Government .


An  albarello  (a name of Italian descent meaning "cell", plural:  albarelli ) also known as a "majolica drug jar" because of the type of tin glaze used is known as  Majolica  (also known as maiolica). [ 1 ] [ 2 ]  This cylindrical storage unit or  maiolica  earthenware jar, is used for a plethora of purposes, most commonly for drug storage as a  medicinal jar . [ 1 ] [ 2 ]  The jar was also used for other purposes such as storing dried fruit, herbs, balms, and  apothecaries'  ointments and dry drugs. [ 3 ]


People usually stored their  albarelli  in buildings with medical purposes, like pharmacies, hospitals, and doctors' offices. [ 4 ] [ 5 ]  Such jars served both functional and decorative purposes in traditional apothecaries and  pharmacies , and represented status and wealth. The jars were generally sealed with a piece of  parchment  or  leather  tied with a piece of cord. Hospitals often used  albarelli  to hold products such as ointments, balms, and different remedies for patients.  [ 3 ]   Albarelli  were also utilized in ways other than its originally intended purpose: they were used to hold perfume, they could function as a form of  décor , and as vases to display flowers. [ 1 ]


According to the Oxford English Dictionary, the Italian word  albarello  means "a decorated ceramic pharmacy jar of a cylindrical shape with a slight constriction halfway up (first used in 1344 as  alberello ; and then later, in the late 15th century as  albarello ), but the term's exact origin and etymology remains a topic for a debate. [ 6 ]  Some scholars argue that its etymology suggests that it derives either from the post-classical Latin word  albarus  meaning "white poplar" or the Classical Latin word  albus  meaning white. [ 6 ]  However, its important to note here that the poplar tree itself is not being compared to the jar, as the Italian usage of the word  albarello  for a white poplar tree came long after the naming of the  albarello  jar. [ 6 ]  The issue has further been muddled because some have claimed that these jars were originally manufactured in wood, even though there is no physical evidence of this in recovered materials and surviving jars. [ 7 ] [ 8 ]  Another possible origin of the term lies in another related Classical Latin word  albaris  ("whitish") and another Classical Latin term  albarius  referencing its relation to a whitewashing vessel. [ 6 ] [ 9 ]  Its important to note that both  albaris  and  albarius  are only recorded as adjectives "of or relating to  stucco " and therefore, do not have usage in relation to pottery or pottery glazes. [ 6 ]


The origin of this type of pharmacy jar has its roots in the  Middle East  during the time of the Islamic conquests. [ 10 ]  The term  majolica  specifically refers to a type of tin glaze that originated in the Near East along Islamic trade routes, showcasing the strong influence of Islamic material culture. [ 1 ]  The characteristic shape of the  arbarello  also has its roots in the East. [ 11 ]  Additionally, Chinese porcelain and its manufacturing played a significant role in influencing the development and spread of  arbarelli  across Europe. [ 10 ]  The influence from the Islamic empire coupled with the manufacturing of Chinese porcelain made for mass manufacture and subsequent exportation of  albarelli  for several cultures including those in Italy,  China , and Spain, and in turn were re-purposed for differing needs. [ 10 ]


Spanning out of the East from the Islamic empires and China, the  albarelli  were first introduced to Europe in  Syria  and  Spain  and then brought to Italy by Muslim Arab traders, during the height of the Italian Renaissance where its shape and purpose was adopted. [ 11 ] [ 10 ]  By importing majolica from Spain and Syria, Italian artists began producing versions of their own that differed from the traditional Islamic  arbarelli  with the addition of handles to heighten the functionality of the jar and the introduction of new designs including "a trofei" (with trophies), "a foglie" (leafy designs), and "a frutti" (decorated with fruits). [ 1 ] [ 2 ] [ 12 ]  While the styles in both Spain and Italy kept on developing, clear influence could still be linked backed to traditional Chinese and Islamic ceramic designs despite the changes in style and designs. [ 10 ]  Eventually Syrian manufacture of the jars lead to them being described in Italian as " porcellana domaschina"  (damascene porcelain), to distinguish that the blue-and-white lusterware were made in  Damascus  and were not authentic Chinese porcelain that had been imported into Europe previously. [ 10 ]


Albarelli  are known for having a cylindrical shape without handles and a thin neck to make them easy to handle and move. [ 1 ] [ 2 ] [ 11 ] [ 13 ] [ 14 ] [ 15 ] [ 16 ]  Albarelli are usually made out of majolica, which has helped historians decipher the history between the  albarelli , due to it being such a resistant and strong material. [ 15 ]  In later forms after it spread throughout Europe, their design included the addition of handles that were adopted by the Italians after the 15th century. [ 17 ]  On average,  albarelli  were recorded to be 7-8 inches in height. [ 11 ]  Instead of having a fitted lid to cover the opening at the top, people would use a fitted paper to lay on top to seal it. [ 17 ]


Spain was introduced to Albarelli by the East, it was adopted quickly. [ 13 ]  They are known to have the same cylindrical shape, with a more narrow opening, and an indented base where artists usually sign their name. Albarelli were also labelled through the symbols on the outside and through parchment paper in the vase. [ 13 ]


The earliest Italian examples were produced in Florence in the 15th century.  Albarelli  were made in  Italy  from the first half of the 15th century through to the late 18th century and beyond. Italian-based  albarelli  are commonly measured to be 7-8 inches in height. [ 11 ] [ 11 ]  Italian  albarelli  adopted its shape from lustreware from Islamic Spain. [ 18 ]  Unlike English  albarelli , Italian-based pots had flat edges on the rims to account for the placement of a paper cover that functioned as a lid. [ 18 ]  There was a lot of Oriental inspiration when making these jars, noticed through the blue and white colors on majority of the pots, also referred to as  alla porcellana,  which means in the form of imported Chinese porcelain, "a trofei" meaning with trophies, "a foglie" meaning leafy designs, and "a frutti" meaning decorated with fruits. [ 2 ] [ 12 ]  Further designs include floral motifs against a white background, to more elaborate designs such as portraits of a  cherub  or  priest , and can include a label describing the contents of the jar. Specific styles of decoration are now associated with various Italian locations, including  Florence ,  Venice ,  Gerace  and  Palermo  in  Sicily .


Middle Eastern and Islamic Styles


Spanish Styles


Italian Styles


An  auxiliary label  (also called  cautionary and advisory label  or  prescription drug warning label ) is a  label  added on to a dispensed medication package by a  pharmacist  in addition to the usual  prescription  label. These labels are intended to provide supplementary information regarding the safe administration, use, and storage of the medication. [ 1 ]  Auxiliary labels provide information which can augment but not replace verbal counselling from a pharmacist. [ 2 ]


Auxiliary labels became popular during the second half of the nineteenth century. [ 3 ]


In 2013, the first recommendations for auxiliary label usage in the  United States  were published as  USP  Chapter <17>. [ 4 ]  This included a recommendation to limit the use of auxiliary labels to evidence-based labels with critical information, and without pictures unless evidence shows increased efficacy when a picture is used. It is further recommended that labels are placed in a manner obvious to the patient without having to turn or rotate the package. [ 4 ]


Auxiliary labels are small stickers consisting of one or more lines of text intended to enhance patient knowledge, with or without a  pictogram . The directions for use included on the standard prescription label are typically limited to direct administration information, such as how often, when, and how to take the medication. As such, auxiliary labels are used for additional information that is not included in those directions for use printed on the label, or information which cannot fit on the prescription label itself due to limited space. Overall, auxiliary labels contain information intended to promote proper medication adherence through reminders about important information that will be seen anytime the bottle is picked up. [ 5 ]  They should be designed to be as simple as possible, written in plain language, and understandable for people with low health literacy. [ 6 ]


Sometimes auxiliary labels are used not to add additional information to the packaging, but instead to reinforce information with a pictorial representation of the instructions for use. This may consist of a pictoral representation of the frequency of use, time of day to take, the administration route, or other information. [ 7 ]  Picture representations of directions can be useful for patients with low literacy, or who have trouble reading and comprehending text instructions due to age, eyesight, or language barriers. [ 7 ]


As some medications must be stored under specific conditions (such as in original container with dessicant, or refrigerated), auxiliary labels may be used to reinforce these storage requirements to ensure it does not degrade through improper storage. Because some people may have difficulty swallowing medications whole, auxiliary labels may be used to provide advice on solutions, such as whether the medication can be chewed, crushed, or cut. Another use of auxiliary labels is important information on side effects or drug/food interactions. [ 8 ] [ 6 ]


A 2016 study found that many patients consider side effects to be important information to be included on a prescription package and that auxiliary labels are a good tool to provide this information on the packaging itself (as opposed to a separate information sheet/handout). [ 9 ]  The same study found that patients associated the use of red as a highlight color with information regarding warnings, allergies, or side effects. [ 9 ]


Deciding what auxiliary labels are suitable for a particular prescription requires knowledge of the drug's classification, interactions, and side effects. [ 10 ]  One study of auxiliary label usage found that about 80% of dispensed prescriptions would benefit from at least one auxiliary label to reinforce information, or provide  additional important information aside from the directions for use. [ 6 ]  The most common auxiliary labels on prescriptions include "May cause drowsiness" and "alcohol may intensify the effect of this medication". [ 6 ]


There is no standard for how to place auxiliary labels on a prescription, but they should be placed in a manner that they will be visible and intelligible in the normal course of medication usage. [ 6 ]  Auxiliary labels placed on a prescription vial may be placed vertically, horizontally, or on the vial cap, which is called "interactive placement". Placement of the label in an interactive manner where the patient must interact with it to open the vial increases the chance the label is noticed and considered by the patient. [ 4 ]  Both horizontal and interactive placement are superior to vertical placement, which is due to the need to rotate the vial to read the information on a vertically placed label. [ 4 ]  One study in 2007 found that 82% of prescriptions had auxiliary labels placed vertically, requiring the bottle to be tilted to read the text. The same study found a wide variation in coloring used on auxiliary labels from different pharmacies, and that between 8-25% of prescriptions filled had no warning labels at all. [ 11 ]


The use of auxiliary labels does not substitute for pharmacist consultation about medications, nor for any supplemental medication guides or handouts recommended or required to be distributed with a drug. Auxiliary labels should only be used to remind or enhance instructions for use or warnings that have already been given by the pharmacist or doctor to the patient verbally. [ 12 ]


Auxiliary labels can commonly be misinterpreted, especially when multi-step or multi-part instructions are present on one label. [ 5 ]  Misinterpretation of auxiliary labels can occur when patients are unable to understand the wording of the label, and thus assume an instruction based on the pictogram or color of the label. [ 5 ]  In addition to misinterpretation, some studies have found that most patients ignore auxiliary labels on prescriptions completely, especially those with low  health literacy . [ 8 ]  This may be due in part to the belief that information presented on the bottle is not important, or due to the manner in which the labels are affixed to the vial. [ 8 ]  When auxiliary labels are used as a reminder to the patient of important information, failure to understand and follow the instructions from auxiliary labels can result in treatment failure or adverse effects. [ 8 ]  The effectiveness of auxiliary labels can vary greatly between different label formats and specific text, with a 2006 survey finding that one common multi-step, complex label ("Do not take dairy products, antacids, or iron preparations within 1 hour of this medication") was interpreted correctly only 7.6% of the time. [ 5 ]


The overall effectiveness of auxiliary labels depends on the number of labels affixed, the design of the label, and their positioning on the medication package or vial. [ 13 ]  Simplifying the content and number of auxiliary labels can improve patient comprehension. [ 14 ]  In the United States, many labels are commonly only stocked in English, which can decrease the chance of understanding in areas with significant non-English speaking populations. Only one third of auxiliary labels in the United States are available in languages other than English. [ 5 ]


Common elements considered to increase the chance of effectiveness of an auxiliary label include a single-step instruction, using easy-to-read text (for example, low  Lexile score ), use of clear, simple icons (if present), use of color to represent severity, and clarity of the instruction being represented. [ 15 ]  Font size and style, including boldface or capitalization patterns, can also impact the effectiveness of an auxiliary label. [ 15 ]  The effectiveness of auxiliary labels is also increased when pharmacists explicitly instruct patients on their presence on the package, and explain the importance of each of the warnings being presented using the auxiliary labels. [ 12 ]  It has also been recommended that people with low  health literacy  and low  literacy  in general be consulted during the design process for auxiliary labels to improve the chance for comprehension and effectiveness. [ 5 ]


Barrier isolator  is a general term that includes two types of devices: isolators and  restricted access barriers  (RABS).   Both are devices that provide a physical and aerodynamic (air overpressure) barrier between the external clean room environment and a work process. The isolator design is the more dependable of the two barrier design choices, as it prevents contamination hazards by achieving a more comprehensive separation of the processing environment from the surrounding facility.  Nonetheless, both Isolator and RABS designs are contemporary approaches developed over the last 35 years and a great advancement over designs of the 1950s-70s that were far more prone to microbial contamination problems.


Barrier and Isolator designs are used throughout the industries, from sterile injectable drug filling to  cytotoxic  sterile drug compounding to electronics manufacturing to orange juice filling.  Pharmaceutical industry and pharmacy compounding isolators are used for maintaining sterility of a drug, and that is the focus of this article.  This type of strict design and control is important when producing sterile medicines because consumers receiving injections, surgical irrigation fluid, or other "parenterally"-administered drugs are often highly vulnerable to infection.  As a result, contaminated drugs have caused grave (e.g., permanent injury, death) consequences for the consumer.   The sterility of other dosage forms, such as ophthalmic, is similarly important, as blindness or partial loss of vision has occurred due to intrinsically contaminated eye medications.


Isolators  are routinely found within the  pharmaceutical industry  and are widely used in Europe (and increasingly in the US) for  pharmacy  aseptic compounding applications. See also  Asepsis .  They are designed to provide continuous and complete isolation of the inside of the isolator from the external room environment (including its operators).  Only installed gloves or robotic arms are used to manipulate the product.  This ensures that the environment is maintained as contamination-free to safeguard patients who will later be administered the drug.  Isolators operate as positive-pressure devices, and use full wall separation and substantial overpressure to both physically and aerodynamically separate the interior from the external room environment.  The more complete technical definition is as follows:


An isolator is a decontaminated unit, supplied with Class 100 (ISO 5) or higher air quality, that provides uncompromised, continuous isolation of its interior from the external environment (e.g., surrounding cleanroom air and personnel). There are two major types of isolators:


While the positive pressure isolator is most common, "negative" pressure devices also exist for very large industrial operations that handle toxic products.  The "negative pressure isolator," and has become less common and desirable, but is superior to the traditional biosafety cabinet which is vulnerable to contamination and can expose the worker to toxicological hazards if not operated properly.


A simpler and more effective option for nearly all toxicological containment applications is the use of "closed isolator" design, which is maintained under positive pressure (this is the most appropriate containment option unless a company processes thousands of units per minute).


If a negative isolator is used, its intricate design must fulfill two objectives: protect workers outside of the isolator, and assure sterility of sterile drugs inside the isolator.  As such, the term "negative pressure" isolator is somewhat of a misnomer, as contaminated ("polluted") room air must not be pulled into the main workstation isolator in a sterile operation.  Thus, the actual workstation isolator is always maintained under substantial positive pressure.   The "negative" pressure isolator does however include a separate buffer zone (an extra isolator compartment) that is designed to exhaust both incoming room air and outgoing positive pressure air from the main workstation.  The main workstation isolator, in which the sterile product is exposed, is therefore protected from contaminated air as the toxic product should be exhausted via the buffer zone before it reaches operators working outside of the isolation.


In addition to Isolators, there are also extensive barriers that provide sub-isolation protection, but have a very good track record of reducing hazards to sterile drugs during processing when they are designed and operated properly.  This extensive barrier is known as a  restricted access barrier system , or  RABS .  A barrier cabinet using RABS design and control, is below the isolator in its ability to assure sterility assurance and containment, but far better than the traditional laminar air flow hood or "open process" designs that are progressively being phased-out by the industries.  In particular, a RABS that operates only in closed-door mode after the equipment setup and sporadic disinfection is performed, is commonly used now and provides substantial risk mitigation.  These "closed RABS" require all processing interventions to be done using gauntlet gloves attached to the RABS walls.  RABS doors are only opened at the start of an operation to perform equipment setup, and must be locked thereafter until the conclusion of operations.


In contrast, other RABS designs allow for rare door openings in specified circumstances. Because this "open RABS" allows for a door to be opened to the surrounding cleanroom (albeit into a fully HEPA-filtered perimeter around the RABS structure) during aseptic operations, the design allows for higher contamination hazard than a RABS that is kept closed. If doors are opened to the "open RABS" on anything other than an exceptional basis, it may not represents an improvement over traditional aseptic processes.  Therefore, "open RABS" must be operated properly to realize sterility assurance gains.


Some historical background regarding isolators and RABS is also important to understand how sterile product proaction has evolved. In the mid-1980s, after the industry had already begun to employ isolators,  RABS units became an alternative to separating people from the process.  While isolator usage continued to expand, RABS also became popular in the 1990s.  The acronym RABS was coined by Stewart Davenport of Upjohn (now  Pfizer ).  (See ISPE publications for a definition of RABS.)  Since that time, the technology and applications of these systems has developed and broadened significantly.  It is now very unusual for a sterile drug operation to be run without either an Isolator or RABS protective design.


There are also other devices, which can offer some helpful separation.  These devices are known as  Gloveboxes .  Gloveboxes do not offer the separative control provisions of an isolator or RABS.  Gloveboxes were originally designed for non-sterile product applications, such as weighing or manipulating a toxic drug and have a long track record for such non-sterile applications.  Such gloveboxes can be very effective in preventing exposure of an operator to a toxic drug.  In limited cases, they can also be used to protect a sterile product, when supplied with ISO 5 unidirectional air.  However, in some notable cases, gloveboxes used for aseptic processing have provided no more sterile product protection than the traditional  laminar air flow hood  (LAF) design of the 1960s. In these cases, the glove boxes were problematic due to inappropriate design or controls (e.g., insufficient disinfection, transfer of contaminated materials, ingress of lower quality air into glovebox, poor design/integrity, poor transfers).  However, if gloveboxes are very meticulously designed, thoroughly disinfected (e.g., using sporocides) and carefully operated by well-trained aseptic processing personnel to prevent introduction of microbial contamination, it is possible to obtain some degree of increased sterile product protection versus the simple traditional LAF hood.


Bioburden  is normally defined as the number of bacteria living on a surface that has not been sterilized. [ 1 ]


The term is most often used in the context of bioburden testing, also known as microbial limit testing, which is performed on  pharmaceutical products  and medical products for  quality control  purposes.  Products or components used in the pharmaceutical or medical field require control of  microbial  levels during processing and handling. Bioburden or microbial limit testing on these products proves that these requirements have been met.  Bioburden testing for medical devices made or used in the USA is governed by  Title 21 of the Code of Federal Regulations  and worldwide by  ISO  11737.


The aim of bioburden testing is to measure the total number of viable micro-organisms (total microbial count) on a medical device prior to its final sterilization before implantation or use. [ 2 ]


21 C.F.R. 211.110 (a)(6) states that bioburden in-process testing must be conducted pursuant to written procedures during the manufacturing process of drug products. [ 3 ]  The United States Pharmacopeia (USP) outlines several tests that can be done to quantitatively determine the bioburden of non-sterile drug products. [ 4 ]


It is important when conducting these tests to ensure that the testing method does not either introduce bacteria into the test sample or kill bacteria in the test sample. [ 4 ]  To prepare drug products for testing, they must be dissolved in certain substances based on their "physical characteristics." [ 4 ]  For example, a water-soluble drug product should be dissolved in "Buffered Sodium Chloride-Peptone Solution pH 7.0, Phosphate Buffer Solution pH 7.2, or Soybean-Casein Digest Broth." [ 4 ]


The Membrane-Filtration Method and Plate Count Method can be used to measure the number of microbes in a sample. [ 4 ]  In the  Membrane-Filtration Method , the sample is passed through a membrane filter with a pore size of 0.45 micrometers or less. [ 4 ]  The membrane filter is then placed onto Soybean-Casein Digest Agar and incubated in order to be able to determine the total aerobic microbial count (TAMC). [ 4 ]


In the  Plate Count Method , the sample of drug product to be tested and Soybean-Casein Digest Broth is poured into a Petri dish. [ 4 ]  The Petri dish is then incubated. The  most probable number  method (MPN) can also be performed for products considered to have a low bioburden [ clarification needed ] . The MPN is considered to be one of the least accurate tests. [ 4 ]


The bioburden quantification is expressed in  colony forming unit  (CFU). There are generally established guidelines for the maximum CFU that a drug product can contain. [ 4 ]  Contact plates or sterile swabs can also be used to test for microbes on a surface when compounding sterile products to ensure compliance with USP 797. [ 5 ]


As an alternative to traditional methods (membrane-filtration and plate count method) there are rapid microbiological methods (RMM) that correlate to plate counting and give results in less time (minutes or hours instead of days).  Soleil by Sievers is an example of a RMM that gives results in 45 minutes and detects biotics/ml thanks to flow cytometry.


Bioburden is also associated with  biofouling , where microbes collect on the surface of a device or inside of fan cooled equipment.  In healthcare settings, this increases the risk of  Healthcare-associated infections  (HAIs) or  Hospital-acquired infection  as pathogens can be spread through contact or through the air to new patients and hospital staff.  Fan cooled system are generally avoided in critical care and operating rooms, thus relying on natural convection or liquid cooling to cool devices and equipment. Clean rooms (surgical operating rooms, for example) are also required to maintain positive air pressure so that air may leave those rooms, but contaminated air cannot enter from adjacent spaces. [ 6 ]   HEPA  filters are also used to collect airborne pathogens larger than 0.3 microns.


Bioenhancers  or biopotentiators [ 1 ]  or  bioavailability enhancers  is a new chapter in medical science first scientifically established in 1979 after the discovery of world's first bioenhancer piperine. [ 2 ]  It is a pocket friendly drug technology which reduces the destruction, wastage and elimination of several orally administered drugs inside the body.


Definition  Bioenhancers are defined as substances that increase the  bioavailability  leading to increased bioefficacy of active substances with which they are combined without having any pharmacological activity of their own at the dose used. [ 1 ]  They may enhance bioavailability of allopathic drugs, vitamins, nutrients and toxins depending on its mechanism of action. For example, piperine increases bioavailability of several nutrients such as beta-carotene, [ 3 ]  vitamin A, vitamin B6, coenzyme Q10, [ 4 ] [ 5 ]  drugs such as phenytoin, [ 6 ]   theophylline , [ 7 ]  propanolol [ 7 ]  and a toxin called aflatoxin B1. [ 8 ]


Increased Bioavailabiity means increased levels of drug in the blood stream available for drug action. Increased Bioefficacy means the increased effectiveness of the drug due to increased bioavailability or due to other mechanisms.


An observation made in 1929 by Bose describes an increased antiasthmatic activity of vasaka leaves when pepper was added to it.  No explanation for this observation was given nor any studies were done to explain the observation. The breakthrough in bioenhancers was finally provided about 50 years later in 1979 by Dr. C. K. Atal, director of RRL Jammu, who was researching on medicinal plants.   [ 1 ]  Bioenhancers or bioavailability enhancers as a term and chapter did not exist in any modern scientific literature prior to 1979. The term bioavailability enhancers was first coined in 1979 at Indian Institute of Integrative medicine, Jammu, formerly RRL, Jammu, by Indian scientists Dr. C. K. Atal, the Director of institute RRL Jammu proposed the hypothesis of increased bioavailability of drugs from a clue during research on traditional medicinal drugs. Subsequently, the concept of bioavailability enhancers was scientifically researched and scientifically established by him and his research team at RRL Jammu. The institute then discovered and scientifically validated Piperine as the world's first bioenhancer using Sparteine and Vasicine which became the world's first experimentally bioenhanced drugs. Dr. Atal also initiated the bioenhanced anti tubercular drug research project using Rifampicin [ 9 ]  which later resulted in development of world's first bioenhanced anti tubercular drug formulation. This DCGI approved formulation was officially released by Indian government at Anusandhan Bhawan Delhi on world tuberculosis day 2011, and also presented to Mr. Bill Gates, chairman of Microsoft same day at a function at Le Meridian in Delhi.


After the discovery of bioenhancer Piperine in 1979, a new chapter was added in medical science. Since then it has generated global interest and research in the field and has led to discovery of many other new bioenhancers. Piperine remains the most potent and extensively researched bioenhancer till date. It is safe, effective, extremely economical and  easily manufactured for commercial use. It is also a broad spectrum bioenhancer acting on several classes of modern drugs as noted elsewhere. [ 10 ] [ 11 ] [ 12 ]


Bioenhancers can be classified according to their source of origin, either plant based or animal based or else according to their site of action. Bioenhancers so far almost exclusively discovered in plants, increase the bioavailability of other substances in different ways:


Bioenhancers prevent this wastage of ingested drugs inside the body and increase quantity of drug reaching the blood, therefore a reduced dosage of oral drug is sufficient to achieve the desired blood levels.


This reduced dose needed for desired drug action means beneficial effect on raw materials consumption required to develop drugs which is a great savings for any country.


This also translates into ecological advantage in case of rare and expensive plant based drugs as less trees or plant have to be consumed to produce drugs, an example being the costly anti cancer drug taxol derived from very slow growing yew trees.


This reduced dose in turn also reduces the cost of drugs. Billions of dollars are wasted globally in various countries due to poor bioavailability of drugs, which is a huge financial burden on any nation, particularly poor developing countries. This is particularly relevant in serious and dreaded diseases on mankind like tuberculosis for which treatment is expensive, toxic and prolonged and for which an emergency situation has been declared by UN due to emergence of AIDS and development of serious drug resistance.


This reduced dose in turn also reduces the side effects of drugs.


Lesser side effects also improve drug tolerability, drug compliance and promote completion of treatment.


This improved tolerability and compliance in turn reduces risk of developing dangerous drug resistance.


Even though bioenhancers are not pharmacologically active, [ 1 ]  they can have added benefits such as reduction of gastrointestinal side effects and hepatotoxicity of primary active drug which further makes formulation safer, better tolerated and again reduces drug toxicity and drug resistance.


For example, by reducing the required dose of expensive toxic Rifampicin by 60 percent, it correspondingly reduces the cost and side effects of Rifampicin while treating the dreaded disease Tuberculosis. [ 13 ]  This is a great advantage to poor patients, poor countries and for dreaded diseases of man.


The following examples of bioenhancers give an insight into the current pharmacological research and show how with pepper, curry, ginger and other herbal ingredients in food a lack of nutrients or insufficient effects of active agents can be prevented:


Piperine , an ingredient of pepper, promotes intestinal absorption by activation of the γ-glutamyltranspeptidase and inhibits the degradation of many compounds, by inhibiting different enzymes: aryl hydrocarbon hydroxylase (AHH), [ 14 ]  ethylmorphine N-demethylase, [ 14 ]  Uridine diphosphate glucuronic_acid, [ 15 ]  Uridine diphosphate glucuronyltransferase (UGT), [ 14 ]  P-glycoprotein, [ 16 ] [ 17 ]  CYP2EI [ 18 ]  and CYP3A4. [ 16 ] [ 19 ]  Especially the latter two enzymes contribute significantly to the first-pass effect.


Piperine acts as bioenhancer to vitamins (A, B1, B2, B6, C, D, E, K), beta-carotene, [ 3 ]  amino acids (lysine, isoleucine, leucine, threonine, valine, tryptophan, phenylalanine, and methionine), minerals (iodine, calcium, iron, zinc, copper, selenium, magnesium, potassium, manganese), herbal compounds (including ginsenosides, Pycnogenol, resveratrol, epigallocatechin, curcumin [ 20 ] ), and drugs (such as ampicillin, [ citation needed ]  carbamazepine, [ 19 ]  chlorzoxazone, [ 18 ]  diclofenac, [ 21 ]  fexofenadine, [ 17 ]  ibuprofen, [ 22 ]  rifampicin, [ 23 ]  tetracycline, pyrazinamide).


Allicin  from garlic enhances the effect of the fungicide amphotericin B on yeast cells by affecting the transport of the fungicide into the yeast vacuole.


Curcumin  which inter alia is found in curry inhibits like piperine the enzyme CYP3A4 and affects the transport function of P-glycoprotein. In combination with curcumin an increased bioavailability of the active compounds celiprolol and midazolam was detected.


Ginger  promotes due to the gingerols the intestinal absorption of many compounds (including drugs) and elements. In most cases, ginger acts synergistically with piperine.


Glycyrrhizin , a saponin of the liquorice plant, promotes the action of numerous antibiotics and the antifungal agent clotrimazole.


Quercetin , a flavonoid from fruits and leaves, acts like curcumin and piperine. It increases the bioavailability of the active agent paclitaxel used to treat cancer.


Carum carvi , a herb from Apiaceae enhances the bioavailability of anti tuberculosis drugs such as rifampicin, isoniazid, and pyrazinamide. [ 24 ]


The bioenhancer technology is primarily targeted for toxic drugs, expensive drugs, scarce drugs, poorly bioavailable drugs or drugs which need to be given for prolonged periods. However it can also be used in any drugs influenced by bioenhancers. The discovery and characterization of bioenhancers has led to several patent applications. [ 25 ] [ 26 ]  Piperine is marketed as bioenhancer in mono preparations and as a component of  dietary supplements  that contain different vitamins,  curcumin ,  resveratrol  or  Coenzyme Q 10 .


Since  bioenhancers can reduce the dosage and cost of expensive medication while making treatment safer, its application has for the first time been done in humans in treating tuberculosis for which the existing drugs are toxic and expensive and need to be administered over prolonged periods. In India where low treatment costs for medical care are essential, the drug Risorine is approved against tuberculosis. Besides the  antibiotics  rifampicin and isoniazid it contains piperine. [ 27 ]


The  Bloomsbury Dispensary for the Relief of the Sick Poor  was an institution founded in 1801 to provide medical aid and suitable nourishment to the poor people of  that part of London .


George Pinckard  founded the  dispensary  on 26 October 1801 and became its first physician, remaining there for thirty years. [ 1 ]  It was established at  62  Great Russell Street . [ 2 ]


The  Bowl of Hygieia ,  ⟨🕏⟩ , is one of the  symbols  of  pharmacology , and along with the  Rod of Asclepius , it is one of the most ancient and important symbols related to medicine in western countries.  Hygieia  was the Greek goddess of health,  hygiene , cleanliness, and  sanitation , and the daughter of  Asclepius , who she is often closely associated with e.g. in prayers and hymns. Asclepius' symbol is his  rod , with a  snake  twined around it; correspondingly, Hygieia's symbol is a  cup  or  chalice  with a snake twined around its stem. Hygieia was also invoked, along with her father Asclepius, and  Panacea  in the original  Hippocratic Oath .


The bowl of Hygieia has been used as a symbol of the pharmacy profession at least as far back as 1796, when it was used on a coin minted for the Parisian Society of Pharmacy. [ 1 ]  It has since been adopted by many more pharmaceutical associations worldwide, such as the  American Pharmacists Association , [ 2 ]  the  Canadian Pharmacists Association , [ 3 ]  the  Pharmaceutical Society of Australia , [ 4 ]  and the Doctor of pharmacy Association, [ 5 ]   Conseil de l'Ordre des Pharmaciens  in France [ 6 ]  (where is written in law with another symbol, the green Greek cross). [ 7 ]


The bowl of Hygieia is a common symbol on signs outside of pharmacies in Europe.  A  mortar and pestle  is a more common symbol in the United States.


Breakthrough therapy  is a United States  Food and Drug Administration  designation that expedites  drug development  that was created by Congress under Section 902 of the 9 July 2012  Food and Drug Administration Safety and Innovation Act . [ 1 ] [ 2 ]  The FDA's "breakthrough therapy" designation is not intended to imply that a drug is actually a "breakthrough" or that there is high-quality evidence of treatment efficacy for a particular condition; [ 3 ] [ 4 ]  rather, it allows the FDA to grant  priority review  to drug candidates if preliminary  clinical trials  indicate that the therapy may offer substantial treatment advantages over existing options for patients with serious or life-threatening diseases. [ 4 ] [ 5 ]  The FDA has other mechanisms for expediting the review and approval process for promising drugs, including  fast track  designation,  accelerated approval , and  priority review . [ 4 ] [ 6 ]


A breakthrough therapy designation can be assigned to a drug if "it is a drug which is intended alone or in  combination  with one or more other drugs to treat a serious or life threatening disease or condition" and if the  preliminary clinical evidence  indicates that the drug may demonstrate substantial improvement over existing therapies on one or more clinically significant endpoints, such as substantial treatment effects observed early in clinical development." [ 5 ] [ 7 ]


Requests are reviewed by the  Center for Drug Evaluation and Research  (CDER) and the  Center for Biologics Evaluation and Research  (CBER). CDER receives approximately 100 requests per year for breakthrough designation. Historically, about one third were approved. CBER receives 15–30 requests per year. [ 8 ]  Sponsors must apply for breakthrough status separately for each indication they intend to label the drug for.


Breakthrough designation applications are submitted as an amendment to the  IND  applications, usually prior to end of Phase II meeting. [ 9 ]


Drugs that have been granted breakthrough status are given priority review. The FDA works with the sponsor of the drug application to expedite the approval process. This expedited process can include rolling reviews, smaller clinical trials, and alternative trial designs. [ 9 ]


Critics have said that the name is misleading and provides companies that obtain a breakthrough designation for a drug candidate with a marketing advantage that may be undeserved. [ 10 ] [ 11 ]  The FDA acknowledges that the name "breakthrough therapy" may be misleading. It was never meant to imply that these drugs are actually "breakthroughs," and it does not ensure that they will provide clinical benefit, but still critics complain that they are based on preliminary evidence, including changes in surrogate markers such as laboratory measurements, that often don't reflect "meaningful clinical benefit." [ 3 ]
The FDA guidance states: "Not all products designated as breakthrough therapies ultimately will be shown to have the substantial improvement over available therapies suggested by the preliminary clinical evidence at the time of designation.  If the designation is no longer supported by subsequent data, FDA may rescind the designation." [ 12 ]


As of August 2020, the FDA had granted breakthrough device designations to 298  medical devices  in total since its inception, including 50 for the year 2020. [ 13 ]


Clinical pharmacy  is the branch of  pharmacy  in which  clinical pharmacists  provide direct  patient   care  that optimizes the use of  medication  and promotes  health ,  wellness , and  disease   prevention . [ 1 ] [ 2 ]  Clinical  pharmacists  care for patients in all health care settings but the clinical pharmacy movement initially began inside  hospitals  and clinics. Clinical pharmacists often work in collaboration with  physicians , physician assistants,  nurse practitioners , and other  healthcare professionals . [ 3 ]  Clinical pharmacists can enter into a formal  collaborative practice agreement  with another healthcare provider, generally one or more physicians, that allows pharmacists to prescribe medications and order laboratory tests.


Clinical pharmacists have extensive  education  in the biomedical,  pharmaceutical , socio-behavioural and clinical sciences.  Most clinical pharmacists have a  Doctor of Pharmacy  (Pharm.D.)  degree  and many have completed one or more years of  post-graduate  training (for example, a general and/or specialty  pharmacy residency ). In the  United States , clinical pharmacists can choose to become Board-certified through the  Board of Pharmacy Specialties  (BPS), which was organized in 1976 as an independent certification agency of the  American Pharmacists Association . The BPS certifies pharmacists in the following specialties: [ 4 ]


There are several types of clinical pharmacists in the United States. In California they are called advanced practice pharmacists (APh). [ 5 ]  In New Mexico, they are known as Pharmacist Clinicians (PhC) [ 6 ]  and lastly in Montana and North Carolina they are known as Clinical Pharmacist Practitioners (CPP). [ 7 ]  Clinical pharmacists in the Veteran Administration are known as Clinical Pharmacy Specialists (CPS). [ 8 ]


Role in the health care system


Within the system of  health care , clinical pharmacists are  experts  in the therapeutic use of medications. They routinely provide medication  therapy  evaluations and recommendations to patients and other health care professionals. Clinical pharmacists are a primary source of scientifically valid  information  and advice regarding the safe, appropriate, and cost-effective use of medications. [ 9 ]  Clinical pharmacists are also making themselves more readily available to the public. In the past, access to a clinical pharmacist was limited to hospitals, clinics, or educational institutions. However, clinical pharmacists are making themselves available through a medication information hotline, and reviewing medication lists, all in an effort to prevent medication errors in the foreseeable future. In the United Kingdom, clinical pharmacists are routinely involved in the direct care of patients within hospitals, and increasingly, in doctors surgeries. They also develop  post registration professional education , professional curricula for workforce development, provide expertise on the use of medicines to national organizations such as  NICE , the  Department of Health , and the  MHRA , and develop medicines guidelines for use in therapeutic areas. [ citation needed ]


Clinical pharmacists interact directly with patients in several different ways. They use their knowledge of medication (including dosage, drug interactions, side effects, expense, effectiveness, etc.) to determine if a medication plan is appropriate for their patient. If it is not, the pharmacist will consult the primary physician to ensure that the patient is on the proper medication plan. [ 10 ]  The pharmacist also works to educate their patients on the importance of taking and finishing their medications. Studies conducted into Pharmacist-led Chronic Disease Management show that it was associated with effects similar to usual care and might improve physiological goal attainment. [ 11 ]


In some states in the USA, clinical pharmacists are given prescriptive authority under protocol with a medical provider, and their scope of practice is constantly evolving. [ 12 ] [ 13 ]  In the United Kingdom clinical pharmacists are given independent prescriptive authority. [ 14 ]


Basic components of clinical pharmacy practice include prescribing drugs, [ 15 ]  administering drugs, monitoring prescriptions, managing drug use, and counselling patients. [ citation needed ]


The  Committee for Veterinary Medicinal Products  ( CVMP ) is the  European Medicines Agency 's  committee  responsible for elaborating the agency's opinions on all issues regarding veterinary medicines. [ 1 ]


This article about the  European Union  is a  stub . You can help Wikipedia by  expanding it .


In the field of  pharmacy ,  compounding  (performed in  compounding pharmacies ) is preparation of custom medications to fit unique needs of patients that cannot be met with mass-produced products. This may be done, for example, to provide medication in a form easier for a given patient to ingest (e.g., liquid vs. tablet), or to avoid a  non-active ingredient  a patient is allergic to, or to provide an exact dose that isn't otherwise available. This kind of patient-specific compounding, according to a prescriber's specifications, is referred to as "traditional" compounding. [ 1 ]  The nature of patient need for such customization can range from absolute necessity (e.g. avoiding allergy) to individual optimality (e.g. ideal dose level) to even preference (e.g. flavor or texture).


Hospital pharmacies typically engage in compounding medications for  intravenous  administration, whereas outpatient or community pharmacies typically engage in compounding medications for  oral  or  topical  administration. Due to the rising cost of compounding and drug shortages, some hospitals  outsource  their compounding needs to large-scale compounding pharmacies, particularly of sterile-injectable medications.


Compounding preparations of a given formulation in advance batches, as opposed to preparation for a specific patient on demand, is known as "non-traditional" compounding and is akin to small-scale manufacturing. Jurisdictions have varying regulations that apply to  drug manufacturers  and pharmacies that do advance bulk compounding.