What is a Tablet (Pharmacy)?

Introduction

A tablet (also known as a pill) is a pharmaceutical oral dosage form (oral solid dosage, or OSD) or solid unit dosage form. Tablets may be defined as the solid unit dosage form of medicament or medicaments with suitable excipients. It comprises a mixture of active substances and excipients, usually in powder form, pressed or compacted from a powder into a solid dose.

Tablets are prepared either by moulding or by compression. The excipients can include diluents, binders or granulating agents, glidants (flow aids) and lubricants to ensure efficient tabletting; disintegrants to promote tablet break-up in the digestive tract; sweeteners or flavours to enhance taste; and pigments to make the tablets visually attractive or aid in visual identification of an unknown tablet. A polymer coating is often applied to make the tablet smoother and easier to swallow, to control the release rate of the active ingredient, to make it more resistant to the environment (extending its shelf life), or to enhance the tablet’s appearance. Medicinal tablets were originally made in the shape of a disk of whatever colour their components determined, but are now made in many shapes and colours to help distinguish different medicines. Tablets are often stamped with symbols, letters, and numbers, which enable them to be identified. Sizes of tablets to be swallowed range from a few millimetres to about a centimetre.

The compressed tablet is the most popular dosage form in use today. About two-thirds of all prescriptions are dispensed as solid dosage forms, and half of these are compressed tablets. A tablet can be formulated to deliver an accurate dosage to a specific site; it is usually taken orally, but can be administered sublingually, buccally, rectally or intravaginally. The tablet is just one of the many forms that an oral drug can take such as syrups, elixirs, suspensions, and emulsions.

Brief History

Pills are thought to date back to around 1500 BC. Earlier medical recipes, such as those from 4000 BC, were for liquid preparations rather than solids. The first references to pills were found on papyruses in ancient Egypt, and contained bread dough, honey or grease. Medicinal ingredients, such as plant powders or spices, were mixed in and formed by hand to make little balls, or pills. In ancient Greece, such medicines were known as katapotia (“something to be swallowed”), and the Roman scholar Pliny, who lived from 23 to 79 AD, first gave a name to what we now call pills, calling them pilula.

Pills have always been difficult to swallow and efforts long have been made to make them go down easier. In medieval times, people coated pills with slippery plant substances. Another approach, used as recently as the 19th century, was to gild them in gold and silver, although this often meant that they would pass through the digestive tract with no effect. In the 1800s sugar-coating and gelatine-coating was invented, as were gelatine capsules.

In 1843, the British painter and inventor William Brockedon was granted a patent for a machine capable of “Shaping Pills, Lozenges and Black Lead by Pressure in Dies”. The device was capable of compressing powder into a tablet without use of an adhesive.

Types

Pills

A pill was originally defined as a small, round, solid pharmaceutical oral dosage form of medication. The word’s etymology reflects the historical concepts of grinding the ingredients with a mortar and pestle and rolling the resultant paste or dough into lumps to be dried. Today, in its strict sense, the word pill still refers specifically to tablets (including caplets) rather than capsules (which were invented much later), but because a simple hypernym is needed to intuitively cover all such oral dosage forms, the broad sense of the word pill is also widely used and includes both tablets and capsules – colloquially, any solid oral form of medication falls into the “pill” category.

An early example of pills came from Ancient Rome. They were made of the zinc carbonates hydrozincite and smithsonite. The pills were used for sore eyes, and were found aboard a Roman ship that wrecked in 140 BC. However, these tablets were meant to be pressed on the eyes, not swallowed.

Caplets

A caplet is a smooth, coated, oval-shaped medicinal tablet in the general shape of a capsule. Many caplets have an indentation running down the middle so they may be split in half more easily. Since their inception, capsules have been viewed by consumers as the most efficient method of taking medication. For this reason, producers of drugs such as OTC analgesics wanting to emphasize the strength of their product developed the “caplet”, a portmanteau of capsule-shaped tablet, in order to tie this positive association to more efficiently produced tablet pills, as well as being an easier-to-swallow shape than the usual disk-shaped tablet.

Orally Disintegrating Tablets (ODT)

An orally disintegrating tablet or orodispersible tablet (ODT), is a drug dosage form available for a limited range of over-the-counter (OTC) and prescription medications.

Film Coated Tablets (FCT)

A film coated tablet is a drug dosage form available for a limited range of over-the-counter (OTC) and prescription medications. The used films protect the drug substance against denaturation by stomach acid and/or support a delayed (modified) release of the drug substance (“retard effect”). Such tablets should not be damaged or broken.

Tabletting Formulations

In the tablet-pressing process, it is important that all ingredients be fairly dry, powdered or granular, somewhat uniform in particle size, and freely flowing. Mixed particle sized powders segregate during manufacturing operations due to different densities, which can result in tablets with poor drug or active pharmaceutical ingredient (API) content uniformity, but granulation should prevent this. Content uniformity ensures that the same API dose is delivered with each tablet.

Some APIs may be tableted as pure substances, but this is rarely the case; most formulations include excipients. Normally, a pharmacologically inactive ingredient (excipient) termed a binder is added to help hold the tablet together and give it strength. A wide variety of binders may be used, some common ones including lactose, dibasic calcium phosphate, sucrose, corn (maize) starch, microcrystalline cellulose, povidone polyvinylpyrrolidone and modified cellulose (for example hydroxypropyl methylcellulose and hydroxyethylcellulose).

Often, an ingredient is also needed to act as a disintegrant to aid tablet dispersion once swallowed, releasing the API for absorption. Some binders, such as starch and cellulose, are also excellent disintegrants.

Tablet Properties

Tablets can be made in virtually any shape, although requirements of patients and tableting machines mean that most are round, oval or capsule shaped. More unusual shapes have been manufactured but patients find these harder to swallow, and they are more vulnerable to chipping or manufacturing problems.

Tablet diameter and shape are determined by the machine tooling used to produce them – a die plus an upper and a lower punch are required. This is called a station of tooling. The thickness is determined by the amount of tablet material and the position of the punches in relation to each other during compression. Once this is done, we can measure the corresponding pressure applied during compression. The shorter the distance between the punches, thickness, the greater the pressure applied during compression, and sometimes the harder the tablet. Tablets need to be hard enough that they do not break up in the bottle, yet friable enough that they disintegrate in the gastric tract.

Tablets need to be strong enough to resist the stresses of packaging, shipping and handling by the pharmacist and patient. The mechanical strength of tablets is assessed using a combination of simple failure and erosion tests, and more sophisticated engineering tests. The simpler tests are often used for quality control purposes, whereas the more complex tests are used during the design of the formulation and manufacturing process in the research and development phase. Standards for tablet properties are published in the various international pharmacopeias‘ (USP/NF, EP, JP, etc.). The hardness of tablets is the principal measure of mechanical strength. Hardness is tested using a tablet hardness tester. The units for hardness have evolved since the 1930s, but are commonly measured in kilograms per square centimetre. Models of tester include the Monsanto (or Stokes) Hardness Tester from 1930, the Pfizer Hardness Tester from 1950, the Strong Cob Hardness Tester and the Heberlain (or Schleeniger) Hardness Tester.

Lubricants prevent ingredients from clumping together and from sticking to the tablet punches or capsule filling machine. Lubricants also ensure that tablet formation and ejection can occur with low friction between the solid and die wall, as well as between granules, which helps in uniform filling of the die.

Common minerals like talc or silica, and fats, e.g. vegetable stearin, magnesium stearate or stearic acid are the most frequently used lubricants in tablets or hard gelatine capsules.

Manufacturing

Manufacture of the Tableting Blend

In the tablet pressing process, the appropriate amount of active ingredient must be in each tablet. Hence, all the ingredients should be well-mixed. If a sufficiently homogenous mix of the components cannot be obtained with simple blending processes, the ingredients must be granulated prior to compression to assure an even distribution of the active compound in the final tablet. Two basic techniques are used to granulate powders for compression into a tablet: wet granulation and dry granulation. Powders that can be mixed well do not require granulation and can be compressed into tablets through direct compression (“DC”). Direct Compression is desirable as it is quicker. There is less processing, equipment, labour, and energy consumption. However, DC is difficult when a formulation has a high content of poorly compressible active ingredient.

Wet Granulation

Wet granulation is a process of using a liquid binder to lightly agglomerate the powder mixture. The amount of liquid has to be properly controlled, as over-wetting will cause the granules to be too hard and under-wetting will cause them to be too soft and friable. Aqueous solutions have the advantage of being safer to deal with than solvent-based systems but may not be suitable for drugs which are degraded by hydrolysis.

Procedure

  • The active ingredient and excipients are weighed and mixed.
  • The wet granulate is prepared by adding the liquid binder-adhesive to the powder blend and mixing thoroughly. Examples of binders/adhesives include aqueous preparations of corn starch, natural gums such as acacia, cellulose derivatives such as methyl cellulose, gelatine, and povidone.
  • Screening the damp mass through a mesh to form pellets or granules.
  • Drying the granulation. A conventional tray-dryer or fluid-bed dryer are most commonly used.
  • After the granules are dried, they are passed through a screen of smaller size than the one used for the wet mass to create granules of uniform size.

Low shear wet granulation processes use very simple mixing equipment, and can take a considerable time to achieve a uniformly mixed state. High shear wet granulation processes use equipment that mixes the powder and liquid at a very fast rate, and thus speeds up the manufacturing process. Fluid bed granulation is a multiple-step wet granulation process performed in the same vessel to pre-heat, granulate, and dry the powders. It is used because it allows close control of the granulation process.

Dry Granulation

Dry granulation processes create granules by light compaction of the powder blend under low pressures. The compacts so-formed are broken up gently to produce granules (agglomerates). This process is often used when the product to be granulated is sensitive to moisture and heat. Dry granulation can be conducted on a tablet press using slugging tooling or on a roll press called a roller compactor. Dry granulation equipment offers a wide range of pressures to attain proper densification and granule formation. Dry granulation is simpler than wet granulation, therefore the cost is reduced. However, dry granulation often produces a higher percentage of fine granules, which can compromise the quality or create yield problems for the tablet. Dry granulation requires drugs or excipients with cohesive properties, and a ‘dry binder’ may need to be added to the formulation to facilitate the formation of granules.

Hot Melt Extrusion

Hot melt extrusion is utilised in pharmaceutical solid oral dose processing to enable delivery of drugs with poor solubility and bioavailability. Hot melt extrusion has been shown to molecularly disperse poorly soluble drugs in a polymer carrier increasing dissolution rates and bioavailability. The process involves the application of heat, pressure and agitation to mix materials together and ‘extrude’ them through a die. Twin-screw high shear extruders blend materials and simultaneously break up particles. The extruded particles can then be blended and compressed into tablets or filled into capsules.

Granule Lubrication

After granulation, a final lubrication step is used to ensure that the tableting blend does not stick to the equipment during the tableting process. This usually involves low shear blending of the granules with a powdered lubricant, such as magnesium stearate or stearic acid.

Manufacture of the Tablets

Whatever process is used to make the tableting blend, the process of making a tablet by powder compaction is very similar. First, the powder is filled into the die from above. The mass of powder is determined by the position of the lower punch in the die, the cross-sectional area of the die, and the powder density. At this stage, adjustments to the tablet weight are normally made by repositioning the lower punch. After die filling, the upper punch is lowered into the die and the powder is uniaxially compressed to a porosity of between 5 and 20%. The compression can take place in one or two stages (main compression, and, sometimes, pre-compression or tamping) and for commercial production occurs very fast (500-50 mg per tablet). Finally, the upper punch is pulled up and out of the die (decompression), and the tablet is ejected from the die by lifting the lower punch until its upper surface is flush with the top face of the die. This process is repeated for each tablet.

Common problems encountered during tablet manufacturing operations include:

  • Fluctuations in tablet weight, usually caused by uneven powder flow into the die due to poor powder flow properties.
  • Fluctuations in dosage of the Active Pharmaceutical Ingredient, caused by uneven distribution of the API in the tableting blend (either due to poor mixing or separation in process).
  • Sticking of the powder blend to the tablet tooling, due to inadequate lubrication, worn or dirty tooling, or a sticky powder formulation.
  • Capping, lamination or chipping. This is caused by air being compressed with the tablet formulation and then expanding when the punch is released: if this breaks the tablet apart, it can be due to incorrect machine settings, or due to incorrect formulation: either because the tablet formulation is too brittle or not adhesive enough, or because the powder being fed to the tablet press contains too much air (has too low bulk density).
  • Capping can also occur due to high moisture content.

Tablet Compaction Simulator

Tablet formulations are designed and tested using a laboratory machine called a Tablet Compaction Simulator or Powder Compaction Simulator. This is a computer controlled device that can measure the punch positions, punch pressures, friction forces, die wall pressures, and sometimes the tablet internal temperature during the compaction event. Numerous experiments with small quantities of different mixtures can be performed to optimise a formulation. Mathematically corrected punch motions can be programmed to simulate any type and model of production tablet press. Initial quantities of active pharmaceutical ingredients are very expensive to produce, and using a Compaction Simulator reduces the amount of powder required for product development.

Tablet Presses

Tablet presses, also called tableting machines, range from small, inexpensive bench-top models that make one tablet at a time (single-station presses), with only around a half-ton pressure, to large, computerised, industrial models (multi-station rotary presses) that can make hundreds of thousands to millions of tablets an hour with much greater pressure. The tablet press is an essential piece of machinery for any pharmaceutical and nutraceutical manufacturer. Tablet presses must allow the operator to adjust the position of the lower and upper punches accurately, so that the tablet weight, thickness and density/hardness can each be controlled. This is achieved using a series of cams, rollers, or tracks that act on the tablet tooling (punches). Mechanical systems are also incorporated for die filling, and for ejecting and removing the tablets from the press after compression. Pharmaceutical tablet presses are required to be easy to clean and quick to reconfigure with different tooling, because they are usually used to manufacture many different products. There are two main standards of tablet tooling used in pharmaceutical industry: American standard TSM and European standard EU. TSM and EU configurations are similar to each other but cannot be interchanged.

Modern tablet presses reach output volumes of up to 1,700,000 tablets per hour. These huge volumes require frequent in-process quality control for the tablet weight, thickness and hardness. Due to reduce rejects rates and machine down-time, automated tablet testing devices are used on-line with the tablet press or off-line in the IPC-labs.

Tablet Coating

Many tablets today are coated after being pressed. Although sugar-coating was popular in the past, the process has many drawbacks. Modern tablet coatings are polymer and polysaccharide based, with plasticizers and pigments included. Tablet coatings must be stable and strong enough to survive the handling of the tablet, must not make tablets stick together during the coating process, and must follow the fine contours of embossed characters or logos on tablets. Coatings are necessary for tablets that have an unpleasant taste, and a smoother finish makes large tablets easier to swallow. Tablet coatings are also useful to extend the shelf-life of components that are sensitive to moisture or oxidation. Special coatings (for example with pearlescent effects) can enhance brand recognition.

If the active ingredient of a tablet is sensitive to acid, or is irritant to the stomach lining, an enteric coating can be used, which is resistant to stomach acid, and dissolves in the less acidic area of the intestines. Enteric coatings are also used for medicines that can be negatively affected by taking a long time to reach the small intestine, where they are absorbed. Coatings are often chosen to control the rate of dissolution of the drug in the gastrointestinal tract. Some drugs are absorbed better in certain parts of the digestive system. If this part is the stomach, a coating is selected that dissolves quickly and easily in acid. If the rate of absorption is best in the large intestine or colon, a coating is used that is acid resistant and dissolves slowly to ensure that the tablet reaches that point before dispersing. To measure the disintegration time of the tablet coating and the tablet core, automatic disintegration testers are used which are able to determine the complete disintegration process of a tablet by measuring the rest height of the thickness with every upward stroke of the disintegration tester basket.

There are two types of coating machines used in the pharmaceutical industry: coating pans and automatic coaters. Coating pans are used mostly to sugar coat pellets. Automatic coaters are used for all kinds of coatings; they can be equipped with a remote control panel, a dehumidifier, and dust collectors. An explosion-proof design is required for applying coatings that contain alcohol.

Pill-Splitters

It is sometimes necessary to split tablets into halves or quarters. Tablets are easier to break accurately if scored, but there are devices called pill-splitters which cut unscored and scored tablets. Tablets with special coatings (for example enteric coatings or controlled-release coatings) should not be broken before use, as this exposes the tablet core to the digestive juices, circumventing the intended delayed-release effect.

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What is a Pharmacist?

Introduction

Pharmacists – also known as chemists (Commonwealth English) or druggists (North American and, archaically, Commonwealth English) – are health professionals who control, formulate, preserve and dispense medications and provide advice and counselling on how medicines should be used to achieve maximum benefit, minimal side effects and to avoid drug interactions.

They also serve as primary care providers in the community. 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 specialised 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 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. 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 prescriber”) and administering certain medications (e.g. immunisations) in some jurisdictions. Pharmacists may also practice in a variety of other settings, including industry, wholesaling, research, academia, formulary management, military, and government.

Nature of Work

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.

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 counselling skills of the pharmacist. One of the most important roles that pharmacists are currently taking on is one of pharmaceutical care. 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; 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:

  • Clinical medication management, including reviewing and monitoring of medication regimens.
  • Assessment of patients with undiagnosed or diagnosed conditions, and ascertaining clinical medication management needs.
  • Specialised monitoring of disease states, such as dosing drugs in kidney and liver failure.
  • Compounding medicines.
  • Providing pharmaceutical information.
  • Providing patients with health monitoring and advice, including advice and treatment of common ailments and disease states.
  • Supervising pharmacy technicians and other staff.
  • Oversight of dispensing medicines on prescription.
  • Provision of and counselling about non-prescription or over-the-counter drugs.
  • Education and counselling for patients and other health care providers on optimal use of medicines (e.g. proper use, avoidance of overmedication).
  • Referrals to other health professionals if necessary.
  • Pharmacokinetic evaluation.
  • Promoting public health by administering immunisations.
  • Constructing drug formularies.
  • Designing clinical trials for drug development.
  • Working with federal, state, or local regulatory agencies to develop safe drug policies.
  • Ensuring correctness of all medication labels including auxiliary labels.
  • Member of inter-professional care team for critical care patients.
  • Symptom assessment leading to medication provision and lifestyle advice for community-based health concerns (e.g. head colds, or smoking cessation).
  • satged dosing supply (e.g. opioid substitution therapy).

Education and Credentialing

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 EU 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, pharmacokinetics, pharmacodynamics, 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 specialised training, such as in cardiology or oncology. Specialties include:

  • Academic pharmacist.
  • Clinical pharmacy specialist.
  • Community pharmacist.
  • Compounding pharmacist.
  • Consultant pharmacist.
  • Drug information pharmacist.
  • Home health pharmacist.
  • Hospital pharmacist.
  • Industrial pharmacist.
  • Informatics pharmacist.
  • Managed care pharmacist.
  • Military pharmacist.
  • Nuclear pharmacist.
  • Oncology pharmacist.
  • Regulatory-affairs pharmacist.
  • Veterinary pharmacist.
  • Pharmacist clinical pathologist.
  • Pharmacist clinical.

Training and Practice by Country

Armenia

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 Organisation (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.

Australia

The Australian Pharmacy Council is the independent accreditation agency for Australian pharmacists. The accreditation standards for Australian pharmacy degrees include compulsory clinical placements, with an emphasis on encouraging rural experiences to develop a rural workforce. It conducts examinations on behalf of the Pharmacy Board of Australia towards eligibility for registration. The Australian College of Pharmacy provides continuing education programmes for pharmacists. The number of full-time equivalent pharmacists working in Australia over the past decade has remained stable. Pharmacy practice is described by the practice standards and guidelines including those from the Pharmaceutical Society of Australia.

Wages for pharmacists in Australia appear to have stagnated, and even gone backwards. As of 2007, the award wages for a pharmacist is $812 a week. Pharmacist graduates are the lowest paid university graduates most years. Most pharmacists do earn above the award wage; the average male pharmacist earns $65,000, a female pharmacist averages $56,500. 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. There are accounts of underemployment and unemployment emerging recently.

Canada

The Canadian Pharmacists Association (CPhA) is the national professional organisation 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 programme, 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 programme, and fluency in French or English. 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. 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. Pharmacists’ scope of practice varies widely among the 13 provinces and territories and continues to evolve with time. 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.

Germany

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

  • University: Basic studies (at least four semesters).
  • University: Main studies (at least four semesters).
  • Community Pharmacy / Hospital Pharmacy / Industry: Practical training (12 months; 6 months in a Community Pharmacy).

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.

Japan

Brief History

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 organisational 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.

Contemporary

As of 1997, 46 universities of pharmacy in Japan graduated about 8000 students annually. 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.

Nigeria

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 two (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, 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 one (1) year of Tutelage under the supervision of an already Registered Pharmacist(a preceptor) in a recognised 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.

Pakistan

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) Programme to a 5-year Pharm.D. (Doctor of Pharmacy) programme. All 21 universities have started the 5-year Pharm.D Programme. 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.

Poland

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 specialisation.

Sweden

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 programme, 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 to 20-year-old students) program in natural science after elementary school (6 to 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. Pharmacy technicians do not have dispensing rights in Sweden but are allowed to advise on and sell over-the-counter medicines.

Switzerland

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 specialise in various fields; this is organised by PharmaSuisse, the pharmacists’ association of Switzerland.

Tanzania

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 organisations. The public sector including public retail pharmacies and faith based organisations 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.

Trinidad and Tobago

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 one (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.

United Kingdom

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.

Practices

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.

The new professional role for pharmacist as prescriber has been recognised 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).

Education and Registration

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.

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):

  • Successful completion of a 4-year Master of Pharmacy degree at a GPhC accredited university. Pharmacists holding degrees in Pharmacy from overseas institutions are able to fulfil this stage by undertaking the Overseas Pharmacist Assessment Programme (OSPAP), which is a one-year postgraduate diploma. On completion of the OSPAP, the candidate would proceed with the other stages of the registration process in the same manner as a UK student.
  • Completion of a 52-week preregistration training period. This is a period of paid or unpaid employment, in an approved hospital or community pharmacy under the supervision of a pharmacist tutor. During this time the student must collect evidence of having met certain competency standards set by the GPhC.
  • A pass mark in the GPhC registration assessment (formally an exam). This includes a closed-book paper and an open-book/mental calculations paper (using the British National Formulary and the GPhC’s “Standards of Conduct, Ethics and Performance” document as reference sources). The student must achieve an overall mark of 70%, which must include at least 70% in the calculations section of the open-book paper. From June 2016, the assessment will involve two papers, as before but the use of a calculator will now be allowed. However, reference sources will no longer be allowed in the assessment. Instead, relevant extracts of the British National Formulary will be provided within the assessment paper.
  • Satisfactorily meeting the GPhC’s Fitness to Practice Standards.

United States

In 2014 the United States Bureau of Labour Statistics revealed that there were 297,100 American pharmacist jobs. By 2024 that number is projected to grow by 3%. 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.

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. In addition, pharmacists are subject to state-level jurisprudence exams in order to practice from state to state.

Pharmacy School Accreditation

The Accreditation Council for Pharmacy Education (ACPE) has operated since 1932 as the accrediting body for schools of pharmacy in the United States. The mission of ACPE is “To assure and advance excellence in education for the profession of pharmacy”. ACPE is recognised for the accreditation of professional degree programmes by the United States Department of Education (USDE) and the Council for Higher Education Accreditation (CHEA). 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.

A Pharmacy school pursuing accreditation must first apply and be granted Pre-candidate status. 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 programme 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 programme are that they continue to mature in accordance with stated plans. The graduates of a Candidate programme are the same as those of fully accredited programmes. Full accreditation is granted to a programme once they have demonstrated they comply with the standards set forth by ACPE.

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

Education

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:

  • Anatomy.
  • Physiology.
  • Biochemistry.
  • Biology.
  • Immunology.
  • Chemical engineering.
  • Economics.
  • Pathophysiology.
  • Physics.
  • Humanities.
  • Microbiology.
  • Molecular biology.
  • Organic chemistry.
  • Physical chemistry.
  • Statistics.
  • Calculus.

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 to 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 programmes via part-time, weekend or on-line programmes. 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 programmes.

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 optimisation. Legal requirements in the US to becoming a pharmacist include: graduating from an accredited PharmD programme, conducting a specified number of internship hours under a licensed pharmacist (i.e. 1,800 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.

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 favour 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 programme and usually require one (1) year of residency at minimum.

Specialisation and Credentialing

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

  • The Board of Pharmacy Specialties certifies pharmacists in thirteen specialties:
    • Ambulatory care pharmacy.
    • Cardiology pharmacy.
    • Compounded sterile preparations pharmacy.
    • Critical care pharmacy.
    • Geriatric pharmacy.
    • Infectious diseases pharmacy.
    • Nuclear pharmacy.
    • Nutrition support pharmacy.
    • Oncology pharmacy.
    • Paediatric pharmacy.
    • Pharmacotherapy.
    • Psychiatric pharmacy.
    • Solid organ transplant pharmacy.
  • The American Board of Applied Toxicology certifies pharmacists and other medical professionals in applied toxicology.

Vaccinations

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

California

All licensed California pharmacists can perform the following:

  • Order and interpret drug therapy related tests.
  • Furnish smoking cessation aids (such as nicotine replacement therapy).
  • Furnish oral self-administered contraception (birth control pills).
  • Furnish travel medications recommended by the CDC.
  • Administer vaccinations pursuant to the latest CDC standards for anyone ages 3+.

The passage of Assembly Bill 1535 (2014) authorises pharmacists in California to furnish naloxone without a physician’s prescription.

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

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. An APh can:

  • Perform patient assessments.
  • Refer patients to other healthcare providers.
  • Participate in the evaluation and management of diseases and health conditions in collaboration with other health care providers.
  • Initiate, adjust, or discontinue therapy pursuant to the regulations outlined in the bill.

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 fulfil two of three requirements, including certification in their area clinical practice. 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.

Vietnam

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.

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