The earliest  chemists  were familiar with various natural substances and their uses. They compounded a variety of preparations such as medications, dyes, incense, perfumes, ceremonial compounds, preservatives and cosmetics. In the  medieval Islamic world  in particular,  Muslim pharmacists  and  chemists  developed advanced methods of compounding drugs. The first  drugstores  were opened by Muslim pharmacists in  Baghdad  in 754. [ 2 ] [ 3 ]  The modern age of pharmacy compounding began in the 19th century with the isolation of various compounds from  coal tar  for the purpose of producing  synthetic dyes . From this came the earliest  antibacterial   sulfa drugs ,  phenolic  compounds made famous by  Joseph Lister , and  plastics .


During the 1800s, pharmacists specialized in the raising, preparation and compounding of  crude drugs .  Crude drugs, like  opium , are from natural sources and usually contain several  chemical compounds .  The pharmacist extracted these drugs using solvents such as  water  or  alcohol  to form  extracts ,  concoctions  and  decoctions . They eventually began isolating and identifying the  active ingredients  in these drug concoctions. Using  fractionation  or  recrystallization , they separated an active ingredient from the crude preparation, and compounded a medication using this active ingredient.


With the isolation of medications from the  raw materials  or crude drugs came the birth of the modern pharmaceutical company. Pharmacists were trained to compound the preparations made by the drug companies, but they could not do it efficiently on a small scale. So  economies of scale , not lack of skill or knowledge, produced the modern  pharmaceutical industry . With the turn of the 20th century came greater government  regulation  of the practice of medicine.  These new regulations forced the drug companies to prove that any new medication they brought to market was safe. With the discovery of  penicillin , modern marketing techniques and  brand  promotion, the drug manufacturing industry came of age.  Pharmacists continued to compound most  prescriptions  until the early 1950s when the majority of dispensed drugs came directly from the large pharmaceutical companies.


A physician may choose to prescribe a compounded medication for a patient with an unusual health need that cannot be met with commercially manufactured products. The physician may choose to prescribe a compounded medication for reasons such as


In hospitals, pharmacists and pharmacy technicians often make compounded sterile preparations (CSPs) using manual methods. The error rate for manually compounded sterile IV products is high. [ 13 ]  The  Institute for Safe Medication Practices  (ISMP) has expressed concern with manual methods, particularly the error-prone nature of the syringe pull-back method of verifying sterile preparations. [ 14 ]  To increase accuracy, some U.S. hospitals have adopted IV workflow management systems and robotic compounding systems. These technologies use barcode scanning to identify each ingredient and  gravimetric  weight measurement to confirm the proper dose amount. The workflow management systems incorporate software to guide pharmacy technicians through the process of preparing IV medications. The robotic systems prepare IV syringes and bags in an ISO Class 5 environment, and support sterility and dose accuracy by removing human error and contamination from the process. [ 15 ] [ 16 ]


In Australia the Pharmacy Board of Australia is responsible for registration of pharmacists and professional practice including compounding. Although almost all pharmacies are able to prepare at least simple compounded medicines, some pharmacy staff undertake further training and education to be able to prepare more complex products. Although pharmacists who have undertaken further training to do complex compounding are not yet easily identified, the Board has been working to put a credentialing system in place. In 2011 the Pharmacy Board convened a Compounding Working Party to advise on revised compounding standards. [ 17 ]  Draft compounding guidelines for comment were released in April 2014. Pharmacists must comply with current guidelines or may be sanctioned by the Board. [ 18 ]


Both sterile and non-sterile compounding are legal provided the compounding is done for therapeutic use in a particular patient, and the compounded product is supplied on or from the compounding pharmacy. [ 19 ]  There are additional requirements for sterile compounding. Not only must a laminar flow cabinet [laminar flow hood] be used, but the environment in which the hood is located must be strictly controlled for microbial and particulate contamination and all procedures, equipment and personnel must be validated to ensure the safe preparation of sterile products. In non-sterile compounding, a powder containment hood is required when any hazardous material (e.g. hormones) are prepared or when there is a risk of cross-contamination of the compounded product. Pharmacists preparing compounded products must comply with these requirements and others published in the Australian Pharmaceutical Formulary & Handbook. [ citation needed ]


In the  United States , compounding pharmacies are licensed and regulated by states. National standards have been created by Pharmacy Compounding Accreditation Board (PCAB), [ 20 ]  however, obtaining accreditation is not mandatory and inspections for compliance occur only every three years. [ 21 ]  The  Food and Drug Administration  (FDA) has authority to regulate "manufacturing" of pharmaceutical products—which applies when drug products are not made or modified as to be  tailored in some way to the individual patient —regardless of whether this is done at a factory or at a pharmacy.


In the Drug Quality and Security Act (DQSA) of 2013 (H.R. 3204), [ 22 ]  Congress amended the Federal Food, Drug, and Cosmetic Act (FFDCA) to clarify limits of FDA jurisdiction over patient-specific compounding, and to provide an optional pathway for "non-traditional" or bulk compounders to operate. The law established that pharmacies compounding only "patient-specific" preparations made in response to a prescription (503A pharmacies) cannot be required to obtain FDA approval for such products, as they will remain exclusively under state-level pharmacy regulation. At the same time, section 503B of the law regulates "outsourcing facilities" which conduct bulk compounding or are used as outsourcing for compounding by other pharmacies. These outsourcing facilities can be explicitly authorized by the Food and Drug Administration under specified circumstances, while being exempted from certain requirements otherwise imposed on mass-producers. In any pharmacy, compounding is not permitted for a drug product that is "essentially a copy" of a mass-produced drug product, however outsourcing pharmacies are subject to a broader definition of "essentially a copy". For traditional/patient-specific compounding, 503A's definition of "copy" retains its original focus on drug  products  or ultimate dosage forms rather than drug substances or active ingredients, [ 23 ]  and in any event it explicitly excludes from its definition any compounded drug product that a given patient's prescribing practitioner determines makes a "significant difference" for the patient.


The FDA weighs the following factors in deciding whether it has authority to "exercise its discretion" to require approval for a custom-compounded drug product: [ 24 ]


The DQSA amended the FFDCA to create a new class of FDA-regulated entities known as "outsourcing facilities" whose compounding activities "may  or  may not" be patient-specific based on individualized prescriptions. [ 25 ]   Registered outsourcing facilities, unlike traditional compounding facilities, are subject to the FDA's oversight. In addition to being subjected to Food and Drug Administration inspections, registration, fees, and specified reporting requirements, other requirements of outsourcing facilities include:


Poor practices on the part of drug compounders can result in contamination of products, or products that do not meet their stated strength, purity, or quality. Unless a complaint is filed or a patient is harmed, drugs made by compounders are seldom tested. In Texas, one of only two states that does random testing, significant problems have been found. Random tests by the state's pharmacy board over the last several years have found that as many as one in four compounded drugs was either too weak or too strong. In Missouri, the only other state that does testing, potency varied by as much as 300 percent. [ 26 ]


In 2002, the  Food and Drug Administration , concerned about the rising number of accidents related to compounded medications, identified "red flag" factors and issued a guide devoted to human pharmacy compounding,  These factors include instances where pharmacists are: [ 27 ]


In October 2012 news reports surfaced of an  outbreak of fungal meningitis  tied to the New England Compounding Center, a pharmacy which engaged in bulk compounding.
 [ 28 ]  At that time it was also disclosed that the United States and Massachusetts state health regulators were aware in 2002 that steroid treatments from the New England Compounding Center could cause adverse patient reactions. [ 29 ]  It was further disclosed that in 2001–02, four people died, more than a dozen were injured and hundreds exposed after they received back-pain injections tainted with a common fungus dispensed by two compounding pharmacies in California and South Carolina. [ 30 ]


In August 2013 further reports tied to the  New England  compounding center said that about 750 people were sickened, including 63 deaths, and that  infections were linked to more than 17,600 doses of  methylprednisolone acetate   steroid  injections used to treat back and  joint  pain that were shipped to 23 states. At that time, another incident was reported  after at least 15 people at two  Texas  hospitals developed bacterial infections. All lots of  medications dispensed since May 9, 2013,  made by Specialty Compounding, LLC of  Cedar Park, Texas  were recalled. The hospitals reported affected  were Corpus Christi Medical Center Bay Area and Corpus Christi Medical Center Doctors Regional. The patients had received intravenous infusions of  calcium gluconate , a drug used to treat  calcium  deficiencies and too much  potassium  in the blood. Implicated in these cases is the  Rhodococcus  bacteria, which can cause symptoms such as fever and pain. [ 31 ]


The FDA, among others, claims that larger compounding pharmacies act like drug manufacturers and yet circumvent FDA regulations under the banner of compounding. Drugs from compounding pharmacies can be cheaper or alleviate shortages, but can pose greater risk of contamination due in part to the lack of oversight. "Non-traditional" compounders behave like drug manufacturers in some cases by having sales teams that market non-personalized drug products or production capability to doctors, by making drugs that are essentially the same as commercially available mass-produced drug products, or by preparing large batches of a given drug product in anticipation of additional prescriptions before actually receiving them. [ 32 ] [ 33 ]  An FDA spokesperson stated, "The methods of these companies seem far more consistent with those of drug manufacturers than with those of retail pharmacies.  Some firms make large amounts of compounded drugs that are copies or near copies of FDA-approved, commercially available drugs. Other firms sell to physicians and patients with whom they have only a remote professional relationship." [ 27 ]  The head of the FDA has recently requested the following authority from Congress: [ 34 ]


Various ideas have been proposed to expand federal US regulation in this area, including laws making it easier to identify misuse or misnomered-use [ 35 ]  and/or stricter enforcement of the longstanding distinction between  compounding  versus  manufacturing . [ 36 ] [ 37 ]  Some US states have also taken initiatives to strengthen oversight of compounding pharmacies. [ 38 ]  A major source of opposition to new Food and Drug Administration regulation on compounding is makers of  dietary supplements . [ 39 ]


Concomitant drugs  are two or more  drugs  used or given at or almost at the same time (one after the other, on the same day, etc.). The term has two contextual uses: as used in  medicine  or as used in  drug abuse .


This designation is used when medicinal drugs are given either at the same time or almost at the same time. This is often the case in medicine.


Chemotherapy for cancer applies is an example. The standard of care (sometimes also called the "gold standard") for the adjuvant treatment of stage III colon cancer is the FOLFOX chemotherapy protocol (used in Europe, Japan, Canada, and Australia) and respectively the FLOX chemotherapy protocol (used in the USA). These 2 chemotherapy protocols are very similar in principle. Both consist of 3 medicinal drugs: a) Leucovorin (=  folinic acid  = calcium folinate), b) 5-Fluorouracil (= 5-FU), and c)  Oxaliplatin . Since these 3 medicinal drugs are "concomitant" to each other, such a constellation is called "concomitant drugs". [ 1 ]


Contrast imaging in medicine is another example. These are imaging procedures in medicine that are performed after giving the patient an  iodinated contrast  medium (e.g. different types of contrast X-rays, CTs, MRIs). It is well known that such iodinated contrast media can lead to acute allergies in some patients. They may also lead to kidney damage. If the patient is receiving a "concomitant" medicinal drug (prescribed to the patient by another physician), and the radiologist performing the imaging procedure is unaware of this, potentially harmful side-effects can occur and increase the risk of contrast medium-induced nephropathy (i.e. increase the risk of damage to the kidneys). In general, radiologists carefully ask their patients about other medicinal drugs they are "concomitantly" taking before the imaging procedure. Often, they monitor the kidney function and the hydration status of their patients during the imaging procedure, especially whenever a concomitant drug (that is harmful to the kidney) is being used. [ 2 ]


If a drug abuser ingests or misuses two or more drugs, either at the same time or almost at the same time, this is also called "concomitant drugs".


Whether concomitant drug abuse leads to an increased number of deaths was scientifically analysed in Sheffield, UK. [ 3 ]  The researchers wanted to find out whether concomitant drug abuse (i.e. an opiate plus another drug of misuse) leads to an increased number of acute accidental opiate-related deaths. The authors showed that at least in the Sheffield area, intravenous (IV) administration of an opiate is the most consistent factor associated with drug abuse deaths. The co-administration of a concomitant drug of misuse appeared to be a feature rather than a risk factor per se in such deaths. [ 3 ]


A  consultant pharmacist  is a  pharmacist  who works as a  consultant  providing expert advice on clinical pharmacy, academic pharmacy or practice, public health pharmacy, industrial pharmacy, community pharmacy or practice, pharmaceutical analysis etc., regarding the safe use and production of  medications  or on the provision of  pharmaceutical services  to medical institutions, hospitals, universities, research institutions, medical practices and individual patients. [ 1 ]


In Australia, a consultant pharmacist has historically referred to a pharmacist accredited to access funding to be remunerated for providing Residential Medication Management Reviews and  Home Medication Reviews .


These pharmacists undergo a credentialing process, that was historically referred to as accreditation, and were then able to access the funding to perform these roles.  The major accreditation organisation, known as the Australian Association of Consultant Pharmacy, was disbanded in 2022.  The Pharmaceutical Society of Australia, Society of Hospital Pharmacists Australia and the Australian College of Pharmacy (owned by the Queensland branch of the Pharmacy Guild of Australia) are now the three organisations that provide credentialing for pharmacists to be able to undertake domiciliary medication management reviews.


The Australian Pharmacy Council will develop Aged Care Accreditation Standards in 2023 for pharmacists working in residential aged care settings and undertaking medication management reviews. These standards are being developed in response to a series of research papers published by the Consultant Pharmacists' Services Research Network (COHERENT) that has found inconsistencies in the delivery of these services and the preparedness of pharmacists generally to move into these settings. [ 2 ] [ 3 ] [ 4 ]


In the US, a consultant pharmacist focuses on reviewing and managing the medication regimens of  patients , particularly those in institutional settings such as  nursing homes . Consultant pharmacists ensure their patients’ medications are appropriate, effective, as safe as possible and used correctly; and identify, resolve, and prevent  medication-related problems  that may interfere with the goals of therapy.


The demand for consultant pharmacists is on the rise. Licensing and accrediting agencies such as Centers for Medicare and Medicaid (CMS), [ 5 ]  Accreditation Association for Ambulatory Health Care (AAAHC), The Joint Commission (JC) and individual states licensing bodies encourage healthcare facilities to use consultant pharmacists.


Consultants may specialize in one of the following areas: Regulatory, Quality, Technical, or Clinical.


In the UK's  NHS , the term consultant pharmacist refers to a pharmacist who has advanced roles in patient care, research and education in a specific medical speciality or expert area of practice.


The Department of Health for England produced guidance in 2005 which described the role of the Consultant Pharmacist which is distinct from other roles in England and internationally. The posts are intended to be innovative new posts that will help improve patient care by retaining clinical excellence within the NHS and strengthening professional leadership. The consultant pharmacist posts have been created to provide a dynamic link between clinical practice and service development to support new models for delivering patient care. The title consultant pharmacist should only apply to approved posts that meet the principles, set out in the guidance, around four main functions:


The guidance recommends that the title consultant pharmacist is not conferred on individuals purely in recognition of innovative or excellent practice, but for those practitioners who meet the required competencies for the post. In the NHS, the posts created within or across NHS organisations, are approved by Strategic Health Authorities (or clusters of SHA’s). The SHA's provide approval panels for ratification of consultants posts to ensure that business plans match the spirit of this guidance and that posts are sustainable, equitable and transferable across the NHS.


The competency requirements for consultant pharmacists are drawn from the Advanced and Consultant Level Competency Framework designed by the Competency Development and Evaluation Group (CoDEG, see www.codeg.org) which is divided into six capability (competency) clusters. Postholders are required to demonstrate:


There is work is underway to make explicit links between the Competency Framework and the NHS Knowledge and Skills Framework. The role of consultant pharmacists in the NHS is evolving and although many posts are currently based in hospital practice, the role is developing in primary care.


The  defined daily dose  ( DDD ) is a statistical measure of  drug  consumption, defined by the  World Health Organization  (WHO)  Collaborating Centre for Drug Statistics Methodology. It is defined in combination with the  ATC Code  drug classification system for grouping related drugs. The DDD enables comparison of drug usage between different drugs in the same group or between different health care environments, or to look at trends in drug utilisation over time. The DDD is not to be confused with the  therapeutic dose  or  prescribed daily dose  (PDD), or recorded daily dose (RDD), and will often be different to the dose actually prescribed by a physician for an individual person. [ 1 ]


The WHO's definition is: "The DDD is the assumed average  maintenance dose  per day for a drug used for its main indication in adults." [ 1 ]  The Defined Daily Dose was first developed in the late 1970s. [ 2 ]


Before a DDD is assigned by the WHO Collaborating Centre for Drug Statistics Methodology, it must have an  ATC Code  and be approved for sale in at least one country. The DDD is calculated for a 70kg adult, except if this drug is only ever used in children. The dose is based on recommendations for treatment rather than prevention, except if prevention is the main indication. Generally there is only one DDD for all formulations of a drug, however exceptions are made if some formulations are typically used in significantly different strengths (e.g., antibiotic injection in a hospital vs tablets in the community). The DDD of combination tablets (containing more than one drug) is more complex, most taking into account a "unit dose", though combination tablets used for  high blood pressure  take the number of doses per day into account. [ 1 ]


The formula for determining the dose is: [ 1 ]


The DDD of a drug is reviewed after three years. Ad hoc requests for change may be made but are discouraged and generally not permitted unless the main indication for the drug has changed or the average dose used has changed by more than 50%. [ 3 ]


The DDD is generally the same for all formulations of a drug, even if some (e.g., flavoured syrup) are designed with children in mind. Some types of drug are not assigned a DDD, for example: medicines applied to the skin, anaesthetics and vaccines. Because the DDD is a calculated value, it is sometimes a "dose" not actually ever prescribed (e.g., a midpoint of two prescribed tablet strengths may not be equal to or be a multiple of any available tablet). [ 1 ]  Different people may in practice be prescribed higher or lower doses than the DDD, for instance in children, people with liver or kidney impairment, patients with a  combination therapy , or due to differences in  drug metabolism  between individuals or  ethnicities  ( genetic polymorphism ). [ 1 ]


Although designed primarily for drug utilisation research, data using the DDD can only give a "rough estimate" compared with actually collecting statistics on drug use in practice. [ 1 ]  The DDD is often use for long term research and analysis of drug utilisation trends over time, so changes to the DDD are avoided if possible, [ 3 ]  whereas changes in the actual daily dose prescribed for a population may often occur. [ 4 ]  For example, the Recorded Daily Dose (RDD) of  simvastatin  in Canada in 1997 was only 8% different to the DDD, but by 2006 it was 67% different. In 2009, the DDD of several  statins  were updated, with simvastatin changing from 15mg to 30mg. [ 4 ]


The DDD is based on the maintenance dose, but in practice patients in a population will be on a mix of initial and maintenance doses. [ 4 ]


The DDD can be used as the basis for calculating various indicators of drug utilisation. The indicator  DDD per 1000 inhabitants per day  can suggest what portion of a population are regularly using a drug or class of drugs. The indicator  DDD per 100 bed days  estimates on average how many inpatients are given a drug every day in hospital. The indicator  DDDs per inhabitant per year  can be used for drugs normally prescribed for short treatment duration (e.g., antibiotics) to indicate the average number of days in a year a person may take that treatment. The extent to which estimates using DDD reflect actual clinical practice depends on how close the DDD is to the typical prescribed dose in that country or setting and at that point in history. [ 5 ]


Because the primary purpose of the ATC/DDD system is drug consumption measurement, the WHO recommend caution when considering its use for cost analysis: "DDDs, if used with caution can be used to compare, for example, the costs of two formulations of the same drug." [ 5 ]  So, the  cost per DDD  of an extended-release tablet taken once a day compared with a standard tablet taken twice a day, may indicate the extended-release tablet costs much more to treat the same condition.


In contrast, using DDD to compare the cost of different drugs or drug groups is "usually not valid" according to the WHO. They recommend that "DDDs are not suitable for comparing drugs for specific, detailed pricing, reimbursement and cost-containment decisions". The DDD may not necessarily compare well with the actual prescribed daily dose, and two drugs in the same ATC group may not be equally effective at their Daily Defined Dose. [ 5 ]


For example, an analysis of statin use in the Ontario Drug Benefit Program, 2006-07. The average  cost per DDD  of  rosuvastatin  was 21% more expensive than  atorvastatin  ($1.14 compared to $0.94), which would suggest the shift at the time from prescribing atorvastatin to prescribing rosuvastatin would result in increased costs to the healthcare budget. Both had a DDD at that time of 10mg, but 10mg was not the only dose prescribed. For example, atorvastatin once daily at 10mg, 20mg, 40mg and 80mg was prescribed 45%, 36%, 16% and 3% of the time respectively. If one compared  cost per unit  (daily tablet) then rosuvastatin was instead 24% cheaper than atorvastatin ($1.44 vs $1.90), and if one compares  cost per RDD  (recorded daily dose) then rosuvastatin was 26% cheaper than atorvastatin ($1.43 vs $1.93). An erroneous conclusion of a healthcare budget cost increase arises in this case from using  cost per DDD . At the time, the RDD of rosuvastatin was similar to its DDD (12.6 mg vs 10mg), but the RDD of atorvastatin was twice its DDD (20.6 mg vs 10mg). The DDD of atorvastatin was revised in 2009 to 20mg. [ 4 ]


The Canadian  Patented Medicine Prices Review Board  analysed the use of DDD for drug utilisation and cost analysis and offered recommendations. They particularly concentrated on the problems that occur when the Recorded Daily Dose (RDD) observed in the population deviates more than minimally from the Defined Daily Dose. They conclude that the DDD methodology "should generally not be used to interpret Canadian drug utilization; should generally not be applied in cost analyses; and should generally not be applied in policy decisions". [ 4 ]  The Board recommend that provided the agreement between DDD and RDD is known and minimal, then a cost per DDD "can provide a rough idea of the treatment cost" but "caution should still be used, as misinterpretation of the results based on the DDD methodology may still occur". If the agreement between DDD and RDD is unknown or a significant disagreement is known, then the DDD methodology "should not be used in cost analyses". In all cases, the Board state "The DDD methodology should not be used in guiding policy decisions regarding reimbursement, therapeutic substitution and other pricing decisions". [ 4 ]


If the DDD for a certain drug is given, the number of DDDs used by an individual patient or (more commonly) by a collective of patients is as follows.


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 {\displaystyle Drug\ usage\ (in\ DDDs)={\frac {Items\ issued\times Amount\ of\ drug\ per\ item}{DDD}}}


For example, the  analgesic  (pain reliever)  paracetamol  has a DDD of 3 g, which means that an average patient who takes paracetamol for its main indication, which is pain relief, uses 3 grams per day. This is equivalent to six standard tablets of 500 mg each. If a patient consumes 24 such tablets (12 g of paracetamol in total) over a certain span of time, this equals a consumption of four DDDs.


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 {\displaystyle Drug\ usage\ (in\ DDDs)={\frac {24\ (items)\times 500\ (mg/item)}{3000\ mg}}=4}


A  dispensary  is an office in a school,  hospital , industrial plant, or other organization that dispenses  medications , medical supplies, and in some cases even medical and dental treatment. In a traditional dispensary set-up, a pharmacist dispenses medication per the prescription or order form. The English term originated from the  medieval Latin  noun  dispensaria  and is  cognate  with the  Latin  verb  dispensare , 'to distribute'. [ 1 ]


The term also refers to legal  cannabis dispensaries .


The term also has  Victorian antiquity , in 1862 the term dispensary was used in the folk song the  Blaydon Races . [ 2 ]  The folk song differentiated the term dispensary from a Doctors surgery and an Infirmary. [ 2 ]   The advent of huge industrial plants in the late 19th and early 20th centuries, such as large  steel mills , created a demand for in-house  first responder  services, including  firefighting ,  emergency medical services , and even primary care that were closer to the point of need, under closer company control, and in many cases better  capitalized  than any services that the surrounding town could provide. In such contexts, company doctors and nurses were regularly on duty or  on call .


Electronic dispensaries are designed to ensure efficient and consistent dispensing of  excipient  and  active ingredients  in a secure data environment with full audit traceability. A standard dispensary system consists of a range of modules such as manual dispensing, supervisory, bulk dispensing, recipe management and interfacing with external systems. Such a system might dispense much more than just medical related products, such as alcohol, tobacco or vitamins and minerals.


In  Kenya , a dispensary is a small outpatient health facility, usually managed by a registered nurse. It provides the most basic primary healthcare services to rural communities, e.g. childhood immunization, family planning, wound dressing and management of common ailments like colds, diarrhea and simple malaria. The nurses report to the nursing officer at the health center, where they refer patients with complicated diseases to be managed by  clinical officers .


In India, a dispensary refers to a small setup with basic medical facilities where a doctor can provide a primary level of care.
It does not have a hospitalization facility and is generally owned by a single doctor.
In remote areas of India where hospital facilities are not available, dispensaries will be available.


In  Turkey , the term dispensary is almost always used in reference to  tuberculosis  dispensaries ( Turkish :  verem savaş dispanseri ) established across the country under a  programme to eliminate tuberculosis  initiated in 1923, [ 3 ]  the same year the country was founded. Although more than a hundred such dispensaries continue to operate as of 2023, they have been largely supplanted by hospitals by the end of 20th century with increased access to healthcare.


The term  dispensary  in the  United States  was used to refer to government agencies that sell  alcoholic beverages , particularly in the state of  Idaho  and the  South Carolina .


In  Arizona ,  British Columbia ,  California ,  Colorado ,  Connecticut ,  Illinois ,  Maine ,  Massachusetts ,  Oregon ,  Michigan ,  New Jersey ,  New Mexico ,  New York ,  Rhode Island ,  Ontario ,  Quebec , and  Washington ,  medical cannabis  is sold in specially designated stores called  cannabis dispensaries  or "compassion clubs". [ 4 ]  These clubs are for members or patients only, unless legal cannabis has already passed in the state or province in question. In Canada dispensaries are far less abundant than in the USA; most Canadian dispensaries are in British Columbia and Ontario. [ 5 ] [ 6 ]


In 2013  Uruguay  became the first country to legalize marijuana cultivation, sale and consumption. The government is building a network of dispensaries that are meant to help to track marijuana sales and consumption. The move was meant to decrease the role of the criminal world in distribution and sales of it. [ 7 ]


Drug therapy problems  ( DTPs ) (or  drug related problems, DRPs ) represent the categorization and definition of clinical problems related to the use of  medications  or "drugs" in the field of  pharmaceutical care . [ 1 ]  In the course of clinical practice, DTPs are often identified, prevented, and/or resolved by  pharmacists  in the course of  medication therapy management , as experts on the safety and efficacy of medications, but other  healthcare professionals  may also manage DTPs. [ 2 ]


A drug-therapy (related) problem can be defined as an event or circumstance involving  drug   treatment  ( pharmacotherapy ) that interferes with the optimal provision of medical care. In 1990,  L.M. Strand and her colleagues (based on the previous work of R.L Mikeal [ 3 ]  and D.C Brodie, [ 4 ]  published respectively in 1975 and 1980) classified the DTPs into eight different categories. According to these categories, pharmacists generated a list of the DTPs for each patient. As a result, pharmacists had a cleaner picture of the patient's drug therapy and medical conditions. A second publication of R.J Cipolle with L.M Strand in 1998, change the eight categories into seven, grouped in four Pharmacotherapy needs: indication, effectiveness, safety and adherence. [ 5 ]


According to page 73 in  Introduction to Health Care Delivery: A Primer for Pharmacists , drug therapy problems (DTP) originated from Strand et al. (1990) who defined eight problems that could result in poorer health outcomes in an attempt to categorize DTP. [ 7 ]  Helper and Strand later in 1990 stated the mission statement or raison d'etre of  pharmacists  should be to correct these drug therapy problems.


The original eight problems have now been condensed into  seven categories of problems . As given by Shargel, they are:


DRPs can be broken down further into the following categories: [ 8 ] [ 9 ] [ 10 ] [ 11 ] [ 12 ] [ 13 ] [ 14 ] [ 15 ] [ 16 ]


Requires Additional Drug Therapy


Unnecessary Drug Therapy


Requires Different Drug Product


Dosage Too Low


Adverse Drug Reaction


Dosage Too High


Non-adherence


Electronic prescription  ( e-prescribing  or  e-Rx ) is the computer-based electronic generation, transmission, and filling of a  medical prescription , taking the place of paper and faxed prescriptions. E-prescribing allows a  physician ,  physician assistant ,  pharmacist , or  nurse practitioner  to use digital prescription software to  electronically transmit  a new prescription or renewal authorization to a community or mail-order  pharmacy . It outlines the ability to send error-free, accurate, and understandable prescriptions electronically from the  healthcare provider  to the pharmacy. E-prescribing is meant to reduce the risks associated with traditional prescription script writing. It is also one of the major reasons for the push for  electronic medical records . By sharing medical prescription information, e-prescribing seeks to connect the patient's team of healthcare providers to facilitate knowledgeable decision making. [ 1 ]


An e-prescribing system used in the United States must be capable of performing all of the following functions: [ 2 ] [ 3 ] [ 4 ]


The basic components of an electronic prescribing system are the: [ 3 ]


The PBM and transaction hub work closely together. The PBM works as an intermediate actor to ensure the accuracy of information, although other models may not include this to streamline the communication process.


In addition to pharmacies, medical tests can also be prescribed.


The prescriber, generally a clinician or healthcare staff, is defined as the electronic prescribing system user and sign into the system through a verification process to authenticate their identity. [ 3 ]


The prescriber searches through the database of patient records by using patient-specific information such as first and last name, date of birth, current address etc. Once the correct patient file has been accessed, the prescriber reviews the current medical information and uploads or updates new prescription information to the medical file. [ 3 ]


The transaction hub provides the common link between all actors (prescriber, pharmacy benefit manager, and pharmacy). It stores and maintains a master patient index for quick access to their medical information as well as a list of pharmacies. [ 3 ]


When the prescriber uploads new prescription information to the patient file, this is sent to the transaction hub. The transaction hub will verify against the patient index. This will automatically send information about this transaction to the PBM, who will respond to the hub with information on patient eligibility, formulary, and medication history back to the transaction hub. The transaction hub then sends this information to the prescriber to improve patient management and care by completing and authorizing the prescription. Upon which, the prescription information is sent to the pharmacy that the patient primarily goes to. [ 3 ]


When a pharmacy receives the prescription information from the transaction hub, it will send a confirmation message. The pharmacy also has the ability to communicate to the prescriber that the prescription order has been filled through the system. Further system development will soon allow different messages such as a patient not picking up their medication or is late to pick up medication to improve patient management. [ 3 ]


When an imaging center receives the prescription, the imaging center will then contact the patient and schedule the patient for his/her scan.  The advantage of ePrescribing radiology is that often when a patient is handed a paper script, the patient will lose the prescription or wait to call and schedule.  This can be disastrous for patients with severe underlying conditions.  The imaging center will call and schedule the patient as soon as the referral arrives.  There are mobile ePrescribing portals as well as web portals that handle this well, and there are advantages. [ 5 ]


Compared to paper-based prescribing, e-prescribing can improve health and reduce costs because it can: [ 2 ] [ 6 ]


Safety improvements are highly desirable; in 2000, the Institute of Medicine identified medication errors as the most common type of  medical error  in health care, estimating that this leads to several thousand deaths each year. [ 8 ]


Illegibility from handwritten prescriptions is eliminated, decreasing the risk of medication errors while simultaneously decreasing risks related to liability.  Oral miscommunications regarding prescriptions can be reduced, as e-prescribing should decrease the need for phone calls between prescribers and dispensers.  Causes of medication errors include mistakes by the pharmacist incorrectly interpreting illegible handwriting or ambiguous nomenclature, and lapses in the prescriber's knowledge of desired dosage of a drug or undesired interactions between multiple drugs. Electronic prescribing has the potential to eliminate most of these types of errors. Warning and alert systems are provided at the point of care. E-prescribing systems can enhance an overall medication management process through clinical decision support systems that can perform checks against the patient's current medications for drug-drug interactions, drug-allergy interactions, diagnoses, body weight, age, drug appropriateness, and correct dosing.  Based on these algorithms, the system can alert prescribers to contradictions, adverse reactions, and duplicate therapies.  The computer can also ensure that clear and unambiguous instructions are encoded in a structured message to the pharmacist, and  decision support systems  can flag lethal dosages and lethal combinations of drugs. [ 7 ]   E-prescribing allows for increased access to the patient's medical records and their medication history. Having access to this information from all health care providers at the time of prescribing can support alerts related to drug inappropriateness, in combination with other medications or with specific medical issues at hand.  Electronic prescribing has been shown to reduce prescribing errors by up to 30%. [ 9 ]


According to estimates, almost 30 percent of prescriptions require pharmacy callbacks. [ 10 ]  This translates into less time available to the pharmacist for other important functions, such as educating consumers about their medications.  In response, E-prescribing can significantly reduce the volume of pharmacy call-backs related to illegibility, mistaken prescription choices, formulary and pharmacy benefits, decreasing the amount of time wasted on the phone.  This ultimately impacts office workflow efficiency and overall productivity in a positive manner.


Both prescribers and pharmacists can save time and resources spent on faxing prescriptions through a reduction in labor costs, handling costs, and paper expenses waste due to unreliability.


With e-prescribing, renewal authorization can be an automated process that provides efficiencies for both the prescriber and pharmacist.  Pharmacy staff can generate a renewal request (authorization request) that is delivered through the electronic network to the prescriber's system.  The prescriber can then review the request and act accordingly by approving or denying the request through updating the system.  With limited resource utilization and just a few clicks on behalf of the prescriber, they can complete a medication renewal task while enhancing continuous patient documentation.


It is estimated that 20% of paper-based prescription orders go unfilled by the patient, partly due to the hassle of dropping off a paper prescription and waiting for it to be filled.  By elimination or reducing this waiting period, e-prescribing may help reduce the number of unfilled prescriptions and hence, increasing medication adherence.  Allowing the renewal of medications through this electronic system also helps improve the efficiency of this process, reducing obstacles that may result in less patient compliance.  Availability of information on when patient's prescriptions are filled can also help clinicians assess patient adherence.


Improved prescriber convenience can be achieved when using mobile devices, that work on a wireless network, to write and renew prescriptions.  Such mobile devices may include laptops, PDAs, tablet computers, or mobile phones.  This freedom of mobility allows prescribers to write/renew prescriptions anywhere, even when not in the office.


E-prescribing systems enable embedded, automated analytic tools to produce queries and reports, which would be close to impossible with a paper-based system.  Common examples of such reporting would be: finding all patients with a particular prescription during a drug recall, or the frequency and types of medication provided by certain health care providers.


Although e-prescribing has the ability to streamline workflow process and increase the system's efficiency, challenges and limitations that may hinder the widespread adoption of e-prescribing practices include: [ 2 ]


The vast majority of community medical prescriptions in Australia continue to be delivered on paper, either in printed or hand-written format. Electronic prescription in Australia is currently provided by two service providers, MediSecure and eRx. Both services can be integrated into many of the existing clinical and pharmacy prescribing software systems. Since December 1991, they have become interoperable allowing bilateral transfer of information. [ 17 ] [ 18 ] [ 19 ]


Private companies started working with electronic prescriptions. On 2017 July easypres.com launched Bangladesh's [ 20 ]  first cloud-based electronic prescription and patient management software for Doctors in Bangladesh. [ 21 ]  Within a year, more than a thousand doctors registered for the software out of 83 thousand registered MBBS doctors in Bangladesh for this Digital prescription writing software. High court of Bangladesh issued a rule that doctors need to write the prescription in readable format meaning they need to use software of ALL caps later while writing prescription. This software also stores the medical history of patients and doctors can access these data easily from anywhere using the Internet.


On March 22, 2016, the  Government of Canada  allocated funds to  Canada Health Infoway  to develop an e-prescribing service. [ 22 ]  Infoway is working with Health Canada, the provinces and territories and industry stakeholders to create PrescribeIT, a multi-jurisdiction e-prescribing service. Infoway will create, operate and maintain the service, along with its partners. The service will be financially self-sustaining and is designed to be scaled across the country and will enable prescribers to electronically transmit a prescription to a patient's pharmacy of choice. [ 23 ]  Physicians, physician assistants, nurse practitioners and other prescribers will be able to use the system either through their existing electronic medical record or through a standalone application. Health Canada included supporting better prescribing practices, including e-prescribing, as part of its Action on Opioid Misuse plan. [ 24 ]


Until recently in Canada, it was the position of Health Canada that, to allow for e-prescribing, amendments to Part C of the Food and Drugs Regulations made under the Food and Drugs Act, regulations made under the Controlled Drugs and Substances Act and possibly regulations made under Personal Information Protection and Electronic Documents Act would be required. After further review, Health Canada has concluded that there are currently no regulatory impediments to moving ahead with electronically generated and transmitted prescriptions and that these are permissible to the extent that they achieve the same objectives as written prescriptions. Provinces and territories wishing to proceed with e-prescribing are obligated to ensure that electronic prescriptions meet existing regulatory requirements and achieve the same objectives as written prescriptions. For example, there must be evidence of a genuine practitioner/patient relationship, and in the case of controlled substances, pharmacists filling prescriptions must verify prescriptions are signed by the practitioner before selling or providing drugs containing controlled substances to a patient. Health Canada has collaborated with Canada Health Infoway on the development of a technical document entitled Ensuring the Authenticity of Electronic Prescriptions, in order to provide advice about how to ensure the authenticity of electronic signatures.
 [ 25 ]


The Czech healthcare system is moving towards a mandatory electronic prescribing system to take effect in 2020.  Patients and clinicians will have access to the prescribing records. Codes and names of medications are allocated by the  State Institute for Drug Control . [ 26 ]


Electronic prescriptions were introduced in Estonia in January 2010 [ 27 ]  and by mid-2013, 95% of all prescriptions in the country were being issued electronically. [ 28 ]
e-Prescription, is a centralized paperless system for issuing and handling medical prescriptions. When a doctor prescribes medicine using the system, he or she does so electronically, with the aid of an online form. At the pharmacy, all a patient needs to do is present an ID-card. The pharmacist then retrieves the patient's information from the system and issues the medicine. Because the e-Prescription system draws on data from the national health insurance fund, any state medical subsidies that the patient is entitled to, also appear, and the medicine is discounted accordingly. Another major advantage of the system is that doctor visits are no longer needed for repeat prescriptions. A patient can contact the doctor by e-mail, Skype or phone, and the doctors can issue repeats with just a few clicks, and the patient can collect the medicine from their closest pharmacy. 99% of all prescriptions in the country are issued electronically. This frees up time for patients and doctors, and reduces administrative strain on hospitals.


The use of electronic prescription has been designated as an important strategic policy to improve health care in Europe. The aim of the European Union is to have a cross-border electronic healthcare system in Europe which will enable EU citizens to obtain e-Prescriptions anywhere in Europe. The Scandinavian countries are leading Europe in deploying e-Prescription. Other countries which use the prescription process routinely are Norway, Denmark, Finland, Sweden, Belgium, [ 29 ]  the Netherlands, Italy, [ 30 ]  Iceland, Greece, England, Scotland, Wales and Northern Ireland.
The European Union is pushing for more cross border health data exchange. Multiple perceived barriers impede its incorporation in clinical practice. There are varying interpretations and implementations of data protection and confidentiality laws in the 27 member states. Infrastructures are not in place to support the system and stakeholders in some jurisdictions are reluctant to embrace e-health due to the high cost and the lack of security of the systems. Interoperability of different systems is only a partial solution. Security and enforcement of privacy must also be equally enforced. [ 31 ]


In India some private hospitals started using electronic prescription. But a major step was taken by government of West Bengal in August 2014 when they started the process of issuing e-prescriptions instead of hand-written instructions in top government hospitals.
The biggest advantage of the system is that a patient has all his medical data stored in the server of state health department which can be referred to in future.
In the private sector, a number of companies have started initiatives to build software to support e-prescriptions.


With the development and implementation of electronic technologies in Russian healthcare system, electronic prescription became part of the project called  EMIAS .  EMIAS  is the digital system designed to increase the quality and access of the medical aid in the public health facility. The project was designed and being implemented as part of «Digital city» program in execution of the Moscow Government's order from April 7, 2014 (as Moscow government amended on 21.05.2013 No. 22-PP).
The system offers special portal  Emias.Info , that provides appointment service to the patients and client area with different services including e-Prescription. Government social program allows getting pharmaceutical products for free or with the discount, depending on the category of the citizen.


About 420 million repeat prescriptions are generated in the UK each year - about 200 for each general practitioner each week. They account for about 80% of the cost of medication in primary care. Paper based Repeat Dispensing Services were introduced by the  NHS  in 1991, and in 1992 it became possible to use the NHS Electronic Prescription Service for this purpose. In 2017 awareness of the scheme among patients was low. [ 32 ]
In October 2017 Keith McNeil,  NHS England 's chief clinical information officer demanded that NHS hospitals should be moved rapidly onto electronic prescribing in the light of research showing it would cut serious prescribing errors by more than half.  There was no information about the extent to which it is happening in hospitals. [ 33 ]


After successful pilots in London and the East Midlands it was agreed in April 2018 that electronic prescribing should be introduced in all urgent care settings in England, including  NHS 111  and other  Out-of-hours services  so that dispensed medication can be ready for collection at a pharmacy when patients arrive. [ 34 ]  £78 million was allocated in December 2018 to encourage progress with implementing electronic prescribing in NHS organisations which were struggling. [ 35 ]


Electronic prescribing is to start in English hospitals in the summer of 2022, using the IC24 system which was piloted at  Midlands Partnership NHS Foundation Trust  from 2020. [ 36 ]


In the United States, the  HITECH Act  promotes adoption of this technology by defining e-prescribing as one meaningful use of an  electronic medical record . [ 37 ]  Standards for transmitting, recording, and describing prescriptions have been developed by the  National Council for Prescription Drug Programs , in particular the  SCRIPT  standard, which describes data formats.  Elsewhere in the world, health care systems have been slower to adopt e-prescribing standards. [ 38 ]


Adoption of e-prescribing technology has accelerated in the United States, in large part, due to the arrival of Stage 2 of meaningful use. One of the Stage 2 core measures is: "Generate and transmit permissible prescriptions electronically (e-Rx.)" In order to meet this measure, practices must prescribe and transmit at least 50 percent of permissible prescriptions electronically. [ 39 ]


According to data released in May 1991 by  Surescripts , a company which operates the nation's largest health information (e-prescribing) network, roughly 317,000 office-based physicians now e-prescribe in the United States. [ 40 ]
A more recent report released by the Office of the National Coordinator for Health IT in June 2012 finds that 48 percent of U.S. physicians use e-prescribing systems. National growth in e-prescribing over the period September 2008 through June 2012 increased over 40 percent, with individual states increasing adoption anywhere from 28 percent to 70 percent. [ 41 ]   In 2019, the Federal Trade Commission sued Surescripts, alleging that the company employed unlawful restraints in order to maintain its monopolies over electronic prescribing. [ 42 ] [ 43 ]


Starting from April 2019, ePrescription is one of the key components of the reimbursement system in Ukraine. [ 44 ]  The e-prescription module integrates all primary care physicians (over 23,000 doctors) and almost 50% of pharmacies across the country. [ 45 ] [ 46 ]


While the launch of e-prescription was done quickly, the quality was not compromised. The development of the tool was completed according to international standards as well as HL7 FHIR medical data requirements. Ukrainian eHealth system is a two layer system with central core component developed as storage of dictionaries and rules and private IT-companies who offers e-prescription's functionality through interfaces of the doctors and pharmacists. [ 47 ] [ 48 ]  The e-prescription code is open and available. [ 49 ]


As a next step of expansion of eRx functions in Ukraine, Ministry of Health of Ukraine develop the technical requirement for substitution of oldfashion, paper-based prescriptions with digital eRx for all applicable medicines. [ 50 ]


A study in the UK tested the Salford Medication Safety Dashboard (SMASH), a web application to help GPs and pharmacists find people in their electronic health records who might face safety hazards due to prescription errors. The dashboard was successfully used in identifying and helping patients with already registered unsafe prescriptions and later it helped monitoring new cases as they appeared. [ 51 ] [ 52 ]


Essential medicines , as defined by the  World Health Organization  (WHO), are  medicines  that " satisfy the priority  health care  needs of the population ". [ 1 ]  Essential medicines should be  accessible  to people at all times, in sufficient amounts, and be generally affordable. [ 2 ]  Since 1977, the WHO has published a model list of essential medicines, with the  2019 list for adult patients  containing over 400 medicines. [ 3 ]  Since 2007, a  separate list of medicines intended for child patients  has been published. [ 4 ]  A new list was published in 2021, for both adults and children. [ 5 ]


Several changes have been implemented since the 2021 edition, including that medication cost should not be grounds for exclusion criteria if it meets other selection criteria, and  cost-effectiveness  differences should be evaluated within therapeutic areas. The following year,  antiretroviral  agents, usually used in the treatment of  HIV/AIDS , were included on the list of essential medicines. [ 6 ]


The WHO distinguishes between "core list" and "complementary list" medications.


This list forms the basis of the  national drugs policy  in more than 155 countries, both in the  developed  and  developing world . Many governments refer to WHO recommendations when making decisions on health spending. Countries are encouraged to prepare their own lists considering local priorities. Over 150 countries have published an official essential medicines list. [ 7 ]  Despite these efforts, an estimated 2 billion people still lack access to essential medicines, with some of the major obstacles being low supply, including shortages of inexpensive drugs. Following these shortages, the  US Food and Drug Administration  (FDA) released a report in fall of 2019 with strategies to overcome and  mitigate  supply issues. [ 8 ]


The original WHO definition in 1977 was that they were medicines " of utmost importance, basic, indispensable, and necessary for the healthcare needs of the population ". [ 9 ]  The concept was mentioned in one of the ten points of the 1978  Alma Ata Declaration  on  primary health care .


In 2002 the definition was changed to:


Essential medicines are those that satisfy the priority health care needs of the population. [ 10 ]


This remains the definition as of 2019 [update] . [ 1 ]


The use of essential medicines lists has resulted in better quality of care and improved management of health resources in the most cost-effective manner. The lists serve as a baseline for  health insurance  entities to include or exclude the medication, and modify the dose based on  clinical study  evidence. To improve the accessibility of essential medicines for both children and adults, it is necessary to ensure the rational use of medicine while also being cost-effective. [ 11 ]


In a 2023 study evaluating the availability, distribution, and progress of essential medicines in  China , results showed that access to essential medicines is lower in comparison to the WHO's goal, with little progress in expansion over the years. This systematic review and meta-analysis study pooled studies that reported the availability of essential medicines in various regions of China from 2009 to 2019.  [ 12 ]  The data supports the need to improve the access and distribution of medication across regions to ensure that the goal of  universal health coverage  is reached. [ 12 ]  Having essential medications be accessible to everyone is the foundation to a better health without financial hardships for the general public.  [ 13 ]


The goal of  universal health coverage  was set in place in 2015, where multiple countries have taken steps towards ensuring treatment,  palliation ,  rehabilitation , and  preventative  health measures for everyone. [ 13 ]  Understanding that accessibility to appropriate and applicable essential medications within the region, is the first step towards reaching equitable and  universal healthcare .  [ 13 ]


Items are chosen as essential medicines based on how common the disease that is being treated, evidence of benefit, the degree of  side effects  and the cost compared to other options. [ 14 ]  In order to explore the human rights law and WHO's essential medicines policies into national legislation regarding medicines, affordability and financing needs to be understood to enhance universal access to essential medicines. [ 15 ]  The intention of essential medicine lists is to provide appropriate use of treatment and not include medications that have been withdrawn from the market in other countries due to unfavorable benefit-to-harm balance. [ 16 ]  Despite many efforts from different countries, some individuals do not have their needs met and have to turn to an alternative plan called the judiciary in order to receive the medications required. The Judiciary also known as the " Judicialization of access to medicines, " this involves technical, scientific, legal, and social aspects. Further research is needed to explore these aspects comprehensively. [ 17 ]


Medications can be priced differently, due to the fact that each medication can have many qualities and uses. Because various medicines have different costs, individual uses, and distinct advantages, it prompts the theory of  cost effectiveness . [ 18 ]  Cost effectiveness is the subject of debate between producers ( pharmaceutical companies ) and purchasers of drugs (national health services). It is estimated that access to essential medicines could save 10 million people a year. [ 19 ]  Access to essential medicine is a cornerstone of effective healthcare systems and a fundamental component of  global health initiatives  aimed at improving  quality of life , reducing  health disparities , and fostering  sustainable development . [ 20 ]  Proper access to essential medicine can lower the amount for really expensive treatments and  hospitalizations  by managing early and effectively.


The WHO made the  Model List of Essential Medicines  in 1977 based on the idea that certain medicines are required more often than others and are often inaccessible to many different populations. [ 21 ]  As of 2018, 146 countries are using the Essential Medicines concept, which is also used to guide the reimbursement of medicines depending on the importance to public health, the efficacy, the safety, and the cost of the medicines.  [ 22 ]  The goal of the Essential Medicine concept is that medicines that have the highest relevance in public health, meaning medicines that are used the most often, should be available equally to everyone in a population either for free or at a very affordable cost.  [ 22 ]


The  WHO Model List of Essential Medicines  has been updated every two years since 1977. The 23rd version was published in July 2023. [ 23 ]  Over that period, the number of medications has more than doubled, from the original 208 in 1977, [ 7 ]  to more than 500 in 2023. [ 23 ]  Medicines are then categorized as essential or non-essential based on their inclusion in each country's EML. results are then analyzed by WHO regions, World Bank income groups, wealth inequality, and therapeutic groups. The group for essential medicines availability was higher (61.5%) than non-essential medicines (27.3%). But in the public sector, the median availability was 40% for essential medicines, compared to 6.6% for non-essential medicines. Thus, overall, the availability of essential medicines in the public sector is still suboptimal, indicating challenges in achieving equitable access. [ 24 ]


The first edition of the " WHO Model List of Essential Medicines for Children ", was published in 2007, while the 9th edition was published in 2023. [ 7 ] [ 4 ] [ 23 ]  It was created to make sure that the needs of children were systematically considered such as availability of proper  formulations . [ 7 ]  While the EML (Essential Medicine List) is intended for the population as a whole, the EMLc (Essential Medicine List for Children) is intended for children up to 12 years old. [ 25 ]  The first edition contained 450 formulations of 200 different medications [ 7 ]  and the 2023 list contains 361 medications. [ 23 ]  The intention of creating an EML for children is to improve child survival and provide treatment options for mortality and  morbidity  causes. [ 26 ]


WHO launched a "Make Medicines Child Size" (MMCS) campaign in 2007 with the purpose of creating appropriate regimens and formulations for children based on their weight and age.  [ 27 ]  A 2021 study assessing the age-appropriateness of  enteral  formulations listed on the WHO Essential Medicine List for Children (EMLc) highlighted the dependence on factors such as dose adaptability, formulation flexibility, and the child's swallowing ability. Analysis of the EMLc between 2011 and 2019 revealed that most enteral medications were not age-appropriate for children under six years old, necessitating manipulation of the medicine prior to administration. This practice raises concerns regarding safety and efficacy. Consequently, the study emphasizes the urgent need for more comprehensive information and guidelines for selecting and developing age-appropriate essential enteral medicines for  pediatric  populations. [ 28 ]


While the practice of maintaining separate lists for the general population and children under 12 years of age is beneficial in tailoring healthcare interventions, it inadvertently excludes  adolescents  from the latter category. This age-based cutoff may lead to an oversight of the unique healthcare needs of this demographic.  [ 25 ]  It would be a good idea to create a list for adolescents as well. This is important as it allows healthcare providers to offer tailored care for each group. This differentiation ensures that treatments are appropriate for children's unique  physiological  needs.


The first EML was published in 1977 and was created as a tool to improve the accessibility and availability of medications for everyone. Multiple editions of EMLs and studies since then have been released, comparing the necessity, efficacy, safety, and of certain medications on the list. [ 29 ]  In addition, studies have been done comparing EMLs from multiple regions to ensure the appropriateness of dosing and safety of drug classes. [ 29 ]


Medication like  Codeine  has a potential of drug abuse and was established as an essential medication, yet raised some ethical questions. With the lack of literature highlighting its safety, it was highly discouraged to place Codeine as an essential medication. [ 29 ]  Not to mention, it was further discouraged in 2011 when Codeine was removed from WHO essential medicine list for children, causing greater discussion of its use in adults. [ 29 ]  Another article discusses the appropriateness of empirical dosing of different  antibiotics  on EMLs from multiple countries. [ 30 ]  Using the top 31 priority bacterial infections as a comparator, results showed how broadening the antibiotic list and dose, would not only increase adherence to treating the infections. It would also address the  antibiotic resistance  complication in most bacterial infections. [ 30 ]  This 2021  Cross-Sectional study , reviewed the antibiotics on the essential medicines list from 138 countries and assessed each countries national listing. The data showed that on average of the 44 essential antibiotic medications, 24 of them were accessible to the population, 5 of them considered on reserve, and 15 of them on WATCH using the AWaRe classification.  [ 30 ]


Additionally, the use of therapeutic guidelines as a reference for the creation of the WHO Essential Medicine List has been used to provide consistency and alignment of treatment across the nation. [ 31 ]  In the 2022 quantitative analysis study of  cardiovascular  medications, the data suggests how adopting a common formulary of combination therapy and specific types of drug classes improved patient adherence and cardiovascular outcomes within the region. [ 31 ]  The study compared  South Africa  and 15 different South African Development Communities (SADC) essential medication lists of  2021 for cardiovascular medications. [ 31 ]  Having majority of SADC lists aligned with the WHO essential medicine lists of South Africa, supports how implementing this into the national EML would provide greater accessibility and availability of CVD medications consistently throughout the nation. [ 31 ]


While the WHO Essential Medicine Lists are a very valuable tool and integral to the country's medicine policy, there has not yet been enough effort to implement them. There are several factors that affect the adaptation and implementation of the WHO Essential Medicine Lists, as found by a 2022 qualitative evidence synthesis. [ 32 ]  This study identified areas that need support in order to implement EML at a country level.  [ 32 ]  The lack of effort to implement WHO Essential medicines lists undermines the potential health benefits, exacerbates inequities in access, increase health costs and infrastructure.


Implementation of the WHO EML can be done with national medication selection committees that are able to operate with consultive mandates. [ 32 ]  These committees also need very clear leadership, monitoring, and evaluations. Implementation of EMLs can be done efficiently if there is a form of a reimbursement process in order to help keep costs low. [ 32 ]  Additionally, EMLs should have recommended clinical practices, such as listing necessary items, in order to make implementation of the list easy to do. For example, in the case of injectable medications, the EML should indicate that in addition to the medication a patient would also need an injection device and safety box. [ 33 ]  Finally, there needs to be clear legislation and monitoring to make sure there is compliance. [ 32 ]


Access to essential medicines are part of the  Sustainable Development Goals , specifically goal 3.8. [ 34 ]


A number of organizations, which are global in scope, use the list to determine which medications they will supply. [ 7 ]  Rather than strictly following the list, many nations refer to the essential medicines list as a guide for developing their own laws and regulations based on their own requirements. [ 35 ]


Ecuador ,  Ghana ,  The Philippines ,  South Africa , and  Ukraine  all include some mention of essential medicines or other health infrastructure that helps guide their economic policies on medicine pricing and benefit selection. [ 36 ]  Especially in middle income countries where  out-of-pocket spending  on medications is common, health equity measures and economic policy helps evaluate the affordability of medications as well as the effects of public health legislation.  [ 36 ]


Brazil  had published their first EML called RENAME 13 years prior to the WHO's first essential medicines list. [ 37 ]  RENAME included medicines that focused on safety, efficacy, and availability of medications, as well as Brazil's health priority of their population. The WHO EML encouraged Brazil to separate medications based on therapeutic classes, leading to both lists having the same format, despite different medications listed. The addition of the WHO's 2009 children's EML inspired Brazil to consider their own RENAME pediatric list. But limitations have caused Brazil to wait for further pediatric drug evidence within the country before finalizing their own children-specific EML. Challenges such as high prices and poor availability have impacted how citizens are actually able to obtain their medications, despite healthcare being a constitutional right in the country.  [ 37 ]


China first published their own EML in 1982, with the current EML containing over 2,000 herbal, chemical, and biological medicines.  [ 38 ]  The  Ministry of Health  (MOH) consists of medical and economic experts that are divided into a consult and review group to develop their national medicines list. Provinces in China are able to form their own EML, but are not allowed to remove medicines already listed in the national EML.  [ 39 ]


India  first developed their National List of Essential Medicines (NLEM) back in 1996 with only a minimal amount of revisions. Evidence-based criteria is used to determine which medications to add or remove to the list. Clinicians,  pharmacologists ,  pharmacists , etc. discuss and review the list where an open-house discussion is used to modify and finalize the NLEM.  [ 40 ]  However, poor medical supplies and staff with low health investments in implementations have caused people to go to  private hospitals  and clinics for  treatment . And with a large variety on rural and urban populations throughout the country, healthcare services and general access are favored more towards the urban population.  [ 40 ]


Many  developing nations  have developed national drug policies, a concept that has been actively promoted by the  WHO . For example, the  national drug policy  for  Indonesia [ 1 ]  drawn up in 1983 had the following objectives:


To achieve these objectives in Indonesia, the following changes were implemented:


One of the first challenges is to promote and develop rational prescribing, and a number of international initiatives exist in this area. WHO has actively promoted rational drug use as one of the major elements in its  Drug Action Programme . In its publication  A Guide to Good Prescribing [ 2 ]  the process is outlined as:


The emphasis is on developing a logical approach, and it allows for  clinicians  to develop personal choices in medicines (a personal formulary) which they may use regularly. The program seeks to promote appraisal of evidence in terms of proven efficacy and safety from controlled  clinical trial  data, and adequate consideration of quality, cost and choice of competitor drugs by choosing the item that has been most thoroughly investigated, has favorable  pharmacokinetic  properties and is reliably produced locally. The avoidance of combination drugs is also encouraged.


The routine and irrational use of  injections  should also be challenged. One study undertaken in Indonesia found that nearly 50% of infants and children and 75% of the patients aged five years or over visiting government health centers received one or more injections. [ 3 ]  The highest use of injections was for  skin disorders ,  musculoskeletal  problems and  nutritional deficiencies . Injections, as well as being used inappropriately, are often administered by untrained personnel; these include drug sellers who have no understanding of clean or  aseptic  techniques.


Another group active in this area is the  International Network for the Rational Use of Drugs  (INRUD). This organization, established in 1989, exists to promote rational drug use in developing countries. As well as producing training programs and publications, the group is undertaking research in a number of member countries, focused primarily on changing behavior to improve drug use. One of the most useful publications from this group is entitled  Managing Drug Supply . [ 4 ]  It covers most of the drug supply processes and is built up from research and experience in many developing countries. There a number of  case studies  described, many of which have general application for pharmacists working in developing countries.


In all the talk of rational drug use, the impact of the  pharmaceutical industry  cannot be ignored, with its many incentive schemes for doctors and pharmacy staff who dispense, advise or encourage use of particular products. These issues have been highlighted in a study of  pharmaceutical sales representative  (medreps) in Mumbai. [ 5 ]  This was an observational study of medreps' interactions with  pharmacies , covering a range of neighborhoods containing a wide mix of  social classes . It is estimated that there are approximately 5000 medreps in Mumbai, roughly one for every four doctors in the city. Their salaries vary according to the employing organization, with the  multinationals  paying the highest salaries. The majority work to performance-related incentives. One medrep stated "There are a lot of companies, a lot of competition, a lot of pressure to sell, sell! Medicine in India is all about incentives to doctors to buy your medicines, incentives for us to sell more medicines. Even the patient wants an incentive to buy from this shop or that shop. Everywhere there is a scheme, that's business, that's medicine in India.'


The whole system is geared to winning over confidence and getting results in terms of sales; this is often achieved by means of gifts or invitations to symposia to persuade doctors to prescribe. With the launch of new and expensive antibiotics worldwide, the pressure to sell with little regard to the national essential drug lists or  rational prescribing . One medrep noted that this was not a business for those overly concerned with morality. Such a statement is a sad reflection on parts of the pharmaceutical industry, which has an important role to play in the development of the health of a nation. It seems likely that short-term gains are made at the expense of increasing problems such as  antibiotic resistance . The only alternatives are to ensure practitioners have the skills to appraise medicine promotion activities or to more stringently control pharmaceutical promotional activities.


In situations where medicines are dispensed in small, twisted-up pieces of brown paper, the need for patient instruction takes on a whole new dimension. Medicines should be issued in appropriate containers and labelled. While the patient may be unable to read, the  healthcare  worker is probably  literate . There are many tried-and-tested methods in the literature for using pictures and diagrams to aid  patient compliance . Symbols such as a rising or setting sun to depict time of day have been used, particularly for treatments where regular medication is important, such as cases of  tuberculosis  or  leprosy . [ 6 ]


Poverty  may force patients to purchase one day's supply of medicines at a time, so it is important to ensure that  antibiotics  are used rationally and not just for one or two days' treatment. Often, poor patients need help from  pharmacists  to understand which are the most important medicines and to identify the items, typically  vitamins , that can be missed to reduce the cost of the  prescription  to a more manageable level.


The essential drugs list concept was developed from a report to the 28th  World Health Assembly  in 1975 as a scheme to extend the range of necessary drugs to populations who had poor access because of the existing supply structure. The plan was to develop essential drugs lists based on the local health needs of each  country  and to periodically update these with the advice of experts in  public health ,  medicine ,  pharmacology ,  pharmacy  and drug management. Resolution number 28.66 at the Assembly [ 7 ]  requested the  WHO Director-General  to implement the proposal, which led subsequently to an initial model list of essential drugs (WHO Technical Series no 615, 1977). This model list has undergone regular review at approximately two-yearly intervals and the current 14th list was published in March 2005. [ 8 ]  The model list is perceived by the WHO to be an indication of a common core of medicines to cover most common needs. There is a strong emphasis on the need for national policy decisions and local ownership and implementation. In addition, a number of guiding principles for essential drug programs have emerged.


The model list of essential drugs is divided into 27 main sections, which are listed in  English  in alphabetical order. Recommendations are for drugs and presentations. For example,  paracetamol  appears as  tablets  in strengths of 100 mg to 500 mg,  suppositories  100 mg and  syrup  125 mg/5ml. Certain drugs are marked with an asterisk (previously a ៛), which denotes an example of a therapeutic group, and other drugs in the same group could serve as alternatives.


The lists are drawn up by  consensus  and generally are sensible choices. There are ongoing initiatives to define the evidence that supports the list. This demonstrates the areas where RCTs ( randomized controlled trials ) or  systematic reviews  exist and serves to highlight areas either where further research is needed or where similar drugs may exist which have better supporting  evidence .


In addition to work to strengthen the evidence base, there is a proposal to encourage the development of  Cochrane  reviews for drugs that do not have systematic review evidence.


Application of NNTs ( numbers needed to treat ) to the underpinning evidence should further strengthen the lists. At present, there is an assumption among doctors in some parts of the world that the essential drugs list is really for the poor of society and is somehow inferior. The use of NNTs around  analgesics  in the list goes some way to disprove this and these developments may increase the importance of essential drugs lists.


The impact of pharmaceutical representatives and the power of this approach has led to the concept of  academic detailing  to provide clear messages. A study by Thaver and Harpham [ 9 ]  described the work of 25 private practitioners in area around  Karachi . The work was based on assessment of prescribing practices, and for each practitioner included 30 prescriptions for  acute respiratory infections  (ARIs) or  diarrhea  in children under 12 years of age. A total of 736 prescriptions were analysed and it was found that an average of four drugs were either prescribed or dispensed for each consultation. An  antibiotic  was prescribed in 66% of prescriptions, and 14% of prescriptions were for an  injection . Antibiotics were requested for 81% of diarrhea cases and 62% of ARI cases. Of the 177 prescriptions for diarrhea, only 29% were for oral  rehydration  solution. The researchers went on to convert this information into clear messages for academic dealing back to the doctors. The researchers went on to implement the program and assessed the benefits. This was a good piece of work based on developing messages that are supported by evidence.


It is a natural human reaction to want to help in whatever way possible when face with human disaster, either as a result of some  catastrophe  or because of  extreme poverty . Sympathetic individuals want to take action to help in a situation in which they would otherwise be helpless, and workers in difficult circumstances, only too aware of waste and excess at home, want to make use of otherwise worthless materials. The problem is that these situations do not lend themselves to objectivity. There are numerous accounts of tons of useless drugs being air-freighted into disaster areas. It the requires huge resources to sort out these charitable acts and often the drugs cannot be identified because the labels are not in a familiar language. In many cases, huge quantities have to be destroyed simply because the drugs are out of date,  spoiled , unidentifiable, or totally irrelevant to local needs. Generally, had the cost of shipping been  donated  instead, then many more people would have benefited.


In response to this, the WHO has generated guidelines for drug donations from a consensus of major international agencies involved in  emergency relief . If these are followed, a significant improvement in terms of patient benefit and use of  human resources  will result.


While modern practices, including the development of  clinical pharmacy , are important, many basic issues await significant change in developing countries.


Evidence is as important in the developing world as it is in the developed world.  Poverty  comes in many forms. While the most noticed are  famine  and poor  housing , both potent killers, medical and knowledge poverty are also significant.  Evidence-based  practice is one of the ways in which these problems can be minimized. Potentially, one of the greatest benefits of the  internet  is the possibility of ending  knowledge poverty  and in turn influencing the factors that undermine  wellbeing . Essential drugs programs have been a major step in ensuring that the maximum number benefit from effective  drug therapy  for disease.


The following is a list of useful publications from the WHO  Department of Essential Drugs and Medicines Policy  about essential drugs programs.


An excipient is a substance formulated alongside the  active ingredient  of a  medication . They may be used to enhance the active ingredient’s therapeutic properties; to facilitate drug absorption; to reduce viscosity; to enhance solubility; to improve long-term stabilization (preventing denaturation and aggregation during the expected shelf life); or to add bulk to solid formulations that have small amounts of potent active ingredients (in that context, they are often referred to as "bulking agents", "fillers", or "diluents"). [ 1 ] [ 2 ]  During the manufacturing process, excipients can improve the handling of active substances and facilitate powder flow. The choice of excipients depends on factors such as the intended route of administration, the dosage form, and compatibility with the active ingredient.


Virtually all marketed drugs contain excipients, and final drug formulations commonly contain more excipient than active ingredient.  Pharmaceutical regulations and standards mandate the identification and safety assessment of all ingredients in drugs, including their chemical decomposition products. Novel excipients can sometimes be patented, or the specific formulation can be kept as a  trade secret  to prevent competitors from duplicating it through  reverse engineering . [ citation needed ]


Though excipients were at one time assumed to be "inactive" ingredients, it is now understood that they can sometimes be "a key determinant of dosage form performance"; [ 3 ]  in other words, their effects on  pharmacodynamics  and  pharmacokinetics , although usually negligible, cannot be  known  to be negligible without  empirical confirmation  and sometimes are important. For that reason, in  basic research  and  clinical trials  they are sometimes included in the  control substances  in order to minimize  confounding , reflecting that otherwise, the absence of the active ingredient would not be the only variable involved, because absence of excipient cannot always be assumed not to be a variable. [ 4 ]  Such studies are called excipient-controlled or  vehicle -controlled studies.


Adjuvants are added to vaccines to enhance or modify the immune system response to an immunization. An adjuvant may stimulate the immune system to respond more vigorously to a vaccine, which leads to more robust immunity in the recipient.


Antiadherents reduce the  adhesion  between the  powder  ( granules ) and the  punch  faces and thus prevent sticking to tablet punches by offering a  non-stick surface . They are also used to help protect tablets from sticking. The most commonly used is  magnesium stearate .


Binders hold the ingredients in a tablet together. Binders ensure that tablets and granules can be formed with required mechanical strength, and give volume to low active dose tablets. Binders are usually:


Binders are classified according to their application:


Tablet coatings protect tablet ingredients from deterioration by moisture in the air and make large or unpleasant-tasting tablets easier to swallow. For most coated tablets, a cellulose ether  hydroxypropyl methylcellulose  (HPMC) film coating is used which is free of sugar and potential  allergens . Occasionally, other coating materials are used, for example synthetic polymers,  shellac , corn protein  zein  or other polysaccharides.  Capsules  are coated with gelatin.


Enterics  control the rate of drug release and determine where the drug will be released in the digestive tract. Materials used for enteric coatings include fatty acids, waxes, shellac, plastics, and plant fibers.


Colours  are added to improve the appearance of a formulation. Colour consistency is important as it allows easy identification of a medication. Furthermore, colours often improve the aesthetic look and feel of medications. Small amounts of colouring agents are easily processed by the body, although rare reactions are known, notably to  tartrazine . [ 5 ]  Commonly, titanium oxide is used as a colouring agent to produce the popular opaque colours along with azo dyes for other colors. By increasing these  organoleptic  properties a patient is more likely to adhere to their schedule and therapeutic objectives will also have a better outcome for the patient especially children.


Disintegrants expand and dissolve when wet causing the tablet to break apart in the  digestive tract , or in specific segments of the digestion process, releasing the active ingredients for  absorption . They ensure that when the tablet is in contact with  water , it rapidly breaks down into smaller fragments, facilitating  dissolution . [ 5 ]


Examples of disintegrants include:


Flavours  can be used to mask unpleasant tasting active ingredients and improve the acceptance that the patient will complete a course of medication. Flavourings may be natural (e.g. fruit extract) or artificial. [ 6 ] [ 5 ]


For example, to improve: [ 6 ]


Glidants  are used to promote powder flow by reducing interparticle friction and cohesion. These are used in combination with lubricants as they have no ability to reduce wall friction. Examples include  silica gel ,  fumed silica ,  talc , and  magnesium carbonate . However, some silica gel glidants such as Syloid(R) 244 FP and Syloid(R) XDP are multi-functional and offer several other performance benefits in addition to reducing interparticle friction including moisture resistance, taste, marketing, etc.


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. [ 5 ]


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 gelatin capsules. Lubricants are agents added in small quantities to tablet and capsule formulations to improve certain processing characteristics. While lubricants are often added to improve manufacturability of the drug products, it may also negatively impact the product quality. For example, extended mixing of lubricants during blending may results in delayed dissolution and softer tablets, which is often referred to as "over-lubrication". Therefore, optimizing lubrication time is critical during pharmaceutical development. [ 7 ] [ 8 ] [ 9 ]


There are three roles identified with lubricants as follows:


There are two major types of lubricants:


Some typical  preservatives  used in pharmaceutical formulations are


Sorbents  are used for tablet/capsule moisture-proofing by limited fluid sorbing (taking up of a liquid or a gas either by  adsorption  or by  absorption ) in a dry state. For example,  desiccants  absorb water,  drying  out ( desiccating ) the surrounding materials.


Sweeteners  are added to make the ingredients more palatable, especially in chewable tablets such as  antacid  or liquids like  cough syrup .  Sugar  can be used to mask unpleasant tastes or smells, but artificial sweeteners tend to be preferred, as natural ones tend to cause tooth decay. [ 5 ]


In liquid and gel formulations, the bulk excipient that serves as a medium for conveying the active ingredient is usually called the  vehicle .  Petrolatum ,  dimethyl sulfoxide  and  mineral oil  are common vehicles.


A  film coating  is a thin  polymer -based coat that is typically sprayed onto solid  pharmaceutical   dosage forms , such as  tablets ,  capsules , pellets or granules. Film coating can impact both its appearance and its pharmacokinetics making it an essential process in making the final drug product.


Film coatings are the most common form of drug coating and are generally applied in orally-administered pharmaceuticals. The motivation for applying film coatings to dosage forms range from cosmetic considerations (colour, gloss and branding), improving the  shelf life  by providing a protective barrier between the drug and the surrounding environment. These types of film coatings are known as non-functional film coatings. They may also be used to delay or augment the delivery and uptake of medications or delay release and uptake until the medication passes through the  stomach . These types of film coatings are known as functional film coatings.


The conventional method of applying film coatings to oral dosage forms comprises a spraying phase and a drying phase. [ 1 ]  The spraying phase consists of applying a layer of a polymer,  plasticizer ,  colourant ,  opacifier ,  solvent , and a  vehicle  to the oral dosage form's core. [ 2 ]  Once applied, the oral dosage form is dried by passing hot air over the dosage form, which typically also removes the solvent as well. The final result is a thin film coating with the desired plasticizer, colour, opacifier, and vehicle. [ 1 ]


Non-functional film coating involves changes made to the aesthetic of the oral dosage form. Such changes affect an oral dosage form's appearance, organoleptic properties, swallowing properties, and provide protection against harsh environmental conditions that can damage the active pharmaceutical ingredient. [ 2 ]  These changes are conducted to improve the compliance and effects of the oral dosage form. For instance, changing appearance can be done by changing the colour of the drug, leading to a more appealing product. [ 2 ]  Changing the swallowing properties can make it easier for those suffering from dysphagia. [ 2 ]  Finally, adding a film that protects from harsh environments, such conditions include humidity, oxidation, or light, increases the shelf life of the final product. [ 2 ]


Functional film coating provides the same properties as non-functional film coating, but also has added properties that affect drug release. [ 2 ]  These changes alter the region in the gastrointestinal tract that the final drug product is released. [ 2 ]  See  modified-release dosage  and  enteric coatings .


Organic solvent use in film coating is typically used to incorporate protective coatings to the oral dosage form, which aids in increasing the shelf life of the final drug product. [ 1 ]  This type of film coating can be dangerous  due to its potential for toxicity in the final product and flammability during the film coating process. [ 1 ]  As such, it is integral to have proper safety measures and ventilation in place when film coating.


Aqueous film coating is the most common film coating method currently used. [ 1 ]  This type of film coating uses water to aid in the film coating process instead of organic solvents. [ 1 ]  The result is a safer means of film coating, as it avoids the toxic and flammable properties of organic solvents. Aqueous film coating requires the use of water insoluble polymer mixtures, with the addition of a plasticizer. [ 1 ]  Despite its widespread popularity, aqueous film coating is more time consuming than organic solvent-based coating, due to the increased time needed for complete evaporation of water. [ 1 ]


Solvent-free film coating is most commonly used in coating heat sensitive drugs due to the benefit of not requiring a drying phase. [ 1 ]  The end result of this type of film coating is an inert film coating that does not react with the  active pharmaceutical ingredients . [ 1 ]  Some methods to create a solvent-free film coating include injection molding coating, hot-melt coating, and spray congealing. [ 1 ]  Each method has its own advantages and disadvantages, but the common theme amongst them is the need for very precise conditions that can satisfactorily apply a film coating to the oral dosage form. [ 1 ]  As such, it is an inefficient type of film coating that has resulted in its lack of widespread use.


A  formulary  is a list of  pharmaceutical drugs , often decided upon by a group of people, for various reasons such as insurance coverage or use at a medical facility. [ 1 ]  Traditionally, a formulary contained a collection of formulas for the  compounding  and testing of medication (a resource closer to what would be referred to as a  pharmacopoeia  today). Today, the main function of a prescription formulary is to specify particular medications that are approved to be  prescribed  at a particular  hospital , in a particular  health system , or under a particular  health insurance  policy. The development of prescription formularies is based on evaluations of efficacy, safety, and  cost-effectiveness  of drugs.


Depending on the individual formulary, it may also contain additional clinical information, such as  side effects ,  contraindications , and  doses .


By the turn of the millennium, 156 countries had national or provincial  essential medicines  lists and 135 countries had national treatment.


In Australia, where there is a public health care system, medications are subsidised under the  Pharmaceutical Benefits Scheme  (PBS) and medications that are available under the PBS and the indications for which they can be obtained under said scheme can be found in at least two places, the PBS webpage [ 2 ]  and the  Australian Medicines Handbook . [ citation needed ]


The Prescription Drug List  is the national formulary that lists all medical ingredients for human and animal use available with a prescription with the exception of those under the  Controlled Drugs and Substances Act . [ 3 ] [ 4 ]  The  Canadian Agency for Drugs and Technologies in Health  (CADTH) is the advisory body that evaluates new medical technologies and prescription medication. Based on recommendations the provincial and territorial governments decide whether or not to implement changes to their healthcare system and public drug formularies. [ 5 ]  Provincial and territorial government provide partial prescription drug coverage and the overall drug payment is a mix of public taxation, private insurance and out-of-pocket expenses. [ 4 ] [ 6 ]  Insurance coverage differs regionally, although each public drug coverage plan must meet standards set by the federal government. [ 6 ]  Regional health authorities are in charge of regulating and providing its residents insurance while the federal government provides insurance for specifically eligible veterans,  First Nations ,  Inuit , Canadian Forces, federal inmates and some refugees. [ 4 ] [ 6 ]


In the US, where a system of quasi-private healthcare is in place, a formulary is a list of  prescription drugs  available to enrollees, and a tiered formulary provides financial incentives for patients to select lower-cost drugs. For example, under a 3-tier formulary, the first tier typically includes generic drugs with the lowest cost sharing (e.g., 10% coinsurance), the second includes preferred brand-name drugs with higher cost sharing (e.g., 25%), and the third includes non-preferred brand-name drugs with the highest cost-sharing (e.g., 40%). [ 7 ]