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144-486: Pharmacovigilance ( PV , or PhV ), also known as drug safety , is the pharmaceutical science relating to the "collection, detection, assessment, monitoring, and prevention" of adverse effects with pharmaceutical products . The etymological roots for the word "pharmacovigilance" are: pharmakon (Greek for drug) and vigilare (Latin for to keep watch). As such, pharmacovigilance heavily focuses on adverse drug reactions (ADR), which are defined as any response to

288-548: A Catalan enclave close to Puigcerdà , is a museum: the building dates back to the 15th century and the museum keeps albarellos from the 16th and 17th centuries, old prescription books and antique drugs. Pharmacists practice in a variety of areas including community pharmacies, infusion pharmacies, hospitals, clinics, insurance companies, medical communication companies, research facilities, pharmaceutical companies, extended care facilities, psychiatric hospitals, and regulatory agencies. Pharmacists themselves may have expertise in

432-617: A medical specialty . A pharmacy (also known as a chemist in Australia , New Zealand and the British Isles ; or drugstore in North America ; retail pharmacy in industry terminology; or apothecary , historically) is where most pharmacists practice the profession of pharmacy. It is the community pharmacy in which the dichotomy of the profession exists; health professionals who are also retailers. Community pharmacies usually consist of

576-509: A case. Within clinical trials such a case is referred to as a SUSAR (a Suspected Unexpected Serious Adverse Reaction). If the SUSAR involves an event that is life-threatening or fatal, it may be subject to a 7-day "clock". Cases that do not involve a serious, unlisted event may be subject to non-expedited or periodic reporting. Also known as AE (adverse event) or SAE (serious AE) reporting from clinical trials, safety information from clinical studies

720-559: A centralised (or "community") marketing authorisation (MA) valid in all European Union member states and in Iceland , Liechtenstein and Norway . The centralised procedure is compulsory for all medicines derived from biotechnology and other high-tech processes, as well as for human medicines for the treatment of HIV/AIDS, cancer, diabetes, neurodegenerative diseases, auto-immune and other immune dysfunctions, and viral diseases, and for veterinary medicines for use for growth or yield enhancers. It

864-430: A company to submit a document called a Risk Evaluation and Mitigation Strategy (REMS) for a drug that has a specific risk that FDA believes requires mitigation. While not as comprehensive as a risk management plan, a Risk Evaluation and Mitigation Strategy can require a sponsor to perform certain activities or to follow a protocol, referred to as Elements to Assure Safe Use, to assure that a positive risk-benefit profile for

1008-464: A compounding pharmacist might make a medicated lollipop that contains the drug. Patients who have difficulty swallowing the tablet may prefer to suck the medicated lollipop instead. Another form of compounding is by mixing different strengths (g, mg, mcg) of capsules or tablets to yield the desired amount of medication indicated by the physician , physician assistant , nurse practitioner , or clinical pharmacist practitioner . This form of compounding

1152-474: A concept, is also subject to debate. While permanent disability following a stroke would no doubt be serious, would "complete blindness for 30 seconds" be considered "significant disability"? For birth defects, the seriousness of the event is usually not in dispute so much as the attribution of the event to the drug. Finally, "medically significant events" is a category that includes events that may be always serious, or sometimes serious, but will not fulfill any of

1296-550: A decentralised scientific agency (as opposed to a regulatory authority ) of the European Union (EU) and its main responsibility is the protection and promotion of public and animal health, through the evaluation and supervision of medicines for human and veterinary use. More specifically, it coordinates the evaluation and monitoring of centrally authorised products and national referrals, develops technical guidance and provides scientific advice to sponsors. Its scope of operations

1440-441: A different set of warnings, precautions or contraindications (where the drug should not be used at all) for the product's labeling may be necessary in order to maintain a positive risk/benefit profile in all known populations using the drug. Pharmacoepidemiology is the study of the incidence of adverse drug reactions in patient populations using drug agents. Although often used interchangeably, there are subtle differences between

1584-749: A drug off the market or a label change due to safety problems. Spontaneous reporting is the core data-generating system of international pharmacovigilance, relying on healthcare professionals (and in some countries consumers) to identify and report any adverse events to their national pharmacovigilance center, health authority (such as the European Medicines Agency or FDA), or to the drug manufacturer itself. Spontaneous reports are, by definition, submitted voluntarily although under certain circumstances these reports may be encouraged, or "stimulated", by media reports or articles published in medical or scientific publications, or by product lawsuits. In many parts of

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1728-406: A drug therapy plan. Since the emergence of modern clinical pharmacy, ambulatory care pharmacy practice has emerged as a unique pharmacy practice setting. Ambulatory care pharmacy is based primarily on pharmacotherapy services that a pharmacist provides in a clinic. Pharmacists in this setting often do not dispense drugs, but rather see patients in-office visits to manage chronic disease states. In

1872-696: A drug which is noxious and unintended, including lack of efficacy (the condition that this definition only applies with the doses normally used for the prophylaxis , diagnosis or therapy of disease, or for the modification of physiological disorder function was excluded with the latest amendment of the applicable legislation). Medication errors such as overdose, and misuse and abuse of a drug as well as drug exposure during pregnancy and breastfeeding, are also of interest, even without an adverse event, because they may result in an adverse drug reaction. Information received from patients and healthcare providers via pharmacovigilance agreements, as well as other sources such as

2016-498: A drug, once authorized, may be used in ways not originally studied in clinical trials, this potential " off-label use ", and its associated risks, is also described within the risk management plan. Risk management plans can be very lengthy documents, running in some cases hundreds of pages and, in rare instances, up to a thousand pages long. In the US, under certain circumstances, the FDA may require

2160-417: A key role in the safety assessment of drugs. Aggregate reporting involves the compilation of safety data for a drug over a prolonged period of time (months or years), as opposed to single-case reporting which, by definition, involves only individual AE reports. The advantage of aggregate reporting is that it provides a broader view of the safety profile of a drug. Worldwide, the most important aggregate report

2304-537: A level lower than pharmacovigilance. AE and SAE information, which may also include relevant information from the patient's medical background, are reviewed and assessed for both causality and degree of seriousness by the study investigator. This information is forwarded to a sponsoring entity (typically a pharmaceutical company or academic medical center) that is responsible for the reporting of this information, as appropriate, to drug regulatory authorities. Spontaneous reports are termed spontaneous as they take place during

2448-481: A life-threatening or fatal event will be closer to a "10" in terms of its likelihood of being reported. In view of this, medical personnel may not always see AE reporting as a priority, especially if the symptoms are not serious. And even if the symptoms are serious, the symptoms may not be recognized as a possible side effect of a particular drug or combination thereof. In addition, medical personnel may not feel compelled to report events that are viewed as expected. This

2592-614: A manuscript "Recipes for 52 Ailments", found in the Mawangdui , sealed in 168 BC. In Japan, at the end of the Asuka period (538–710) and the early Nara period (710–794), the men who fulfilled roles similar to those of modern pharmacists were highly respected. The place of pharmacists in society was expressly defined in the Taihō Code (701) and re-stated in the Yōrō Code (718). Ranked positions in

2736-417: A report might technically be considered valid, but will be of very limited value to the pharmacovigilance department of the company or to drug regulatory authorities. 1- Case-control study ( Retrospective study ) 2- Prospective study ( Cohort study ). 3- Population statistics. and 4- Intensive event report. 5- The spontaneous report in the case is the population of the single case report. Adverse event coding

2880-562: A retail storefront with a dispensary, where medications are stored and dispensed. According to Sharif Kaf al-Ghazal, the opening of the first drugstores are recorded by Muslim pharmacists in Baghdad in 754 AD. Pharmacies within hospitals differ considerably from community pharmacies. Some pharmacists in hospital pharmacies may have more complex clinical medication management issues, and pharmacists in community pharmacies often have more complex business and customer relations issues. Because of

3024-418: A safety signal as: "Reported information on a possible causal relationship between an adverse event and a drug, the relationship being unknown or incompletely documented previously". Usually more than a single report is required to generate a signal, depending upon the event and quality of the information available. Data mining pharmacovigilance databases is one approach that has become increasingly popular with

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3168-433: A separate board certification. The official designation for pharmacists who pass the ambulatory care pharmacy specialty certification exam will be Board Certified Ambulatory Care Pharmacist and these pharmacists will carry the initials BCACP. Compounding involves preparing drugs in forms that are different from the generic prescription standard. This may include altering the strength, ingredients, or dosage form. Compounding

3312-639: A set of criteria within pharmacovigilance that are used to distinguish a serious adverse event from a non-serious one. An adverse event is considered serious if it meets one or more of the following criteria: Aside from death, each of these categories is subject to some interpretation. Life-threatening, as it used in the drug safety world, specifically refers to an adverse event that places the patient at an immediate risk of death , such as cardiac or respiratory arrest. By this definition, events such as myocardial infarction , which would be hypothetically life-threatening, would not be considered life-threatening unless

3456-491: Is a complex process that requires adequate training of personnel, quality assurance of products, and adequate facilities. Several hospital pharmacies have decided to outsource high-risk preparations and some other compounding functions to companies who specialize in compounding. The high cost of medications and drug-related technology and the potential impact of medications and pharmacy services on patient-care outcomes and patient safety require hospital pharmacies to perform at

3600-403: Is a way to create custom drugs for patients who may not be able to take the medication in its standard form, such as due to an allergy or difficulty swallowing. Compounding is necessary for these patients to still be able to properly get the prescriptions they need. One area of compounding is preparing drugs in new dosage forms. For example, if a drug manufacturer only provides a drug as a tablet,

3744-446: Is also compulsory for advanced-therapy medicines such as gene-therapy, somatic cell-therapy or tissue-engineered medicines and for orphan medicines (for rare diseases). The centralised procedure is also open to products that bring a significant therapeutic, scientific or technical innovation, or is in any other respect in the interest of patient or animal health. As a result, the majority of genuinely novel medicines are authorised through

3888-429: Is also important, as whistle blower protection is not granted in all countries. In general, the drug must also be specifically named. Note that in different countries and regions of the world, drugs are sold under various tradenames. In addition, there are a large number of generics which may be mistaken for the trade product. Finally, there is the problem of counterfeit drugs producing adverse events. If at all possible, it

4032-634: Is an agency of the European Union (EU) in charge of the evaluation and supervision of pharmaceutical products . Prior to 2004, it was known as the European Agency for the Evaluation of Medicinal Products or European Medicines Evaluation Agency ( EMEA ). The EMA was set up in 1995, with funding from the European Union and the pharmaceutical industry , as well as indirect subsidy from member states, its stated intention to harmonise (but not replace)

4176-461: Is an essential part of drug use and safety surveillance. Ideally, the goal of signal detection is to identify adverse drug reactions that were previously considered unexpected and to be able to provide guidance in the product's labeling as to how to minimize the risk of using the drug in a given patient population. A risk management plan is a documented plan that describes the risks (adverse drug reactions and potential adverse reactions) associated with

4320-563: Is anticipated to pass Japan to become second in the ranking of individual countries' in pharmaceutical purchases by 2015, and so its PV regulation will become increasing important; China's regulation of PV is through its National Center for Adverse Drug Reaction Monitoring, under China's Ministry of Health. As JE Sackman notes, as of April 2013 "there is no Latin American equivalent of the European Medicines Agency—no common body with

4464-537: Is best to try to obtain the sample which induced the adverse event, and send it to either the European Medicines Agency , FDA or other government agency responsible for investigating AE reports. If a reporter can't recall the name of the drug they were taking when they experienced an adverse event, this would not be a valid case. This concept also applies to adverse events. If a patient states that they experienced "symptoms", but cannot be more specific, such

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4608-737: Is carried out through the Committee for Medicinal Products for Human Use (CHMP). If the Committee concludes that the quality, safety and efficacy of the medicinal product is sufficiently proven, it adopts a positive opinion. This is sent to the European Commission to be transformed into a marketing authorisation valid for the whole of the EU. A special type of approval is the paediatric-use marketing authorisation (PUMA), which can be granted for medical products intended exclusively for paediatric use. The CHMP

4752-528: Is concerned with identifying the hazards associated with pharmaceutical products and with minimizing the risk of any harm that may come to patients. Companies must conduct a comprehensive drug safety and pharmacovigilance audit to assess their compliance with worldwide laws, regulations, and guidance. Pharmacovigilance has its own unique terminology that is important to understand. Most of the following terms are used within this article and are peculiar to drug safety, although some are used by other disciplines within

4896-435: Is considered related to the use of the drug (US FDA). (Spontaneous reports are typically considered to have a positive causality, whereas a clinical trial case will typically be assessed for causality by the clinical trial investigator and/or the license holder.) In most countries, the time frame for reporting expedited cases is 7/15 calendar days from the time a drug company receives notification (referred to as "Day 0") of such

5040-976: Is developed by Hepler and Strand in 1990. Veterinary pharmacies, sometimes called animal pharmacies , may fall in the category of hospital pharmacy, retail pharmacy or mail-order pharmacy. Veterinary pharmacies stock different varieties and different strengths of medications to fulfill the pharmaceutical needs of animals. Because the needs of animals, as well as the regulations on veterinary medicine , are often very different from those related to people, in some jurisdictions veterinary pharmacy may be kept separate from regular pharmacies. Nuclear pharmacy focuses on preparing radioactive materials for diagnostic tests and for treating certain diseases. Nuclear pharmacists undergo additional training specific to handling radioactive materials, and unlike in community and hospital pharmacies, nuclear pharmacists typically do not interact directly with patients. European Medicines Agency The European Medicines Agency ( EMA )

5184-497: Is especially important when one has obtained one's pharmaceutical from a compounding pharmacy. As such, spontaneous reports are a crucial element in the worldwide enterprise of pharmacovigilance and form the core of the World Health Organization Database, which includes around 4.6 million reports (January 2009), growing annually by about 250,000. Aggregate reporting, also known as periodic reporting, plays

5328-619: Is found at community or hospital pharmacies or in-home administration therapy. Compounding pharmacies specialize in compounding, although many also dispense the same non-compounded drugs that patients can obtain from community pharmacies. Consultant pharmacy practice focuses more on medication regimen review (i.e. "cognitive services") than on actual dispensing of drugs. Consultant pharmacists most typically work in nursing homes , but are increasingly branching into other institutions and non-institutional settings. Traditionally consultant pharmacists were usually independent business owners, though in

5472-580: Is globally oriented think tank that provides guidance on drug safety related topics through its Working Groups. The CIOMS prepares reports that are used as a reference for developing future drug regulatory policy and procedures, and over the years, many of CIOMS' proposed policies have been adopted. Examples of topics these reports have covered include: Current Challenges in Pharmacovigilance: Pragmatic Approaches (CIOMS V); Management of Safety Information from Clinical Trials (CIOMS VI);

5616-490: Is medicinal products for human and veterinary use including biologics and advanced therapies, and herbal medicinal products . The agency is composed of the Secretariat (ca. 600 staff), a management board, seven scientific committees (human, veterinary and herbal medicinal products, orphan drugs , paediatrics, advanced therapies and pharmacovigilance risk assessment) and a number of scientific working parties. The Secretariat

5760-399: Is missing, the case is not a valid individual case safety report. Although there are no exceptions to this rule there may be circumstances that may require a judgment call. For example, the term "identifiable" may not always be clear-cut. If a physician reports that he/she has a patient X taking drug Y who experienced Z (an AE), but refuses to provide any specifics about patient X, the report

5904-413: Is not specific to pharmacy. Both disciplines are distinct. Those who wish to practice both pharmacy (patient-oriented) and pharmacology (a biomedical science requiring the scientific method) receive separate training and degrees unique to either discipline. Pharmacoinformatics is considered another new discipline, for systematic drug discovery and development with efficiency and safety. Pharmacogenomics

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6048-568: Is obliged by the regulation to reach decisions within 210 days, though the clock is stopped if it is necessary to ask the applicant for clarification or further supporting data. The review process of the European Medicines Agency regarding medical issues has been criticized for its lack of transparency. In a rebuttal of an EMS review that included her work, Louise Brinth, a Danish physician, noted that "experts" reviewing data remain unnamed and seem to be bound to secrecy. Minutes are not released and diverging opinions are not reported suggesting that all

6192-478: Is on a number of medications, it may be the combination of these drugs which causes the AE, and not any one individually. There have been a number of recent high-profile cases where the AE led to the death of an individual. The individuals were not overdosed with any one of the many medications they were taking, but the combination there appeared to cause the AE. Hence it is important to include in your/one's AE report, not only

6336-517: Is on the benefit-risk profile of the drug, which includes a review of relevant safety data compiled for a drug product since its development. Some countries legally oblige spontaneous reporting by physicians. In most countries, manufacturers are required to submit, through its Qualified Person for Pharmacovigilance (QPPV), all of the reports they receive from healthcare providers to the national authority. Others have intensive, focused programmes concentrating on new drugs, or on controversial drugs, or on

6480-473: Is organised into five units: Directorate, Human Medicines Development and Evaluation, Patient Health Protection, Veterinary Medicines and Product Data Management, Information and Communications Technology and Administration. The Management Board provides administrative oversight to the Agency: including approval of budgets and plans, and selection of executive director . The Board includes one representative of each of

6624-527: Is received. Legislation requires the supervision of certain pharmacy technician's activities by a pharmacist. The majority of pharmacy technicians work in community pharmacies . In hospital pharmacies, pharmacy technicians may be managed by other senior pharmacy technicians. In the UK the role of a PhT in hospital pharmacy has grown and responsibility has been passed on to them to manage the pharmacy department and specialized areas in pharmacy practice allowing pharmacists

6768-634: Is regulated by the Egyptian Pharmacovigilance Center of the Egyptian Ministry of Health. Pharmaceutical science The scope of pharmacy practice includes more traditional roles such as compounding and dispensing of medications. It also includes more modern services related to health care including clinical services, reviewing medications for safety and efficacy, and providing drug information with patient counselling. Pharmacists , therefore, are experts on drug therapy and are

6912-425: Is required to be submitted, in a specified format, with all new market authorization requests within the European Union (EU). Although not necessarily required, risk management plans may also be submitted in countries outside the EU. The risks described in a risk management plan fall into one of three categories: identified risks, potential risks, and unknown risks. Also described within a risk management plan are

7056-413: Is still a valid case even though the patient is not specifically identified. This is because the reporter has first-hand information about the patient and is identifiable (i.e. a real person) to the physician. Identifiability is important so as not only to prevent duplicate reporting of the same case, but also to permit follow-up for additional information. The concept of identifiability also applies to

7200-416: Is that of the determination of causality. Causality refers to the relationship of a given adverse event to a specific drug. Causality determination (or assessment) is often difficult because of the lack of clear-cut or reliable data. While one may assume that a positive temporal relationship might "prove" a positive causal relationship, this is not always the case. Indeed, a "bee sting" Adverse Event — where

7344-657: Is the Periodic Safety Update Report (PSUR) and Development Safety Update Report (DSUR). This is a document that is submitted to drug regulatory agencies in Europe, the US and Japan (ICH countries), as well as other countries around the world. The PSUR was updated in 2012 and is now referred to in many countries as the Periodic Benefit Risk Evaluation report (PBRER). As the title suggests, the PBRER's focus

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7488-464: Is the process by which information from an AE reporter, called the "verbatim", is coded using standardized terminology from a medical coding dictionary, such as MedDRA (the most commonly used medical coding dictionary). The purpose of medical coding is to convert adverse event information into terminology that can be readily identified and analyzed. For instance, Patient 1 may report that they had experienced "a very bad headache that felt like their head

7632-429: Is the study of genetic-linked variants that effect patient clinical responses, allergies, and metabolism of drugs. The World Health Organization estimates that there are at least 2.6 million pharmacists and other pharmaceutical personnel worldwide. Pharmacists are healthcare professionals with specialized education and training who perform various roles to ensure optimal health outcomes for their patients through

7776-435: Is used to establish a drug's safety profile in humans and is a key component that drug regulatory authorities consider in the decision-making as to whether to grant or deny market authorization (market approval) for a drug. AE reporting occurs when study patients (subjects, participants) experience any kind of "untoward" event during the conducting of clinical trials. Non-serious adverse events are typically captured separately at

7920-467: Is why reports from patients themselves are of high value. The confirmation of these events by a healthcare professional is typically considered to increase the value of these reports. Hence it is important not only for the patient to report the AE to his health care provider (who may neglect to report the AE), but also report the AE to both the biopharmaceutical company and the FDA, European Medicines Agency, ... This

8064-703: The Coalition for Epidemic Preparedness Innovations ' Joint Coordination Group. It is also a benefactor of Health Level Seven International , a member of the International Council for Harmonisation of Technical Requirements for Pharmaceuticals for Human Use and the International Pharmaceutical Regulators Programme (IPRP), and a partner of the Society for Immunotherapy of Cancer and Vaccine Confidence Project . A single evaluation

8208-599: The European Commission had to decide on the fate of the EMA's location. The EU ministers met to vote on their preferred successor. The EU's Health Commissioner Vytenis Andriukaitis said that the preferred choice would be a location where an "easy set up and guarantee of smooth operations" would be available. Member states who had expressed their bid for the new EMA location were Austria , Belgium , Bulgaria , Croatia , Cyprus , Czech Republic , Denmark , Finland , France , Germany , Greece , Hungary , Ireland , Italy , Malta ,

8352-604: The International Pharmaceutical Federation (FIP), an NGO linked with World Health Organization (WHO). They are represented at the national level by professional organisations such as the Royal Pharmaceutical Society in the UK, Pharmaceutical Society of Australia (PSA), Canadian Pharmacists Association (CPhA), Indian Pharmacist Association (IPA), Pakistan Pharmacists Association (PPA), American Pharmacists Association (APhA), and

8496-675: The Islamic Golden Age , themselves deriving their knowledge from earlier Greek Byzantine medicine . Pharmacy in China dates at least to the earliest known Chinese manual, the Shennong Bencao Jing ( The Divine Farmer's Herb-Root Classic ), dating back to the 1st century AD. It was compiled during the Han dynasty and was attributed to the mythical Shennong . Earlier literature included lists of prescriptions for specific ailments, exemplified by

8640-460: The Islamic Golden Age . By the 9th century, these pharmacies were state-regulated. The advances made in the Middle East in botany and chemistry led medicine in medieval Islam substantially to develop pharmacology . Muhammad ibn Zakarīya Rāzi (Rhazes) (865–915), for instance, acted to promote the medical uses of chemical compounds. Abu al-Qasim al-Zahrawi (Abulcasis) (936–1013) pioneered

8784-919: The Malaysian Pharmaceutical Society (MPS). In some cases, the representative body is also the registering body, which is responsible for the regulation and ethics of the profession. In the United States, specializations in pharmacy practice recognized by the Board of Pharmacy Specialties include: cardiovascular, infectious disease , oncology , pharmacotherapy, nuclear, nutrition , and psychiatry . The Commission for Certification in Geriatric Pharmacy certifies pharmacists in geriatric pharmacy practice. The American Board of Applied Toxicology certifies pharmacists and other medical professionals in applied toxicology . Pharmacy technicians support

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8928-647: The Netherlands , Poland , Portugal , Romania , Slovakia , Slovenia , Spain , and Sweden (or in other words all remaining member countries except for the Baltic States and Luxembourg). It had also been speculated that the Strasbourg -based seat for the European Parliament could be moved to Brussels, in exchange for the city to host the EMA. Others speculated on the merits of Amsterdam, well before

9072-433: The distillation of sea-water for drinking. In Europe , pharmacy-like shops began to appear during the 12th century. In 1240, emperor Frederic II issued a decree by which the physician's and the apothecary's professions were separated. There are pharmacies in Europe that have been in operation since medieval times. In Florence , Italy, the director of the museum in the former Santa Maria Novella pharmacy says that

9216-408: The medical literature , plays a critical role in providing the data necessary for pharmacovigilance to take place. In order to market or to test a pharmaceutical product in most countries, adverse event data received by the license holder (usually a pharmaceutical company) must be submitted to the local drug regulatory authority. (See Adverse event reporting below.) Ultimately, pharmacovigilance

9360-571: The "experts" are of the same opinion. In her view the process is unscientific and undemocratic. The Committee for Medicinal Products for Veterinary Use (CVMP) operates in analogy to the CHMP as described above. The Committee on Orphan Medicinal Products (COMP) administers the granting of orphan drug status since 2000. Companies intending to develop medicinal products for the diagnosis, prevention or treatment of life-threatening or very serious conditions that affect not more than five in 10,000 persons in

9504-655: The 27 Member States, two representatives of the European Commission , two representatives of the European Parliament , two representatives of patients' organisations, one representative of doctors' organisations and one representative of veterinarians' organisations. The Agency decentralises its scientific assessment of medicines by working through a network of about 4500 experts throughout the EU. The EMA draws on resources of over 40 National Competent Authorities (NCAs) of EU Member states. The EMA additionally engages with international agencies and non-governmental organizations on areas of mutual interest, such as its participation on

9648-533: The 3rd or 4th century AD. Many Sumerian (4th millennium BC – early 2nd millennium BC) cuneiform clay tablets record prescriptions for medicine. Ancient Egyptian pharmacological knowledge was recorded in various papyri such as the Ebers Papyrus of 1550 BC, and the Edwin Smith Papyrus of the 16th century BC. In Ancient Greece , Diocles of Carystus (4th century BC) was one of several men studying

9792-399: The AE can clearly be attributed to a specific cause — is by far the exception rather than the rule. This is due to the complexity of human physiology as well as that of disease and illnesses. By this reckoning, in order to determine causality between an adverse event and a drug, one must first exclude the possibility that there were other possible causes or contributing factors. If the patient

9936-660: The Committee for Proprietary Medicinal Products and the Committee for Veterinary Medicinal Products, though both of these were reborn as the core scientific advisory committees. The agency was located in London prior to the United Kingdom's vote for withdrawal from the European Union , relocating to Amsterdam in March 2019. Prior to 2004, it was known as the European Agency for the Evaluation of Medicinal Products or European Medicines Evaluation Agency ( EMEA ). The EMA contributed to

10080-655: The Development Safety Update Report (DSUR): Harmonizing the Format and Content for Periodic Safety Reporting During Clinical Trials (CIOMS VII); and Practical Aspects of Signal Detection in Pharmacovigilance: Report of CIOMS Working Group (CIOMS VIII). The International Society of Pharmacovigilance is an international non-profit scientific organization, which aims to foster pharmacovigilance both scientifically and educationally, and enhance all aspects of

10224-419: The EMA. For products eligible for or requiring centralised approval, a company submits an application for a marketing authorisation to the EMA. The EMA was set up in 1995, with funding from the European Union and the pharmaceutical industry , as well as indirect subsidy from member states, its stated intention to harmonise (but not replace) the work of existing national medicine regulatory bodies. The hope

10368-729: The Emperor. There is a stone sign for a pharmacy shop with a tripod, a mortar, and a pestle opposite one for a doctor in the Arcadian Way in Ephesus near Kusadasi in Turkey. The current Ephesus dates back to 400 BC and was the site of the Temple of Artemis, one of the seven wonders of the world. In Baghdad the first pharmacies, or drug stores, were established in 754, under the Abbasid Caliphate during

10512-715: The European Union , seeking to expedite the development and approval of COVID-19 vaccines and treatments . It participated in the Accelerating COVID-19 Therapeutic Interventions and Vaccines (ACTIV) public–private partnership hosted by the Foundation for the National Institutes of Health , collaborating with international government agencies and corporations to coordinate a research strategy for prioritizing and speeding up development of COVID-19 vaccines and pharmaceutical products. While in

10656-498: The European Union can apply for 'orphan medicinal product designation'. The COMP evaluates the application and makes a recommendation for the designation which is then granted by the European Commission . The Committee on Herbal Medicinal Products (HMPC) assists the harmonisation of procedures and provisions concerning herbal medicinal products laid down in EU Member States, and further integrating herbal medicinal products in

10800-517: The European regulatory framework since 2004. The Paediatric Committee (PDCO) deals with the implementation of the paediatric legislation in Europe Regulation (EC) No 1901/2006 since 2007. Under this legislation, all applications for marketing authorisation of new medicinal products, or variations to existing authorisations, have to either include data from paediatric studies previously agreed with

10944-754: The Global Vaccine Action Plan developed by the Decade of Vaccines Collaboration, endorsed by the 194 Member States of the World Health Assembly in May 2012, and published on the World Health Organization 's website in February 2013. Following the 2016 decision of the United Kingdom to leave the European Union (" Brexit "), the EMA chose to search for another base of operations. According to EU Law

11088-446: The PDCO, or obtain a PDCO waiver or a deferral of these studies. The Committee for Advanced Therapies (CAT) was established in accordance with Regulation (EC) No 1394/2007 on advanced-therapy medicinal products (ATMPs) such as gene therapy , somatic cell therapy and tissue engineered products. It assesses the quality, safety and efficacy of ATMPs, and follows scientific developments in

11232-701: The SC. Other parties have a significant interest in the International Council for Harmonisation and have been invited to nominate Observers to the SC; three current observers are the WHO, Health Canada , and the European Free Trade Association , with the International Federation of Pharmaceutical Manufacturers Association participating as a non-voting member of the SC. The CIOMS, a part of the WHO,

11376-429: The U.S. Code of Federal Regulations (CFR); the principal drug safety regulations are found in 21 CFR Part 312 (IND regulations) and 21 CFR Part 314 (NDA regulations). While those regulatory efforts address pre-marketing concerns, pharmaceutical manufacturers and academic/non-profit organizations such as RADAR and Public Citizen do play a role in pharmacovigilance in the US. The post-legislative rule-making process of

11520-544: The U.S. federal government provides for significant input from both the legislative and executive branches, which also play specific, distinct roles in determining FDA policy. The "pharmerging", or emerging pharmaceutical market economies, which include Brazil, India, Russia, Argentina, Egypt, Indonesia, Mexico, Pakistan, Poland, Romania, South Africa, Thailand, Turkey, Ukraine and Vietnam, accrued one fifth of global 2011 pharmaceutical expenditures; in future, aggregated data for this set will include China as well. China's economy

11664-522: The U.S. federal health care system (including the VA, the Indian Health Service, and NIH) ambulatory care pharmacists are given full independent prescribing authority. In some states, such as North Carolina and New Mexico , these pharmacist clinicians are given collaborative prescriptive and diagnostic authority. In 2011 the board of Pharmaceutical Specialties approved ambulatory care pharmacy practice as

11808-475: The UK, this group of staff can sell certain medicines (including pharmacy only and general sales list medicines) over the counter. They cannot prepare prescription-only medicines for supply to patients. The earliest known compilation of medicinal substances was the Sushruta Samhita , an Indian Ayurvedic treatise attributed to Sushruta in the 6th century BC. However, the earliest text as preserved dates to

11952-498: The United States many now work for a large pharmacy management company such as Omnicare , Kindred Healthcare or PharMerica . This trend may be gradually reversing as consultant pharmacists begin to work directly with patients, primarily because many elderly people are now taking numerous medications but continue to live outside of institutional settings. Some community pharmacies employ consultant pharmacists and/or provide consulting services. The main principle of consultant pharmacy

12096-530: The agencies involved are listed below (in order of 2011 spending on pharmaceuticals, from the IMS Institute for Healthcare Informatics). In the U.S., with about a third of all global 2011 pharmaceutical expenditures, the drug industry is regulated by the FDA , the largest national drug regulatory authority in the world. FDA authority is exercised through enforcement of regulations derived from legislation, as published in

12240-438: The availability of extensive data sources and inexpensive computing resources. The data sources (databases) may be owned by a pharmaceutical company, a drug regulatory authority, or a large healthcare provider. Individual case safety reports in these databases are retrieved and converted into structured format, and statistical methods (usually a smathematical algorithm) are applied to calculate statistical measures of association. If

12384-416: The background incidence of an event is less than that found in a group taking a drug. If the incidence of an event is statistically significantly higher in the "active" group versus the placebo group (or other control group), it is possible that a causal relationship may exist to a drug, unless other confounding factors may exist. Signal detection involves a range of techniques (CIOMS VIII). The WHO defines

12528-413: The clinician's normal diagnostic appraisal of a patient, when the clinician is drawing the conclusion that the drug may be implicated in the causality of the event. Spontaneous reporting system (SRS) relies on vigilant physicians and other healthcare professionals who not only generate a suspicion of an adverse drug reaction, but also report it. It is an important source of regulatory actions such as taking

12672-899: The complexity of medications including specific indications, effectiveness of treatment regimens, safety of medications (i.e., drug interactions) and patient compliance issues (in the hospital and at home), many pharmacists practicing in hospitals gain more education and training after pharmacy school through a pharmacy practice residency, sometimes followed by another residency in a specific area. Those pharmacists are often referred to as clinical pharmacists and they often specialize in various disciplines of pharmacy. For example, there are pharmacists who specialize in hematology/oncology, HIV/AIDS, infectious disease, critical care, emergency medicine , toxicology, nuclear pharmacy, pain management, psychiatry, anti-coagulation clinics, herbal medicine , neurology/epilepsy management, pediatrics, neonatal pharmacists and more. Hospital pharmacies can often be found within

12816-549: The country. Since 1978, the programme has been managed by the Uppsala Monitoring Centre to which member countries send their reports to be processed, evaluated and entered into an international database called VigiBase . Membership in the WHO Programme enables a country to know if similar reports are being made elsewhere. When there are several reports of adverse reactions to a particular drug, this process may lead to

12960-447: The detection of a signal, and an alert about a possible hazard communicated to members countries after detailed evaluation and expert review on the biological stasis and homeostasis of the body. Clb12/2020001 The International Council for Harmonisation is a global organization with members from the European Union, the United States and Japan; its goal is to recommend global standards for drug companies and drug regulatory authorities around

13104-407: The determination of risk factors is an important step of confirming or ruling-out a causal relationship between an event and a drug. Often the only way to confirm the existence of a causal relationship of an event to a drug is to conduct an observational study where the incidence of the event in a patient population taking the drug is compared to a control group. This may be necessary to determine if

13248-401: The drug being reported, but also all other drugs the patient was also taking. For instance, if a patient were to start Drug X and then three days later were to develop an AE, one might be tempted to attribute blame Drug X. However, before that can be done, the patient's medical history would need to be reviewed to look for possible risk factors for the AE. In other words, did the AE occur with

13392-434: The drug is designed – at most a few thousand – along with a comparable control group. The control group may receive a placebo and/or another drug, often a so-called "gold standard" that is "best" drug marketed for the disease. The purpose of clinical trials is to determine: Clinical trials do, in general, tell a good deal about how well a drug works. They provide information that should be reliable for larger populations with

13536-440: The drug is maintained for the circumstances under which the product is marketed. Pharmaceutical companies are required by law in most countries to perform clinical trials , testing new drugs on people before they are made generally available. This occurs after a drug has been pre-screened for toxicity, sometimes using animals for testing. The manufacturers or their agents usually select a representative sample of patients for whom

13680-521: The drug or because of the drug? This is because a patient on any drug may develop or be diagnosed with a condition that could not have possibly been caused by the drug. This is especially true for diseases, such as cancer, which develop over an extended period of time, being diagnosed in a patient who has been taken a drug for a relatively short period of time. On the other hand, certain adverse events, such as blood clots (thrombosis), can occur with certain drugs with only short-term exposure. Nevertheless,

13824-428: The field are also pioneering. Living in the 10th century, he wrote The foundations of the true properties of Remedies , amongst others describing arsenious oxide , and being acquainted with silicic acid . He made clear distinction between sodium carbonate and potassium carbonate , and drew attention to the poisonous nature of copper compounds, especially copper vitriol , and also lead compounds. He also describes

13968-551: The field. A seventh committee, the Pharmacovigilance Risk Assessment Committee (PRAC) has come into function in 2012 with the implementation of the new EU pharmacovigilance legislation (Directive 2010/84/EU). The Agency carries out a number of activities, including: The centralised procedure allows companies to submit a single application to the agency to obtain from the European Commission

14112-529: The final decision was made. The decision on the relocation was made on 20 November 2017, during the EU General Affairs Council meeting, after three voting rounds and finally drawing of lots. After the first round of voting, Milan (25 votes), Amsterdam (20 votes) and Copenhagen (20 votes) were the only contenders left. After the second voting round, two cities were left: Milan (twelve votes) and Amsterdam (nine votes). These two cities tied in

14256-441: The fundamental principles of adverse event reporting is the determination of what constitutes an individual case safety report. During the triage phase of a potential adverse event report, it is important to determine if the "four elements" of a valid individual case safety report are present: (1) an identifiable patient, (2) an identifiable reporter, (3) a suspect drug, and (4) an adverse event. If one or more of these four elements

14400-502: The highest level possible. Pharmacists provide direct patient care services that optimize the use of medication and promotes health, wellness, and disease prevention. Clinical pharmacists care for patients in all health care settings, but the clinical pharmacy movement initially began inside hospitals and clinics . Clinical pharmacists often collaborate with physicians and other healthcare professionals to improve pharmaceutical care. Clinical pharmacists are now an integral part of

14544-589: The interdisciplinary approach to patient care. They often participate in patient care rounds for drug product selection. In the UK clinical pharmacists can also prescribe some medications for patients on the NHS or privately, after completing a non-medical prescribers course to become an Independent Prescriber. The clinical pharmacist's role involves creating a comprehensive drug therapy plan for patient-specific problems, identifying goals of therapy, and reviewing all prescribed medications prior to dispensing and administration to

14688-416: The introduction of new therapeutics and methods for patient care. However, pharmacy is not a basic or biomedical science in its typical form. Medicinal chemistry is also a distinct branch of synthetic chemistry combining pharmacology, organic chemistry, and chemical biology. Pharmacology is sometimes considered the fourth discipline of pharmacy. Although pharmacology is essential to the study of pharmacy, it

14832-480: The measures that the Market Authorization Holder, usually a pharmaceutical company, will undertake to minimize the risks associated with the use of the drug. These measures are usually focused on the product's labeling and healthcare professionals. Indeed, the risks that are documented in a pre-authorization risk management plan will inevitably become part of the product's post-marketing labeling. Since

14976-421: The media (including social media and websites); and reports reported to drug regulatory authorities themselves. For pharmaceutical companies, AE reporting is a regulatory requirement in most countries. AE reporting also provides data to these companies and drug regulatory authorities that play a key role in assessing the risk-benefit profile of a given drug. The following are several facets of AE reporting: One of

15120-408: The medicinal properties of plants. He wrote several treatises on the topic. The Greek physician Pedanius Dioscorides is famous for writing a five-volume book in his native Greek Περί ύλης ιατρικής in the 1st century AD. The Latin translation De Materia Medica ( Concerning medical substances ) was used as a basis for many medieval texts and was built upon by many middle eastern scientists during

15264-417: The monitoring of the risk-benefit profile of drugs. Other key activities within the area of risk management are that of the compilation of risk management plans (RMPs) and aggregate reports such as the Periodic Safety Update Report (PSUR), Periodic Benefit-Risk Evaluation Report (PBRER), and the Development Safety Update Report (DSUR). One of the most important, and challenging, problems in pharmacovigilance

15408-499: The most valuable Islamic works on pharmacology, entitled Kitab al-Saydalah ( The Book of Drugs ), in which he detailed the properties of drugs and outlined the role of pharmacy and the functions and duties of the pharmacist. Avicenna , too, described no less than 700 preparations, their properties, modes of action, and their indications. He devoted in fact a whole volume to simple drugs in The Canon of Medicine . Of great impact were also

15552-417: The other criteria. Events such as cancer might always be considered serious, whereas liver disease, depending on its Common Terminology Criteria for Adverse Events (CTCAE) grade—Grades 1 or 2 are generally considered non-serious and Grades 3-5 may be considered serious. This refers to individual case safety reports that involve a serious and unlisted event (an event not described in the drug's labeling) that

15696-616: The other hand, is the broader application of genomic technologies to new drug discovery and further characterization of older drugs. The following organizations play a key collaborative role in the global oversight of pharmacovigilance. The principle of international collaboration in the field of pharmacovigilance is the basis for the WHO Programme for International Drug Monitoring, through which over 150 member nations have systems in place that encourage healthcare personnel to record and report adverse effects of drugs in their patients. These reports are assessed locally and may lead to action within

15840-428: The other three elements. Although uncommon, it is not unheard of for fictitious adverse event "cases" to be reported to a company by an anonymous individual (or on behalf of an anonymous patient, disgruntled employee, or former employee) trying to damage the company's reputation or a company's product. In these and all other situations, the source of the report should be ascertained (if possible). But anonymous reporting

15984-505: The patient went into cardiac arrest following the MI. Defining what constitutes hospitalization can be problematic as well. Although typically straightforward, it's possible for a hospitalization to occur even if the events being treated are not serious. By the same token, serious events may be treated without hospitalization, such as the treatment of anaphylaxis may be successfully performed with epinephrine. Significant disability and incapacity, as

16128-420: The patient. The review process often involves an evaluation of the appropriateness of drug therapy (e.g., drug choice, dose, route, frequency, and duration of therapy) and its efficacy. Research shows that pharmacist led strategies reduce errors related to medication use. The pharmacist must also consider potential drug interactions, adverse drug reactions, and patient drug allergies while they design and initiate

16272-468: The pharmaceutical sciences as well. The European Medicines Agency defines terms in its Guideline on good pharmacovigilance practices (GVP): The activity that is most commonly associated with pharmacovigilance (PV), and which consumes a significant number of resources for drug regulatory authorities (or similar government agencies) and drug safety departments in pharmaceutical companies, is that of adverse event reporting. Adverse event (AE) reporting involves

16416-707: The pharmacy there dates back to 1221. In Trier (Germany), the Löwen-Apotheke is in operation since 1241, the oldest pharmacy in Europe in continuous operation. In Dubrovnik (Croatia), a pharmacy that first opened in 1317 is located inside the Franciscan monastery: it is the 2nd oldest pharmacy in Europe that is still operating. In the Town Hall Square of Tallinn (Estonia), there is a pharmacy dating from at least 1422. The medieval Esteve Pharmacy , located in Llívia ,

16560-671: The pharmerging nations are as follows. In India, the PV regulatory authority is the Indian Pharmacopoeia Commission, with a National Coordination Centre under the Pharmacovigilance Program of India, in the Ministry of Health and Family Welfare. Scientists working on pharmacovigilance share their experiences, findings, innovative ideas and researches during the annual meeting of Society of Pharmacovigilance, India . In Egypt, PV

16704-984: The power to facilitate greater consistency across countries". For simplicity, and per sources, 17 smaller economies are discussed alongside the 4 pharmemerging large economies of Argentina, Brazil, Mexico and Venezuela—Bolivia, Chile, Colombia, Costa Rica, Cuba, Dominican Republic, Ecuador, El Salvador, Guatemala, Haiti, Honduras, Nicaragua, Panama, Paraguay, Peru, Suriname, and Uruguay. As of June 2012, 16 of this total of 21 countries have systems for immediate reporting and 9 have systems for periodic reporting of adverse events for on-market agents, while 10 and 8, respectively, have systems for immediate and periodic reporting of adverse events during clinical trials; most of these have PV requirements that rank as "high or medium...in line with international standards" ( ibid. ). The WHO's Pan American Network for Drug Regulatory Harmonization seeks to assist Latin American countries in develop harmonized PV regulations. Some further PV regulatory examples from

16848-538: The pre- Heian Imperial court were established; and this organizational structure remained largely intact until the Meiji Restoration (1868). In this highly stable hierarchy, the pharmacists—and even pharmacist assistants—were assigned status superior to all others in health-related fields such as physicians and acupuncturists. In the Imperial household, the pharmacist was even ranked above the two personal physicians of

16992-446: The premises of the hospital. Hospital pharmacies usually stock a larger range of medications, including more specialized medications, than would be feasible in the community setting. Most hospital medications are unit-dose, or a single dose of medicine. Hospital pharmacists and trained pharmacy technicians compound sterile products for patients including total parenteral nutrition (TPN), and other medications are given intravenously. That

17136-466: The preparation of medicines by sublimation and distillation . His Liber servitoris is of particular interest, as it provides the reader with recipes and explains how to prepare the "simples" from which were compounded the complex drugs then generally used. Sabur Ibn Sahl (d 869), was, however, the first physician to record his findings in a pharmacopoeia , describing a large variety of drugs and remedies for ailments. Al-Biruni (973–1050) wrote one of

17280-411: The prescribing habits of groups of doctors, or involving pharmacists in reporting. All of these generate potentially useful information. Such intensive schemes, however, tend to be the exception. A number of countries have reporting requirements or reporting systems specific to vaccine-related events. Risk management is the discipline within pharmacovigilance that is responsible for signal detection and

17424-753: The primary health professionals who optimize the use of medication for the benefit of the patients. An establishment in which pharmacy (in the first sense) is practiced is called a pharmacy (this term is more common in the United States) or chemists (which is more common in Great Britain, though pharmacy is also used). In the United States and Canada, drugstores commonly sell medicines, as well as miscellaneous items such as confectionery , cosmetics , office supplies , toys , hair care products and magazines , and occasionally refreshments and groceries. In its investigation of herbal and chemical ingredients,

17568-574: The process of evaluating the Pfizer–BioNTech COVID-19 vaccine in December 2020, the EMA suffered a cyberattack , resulting in the leak of classified regulatory documents to journalists, academics and the public via the dark web . The documents revealed internal concerns about low production quality in the mRNA vaccine candidate, and regulators' efforts to have Pfizer and BioNTech rectify these deficiencies. The EMA ultimately authorized

17712-409: The quality use of medicines. Pharmacists may also be small business proprietors, owning the pharmacy in which they practice. Since pharmacists know about the mode of action of a particular drug, and its metabolism and physiological effects on the human body in great detail, they play an important role in optimization of drug treatment for an individual. Pharmacists are represented internationally by

17856-401: The receipt, triage, data entry, assessment, distribution, reporting (if appropriate), and archiving of AE data and documentation. The source of AE reports may include: spontaneous reports from healthcare professionals or patients (or other intermediaries); solicited reports from patient support programs; reports from clinical or post-marketing studies; reports from literature sources; reports from

18000-446: The role of counseling patients on the proper use of their medications. Some states have a legally mandated pharmacist-to-pharmacy technician ratio . Dispensing assistants are commonly referred to as "dispensers" and in community pharmacies perform largely the same tasks as a pharmacy technician. They work under the supervision of pharmacists and are involved in preparing (dispensing and labelling) medicines for provision to patients. In

18144-636: The safe and proper use of medicines, in all countries. It was established in 1992 as the European Society of Pharmacovigilance. Society of Pharmacovigilance, India , also established in 1992, is partner member of the International Society of Pharmacovigilance. Other local societies include the Boston Society of Pharmacovigilance Physicians. Drug regulatory authorities play a key role in national or regional oversight of pharmacovigilance. Some of

18288-423: The same characteristics as the trial group – age, gender, state of health, ethnic origin, and so on though target clinical populations are typically very different from trial populations with respect to such characteristics. The variables in a clinical trial are specified and controlled, but a clinical trial can never tell you the whole story of the effects of a drug in all situations. In fact, nothing could tell you

18432-402: The seriousness of the events, but in general probably less than 10% (some studies suggest less than 5%) of all adverse events that occur are actually reported. The rule-of-thumb is that on a scale of 0 to 10, with 0 being least likely to be reported and 10 being the most likely to be reported, an uncomplicated non-serious event such as a mild headache will be closer to a "0" on this scale, whereas

18576-408: The statistical measure crosses an arbitrarily set threshold, a signal is declared for a given drug associated with a given adverse event. All signals deemed worthy of investigation, require further analysis using all available data in an attempt to confirm or refute the signal. If the analysis is inconclusive, additional data may be needed such as a post-marketing observational trial. Signal detection

18720-570: The subsequent vote (thirteen votes each), after which a drawing of lots identified Amsterdam as the host city of EMA. EMA staff left its London premises in March 2019 to relocate to a temporary building in Amsterdam, and by January 2020 the relocation to the permanent building in Amsterdam Zuidas district was finalised. The EMA played a significant role in the response to the COVID-19 pandemic in

18864-599: The time to specialize in their expert field as medication consultants spending more time working with patients and in research. Pharmacy technicians are registered with the General Pharmaceutical Council (GPhC). The GPhC is the regulator of pharmacists, pharmacy technicians, and pharmacy premises. In the US, pharmacy technicians perform their duties under the supervision of pharmacists. Although they may perform, under supervision, most dispensing, compounding and other tasks, they are not generally allowed to perform

19008-450: The two disciplines. Pharmacogenetics is generally regarded as the study or clinical testing of genetic variation that gives rise to differing responses to drugs, including adverse drug reactions. It is hoped that pharmacogenetics will eventually provide information as to which genetic profiles in patients will place those patients at greatest risk, or provide the greatest benefit, for using a particular drug or drugs. Pharmacogenomics , on

19152-428: The use of a drug and how they are being handled (warning on drug label or on packet inserts of possible side effects which if observed should cause the patient to inform/see his physician and/or pharmacist and/or the manufacturer of the drug and/or the FDA , European Medicines Agency. The overall goal of a risk management plan is to assure a positive risk-benefit profile once the drug is (has been) marketed. The document

19296-420: The vaccine on 21 December 2020, satisfied that the product quality was "sufficiently consistent and acceptable." As of 2016, the EMA was roughly parallel to the drug part of the U.S. Food and Drug Administration (FDA), but without centralisation . The timetable for product approval via the EMA's centralised procedure of 210 days compares well with the average of 500 days taken by the FDA in 2008 to evaluate

19440-424: The whole story, but a clinical trial must tell you enough; "enough" being determined by legislation and by contemporary judgements about the acceptable balance of benefit and harm. Ultimately, when a drug is marketed it may be used in patient populations that were not studied during clinical trials (children, the elderly, pregnant women, patients with co-morbidities not found in the clinical trial population, etc.) and

19584-423: The work of existing national medicine regulatory bodies. The hope was that this plan would not only reduce the €350 million annual cost drug companies incurred by having to win separate approvals from each member state but also that it would eliminate the protectionist tendencies of sovereign states unwilling to approve new drugs that might compete with those already produced by domestic drug companies. The EMA

19728-429: The work of pharmacists and other health professionals by performing a variety of pharmacy-related functions, including dispensing prescription drugs and other medical devices to patients and instructing on their use. They may also perform administrative duties in pharmaceutical practice, such as reviewing prescription requests with medic's offices and insurance companies to ensure correct medications are provided and payment

19872-468: The work of the apothecary may be regarded as a precursor of the modern sciences of chemistry and pharmacology , prior to the formulation of the scientific method . The field of pharmacy can generally be divided into various disciplines: The boundaries between these disciplines and with other sciences, such as biochemistry, are not always clear-cut. Often, collaborative teams from various disciplines (pharmacists and other scientists) work together toward

20016-535: The works by al-Maridini of Baghdad and Cairo , and Ibn al-Wafid (1008–1074), both of which were printed in Latin more than fifty times, appearing as De Medicinis universalibus et particularibus by ' Mesue ' the younger, and the Medicamentis simplicibus by ' Abenguefit '. Peter of Abano (1250–1316) translated and added a supplement to the work of al-Maridini under the title De Veneris . Al-Muwaffaq's contributions in

20160-404: The world adverse event reports are submitted electronically using a defined message standard. One of the major weaknesses of spontaneous reporting is that of under-reporting, where, unlike in clinical trials, less than 100% of those adverse events occurring are reported. Further complicating the assessment of adverse events, AE reporting behavior varies greatly between countries and in relation to

20304-745: The world, with its activities overseen by the Steering Committee overseeing harmonization activities. Established in 1990, each of its six co-sponsors—the EU, the European Federation of Pharmaceutical Industries and Associations, Japan's Ministry of Health, Labor and Welfare, the Japanese Pharmaceutical Manufacturers Association, the U.S. Food and Drug Administration (FDA), and the Pharmaceutical Research and Manufacturers of America (PhRMA)—have two seats on

20448-635: Was being hit by a hammer" [Verbatim 1] when taking Drug X. Or, Patient 2 may report that they had experienced a "slight, throbbing headache that occurred daily at about two in the afternoon" [Verbatim 2] while taking Drug Y. Neither Verbatim 1 nor Verbatim 2 will exactly match a code in the MedDRA coding dictionary. However, both quotes describe different manifestations of a headache. As a result, in this example both quotes would be coded as PT Headache (PT = Preferred Term in MedDRA). Although somewhat intuitive, there are

20592-473: Was founded after more than seven years of negotiations among EU governments and replaced the Committee for Proprietary Medicinal Products and the Committee for Veterinary Medicinal Products, though both of these were reborn as the core scientific advisory committees. The agency was located in London prior to the United Kingdom's vote for withdrawal from the European Union , relocating to Amsterdam in March 2019. The European Medicines Agency (EMA) operates as

20736-445: Was that this plan would not only reduce the €350 million annual cost drug companies incurred by having to win separate approvals from each member state but also that it would eliminate the protectionist tendencies of Sovereign states unwilling to approve new drugs that might compete with those already produced by domestic drug companies. The EMA was founded after more than seven years of negotiations among EU governments and replaced

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