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The history of phamaceutical compounding flashcard

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The profession of pharmacy was founded in the art and science of compounding medications. The beginning of compounding dates back to medieval times with priests, monks, and medicine men. Specialization first occurred in the early 9th century in the civilized world around Baghdad. Over time it gradually spread to Europe as alchemy evolved into chemistry as doctors began to abandon beliefs that were not demonstrable in the physical world. During this time, doctors began prescribing medications to patients. Pharmacists then began compounding these prescriptions and producing them in mass quantities for general sale. It was not until the 19th century that there was a distinct difference between the pharmacist as a compounder of medications and the physician as the therapist. In the 1930s and 1940s, approximately 60 percent of all medications dispensed were compounded. Then in the 1950s and 1960s, with the creation of commercial drug manufacturers, compounding declined. It was during this time that a pharmacist, known as a compounder or apothecary, became known as a dispenser of manufactured drugs. In the 1980s and now in the 1990s, patients and doctors are realizing the need for specific doses and customized medications.

Today, almost 43, 000 compounded dosage forms are dispensed each day. In the 1990s, even with the popularity of compounding growing again only a few pharmacists can be known as a compounder or apothecary, because this technique was forgotten by most. The Evolution of the Word “ Pharmacy” It is from this evolution of a pharmacist being the maker and compounder of medications that the word pharmacy is defined. The word pharmacy is defined as “ the art of preparing and dispensing drugs or a place where drugs are sold; a drugstore.” The word pharmacy originates from the Greek word pharmakon or remedy. There has been some arguments that the word pharmacy came from the Egyptian term ph-ar-maki or the bestower of security, which the god Thoth, patron of physicians, conferred as approbation on a ferryman who had managed a safe crossing. However, the word pharmacy and its many cognates derived, like many of the other scientific terms, most likely originates from the Greeks. It is impossible to put a exact date when the word pharmacy originated since people were practicing medicine before the word even existed.

Priests and Doctors in the medieval times were combining different ingredients or compounding, but was it called compounding, we are not sure. The Artisans of Mesopotamia, Egypt, and China were the first known people to actually carry out chemical processes. Most of these people worked in the temples and palaces, making luxury goods for priests and nobles. Priests also speculated on all the changes that were going on in the world about them. Their theories often involved magic. However, some of these theories are now considered chemical. Greeks Think Scientifically The Greeks were the first culture to think scientifically and not just rely on myths to explain occurrences. This began during the time of Thales about 600 B. C. Thales believed that all matter was derived from water, which could evaporate into the air or dissolve into the earth. His successors expanded on this theory and came up with the idea of the four elements that composed the earth: earth, water, air, and fire.

With this scientific break through, others like Democritus thought these elements were composed of atoms with minute particles moving in a vacuum. Aristotle believed that the elements formed a continuum of mass and therefore a vacuum could not exist. Slowly, the atomic idea was lost by the Greeks, but it was revived in the Renaissance once again. Today, the modern pharmacist deals with more complex pharmaceutical remedies than the elixirs, spirits, and powders described in the Pharmacopoeia of London (1618) and the Pharmacopoeia of Paris (1639). Today, all major medicines which are considered having the greatest therapeutic value have to be passed by the Pharmacopoeia of the United States. The Pharmacopoeia of the United States was first published in 1820 by a Committee on Revision.

This Committee was represented by all colleges of medicine, all colleges of pharmacy, all state medical associations, all state pharmaceutical associations and the surgeon general. After the drugs are chosen, the standards for quality and potency are formulated by the pharmacists and pharmaceutical chemists. Other drugs that are considered to have less therapeutic value are analyzed by the National Formulary. These less therapeutic value drugs are then published by the American pharmaceutical Association which was founded in 1852. They have been published since 1888. If their is any significant variation from the pharmacopoeia and formulary standards, the violator may be prosecuted by the Food and Drug Administration under the Pure Food, Drug and Cosmetic Acts. The word “ Pharmacy” began to develop as a profession separate from medicine in the early 18th century. In 1821, the first U. S. school of pharmacy was established in Philadelphia. Since then, the community pharmacist, or druggist, is increasingly called upon to give advice in matters of health and hygiene.

The advise they are now called on to give to their patients and doctors are drug action, the use of drugs in treating certain diseases and drug-induced side effects. Neighborhood Compounding Pharmacy The Industrial Revolution had a major effect on how the art of Pharmacy was practiced. The making of medications by hand almost became extinct when scientific developments through the use of machines developed. Phytochemistry and synthetic chemistry created new derivatives of old drugs and new chemical entities of medicinal value that strained the capacity of the individual pharmacy. The result of the Industrial revolution was Pharmaceutical Companies. These companies were founded to manufacture drugs in mass quantities. Pharmacies then worked with companies such as G. D. Searle, which by the late 1880s listed 400 fluid extracts, 150 elixirs, 100 syrups, 75 powdered extracts and 25 tinctures and other drug forms.

With the increase number of pharmaceutical companies being formed patents were created during the industrial revolution. The industrialization of the medical industry had an impact in every aspect in the medical community. First, it led to the creation of new drugs. These new drugs could not be created by pharmacists because they did not have the resources to create them. Second, drugs that could be made by the local pharmacist could be made in a more economical manner by the larger companies in a purer form. Third, pharmaceutical companies assumed responsibility for the quality of the medication they were producing. Finally, it opened the market to more competition from merchants and grocers that pharmacies had not occurred before.

During the Industrial Revolution and the nineteenth century, the art of compounding was not dead, although the number of pharmacists practicing it declined. It has been estimated that eighty percent of the prescriptions dispensed in the 1920s required a broad knowledge of compounding. During this time, however, pharmacists increasingly relied on the purchase of chemicals from manufacturers in order to fill these prescriptions. Pharmacists still spread their own plasters, prepared pills, powders, and made up medicated waters. They also frequently combined a single dosage from several medicines that today would be written and dispensed as separate prescriptions. During this time period, pharmacists were also called upon to provide first aid and medications for common ailments such as burns, frostbite, flesh wounds, poisoning constipation, and diarrhea. Therefore, they still maintained a prescription laboratory, but also carried the pharmaceutical companies medications as well. Twentieth Century Pharmacist The virtual disappearance of the preparation and compounding medicines is the most notable change in pharmacy in modern times. In the 1920s, over 80 percent of the prescriptions filled in American Pharmacies required a knowledge of compounding. However, in the 1970s only one percent or less combined two or more active ingredients.

Another change that has occurred is what the pharmacist now actually knows. Most pharmacists now only know the facts such as the shelf life of the medication, the effect on the drug when exposed to light, and the reliability and reputations of the manufacturer. When in the past, all pharmacists were committed to maintaining the quality of drugs dispensed. All of these changes meant that the pharmacists education and activities had to undergo changes as well. The scientific education of the pharmacist increased and therefore more demanding. Also, their role in the provision of health care was becoming more and more circumscribed. Moreover, they were increasingly subject to government and institutional requirements that diminished the importance of the patient-pharmacist relationships. Also, they were under heavy competition from chain and department stores which demeaned both the role and the dignity of the pharmacist as a health-care professional. The reaction to these changes was the increasing number of students that changed from community pharmacy to other areas of pharmacy.

In 1947, about 90 percent of graduates planned to go into some aspect of community pharmacy; in 1973 only 76. 6 percent and in 1988 only 57. 1 percent. Today, custom compounding pharmacies are on the rise. Medical institutions, doctors, and veterinarians realize more than ever the importance of tailoring an individuals medications to meet their unique needs. This has allowed many pharmacists to once again look out for the well being of the patient and go back to the roots of practicing pharmacy. Finally, it has also allowed the pharmacist to enter the search for new drugs and innovations that have been rapidly attaching themselves to the medical industry. Philosophy Traditionally, the pharmacist’s role has been that of a dispenser of medications. However, this traditional method of practice is no longer adequate to ensure safety and effectiveness in the use of medications and health devices. The focus of practice must change from one of product distribution to a more expansive duty; assuming the responsibility for our patients’ outcomes from the medications we dispense.

Health care reform has put an emphasis on primary health care. This emphasis coupled with a lack of access, increasingly rising costs, and a concern for quality is placing the pharmacist in an important role as a member of the primary health care delivery team. Pharmacies are located in most rural communities and throughout inner cities and urban sprawl across the country. This physical placement of the pharmacist, who is trained in delivering comprehensive care to the public, allows access to primary health care where it is critically lacking. The role of the pharmacist as a member of the primary health care team does not replace the physician, physician assistant or nurse practitioner, but enhances their effectiveness. The pharmaceutical services provided in this changing arena will include participating in the drug therapy decision process through recommending therapeutic objectives, selecting the most appropriate drug product to achieve the desired therapeutic outcomes given the patient’s unique characteristics, determining dose and dosage schedule, selecting the drug product source of supply and drug preparation, and monitoring the patient’s response to the therapy so that the patient receives the optimal benefits with minimal adverse drug effects.

Newer roles for pharmacists as therapeutic managers of patients, including prescribing of legend medications pursuant to a physician’s written protocol, are being established by advanced trained pharmacists About the Profession of Pharmacy Pharmacy has taken on a bigger role in patient outcome compared to the days of only preparation and dispensing of medicine. Today’s pharmacist are more involved in communicating with the patient about their medication, monitoring of drug therapy, and community education of medication and medical supplies. The communication between the pharmacist and the patient allows for better patient understanding, compliance, and outcome. The pharmacist is committed in giving the patient a understandable view about their medication. Teaching a patient about their medication may involve a one-on-one consultation between the pharmacist and the patient. In this consultation the pharmacist will discuss the role of the medication in the patients treatment and patient feedback is encouraged. As the patient gains a better understanding of their medication, the role of compliance will be strongly followed.

Many pharmacies are supplying patient information through computer leaflets which gives information about a particular medicine or videotapes on a particular condition and drug compliance. With the patient having the understanding of their condition by their physician and the understanding of their medication by their pharmacist. An informed patient will have a higher percentage of recovery in their treatment. The pharmacist is frequently interacting with health care professionals in regard to drug therapy of patients. This may involve placing calls to physicians to clarify or discuss possible interactions in the patients drug therapy. One area of importance is the role of over-the-counter medication in the patients drug therapy. The pharmacist is asked questions daily in regard to interactions between prescription and nonprescription medication. A proper drug profile of a patient is essential in drug therapy. This profile consists of the patient filling out a drug/medical profile sheet that is supplied by the pharmacy.

The profile sheet will ask questions in regard to prescription history, disease state, allergies, nonprescription history, age, date of birth, sex, address, name of physician, and insurance information. The profile provides the pharmacist the information in detecting and counseling the patients progress to the physician and the patient. More pharmacists are becoming involved in community education. This education may be seen through the areas of public speaking, on-line computer systems and publications. Many pharmacist are speaking to community organizations, schools, and retirement villages about various topics such as poison prevention, drug abuse, or nonprescription medication. On-line systems allow any person who has a question or is interested in pharmacy to use their computer system to find out information in regard to medication, medical equipment, Medicare, or to ask the pharmacist a question. Various community newspapers run articles where a pharmacist will answer a question that a person may have or discuss new prescription and nonprescription medication.

Today’s profession of pharmacy has the opportunity to have a major impact on therapy and to make the patient comfortable with their drug treatment. The Pharmacist in Society Pharmacists offer their professional service in many different areas of practice that include community, hospital, pharmaceutical industry, medical drug firms representation, and academic activities. Their specialised knowledge regarding the management and properties of medicines brings pharmacists close to prescribing doctors and patients. Their role is to ensure optimum drug therapy both by contributing to the preparation, promotion, supply and control of medicines and by providing information and advice to both the prescriber and the user of pharmaceutical products Pharmacist General Summary Monitors and dispenses pharmaceuticals to patients, physicians offices, clinics, or other designated sites. Provides clinical support to management and sales staff.

Job Responsibilities and Performance Objectives 1. Dispenses blood factor concentrate, ancillary supplies, biotech drugs, other pharmaceuticals, and other related items for disease management of patients with chronic health problems. 2. Develops and maintains policies and procedures, product information brochures and other data for distribution to appropriate people in organization. 3. Keeps abreast of latest development concerning new therapies, technologies, or developments reported from current medical and pharmacy literature regarding biotech drug therapy and disease management. 4. Checks pharmacy stock on a regular basis to insure inventory management is meeting our company goals in the areas of DIOH (days inventory on hand), escess no-move, outdated and other areas identified. Ensures that stock is maintained in accordance with manufacturer requirements. 5. Advises and corresponds with patients/families, physicians, and sales staff on various medications including dosage, side effects, etc. 6. Prepares, updates, and maintains patient chards and required reports, as needed for physician and pharmacy review.

7. Maintains and prepares “ pharmacy law” files on states in which company is doing business and assures compliance. 8. Monitors pharmacy activities to ensure compliance with applicable state and federal laws and regulations. 9. Performs other related duties as assigned or requested. Job Qualifications Minimum EducationUndergraduate degreeLicenses and CertificationsCurrent professional liscensure in state of practice DEA (licensed to dispense controlled substances) Registered PharmacistMinimum Experience1 year up to 2 yearsPreferred Field-of-ExpertiseHome infusion, consultantDecision MakingAppropriate dosage, stability of drug, stocking of drugs and solutions, inventory, purchasingSkills: AdministrativeAnalyze data Compose letters/memorandums Input data into computer programs Maintain patient charts Negotiation Research information Skills: MachineCRT (Mainframe) Calculator Personal Computer Contact with OthersPatients/families, physicians, nurses, sales representatives. Working ConditionsExposure to chemicals Open office environment Visual concentration on computer screens Bending or reaching Lifting between 10 and 25 pounds Pharmacy is a specialised profession requiring graduate level qualifications and is concerned with researching and development of drugs, their preparation, dispensing, eventual use and their action on the human body.

Pharmacists have to master the chemical, physical and biological properties of substances employed in drugs and how they can be put to optimum use. They must also understand how the human body functions in health and sickness and how it reacts to different medicines. The practice of pharmacy then entails a detailed knowledge of classification, selection, analysis and standardisation, pharmacological effect, toxicity, combination and preservation of drugs. The pharmacist is an expert on medicines, a custodian of drugs and an authority on poisons, and is vitally involved in the spectacular advances in the quality of life in recent years. Pharmacists are involved in :- providing drug information and patient counselling on proper use of prescription and non-prescription drugs patient profile monitoring to detect possible drug allergies, interactions and or potential problems related to drug therapy. purchasing, proper storage and handling of drugs observing accepted ethical and professional standards and all legal requirement including regulations for narcotic and controlled drugs and compounding special drug products which are not pre-manufactured There are three main categories of work available to qualified pharmacists.

Community Pharmacist

Community Pharmacy is the largest branch of the profession and involves a qualified pharmacist working in a retail environment. The main duties of a community pharmacist are to prepare and dispense drugs on prescription to the general public with professional responsibility although there is now a trend towards pre-packaged and prepared medicines. Prescriptions, dosages and labels must be checked with meticulous care and accuracy and legality. A pharmacist may give advice to customers on how to use prescribed drugs and ensure that customers realise when prescriptions should not be taken in combination with alcohol, certain foods or with other medications. They also provide information on the sale of over- the- counter medicines and general health care issues. If a patient’s condition so warrants or the prescribed dosage unusual then a pharmacist may need to refer to the doctor or dentist. The community pharmacists is in close personal contact with the public. They also oversee stock control, stock rotation and purchasing. Records must be strictly maintained such as the Poisons Register and use is increasingly made of computer technologies to control patient records and drug information databases.

Pharmacists normally undertake the supervision and training of technicians. It is unlawful for a pharmacy to operate without the presence of a qualified pharmacists. A community is also likely to be a business manager with basic accounting and management skills and must run a chemist shop efficiently and profitably. Most sell a wide range of products including non pharmaceuticals such as toiletries, cosmetics and vitamins. The work therefore includes financial management, merchandising and responsibility for staff and premises. Hospital Pharmacists The hospital pharmacy leads a team of specially trained pharmacy assistants providing an essential component of professional health service within the hospital environment and without becoming involved in the commercial aspect be it in the Government of private. He works in close association with allied medical staff ensuring the best patient health care. Hospital pharmacy service encompasses small scale manufacturing and dispensing of drugs, preparation of pharmaceuticals for hospital patients and the provision of drug information and consultative services especially on drug utilisation to the medical, nursing and other staff.

In general hospitals the pharmacist is also responsible for the meticulous preparation of sterile intravenous and related injectable products. Apart from these he is also responsible for standards, storage, distribution and supply of drugs surgical and other hospital supplies. He will at times be involved in projects which serve to evaluate the appropriateness and effectiveness of drug use to better compliance. In some hospitals, the pharmacist is called upon to give basic lectures on pharmacy and pharmacology to paramedics and participate in ward consultation as well as medical conferences. He is also required to serve in many drug and therapeutic committees, being the resource person in this area of study. Hospital pharmacy in Malaysia is increasingly becoming clinically oriented. In short, hospital pharmacy offers a breath of professional experience that for many pharmacists make it a branch of the profession matched by no other. Industrial Pharmacist Industrial pharmacists are concerned with researching and developing pharmaceutical products.

There are many areas in which an industrial pharmacist can specialise. One such field is clinical trials, where drugs are tested for safety and effectiveness with the co-operation of volunteers and patients. Another branch is production where medicines and drugs are manufactured, packed, stored or delivered. Other areas are research and development, marketing and quality assurance. Industrial pharmacists ensure that the laws controlling medicines are complied with. Others work as medical representatives and provide the link between the manufacturers on the one hand and doctors and pharmacists on the other. Medical representatives must have a thorough technical knowledge of the products they sell and be able to judge market reactions, budget for stock requirements and participate in general administration. Other settings in this field are consultant pharmacists who work in administrative positions in government or business.

Education pharmacists may combine research and teaching with administrative activities. Pharmacists should be interested in science, health and medicine and capable of degree level study. They have considerable responsibility and must work carefully and accurately. They should be observant, capable of clear logical thought when carrying out laboratory tasks and medical supplies and be prepared to keep abreast with new advances in the pharmaceutical sciences. They need an inquiring mind, good powers of concentration, be methodical, well organised, patient and persistent. Pharmacists with staff responsibility must have effective management skills and the ability to supervise and delegate work to subordinate staff. In retailing, pharmacists need business acumen.

Pharmacists dealing with the public or patients must have a caring and sympathetic manner, a friendly personality and excellent communication skills. Other attributes include – interest in providing a service to people; able to work as a member of a team; accurate attention to detail; a high degree of integrity; precise work habits; independence; decision making skills; and high ethical standards. The personal qualities required for success in pharmacy depend to some extent on the branch of the profession in which it is intended to practise. Pharmacy is a multi faceted science based discipline and the entry requirements for a course leading to a degree in Pharmacy at the Universiti Sains Malaysia, the only local institution currently offering such a course in Malaysia reflect this. Currently, degrees granted by certain overseas universities in Australia, Saudi Arabia, Canada, Japan, Indonesia, Iraq, New Zealand, Egypt, Singapore, USA, United Kingdom, Turkey, India, Pakistan and Ireland are recognised for registration purposes. In the case of some of these, registration is on fulfillment of certain extra criteria.

With regard to the accredited foreign universities, contact: The Secretary, Pharmacy Board, Bangunan MMA, 1st Floor, Jalan Pahang, 53000 Kuala Lumpur. Pharmacy graduates from some of these institutions may be required to do an extra year of housemanship followed by a year’s service with the Ministry of Health as a provisionally registered pharmacist. Other’s must serve a year’s housemanship and pass an examination in practical pharmaceutics. A local forensic pharmacy examination may be necessary in all cases. After passing an examination on local Forensic Pharmacy and satisfactorily completing the housemanship the pupil will be eligible for registration with the Pharmacy Board to practice as a registered pharmacist in Malaysia. A pharmacy degree offers excellent employment prospects given the present steady demand in Malaysia. Factors likely to spur demand for pharmacists through the mid 1990’s include scientific advances that have made a wider range of drug products available for preventive and therapeutic uses and the widespread availability of health insurance cover which generally pays for prescription drugs, among other things.

Demand for pharmacists will be further stimulated by population growth and the ageing of the population. As in most other occupations the majority of job openings will result from the need to replace pharmacists who leave the profession. In pharmacy this generally means retirement for like doctors and dentists they tend to remain in the job until they retire. Relatively few transfer to other lines of work. After graduation pharmacists enter community practice at a basic level. Promotion prospects are excellent in larger chemist shops and may lead to regional management. Some pharmacists may wish to run their own establishment although this requires capital. Pharmacists also work for : health care and facilities; pharmaceutical companies; government (public health units, food and drug inspection services, law enforcement, laboratories); universities in teaching and research positions; and provincial regulatory bodies

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