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VO TRUONG TOAN UNIVERSITY PHARMACY DEPARTMENT  SUBJECT ENGLISH FOR THE PHARMACY STUDENT A self-study reference and practice book for intermediate learners designed to develop a language competence required in pharmacy-related studies and professions DEPARTMENT: PHARMACY DEPARTMENT Hau Giang – 2015 SUBJECT OUTLINE: LESSONS PAGE UNIT 1: Pharmacy and Pharmacists - What the field of science is concerned with - The scope of pharmacy - Traditional and modern services - Trained-related fields of pharmacists - Traditional and modern roles - British English and American English to define pharmacies and pharmacists UNIT 2: Pharmacology - Pharmacology and pharmacy: o What the field includes o Difference between Pharmacology and pharmacy o Sub disciplines included - Scientific background: o Pharmacokinetics and Pharmacodynamics o Pharmacokinetics: LADME UNIT 3: Types of drugs - Definition of a drug: o Difference between endogenous and exogenous biochemical, drugs and hormones - Recreational drug: definition, use and effects, prohibition and restriction - Medicinal drugs: o Definitions, dispensing and administering methods o OTC, BTC, POM medicines o Patented and generic medicines UNIT 4: Terminology of drug action (1) - Drug use, drug misuse, Tolerance, Addiction, Withdrawal symptoms, Stimulants, Depressants 11 UNIT 5: Terminology of drug action (2) - Cross tolerance and cross dependence - Potentiation, Additive effect, Antagonism, Hypersensitivity, Side effects 13 UNIT 6: FDA and EMEA - Medicine development and testing: the USA and EU regulating bodies - FDA: functions and responsibilities, testing process - EMEA: functions, mission, advantages for EU patients 15 UNIT 7: OTC pain relievers - Common types of OTC medicines: A Pain relievers, B Antihistamines, C Decongestants, D Cough medicines - A Pain relievers, action, side effects: o NSAIDs (Aspirin, Ibuprofen, Naproxen, Ketoprofen) action and side effects 17 Teaching periods 2 2 2 2 o Acetaminophen: action and side effects UNIT 8: OTC medicines to children - Side effects with OTC medicines for special groups o Children: Acetaminophen for children’s pain relief, Ibuprofen’s side effects with children allergic to Aspirin Reye’s syndrome Cough suppressant without Codeine o Giving the right dose at the right time What every six, eight hours means, teaspoons and milliliters measurements 19 UNIT 9: OTC medicines to other groups - Elderly people: o NSAIDs possible side effects, o When to avoid Pseudoephedrine and Dextromethorphan Side effects - Pregnant and breastfeeding women: o Safe and dangerous OTC medicines o General tips 21 UNIT 10: Generic drugs - What are generic drugs? What is brand name? - International Nonproprietary Names (INN) - Generic drugs approval: what manufactures need to prove - Comparing prices between branded and generic medicines 23 UNIT 11: Branded versus generic medicines - Switching to generic: definition of generic medicines, comparison with branded ones, regulations in Italy - Why are brand name drugs more expensive? UNIT 12: Biosimilar medicines - Europe’s estimates concerning the date 2015 - Advantage of introduction of biotechnology-derived medicines - What is GMP? (Good Manufacturing Practice) - How can patients be assured of good quality? - What European pharmaceutical companies need to prove? - What are some biological active substances? - Where they originate from? - What are they used for? 25 UNIT 13: Prescription inserts - What are they? What they contain? Description, Clinical pharmacology, Indications and Usage, Contraindications, Warnings, Precautions, Adverse reactions, Drug abuse and dependence, Overdosage, ect 29 UNIT 14: Reading OTC medicine labels - Type of Antihistamine Active ingredient, uses, warnings, directions, other information, inactive ingredients 32 UNIT 15: Most common forms of medications - Tablets, Capsules, Powders, Drops, Liquids, Injectable solutions, Inhalants and spray, 34 2 2 27 2 2 - Suppository, Skin preparations (creams, ointments, lotions, pastes) TOTAL 30 SCHEDULE LECTURE Lessons Study method Pharmacy and Pharmacists Listen, take notes and discuss Teaching periods Pharmacology Listen, take notes and discuss 3 Types of drugs; Listen, take notes and discuss Listen, take notes and discuss Listen, take notes and discuss Listen, take notes and discuss Listen, take notes and discuss Listen, take notes and discuss Listen, take notes and discuss Listen, take notes and discuss Terminology of drug action (1) Terminology of drug action (1); Terminology of drug action (2) OTC pain relievers; OTC medicines to children OTC medicines to children; OTC medicines to other groups Generic drugs; Branded versus generic medicines FDA and EMEA; Biosimilar medicines Prescription inserts; Reading OTC medicine labels 10 Most common forms of medications UNIT 1: PHARMACY AND PHARMACISTS1 Pharmacy It is a multidisciplinary field of science that specializes in medicinal treatment and studies drugs2, medicines, and their development, their use and effects mainly from the point of view of natural sciences, health sciences, as well as social sciences It is the health field that links health sciences with chemical sciences, and it is charged not only with ensuring the safe use of medication, but also more modern services related to patient care, such as reviewing medications for safety and efficacy, and providing drug information Pharmacists Pharmacists have many areas of expertise and are a critical source of medical knowledge in clinics, and community pharmacies throughout the world Pharmacists are exceptionally trained in medicine-related fields including pharmacology, pharmacognosy3, chemistry, pharmaceutical chemistry, pharmacy practice (including drug interactions, medicine monitory and medicine management), pharmaceutics, pharmacy law, physiology, anatomy, biochemistry, kinetics, nephrology, hepatology, and compounding medications In their traditional role, pharmacists are health professionals trained in the art of preparing and dispensing drugs; they take medical prescriptions, dispense medications to patients and counsel them on the proper use and adverse effects of those medications One of the most important roles that pharmacists are currently taking on is one of the pharmaceutical cares, in this role, pharmacists ensure the safe and effective use of medications They may participate in disease state management in order to optimize and monitor drug therapy often in collaboration with physicians or other health professionals They may have direct responsibility for patients and their disease states, medications, and the management of each in order to improve the outcome for each individual patient Pharmacists are often the first point of contact for patients with health inquiries This means that they have large roles in assessing medication management in the primary care of patients Pharmacist, dispensing chemist, druggist Pharmacists are sometimes referred to as chemists or dispensing chemists, in British English and Australian English, or druggists in North American English In this case, they are allowed to fulfill prescriptions and usually operate in a pharmacy or chemist’s shop, usually abbreviated to “the chemist’s” in the United Kingdom, Australia and New Zealand The United States and Canada use the term drugstore or pharmacy It is possible for a shop to be a general chemist without the ability to fulfill prescriptions In such cases, only “Over the Counter” (OTC) drugs and medications may be supplied, as these not require the services of a licensed pharmacist Such shops will also usually supply a wide range of heath related goods Adapted from http://en.wikipedia.org/wiki/Pharmacy A drug is the chemical basis for the production of a medicine; a medicine is the finished product after a drug is manufactured for use as a cure, treatment or prevention of a disease This name is formed from Greek words, pharmakon, drug, gnosis, knowledge, and literally means the “entire knowledge of drugs” (distribution, cultivation, collection, selection, preparation, commerce, identification, evaluation, preservation, and use) UNIT 1: PHARMACY AND PHARMACISTS (PRACTICE) Make word combinations using a word from each box There may be various ones Monitor Provide Optimize Fulfill Dispense Compound Review Prepare Supply Assess Medications, drugs Drug information Drug therapy Prescriptions 10 Complete the grid with suitable words Verb Noun Treatment Assess Adjective Noun Responsibility Chemical Practice Provide Prescription Pharmacy Safe Efficient Dispense Practice Owner Medication Medicinal Health Answer the questions Why is pharmacy a multidisciplinary field of studies? What are the pharmacist’s two main roles? ………………………………………………………………………………………………………………… ………………………………………………………………………………………………………………… What their traditional roles consist of? ………………………………………………………………………………………………………………… ………………………………………………………………………………………………………………… What is a more modern role of pharmacists? ………………………………………………………………………………………………………………… ………………………………………………………………………………………………………………… What fields are they trained in? ………………………………………………………………………………………………………………… ………………………………………………………………………………………………………………… UNIT 2: PHARMACOLOGY Pharmacology and pharmacy Pharmacology is a chemical science which studies the properties and reactions of drug especially with relation to their therapeutic value1 If substances have medicinal properties, they are considered pharmaceutical The field includes drug composition and properties, interactions, toxicology, therapy, medical applications and antipathogenic capabilities Pharmacology is not synonymous with pharmacy, though in common usage, the two are at times confused Pharmacy is a medical science concerned with the safe and effective use of medicines while pharmacology studies how drug interact with biological systems The effect of chemicals may be beneficial (therapeutic) or harmful (toxic) The pure chemicals or mixtures may be of natural origin (plant, animal, or mineral) or may be synthetic compounds Some subdisciplines can be:  Clinical pharmacology: the medical field of medication effects on humans,  Neuro- and psychopharmacology: effects of medication on behavior and nervous system functioning,  Pharmacoepidemiology: study of effects of drugs in large numbers of people,  Toxicology: study of the effects of poisons,  Posology: how medicines are dosed Scientific background: LADME With the increasing knowledge of cell biology and biochemistry, the field of pharmacology has also changed substantially From the pharmacological point of view, a chemical has various properties: pharmacokinetics describes the effect of the body on the chemical, and pharmacodynamics describes the chemical’s effect on the body (desired or toxic) When describing the pharmacokinetics properties of a chemical, pharmacologists are often interested in LADME: an acronym which stands for liberation, absorption, distribution, metabolism and excretion It describes the deposition of a pharmaceutical compound within an organism:  Liberation: it is the release of a drug from its dosage form  Absorption: it is the movement of a drug into the bloodstream, how it is absorbed through the skin, the intestine, the oral mucosa Before a compound can exert a pharmacological effect on tissues, it has to be taken into the bloodstream, usually via mucous surfaces like the digestive tract (intestinal absorption) Factors such as poor compound solubility, chemical instability in the stomach, and inability to permeate the intestinal wall, can all reduce the extent to which a drug is absorbed after oral administration Drugs that not absorb properly when taken orally must be administered in some less desirable ways, either intravenously or by inhalation  Distribution: it is how substances spread through the organism, how they are dispersed and/or disseminated throughout the fluids and tissues of the body  Metabolism: it is the medication converted chemically inside the body Compounds begin to break down as soon as they enter the body The majority of small molecule drug metabolism is carried out in the liver As metabolism occurs, the initial (parent) compound is converted into new compounds called metabolites  Excretion: it is how the medication is eliminated It is the removal of the substances from the body Compounds and their metabolites need to be removed from the body via excretion, usually through the kidneys (urine) or in the faeces Unless excretion is completed, accumulation of foreign substances can adversely affect normal metabolism There are four ways how drug excretion occurs: kidney excretion, biliary excretion or faecal excretion and excretion through the lungs (breath) and skin It emerged as a major area in American medicine thanks to the efforts of John Abel (1857 – 1938) who stressed the importance of chemistry in medicine, did research on the endocrine glands, and became the first pharmacology professor in the U.S UNIT 2: PHARMACOLOGY (PRACTICE) A Write the correct word Choose from the ones given in the box Pharmacoepidemilogy Liberation Pharmacodynamics Distribution Pharmacokinetics Absorption Pharmacology Pharmacy Excretion Metabolism ………… .deals with how drugs interact within biological systems to affect function …………… is a medical science concerned with the safe and effective use of medicines …………… describes the effect of the body on the chemical …………… studies of effects of drugs in large numbers of people …………… describes the chemical’s desired or toxic effects on the body ………………is the release of a drug from its dosage form ………………is the movement of a drug into the bloodstream, through the skin, the intestine, the oral mucosa ………………is the dispersion or dissemination of substances throughout the fluids and tissues of the body ………………is the medication converted chemically inside the body 10 ………………is how the medication is removed from the body B1 Insert the correct preposition Out Down With From On In For to be concerned ………… to interact……………… to act…………………… to be interested………… to deal…………………… to stand………………… to break………………… to carry………………… to remove……………… B2 Complete with some of the previous verbal expressions Use the correct tense You don’t need them all Pharmacology studies how drugs …………………… the biological systems Compounds begin ………………… as soon as they enter the body Pharmacologists are often …………… the pharmacokinetic properties of a chemical LADME …………… Liberation, Absorption, Distribution, Metabolism, and Excretion Pharmacy is a medical science……………….the safe and effective use of medicines The majority of small molecule drug metabolism is ………………in the liver It has become possible to design chemicals that ……………specific cellular pathways UNIT 3: TYPES OF DRUGS Definition of Drug A drug, broadly speaking, is any substance that alters normal body functions There is no single, precise definition, as there are different meanings in medicine, government regulations, and colloquial usage In pharmacology, Dictionary.com defines a drug as “a chemical substance used in the treatment, cure, prevention, or diagnosis or otherwise used to enhance physical or mental well – being.” Drugs may be prescribed for a limited duration or on a regular basis for chronic disorders A drug may be used for medical, spiritual, or recreational purposes therefore they are distinguished into recreational drugs and medicinal drugs or medicines1 Drugs are usually distinguished from endogenous2 biochemicals such as hormones, by being introduced from outside the organism For example, insulin is called a hormone when it is synthesized by the pancreas inside the body, but if it is introduced into the body from outside, it is called a drug Many natural substances such as beers, wines, and some mushrooms, blur the line between food and drugs, since when they are ingested they affect the function of both mind and body Recreational Drugs They are psychoactive substances used to have fun, for a new experience, or to enhance an already positive experience Recreational drugs are chemical substances that affect the central nervous system, such as narcotics or hallucinogens They may be used for perceived beneficial effects on perception, consciousness, personality, and behavior Some recreational drugs can cause addiction and habituation National laws prohibit the use of many different recreational drugs and they also strictly regulate medical drugs that have the potential for recreational uses Many other recreational drugs, on the other hand, are legal, widely culturally accepted, and, at the most, have an age restriction on using and/or purchasing them These include alcohol, tobacco and caffeine products Medicinal Drugs (Medicines): Definition, Dispensing And Administering Methods A medicine is a drug used to prevent or cure diseases or to relieve pain It may be used as a preventive medicine that has future benefits but does not treat any existing diseases or symptoms The dispensing of medicines is often regulated by government into three categories:  Over – the – counter (OTC) medications which are available in pharmacies and supermarkets without special restrictions  Behind – the – counter (BTC) medications which are dispensed by a pharmacist without needing a doctor’s prescription  Prescription only medicines (POM) medications which must be prescribed by a licensed medical professional, usually a physician In the UK, BTC medicines are called pharmacy medicines which can only be sold in registered pharmacies by or under the supervision of a pharmacist However, the precise distinction between OTC and prescription drugs depends on the legal jurisdiction of each country Medicines are typically produced by pharmaceutical companies and are often patented to give the developer exclusive rights to produce them, but they can also be derived from natural substances called herbal medicines Those that are not patented (or with expired patents) are called generic drugs since they can be produced by other companies without restrictions or license from the patent holder The word medicine can also refer to the practice of disease prevention and cure (e.g., a doctor practices medicine) and the science of drugs (e.g., drug research and development), rather than medical activities such as surgery or physiotherapy The word endogenous means “arising from within”, the opposite of exogenous Endogenous substances are those that originate from within an organism, tissue, or cell UNIT 3: TYPES OF DRUGS (PRACTICE) A Complete the grid with suitable nouns or verbs Use the dictionary for help VERB NOUN Prevention VERB Addict Relieve Synthesis Introduction Ingestion Treat Perceive Distinguish Define NOUN Prohibit Existence Breath Produce B Multiple choices Fill in the spaces with a suitable connector from the grid (1) …………………… speaking, a drug is any substance that alters normal body functions, yet there isn’t only one definition (2) ……………………… the different meaning in various fields In the UK, BTC are dispensed by a pharmacist without needing a doctor’s prescription, (3) ……………………… OTC medicines are available in pharmacies and supermarkets without special restrictions (4) ……………………, the precise distinction between OTC and prescription drugs depends on individual countries’ legislation Many natural substances (5) ………………… beers, wines, and some mushrooms, can have the same effects as drugs, (6) …………………… they may affect both mind and body National laws not only impose heavy regulations on the use of recreational drugs but they (7) …… … prohibit the use of them (8) ………… many other recreational drugs, are legal, and, (9) ……………………., have an age restriction on using and/or purchasing them Some recreational drugs include, for example, tobacco and caffeine products Drugs (10)……………… medicinal ………… recreational, can be administered in a number of ways 10 Broadly Owing that While Whatever Like as For However In addition At least Both … and Largely Depending on When However Such as Since Also On the contrary At the most Either … or Widely Because of Although Whenever Among whom BUT Besides On the other hand At large Neither … nor C Red the text and answer the question How is a drug defined in pharmacology? ……………………………………………………………………………………………………………………… How can drugs be distinguished? ……………………………………………………………………………………………………………………… What is the difference between hormones and drugs? ……………………………………………………………………………………………………………………… Why are some natural substances similar to drugs? What are some of them? ……………………………………………………………………………………………………………………… What are recreational drugs? ……………………………………………………………………………………………………………………… 10 UNIT 9: OTC MEDICINES TO OTHER GROUPS Older Adults Elderly people use a number of medications at the same time and therefore needs to pay careful attention to drug – to – drug interactions between OTC medications and prescription medications Older adults should talk to their doctor about the medications they take and potential interactions with OTC medicines  There is a relatively high risk of kidney disease and GI bleeding in elderly patients who use NSAIDs  The use of Pseudo ephedrine2 can increase blood pressure and the pressure in the eyes that can lead to glaucoma It can also make existing blockages in the urinary tract worse Pseudo ephedrine interacts negatively with many other drugs such as beta – blockers, antidepressants, insulin, and some medications that treat low blood sugar  If you use a monoamine oxidase inhibitor (MAOI)3, a type of prescription antidepressant, or take any medication for a seizure disorder4, you should avoid using pseudo ephedrine Pseudo ephedrine can change the way these drugs work in your system Some common MAOIs include the following generic substances: isocarboxazide, phenelzine sulfate and tranylcypromine sulfate  If you use a MAOI, you should not use dextromethorphan5 as it interferes with the way MAOIs work Pregnant or Breastfeeding Women Pregnant or Breastfeeding women should talk to their doctor before using any medicine Some can affect the baby The followings are some general guidelines Pregnancy:  Acetaminophen is generally considered safe for short – term pain relief during pregnancy  Avoid using aspirin during pregnancy It can cause abnormalities in the baby or problems during delivery  Avoid using other NSAIDs, especially during the third trimester of pregnancy They can cause heart abnormalities in the baby Breastfeeding women:  Acetaminophen and NSAIDs such as Ibuprofen provide safe pain relief for women who are breastfeeding  Avoid using aspirin because it’s excreted in breast milk and causes rash and bleeding problems in nursing infants  Limit long – time use of antihistamines Antihistamines are excreted in breast milk, and may cause side effects such as sedation, irritability, crying, and sleep disturbances in nursing infants Antihistamines may also interfere with the production of milk General Tips These steps can help minimize the risk of side effects during pregnancy and breastfeeding:  Talk to your doctor about possible alternatives to medicine  Avoid the use of medications during the first trimester  Take oral medications after nursing or before the infant’s longest sleep period  Avoid the use of extra – strength, maximum – strength, or long – acting medications  Avoid “combination” products  Watch your infants for possible side effects such as rash, difficulty breathing, headache or other symptoms that your child didn’t have before taking the medicine A nonsteroidal anti – inflammatory drug (as ibuprofen) A crystalline alkaloid C10H15NO that is isomeric with ephedrine and is administered chiefly in the form of its hydrochloride C10H15NO.HCl or sulfate (C10H15NO)2.H2SO4 especially to relieve nasal congestion Any of various antidepressant drugs which increase the concentration of monoamines in the brain by inhibiting the action of monoamine oxidase A sudden attack (as of disease); especially: the physical manifestations (as convulsions, sensory disturbances, or loss of consciousness) resulting from abnormal electrical discharges in the brain (as in epilepsy) A nonaddictive cough suppressant that is widely used especially in the form of its hydro bromide C H NO.HBr in over – the counter 18 25 cough and cold preparations 21 UNIT 9: OTC MEDICINES TO OTHER GROUPS (PRACTICE) A Scan the text and find similar words to the following ones In the text In the text over sixty people physical or mental defectiveness raise (v) ill humor rule alleviation interrupt (v) illness hardship influence (v) B Cause and effect: When you talk about cause and effect you can either put the cause first of the effect For example Cause Taking more OTC medicines at the same time Effect causes resulting in give raise to brings about leads to drug interaction Effect Drug interaction Cause is caused by resulting from is the effect of is the result of is brought about is due to taking more OTC medicines at the same time Study the following list Items in column A are causes of items in column B but they are mixed up a match causes with their effects b link them by using a suitable linker with the modal verb “can” or “may” if necessary For each sentence there may be two solutions following the example in the previous table a Solution (match) A (cause) The use of medicines that contains the same active ingredient The use of Aspirin in children under 18 Using Pseudoephedrine together with beta – blocker, antidepressants, and insulin The use of Aspirin during pregnancy Using Aspirin while breastfeeding Antihistamines B (effect) a the risk of Reye’s syndrome b rash and bleeding problem in nursing infants c interruption with the milk production d serious health complication in young children e high blood pressure and other complications f problem in delivery or baby abnormalities 22 UNIT 10: GENERIC DRUGS What are generic drugs? When a new drug is developed, it is given a name that indicates the chemical substance of that drug This is called generic or chemical name The new drug is also given a brand name for making purposes The brand name is usually easier to say and remember than the chemical name Patients and doctors will learn to know the new drug by this brand name A well – known example of a brand name drug is Prozac (proprietary name), it’s generic or chemical name is fluoxetine hydrochloride3 Generic medicines are copies of brand name medicines with the same active ingredients Therefore, equivalent brand name and generic medicines have the same chemical name and the same therapeutic effect International Nonproprietary Names An International Nonproprietary Name (INN) is the official chemical name (nonproprietary name) given to a pharmaceutical substance as designated by the World Health Organization (WHO) The proprietary name is the brand name The intention of an INN is to ensure there is a standard name for each chemical substance across the world Occasionally, the United States and/or Britain may designate their own nonproprietary name for a particular substance, rather than adhering to the INN In such instances, the nonproprietary name may be referred to as a “United States Adopted Name” (USAN) or as a “British Approved Name” (BAN) Sometimes the USAN or the BAN can differ from the INN This is the case with the nonproprietary name for the common asthma product: Ventolin The INN and the BAN for Ventolin is Salbutamol, while the USAN is Albuterol Another example is the commonly used diuretic Lasix The INN and the USAN is furosemide, while furosemide is the nonproprietary name that the British has approved The brand name is usually written most clearly on any packaging However, you will always see the generic name written somewhere on the packet (often in small print) Some medicines only have the generic name on the packet Generic Drugs Approval The approval process for generic drugs is rigorous A company that manufactures a generic drug needs to prove that is has the same effect in the body and is manufactured according to the same high standard of its brand name counterpart before it can be registered and therefore sold to patients In order to obtain the FDA approval, generic medicines must show that they:  Contain the same active ingredients as the brand name drug (inactive ingredients may vary)  Are identical in strength, dosage, form, and route of administration  Are bio – equivalent (i.e are available to the same extent in the body when taken or administered)  Meet the same requirements for strength, purity, and quality  Are manufactured under the same strict standards of good manufacturing practice as required for brand name products Comparing prices It is common perception that more expensive equals better quality In the case of drugs, however, this is not necessarily true When a brand name drug has a generic competitor, this simply means that the brand name product has been around long enough for its patent to expire which then allows copy products (“generic”) to be made Most often generic drugs will be the cheapest when compared to their brand name counterparts There are the same requirements that exist in most developed nations, where the quality standards required for the cheapest drugs (usually generic) are as high as they are for the most expensive drugs (usually brand name products) http://www.medstoreinternational.com Brand were originally developed as label of ownership: name, term, design, symbol Today powerful brands can drive success in competitive and financial markets, and indeed become the organization’s most valuable assets An antidepressant drug that í administered in the form of its hydrochloride C 17H18F3NO.HCl and enhances serotonin activity 23 UNIT 10: GENERIC DRUGS (PRACTICE) A1 Find Verbs in the test that have the meaning, Write the infinitive form of the verb underlined Verbs in the text Meanings to guarantee, to make certain of something to end, to stop, to case, to lose validity to demonstrate, to support to dispense, distribute, to treat to be identical or equivalent to be different from to need, to necessitate, to demand to grant, to permit to agree, to accept to decide, to fix, to establish A2 Complete the sentences with a suitable verb form the grid on the left column You don’t’ need them all Manufacturing companies are ………………… to prove that generic drugs produce the same effect as their brand name counterparts The FDA ………………… companies to produce and sell generics after a rigorous approval process By using the INN, the WHO wants ……………….that there is a standard name for each chemical substance across the world Occasionally, Britain and the USA not ……………….to INN …………………by the WHO Generic drugs are often made when the brand name’s patent…………… after being around for a long time B Circle the correct alternative Broadly speaking / Strictly speaking the generic name indicates the chemical composition of a drug although / while the brand name is given by the manufacturing company for marketing purposes In addition / on the contrary the brand name is easier to remember both / either for patients and / or doctors An example can be given with Prozac, the brand name accordingly / whereas fluoxetine hydrochloride is the generic name Yet / Since generic drugs contain the same active ingredients of brand name drugs, they neither / also have the same therapeutic effect Anyway / Although the WHO usually gives drugs standard names (INN) to be used across the world, the USA and Britain may occasionally / always choose their own names For example / After all, the international standard name Ventolin corresponds to Salbutamol in Britain and Albuterol in the USA In order / As a result to obtain the approval for registering and selling a drug, the manufacturing company needs to prove that it has the same effects and responds to the same high standards of its counterpart brand name, similarly / consequently the approval process for generic drugs is very rigorous In general, there’s the common perception that more expensive items offer better quality, moreover / however this is not true in the case of medicines In fact / because of generics are usually much cheaper than their counterparts despite having the same active ingredients 24 UNIT 11: BRANDED VERSUS TO GENERIC MEDICINES Switching to Generics In some countries, over half of all prescriptions filled in are for generic medicines A generic prescription drug is usually a discount prescription drug However, this does not mean it is a lower quality product, provided it is manufactured in a country that has strong regulations controlling the standards that generic pharmaceuticals must meet in order to be available there Many brand name drugs have generic equivalents available This is expected to increase over the next decade In some countries, including Italy, pharmacists are requested to substitute a generic medicine on prescription even though a brand name product may have initially been prescribed, whenever the generic medicine is sold at a lower price than its brand name counterpart Many insurance plans, in the USA, also encourage patients to accept generic medicines over their brand name counterparts whenever it’s medically safe This level of use demonstrates the widespread acceptance of generic medicines as discount prescription drug alternatives as long as the quality is assured There is a small number of brand name drugs with which great care should be taken when substituting generic pharmaceuticals These are drugs that have what is term a “narrow therapeutic index” This means that for these drugs, a small variation in dose can cause problems, such as too little effectiveness or too many side effects In these few cases, a patient should only switch to generics after consulting with their doctor and then so only with his or her approval and close supervision Why are brand name drugs more expensive? While the active ingredients in generic pharmaceuticals are the same as the active ingredients in their brand name counterparts, there may be differences in their appearance, for example, the shape or the color of a tablet If your doctor has suggested switching to generic drugs, or has prescribed one the first time, you can expect to receive the same clinical effect as with its brand name counterpart, but at a considerably reduced cost Generic medicines are usually less expensive than their brand equivalents because the investment in discovering them is not required or less intensive or because they are essentially copy products Original brand name drugs usually have 20 years patent protection from initial discovery of the molecule before copy generic medicines can be marketed along side them However, research has shown that after discovery the average drug takes approximately 12 years to develop and costs several hundred million dollars from initial discovery to public release This may mean that the original manufacturer has only a few short years of exclusivity in the market before the copy medicines are introduced Manufacturers of brand name products must, therefore, charge a price that will compensate the research and development costs of their new drug when it finally reaches the market Following approval to sell a new drug, there are additional large costs required to promote the product and educate medical professionals in its use Manufacturers of generic not incur the risks and costs associated with the research and development if innovative medicines Since generics contain well-known, safe and effective substances, pre-clinical tests and clinical trials can be replaced by simple bioequivalence studies By the end of 2004, about 35% of the top selling pharmaceuticals became patent expired, creating a major opportunity over the following years for increasing the purchase of generic medicines, both in community prescription and in hospital sectors 25 UNIT 11: BRANDED VERSUS TO GENERIC MEDICINES (PRACTICE) A The following sentences make up a short summary of the text Complete them with ideas from the text There may be more than one answer A generic medicine offers the same quality of a branded medicine as long as it is…………………………… ……………………………………………………………………………………………………………………… In some countries a large part of prescriptions ………………………………………………………………… Even though a brand name product may have been prescribed pharmacists are requested to substitute the generic medicine on prescriptions whenever ……………………………………………………………………… With a small number of brand name drugs it is necessary to use……………………………………………… Problems such as too little effectiveness or other side effects may be caused by substituting generics ……… ……………………………………………………………………………………………………………………… In this case, before switching to generics, patients should ……………………………………………………… ……………and use them only ………………………… …………………………… …………………………… Although generic pharmaceuticals contains the same active ingredients of …………………………………… …………………………………………………………………………………………………………………… Since generic medicines not involve investment expenses and are mainly copy products, they are usually less ………………………………………………………………………………………………………………… Brand name drugs have patent protection for a period of years, that goes from initial discovery of …………… ……………………………………………………………………………………………………………………… 10 After the initial discovery, the drug takes about twelve years to develop, therefore, the effective period of exclusivity in the market ………………………………………………………………………………………… 11 When calculating selling prices, manufacturers need also to calculate the costs ……………………………… … ………………………………………………………………………………………………………………… 12 When producing generics, pre-clinical tests and clinical trials can be replaced ……………………………… ……………………since they contain …………………………………………………………………………… 26 UNIT 12: BIOSIMILAR MEDICINES1 Why are biosimilar medicines being introduced? Medicinal products developed through biotechnology constitute an essential part of medicines available for patients today They represent approximately 6% of the pharmaceuticals currently marketed and account for more than 9% of the total pharmaceuticals expenditure As already noted, Europe has a critical need to control healthcare costs It is estimated that by 2015 the number of people over 60 will be at least 25% of the total population This equates to approximately 120 millions people aged over 60 Since this age group spends on average three to four times more on medicines than when they were 30 Costs for providing access to medicines for these people are going to explode Oncology is the largest area of biotechnology However, many biopharmaceuticals are more and more used to treat long-term conditions such as diabetes, cancer, chronic kidney failure and multiple sclerosis Some major biotechnology-derived medicines are, or will soon, no longer be protected by patents As for all other medicines when their 20 year patent expires, they will become open to development and manufactured by other companies This introduces competition on the market which ensures patient access to safe, effective and more affordable biotechnology-derived medicines Many patients who could benefit from these medicines not have access to them and with pharmaceutical spending growing more than twice as fast as the gross domestic product (GDP), that situation can only worsen It is therefore essential to facilitate patient access to cost effective biopharmaceuticals and biosimilar medicines as soon as patents expire How can patients be assured of quality? Both originator reference products and biosimilar medicines are made under carefully controlled conditions to ensure the products are consistent and of the required quality This is known as Good Manufacturing Practice (GMP) Companies involved in the development of biosimilar medicines must demonstrate, with a high degree of certainty, that the quality of the medicine is comparable to the originator/reference medicinal product All biotechnology medicines, including biosimilar biotechnology-derived medicines, are or will be assessed by the European Medicines Agency in London (EMEA) When the EMEA assesses date for biosimilar medicines, the scientific principles for ensuring product quality, safety and efficacy are identical to those applied to the originator/brand reference medicines with which comparability is demonstrated All European pharmaceutical companies are legally required to monitor the use and effects of all their medicines They must have systems capable to detect, assess, understand and communicate any adverse reactions or any other medicine-related problems Examples of active substances or originator reference products Scientific name of the biological active substance Main treatment area (INN – International Non-Proprietary Name) Imiglucerase (from Chinese hamster ovary cells) Gaucher’s disease2 Human Insulin (from the cells of the Pancreas) Diabetes Interferon Alpha (from peripheral blood leukocytes3 Various cancers, Hepatitis B/C Interferon Beta (from Fibroblasts ) Multiple Sclerosis Somatropin (from the human pituitary gland) Human Growth hormone deficiency Erythropoietin (EPO) (from specialized cells in the Anaemia associated with chronic kidney failure kidneys) http://www.egagenerics.com/FAQ-biosimilar.htm – September 2007 Gaucher’s disease is an inherited metabolic disorder in which harmful quantities of a fatty substance accumulate in the spleen, liver, lungs, bone marrow, and sometimes in the brain White blood cells Connective tissue cells that secretes proteins and molecular collagen 27 UNIT 12: BIOSIMILAR MEDICINES (PRACTICE) A Write sentences changing from passive to active or vice versa Biopharmaceuticals represent approximately 6% of medicinal products …………………………………………………………………………………………………………………… Elderly people spend a lot more on medicines ……………………………………………………………………………………………………………………… Many biopharmaceuticals are being used by physicians to treat long-term illnesses ……………………………………………………………………………………………………………………… Some major biotechnology –derived medicines will no longer be protected by patents ……………………………………………………………………………………………………………………… They need to everything possible to facilitate patient access to cost effective biopharmaceuticals ……………………………………………………………………………………………………………………… All European pharmaceutical companies are required by EMEA to monitor the use and effects of all their medicines ……………………………………………………………………………………………………………………… B Here is a short summary of the text Complete it with the combination of Adjective and Noun monitoring originator pharmaceutical high certainty essential part careful control systems medicine expenditure medicinal growing number easy access scientific body biosimilar drugs products Today an …………….……… of medicines available to patients is represented by …………………… ……… developed through biotechnology Nearly 10% of the total …………………………… is covered by biosimilar medicines The largest area is Oncology By the year 2015, the cost for providing medicines to the ………………………… of elderly people will increase considerably At present, the number of patients treated with ………………… is still low However, once patents expired, companies are or will be able to manufacture them ensuring patients ………………… to safe, effective and more affordable biopharmaceuticals In order to ensure that medicines respond to the required quality, both originator reference products and biosimilar medicines are made under …………………… Companies developing biosimilar medicines need to prove with …………………… that the quality of the biosimilar medicine is comparable to the originator/reference medicinal product The European Medicines Agency in London (EMEA) is the ………… ……… of the European Commission responsible for the evaluation of medicines The EMEA uses the same scientific principles for ensuring product quality, safety and efficacy as those applied to the …………………… ……………… However, all European pharmaceutical companies are legally required to adopt ……………… ……………… and to communicate any adverse reactions related to the medicine problems 28 UNIT 13: PRESCRIPTION INSERTS A prescription insert or a Patient Package Insert (PPI) is a printout that contains specific information on a particular prescription drug There are many online resources that allow patients to print out inserts for all prescription drugs at no cost Companies may use different insert styles to convey drug information, but inserts usually include related sections in a similar order Common sections include:  Description: this section includes general information about prescription drug People with drug allergies can review this section to ensure that they are not taking a medication that may trigger an allergic reaction This section contains:  o Generic name (the scientific or chemical name) o Brand name o Type of dosage (e.g liquid, tablets, capsule, etc.) o Administration method (e.g oral, intravenous, rectal, etc.) o Pharmacological or therapeutic class (e.g analgesics, antibiotics, etc.) o Chemical information, including name, structural formulas and other information Clinical pharmacology: they state how the drug actually works (e.g how the medicine acts in the body, how it is absorbed and eliminated, its effects with different concentrations)  Indications and usage: information about the condition(s), diagnosis or symptom(s) is declared in this section following the approval obtained However, drugs can sometimes be prescribed for reasons other than for what they were approved initially (off-label use)  Contraindications: this section describes those circumstances in which the drug should not be used or should be used with caution because the potential risks may outweigh any potential benefits For example, using the drug at a particular age, by a particular gender, with pre-existing diseases or mixing it with other drugs may cause a serious risk This section may also urge not to use the drug in an individual with an allergy or known hypersensitivity to specific substances  Warnings: adverse reactions and possible hazards are indicated here and what to if they occur  Precautions: vital information about precautions for most people taking the drug is displayed in this section Special groups of people, such as children, pregnant women and nursing mothers, may also have information specifically adapted for them This section includes also advice and instructions for special care 29 to be taken by the physician (e.g precautions when using alcohol or other drugs) Information about laboratory tests and possible adverse reactions will be listed here  Adverse effects: (commonly called “side effects”): any unwanted effect that may be connected with the use of the drug is listed here Adverse reactions can be caused be medication errors (e.g overdose), drug or food interactions, allergic reactions or other causes Information about adverse reactions with drugs in the same class (e.g antihistamines, bronchodilators, corticosteroids) may be in this section of package insert  Drug abuse and dependence: it will be clearly stated in this section if a drug is thought to have a potential for abuse, dependence or withdrawal symptoms  Overdosage: any information referring to signs, symptoms and laboratory findings associated with an overdosage of a drug will be confirmed here  Dosage and administration: under this section heading, the recommended dose is stated along with the usual dosage range allowed, and perhaps an upper limit beyond which safety and effectiveness have not been established Also included in this section is information about the intervals recommended between doses, the usual duration of treatment and any changes of dosage needed for special patients such as children, the elderly or patients with a disease  How supplied: this section includes information about available dosage forms The strength of the dosage forms is indicated here along with the units in which the dosage form is usually available for prescribers, the description or appearance of the dosage form and special handling and storage conditions  Additional sections: this section will include additional information if appropriate The package insert contains important information and instructions but it should not take the place of instructions from a physician or healthcare professional It is important, however, to review the inserts for details regarding patient-specific conditions (e.g allergies, adverse effects to medications) Studying the information in the inserts will help avoid errors and increase patient awareness of potential problems 30 UNIT 13: PRESCRIPTION INSERTS (PRACTICE) A Find in the text the opposites to the following words Choose from the underlined words Two of them are not necessary In the text In the text Favorable (adj) Exclude Prohibit (v) Expected (v) Refuse/reject (v) Damage (n) Hide (v) Lower (adj) Weakness (n) Eliminate (v) B Find suitable nouns in the text for the following definitions Noun Definition Identifying the nature or cause of some phenomenon Maltreatment, ill-treatment, ill-usage How medication is given Written instructions from a physician concerning the form and dosage of a drug A process in which one or more substances are changed into others Excessive quantity or amount of a drug Hypersensitivity reaction to a particular drug or substance Any sensation or change in body function experienced by a patient and associated with a particular disease C Make noun + noun combinations using a word from each box drug patient prescription brand administration laboratory food dosage storage 10 withdrawal Test Interaction Range Symptoms Insert Abuse Awareness Name Method condition 10 D Complete the sentences with the combinations made in the previous exercise You not need them all Detailed information on a particular prescription drug is contained in the ………………………………… … In the section abuse, dependence and …………………… associated with ………………… are clearly stated In this section, you will find the recommended ……………… as well as information about the intervals between doses In the section “Overdosage”, any information referring to results from …………………… are confirmed Medication errors, drug or …………………, allergic reactions or other causes may cause adverse reactions 31 UNIT 14: READING OTC MEDICINES LABELS Drug Facts Active ingredient (in each tablet) Purpose Chlorpheniramine malate mg………………………………………………………………… … Antihistamine Uses temporarily relieves symptoms due to hayfever or other upper respiratory allergies:  Sneezing  Runny nose  Itchy, watery eyes  Itchy throat Warnings Ask a doctor before use if you have:  Glaucoma A breathing problem such as emphysema or chronic bronchitis  Trouble urinating due to an enlarged prostate gland Ask a doctor or pharmacist before use if you are taking tranquilizers or sedatives When using this product  You may get drowsy  Avoid drinking alcoholic drinks  Alcohol, sedatives, and tranquilizers may increase drowsiness  Be careful when driving a motor vehicle or operating machinery  Excitability may occur, especially in children If pregnant or breastfeeding, ask a health professional before use Keep out of reach of children In case of overdose, get medical help or contact a Poison Control Centre right away Directions Adults and children 12 years and over take tablets every to hours; not more than 12 tablets in 24 hours Children years to under 12 years take tablet every to hours; not more than tablets in 24 hours Children under years ask a doctor Other information  Store at 20 -250C (68 -77 F)  Protect form excessive moisture Inactive ingredients D&C yellow no 10, lactose, magnesium stearate, microcrystalline cellulose, pregelatinized starch Active ingredient Directions Inactive ingredients An active ingredient is the chemical compound in the medicine that works with your body to bring relief to your symptoms It can always be found as the first item on the label The only recommended daily dosage and frequency of dosage will be listed here You should follow this strictly It’s not just how much you take, but also how often An inactive ingredient is a chemical compound in the medicine that has no effect on your body Preservatives, items that bind the pill together and food colors are listed here Uses Warnings Sometimes also referred to as indications, this section tells you the ONLY symptoms the medicine is approved to treat This section will tell you what other medications, foods or situations to avoid (such as driving) when taking this medicine Other information Any other important information about the product, such as how to store the medicine, will be listed in this section 32 UNIT 14: READING OTC MEDICINES LABELS (PRACTICE) A Here are some words expressions related to symptoms Write the equivalent in your language Verbal expression To have itchy eyes/nose To have runny eyes/nose To have watery eyes To have breathing problems To have chills In your language Verbal expression To feel drowsy To feel anxious To feel dizzy To feel moody To rest To breathe To sneeze To sweat To shiver In your language Nouns Drowsiness Anxiety Dizziness Mood Rest Breath Sneeze Sweat shiver B Say if the sentences are true or false Correct the false statements in the spaces provided Some answers depend on you previous knowledge (find answers in http://familydoctor.org) Antihistamines can help prevent and treat the symptoms of allergies, colds and flu These symptoms include sneezing, itchy, watery eyes, and a runny nose Antihistamines can also relieve itchiness caused by insect bites and stings On of the most common side effects of antihistamines is feeling excited therefore they are not used to help people who feel weak Broadly speaking, OTC antihistamines not work as well as prescription medicines It is recommended to ask a doctor before using antihistamines in the case patients suffer from a chronic bronchitis Brompherinamine, Chlorpheniramine, Doxylamine and magnesium stearate are active ingredients for antihistamines Antihistamines may slow people’s reactions without you even being aware of it Children under can take no more than tablets each day 10 Moisture might damage the substance therefore it should be stored at dry house temperature Possible corrections: N0 ………………………………………………………………………………………………………………… N0 ………………………………………………………………………………………………………………… N0 ………………………………………………………………………………………………………………… N0 ………………………………………………………………………………………………………………… N0 ………………………………………………………………………………………………………………… N0 ………………………………………………………………………………………………………………… 33 UNIT 15: MOST COMMON FORMS OF MEDICATION This is how most common forms of medications are produced:  Tablet: this is a solid pill created by packing the active ingredient together with a binding agent Tablets are usually the cheapest form of medication, but they may be difficult for some people to swallow  Capsule: this is the term for a hollow gelatin container that holds a powdered medication Many people have less difficulty in swallowing capsules than they in swallowing ordinary tablets  Powders: ultra fine drug particles in a dry form Depending on the specific medication, they are usually dissolved or mixed in liquids or food and taken immediately after being prepared  Drops: sterile solution or suspension administered by a dropper directly into the eye, the outer ear canal or the nose  Liquids: they are available in the following forms: o Solutions: drug preparations that are already dissolved; o Syrups: which are mixed with sugar and water; o Suspensions: drug preparations that need to be dissolved; o Elixirs: medications dissolved in alcohol and water;  Injectable solutions: sterile solutions or suspensions supplied in ampoules, vials, bags, or bottles  Inhalants and sprays: medication is breathed or sprayed into the nose or mouth, some medications are formulated to deliver specific fixed doses, while others are formulated to deliver at random without fixed doses  Suppository: large bullet-shaped tablets administered either rectally or vaginally, they are designed to melt at body temperature, they come in forms of rectal, vaginal or urethral applications  Skin preparations: available in the following forms : o Creams: they are not greasy and used on the skin only; o Ointments: spreadable, greasy preparations used for local applications, they have a thicker texture than creams ; o Lotions: solutions or suspensions used on the skin and are not as sticky and greasy as creams and ointments, they are usually used in area such as the scalp where an ointment or cream would adhere to the hair ; o Pastes: they are stiffer preparations which contain more powdered solids 34 UNIT 15: MOST COMMON FORMS OF MEDICATION (PRACTICE) A Read the text and write the correct name under the illustrated forms of medications 10 B Answer the questions What sort of problems may tablets cause ? ……………………………………………………………………………………………………………………… What are capsules made of ? ……………………………………………………………………………………………………………………… How many forms of suppositories can be found in pharmacies ? ……………………………………………………………………………………………………………………… Why many people choose capsules instead of tablets ? ……………………………………………………………………………………………………………………… How are powders usually administered ? ……………………………………………………………………………………………………………………… Are all inhalants formulated in the same way ? ……………………………………………………………………………………………………………………… What makes ointments different from creams ? ……………………………………………………………………………………………………… …………… What are possible forms of injectable solutions ? ……………………………………………………………………………………………………………………… 35