June 26, 2024

№1. Subject: Pharmacy: Science and Technology. Prescription and OTC Drugs.

The mortar and pestle, one of the internationally recognized symbols to represent the pharmacy profession

Typical American drug store with a soda fountain, about 1905

Drug store restoration ca. 1920 at Collingsworth County Museum and Art Center across from the courthouse in Wellington, Texas

Pharmacy is the health profession that links the health sciences with the chemical sciences and it is charged with ensuring the safe and effective use of pharmaceutical drugs.

The scope of pharmacy practice includes more traditional roles such as compounding and dispensing medications, and it also includes more modern services related to health care, including clinical services, reviewing medications for safety and efficacy, and providing drug information. Pharmacists, therefore, are the experts on drug therapy and are the primary health professionals who optimize medication use to provide patients with positive health outcomes.

An establishment in which pharmacy (in the first sense) is practiced is called a pharmacy, chemist’s or drugstore. In the United States and Canada, drug stores commonly sell not only medicines, but also miscellaneous items such as candy (sweets), cosmetics, and magazines, as well as light refreshments or groceries.

The word pharmacy is derived from its root word pharma which was a term used since the 15th–17th centuries. However, the original Greek roots from “Pharmakos” imply sorcery or even poison. In addition to pharma responsibilities, the pharma offered general medical advice and a range of services that are now performed solely by other specialist practitioners, such as surgery and midwifery. The pharma (as it was referred to) often operated through a retail shop which, in addition to ingredients for medicines, sold tobacco and patent medicines. The pharmas also used many other herbs not listed. The Greek word Pharmakeia (Greek: φαρμακεια) derives from Greek: φάρμακον (pharmakon), meaning “drug” or “medicine” (the earliest form of the word is the Mycenaean Greek pa-ma-ko, attested in Linear B syllabic script.

In its investigation of herbal and chemical ingredients, the work of the pharma may be regarded as a precursor of the modern sciences of chemistry and pharmacology, prior to the formulation of the scientific method.

Disciplines

Pharmacy, tacuinum sanitatis casanatensis (14th century)

The field of pharmacy can generally be divided into three primary disciplines:

The boundaries between these disciplines and with other sciences, such as biochemistry, are not always clear-cut; and often, collaborative teams from various disciplines research together.

Pharmacology is sometimes considered a fourth discipline of pharmacy. Although pharmacology is essential to the study of pharmacy, it is not specific to pharmacy. Therefore it is usually considered to be a field of the broader sciences.

Pharmacoinformatics is considered another new discipline, for systematic drug discovery and development with efficiency and safety.

Types of pharmacy practice areas

Pharmacists practice in a variety of areas including community pharmacies, hospitals, clinics, extended care facilities, psychiatric hospitals, and regulatory agencies. Pharmacists can specialize in various areas of practice including but not limited to: hematology/oncology, infectious diseases, ambulatory care, nutrition support, drug information, critical care, pediatrics, etc.

Community pharmacy

19th century Italian pharmacy

Modern pharmacy in Norway

A pharmacy (commonly the chemist in Australia, New Zealand and the UK; or drugstore in North America; retail pharmacy in industry terminology; or Apothecary, historically) is the place where most pharmacists practice the profession of pharmacy. It is the community pharmacy where the dichotomy of the profession exists—health professionals who are also retailers.

Community pharmacies usually consist of 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.

In most countries, the dispensary is subject to pharmacy legislation; with requirements for storage conditions, compulsory texts, equipment, etc., specified in legislation. Where it was once the case that pharmacists stayed within the dispensary compounding/dispensing medications, there has been an increasing trend towards the use of trained pharmacy technicians while the pharmacist spends more time communicating with patients. Pharmacy technicians are now more dependent upon automation to assist them in their new role dealing with patients’ prescriptions and patient safety issues.

Pharmacies are typically required to have a pharmacist on-duty at all times when open. It is also often a requirement that the owner of a pharmacy must be a registered pharmacist, although this is not the case in all jurisdictions, such that many retailers (including supermarkets and mass merchandisers) now include a pharmacy as a department of their store.

Likewise, many pharmacies are now rather grocery store-like in their design. In addition to medicines and prescriptions, many now sell a diverse arrangement of additional items such as cosmetics, shampoo, office supplies, confections, snack foods, durable medical equipment, greeting cards, and provide photo processing services.

Hospital pharmacy

Pharmacies within hospitals differ considerably from community pharmacies. Some pharmacists in hospital pharmacies may have more complex clinical medication management issues whereas pharmacists in community pharmacies often have more complex business and customer relations issues.

Because of 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 and 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 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 given intravenously. This 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, combined with the potential impact of medications and pharmacy services on patient-care outcomes and patient safety, make it imperative that hospital pharmacies perform at the highest level possible.

Clinical pharmacy

Pharmacists provide direct patient care services that optimizes 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 the interdisciplinary approach to patient care. They often participate in patient care rounds and drug product selection.

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 the patient. The review process often involves an evaluation of the appropriateness of the drug therapy (e.g., drug choice, dose, route, frequency, and duration of therapy) and its efficacy. The pharmacist must also monitor for potential drug interactions, adverse drug reactions, and assess patient drug allergies while designing and initiating a drug therapy plan.

Ambulatory care pharmacy

Since the emergence of modern clinical pharmacy, ambulatory care pharmacy practice has emerged as a unique pharmacy practice setting. In 2011 the board of Pharmaceutical Specialties approved ambulatory care pharmacy practice as 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.

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 the 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 North Carolina and New Mexico these pharmacist clinicians are given collaborative prescriptive and diagnostic authority.

Compounding pharmacy

Compounding is the practice of preparing drugs iew forms. For example, if a drug manufacturer only provides a drug as a tablet, 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 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

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 the United States many now work for several large pharmacy management companies (primarily Omnicare, Kindred Healthcare and 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 is developed by Hepler and Strand in 1990. Internet pharmacy

Since about the year 2000, a growing number of Internet pharmacies have been established worldwide. Many of these pharmacies are similar to community pharmacies, and in fact, many of them are actually operated by brick-and-mortar community pharmacies that serve consumers online and those that walk in their door. The primary difference is the method by which the medications are requested and received. Some customers consider this to be more convenient and private method rather than traveling to a community drugstore where another customer might overhear about the drugs that they take. Internet pharmacies (also known as online pharmacies) are also recommended to some patients by their physicians if they are homebound.

While most Internet pharmacies sell prescription drugs and require a valid prescription, some Internet pharmacies sell prescription drugs without requiring a prescription. Many customers order drugs from such pharmacies to avoid the “inconvenience” of visiting a doctor or to obtain medications which their doctors were unwilling to prescribe. However, this practice has been criticized as potentially dangerous, especially by those who feel that only doctors can reliably assess contraindications, risk/benefit ratios, and an individual’s overall suitability for use of a medication. There also have been reports of such pharmacies dispensing substandard products.

Of particular concern with Internet pharmacies is the ease with which people, youth in particular, can obtain controlled substances (e.g., Vicodin, generically known as hydrocodone) via the Internet without a prescription issued by a doctor/practitioner who has an established doctor-patient relationship. There are many instances where a practitioner issues a prescription, brokered by an Internet server, for a controlled substance to a “patient” s/he has never met. In the United States, in order for a prescription for a controlled substance to be valid, it must be issued for a legitimate medical purpose by a licensed practitioner acting in the course of legitimate doctor-patient relationship. The filling pharmacy has a corresponding responsibility to ensure that the prescription is valid. Often, individual state laws outline what defines a valid patient-doctor relationship.

Canada is home to dozens of licensed Internet pharmacies, many of which sell their lower-cost prescription drugs to U.S. consumers, who pay one of the world’s highest drug prices. In recent years, many consumers in the US and in other countries with high drug costs, have turned to licensed Internet pharmacies in India, Israel and the UK, which often have even lower prices than in Canada.

In the United States, there has been a push to legalize importation of medications from Canada and other countries, in order to reduce consumer costs. While in most cases importation of prescription medications violates Food and Drug Administration (FDA) regulations and federal laws, enforcement is generally targeted at international drug suppliers, rather than consumers. There is no known case of any U.S. citizens buying Canadian drugs for personal use with a prescription, who has ever been charged by authorities.

Recently developed online services which promote generic drug alternatives by offering comparative information on price and effectiveness.

Veterinary pharmacy

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, veterinary pharmacy is often kept separate from regular pharmacies.

Nuclear pharmacy

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.

Military pharmacy

Military pharmacy is an entirely different working environment due to the fact that technicians perform most duties that in a civilian sector would be illegal. State laws of Technician patient counseling and medication checking by a pharmacist do not apply.

Pharmacy informatics

Pharmacy informatics is the combination of pharmacy practice science and applied information science. Pharmacy informaticists work in many practice areas of pharmacy, however, they may also work in information technology departments or for healthcare information technology vendor companies. As a practice area and specialist domain, pharmacy informatics is growing quickly to meet the needs of major national and international patient information projects and health system interoperability goals. Pharmacists in this area are trained to participate in medication management system development, deployment and optimization.

Issues in pharmacy

Separation of prescribing from dispensing

In most jurisdictions (such as the United States), pharmacists are regulated separately from physicians. These jurisdictions also usually specify that only pharmacists may supply scheduled pharmaceuticals to the public, and that pharmacists cannot form business partnerships with physicians or give them “kickback” payments. However, the American Medical Association (AMA) Code of Ethics provides that physicians may dispense drugs within their office practices as long as there is no patient exploitation and patients have the right to a written prescription that can be filled elsewhere. 7 to 10 percent of American physicians practices reportedly dispense drugs on their own.

In some rural areas in the United Kingdom, there are dispensing doctors who are allowed to both prescribe and dispense prescription-only medicines to their patients from within their practices. The law requires that the GP practice be located in a designated rural area and that there is also a specified, minimum distance (currently 1.6 kilometres) between a patient’s home and the nearest retail pharmacy.

In other jurisdictions (particularly in Asian countries such as China, Malaysia, and Singapore), doctors are allowed to dispense drugs themselves and the practice of pharmacy is sometimes integrated with that of the physician, particularly in traditional Chinese medicine.

In Canada it is common for a medical clinic and a pharmacy to be located together and for the ownership in both enterprises to be common, but licensed separately.

The reason for the majority rule is the high risk of a conflict of interest and/or the avoidance of absolute powers. Otherwise, the physician has a financial self-interest in “diagnosing” as many conditions as possible, and in exaggerating their seriousness, because he or she can then sell more medications to the patient. Such self-interest directly conflicts with the patient’s interest in obtaining cost-effective medication and avoiding the unnecessary use of medication that may have side-effects. This system reflects much similarity to the checks and balances system of the U.S. and many other governments.

A campaign for separation has begun in many countries and has already been successful (like in Korea). As many of the remaining nations move towards separation, resistance and lobbying from dispensing doctors who have pecuniary interests may prove a major stumbling block (e.g. in Malaysia).

The future of pharmacy

In the coming decades, pharmacists are expected to become more integral within the health care system. Rather than simply dispensing medication, pharmacists are increasingly expected to be compensated for their patient care skills. In particular, Medication Therapy Management (MTM) includes the clinical services that pharmacists can provide for their patients. Such services include the thorough analysis of all medication (prescription, non-prescription, and herbals) currently being taken by an individual. The result is a reconciliation of medication and patient education resulting in increased patient health outcomes and decreased costs to the health care system.

This shift has already commenced in some countries; for instance, pharmacists in Australia receive remuneration from the Australian Government for conducting comprehensive Home Medicines Reviews. In Canada, pharmacists in certain provinces have limited prescribing rights (as in Alberta and British Columbia) or are remunerated by their provincial government for expanded services such as medications reviews (Medschecks in Ontario). In the United Kingdom, pharmacists who undertake additional training are obtaining prescribing rights. They are also being paid for by the government for medicine use reviews. In Scotland the pharmacist can write prescriptions for Scottish registered patients of their regular medications, for the majority of drugs, except for controlled drugs, when the patient is unable to see their doctor, as could happen if they are away from home or the doctor is unavailable. In the United States, pharmaceutical care or clinical pharmacy has had an evolving influence on the practice of pharmacy. Moreover, the Doctor of Pharmacy (Pharm. D.) degree is now required before entering practice and some pharmacists now complete one or two years of residency or fellowship training following graduation. In addition, consultant pharmacists, who traditionally operated primarily in nursing homes are now expanding into direct consultation with patients, under the banner of “senior care pharmacy.”

List of pharmaceutical sciences journals

Symbols

The two symbols most commonly associated with pharmacy are the mortar and pestle and the ℞ (recipere) character, which is often written as “Rx” in typed text. The show globe was also used in English-speaking countries until the early 20th century. Pharmacy organizations often use other symbols, such as the Bowl of Hygieia which is often used in the Netherlands, conical measures, and caduceuses in their logos. Other symbols are common in different countries: the green Greek cross in France, Argentina, the United Kingdom, Belgium, Ireland, Italy, Spain, and India, the increasingly rare Gaper in the Netherlands, and a red stylized letter A in Germany and Austria (from Apotheke, the German word for pharmacy, from the same Greek root as the English word ‘apothecary‘).

Bowl of Hygieia, the internationally-recognised symbol of pharmacy (the profession)

Rod of Asclepius, the internationally-recognised symbol of medicine

Green cross and Bowl of Hygieia used in Europe (with the exception of Germany and Austria) and India

Simple green cross, also used in Europe and India

Red “A” (Apotheke) sign, used in Germany

Similar red “A” sign, used in Austria

The mortar and pestle, used in the United States and Canada

A hanging show-globe, formerly used in the United States

The Gaper, formerly used in the Netherlands

The symbol used on medical prescriptions, from the Latin Recipe

Medical prescriptions

A prescription is a health-care programme that governs the plan of care for an individual patient and is implemented by a qualified practitioner. A qualified practitioner might be a physician, dentist, nurse practitioner, pharmacist, psychologist, or other health care provider. Prescriptions may include orders to be performed by a patient, caretaker, nurse, pharmacist, physician, other therapist, or by automated equipment, such as an intravenous infusion pump. Formerly, prescriptions often included detailed instructions regarding compounding of medications but as medications have increasingly become pre-packaged manufactured products, the term “prescription” now usually refers to an order that a pharmacist dispense and that a patient take certain medications. Prescriptions have legal implications, as they may indicate that the prescriber takes responsibility for the clinical care of the patient and in particular for monitoring efficacy and safety. As medical practice has become increasingly complex, the scope of meaning of the term “prescription” has broadened to also include clinical assessments, laboratory tests, and imaging studiesFormat and definition

Prescriptions are typically handwritten on preprinted prescription forms that are assembled into pads, or alternatively printed onto similar forms using a computer printer or are in an electronic format. Preprinted on the form is text that identifies the document as a prescription, the name and address of the prescribing provider and any other legal requirement such as a registratioumber (e.g. DEA Number in the United States). Unique for each prescription is the name of the patient. In the United Kingdom and Ireland, the patient’s name and address must also be recorded. Each prescription is dated and some jurisdictions may place a time limit on the prescription. There is the specific “recipe” of the medication and the directions for taking it.

℞ is a symbol meaning “prescription”. It is sometimes transliterated as “R_x” or just “Rx”. This symbol originated in medieval manuscripts as an abbreviation of the Late Latin verb recipe, the imperative form of recipere, “to take” or “take thus”.Literally, the Latin word recipe means simply “Take….” and medieval prescriptions invariably began with the command to “take” certain materials and compound them in specified ways. Today, when a medical practitioner writes a prescription beginning with “℞“, he or she is completing the command.

Folk theories about the origin of the symbol ℞ note its similarity to the Eye of Horus, or to the ancient symbol for Zeus or Jupiter, (♃), gods whose protection may have been sought in medical contexts.

The word “prescription”, from “pre-” (“before”) and “script” (“writing, written”), refers to the fact that the prescription is an order that must be written down before a compound drug can be prepared. Those within the industry will often call prescriptions simply “scripts”.

The fact that a prescription instructs someone to “take” rather than “give” is not a trivial distinction, but makes clear it is directed at the patient, and is not directly an instruction to anyone else. In certain states medical marijuana legislation has been drafted calling for a health care professional’s written or oral “recommendation”, in the belief that a written one would be legally distinguishable from a prescription, but since written advice to a patient is what a prescription is, that belief is mistaken. Jurisdictions may adopt a statutory definition of “prescription” which is applicable as a term of art only to the operation of that statute (see below about prescriptions that may legally be filled with prescription-only items), but the general legal definition of the word is this broad one.

Both pharmacists and prescribers are regulated professions in most jurisdictions. A prescription as a communications mechanism between them is also regulated and is a legal document.

Regulations may define what constitutes a prescription, the contents and format of the prescription (including the size of the piece of paper – see Exhibit C paragraph 10) and how prescriptions are handled and stored by the pharmacist. Many jurisdictions will now allow faxed or phone prescriptions containing the same information. Exhibit A below illustrates the legal definition of a prescription.

Drug companies use direct-to-prescriber advertising in an effort to convince prescribers to dispense as written with brand-name products rather than generic drugs.

Many brand name drugs have cheaper generic drug substitutes that are therapeutically and biochemically equivalent. Prescriptions will also contain instructions on whether the prescriber will allow the pharmacist to substitute a generic version of the drug. This instruction is communicated in a number of ways.

In some jurisdictions, the preprinted prescription contains two signature lines: one line has “dispense as written” printed underneath; the other line has “substitution permitted” underneath. Some have a preprinted box “dispense as written” for the prescriber to check off (but this is easily checked off by anyone with access to the prescription). Other jurisdictions the protocol is for the prescriber to handwrite one of the following phrases: “dispense as written”, “DAW”, “brand necessary”, “do not substitute”, “no substitution”, “medically necessary”, “do not interchange”. In other jurisdictions may they use completely different languages, never mind a different formula of words. In some jurisdictions, it may be a legal requirement to include the age of child on the prescription. For pediatric prescriptions some advise the inclusion of the age of the child if the patient is less than twelve and the age and months if less than five. (In general, including the age on the prescription is helpful.) Adding the weight of the child is also helpful.

Prescriptions often have a “label” box. When checked, the pharmacist is instructed to label the medication. Wheot checked, the patient only receives instructions for taking the medication and no information about the prescription itself.

Some prescribers further inform the patient and pharmacist by providing the indicator for the medication; i.e. what is being treated. This assists the pharmacist in checking for errors as many common medications can be used for multiple medical conditions.

Some prescriptions will specify whether and how many “repeats” or “refills” are allowed; that is whether the patient may obtain more of the same medication without getting a new prescription from the medical practitioner. Regulations may restrict some types of drugs from being refilled.

In group practices, the preprinted portion of the prescription may contain multiple prescribers’ names. Prescribers typically circle themselves to indicate who is prescribing or there may be a checkbox next to their name.

Handling

When filled by a pharmacist, as a matter of business practice, the pharmacist may write certain information right on the prescription. This may also be mandated by legislation (see Exhibit D). Information such as the actual manufacturer of the drug and the date the medication was dispensed may be written right onto the prescription. Legislation may require the pharmacist to sign the prescription. In computerized pharmacies, all such information is printed and stapled to the prescription. Sometimes such information is printed onto labels and the labels affixed right onto the prescription.

When filled by the pharmacist, prescriptions are typically assigned a “prescriptioumber” (often abbreviated “Rx#” in the US) that is unique to the pharmacy that filled the prescription. The prescriptioumber is written right on the prescription by the pharmacist. The prescriptioumber has the practical purpose of uniquely identifying the prescription later on while filed (both manual and electronic). The prescriptioumber is also put on the label on the dispensed medication. The patient may be required to reference the prescription number for refills and drug insurance claims. There may also be a legal requirement for prescriptioumbers for subsequent identification purposes.

As a legal document, some jurisdictions will mandate the archiving of the original paper prescription in the pharmacy. Often the patient cannot take the original prescription with them. Some jurisdictions may entitle patients to a copy. The retention period varies but can be as long as ten years (requirement of all prescriptions billed to a Medicare Part D plan.) See Exhibit B for sample legislation governing the archiving of prescriptions. Once the retention period has passed, privacy legislation may dictate what can be done with the original paper prescription. Legislation may also dictate what happens to the prescriptions if the pharmacy closes or is sold. For example, if the pharmacy goes out of business, the pharmacist may be required to return the prescription to the patient, to the next closest pharmacy or to the governing body for pharmacists.

Prescriptions for non-narcotic drugs may also be “transferred” from one pharmacy to another for subsequent repeats to be dispensed from another pharmacy. The physical piece of paper that is the prescription is not transferred, but all the information on it is transferred from one pharmacy to another. Legislation may dictate the protocol by which the transfer occurs and whether the transfer needs to be noted on the original paper prescription.

It is estimated that three billion prescriptions were written in the United States in 2002. This number grew from 1.5 billion in 1989 and is expected to continue to grow.

Rx security – forgeries and prevention

Prescriptions are sometimes forged because many narcotics are cheaper and safer as prescription drugs than as street drugs. Forgery takes many forms: Prescription pads are sometimes stolen, amounts may be altered on legitimate prescriptions, call back numbers may be falsified and phoned or faxed prescriptions faked.

To make photocopying prescriptions more difficult, some medical practitioners use prescription pads that contain security measures similar to those used on bank checks. These security measures may be mandated by law—see Exhibit C for sample legal specifications. Legislation may mandate that only certain printers may print prescriptions. New Jersey, for example, requires that only state approved printers may be used to print official “New Jersey Prescription Blanks.” (See Exhibit E.) Prescribers can make it more difficult to forge dosages and quantities by writing out numbers in words. Again, this may be mandated by law.

Some jurisdictions help control stolen prescriptions by requiring special “triplicate prescriptions” for certain classes of drugs. Blank triplicates are only available from the regulating agency and are individually numbered. The medical practitioner retains a copy, the second and third copies are given to the patient to give to the pharmacist. The pharmacist retains the second copy and the third copy is submitted to the regulating agency. The regulating agency can issue lists of forged prescriptions that pharmacists can check. In this example, the prescription’s validity is further limited to 72 hours from issuance. California has recently replaced triplicate forms with new forms that are impossible to photocopy or fax: the background is printed with repetitions of the word void in a color that shows up as black on a photocopy.

States have various laws making theft of prescription blanks or forgery of prescriptions criminal offenses and/or providing special treatment for these offenses (for Example N.J. Stat. 2C:21-1. making forgery of a prescription blank a third degree rather than fourth degree offense).

When forgery is suspected, pharmacists will call the medical practitioner to verify the prescription. Forged prescriptions are no longer considered medical documents and doctor-patient confidentiality rules no longer apply.

Writing prescriptions

Any jurisdiction that allows freedom of written communication generally must therefore allow anybody to write a prescription to anybody, inasmuch as the prescription itself is just written advice. Therefore “who can write prescriptions” will be explained below as shorthand for “whose prescriptions may legally be filled with items restricted to dispensing via the order of certain persons”.

National or local (i.e. state or provincial) legislation governs who can write a prescription. In North America, physicians (either M.D. or D.O.) have the broadest prescriptive authority. All 50 States and the District of Columbia allow licensed certified Physician Assistants (PAs) prescription authority (with some limitations to controlled substances). All 50 States allow registered certified nurse practitioners and other advanced practice registered nurses (such as certified nurse-midmives) prescription power (with some states including limitations to controlled substances). Many other healthcare professions also have prescriptive authority related to their area of practice. Veterinarians, dentists, and podiatrists have prescribing power in all 50 states and the District of Columbia. Clinical pharmacists are allowed to prescribe in some states through the use of a drug formulary or collaboration agreements. Florida Pharmacists can write prescriptions for a limited set of drugs. In all states, optometrists prescribe medications to treat certain eye diseases, and also issue spectacle and contact lens prescriptions for corrective eyewear. Several states have passed RxP legislation, allowing clinical psychologists (PhD’s or PsyD’s) who are registered as medical psychologists and have also undergone specialized training in script-writing to prescribe drugs to treat emotional and mental disorders. Physicians who practice chiropractic medicine may have the ability to write a prescription, depending on scope of practice laws in a jurisdiction.

Legibility

Prescriptions, when handwritten, are notorious for being often illegible. In the US, medical practitioners’ sloppy handwriting kills more than 70,000 people annually, according to a July 2006 report from the National Academies of Science’s Institute of Medicine (IOM). Historically, physicians used Latin words and abbreviations to convey the entire prescription to the pharmacist. Today, many of the abbreviations are still widely used and must be understood to interpret prescriptions. At other times, even though some of the individual letters are illegible, the position of the legible letters and length of the word is sufficient to distinguish the medication based on the knowledge of the pharmacist. When in doubt, pharmacists call the medical practitioner. Some jurisdictions have legislated legible prescriptions (e.g. Florida). Some have advocated the elimination of handwritten prescriptions altogether and computer printed prescriptions are becoming increasingly common in some places.

Conventions for avoiding ambiguity

Over the years, prescribers have developed many conventions for prescription-writing, with the goal of avoiding ambiguities or misinterpretation. These include:

Careful use of decimal points to avoid ambiguity:

Avoiding unnecessary decimal points: a prescription will be written as 5 mL instead of 5.0 mL to avoid possible misinterpretation of 5.0 as 50.
Always using zero prefix decimals: e.g. 0.5 instead of .5 to avoid misinterpretation of .5 as 5.
Avoiding trailing zeros on decimals: e.g. 0.5 instead of .50 to avoid misinterpretation of .50 as 50.

“mL” is used instead of “cc” or “cm?” even though they are technically equivalent to avoid misinterpretation of ‘c’ as ‘0’ or the common medical abbreviation for “with” (the Latin “cum“), which is written as a ‘c’ with a bar above the letter. Further, cc could be misinterpreted as “c.c.”, which is an uncommonly used abbreviation for “take with meals” (the Latin “cum cibo“).
Directions written out in full in English (although some common Latin abbreviations are listed below).
Quantities given directly or implied by the frequency and duration of the directions.
Where the directions are “as needed”, the quantity should always be specified.
Where possible, usage directions should specify times (7 am, 3 pm, 11 pm) rather than simply frequency (three times a day) and especially relationship to meals for orally consumed medication.
The use of permanent ink.
Avoiding units such as “teaspoons” or “tablespoons.”
Writing out numbers as words and numerals (“dispense #30 (thirty)”) as in a bank draft or cheque.
The use of apothecary/avoirdupois units and symbols of measure — pints (O), ounces (℥), drams (ℨ), scruples (℈), grains (gr), and minims (♏) — is discouraged given the potential for confusion. For example, the abbreviation for a grain (“gr”) can be confused with the gram, abbreviated g, and the symbol for minims (♏), which looks almost identical to an ‘m’, can be confused with micrograms or metres. Also, the symbols for ounce (℥) and dram (ℨ) can easily be confused with the numeral ‘3’, and the symbol for pint (O) can be easily read as a ‘0’. Given the potential for errors, metric equivalents should always be used.
The use of the degree symbol (°), which is commonly used as an abbreviation for hours (e.g., “q 2-4°” for every 2 – 4 hours), should not be used, since it can be confused with a ‘0’. Further, the use of the degree symbol for primary, secondary, and tertiary (1°, 2°, and 3°) is discouraged, since the former could be confused with quantities (i.e. 10, 20 and 30, respectively).

Abbreviations

Many abbreviations are derived from Latin phrases. Hospital pharmacies have more abbreviations, some specific to the hospital. Different jurisdictions follow different conventions on what is abbreviated or not. Prescriptions that don’t follow area conventions may be flagged as possible forgeries.

Some abbreviations which are ambiguous, or which in their written form might be confused with something else, are not recommended and should be avoided. These are included in a separate list in Appendix 1. However, all abbreviations carry an increased risk for confusion and misinterpretation and should be used cautiously.

In Continental Europe

In continental Europe, prescriptions differ from their counterparts in the Anglosphere. With the exception of patient directions, they are written out entirely in abbreviations deriving from the Latin language. Furthermore, a larger proportion of prescriptions are compounded, and appropriate abbreviations and phrases exist for this. Many medical schools require up to two years of Latin as part of the curriculum for medical doctors and pharmacists.

Parts of a European prescription

A continental European prescription consists of three parts:

the inscritio, also known as the superscriptio, is the header of the prescription and consists of the patient’s name, address, and identity document number, as well as the identifying number of the patient’s private health insurance company, if applicable; and
the praescriptio is the prescription itself; that is, directions to the dispensing pharmacist to supply medication, made up of the following:

the invocatio, consisting of the abbreviation Rp; this is analogous to the Rx used in the Anglosphere, and stands for recipe, Latin for take [from the shelf]; and
the ordinatio, also known as the compositio, which consists either of the brand name, strength, and number and type of dosage units of a particular drug, or else of directions written entirely in the Latin accusative case, with the exception of ingredient names, written in the genitive case. Masses are written in grammes, without the unit name. The compositio is followed by

the subscriptio, which consists of the directions according to which the medicament is to be prepared. An important part of this is the signatura, which is directed towards the patient and explains how to use the medication. Unlike the rest of the prescription, the signatura is written in the national vernacular.

Examples

Prescription

Reading

Translation

For off-the-shelf morphine tablets:

Rp.

Sevredol tbl. 60×20 mg

Exp. orig. No II (duas)

D.S. For pain 4×1 by mouth

Recipe

Sevredol tabulettae sexaginties milligrammae viginti

Expeditiones originales numero duas

Da Signa: For pain, one pill four times a day by mouth

Take

Sevredol, sixty twenty-milligramme tablets

Two packages

Directions for use: For pain, one pill four times a day by mouth

Individually compounded medication

Rp.

Pentobarbitali natrici 3

Morphiae sulphas 2

Chlorali hydrati 15

Saccharum ad 50

M.f.plv.

Div. in doses aeq. No XXX (triginta)

D.S. For sleep: one sachet to be taken at bedtime

Recipe

Pentobarbitali natrici grammata tres

Morphiae sulphas grammata duo

Chlorali hydrati grammata quindecim

Saccharum ad grammata quinquaginta

Misce fiat pulvis

Divide in doses aequalis numero triginta

Da Signa: For sleep: one sachet to be taken at bedtime

Take

of pentobarbitone sodium, three grammes

of sulphate of morphia, two grammes

of hydrate of chloral, fifteen grammes

of table sugar, enough to make fifty grammes

Mix to make powder

Divide into thirty equal doses

Directions for use: For sleep: one sachet to be taken at bedtime

Other conventions

Should a patient require a dosage in excess of the maximum as established by the appropriate governmental body, this is marked by an exclamation mark and the highest recommended dosage in Latin. If this is not done, it is the responsibility of the pharmacist to contact the doctor as to dose requirements, or amend the dose to the highest recommended one.

In emergency situations, a prescription pad may not be available. In this situation, any piece of paper will do, provided it is marked Periculum in mora!; that is, danger in delay (other designations, such as Cito! or Statim!, are also used and understood). Such ad-hoc prescriptions have a limited period of validity; typically, this is the day after the prescription is written.

A doctor may self-prescribe, or prescribe for his family; this is done by replacing the signatura by the Latin phrase pro manus medici (for medical hands) or ad usum proprium (for own use). This is to be done with caution; certain drugs self-prescribed will arouse suspicion, and may result in investigation by the medical board or another governmental body.

Brand-name drugs may be swapped for generics; if this is not wanted by the doctor, he may write dispense as written in the local language on the prescription.

Non-prescription drug prescriptions

Prescriptions are also used for things that are not strictly regulated as a prescription drug. Prescribers will often give non-prescription drugs out as prescriptions because drug benefit plans may reimburse the patient only if the over-the-counter medication is taken under the direction of a medical practitioner. Conversely, if a medication is available over-the-counter, prescribers may ask patients if they want it as a prescription or purchase it themselves. Pharmacists may or may not be able to price the medication competitively with over-the-counter equivalents. If the patient wants the medicatioot under prescription, the prescriber is usually careful to give the medicatioame to the patient on a blank piece of paper to avoid any confusion with a prescription. This is applied to non-medications as well. For example, crutches, and registered massage therapy may be reimbursed under some health plans, but only if given out by a prescriber as a prescription.

Prescribers will often use blank prescriptions as general letterhead. Legislation may define certain equipment as “prescription devices”. Such prescription devices can only be used under the supervision of authorized personnel and such authorization is typically documented using a prescription. Examples of prescription devices include dental cement (for affixing braces to tooth surfaces), various prostheses, gut sutures, sickle cell tests, cervical cap and ultrasound monitor.

In some jurisdictions, hypodermic syringes are in a special class of their own, regulated as illicit drug use accessories, separate from regular medical legislation. Such legislation will often specify a prescription as the means by which one may legally possess syringes.

Related usage of the term prescription

Prescription may also be used as a short form for prescription drugs to distinguish from over-the-counter drugs. In reference to the entire system of controlling drug distribution (as opposed to illicit drugs), “prescription” is often used as a metaphor for healthy directions from a prescribing medical practitioner. A green prescription is direction from a medical practitioner to a patient for exercise and healthy diet.

History

The concept of prescriptions dates back to the beginning of history. So long as there were medications and a writing system to capture directions for preparation and usage, there were prescriptions.

Modern prescriptions are actually “extemporaneous prescriptions” from the Latin (ex tempore) for “at/from time”. “Extemporaneous” means the prescription is written on the spot for a specific patient with a specific ailment. This is distinguished from a non-extemporaneous prescription which is a generic recipe for a general ailment. Modern prescriptions evolved with the separation of the role of the pharmacists from that of the physician. Today the term “extemporaneous prescriptions” is reserved for “compound prescriptions” which requires the pharmacist to mix or “compound” the medication in the pharmacy for the specific needs of the patient.

Predating modern legal definitions of a prescription, a prescription traditionally is composed of four parts: a “superscription”, “inscription”, “subscription” and “signature”.

The superscription section contains the date of the prescription and patient information (name, address, age, etc.). The symbol “℞” separates the superscription from the inscriptions sections. In this arrangement of the prescription, the “℞” is a symbol for recipe or literally the imperative “take.” This is an exhortation to the pharmacist by the medical practitioner, “I want the patient to have the following medication”- in other words, “take the following components and compound this medication for the patient.”

The inscription section defines what is the medication. The inscription section is further composed of one or more of:

a “basis” or chief ingredient indended to cure (curare)
an “adjuvant” to assist its action and make it cure quickly (cito)
a “corrective” to prevent or lessen any undesirable effect (tuto)
a “vehicle” or “excipient” to make it suitable for administration and pleasant to the patient (jucunde)

The “subscription” section contains dispensing directions to the pharmacist. This may be compounding instructions or quantities.

The “signature” section contains directions to the patient and is often abbreviated “Sig.” or “Signa.” It also obviously contains the signature of the prescribing medical practitioner though the word “signature” has two distinct meanings here and the abbreviations are sometimes used to avoid confusion.

Thus sample prescriptions in modern textbooks are often presented as:

℞:  medication

Disp.:  dispensing instructions

Sig.: patient instructions

Use of technology

As a prescription is nothing more than information among a prescriber, pharmacist and patient, information technology can be applied to it. Existing information technology is adequate to print out prescriptions. Medical information systems in some hospitals do away with prescriptions within the hospital. There are proposals to securely transmit the prescription from the prescriber to the pharmacist using smartcard or the internet. In the United Kingdom a project called the Electronic Transfer of Prescriptions (ETP) within the National Programme for IT (NPfIT) is currently piloting such a scheme between prescribers and pharmacies.

Within computerized pharmacies, the information on paper prescriptions is recorded into a database. Afterwards, the paper prescription is archived for storage and legal reasons.

A pharmacy chain is often linked together through corporate headquarters with computer networking. Walgreens, for example, uses satellite technology to share patient information. A person who has a prescription filled at one Walgreens can get a refill of that prescription at any other store in the chain, as well as have their information available for new prescriptions at any Walgreens.

Some online pharmacies also offer services to customers over the internet. Walgreens’ web site, for example, allows customers to order refills for medicine over the internet, and allows them to specify the store that they will pick up the medicine from. Their web site also allows consumers to look up their prescription history, and to print it out.

Many pharmacies now offer services to ship prescription refills right to the patient’s home. CVS, for example, will ship refills free of charge. They also offer mail service where you can mail in a new, original prescription and a signed document, and they will ship the filled prescription back to you. Pharmacy information systems are a potential source of valuable information for pharmaceutical companies as it contains information about the prescriber’s prescribing habits. Prescription data mining of such data is a developing, specialized field. Many prescribers lack the digitized information systems that reduce prescribing errors. To reduce these errors, some investigators have developed modified prescription forms that prompt the prescriber to provide all the desired elements of a good prescription. The modified forms also contain pre-defined choices such as common quantities, units and frequencies that the prescriber may circle rather than write out. Such forms are thought to reduce errors, especially omission and handwriting errors and are actively under evaluation. (See: Kennedy AG, Littenberg B. A Modified Outpatient Prescription Form to Reduce Prescription Errors. Joint Commission Journal of Quality and Safety 2004; 30:480-487.)

Over-the-counter drug

OTC medication with child-resistant packaging (cap) and tamper-resistant carton and innerseal

Over-the-counter (OTC) drugs are medicines that may be sold directly to a consumer without a prescription from a healthcare professional, as compared to prescription drugs, which may be sold only to consumers possessing a valid prescription. In many countries, OTC drugs are selected by a regulatory agency to ensure that they are ingredients that are safe and effective when used without a physician‘s care. OTC drugs are usually regulated by active pharmaceutical ingredients (APIs), not final products. By regulating APIs instead of specific drug formulations, governments allow manufacturers freedom to formulate ingredients, or combinations of ingredients, into proprietary mixtures.

The term over-the-counter may be somewhat counterintuitive, since, in many countries, these drugs are often located on the shelves of stores like any other packaged product. In contrast, prescription drugs are almost always passed over a counter from the pharmacist to the customer. Some drugs may be legally classified as over-the-counter (i.e., no prescription is required), but may only be dispensed by a pharmacist after an assessment of the patient’s needs and/or the provision of patient education. In many countries, a number of OTC drugs are available in establishments without a pharmacy, such as general stores, supermarkets, gas stations, etc. Regulations detailing the establishments where drugs may be sold, who is authorized to dispense them, and whether a Regulation by country.

Canada

An intermediate category—non-prescription items that must be kept behind the counter, in a store room, or on a shelf readily visible by the pharmacist, which includes weak codeine products, muscle relaxants, and some antihistamines—exists.

United States

In the United States, the manufacture and sale of OTC substances is regulated by the Food and Drug Administration. The FDA requires that all “new drugs” obtain a New Drug Application (“NDA”) prior to entering interstate commerce, but the act exempts any drugs generally recognized as safe and effective (“GRAS/E”) from this requirement. In order to deal with the vast number of OTC drugs that were already on the market prior to the requirement that all drugs obtain an NDA, the FDA created the OTC monograph system to review classes of drugs and categorize them as GRAS/E after review by expert panels. This meant that certain classes of OTC drugs would not be required to obtain an NDA and could remain on the market if they conformed to the monograph guidelines for doses, labeling, and warnings which are finalized in the Code of Federal Regulations.

Thus, in the United States an OTC drug product is allowed to be marketed either: (1) pursuant to an FDA monograph; or (2) pursuant to an NDA for products that do not fit within a specific monograph. There is also the possibility that certain OTC drug products are marketed under the grandfather provisions of the Federal Food, Drug, and Cosmetic Act, but FDA has never formally acknowledged that any legitimate grandfather OTC drug exists.

Examples of OTC substances approved in the United States are sunscreens, anti-microbial and anti-fungal products, external and internal analgesics such as lidocaine and aspirin, psoriasis and eczema topical treatments, anti-dandruff shampoos containing coal tar, and other topical products with a therapeutic effect.

The Federal Trade Commission regulates advertising of OTC products. This is in contrast to prescription drug advertising, which is regulated by the FDA.

The FDA requires that OTC products are labeled with an approved Drug Facts label to educate consumers about their medications. These labels comply to a standard format and are intended to be easy for typical consumers to understand. Drug Facts labels include information on the product’s active ingredient(s), indications and purpose, safety warnings, directions for use, and inactive ingredients.

Restricted OTC Substances

An ill-defined third category of substances comprises those products having over-the-counter status from the FDA, while being simultaneously subject to other restrictions on sale. While these products are legally classified as OTC drugs, they are typically stored behind the pharmacy counter and are sold only in stores employing a registered pharmacist; such items may be unavailable in convenience or grocery stores that stock other non-restricted OTC medications.

For example, many U.S. drugstores have moved products containing pseudoephedrine, an OTC product, into locations where customers must ask a pharmacist for them. A prescription is not required; the change has been made in an effort to reduce methamphetamine production. Since the passage of the Illinois Methamphetamine Precursor Control Act and the subsequent Federal Combat Methamphetamine Epidemic Act of 2005, the purchase of pseudoephedrine in the United States is restricted. Sellers of pseudoephedrine must obtain and record the identity of the purchaser and enforce quantity restrictions. Some states may have more stringent requirements (e.g., Oregon , where a medical prescription is required to purchase any quantity of pseudoephedrine). After initial attempts to control meth use by requiring documentation of sale with government issued ID as well as limits on the quantity an individual could purchase failed to realize meaningful reductions in methamphetamine use and production, Mississippi passed House Bill 512 in the State Senate on February 2, 2010,” to require a prescription from a licensed medical professional to purchase over-the-counter medicines with pseudoephedrine, ephedrine, or any other precursor chemical that can readily and illicitly be converted into methamphetamine, Methcathinone or any active/scheduled analogs of Phenylethylamines/ amphetamine. Despite these restrictions, products containing the substance are still OTC in most states, since no prescription is required.

A similar regulation applies to various forms of Emergency Contraception. The FDA considers these products to be OTC substances for women aged 17 or over, but prescription drugs for younger women. To enforce this restriction and to provide counseling and education on proper use, an agreement between the manufacturer and the FDA requires that these drugs are stored behind the pharmacy counter. Women may obtain the medication without a prescription after providing proof of age to pharmacy staff and receiving any necessary patient education.

Furthermore, some Schedule V controlled substances may be classified as OTC products in certain states. Such drugs are sold without a prescription, but are subject to record-keeping rules and quantity and/or age restrictions, and must be dispensed by a pharmacy.

United Kingdom

In the United Kingdom, medication is governed by the Medicines Act 1968. Medication will fall into one of three categories:

1. Prescription Only Medication (POM), which are legally available only with a valid prescription from a prescriber. A pharmacist has to be on the premises for POM medicines to be dispensed, required by law. The medicine has been specifically prescribed for the patient holding the prescription, so it is considered safe for only the recipient to take. Just a small example of these include most Antibiotics, and all Antidepressants or Antidiabetic medications. Drugs also included as POM are high-strength painkillers such as Oxycodone and Tramadol, medications such as Sildenafil (Viagra) and Diazepam (Valium), and certain topical preparations such as nCorticosteroids. These medicines are often sold by drug dealers, especially those marked as “CD POM,” which are controlled due to abuse risk such as Diconal, Temazepam, and Methadone.

2. General Sales List (GSL), available off the shelf with no pharmacy training required to sell (so they can be sold anywhere, such as supermarkets). In general, they are considered safe for most people when taken correctly. Examples of these include 16-packs (or less) of painkillers such as paracetamol & ibuprofen as well as a host of other safe medications such as small pack sizes of Antiallergy tablets, Laxative medication, and skin creams.

3. Pharmacy Medicines (P), are medicines which are legally neither a POM or GSL medication. These can be sold from a registered pharmacy but should not be available for self selection (although directions to discuss a ‘P’ product may also be allocated shelf space with associated GSL items). ‘P’ medications are reserved from the GSL list as they are either associated with a need for advice on use, or used in conditions which may require referral to a medical prescriber. Suitable trained counter assistants may sell a ‘P’ medication under the supervision of a pharmacist and will ask questions to determine if the customer needs to be referred for a discussion with a pharmacist. Some ‘POM’ medicines are available for use in certain situations and doses as ‘P’ medicines.

If it is not appropriate to sell a ‘P’ medication, i.e. the condition is not suitable for self management and requires referral to a medical prescriber then a sale should not occur and the pharmacist has a legal and professional obligation to refer this on to an appropriate service. Examples of these include some sleep aid tablets such as Nytol, Human de-worming tablets such as Mebendazole, painkillers with small amounts of Codeine (up to 12.8 mg per tablet), and pseudoephedrine. Medication available only with a prescription is marked somewhere on the box/container with [POM]. Pharmacy-only products are marked with [P]. A prescription is not required for [P] medicines, and pharmacy sales assistants are required by Royal Pharmaceutical Society codes to ask certain questions, which varies for what the customer says. If they ask for a specific product, the Pharmacy Assistant must ask “Who is it for,” “How long have you had the symptoms,” “Are you allergic to any medication,” “Are you taking any medication” (WHAM Questions). If a customer asks for a remedy, e.g., hay fever, then the 2WHAM questions must be followed “Who is it for,” “What are the symptoms,” “How long have you had the symptoms,” “Have you taken any action towards your symptoms,” and “Are you taking any other medication.” It is with this information that the pharmacist can halt the sale, if need be. No [POM] [P] or [GSL] products that are stocked in a pharmacy can be sold, dispensed, or pre-made until a responsible pharmacist is signed in and on the premises. Some medication available in supermarkets and petrol stations is sold only in smaller packet sizes. Often, larger packs will be marked as [P] and available only from a pharmacy. Frequently, customers buying larger-than-usual doses of [P] medicines (such as DXM, promethazine, codeine or Gee’s linctus) will be queried, due to the possibility of abuse.

Switches between prescription and OTC

As a general rule, over-the-counter drugs have to be used primarily to treat a condition that does not require the direct supervision of a doctor and must be proven to be reasonably safe and well tolerated. OTC drugs are usually also required to have little or no abuse potential, although in some areas drugs such as codeine are available OTC (usually in strictly limited formulations or requiring paperwork or identification to be submitted during purchase). One of the oldest OTC drugs is aspirin.

Over time, often 3–6 years, drugs that prove themselves safe and appropriate as prescription medicines may be switched from prescription to OTC. An example of this is diphenhydramine (Benadryl), which once required a prescription but now is available OTC nearly everywhere. Diphenhydramine is an anti-histamine. More recent examples are cimetidine and loratadine in the United States, and ibuprofen (Herron Blue/Nurofen) in Australia.

It is somewhat unusual for an OTC drug to be withdrawn from the market as a result of safety concerns, rather than market forces, though it does happen occasionally. Phenylpropanolamine is one such example: after it was removed from sale in the United States over concern regarding strokes in young women. A study has been done examining consumer’s perceptions about the risk of and access to nonprescription medication. A substantial minority of the public appears willing to accept considerable risk to gain greater access to pharmaceuticals.

In the United Kingdom, it was announced In February 2007, that Boots the Chemist would try over-the-counter sales of Viagra in stores in Manchester, England (previous available as prescription only). Men aged between 30 and 65 would be eligible to buy four tablets after a consultation with a pharmacist.

Pharmaceuticals

Medicines contribute enormously to the health of the nation. The discovery, development and effective use of drugs have improved many people’s quality of life, reduced the need for surgical intervention and the length of time spent in hospital and saved many lives. Our consumption of drugs is vast and is increasing. About 650 million prescriptions are written each year by GPs alone. Medicines cost the NHS in England over Ł7 billion every year, 80% of which is spent on branded (patented) products. The industry which has produced these drugs has understandably been described as “world class and a jewel in the crown of the UK economy”. It is the third most profitable economic activity after tourism and finance.

While the United States is the industry’s largest market and is the site of most drug research and development, the UK industry, nevertheless, has a remarkably impressive record. It is a centre of world class science, accounting for 10% of global pharmaceutical R&D expenditure. It has been estimated to fund 65% of all health-related R & D in the UK. However, there are disadvantages in the increasing use of and reliance on medicines. The inappropriate or excessive use of medicines can cause distress, ill-health, hospitalisationand even death. Adverse drug reactions are responsible for about 5% of all admissions to hospitals in the UK.

The interests of pharmaceutical companies and those of the public, patients and the NHS often overlap but they are not identical. For the industry, medical need must be combined with the likelihood of a reasonable return on investment. An effective regulatory regime to ensure that the industry works in the public interest is essential. Unfortunately, the present regulatory system is failing to provide this. The system is at times frustrating, arguably with excessive attention to unimportant detail, but it is, as we describe below, insufficiently effective.

The Department of Health has for too long optimistically assumed that the interests of health and of the industry are as one. This may reflect the fact that the Department

sponsors the industry as well as looking after health. The result is that the industry has been left to its own devices for too long. It may be relevant that this is the first major select

committee inquiry into the pharmaceutical industry for almost one hundred years – the last was undertaken by the Select Committee on Patent Medicines which reported iAugust 1914.

The consequences of lax oversight is that the industry’s influence has expanded and a

number of practices have developed which act against the public interest. The industry

affects every level of healthcare provision, from the drugs that are initially discovered and

developed through clinical trials, to the promotion of drugs to the prescriber and the

patient groups, to the prescription of medicines and the compilation of clinical guidelines.

We heard allegations that clinical trials were not adequately designed – that they could be

designed to show the new drug in the best light – and sometimes fail to indicate the true

effects of a medicine on health outcomes relevant to the patient. We were informed of

several high-profile cases of suppression of trial results. We also heard of selective

publication strategies and ghost-writing. The suppression of negative clinical trial findings

leads to a body of evidence that does not reflect the true risk:benefit profile of the medicine

in question. Guidance produced by NICE and others relies on the published evidence. If all

the evidence is not published, or if negative findings are hidden, accurate guidance cannot

be issued and prescribers cannot make truly evidence-based decisions.

Once licensed, medicines are intensely promoted to prescribers. The very high costs of

developing a new drug make it vital that a company recoups its costs as quickly as possibly

after licensing. Coupled with company-sponsored information from medical journals and

supplements, ‘medical education’ materials, advertisements and sponsorship to attend

conferences, workshops and other events, it is little wonder that prescribing practices are

affected. GPs are particular targets; they have more prescribing freedom than hospital

specialists and their prescribing practices are not limited to hospital formularies.

Promotion of medicines to patients and links between drug companies and patient

organisations may add to this problem, leading patients to demand new drugs from their

doctors. The problem is far less to do with any particular activity; rather the volume may

distort prescribing practice. At the heart of the problem may be the trend for the industry

to become ever more driven by its marketing force.

The most immediately worrying consequence of the problems described above is the

unsafe use of drugs. Over-prescription of the COX-2 inhibitors, Vioxx and Celebrex, has

been linked to thousands of deaths and many more cases of heart failure. These case

illustrate a series of failures. Manufacturers are known to have suppressed certain trials for

these drugs in the US and may have done the same in the UK. In addition, there were

inadequacies in the licensing and post-marketing surveillance procedures and excessive

promotion of the drugs to doctors.

What has been described as the ‘medicalisation’ of society – the belief that every problem

requires medical treatment – may also be attributed in part to the activities of the

pharmaceutical industry. While the pharmaceutical industry cannot be blamed for creating

unhealthy reliance on, and over-use of, medicines, it has certainly exacerbated it. There has

been a trend towards categorising more and more individuals as ‘abnormal’ or ieed of

drug treatment.

The UK pharmaceutical industry

The pharmaceutical industry is a global enterprise. It is dominated by a few

multinationals. The US is the industry’s largest and most profitable market.

Nonetheless, Europe, and the UK in particular, provide a strong market for medicines

and have traditionally been important sites for drug-related R&D. Two of the largest

pharmaceutical companies, questioned as to the relevance of UK health policies to their

global businesses, testified to the importance of the UK as a site for the marketing and

development of medicines:

Both those involved in the UK pharmaceutical industry and its critics have given

evidence of its strength and success. It is fifth largest in the world by total sales,

representing 7% of world sales, after the US, Japan, Germany and France.14 The UK is the

third largest direct exporter of pharmaceuticals; has the third largest world trade surplus;

and accounts for 10% of world pharmaceutical R&D expenditure. The pharmaceutical

industry is an important employer and contributor to the economy of this country.15

The UK industry operates within a highly regulated environment. The way in which it

undertakes research, produces, licenses and markets its products are all subject to a detailed

regulatory system. In this chapter were discuss the industry. We later go on to look at

systems for controlling it.

Research and development

R&D facilities in the UK are world-class and British-based companies have a long

history of success in drug development. The pharmaceutical industry invests some Ł3.3

billion a year into R&D in the UK. Drug companies based in the UK employ 29,000

individuals in R&D, making it one of the largest employers of science graduates. The

industry funds more healthcare-related research in the UK than every other source

combined – six times as much as the Department of Health; five times as much as medical

charities; eight times as much as the Medical Research Council (MRC)

Funding of health-related R&D

The pharmaceuticals sector conducts 65% of health-rated R&D, and accounts for

around 40% of all industrial R&D expenditure in the UK, spending about Ł10 million each

day. The leading UK companies in R&D are GSK, AstraZeneca, Pfizer, Eli Lilly, Wyeth,

Roche, Merck Sharpe & Dohme and Novartis.17

The combination of a strong history and favourable environment means that the UK

pharmaceutical industry is able to “punch well above its market weight”: only 3% (by

value) of the world’s prescription medicines are sold here, yet the UK attracts around 10%

of global investment in pharmaceutical R&D.18 This is more than half of the total

pharmaceutical R&D investment in Europe as a whole (see Figure 2, below). Twenty-five

of the world’s leading medicines have their origins in this country, which is more than any

country except the US.

. The development of effective medicines has contributed significantly to the welfare of

patients, over the last 50 years in particular. Examples include the development of vaccines

against infectious diseases, the use of H2-antagonists in the treatment of peptic ulcers and

the discovery of AZT for the management of HIV/AIDS. The effective treatment of heart

disease with clot-busting medicines and anti-hypertensive drugs has helped reduce related

mortality rates by 40% in the last decade alone.21

According to the Association of the British Pharmaceutical Industry (ABPI), the UK

pharmaceutical industry’s representative body, improved treatments in 12 areas of serious

illness since the 1950s have reduced hospital bed days by a number equivalent to Ł11

billion NHS savings per year. This is 4 billion more than the total annual spend by the

NHS on medicines in England.22 A successful pharmaceutical industry therefore has

unquestionable healthcare as well as economic benefits. Advances in medicines and devices

can mean greater convenience in use as well as sometimes significant improvements in

treatment.

Generic medicines

All the major pharmaceutical companies produce branded products. Another section

of the industry has traditionally produced generic medicines, which come to market once

the branded drug’s patent expires. Generic drugs play a major part in containing NHS

drugs expenditure. In 2002, unbranded medicines accounted for 53% of all prescriptions

dispensed in England, but 20% of total drug costs. Four years after patent expiry of a

branded product, generic drugs will account for about half of the drug’s market (UK

average) and the average price differential between branded and generic versions of the

same drug is approximately 80%.

In the UK, those prescribing in the community are encouraged to write the generic

drug name, whereas in many other countries (and in UK hospitals) there is an automatic

generic substitution system in place. Nevertheless, the rate of generic prescribing is still

very high compared with other major European pharmaceutical markets, and substantial

costs savings are achieved. In 2003, 77.8% of prescriptions were written generically, a

record of which the Department is proud.24 Since 1997, the proportion of prescriptions

written and dispensed generically has significantly increased, though cost savings appear to

have slowed.

Over the past decade, there have been significant changes in the pattern of UK generic

manufacturing ownership, leading to increasing domination by large international generic

manufacturers. In general, these manufacturers operate independently of, and in

competition with, the major brand name companies. However, the Ł4.4 billion acquisition

of two major generic producers by the Swiss firm, Novartis, in February 2005, may presage

a major change. Novartis, the world’s sixth-largest producer of branded drugs, is now the

world’s largest manufacturer of generics.

The Pharmaceutical Industry Competitiveness Task Force

Despite its continuing success during the 1990s, there were increasing concerns about

the competitiveness of the UK pharmaceutical industry that were voiced at a meeting in

November 1999 between the Prime Minister and the Chief Executive Officers (CEOs) of

AstraZeneca, Glaxo Wellcome and SmithKline Beecham. The CEOs argued that the

traditional factors that underpinned the UK’s past success in pharmaceuticals were no

longer sufficient to guarantee good performance, and that an initiative was required to

ensure the UK retained its competitive edge. They expressed particular concern about

difficulty in getting their products to the UK market, and intellectual property protection.

This led to the establishment of the Pharmaceutical Industry Competitiveness Task Force

(PICTF).

The overall aim of PICTF was to look at ways of ensuring that the UK remained an

attractive location for the pharmaceutical industry, with specific reference to international

competitiveness, the free movement of medicines within the EU and European licensing of

medicines, the UK as a site for R&D (including partnerships with academia) and the NHS

as a location for clinical studies. The group was co-chaired by Lord Hunt, then

Parliamentary Under Secretary of State for Health, and Sir Tom McKillop, CEO of

AstraZeneca, with equal representation from Government and the industry.

PICTF published a report in March 2001 that proposed specific measures and

commitments by Government to assist the UK pharmaceutical industry. It also defined

‘Competitiveness and Performance Indicators’ for the industry, to be recorded and

published each year to assess trends over time. These indicators provide the objective data

to underpin assessments of how well the UK is performing in the key areas that are crucial.

The first set of indicators was published in March 2001 and the most recent set was

published in December 2004. They show that the UK currently has:

A pharmaceutical industry that contributes significantly to the UK economy;

A comparatively strong scientific research base;

An impressive record of pharmaceutical innovation;

A relatively rapid regulatory process for medicines compared to other countries; and

Relatively slow uptake of medicines by prescribers.

There are not enough trained medical researchers in the UK. This means there are too

few individuals who can organise clinical trials or take part in a reviewing or

implementation capacity.

There is a shortage of appropriately trained clinical investigators in the UK, and this

reflects lack of investment in clinical research and problems with clinical training

pathways.

Specialist facilities are also lacking. There are very few centres in which paediatric

clinical trials may be effectively conducted, for example. This will become more relevant

following the introduction of a new European Regulation on Paediatric Medicines in 2006,

which will require more medicines to be licensed for use in children.

Medicines licensing

Drug approval and licensing systems worldwide are based on detailed requirements

and elaborate processes, the scope of which is constantly changing. However, the core

elements of drug control remain essentially unchanged.

The executive arm of the UK Licensing Authority is the Medicines and Healthcare

products Regulatory Agency (MHRA), which is also responsible for approving clinical

trials48. The MHRA is assisted by the Committee on the Safety of Medicines (CSM), and

the Medicines Commission. These latter two organisations are due to be merged into one

over-arching body, the Commission for Human Medicines. Medicines may be licensed for

use in the UK either on a national basis (directly through the MHRA), through a

centralised approval system of the European Medicines Agency (EMEA) or through a

procedure for ‘mutual recognition’. Under the centralised scheme, companies apply for a

licence directly to the EMEA. The centralised approval system is already compulsory for

biotechnology products and has expanded in scope to cover drugs for AIDS, cancer,

neurodegenerative diseases and diabetes. Alternatively, a company may designate one EU

country to approve a drug licensing application, and then receive marketing authorisation

in various EU countries, provided these other countries agree. Under this ‘mutual

recognition’ procedure, all EU countries in which marketing permission is sought receive

the full drug licence application, and any objections are considered and resolved through

EMEA’s oversight body, the Committee on Human Medicinal Products (CHMP). Details

for the arrangements for medicines licensing, regulation and post-licensing surveillance are

discussed in Part 5.

Once licensed, the drug itself is under patent protection for 10 years, although in

certain circumstances this may be extended. Once the period of patent protection has

expired, the originating company is deemed to have been rewarded for risks of innovation

and generic versions of the drug may enter the market. A generic medicine contains the

same active ingredients as an original product that has been researched and developed by a

pharmaceutical company. Regulatory standards for safety and efficacy are the same for

generic medicines as for branded products and marketing authorisation must be obtained

from the MHRA before the drug is allowed on to the market. Additional clinical data is not

required. The manufacturers of generic medicines need prove only that their products are

effectively identical to the original branded product, implying that they have identical

effects on patients.

Post-licensing evaluation, including value for money assessments

.The initial marketing authorisation lasts for five years, at which time the company must

apply to the MHRA for a further, essentially permanent, licence if it wishes the product to

remain on the market. The legal criteria for re-licensing are the same as those for the

original assessment (safety, efficacy and quality) but in reality scrutiny is much less

stringent and would rarely involve the CSM. Efficacy is rarely considered. There is no

specific policy regarding the continuing evaluation and safety assessment of medicines.

The MHRA is also charged with conducting more general post-marketing surveillance.

This may involve scrutiny of Phase IV trials, which include patients in a more typical

clinical setting, as well as monitoring published medical literature and evaluation of

spontaneous reports of suspected adverse drug reactions (ADRs.

Legislation requires that pharmaceutical companies must provide information on their

products on request from healthcare professionals. This obligation continues once

medicines come off-patent and does not apply to generic companies. Large companies in

the UK may each receive 15–30,000 requests for information annually. As an example,

Pfizer, the largest supplier of prescription medicines to the NHS, pays over Ł1 million

annually to cover the cost of providing this information service.51

Information to prescribers

A Summary of Product Characteristics (SPC) is issued to prescribers and other

healthcare professionals for every new drug. The detail of content, style, layout and format

are closely defined and approval is part of the licensing process.

The British National Formulary (BNF), which is published biannually, also provides

information to prescribers. The BNF is published jointly by the British Medical Association

(BMA) and the Royal Pharmaceutical Society of Great Britain (RPSGB). It provides

information on the prescription, dispensing, administration and cost of medicines.

A range of alternative sources of independent information is available, including the

Drug and Therapeutics Bulletin (DTB) that is published by Which? and distributed by the

Department of Health to all doctors,52 the Cochrane Collaboration and the James Lind

Library. Medical journals provide a variety of specialist and non-specialist data relating to

clinical trials or basic scientific studies. Industry produced or sponsored information is also

provided to prescribers, in the form of journal supplements, reprints and other literature.

Information to patients

Patient Information Leaflets (PILs), which are legally required documents written in

accordance with EU regulations and approved by the MHRA, are printed and distributed

alongside medicines by pharmaceutical companies to inform patients of how to take their

medicine most effectively and to warn them of possible risks and side-effects. Like the SPC,

they are approved as part of the licensing process; however, the regulations are not so

prescriptive for PILs, allowing limited variation in their content and appearance. The PIL

must correspond to the SPC. In response to long-standing criticisms, the MHRA set up a

Patient Information Working Group in 2003, to review the design, content and utility of

PILs. The work of this group is continuing

In addition to the PIL, patients (and carers) may receive industry-produced pamphlets

or written instructions through their doctor or other healthcare professional. Patients can

also access large amounts of information and promotional material on the Internet.

The Department provides a grant to cover this service.

Professional and patient education

Doctors are required to continue their education after they have qualified by taking

part in accredited activities. These may take the form of attendance at training days or

workshops. Industry funds over half of all postgraduate education and training for doctors

in the UK, often meeting the travel and accommodation costs of attendance. The

pharmaceutical industry also funds a significant amount of training for nurses. In 2003, for

instance, GSK funded 235 nursing diplomas in respiratory disease management and 199

diplomas in diabetes management.

Education for patients is provided in a variety of ways, including disease awareness

campaigns, which are discussed in detail in Part 8. Such campaigns are designed to increase

awareness among the general public of particular conditions that may be under-reported

or under-diagnosed and to encourage people to seek treatment. Often, such campaigns are

sponsored by a drug company and may bear a company’s logo; they may be also endorsed

by a charity or patient organisation and/or supported by a celebrity.

Guidelines for disease awareness campaigns, developed jointly between the MHRA and

the ABPI, were published in April 2003. The guidelines state that educational materials

may highlight the availability of treatment but may not focus on, or name, any single

intervention.

The promotion of drugs

Worldwide, there has been a marked trend to substantially increased expenditure on

marketing. In the US, major pharmaceutical companies spend of the order of 24% to 33%

of sales on marketing, about twice as much as on R&D.55 Exact comparisons are

complicated because of uncertainties about the dividing line/overlap between marketing

and related activities, notably provision of drug information and professional education

programmes. We have not been presented with UK figures, but direct promotional

expenditure in this country is proportionately lower than in most European countries,

reflecting the dominance of the NHS as the major drug purchaser and the terms of the

Pharmaceutical Price Regulation Scheme (PPRS),

Prescription-only medicines may be promoted only to healthcare professionals, except

in very specific cases such as Government-endorsed vaccination programmes. Promotion

to prescribers may take many forms:

a) Drug company representatives. Approximately. 8,000 drug company representatives

operate in the UK and play an important role in information provision and medicines.

b) Sponsored attendance at industry-organised events or medical conferences. Travel and

accommodation costs are often met by the company. Other forms of hospitality are

also provided.

c) Journal articles and supplements supporting use of the company’s drug. These are

distributed free to prescribers and are available at conferences and on the Internet.

d) Direct advertising. Advertisements are placed in medical journals and magazines.

Direct mailing to healthcare professionals often takes the form of informing prescribers

of changes in drug delivery systems or the availability of new drug formulations.

Approximately 80% of medicines advertising is aimed at doctors, with an increasing

amount targeting nurses with new prescribing powers

Public relations and marketing agencies are often used by the pharmaceutical industry

to assist with the promotional activities described above. ‘Medical communications’ play

an important role in the marketing of medicines. The main aim is to improve sales figures

and there are dedicated agencies that often form part of enormous, multinational PR and

communications companies, such as Ogilvy, Burson-Marsteller, Edelman and Ketchum.

Medical communications agencies may be involved in all or some of the following:

a) Pre-marketing of drugs;

b) Identification of disease areas;

c) Disease awareness campaigns;

d) Consumer education and marketing;

e) Publications and papers;

f) Conferences, meetings and hospitality;

g) ‘Product lifecycle management’;

h) Regulatory and policy issues;

i) Grassroots communications;

j) Key opinion leader development; and

k) The production of ‘educational’ materials aimed at prescribers.

A critical element of the work of medical communications companies is the

recruitment and training of key opinion leaders (KOLs), who are usually ‘authoritative

third parties’ such as physicians at the top of their field. These individuals may be paid to

speak and write on behalf of the sponsoring pharmaceutical company.

Increasingly creative methods are used in the promotion of drugs by Industry. Which?

cited a financial donation made by the manufacturers of Cipralex (escitalopram, an

antidepressant manufactured by Eli Lilly) to Depression Alliance when GPs completed and

returned a feedback leaflet relating to their drug58 and a spoof Mr Man book (‘Mr Sneeze’)

that was sponsored by a drug company and carried information about its anti-allergy

product.

The direct advertising of prescription drugs to patients is prohibited. Direct-to-

consumer advertising (DTCA) of prescription-only medicines is permitted only in the US

and New Zealand. Moves towards extending DTCA to Europe proposed by the European Commission were quashed by the European Parliament in October 2002 by a majority of 494 to 42. Only over-the-counter (OTC) medicines may be advertised to the UK general public. The Medicines (Advertising) Regulations 1994, amended in 1999, govern the advertising of these medicines. There are specific regulations relating to promotional methods that could lead to the unnecessary or excessive use of medicines. 85. Complaints regarding advertising material are handled by a variety of bodies. The Proprietary Association of Great Britain (for OTC medicines), the Prescription Medicines Code of Practice Authority (PMCPA, for prescription-only drugs) and the Advertising Standards Authority operate as self-regulatory schemes and take responsibility for handling advertising complaints alongside the MHRA. Corrective statements are rarelymandatory, although a recent increase in the number of such statements required by theMHRA has been observed. A number of processes are in place to control the research, marketing and promotional activities of the UK pharmaceutical industry. These include: a) International standards of good clinical practice (GCP) in research; b) Research Ethics Committees; c) Medicines licensing regulation; d) Post-marketing safety surveillance and drug evaluation; and

e) Cost assessment.

Orphan drugs

In order to increase rates of research into areas of serious disease that affect relatively

few people (and therefore might be expected to have low market value) the US Orphan

Drugs Act was passed in 1983 in the US and its principles were adopted in the European

Orphan Drugs Act in 2000. Incentives to develop orphan drugs include intellectual

property protection and 11-year market exclusivity.

A number of criticisms have been levelled against the current system for encouraging

the development of orphan drugs. The lack of competition drives up orphan drug prices

and this may have important economic implications for PCTs and other healthcare

providers. An example of this is nitric oxide, which was available for years and, unlicensed,

cost very little (it cost approximately Ł2,000 to supply a neo-natal unit with nitric oxide for

one year71). Two clinical trials proved the benefit of inhaled nitric oxide and it was

approved and received a patent in the US and EU on this basis.72 Since licensing, nitric

oxide now costs many times more (it was estimated that supply of nitric oxide for the same

neo-natal unit would now cost over Ł63,000 per year).

Some drugs marketed as Orphan Drugs may have required little research input. The

quality of clinical trials of Orphan Drugs has been questioned. In addition, innovation in a

particular area may be reduced once a single product is available, due to market exclusivity.

The National Institute for Clinical Excellence

The uptake of novel drugs, an issue of great importance to the industry, is partially

determined by NICE. The Institute issues guidance about the use of both old and new

medicines and procedures. Guidance is of four main forms:

a) Technology appraisals: recommendations on the use of new and existing medicines

and other treatments (devices, surgical and other procedures, diagnostic techniques

and health promotion methods);

b) Clinical guidelines: recommendations on the appropriate treatment and care of

patients with specific diseases and conditions, such as diabetes and schizophrenia;

c) Cancer service guidance: recommendations on arrangements for the organisation and

delivery of services for people with cancer; and

d) Interventional procedures: guidance about whether interventional procedures used for

diagnosis and treatment are safe enough and work well enough for routine use. An

interventional procedure is one used for diagnosis or treatment that involves making a

cut or hole in the body, entry into a body cavity or using electromagnetic radiation

(including X-rays or lasers) and ultrasound.

NICE currenty publishes around 25 technology appraisals, 12 clinical guidelines and

60 pieces of interventional procedures guidance each year. Of the 25 technology appraisals,

not all are for new drugs; they can also be reviews of non-drug treatments, re-reviews or

reviews of medicines licensed several years ago. This means that a minority of new drugs

approved by the MHRA are subsequently subject to NICE scrutiny. The Department of

Health asks the Institute to look at particular drugs and devices only where the availability

of the drug or device varies across England and Wales or where there is confusion or

uncertainty over its value.

The pharmaceutical industry has some say in the selection of topics for appraisal.

Drug companies provide information to the National Horizon Scanning Centre on the

development of new pharmaceutical products and their licensing position and have one

seat on the Advisory Committee on Topic Selection (ACTS), which assesses proposals for

work topics for NICE against published criteria. The Joint Planning Group, which

considers ACTS’ proposals and advises Ministers, who take final decisions on NICE’s work

programme, does not include the pharmaceutical industry in its membership. NICE’s

approach to engaging with the pharmaceutical industry in the development of its

technology appraisals and clinical guidelines is as follows:

a) NICE drafts a written consultation on the scope for a technology appraisal or a clinical

guideline.

b) NICE invites relevant members of the pharmaceutical industry, alongside the other

stakeholders, to a meeting at the start of the development of a piece of guidance to

discuss the scope, the approach to assembling the evidence base, and the key issues that

will be addressed during the development of the guidance.

c) NICE consults on the evidence to be used by the advisory body and all stakeholders are

given the opportunity to supplement the evidence base. Ultimately, the evidence that is

taken account of is a matter for the advisory body, which sets out the rationale for the

use or otherwise of the evidence submitted by all stakeholders.

d) The advisory body prepares a written consultation on the draft recommendations, on

two occasions during the development of a clinical guideline (where there is no appeal

stage), and on one occasion during the development of technology appraisal guidance

(where there is an appeal stage). Comments received from the pharmaceutical industry

on draft documents, in common with responses from other stakeholders, are posted on

the Institute’s website.

e) In the technology appraisal programme the relevant pharmaceutical company,

alongside other stakeholders, has the opportunity to submit an appeal on the grounds

that the Institute has exceeded its powers or has failed to follow its process, or that the

guidance is perverse.

The Pharmaceutical Price Regulation Scheme

The Pharmaceutical Price Regulation Scheme (PPRS) is a mechanism for determining

the profit made by drug companies through the sales of their medicines to the NHS.73

Details of the Scheme, which has been running since 1956 (when it was known as the

Voluntary Price Regulation Scheme) are negotiated periodically by the Department of

Health and the ABPI. The present Scheme came into force on 1 January 2005 and, unless

either side withdraws beforehand, will continue until at least 2010. The overall objectives of

the PPRS are to:

Secure the provision of safe and effective medicines for the NHS at reasonable prices;

Promote a strong and profitable industry capable of such sustained research and

development expenditure as should lead to the future availability of new and improved

medicines; and

Encourage the efficient and competitive development and supply of medicines to

pharmaceutical markets in this and other countries.

The PPRS, which applies only to companies supplying licensed brand name products

to the NHS, indirectly controls drug prices. Although it nominally applies to all such drug

suppliers, only those companies with sales each year to the NHS of more than Ł25 million

become involved in detailed negotiations. Sales by the 44 companies currently involved at

this level account for 94% of the total amount the NHS spends on purchasing brand name

products.

Through the Scheme, each year individual companies are set a level of return on

capital (ROC; the amount of money they can earn through sales to the NHS). Once this

profit target has been agreed, it is for the company to adjust the prices of its portfolio to

reach that target. Companies are required to reimburse the NHS when their returns are

above target, and may increase their prices when returns are below target.

Target ROCs are set in advance, so the profit actually achieved may differ from that

predicted. To take this into account, margins of tolerance (MOTs) are built into the PPRS

such that reimbursement is not required until returns are over 140% of the ROC target,

and price rises not permitted until returns are less than 40% of the ROC target. Increasing

the prices of established drugs is not encouraged, so companies generally aim to reach their

ROC targets by charging high prices for their drugs at the time of launch or by broadening

their sales base.

In order to set the ROC target, each year the company submits details of its business

in an annual financial return (AFR). One section of the AFR seeks information on the

company’s fixed assets (which includes the historic cost of the company’s UK sites, land,

buildings, plant and machinery). The profit the company is allowed is then calculated as

21% of the fixed asset figure, which, with the MOT, may rise to 29.4% of the fixed assets.

118. Also included in the determination of the final ROC are allowances for the company’s

spend on R&D, marketing and the provision of information. For R&D, the allowance is

equivalent to up to 28% of the company’s sales to the NHS, and in this figure provision is

made for each new drug introduced. For drug promotion, the figure is 4% of sales, and to

this is added further allowances depending on the number of drugs available. For

providing information, the allowance is again equivalent to 4% of sales to the NHS.

By determining company profit margins allowed against the sale of medicines to the

NHS, and by incorporating into these margins allowances for R&D, innovation, drug

promotion and the provision of information, the PPRS provides a key mechanism by

which the Department can act as the UK-based industry’s sponsor.

The price of generic medicines is not controlled by the PPRS but, since August 2000,

the main generics used in the community have been subject to a statutory maximum price

scheme. This cap on prices was introduced following ‘turbulence’ and alleged price-fixing

in the generics market that led to substantial prices increases in 1999/2000.

Drug and Therapeutics Committees

Local NHS measures may also be in place to control the activities of the

pharmaceutical industry. Drug and Therapeutics Committees (also known as Use of

Medicines Committees), which operate in local hospital Trusts, address prescribing and

medicines use across the Trust, including affiliated primary care trusts (PCTs). Their

guidance may be stricter than that of NICE. [See boxed text in Part 6 for an example of a

Drug and Therapeutics Committee.]

There are also Area Prescribing Committees, which operate across health authorities

and aim to ensure appropriate medicines use across the primary and secondary care

boundary. In addition, there are prescribing advisers, usually pharmacists, who are

employed by Strategic Health Authorities and PCTs, and work to encourage rational and

cost-effective prescribing in primary care. According to the Department of Health, over

1,200 prescribing advisers are now in place in England and Wales.74 This works out at an

average of fewer than four per PCT.

Professional bodies

The core guidance booklet published by the General Medical Council (GMC), Good

Medical Practice, warns doctors against “involvement in any relationships with

pharmaceutical or other companies which could raise, or be seen to raise, a conflict of

interests”.75 The GMC states that this is intended to cover matters such as accepting any

kind of substantial hospitality or gifts from pharmaceutical companies. According to Good

Medical Practice, doctors must be honest about any financial or commercial interests they

have in pharmaceutical companies and ensure that those interests do not affect their

independent judgement in providing and arranging patient care. No mention is made of

guidelines for medically qualified doctors working within the industry but the GMC is

reported to be working with Faculty of Pharmaceutical Medicine to set standards for

. The World Medical Association also issued guidelines in October 2004 on the relationship between doctors and commercial enterprises, with particular reference to the disclosure of interests in the context of

research, conference attendance, gifts and affiliations.

Other professional bodies, such as the Royal College of Nursing (RCN), Royal College

of General Practitioners (RCGP) and National Pharmaceutical Association (NPA), may

have individual policies in place regarding funding received from the pharmaceutical

industry. For example, the RCGP, which received 3% of its annual income from the

industry in the 2003–2004 financial year, stated:

The College has strict guidelines on accepting money from any sponsor, in order to

ensure that the sponsor has no direct influence on the educational content of an

event or conference.Although the GMC pointed out that, “complaints about doctors asking for or

accepting inappropriate fees or hospitality” from pharmaceutical companies are unusual,

we have not heard of any standard policies in place among professional organisations

governing the interaction between industry and their members. There is no centrally held

receives approximately 30% of its annual sponsorship income from the pharmaceutical

industry, stated that individual contact betweeurses and drug company representatives

does not involve the College:

Nurses can get offered the opportunity to negotiate payment of expenses for further

training directly with company representatives without reference, support or the

knowledge of the RCN. In these situations the RCN is not in any way involved, and

does not attempt to regulate.

The industry’s codes of practice

The industry has its own arrangements for regulating the sales and marketing

activities of its companies. This is largely achieved through the Code of Practice of the

ABPI.81 The Medicines Act and related EU legislation requires Ministers to exercise

oversight of these activities. All aspects of the promotion of medicines, including

advertisements, representatives’ activities, meetings, the provision of education and

hospitality and the provision of medical information by the industry are subject to self-

regulation through the Code. The ABPI states that the industry “works well within self-

regulation”.

Functional gastrointestinal disturbances in the early age children

Diseases of the lips and tongue in children

Diaphragmatic hernia. Disease of mediastinum

IMMUNE PREPARATIONS

Lecture 1

Articulation and occlusion. Biomechanics of movement of the mandible (Vertical, sagittal, transversal movements of the mandible).

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Disciplines

Types of pharmacy practice areas

Community pharmacy

Hospital pharmacy

Clinical pharmacy

Ambulatory care pharmacy

Compounding pharmacy

Consultant pharmacy

The main principle of consultant pharmacy is developed by Hepler and Strand in 1990. Internet pharmacy

Veterinary pharmacy

Nuclear pharmacy

Military pharmacy

Pharmacy informatics

Issues in pharmacy

Separation of prescribing from dispensing

The future of pharmacy

List of pharmaceutical sciences journals

Symbols

Medical prescriptions

Contents

Handling

Rx security – forgeries and prevention

Writing prescriptions

Legibility

Conventions for avoiding ambiguity

Abbreviations

Many abbreviations are derived from Latin phrases. Hospital pharmacies have more abbreviations, some specific to the hospital. Different jurisdictions follow different conventions on what is abbreviated or not. Prescriptions that don’t follow area conventions may be flagged as possible forgeries.

In Continental Europe

Parts of a European prescription

Examples

Other conventions

Non-prescription drug prescriptions

Related usage of the term prescription

History

Use of technology

Over-the-counter drug

Canada

United States

Restricted OTC Substances

United Kingdom

Switches between prescription and OTC

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Functional gastrointestinal disturbances in the early age children

Diseases of the lips and tongue in children

Diaphragmatic hernia. Disease of mediastinum

IMMUNE PREPARATIONS

Lecture 1

Articulation and occlusion. Biomechanics of movement of the mandible (Vertical, sagittal, transversal movements of the mandible).