medical prescription

Medical prescription From Wikipedia, the free encyclopedia Jump to: navigation, search This article may require cleanup to meet Wikipedia's quality standards. Please improve this article if you can. (March 2009) A prescription (℞) is a health-care program implemented by a physician or other medical practitioner in the form of instructions that govern the plan of care for an individual patient.[1] Prescriptions may include orders to be performed by a patient, caretaker, nurse, pharmacist or other therapist. Commonly, the term prescription is used to mean an order to 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. However, as medications have increasingly become pre–packaged manufactured products and medical practice has become more complex, the scope of meaning of the term "prescription" has broadened to also include clinical assessments, laboratory tests, and imaging studies relevant to optimizing the safety or efficacy. Contents [hide]               1 Format and definition o 1.1 Contents o 1.2 Handling o 1.3 Forgeries and prevention 2 Writing prescriptions o 2.1 Who can write prescriptions o 2.2 Legibility o 2.3 Conventions for avoiding ambiguity o 2.4 Abbreviations 3 Non-prescription drug prescriptions 4 Related usage of the term prescription 5 History 6 Use of Technology 7 Exhibit A: sample legal definition of a prescription 8 Exhibit B: sample legal requirement for storage of prescriptions 9 Exhibit C: sample legal requirements for security and format 10 Exhibit D: sample requirements on information added by the pharmacist 11 Exhibit E: New Jersey requirements for prescription blanks 12 Notes 13 References 14 See also [edit] Format and definition Prescription symbol Prescriptions are handwritten on preprinted prescription forms that are assembled into pads, or alternatively printed onto similar forms using a computer printer. 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 registration number (e.g. DEA Number in the United States). Unique for each prescription is the name of the patient. In the United Kingdom 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 [2]. There is the specific "recipe" of the medication and the directions for taking it. The symbol "Rx" meaning "prescription" is a transliteration of a symbol resembling a capital R with a cross on the diagonal (℞). There are various theories about the origin of this symbol - some note its similarity to the Eye of Horus[3] [4], others to the ancient symbol for Jupiter, both gods whose protection may have been sought in medical contexts. Alternatively, it may be intended as an abbreviation of the Latin "recipe" [5], the imperative form of "recipere", "to take or take thus"[6], and it is quite possible that more than one of these factors influenced its form. Literally, "Recipe" means simply "Take...." and when a medical practitioner writes a prescription beginning with "Rx", he or she is completing the command. This was probably originally directed at the pharmacist who needed to take a certain amount of each ingredient to compound the medicine, rather than at the patient who must "take" the medicine, in the sense of consuming it. The word "prescription" can be decomposed into "pre" and "script" and literally means, "to write before" a drug can be prepared. Those within the industry will often call prescriptions simply "scripts". [edit] Contents 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 less expensive generic drug substitutes that are therapeutically 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"[7]. 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 [8]. 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 [9]. When checked, pharmacist is instructed to label the medication. When not 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. [edit] 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 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 "prescription number" (often abbreviated "Rx#" in the US) that is unique to the pharmacy that filled the prescription. The prescription number is written right on the prescription by the pharmacist. The prescription number has the practical purpose of uniquely identifying the prescription later on while filed (both manual and electronic). The prescription number 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 prescription numbers 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 six years. 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 3 billion (3 thousand million) prescriptions were written in the United States in 2002[10]. This number has grown from 1.5 billion in 1989 and is expected to continue to grow. [edit] 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 [11]. Some medical practitioners will use prescription pads that contain similar security measures as checks to make photocopying prescriptions harder. 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 [12][dead link] . New Jersey, for example, requires that only state approved printers may be used to print official "New Jersey Prescription Blanks."[13][dead link] (See Exhibit E.) Prescribers can make it harder for amount forgeries by writing out the amounts in words. Again, this may be mandated by law[14][dead link]. Wikinews has related news: Canadian woman faces 234 counts of double-doctoring Some jurisdictions help control stolen prescriptions by requiring special "triplicate prescriptions" for certain classes of drugs [15][dead link]. 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).[16] 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. [edit] Writing prescriptions [edit] Who can write prescriptions Who can issue prescriptions is governed by local legislation. In the United States medical practitioners, veterinarians, dentists, and podiatrists have prescribing power. In addition, clinical pharmacists are allowed to prescribe in some states through the use of a drug formulary or collaboration agreements. In all states, optometrists prescribe medications to treat certain eye diseases, and also issue spectacle and contact lens prescriptions for corrective eyewear.[17] States allow registered certified physician assistants (also known as physician associates or PAs) prescription powers in all 50 states. 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 a limited number of drugs to treat emotional and mental disorders. [edit] Legibility Prescriptions, when handwritten, are notorious for being often illegible . In the US, medical practitioners' sloppy handwriting kills more than 7,000 people annually, according to a July 2006 report from the National Academies of Science's Institute of Medicine (IOM).[18]. 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 [19]). Some have advocated the elimination of handwritten prescriptions altogether [20] and computer printed prescriptions are becoming increasingly common in some places. [edit] Conventions for avoiding ambiguity Over the years, prescribers have developed many conventions for prescription-writing, with the goal of avoiding ambiguities or misinterpretation.[21] [22] [23] These include:  Careful use of decimal points to avoid ambiguity: o 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. o 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. o Avoiding decimals altogether by changing the units: 0.5 g is less easily confused when written as 500 mg. "mL" is used instead of "cc" or "cm³" 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 (3 times a day) and especially relationship to meals for orally consumed medication. The use of permanent ink. Avoiding unspecified prn or "as needed" instructions—instead, specific limits and indicators are provided e.g. "every 3 hours prn pain." For refills, the minimum duration between repeats and number of repeats should be specified. Providing the indication for all prescriptions even when obvious to the prescriber, so that the pharmacist may identify possible errors. 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 meters. 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). o [edit] Abbreviations See list of abbreviations used in medical prescriptions. 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. [edit] 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 competively with over-the-counter equivalents. If the patient wants the medication not under prescription, the prescriber is usually careful to give the medication name 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"[24]. 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 [25] separate from regular medical legislation. Such legislation will often specify a prescription as the means by which one may legally possess syringes. [edit] 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. [edit] 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 [26]. Modern prescriptions are actually "extemporaneous prescriptions" from the Latin (ex tempore) for "at/from time" [27]. "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 [28]. 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" [29]. The superscription section contains the date of the prescription and patient information (name, address, age, etc). The symbol "Rx" separates the superscription from the inscriptions sections. In this arrangement of the prescription, the "Rx" 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" [30] - 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[31]:    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 [32] and is often abbreviated "Sig." [33] 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: Rx: medication Disp.: dispensing instructions Sig.: patient instructions [edit] 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.[34] 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. Afterward, 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 lookup 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.[35] Many prescribers lack the digitized information systems that reduce prescribing errors.[36] 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.) [edit] Exhibit A: sample legal definition of a prescription Taken from California's Business and Professions Code Section 4040 [37]: 4040. (a) "Prescription" means an oral, written, or electronic transmission order that is both of the following: (1) Given individually for the person or persons for whom ordered that includes all of the following: (A) The name or names and address of the patient or patients. (B) The name and quantity of the drug or device prescribed and the directions for use. (C) The date of issue. (D) Either rubber stamped, typed, or printed by hand or typeset, the name, address, and telephone number of the prescriber, his or her license classification, and his or her federal registry number, if a controlled substance is prescribed. (E) A legible, clear notice of the condition for which the drug is being prescribed, if requested by the patient or patients. (F) If in writing, signed by the prescriber issuing the order, or the certified nurse-midwife, nurse practitioner, or physician assistant who issues a drug order pursuant to Section 2746.51,2836.1, or 3502.1. (2) Issued by a precribing medical practitioner if a drug order is issued pursuant to Section 2746.51, 2836.1, or 3502.1. (b) Notwithstanding subdivision (a), a written order of the prescriber for a dangerous drug, except for any Schedule II controlled substance, that contains at least the name and signature of the prescriber, the name and address of the patient in a manner consistent with paragraph (3) of subdivision (b) of Section 11164 of the Health and Safety Code, the name and quantity of the drug prescribed, directions for use, and the date of issue may be treated as a prescription by the dispensing pharmacist as long as any additional information required by subdivision (a) is readily retrievable in the pharmacy. In the event of a conflict between this subdivision and Section 11164 of the Health and Safety Code, Section 11164 of the Health and Safety Code shall prevail. (c) "Electronic transmission prescription" includes both image and data prescriptions. "Electronic image transmission prescription" means any prescription order for which a facsimile of the order is received by a pharmacy from a licensed prescriber. "Electronic data transmission prescription" means any prescription order, other than an electronic image transmission prescription, that is electronically transmitted from a licensed prescriber to a pharmacy. (d) The use of commonly used abbreviations shall not invalidate an otherwise valid prescription. (e) Nothing in the amendments made to this section (formerly Section 4036) at the 1969 Regular Session of the Legislature shall be construed as expanding or limiting the right that a chiropractor, while acting within the scope of his or her license, may have to prescribe a device. [edit] Exhibit B: sample legal requirement for storage of prescriptions From the Mississippi Board of Pharmacy [38]: ARTICLE XIII PRESCRIPTIONS TO BE FILED 1. All prescriptions shall be filed in one of the following ways: A. Three separate files may be maintained; a file for Schedule II prescriptions dispensed; a file for Schedule III, IV and V prescriptions dispensed; and a file for all other prescriptions dispensed. B. Two files may be maintained; a file for all Schedule II prescriptions dispensed and another file for all other prescriptions dispensed, including those in Schedule III, IV and V. If this method is used, the prescriptions for Schedule III, IV and V substances must be stamped with the letter "C" in red ink, not less than one inch high, in the lower right-hand corner. This distinctive marking makes the records readily retrievable for inspection. Pharmacies with automatic data processing systems are exempted from marking Schedule III, IV and V controlled substance prescriptions with the red "C". 2. A hard copy of original prescriptions, whether records are maintained manually or in a data processing system, shall be assigned a serial number and maintained by the pharmacy in numerical and chronological order. All prescriptions shall be maintained for at least five years from the date of original dispensing. 3. If a pharmacy utilizes a data processing system for record keeping, all computer generated labels should be affixed to the prescription document in such a manner as not to obscure information on the face of the document. [edit] Exhibit C: sample legal requirements for security and format From Indiana Board of Pharmacy [39]: 856 IAC 1-34-2 Security feature requirements Authority: IC 35-48-7-8 Affected: IC 16-42-19-5 Sec. 2. (a) All controlled substance prescriptions written by licensed Indiana practitioners, as defined by IC 16-42-19-5, must contain the following security features: (1) A latent, repetitive "void" pattern screened at five percent (5%) in reflex blue must appear across the entire face of the document when the prescription is photocopied. (2) There shall be a custom artificial watermark printed on the back side of the base paper so that it may only be seen at a forty-five (45) degree angle. The watermark shall consist of the words "Indiana Security Prescription", appearing horizontally in a step-and-repeated format in five lines on the back of the document using 12-point Helvetica bold type style. (3) An opaque RX symbol must appear in the upper right-hand corner, one-eighth (1/8) of an inch from the top of the pad and five-sixteenths (5/16) of an inch from the right side of the pad. The symbol must be three-fourths (3/4) inch in size and must disappear if the prescription copy is lightened. (4) Six (6) quantity check-off boxes must be printed on the form and the following quantities must appear and the appropriate box be checked off for the prescription to be valid: (A) 1-24 (B) 25-49 (C) 50-74 (D) 75-100 (E) 101-150 (F) 151 and over. (5) No advertisements may appear on the front or back of the prescription blank. (6) Logos, defined as a symbol utilized by an individual, professional practice, professional association, or hospital, may appear on the prescription blank. The upper left one (1) inch square of the prescription blank is reserved for the purpose of logos. Only logos, as defined by this subdivision, may appear on the prescription blank. (7) Only one (1) prescription may be written per prescription blank. The following statement must be printed on the bottom of the pad: "Prescription is void if more than one (1) prescription is written per blank.". (8) Refill options that can be circled by the prescriber must appear below any logos and above the signature lines on the left side of the prescription blank in the following order: Refill NR 1 2 3 4 5 Void after_____. (9) Practitioner name and state issued professional license number must be preprinted, stamped, or manually printed on the prescription. (10) All prescription blanks printed under this rule shall be four and one-fourth (4-1/4) inches high and five and one-half (51/2) inches wide. (b) Nothing in this rule shall prevent licensed Indiana practitioners from utilizing security paper prescriptions for the prescribing of any legend drug. (Indiana Board of Pharmacy; 856 IAC 1-34-2; filed Jul 5, 1995, 9:45 a.m.: 18 IR 2782, eff Jan 1, 1996) [edit] Exhibit D: sample requirements on information added by the pharmacist Taken from the Ontario's Drug and Pharmacies Regulation Act [40], paragraph 156. (1) Every person who dispenses a drug pursuant to a prescription shall ensure that the following information is recorded on the prescription, (a) the name and address of the person for whom the drug is prescribed; (b) the name, strength (where applicable) and quantity of the prescribed drug; (c) the directions for use, as prescribed; (d) the name and address of the prescriber; (e) the identity of the manufacturer of the drug dispensed; (f) an identification number or other designation; (g) the signature of the person dispensing the drug and, where different, also the signature of the person receiving a verbal prescription; (h) the date on which the drug is dispensed; (i) the price charged. R.S.O. 1990, c. H.4, s. 156 (1). [edit] Exhibit E: New Jersey requirements for prescription blanks From New Jersey official statutes:[41] 45:14-55 Use of New Jersey Prescription Blanks. 16. a. A practitioner practicing in this State shall use non-reproducible, non-erasable safety paper New Jersey Prescription Blanks bearing that practitioner's license number whenever the practitioner issues prescriptions for controlled dangerous substances, prescription legend drugs or other prescription items. The prescription blanks shall be secured from a vendor approved by the Division of Consumer Affairs in the Department of Law and Public Safety. b. A licensed practitioner practicing in this State shall maintain a record of the receipt of New Jersey Prescription Blanks. The practitioner shall notify the Office of Drug Control in the Division of Consumer Affairs as soon as possible but no later than 72 hours of being made aware that any New Jersey Prescription Blank in the practitioner's possession has been stolen. Upon receipt of notification, the Office of Drug Control shall take appropriate action, including notification to the Department of Human Services and the Attorney General. 45:14-56 Health care facility prescriptions. 17. a. Prescriptions issued by a health care facility licensed pursuant to P.L.1971, c.136 (C.26:2H-1 et seq.) shall be written on non-reproducible, non-erasable safety paper New Jersey Prescription Blanks. The prescription blanks shall be secured from a vendor approved by the Division of Consumer Affairs in the Department of Law and Public Safety. The New Jersey Prescription Blanks shall bear the unique provider number assigned to that health care facility for the issuing of prescriptions for controlled dangerous substances, prescription legend drugs or other prescription items. b. A health care facility shall maintain a record of the receipt of New Jersey Prescription Blanks. The health care facility shall notify the Office of Drug Control in the Division of Consumer Affairs as soon as possible but no later than 72 hours of being made aware that any New Jersey Prescription Blank in the facility's possession has been stolen. Upon receipt of notification, the Office of Drug Control shall take appropriate action including notification to the Department of Human Services and the Attorney General. 45:14-57 Requirements for prescription to be filled. 18.A prescription issued by a practitioner or health care facility licensed in New Jersey shall not be filled by a pharmacist unless the prescription is issued on a New Jersey Prescription Blank bearing the practitioner's license number or the unique provider number assigned to a health care facility. 45:14-59 Format for New Jersey Prescription Blanks. 20.The Division of Consumer Affairs in the Department of Law and Public Safety shall establish the format for uniform, non-reproducible, non-erasable safety paper prescription blanks, to be known as New Jersey Prescription Blanks, which format shall include an identifiable logo or symbol that will appear on all prescription blanks. The division shall approve a sufficient number of vendors to ensure production of an adequate supply of New Jersey Prescription Blanks for practitioners and health care facilities statewide. [edit] Notes List of abbreviations used in medical prescriptions From Wikipedia, the free encyclopedia Jump to: navigation, search This article needs additional citations for verification. Please help improve this article by adding reliable references. Unsourced material may be challenged and removed. (September 2008) [hide] v•d•e Medical abbreviations Overview • 0–9 A B C D E F G H I J K L M N O P Q R S T U V W X Y Z "Do not use" list • Latin abbreviations • Prescription (℞) abbreviations • Acronyms in healthcare • Abbreviations for medical organisations and personnel This is a list of abbreviations used in medical prescriptions (sometimes referred to as "sig codes"). Its listing here does not mean such abbreviations should be used. See main article for discussion on the use of abbreviations. This listing does not include abbreviations for actual pharmaceuticals (which is a separate article in itself). Capitalization and the use of a period is a matter of style. In the attached list, Latin is not capitalized whereas English acronyms are. The period is used wherever there are letters omitted in the abbreviation. See also: List of medical abbreviations: Do-not-use list Partial list of prescription abbreviations Abbreviation Latin Meaning aa ana of each ad ad up to a.c. ante cibum before meals a.d. auris dextra right ear ad lib. ad libitum use as much as one desires; freely admov. admove apply agit agita stir/shake alt. h. alternis horis every other hour a.m. Ante Meridiem morning, before noon amp ampule amt amount aq aqua water a.l., a.s. auris laeva, auris sinistra left ear A.T.C. around the clock a.u. auris utraque both ears bis bis twice b.d./b.i.d. bis in die twice daily B.M. bowel movement bol. bolus as a large single dose (usually intravenously) B.S. B.S.A BUCC cap., caps. c c cc cf comp. cr., crm D5W D5NS D.A.W. dc, D/C, disc dieb. alt. dil. disp. div. d.t.d. D.W. elix. e.m.p. emuls. et ex aq fl., fld. ft. g gr gtt(s) H h, hr h.s. ID IM inj. IP IV IVP IVPB L.A.S. LCD bucca capsula cum cibus cum cibo diebus alternis dentur tales doses ex modo prescripto emulsum et ex aqua fiat gutta(e) hora hora somni injectio blood sugar body surface areas inside cheek capsule with (usually written with a bar on top of the "c") food with food, (but also cubic centimetre) with food compound cream dextrose 5% solution (sometimes written as D5W) dextrose 5% in normal saline (0.9%) dispense as written discontinue every other day dilute dispense divide give of such doses distilled water elixir as directed emulsion and in water fluid make; let it be made gram grain drop(s) hypodermic hour at bedtime intradermal intramuscular (with respect to injections) injection intraperitoneal intravenous intravenous push intravenous piggyback label as such coal tar solution lin liq lot. M. m, min mcg m.d.u. mEq mg mist. mitte mL nebul N.M.T. noct. non rep. NS 1/2NS N.T.E. o_2 o.d. o.s. o.u. oz per p.c. p.m. prn p.o. p.r. pulv. q q.a.d. q.a.m. q.d.s. q.p.m. q.h. q.h.s. q.1h q.d. q.i.d. q.o.d. linimentum liquor liniment solution lotion misce mix minimum a minimum microgram more dicto utendus to be used as directed milliequivalent milligram mistura mix mitte send millilitre nebula a spray not more than nocte at night non repetatur no repeats normal saline (0.9%) half normal saline (0.45%) not to exceed both eyes, sometimes written as o2 oculus dexter right eye oculus sinister left eye oculus uterque both eyes ounce per by or through post cibum after meals Post Meridiem evening or afternoon pro re nata as needed per os by mouth or orally by rectum pulvis powder quaque every quoque alternis die every other day quaque die ante meridiem every day before noon quater die sumendus four times a day quaque die post meridiem every day after noon quaque hora every hour quaque hora somni every night at bedtime quaque 1 hora every 1 hour; (can replace "1" with other numbers) quaque die every day quater in die four times a day every other day qqh quater quaque hora q.s. quantum sufficiat QWK R rep., rept. repetatur RL, R/L s sine s.a. secundum artum SC, subc, subcut, subq, SQ sig SL sol solutio s.o.s., si op. sit si opus sit ss semis stat statim supp suppositorium susp syr syrupus tab tabella tal., t talus tbsp troche trochiscus tsp t.i.d. ter in die t.d.s. ter die sumendum t.i.w. top. T.P.N. tr, tinc., tinct. u.d., ut. dict. ut dictum ung. unguentum U.S.P. vag w wf w/o X Y.O. every four hours a sufficient quantity every week rectal repeats Ringer's lactate without (usually written with a bar on top of the "s") use your judgement subcutaneous write on label sublingually, under the tongue solution if there is a need one half immediately suppository suspension syrup tablet such tablespoon lozenge teaspoon three times a day three times a day three times a week topical total parenteral nutrition tincture as directed ointment United States Pharmacopoeia vaginally with with food (with meals) without times years old To avoid ambiguity, the following abbreviations are not recommended [1] [2]:  a.u., a.s., a.d. - Latin for both, left and right ears; the "a" can be misread to be an "o" and interpreted to mean both, right or left eyes                    bt - intended to mean "bedtime", but can be misread as "bid" or twice daily. d/c - can mean "discontinue" or "discharge" h.s. - can mean half strength or "hour of sleep" IJ - intended to mean "injection", but can be misread as "IV" IN - intended to mean "intranasal", but can be misread as "IM" or "IV" IU - intended to mean "international unit", but can be misread as "IV" or "10" o.d., o.s., o.u. - the "o" can be misread as "a". o.d. - can mean "once daily" or "right eye". OJ - intended to mean "orange juice" but can be misread as "OD" or "OS" q4PM - intended to mean "at 4 PM", but can be misread as every 4 hours q.d., q1d - intended to mean "every day" but can be misread as "q.i.d." or 4 times a day q.o.d. - meant "every other day" but the "o" can be interpreted as "." or "i" resulting in double or eight times the frequency SC - meant "subcutaneaous" but mistaken for "SL" for "sublingual" SQ - meant "subcutaneaous" but mistaken for "5Q" or 5 every dose 'ss - intended to mean "sliding scale" or "1/2", but can be mistaken as "55" 'SSI, SSRI - intended to mean "sliding scale insulin" or "sliding scale regular insulin", but can be mistaken as "strong solution of iodine" or "selective serotonin reuptake inhibitor T.I.W - meant 3 times a week but mistaken for twice a week U - meant "units" but mistaken for "0", "4" (so "4U" can become "40" and the "U" is assumed), or misread as "cc" when poorly written; conversely cc can be mistaken for "U" μg - meant "microgram" but mistaken for "mg"; this 1000-fold error can cause potentially fatal misunderstandings [edit] See also   List of medical roots, suffixes and prefixes Apothecaries' system#Medical recipes Prescription drug From Wikipedia, the free encyclopedia (Redirected from Prescription drugs) Jump to: navigation, search A prescription drug is a licensed medicine that is regulated by legislation to require a prescription before it can be obtained. The term is used to distinguish it from over-the-counter drugs which can be obtained without a prescription. Different jurisdictions have different definitions of what constitutes a prescription drug. Dispensation of prescription drugs often includes a monograph (in Europe, a Patient Information Leaflet or PIL) that gives detailed information about the drug. Contents [hide]        1 Regulation in United States 2 Regulation in United Kingdom 3 Expiration date 4 Environmental problems 5 See also 6 References 7 Further reading [edit] Regulation in United States Regulation of therapeutic goods in the United States Prescription drugs Over-the-counter drugs [show]Law [show]Government agencies [show]Process [show]International coordination [show]Non-governmental organizations. This box: view • talk • edit In the United States, the Federal Food, Drug, and Cosmetic Act defines what requires a prescription. Prescription drugs are generally authorized by veterinarians, dentists, optometrists, and medical practitioners. It is generally required that an MD, DO, PA, OD, DPM, DVM, DDS, or DMD write the prescription; basic-level registered nurses, medical assistants, clinical nurse specialists, nurse anesthetists, and nurse midwives, emergency medical technicians, psychologists, and social workers as examples, do not have the authority to prescribe drugs. The package insert for a prescription drug contains information about the intended effect of the drug and how it works in the body. It also contains information about side effects, how a patient should take the drug, and cautions for its use, including warnings about allergies. The safety and effectiveness of prescription drugs in the US is regulated by the federal Prescription Drug Marketing Act of 1987. The Food and Drug Administration is charged with implementing this law. As a general rule, over the counter (OTC) drugs are used to treat conditions not necessarily requiring care from a health care professional and have been proven to meet higher safety standards for self-medication by patients. Often a lower strength of a drug will be approved for OTC use, while higher strengths require a prescription to be obtained; a notable case is ibuprofen, which has been widely available as an OTC pain killer since the mid1980s but is still available by prescription in doses up to four times the OTC dose for use in cases of severe pain not adequately controlled by the lower, OTC strength. Herbal preparations, vitamins, minerals, and food supplements are not regulated by the FDA, so the individual consumer must be aware of the potential negative effects of using these preparations and also the potential interactions with prescription drugs they may be taking. In the United States, the term "prescription drug" is most commonly used, but they are also called Rx-only drugs or legend drugs, after the Federal and State laws which mandate that all such drugs bear a "legend" prohibiting sale without a prescription; though more complex legends have been used, on most original drug packaging today the legend simply says "Rx only". In the United Kingdom, they are referred to as Prescription Only Medicine or POM. Also, pharmacies operated by membership clubs, such as Costco and Sam's Club, by law must allow nonmembers to use their pharmacy services and must charge the same prices as to members. Physicians may legally prescribe drugs for uses other than those specified in the FDA approval; this is known as off-label use. Drug companies may not promote or market drugs for off-label uses. [edit] Regulation in United Kingdom All or part of this section may be confusing or unclear. Please help clarify the article . Suggestions may be on the talk page. (September 2008) In the United Kingdom, according to the Home Office, the Medicines Act 1968 governs the manufacture and supply of three categories of medicine[1]:    Prescription only drugs which can be sold by a pharmacist if prescribed by a doctor Pharmacy medicines which may be sold by a pharmacist without prescription General sales list medicines which may be sold without a prescription in any shop Again according to the Home Office, possession of prescription only medicines without a prescription is a serious offence[1] A patient visits a medical practitioner (GP) who is able to prescribe medication. If given an NHS prescription, this can be taken to a pharmacy to be dispensed.[2] District nurses and health visitors have had limited prescribing rights since the mid-nineties where prescription for dressings and simple medicines would have had to have been signed by a medical practitioner. This charge is paid entirely to the NHS through the pharmacy, while the pharmacy claims the cost of the medicine dispensed. Each "item" can cover any prescribed item in a very large or very small quantity according to the prescribers' prescription. This means that the patients perceived "value" of the charge varies enormously - the actual cost of the medicine given out will routinely vary from a few pence to hundreds of pounds. However, medical practitioners can prescribe a maximum three-month supply of the medication in order for it to be covered under the NHS. If a medical practitioner wishes to prescribe a supply in excess of three months, the prescriber must write a separate, private prescription for the balance of the medication supply over three months which the patient must pay full-price for.[2] Certain groups of patients are exempt from this charge, such as those over 60, under 16 (or under 19 if in full-time education), patients with certain medical conditions, those on certain benefits and those with an HC2 certificate,[3] which is issued if a patient can prove their income is under £8,000 per year. However, in Wales prescription charges have been abolished and in Scotland prescription charges have been reduced to £5 (as of 1 April 2008) as a first phase of abolishing them over the next three years.[4] An HC2 certificate can be applied for – although not automatically granted – by those on a low income or in receipt of incapacity benefit. Claimants of "Jobseekers" and "Income support" automatically receive free prescriptions and dentistry.[3] Those requiring regular prescriptions may make a saving by purchasing a pre-payment certificate which covers the cost of all prescriptions required for three months or a year. As of 1 April 2008 they cost £27.85 for 3 months and £102.50 for 12 months (offering savings to anyone who needs more than 3 prescriptions in 3 months or 14 prescriptions in 12 months). Many of the prescriptions dispensed on NHS are exempt from charges. This is because of the large number of precription drugs needed by, for example, the elderly or those with medical exemptions. NHS prescriptions can also be written for certain items. Some patients also receive private prescriptions, typically either from a medical practitioner seen privately or for medicine not covered on the NHS.[2] For these, the patient will pay the pharmacy directly for the cost of the medicine and the pharmacy's markup. [edit] Expiration date The expiration date, required in several countries, specifies the date the manufacturer guarantees the full potency and safety of a drug. Most medications are potent and safe after the expiration date. A study conducted by the U.S. Food and Drug Administration covered over 100 drugs, prescription and over-the-counter. The results showed that about 90% of them were safe and effective as far as 15 years past their expiration date. Joel Davis, a former FDA expiration-date compliance chief, said that with a handful of exceptions - notably nitroglycerin, insulin and some liquid antibiotics - most expired drugs are probably effective.[5] [edit] Environmental problems Traces of prescription drugs—including antibiotics, anti-convulsants, mood stabilizers and sex hormones—have been detected in drinking water. If ingested these may be harmful to wildlife and humans.[6][7] [edit] See also     Regulation of therapeutic goods Package insert Pill splitting Prescription drug prices in the United States Pill splitting From Wikipedia, the free encyclopedia Jump to: navigation, search A pill-splitter holding a tablet of Seroquel. Pill-splitting refers to the practice of modifying a tablet, capsule or pill to obtain a lower dose of the active ingredient, or to obtain multiple smaller doses, either to reduce cost or because the drug is not available in the dose desired. Often, pills that are meant to be split (Aspirin for instance) come pre-scored so that one may easily divide the pill into halves or quarters. There are a number of situations where it is unsafe to split a prescription medication. Close-up of the blade and place holder. Contents [hide]      1 Pill splitters 2 Dosage uniformity 3 Cost savings o 3.1 Potentially suitable medications o 3.2 Uniformity of split 4 Risks 5 Lawsuits o 5.1 Timmis v. Kaiser Permanente  6 References [edit] Pill splitters A pill-splitter is a simple and inexpensive device to split medicinal pills or tablets, comprising some means of holding the tablet in place, a blade, and usually a compartment in which to store the unused part. The tablet is positioned, and the blade pressed down to split it. With care it is often possible to cut a tablet into quarters. [edit] Dosage uniformity In the U.S.—and for more than 130 countries which use or recognize American pharmaceutical standards— "uniformity of dosage units" is defined by the United States Pharmacopeia (USP), which describes itself as "the official public standards-setting authority for all prescription and over-the-counter medicines, dietary supplements, and other healthcare products manufactured and sold in the United States."[1] The USP standard for dosage uniformity expresses statistical criteria in the language of sampling protocols which defies simple explanation. The pharmaceutical dosage literature sometimes boils this down as requiring a standard deviation in dosage weight of less than 6%, which roughly corresponds to the weaker rule-of-thumb offered for public consumption that the vast majority of dosage units should be within 15% of the dosage target. "Dosage unit" is a technical term which covers oral medications (tablets, pills, capsules), as well as non-oral delivery methods.[2] A 2002 study of pill-splitting as conducted in four American long-term care facilities determined that 15 of the 22 dispensed prescriptions evaluated (68%) had fragment weight variance in excess of USP standards.[3] [edit] Cost savings Pill-splitting can be an effective way to save money on pharmaceutical costs. Many prescription pharmaceuticals are sold on a per dose or tablet basis. For example a 10 mg tablet of a given drug might be sold for the same or nearly the same price as a 5 mg tablet. Splitting a 10 mg tablet allows the patient to purchase half the number of tablets while still receiving the same amount of the active drug. U.S. medications suitable for pill splitting As listed in 2002 Stanford study Medication clonazepam doxazosin atorvastatin pravastatin citalopram sertraline paroxetine lisinopril nefazodone * psychiatric blood pressure cholesterol cholesterol psychiatric psychiatric psychiatric blood pressure Drug class [edit] Potentially suitable medications psychiatric Dr Randall Stafford from the Stanford School of olanzapine psychiatric Medicine published a study in 2002 of common sildenafil erectile dysfunction prescription medications in the United States in * Serzone brand discontinued 2004 in U.S. which he evaluates pill splitting for "potential cost savings and clinical appropriateness". The study identifies eleven prescription medications that satisfied the study criteria, based on American pharmaceutical cost structure, pill formulation, and dosages available at that time.[4] Most of the medications listed in the table from the psychiatric drug class are antidepressants. [edit] Uniformity of split Not all tablets split equally well. In a 2002 study, Paxil, Zestril and Zoloft split cleanly with 0% rejects. Glucophage was described as a hard tablet, requiring significant force, causing tablet halves to fly. Glyburide exhibited very poor splitting with many splitting into multiple pieces. Hydrodiuril and Oretic crumbled. Lipitor did not split cleanly, and the coating peeled. The diamond shaped Viagra tablets made location of the midline difficult. The worst result reported was Oretic 25mg in which 60% of tablets failed to split to within 15% of target weight.[5][6] [edit] Risks Care must be taken in identifying drugs that may be safely split while still delivering half the dose with the same or similar efficacy. Generally scored pills may be safely split however time release and capsule supplied drugs should not be split. Split pills may be uneven and thus the amount per dose may vary. In practice these variations are often minor enough as not to cause major dosing issues and are in fact within generic drug active ingredient guidelines. Patients wishing to split their pills should request their physician to write their prescriptions as such to help avoid incorrect dosing. [edit] Lawsuits [edit] Timmis v. Kaiser Permanente In a California court filing dated April 2001 Trial Lawyers for Public Justice (TLPJ) brought a class-action lawsuit against Kaiser Permanente on the grounds that "Kaiser's mandatory pill-splitting policy endangers patients' health solely to enhance the HMO's profits" in violation of the California Unfair Competition Law (UCL) and the California Consumer Legal Remedies Act (CLRA). [7] [8] In December 2004, the California Court of Appeal affirmed the trial court ruling that Kaiser's policy did not violate UCL or CLRA, noting the suit had failed to present evidence that the policy was unsafe. [9] [edit] References Over-the-counter drug From Wikipedia, the free encyclopedia Jump to: navigation, search This article or section has multiple issues. Please help improve the article or discuss these issues on the talk page.   It does not cite any references or sources. Please help improve it by citing reliable sources. Tagged since February 2008. It may not present a worldwide view of the subject. Tagged since February 2008. Over-the-counter (OTC) drugs are medicines that may be sold to a customer without a prescription. The term "over-the-counter" is somewhat counter-intuitive, since these items can often be found on the shelves of stores and bought like any other packaged product in some countries in contrast to prescription drugs which are more likely to literally be passed over a counter from the pharmacist to the customer. Some medicines considered safe in general terms may be available in general stores, supermarkets, gas stations etc. The rules vary considerably from country to country. Contents [hide]      1 Regulation by country o 1.1 United States o 1.2 United Kingdom 2 Switches between prescription and OTC 3 See also 4 References 5 External links [edit] Regulation by country [edit] United States Regulation of therapeutic goods in the United States Prescription drugs Over-the-counter drugs [show]Law [show]Government agencies [show]Process [show]International coordination [show]Non-governmental organizations. This box: view • talk • edit In the United States, the manufacture and sale of OTC substances is regulated by the FDA. The Federal Food, Drug, and Cosmetic Act requires that all "new drugs" are required to 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 fit the vast amount 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 by regulation. This meant that certain classes of OTC drugs were not required to obtain an NDA and could remain on the market. Thus, manufacture must be done either pursuant to an FDA monograph, which specifies types of OTC drugs, active ingredients and labeling requirements, or pursuant to a New Drug Application (NDA), for products which do not fit within a specific monograph. Because an NDA is extremely expensive to obtain, due primarily to testing requirements, most OTC substances produced in the USA are sunscreens, anti-microbial and antifungal 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. [edit] United Kingdom In the United Kingdom, medication will fall into one of three categories 1. Prescription Only Medication (POM), which is usually only available with a valid prescription from a doctor or via internet suppliers: some POMs including Viagra, Xenical, Valium, Physeptone, DF 118, Dexedrine, Concerta XL, Ritalin, Diconal, MST Continus and anabolic steroids are also sold by street drug dealers and other completely illegal sources. 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. Examples of these include most Antibiotics and all Antidepressants and Antidiabetic drugs. 2. Pharmacy Only Medication (P), containing chemicals, strengths or sizes which require more information, personal to the person taking the medication. The pharmacist will determine whether the medicine is safe for the particular customer based on their responses to a set of questions. Sometimes this is known as "behind-the-counter" medication. Examples of these include some sleep aid tablets such as Nytol and the emergency contraceptive pill to patients over 16. 3. General Sales List(GSL), available off the shelf with no pharmacy training required to sell. Generally considered safe for most people when taken correctly. Examples of these include 16-packs (or less) of painkillers such as Paracetamol & Nurofen as well as a host of other safe medications such as small pack sizes of Antiallergy tablets, Laxative medication and skin creams. Medication available only with a prescription is marked somewhere on the box/container with [POM]. Overthe-counter medicines are marked with [P]. A prescription is not required for [P] medicines and pharmacy sales assistants are required by RSPGB codes to ask certain questions, most of all, whether the patient is taking other medication, before selling these; in fact many pharmacies sell [P] medication "no questions asked". It is with this information that the pharmacist can halt the sale, if need be. Some medication available in supermarkets and petrol stations is sold there 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. [edit] Switches between prescription and OTC As a general rule, over-the-counter drugs have to be primarily used 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, drugs that prove themselves safe and appropriate for self-medication, 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 a deliriant, nevertheless, most recreational drug users find its effects uncomfortable rather than exciting. 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 being one example. Recently many U.S. drugstores have begun moving products containing pseudoephedrine into locations where customers must ask a pharmacist for them. A prescription is not required; the change is allegedly being made in an effort to reduce methamphetamine production. Since the passage of the Methamphetamine Precursor Control Act, the purchase of pseudoephedrine in the United States is restricted and the identity of the purchaser is required to be obtained and recorded. In addition, pseudoephedrine itself is a mild stimulant- somewhere between caffeine and ephedrine. Nonetheless, these products are still considered OTC since no prescription is required. [edit] See also      Pharmacy Medical prescription Regulation of therapeutic goods Generic drug Child-resistant packaging  Generally recognized as safe and effective [edit] References [edit] External links  Over-the-counter (OTC) Medicines at FamilyDoctor.org, maintained by the American Academy of Family Physicians. Contains extensive information on over-the counter drugs and their responsible use, including specific guidance on several drug classes in question-and-answer format and information on common drug interactions. Pharmacy From Wikipedia, the free encyclopedia Jump to: navigation, search For other uses, see Pharmacy (disambiguation). The mortar and pestle, an internationally recognized symbol to represent the pharmacy profession Pharmacy (from the Greek φάρμακον 'pharmakon' = drug) 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 medication. The scope of pharmacy practice includes more traditional roles such as compounding and dispensing medications, and it also includes more modern services related to patient 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. Pharmacy is also the term for an establishment where pharmacy (in the first sense) is practice (synonym: drugstore). The first pharmacy in Europe (still working) was opened in 1241 in Trier, Germany.[citation needed] The word pharmacy is derived from its root word pharma which was a term used since the 1400–1600s. 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. 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. Contents [hide]     1 Disciplines 2 Pharmacists 3 History of pharmacy 4 Types of pharmacy practice areas o 4.1 Community pharmacy       4.2 Hospital pharmacy 4.3 Clinical pharmacy 4.4 Compounding pharmacy 4.5 Consultant pharmacy 4.6 Internet pharmacy 4.7 Veterinary pharmacy 4.8 Nuclear pharmacy 4.9 Military pharmacy 4.10 Pharmacy informatics 5 Issues in pharmacy o 5.1 Separation of prescribing from dispensing o 5.2 The future of pharmacy 6 See also 7 Symbols 8 Notes 9 References 10 External links o 10.1 Other o o o o o o o o o [edit] Disciplines Pharmacy, tacuinum sanitatis casanatensis (XIV century) The field of Pharmacy can generally be divided into three primary disciplines:    Pharmaceutics Medicinal chemistry and Pharmacognosy Pharmacy practice The boundaries between these disciplines and with other sciences, such as biochemistry, are not always clearcut; 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. Other specializations in pharmacy practice recognized by the Board of Pharmaceutical Specialties include: cardiovascular, infectious disease, oncology, pharmacotherapy, nuclear, nutrition, and psychiatry.[1] The Commission for Certification in Geriatric Pharmacy certifies pharmacists in geriatric pharmacy practice. The American Board of Applied Toxicology certifies pharmacists and other medical professionals in applied toxicology. [edit] Pharmacists Main article: Pharmacist Pharmacists are highly-trained and skilled healthcare professionals who perform various roles to ensure optimal health outcomes for their patients. Many pharmacists are also small-business owners, owning the pharmacy in which they practice. Pharmacists are represented internationally by the International Pharmaceutical Federation (FIP). They are represented at the national level by professional organisations such as the Royal Pharmaceutical Society of Great Britain (RPSGB), the Pharmacy Guild of Australia (PGA), the Pakistan Pharmacists Society(PPS) and the American Pharmacists Association (APhA). See also: List of pharmacy associations. In some cases, the representative body is also the registering body, which is responsible for the ethics of the profession. Since the Shipman Inquiry, there has been a move in the UK to separate the two roles. [edit] History of pharmacy Paleopharmacological studies attest to the use of medicinal plants in pre-history.[2] The earliest known compilation of medicinal substances was the Sushruta Samhita, an Indian Ayurvedic treatise attributed to Sushruta in the 6th century BC. However, the earliest text as preserved dates to the 3rd or 4th century AD. Many Sumerian (late 6th millennium BC - early 2nd millennium BC) cuneiform clay tablets record prescriptions for medicine.[3] Ancient Egyptian pharmacological knowledge was recorded in various papyri such as the Ebers Papyrus of 1550 BC, and the Edwin Smith Papyrus of the 16th century BC. The earliest known Chinese manual on materia medica is the Shennong Bencao Jing (The Divine Farmer's Herb-Root Classic), dating back to the 1st century AD. It was compiled during the Han dynasty and was attributed to the mythical Shennong. Earlier literature included lists of prescriptions for specific ailments, exemplified by a manuscript "Recipes for 52 Ailments", found in the Mawangdui tomb, sealed in 168 BC. Further details on Chinese pharmacy can be found in the Pharmacy in China article. The Greek physician Pedanius Dioscorides is famous for writing a five volume book in his native Greek Περί ύλης ιατρικής in the 1st century AD. The Latin translation De Materia Medica (Concerning medical substances) was used a basis for many medieval texts, and was built upon by many middle eastern scientists during the Islamic Golden Age. The title coined the term materia medica. In Japan, at the end of the Asuka period (538-710) and the early Nara period (710-794), the men who fulfilled roles similar to those of modern pharamacists were highly respected. The place of pharmacists in society was expressly defined in the Taihō Code (701) and re-stated in the Yōrō Code (718). Ranked positions in the preHeian Imperial court were established; and this organizational structure remained largely intact until the Meiji Restoration (1868). In this highly stable hierarchy, the pharmacists -- and even pharmacist assistants -- were assigned status superior to all others in health-related fields such as physicians and acupuncturists. In the Imperial household, the pharmacist was even ranked above the two personal physicians of the Emperor.[4] There is a stone sign for a pharmacy with a tripod, a mortar, and a pestle opposite one for a doctor in the Arcadian Way in Ephesus near Kusadasi in Turkey. http://www.pbase.com/tsechien/ephesus_ has photos. The current Ephesus dates back to 400BC and was the site of the Temple of Artemis one of the seven wonders of the world, the home of Mark Anthony and Cleopatra, Mary Magdalen and where St Paul read his letter to the Ephesians. In Baghdad the first pharmacies were established in 754[5]under the Abbasid Caliphate during the Islamic Golden Age. By the 9th century, these pharmacies were state-regulated.[6] The advances in made in the Middle East in botany and chemistry led medicine in medieval Islam substantially to develop pharmacology. Muhammad ibn Zakarīya Rāzi (Rhazes) (865-915), for instance, acted to promote the medical uses of chemical compounds. Abu al-Qasim al-Zahrawi (Abulcasis) (936-1013) pioneered the preparation of medicines by sublimation and distillation. His Liber servitoris is of particular interest, as it provides the reader with recipes and explains how to prepare the `simples’ from which were compounded the complex drugs then generally used. Sabur Ibn Sahl (d 869), was, however, the first physician to initiate pharmacopoedia, describing a large variety of drugs and remedies for ailments. Al-Biruni (973-1050) wrote one of the most valuable Islamic works on pharmacology entitled Kitab al-Saydalah (The Book of Drugs), where he gave detailed knowledge of the properties of drugs and outlined the role of pharmacy and the functions and duties of the pharmacist. Ibn Sina (Avicenna), too, described no less than 700 preparations, their properties, mode of action and their indications. He devoted in fact a whole volume to simple drugs in The Canon of Medicine. Of great impact were also the works by al-Maridini of Baghdad and Cairo, and Ibn al-Wafid (10081074), both of which were printed in Latin more than fifty times, appearing as De Medicinis universalibus et particularibus by `Mesue' the younger, and the Medicamentis simplicibus by `Abenguefit'. Peter of Abano (1250-1316) translated and added a supplement to the work of al-Maridini under the title De Veneris. AlMuwaffaq’s contributions in the field are also pioneering. Living in the 10th century, he wrote The foundations of the true properties of Remedies, amongst others describing arsenious oxide, and being acquainted with silicic acid. He made clear distinction between sodium carbonate and potassium carbonate, and drew attention to the poisonous nature of copper compounds, especially copper vitriol, and also lead compounds. He also describes the distillation of sea-water for drinking.[7] In Europe pharmacy-like shops began to appear during the 12th century. In 1240 emperor Frederic II issued a decree by which the physician's and the apothecary's professions were separated.[8] In Europe there are old pharmacies still operating in Dubrovnik Croatia located inside the Franciscan monastery, opened in 1317 ; and one in the Square Tallinn Estonia dating from at least 1422. The oldest is claimed to be set up in 1221 in the Church of Santa Maria Novella in Florence Itlay, which now houses a perfume museum. Another in Llívia few kilometres from Puigcerdà is a Catalan enclave in Spain almost within France which is also now a museum dating back to the 15 century. [edit] Types of pharmacy practice areas Pharmacists practice in a variety of areas including retail, hospitals, clinics, nursing homes, drug industry, 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. [edit] 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. 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. All pharmacies are required to have a pharmacist on-duty at all times when open. In many jurisdictions, it is also a requirement that the owner of a pharmacy must be a registered pharmacist (R.Ph.). This latter requirement has been revoked in many 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 household items such as cosmetics, shampoo, office supplies, confectionary, and snack foods. Also, retail pharmacists usually make more money than their clinical counterparts. [edit] Hospital pharmacy Main article: 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 haematology/oncology, HIV/AIDS, infectious disease, critical care, emergency medicine, toxicology, nuclear pharmacy, pain management, psychiatry, anticoagulation clinics, herbal medicine, neurology/epilepsy management, paediatrics, neonatal pharmacists and more. Hospital pharmacies can usually 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. [edit] Clinical pharmacy Main article: Clinical pharmacy Clinical pharmacists provide direct patient care services that optimizes the use of medication and promotes health, wellness, and disease prevention.[9] 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 work collaboratively with physicians, nurses and other healthcare personnel in various medical and surgical areas. They often participate in patient care rounds and drug product selection. In most hospitals in the United States, potentially dangerous drugs that require close monitoring are dosed and managed by clinical pharmacists. [edit] Compounding pharmacy Main article: Compounding Compounding is the practice of preparing drugs in new 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. Compounding pharmacies specialize in compounding, although many also dispense the same non-compounded drugs that patients can obtain from community pharmacies. [edit] Consultant pharmacy Main article: Consultant pharmacist 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.[10] 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 pharmaceutical care developed by Hepler and Strand in 1990.[11][12] [edit] Internet pharmacy Main article: Online 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.[citation needed] 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.[citation needed] 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. [edit] 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. [edit] Nuclear pharmacy Main article: 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. [edit] Military pharmacy Main article: 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. [edit] Pharmacy informatics Main article: 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 are well trained to participate in medication management system development, deployment and optimization. [edit] Issues in pharmacy [edit] Separation of prescribing from dispensing In most jurisdictions (such as the United States), pharmacists are regulated separately from physicians. Specifically, the legislation stipulates that the practice of prescribing must be separate from the practice of dispensing.[citation needed] 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.[13] 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. 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 sideeffects. 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). [edit] 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 will be paid for their patient care skills.[14] 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) or are remunerated by their provincial government for expanded services such as medications reviews (Medschecks in Ontario). In the United Kingdom, pharmacists (and nurses) who undertake additional training are obtaining prescribing rights. They are also being paid for by the government for medicine use reviews. In the United States, pharmaceutical care or clinical pharmacy has had an evolving influence on the practice of pharmacy.[9] Moreover, the Doctor of Pharmacy (Pharm. D.) degree is now required before entering practice and many 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."[15] [edit] See also Pharmacy and Pharmacology portal                American Society for Pharmacy Law Apothecary Bachelor of Pharmacy, Master of Pharmacy, Doctor of Pharmacy Clinical pharmacy Consultant pharmacist Doctor of Pharmacy Evidence-based pharmacy in developing countries Hospital pharmacy International Pharmaceutical Federation List of pharmacies List of pharmacy associations List of pharmacy organizations in the United Kingdom List of pharmacy schools Nuclear pharmacy Online pharmacy           Pharmaceutical company Pharmacogenetics Pharmacogenomics Pharmacognosy Pharmacology Pharmaconomist Pharmacy (residency) Pharmacy informatics Professional Further Education in Clinical Pharmacy and Public Health Raeapteek (one of the oldest continuously run pharmacies in Europe dating from the 15th century) [edit] 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, 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, Italy and Spain, 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 Hygeia The green Greek Cross used in Spain, Mortar and pestle Argentina, France, Poland, the United Kingdom Recipe symbol and other countries The red stylized "A" used in Germany Caduceus (used erroneously) Rod of Asclepius Hanging Show Globe [edit] Notes Off-label use From Wikipedia, the free encyclopedia Jump to: navigation, search Off-label use is the practice of prescribing pharmaceuticals for a purpose outside the scope of a drug's approved label, most often concerning the drug's indication. In the United States, the Food and Drug Administration (FDA) requires numerous clinical trials to prove a drug's safety and efficacy in treating a given disease or condition. If satisfied that the drug is safe and effective, the drug's manufacturer and the FDA agree on specific language describing dosage, route and other information to be included on the drug's label. More detail is included in the drug's package insert. However, once the FDA approves a drug for prescription use, they do not attempt to regulate the usage of the medicine, and so the physician makes decisions based on her or his best judgment. It is legal in the United States and in many other countries to use drugs off-label, including controlled substances such as opiates, even though it is a common misconception that it is unlawful to do so. Actiq, for example, is commonly prescribed off-label even though it is a Schedule II controlled substance. However, it is unlawful to market, advertise or otherwise promote the off-label use of drugs, including controlled substances. Off-label use of medications is very common. Up to one-fifth of all drugs are prescribed off-label and amongst psychiatric drugs, off-label use rises to 31 percent (Radley, et al. 2006).[1] New drugs are often not tested for safety and efficacy specifically in children. Therefore, it is believed that between 50 percent and 75 percent of all medications prescribed by pediatricians in the U.S. are for off-label applications.[1] Some drugs are used more frequently off-label than for their original, FDA-approved indications. A 1991 study by the U.S. General Accounting Office found that one-third of all drug administrations to cancer patients were off-label, and more than half of cancer patients received at least one drug for an off-label indication[citation needed]. Frequently, the standard of care for a particular type or stage of cancer involves the off-label use of one or more drugs. An example is the use of tricyclic antidepressants to treat neuropathic pain. This old class of antidepressants is now rarely used for clinical depression due to side effects, but the tricyclics are often effective for treating pain. Contents [hide]       1 Law 2 Veterinary medicine 3 Examples of off-label use (and non-use) 4 See also 5 References 6 External references [edit] Law The examples and perspective in this section deal primarily with the United States and do not represent a worldwide view of the subject. Please improve this article or discuss the issue on the talk page. (March 2009) In the United States, FDA regulations permit physicians and other healthcare practitioners to prescribe approved medications for other than their intended indications. Marketing information for the drug will list one or more indications, that is, illnesses or medical conditions for which the drug has been shown to be both safe and effective. Pharmaceutical companies are not allowed to promote a drug for any other purpose without formal FDA approval. However, once a drug has been approved for sale for one purpose, physicians are free to prescribe it for any other purpose that in their professional judgment is both safe and effective, and are not limited to official, FDAapproved indications. This off-label prescribing is most commonly done with older, generic medications that have found new uses but have not had the formal (and often costly) applications and studies required by the FDA to formally approve the drug for these new indications. However, there is usually extensive medical literature to support the off-label use. In 1993, the US Food and Drug Administration (FDA) approved gabapentin, marked by Pfizer under the name "Neurontin", only for treatment of seizures. Pfizer subsidiary Warner-Lambert used activities not usually associated with sales promotion, including continuing medical education and research, to promote gabapentin, so that within 5 years the drug was being widely used for the off-label treatment of pain and psychiatric conditions. In 2004, Warner-Lambert admitted to charges that it violated FDA regulations by promoting the drug for pain, psychiatric conditions, migraine, and other unapproved uses. [2] The company paid $430 million to the federal government to settle the case.[3] Access to pharmaceutical industry documents have revealed marketing strategies used to promote drugs for offlabel use. [4] The United States federal government is aggressively pursuing criminal and civil cases against pharmaceutical companies and their employees for promoting off-label uses of prescription drugs.[5] Between 2003 and 2008, U.S. federal prosecutors and state attorneys general brought more than a dozen cases against drug makers for off-label marketing and won more than $6 billion in criminal and civil settlements.[6] The position of the British General Medical Council on off-label prescribing may be found here. [edit] Veterinary medicine The veterinarian has a much smaller pharmacopeia available than does the human practitioner. Therefore, drugs are more likely to be used "off-label"—typically, this involves the use of a human medication in an animal, where there is no corresponding medication licenced for that species. This problem is compounded in "exotic" species (such as reptiles and rodents) where there are very few, if any licenced medications. In addition, especially in Europe, equine veterinarians are forced to use many drugs off-label, as the horse is classified as a food-producing animal and many veterinary drugs are labeled specifically not for use in animals intended for human consumption. [edit] Examples of off-label use (and non-use)  Actiq (oral transmucosal fentanyl citrate), a Schedule II controlled substance, is used off-label to treat moderate to severe chronic, non-malignant pain even though it is FDA-approved solely for breakthrough pain in cancer patients. [2]  Bevacizumab has been used against wet age-related macular degeneration, as well as macular edema from diseases such as diabetic retinopathy and central retinal vein occlusion.[3] Buprenorphine has been shown experimentally (1982-1995) to be effective against severe, refractory depression. [4] [7] Carbamazepine, or Tegretol, has been used as a mood stabilizer and is accepted treatment for bipolar disorder. [5] Gabapentin, approved for treatment of seizures and postherpetic neuralgia in adults, is used off-label for a variety of conditions including bipolar disorder, essential tremor, hot flashes, migraine prophylaxis, neuropathic pain syndromes, phantom limb syndrome, and restless leg syndrome. [6] Methotrexate (MTX), approved for the treatment of choriocarcinoma, is frequently used for the medical treatment of an unruptured ectopic pregnancy. [7] There is no FDA-approved drug for this purpose and there is little incentive to sponsor an unpatented drug such as MTX for FDA-approval. The SSRI medication sertraline is approved as an anti-depressant. It is also commonly prescribed offlabel to help men suffering from premature ejaculation. [8] Stimulants such as Amphetamine (Adderall) and Methylphenidate (Ritalin) are indicated for childhood attention deficit disorder (ADD/ADHD), but are often prescribed to treat this condition in adults, as well. Atomoxetine (Strattera), a non-stimulant norepinephrine reuptake inhibitor is currently the only drug (In the United States) indicated for adult ADD.[dubious – discuss] In Australia dextroamphetamine is indicated for adult ADHD treatment. While Atomoxetine is also indicated for the treatment in Australia, it only has a minor percentage of the drugs prescribed for the condition, due to its prohibitively high price, as it is currently not subsidised by the Government's Pharmaceutical Benefits Scheme, whereas the stimulant medications methylphenidate and dextroamphetamine are. Stimulants are also used offlabel to treat depression, usually in conjunction with a standard antidepressant drug.       [edit] See also   Pharmaceutical marketing FDA [edit] References