MODULE 1. GENERAL CONCEPTS OF DRUG TECHNOLOGY. POWDERS. LIQUID DOSAGE FORMS.
CONTENT MODULE 1. GENERAL CONCEPTS OF DRUG TECHNOLOGY. POWDERS.
LESSON 1. STATE SETTING OF NORMS OF PRODUCTION OF MEDICATIONS. A DOSAGE IS IN PHARMACY PRACTICE.
Introduction
Compounding as it relates to pharmacy; includes the preparation, mixing, assembling, packaging or labeling of a drug in response to a prescription written by a licensed practitioner. Extemporaneous compounding is defined as the timely preparation of a drug product according to a physicians prescription, a drug formula, or a recipe in which calculated amounts of ingredients are made into a homogenous (uniform) mixture. Extemporaneous compounding is done when certain medical needs of individual patients cannot be met by the use of an approved commercial drug product.
Today, most dosage forms of medications are already pre-packaged by the manufacturer and thus the Pharmacist role is more in the redistribution of medications and the clinical aspect of Pharmaceutical Care. The role of the Pharmacy Technician continues to grow as Technicians are taking on more of the dispensing functions once reserved for the Pharmacist alone. Pharmacy Technicians are also doing extemporaneous compounding of medications.
Reasons for Extemporaneous Compounding Today
a. Unavailable dosages, strengths and routes of commercial products
b. Dilution of adult doses of medications to Pediatric/Geriatric strengths
c. Conversion of solid dosage forms to solutions or suspensions
d. Combination of topical dermatological products not available by the
manufacturer
e. Inactive ingredients of commercial products which may cause allergic
reactions in individuals.
Goals & Objectives
The Pharmacy Technician will
have a basic understanding
of the following:
1. Compounding defined
2. Reasons for compounding
3. Compounding equipment
1. Principles of compounding
2. Calculations involved
Pharmacy – a complex of science (technology medicine, pharmaceutical chemistry, pharmacognosy, pharmacy organization and economics, management and marketing), which examines issues relating lekarstvovedeniya, training officials, namely:
1. Synthesis and analysis of drugs.
2.Developing new theories and methods of manufacturing dosage forms.
3. Study of the natural resources of plant, animal or mineral origin and processing them into medicines.
4.Development of new machines and devices, means of small mechanization and modernization of existing industrial and pharmaceutical production of drugs.
5. Quality control, storage and dispensing of drugs.
6.Study on the planning, organization and management of pharmacy, management, marketing.
7. Improving the teaching of pharmaceutical education and training of qualified personnel.
Technology medicine – a science of the theoretical foundations of production processes and processing drugs in pharmaceutical products (drugs) by providing them with a particular dosage form based on established physical, chemical, mechanical and other laws.
The word «technology» comes from the Greek techne – skill, ability and logos-science education. In the literal translation of «technology medicine»
Key terms and concepts of drug technology
Pharmacological agent – a substance or mixture of substances with pharmacological activity installed.
Drug – a pharmacological tool allowed by authorized body of the country to apply for treatment, prevention and diagnosis of human or animal.
Drugs – a medicinal product, which is an individual chemical compounds or biological agents. It can be used for preparing dosage forms without prior treatment.
Chemicals is the individual chemical compounds and products originating in its synthesis or purification of natural substances to produce chemical industry.
Vitamins may be in the form of individual chemical compounds (ascorbic acid – vitamin C, nicotinic acid – vitamin PP, riboflavin – vitamin B), as well as extracts and concentrates
Antibiotics – pp waste product of various microorganisms.Produce them by biological synthesis in growing microbes in various environments.
Orhanoterapevtychni substance – a complex of biologically active hormonal substances (adrenaline). Get them from organs and tissues of animal organisms row receive synthetic hormones (sex hormones).To flail groups include enzymes (pepsin, etc.).. Produced by dairy and meat industries.
Galene drugs
Medicinal raw – a natural substance in the form of pending or subjected to a simple, original processing, requiring for the application of any processing or treatment.
Medicinal herbs – a vegetable raw material, allowed authorized body in the prescribed manner for medical use. This group includes dried grass, leaves, flowers, roots, bark and other organs of medicinal plants.
Excipients – is more substances necessary for the preparation of a medicinal product.
In drug technology allowed only excipients permitted for medical use appropriate standard documentation: State Pharmacopoeia, Pharmacopoeia articles (FS), Temporary Pharmacopeia articles (TFS) or special GOST.In a public register is part «Excipients».
Auxiliary substances nominated to the following specifications:
– They should not affect the change of bioavailability of drugs;
– Comply with medical medicinal product, ie to ensure proper expression of pharmacological actions of medicinal product given its pharmacokinetics;
– Should not interact with drugs, packaging and closing means, as well as material processing equipment as in the preparation of drugs, and in their custody;
– Should not affect the organoleptic properties of drugs (taste, smell, color, etc.);
Based on the functions of auxiliary substances as formoutvoryuvachiv and taking into account the impact on the pharmacokinetics of drugs, they are divided into three groups: solvents, bases for ointments; substances for coatings;substances that increase the viscosity, stabilizers, preservatives, koryhenty; prolonhatory; solyubilizatory; dyes.
CONCEPT on dosage and drugs
Dosage form – a condition of a medicinal product or medicinal herbs, suitable for applications where the required treatment effect is achieved.
Sometimes it is hard to make clear the distinction between drug and form of medicines, particularly in cases where the technological operations, which were subjected to drugs in the manufacture of dosage forms were simple. To Visualize cite few examples:
Rp.: SulfadimesiniO, 5
Da tales doses № 10
Signal. By powder 1 through 4 o’clock.
Sulfadymezyn located in one large package (shtanhlas the package) is a medicinal product.The state, in which he prepared to leave, – powder, a pharmaceutical form, and all together, ie powder sulfadymezyn in prescribed dose with a specific purpose – drugs, while sulfadymezyn with pants tone can be used for manufacturing and other forms (ointments,suppositories and others.).
Herbs (medicine) – a medicinal product as defined dosage form. This finished product, packaged, packed, labeled with a defined medical supplies and set the expiration date.
Medicines are prepared from drugs, giving them suitable for medical use status (pharmaceutical form), which achieved the required therapeutic effect.
For example:
Rp.: Extract! Belladonnac 0,015
Papaverini hydrochloridi 0,03
Anaestcsini 0,3
Butyri Cacao qsut fiat suppositorium
Da tales doses № 12
Signal. By and svichtsi 1-2 times naden in pain.
In this case, prescribed suppositories containing belladonna extract, papaverine hydrochloride and anestezyn that represent drugs, ie substances with a definite therapeutic effect.If you consider that samples of writing is not about its content, and type of dosage form, it may be noted that suppositories have a general conical shape, same size and weight, plavlyatsya at body temperature and storage is not deformed.This feature applies only to medical forms – suppositories. All together suppositories with these drugs and defined purpose) are drugs.
From the fact that sulfadymezyn rozvazhenyy in the capsule was to separate doses, and with belladonna extract, papaverine hydrochloride, anestezynu made suppositories, their nature has not changed. So sometimes there are difficulties that should be considered a form of drug, and that – drugs.
Dosage forms are presented to the general requirements;
– They must ensure the maximum therapeutic effect and have a minimum side (negative) effect;
– Provide the specified duration;
– Should be easy to use;
– Must be stable during storage and transport.
Drug of a new type of related medical therapeutic system (new generation drugs), which characterizes the controlled release of active substances and their transport to the destination target.
Therapeutic drug system – a device that contains a drug substance, an element that controls the release of drugs, the platform on which the system, and therapeutic application. Ability to create such products appeared with the development of biotechnology.
State regulation of medical drugs is a set of requirements, novel relevant documents, the quality of medicines, auxiliary substances and materials, process, and drugs as a finished product.
WAREHOUSE in words Pharmaceuticals
Medicines that are prepared according to standard words pharmaceutical industry in large quantities, called ofitsynalnymy – medic-amenta ofjicinalla (from Lat. Of / icina – shop, pharmacy).
Medicines intended for personal use and prepared in the pharmacy with a doctor’s prescription, called the backbone – medicamenta magistralia (from Lat. Magister – teacher, leader, in this case – the doctor that was in words) or ekstemporalnymy (from Lat.EX (strict – once cooked).
Accordingly, all samples of writing on drugs fall paofitsynalni, manual and main (ekstemporalni).Oftsynalni samples of writing (Formulae ojjlcinales) approved by the state legislature – officinal Committee Health UkrayinyManualni samples of writing (Formulae manuales, lat. Manus – hand) – the standard words, a proven and practical medicine.
Trunk samples of writing (Formulae magistrates) – words, designated physician determined patient.
Called the appeal a written prescription (order) doctor to the pharmacist (in pharmacy) on the production of drugs and leave it to the patient indicating the method of application.
Writing prescriptions established by the Ministry of Health of Ukraine 19.07.05r. Number 360.
The right prescription prescriptions given by doctors, nurse, midwife health care regardless of ownership and subordination, which in the presence of the relevant evidence required to give patients prescriptions, certified by his signature and personal stamp.
etsepty for drugs, which released on concessional or free, is permitted to issue government doctors and public health institutions, the head of paramedics, health posts in consultation with health authorities and local government administrations.
Recipes should check out including age of the patient, procedure of payment for drugs and the nature of the drugs on the form printed printed on the prescribed forms F-1, F-3.
By writing prescriptions in Latin, which became international in this area.
In some countries, national write out the recipes, in English, French or Spanish. This structure is the same prescription adopted from Ukraine,although some simplification of the masses.
For example,samples of writing a prescription ointment:
1.Rp.: Unguenti Ichthyoli 50,
DS: Apply to affected skin 2 times pa day. English:
2. Rp.: Ointment oflchthammol 50,0
Apply twice daily to affected skin. French:
3. Rp.: Pommadc d ‘ichthyolammonium
Appliquer sur la region affecte 2 fois par jour. Spanish:
4. Rp.: Pomada de ictamol
Apliques a las partes afectadas 2 vcces diaridis.
In the examples above (2, 3.4) written in the name of the drug nominative (Casus nomenativus).
Parts of the recipe.Recipe must be made out in ink or ballpoint pen, clearly, in this following sequence of all required fields provided in the form of Earl. It must be remembered that the correction in the recipe are not allowed: if the errors, the recipe should be rewritten.
1.Inscriptio – inscription (from Lat. Inscribere – inscribe). In the caption indicating the name, address and phone number of medical institutions in which the prescription was issued.
2. Datum – date of issue of prescription (referred to full number, month, year).
3. Nomen aegroti – surname, initials of the patient.In the recipe specified name and initials of the patient, his age.
4. Nomen mcdici – surname and initials of the doctor (clearly).
5. Invocatio – appeal (from Lat. Invocare – cry, beg). In this part of the recipe submitted by one word Recipe – take (which is usually written in abbreviated: Rp.: Or R.:) And describes the legal order of a doctor pharmacist. It shows that this document is a recipe and it spread vei zakonopolozhennya recipes.
6. Designatio materiarum or Orginatio – transfer of drugs and which is prepared medicine.Drugs prescribed in Latin pronounced in a family of chemical name (according to the nomenclature of the State Pharmacopoeia). At transfer the ingredients of each substance write a single line of capital letters.The names of toxic and potent drugs should always be written completely. Prohibited reduction similar iames of ingredients that do not allow to establish that the medicinal product prescribed.
After the name of the medicinal product on the right side indicates its number.With prescription drugs, graduated in biological terms of (antibiotics, some other substances), the recipe indicates the number of units (OD).In cases where drugs are written in the same quantities after the name of the last of them before writing the number marked «ana» – equally.
Liquid medicines write out in milliliters and drops all the others – in grams.If the amount of fluid is less than one milliliter, of course it is prescribed in drops, signifying the number romaumerals. For example, gti IV (gtt – gitttas – drop). As auxiliary substances, their number of doctor may not specify a register «qs» (quantum satis – as needed).
Usually prescribe drugs in order of decreasing importance. First, write the main medicinal product (basis), then prescribed substances that contribute to essential medicines (adjuvuns – literal translation: the one who helps, assists).More can be discharged substance that fixes the taste or smell of the medicinal product (corrigens), then – formotvorni or grease substances that give form drugs (constituent – filler).
7. Praescriptio or subscriptio-order, signature.After the transfer of drugs indicated that medication form must be prepared, and the basic technological operations that must be done (to mix, fun, and so and.) Where the package should be released drugs (in capsules, vials, in dark glass vessel etc.).When writing dosed drugs indicated number of doses. To indicate dosage form is widely used the term, for example: L /. / Wig. (Misce fiat unguentitm) – mix to get a wax, M. f. pulv. D. td № 6 (Misce fiat pulvis.Da tales doses № 6) – mix, went to powder. Give the following number of doses of 6.
8. Signature – signature mark. Begins to Signa, or Signatur (Mark shall be marked), often written in abbreviated – S.
Contents signature is for the patient, it indicates how one should use drugs. Because the signature is written in Ukrainian or national languages. Unacceptable such general guidelines as «external», «interior», «known», «to take as it», etc.Because it eliminates the possibility of the pharmacist to check the dosage of poison, drugs or potent drugs and can lead to improper admission of medicinal drugs to patients.Dosing should write in detail, indicating the dose, frequency, and if necessary – and the reception, ie before or after meals, fasting, etc.
9. Subscriptio medici – doctor’s personal signature and his personal seal.By signing the prescription, the doctor takes responsibility for the accuracy of the patient’s appointment of a medicinal product. This last part of a legally valid prescription.
In cases envisaged by the order MZ of Ukraine № 360 (paragraph 1.14), in addition – the round seal of the entity that conducts activities related to medical practice.
On the prescription forms F-1 is permitted to issue no more than three names of medications.On the prescription forms F-1, which remain at the pharmacy (and recipes for those privileged to be subject-bin, except for drugs (psychotropic) drugs), and a special prescription forms F-3 is permitted to issue one name drug.
The recipe, which discharged in violation of the rules in a dose which exceeds the highest single dose without the proper clearance or prescription medicines containing incompatible substances considered invalid,drugs and it will not be forgiven. Recipe repaid stamp «Recipe valid» and returned to the patient.
All medicines are packaged according to their aggregate state and the purpose of packaging materials, approved for medical purposes. There are common rules for registration of drugs prepared in pharmacies.
All drugs issuing labels specified size and design.Depending on the method of application, labels are divided into internal, external, for injections, for ophthalmic dosage forms. Labels have different signal colors: green – for drugs, fixable inside, orange – for external use;pink – for full-time medical forms, blue – for injection. All labels must indicate the following: the emblem of medicine, pharmacy number, prescriptioumber, name and initials of the patient;method of application, date of manufacture of the medicinal product, the signature of the person who prepared medicines, and cost, as well as a warning inscription «Keep away from children». On the labels of drugs intended for injection, indicated their composition.To appeal focus on the appointment of a medicinal product used warning inscriptions: «Children», «Heart».
For drugs that are prepared individually, and depending on the dosage form and purpose of using the label «Powders», «mixture», «drops», «Eye drops», «ointment».
A medical prescription in WORLD
A medical prescription (℞) is a written order by a medical doctor to a pharmacist for a treatment to be provided to the doctor’s patient.
Format and definition
Prescriptions are typically handwritten on preprinted prescription forms that are assembled into pads, or alternatively printed onto similar forms using a computer printer. Preprinted on the form is text that identifies the document as a prescription, the name and address of the prescribing doctor 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, date (some jurisdictions may place a time limit on the prescription[1]), the “recipe” of the medication and the directions for taking it. Finally there is the doctor’s signature.
The symbol “Rx” meaning “prescription” is a transliteration of a symbol resembling a capital R with a cross on the diagonal (Template:IPA). There are various theories as to the origin of this symbol – some note its similarity to the eye of Horus, 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 recipere, “to take” [2], and it is quite possible that more than one of these factors influenced its form. Literally, “Rx” indicates an instruction “to take” what is specified in the prescription, although this was probably originally directed at the pharmacist who needed to take a certain amount of each drug and prepare them, 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”.
Both pharmacists and physicians are regulated professions in most jurisdictions. A prescription as a communications mechanism between them is also regulated and is a legal document. Legislation 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.
Many brand name drugs have less expense generic drug substitutes that are chemically equivalent. Prescriptions will also contain instructions on whether the doctor 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 doctor to check off (but this is easily checked off by anyone with access to the prescription). Other jurisdictions the protocol is for the doctor to handwrite one of the following phrases: “dispense as written”, “DAW”, “brand necessary”, “do not substitute”, “no substitution”, “medically necessary”, “do not interchange”[3].
As a guideline, pediatric prescriptions should include 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.) In some jurisdictions, it may be a legal requirement to include the age of child on the prescription [4]. Adding the weight of the child is also helpful.
Prescriptions often have a “label” box [5]. When checked, pharmacist is instructed to label the medication. Wheot checked, the patient only receives instructions for taking the medication and no information about the prescription itself.
Some doctors 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 doctor. Legislation may restrict some categories of drugs from being refilled.
In group practices, the preprinted portion of the prescription may contain multiple doctors’ names. Doctors typically circle themselves to indicate who is prescribing or there may be a checkbox next to their name.
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 “prescriptioumber” (often abbreviated “Rx#”) that is unique to the pharmacy that filled the prescription. The prescriptioumber is written right on the prescription by the pharmacist. The prescriptioumber has the practical purpose of uniquely identifying the prescription later on while filed (both manual and electronic). The prescriptioumber is also put on the label on the dispensed medication. The patient may be required to reference the prescriptioumber 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. Very rarely can the patient 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[6][7]. This number has grown from 1.5 billion in 1989 and is expected to continue to grow.
Prescriptions are sometimes forged because many narcotics are cheaper and safer as prescription drugs than as street drugs. Forgery takes many forms: Doctor’s prescription pads are sometimes stolen by drug addicts, amounts may be altered on legitimate prescriptions, call back numbers may be falsified and phoned or faxed prescriptions faked[8].
Some doctors 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 only authorize certain printers to print prescriptions[9]. Prescribers can make it harder for amount forgeries by writing out the amounts in words. Again, this may be mandated by law[10].
Some jurisdictions help control stolen prescriptions by requiring special “triplicate prescriptions” for certain classes of drugs[11]. Blank triplicates are only available from the regulating agency and are individually numbered. The doctor 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 stolen prescriptions that pharmacists can check. In this example, the prescription’s validity is further limited to 72 hours from issuance. This system also has the further benefit of managing “double doctoring” where patients visit multiple doctors to get prescriptions.
When forgery is suspected, pharmacists will call the doctor to verify the prescription and will attempt to detain the suspect pending arrival of authorities. Forged prescriptions are no longer considered medical documents and doctor-patient confidentiality rules no longer applies.
Who can issue prescriptions are governed by local legislation. In the United States, physicians, veterinarians, dentists, and podiatrists have full prescribing power. In all states optometrists will also issue eyeglass prescriptions for corrective eyeglasses though technically these are not medical prescriptions. In many states, optometrists cannot prescribe medication. States allow mid-level practitioners different prescription privileges. Nurse practitioners (also known as advance practice nurses), physician assistants, optometrists, homeopathic physicians, registered pharmacists, naturopathic physicians, and doctors of oriental medicine currently represent the spectrum of mid-level practitioners. Each state regulates what (if any) prescription powers members of the above group are allowed. Florida, for example, prohibits every member of the above group from any prescription power, where as North Dakota allows registered pharmacists to prescribe certain medications[12].
Prescriptions, when handwritten, are notorious for being often illegible (5% according to an Irish study [13]). Contrary to popular belief, pharmacists do not have special deciphering skills. When in doubt, they call the doctor. 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. For doctors that the pharmacist deals with regularly, they learn to read the doctor’s handwriting. Patients are advised to ensure that the prescription is legible before leaving the doctor’s office. Some jurisdictions have made legible prescriptions a law (e.g. Florida[14]). Some have advocated the elimination of handwritten prescriptions altogether [15] and computer printed prescriptions are becoming increasingly common in some places. However, in the United States, computer-printed prescriptions cannot be used to prescribe Schedule II medications; prescriptions for these medications must be in the physician’s handwriting, or typewritten, and actually signed by the physician.
Independent of the actual prescribing decision, elements of a good prescription writing include: [16] [17] [18]
- careful use of decimal points to avoid ambiguity:
- avoid unnecessary decimal points: 5 mL instead of 5.0 mL to avoid possible misinterpretation of 5.0=50
- alway zero prefix decimals: e.g. 0.5 instead of .5 to avoid misinterpretation with .5=5
- never have trailing zeros on decimals: e.g. use 0.5 instead of .50 to avoid misinterpretation with .50=50
- avoid decimals altogether by changing the units:
0.5 g =500 mg - “mL” is used instead of “cc” or “cm3” even though they are technically equivalent
- directions should be written out in full in English although some common Latin abbreviations are listed below
- quantities can be given directly or implied by the frequency & 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
- use permanent ink
- avoid prn “as needed” – limits & indicators should be specified e.g. “q 3h prn pain”
- for refills – minimum duration between repeats & number of repeats should be specified
See Appendix 1 for a complete list of common abbreviations found on 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.
Non prescription drug prescriptions
Prescriptions are also used for things that are not strictly regulated as a prescription drug. Doctors 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 doctor. Conversely, if a medication is available over-the-counter, doctors may ask patients if they want it as a prescription and possibly incur a pharmacist’s dispensing fee or whether they want to get it themselves at a lower price. If the patient wants the medicatioot under prescription, the doctor is usually careful to give the medicatioame to the patient on a blank piece of paper to avoid any confusion with a prescription. This is applied to non-medications as well. For example, crutches, and registered massage therapy may be reimbursed under some health plans, but only if given out by a doctor as a prescription.
Doctors will often use blank prescriptions as general letterhead. A “doctor’s note” for absent days from school or work for minor illnesses will often be written on a blank prescription.
Legislation may define certain equipment as “prescription devices”[19]. 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 prothesis, gut sutures, sickle cell tests, cervical cap and ultrasound monitor.
In some jurisdictions, hypodermic syringes are in a special class of its own, regulated as illicit drug use accessories[20] separate from regular medical legislation. Such legislation will often specify a prescription as the mean by which one may legally possess syringes.
Related usage of the term prescription
Prescription may also be used as a short form for prescription drugs to distinguish from over-the-counter drugs. It may also be used 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 authority. A “green prescription” is direction from a doctor to a patient for exercise and healthy diet.
The concept of prescriptions date 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 [21][22].
Modern prescriptions are actually “extemporaneous prescriptions” from the Latin (ex tempore) for “instant”[23]. “Extemporaneous” means the prescription is written on the spot for a specific patient with a specific ailment. This is distinguished from the 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[24]. 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”[25].
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 “take thou”. This is most likely an exhortation to the pharmacist by the doctor, “I want the patient to have the following medication”[26]. It should not be interpreted as instructions to the patient to “take thou” as patient instructions are in a later section. Some the literal exhortation to the pharmacist is “take thou this recipe”.
The inscription section defines what is the medication. The inscription section is further composed of one or more of[27]:
- 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[28] and is often abbreviated “Sig.”[29] or “Signa.” It also obviously contains the signature of the prescribing doctor 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
Future directions of prescriptions
As a prescription is nothing more than information among a doctor, 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 doctor to the pharmacist using smartcards and the internet[30].
Within computerized pharmacies, the information on the piece of paper that is the prescription is captured immediately. Thereafter, the prescription is simply an entry within the pharmacy’s information system and the paper prescription is stored for legal reasons only.
In cases where a pharmacy is part of a chain of pharmacies, the pharmacies are often linked together through their corporate headquarters with computer technology. Walgreens, for example, uses satellite technology to share patient information. A person who has a perscription filled at one Walgreens can get a refill of that perscription at any other store in the chain, as well as have their information available for new perscriptions at any Walgreens.
Pharmacy information systems are a potential source of valuable information for pharmaceutical companies as it contains information about doctor’s prescribing habits. Prescription data mining of such data is a developing, specialized field[31].
Appendix 1: Complete list of abbreviations
This appendix is meant to be a complete list of all abbreviations used in prescriptions. 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.
- aa (ana) – of each
- ad – to, up to
- a.c. (ante cibum) – before meals
- a.d. (aurio 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. (aurio laeva, aurio sinister) – left ear
- A.T.C. – around the clock
- a.u. (auris utrae) – both ears
- bis (bis) – twice
- b.i.d. (bis in die) – twice daily
- B.M. – bowel movement
- bol. (bolus) – a large pill
- B.S. – blood sugar
- B.S.A – body surface areas
- cap., caps. (capsula) – capsule
- c (cum) – with (usually written with a bar on top of the “c”)
- c (cibos) – food
- cc – cubic centimetre; also means “with food” (cum cibos)
- cf – with food
- C.H.F. – congestive heart failure
- comp. – compound
- cr., crm – cream
- D5W – dextrose 5% solution (sometimes written as D5W)
- D5NS – dextrose 5% iormal saline (0.9%)
- D.A.W. – dispense as written
- dc, D/C, disc – discontinue
- dieb. alt. (diebus alternis) – every other day
- dil. – dilute
- disp. – dispense
- div. – divide
- d.t.d. (dentur tales doses) – give of such doses
- D.W. – distilled water
- elix. – elixir
- e.m.p. (ex modo prescripto) – as directed
- emuls. (emulsum) – emulsion
- et – and
- ex aq – in water
- fl., fld. – fluid
- ft. (fiat) – make; let it be made
- g – gram
- G.I. – gastrointestinal
- gr – grain
- gtt(s) (gutta(e)) – drop(s)
- G.U. – gentiourinary
- H – hypodermic
- h, hr – hour
- H.A. – headache
- H.B.P. – high blood pressure
- h.s. (hora somni) – at bedtime
- HTN – hypertension
- ID – intradermal
- IM – intramuscular (with respect to injections)
- inj. (injectio) – injection
- IP – intraperitoneal
- IV – intravenous
- IVP – intravenous push
- IVPB – intravenous piggyback
- L.A.S. – label as such
- LCD – coal tar solution
- lin (linimentum) – liniment
- liq (liquor) – solution
- lot. – lotion
- M. (misce) – mix
- m, min (minimum) – a minimum
- mcg – microgram
- mEq – milliequivalent
- mg – milligram
- mist. (mistura) – mix
- mitte (mitte) – send
- mL – millilitre
- N&V, N/V – nausea and vomiting
- nebul (nebula) – a spray
- N.K.A. – no known allergies
- N.K.D.A. – no known drug allergies
- N.M.T. – not more than
- noct. (nocte) – at night
- non rep. (non repetatur) – no repeats
- NPO, n.p.o. (non per os) – nothing by mouth
- NS – normal saline (0.9%)
- 1/2NS – half normal saline (0.45%)
- N.T.E. – not to exceed
- o_2 – both eyes, sometimes written as o2
- o.d. (oculus dexter) – right eye
- o.s. (oculus sinister) – left eye
- o.u. (oculo utro) – both eyes
- oz – ounce
- per – by or through
- p.c. (post cibum) – after meals
- p.m. (post meridiem) – evening or afternoon
- prn (pro re nata) – as needed
- p.o. (per os) – by mouth or orally
- p.r. – by rectum
- pulv. (pulvis) – powder
- q (quaque) – every
- q.a.d. (quoque alternis die) – every other day
- q.h. (quaque hora) – every hour
- q.1h (quaque 1 hora) – every 1 hour; (can replace “1” with other numbers)
- q.d. (quaque die) – every day
- q.i.d. (quater in die) – four times a day
- q.o.d. – every other day
- q.s. (quantum sufficiat) – a sufficient quantity
- R– rectal
- rep., rept. (repetatur) – repeats
- RL, R/L – Ringer’s lactate
- s (sine) – without (usually written with a bar on top of the “s”)
- s.a. (secundum artum) – use your judgement
- SC, subc, subq, subcut – subcutaneous
- sig – write on label
- SL – sublingually, under the tongue
- S.O.B. – shortness of breath
- sol (solutio) – solution
- s.o.s., si op. sit (si opus sit) – if there is a need
- ss (semis) – one half
- stat (statim) – immediately
- supp (suppositorium) – suppository
- susp – supsension
- syr (syrupus) – syrup
- tab (tabella) – tablet
- tal., t (talus) – such
- tbsp – tablespoon
- troche (trochiscus) – lozenge
- tsp – teaspoon
- t.i.d. (ter in die) – three times a day
- t.i.w. – three times a week
- top. – topical
- T.P.N. – total parenteral nutrition
- tr, tinc., tinct. – tincture
- u.d., ut. dict. (ut dictum) – as directed
- ung. (unguentum) – ointment
- U.R.I. – upper respitory infection
- U.S.P. – United States Pharmacopoeia
- U.T.I. – urinary tract infection
- vag – vaginally
- V.S. – vital signs
- w – with
- W.B.C. – white blood count
- w/o – without
- X – times
- Y.O. – years old
To avoid ambiguity, the following abbreviations are not recommended [32]:
- a.u., a.d., a.s. – 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
- d/c – can mean “discontinue” or “discharge”
- h.s. – can mean half strength or “hour of sleep”
- q.d. – meant “every day” but the “.” after the “q” is interpreted to be an “i” thus “q.i.d.” or quadrupling the dose to 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/SQ – meant “subcutaneaous” but mistaken for “SL” for “sublingual”
- T.I.W – meant 3 times a week but mistaken for twice a week
- U – meant “units” but mistaken for “0”, “4” or “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
Exhibit A: sample legal definition of a prescription
Taken from California’s Business and Professions Code Section 4040 [33]:
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 physician, dentist, optometrist, podiatrist, or veterinarian or, if a drug order is issued pursuant to Section 2746.51, 2836.1, or 3502.1, by a certified nurse-midwife, nurse practitioner, or physician assistant licensed in this state.
(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.
Exhibit B: sample legal requirement for filing of prescriptions
From the Mississippi Board of Pharmacy [34]:
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”.
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.
Exhibit C: sample legal requirements for security and format
From Indiana Board of Pharmacy [35]:
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 (5) 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 (c) 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 (5-1/2) 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)
Exhibit D: sample requirements on information added by the pharmacist
Taken from the Ontario’s Drug and Pharmacies Regulation Act [36], 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 identificatioumber 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).
National drug quality control exercised by bodies of state control by the official reference document (DB, existing orders, instructions, etc.).
Carrying control relies on the pharmacy manager, his deputy, pharmacist and pharmacist-analysis technology .Order MZ of Ukraine (Order number 626, etc.)..
Translation control: is a pharmacist and pharmacist-technology in the manufacture of drugs for individual words and the requirements of medical institutions by filling out the passport written in memory of the control (TCP).The passport must be filled immediately after manufacture of the medicinal product according to technology. Passport states: the date, prescriptioumber (the requirement), combined drugs (Latin) and their number, the number of doses, put signatures of persons who manufactured, tested and rozfasuvaly drugs.In the case of manufacture of the medicinal product labels trainee interns and treat the person responsible for production practices.
On medications that contain poisonous, narcotic substances, at the top of the passport takes the letter «A», and the dosage forms for children – the letter «D».
All payments are to manufacture drugs and recorded on the back of the passport. Using semi-states and concentrate their concentration and the number taken. The manufacture of powders, suppositories and tablets specify the weight of individual doses and the number. Size or suppositories mass number and stabilizing substances are added to eye drops and injection, as indicated in their passports, and on the back of the recipes.Passport specified ratios used in calculations for water absorption medicinal herbs, the coefficients increase of dissolution in aqueous solutions of drugs, formula.
Prepared medicines, prescriptions filled and sent to the TCP scan technologist or a person who carries out his functions. The control is inspection of records in accordance with TCP samples of writing in the recipe, made the correct calculations. If the medicine tested pharmacist analyst complete chemical control to put the passport number and signature analysis of pharmacist-analysis.
When the medicine is produced and released the same person, doing as well as TCP. The manufacture injection all records kept in a special journal. TCP is stored in the pharmacy within a month.
2. Questionnaire control is pharmacist-tshnolohom and applied selectively.After making the pharmacist is not more than 5 drugs pharmacist-technology called first ingredient includes drugs and medicines in the complex indicating its number, then pharmacist must identify all ingredients and combined them their number.
3.Organoleptic control, is an analyst or pharmacist technologies and is checking the appearance of dosage form, its color, taste, smell, mixing homogeneity, the absence of mechanical inclusions in liquid dosage forms.
Homogeneous mixing of powders, ointments, tablets, suppositories tested to the division of weight on dose. Verification is selectively each of the pharmacist during the day (but not less than 3 dosage forms per day).
Taste tested dosage forms for internal use selectively and in case of doubt as prepared dosage form. Particular attention is pa medicines for children. Results of organoleptic control of dosage forms recorded in the journal.
4.Physical control is an analyst or pharmacist technologies and is verifying the total mass or volume of dosage form, quantity and weight of individual doses, which are included in this pharmaceutical form (but not less than 3 doses), monitored the quality of closing. Physical control are:
– Each episode filling and stocking vnutriaptechnoyi (3 to 5 units of samples from each series or harvesting;
– Selectively dosage forms prepared according to individual prescriptions per day (but not less than 3% of the total);
– Dosage forms that require sterilization after packaging to their sterilization.
5.Chemical control is pharmacist-analyst (qualitative and quantitative) and pharmacist-tshnolohom (optional – high quality) and is to determine the quantity and content of drugs, belonging to the dosage form.
Qualitative analysis are: purified water, water for injection, all drugs coming from the warehouse, solutions, concentrates, intermediate products, packaging, selective – all kinds of dosage forms prepared by recipes (requirements).
Complete chemical analysis are: all injection before and after sterilization, eye drops and ointments containing narcotic and poisonous substances;all dosage forms for newborns, hydrochloric acid solutions (for internal use), atropine sulfate, mercury dichloride and arheytum nitrate, all concentrates, intermediate products and vnutriaptechna harvested;stabilizers, used in the manufacture of injection and eye drops, the concentration of ethanol; selective all kinds of dosage forms (but not less than eight, prepared for the change).
Particular attention is paid to control children’s dosage forms of eye and those that contaiarcotic and poisonous substances.
6. Control in dispensing pharmacist by technology. Control are all prepared in the pharmacy dosage forms.Checking: packaging (must match the mass (volume) and type of dosage form and properties of the input components), design (must meet the requirements of existing regulations) specified in the recipe line doses of medicines lists A and B age of the patient;match the number of recipe and number on the label, matching copies of the recipes in words of recipes.
Thus, quality control of drugs includes how to monitor production of drugs at all stages of technology and control of finished products.
More material on the organization of quality control of drugs is considered in the course of pharmaceutical chemistry.
Types of scales. One of the most widespread methods of dosage there is weighting which is executed by scales.
Balance (scales) – a device designed to determine the weight of weight of medicines way to compare it with the standards of the masses (with conventionally accepted units – weights).
For structural features distinguish hydrostatic, Spring and weighing scales.
From the viewpoint of metrological characteristics (stability, sustainability indications, accuracy and sensitivity) distinguish scales:
To prepare medicines in a pharmacy practice applying straightshouldered scales 2-class: technical chemist (container) and hand chemist. Material used in conventional desktop cup scales, and large masses – and decimals centesimal scales.
Packaging scales used to weight solid, thick and liquid. They are made from outside the allowable load of
Balance (scales) Technical (TT-4) 2-class by TУ 64-1-1065-79 have the following characteristics: measurement range 0,1-
Hand Weights (RT) pharmacy brand BP (ДТС 7328-61) designed for dosing by weight of dry medicinal substances in quantities from 0.02 to
For manual weighing scales are in the ring oboymytsi thumb and the forefinger of the left hand so that the middle and unnamed finger, without touching oboymytsi could limit the fluctuations in the hands as one, and the second side, and after weighing – to hold the arrow inside oboymytsi (Figure . 12). In the out-of-scales remain hanging on a hook special tripod, as shown in Fig. 13, or laid in a box. It protects the prism scale from unnecessary wear.
Widespread use of electronic scales are manufactured by various companies
Balance (scales) ordinary desktop (scales Berenger) – used for weighing substances that do not require much precision, because they are less sensitive than the formulation and.
Make their capacity from
Tens and centesimal scales are used in warehouses for weighing loads in the form of barrels, drawers, containers etc. Disstraight shoulder scales makes it possible to balance them on the platform load weights of 10 and 100 times respectively less weight. For decimal scale using standard weights, and for centesimal – in the form of special plates for them to threading vertical rod
METROLOGY BALANCE (SCALES) PROPERTIES
Stability – the ability to scale derived from the equilibrium state, quickly return to the original position.
Sustainability of evidence – the ability to scale to show the same results with multiple definitions of body weight carried pa these scales in the same conditions.
Sensitivity – the ability to scale to show minor changes in the load point of equilibrium.
Thus, the less difference in weight, weights, you can identify these scales, the higher their sensitivity and thus more accurate weighing results.
Checking the sensitivity scale is done by determining the minimum load (mg), which is the standard deviation from the equilibrium arrows. By taking the standard deviation of deflection, equal to
Thus, scales and technical CGT-1000 with the following error values:
– Not loaded – 20 mg;
– 1 / 10 maximum load – 60 mg;
– Heavy loads – 100 mg.
In determining the value of the sensitivity of these scales with 1 / 10 load do so: scales resulting in equilibrium, for each cup put weights on the weight of
With regard to determining the sensitivity of manual scales, it is the same way the standard deviation of the arrow. In these cases, the sensitivity scales reflected the number of milligrams that raise the required swing.
In practice is important so-called relative sensitivity, which may indicate the relative weighting of error (accuracy of dosing).
Relative sensitivity of the scales can be expressed in the minimum load (R), which causes a significant deflection from the zero position of the scale, the load (P), lying in one cup of scale, because the sensitivity of scales may vary slightly depending on the size of the load:
Definition of error weighting.
At the same load can weigh scales with varying accuracy. The greatest accuracy can be obtained wheavazhka close to the value of the largest permissible load scales. Error weighting increases if cross border or a minimum load limit marked on the beam scale data.
To conclude, as properly chosen scales for the determination of mass, we must establish the accuracy of weighing or relative error (in%).
The relative error weighting determined by the formula: Svidn. = Sabs. : Mnavazhky · 100%.
Accuracy or correctness – the ability to scale to show the correct ratio between the weight of substance is weighed and the corresponding weights.
Accuracy or correctness, scale depends on the following factors:
– From straightshouldered beam;
– Parallelism of the edge of the base and weigthaccepted prisms;
– The position of center of gravity beam that must be placed precisely on the vertical which passes through the point of support, that is below her;
– Of equal weight cups.
If the scales meet the specified requirements, they should be in the beam horizontally, and balance index (arrow) – in a strictly vertical as in the hollow, and at the same loaded cargo cups.
Checking the accuracy of scales conducted at 1 / 10 of maximum load at full load and loaded scales.
Weights and sets of weights.
It is difficult to represent a set of weights. Weights – a measure clearly established by mass (weight) applied to weight. For calibration and validation scales.
Weighing the body, we compare it with the largest mass adopted for the unit in the international metrology system measures. Per unit mass of a kilogram has been adopted. The names of the lower units of grams of particles formed by the Latin prefixes “detsy” (0.1), “Santa” (0.01), “milli” (0.001). Depending on the destination distinguish these weights;
– Samples made of gold, platinum and copper alloys;.
– Analytical, made of copper alloy and steel with carefully polished surfaces, coated with gold, platinum, nickel or chromium;
– Technical weights
In practice, pharmacies apply technical weights 2-class in the form of special sets (seriously): large (gram), which contains the weights from
Should only take them with tweezers, clean the weight of different polishing means is strictly prohibited.
Weights and scales undergo testing and marking every year.
Terms of weighing the technical and manual straightshouldered scales.
Before you start weighing, check the compliance with the above scale metrology properties that ensure their accuracy, sensitivity, stability and immutability of the testimony. You must comply with the limit load and the minimum set for data scales.
Before the work scales should look, wipe gauze pad soaked in alcohol-ether mixture, to make sure they are not loaded in the equilibrium state. If scales are not balanced, they balance with the regulators placed on the ends of the beam.
As a rule (for convenience), the weight placed on the left cup of scales and weigh the medicinal product – on the right.
When you weight drugs and excipients, start toassistate with three duties: removing from the rotator, and return to weighting shtanhlasa place. Calculating mass has to be done twice – at the beginning and after weighing.
Powdery substance on hand in the weighing scales placed directly in the cup and thick – the cups Butter or filter paper (previously starovanyy).
Weigh any matter directly to the bowl tare scale is unacceptable, you must use the appropriate containers (bottles, jars, capsules and N).. To avoid mistakes is not recommended for use calibration difficult.
Friable substances weight as matter directly with shtanhlasa by light pattering on it forefinger of his right hand. They add substance in small portions, so that threads do not get dirty. As you approach the moment of balance portion of the substances added to reduce, to avoid possible overdose of powder. If necessary, a substance selected by celluloid or plastic plates. After weighing on scales initially its difficult to remove (and once the counting of mass weights), and drugs. After each weighting drugs with shtanhlasa neck and cork shtanhlasa and scales carefully wipe gauze pad.
Describe the main technological operations for weighing, packaging and design to leave 100.0 chloroform. Correctness of the assignment number 5 compare with the standard answer.
When a package of fluid that differs from the density of water at weight taryrnyh weights directly in the bottle for a vacation.
Pick up a glass bottle of orange (as chloroform – photosensitive material) with a volume of 100 ml. Pick up plastic and rubber stopper.
Verify installation taryrnyh weights, balance in unloaded condition, clean cups. Picked bottle put on the right cup taryrnyh weights, balance and left the same bottle. If necessary, add a small weight.
On the left cup placed small weight weight 100.0 and gradually pour in the bottle with shtanhlasu chloroform, reducing its speed waving. As the moment of equilibrium (shtanhlas with chloroform are in the closet “odorous and dyeing). This index finger of the left hand touch edges left cup to feel the moment approaching equilibrium. When weighting shtanhlas keep up the label, not to soil her neck shtanhlasa should not touch the bottle.
Closing the bottle, check for leaks and issuing packaging label “external”.
Dosage volume and drops
Measuring instruments. When cooking liquid pharmaceutical dosage forms made using special utensils dimensional graded a certaiumber of milliliters. International System of Units (SI) unit of capacity taken cubic meter (1 m-1). In practice, pharmacies such unit is used (1 ml), which equals one-millionth share cubic meter (1 ml = 1h10′
For the dosage of water (mass and ml of water at room temperature is practically equal to
Volumetric flask (labeled on the neck) are different sizes. Often they are used in the preparation of stock solutions for burette plants and injecting fluids.
Measuring cylinders (cylindrical receptacles), beaker (conical vessels) – Dosing relatively large quantities of liquids, especially wheot required accuracy.
Pharmacy burette. Burette is for a precise measure of water solutions and in the form burette system (set of special burettes and pipettes) used in pharmacies in the preparation of drugs from stock solutions.
Burette is a graded glass tube connected through feed tube from the feed vessel. Pharmacy burette is a bottle of liquid and is designed for accurate weighting water and various water and water-alcohol mixtures of drugs.
Pharma manufacturing burette capacity 10, 25, 60, 100 and 200 ml. graduate them to dial in 0.1 ml. Length burettes all volumes –
Pharmacy pipette. Pharmacy is part of the pipette burette system. It gauges, graduated in milliliters to liquid small (15 ml) volumes of fluid, easy motion and weak binders.
They are a capacity for 3.6, 10 and 15 ml of the price of dial scale 0.1, 0.2 and 0.5 ml respectively.
Liquids in gaining rubber dropper bottles. This pipette slightly raised above the fluid and a grip rubber bulb to squeeze out of him a certain amount of air. Then pipette immersed in the liquid and slowly release the bulb, recruited her. For equilibrium press on the beads on the side tube. Liquids poured pipette with continuous stream, not subtract it from the tip of the vascular wall for 3 seconds. You caot avoid getting fluid Shea to avoid its pollution, while repeated cases – the contamination of fluids.
Dosage by volume.
Because the relative accuracy of devices used for the dosing solution volume depends on temperature, and other factors in liquid to observe the following rules:
1. Liquid done at a temperature at which the calibration was conducted dosing devices.
2. The level of dosed liquid, if it is transparent and wet surface of the glass, determined at eye level working on the lower meniscus, and painted – on top. Dosing device should be placed in strictly vertical position, otherwise avoid errors due to parallax (imaginary shear fluid level).
3. Measure the liquid should not be empty very quickly, because it not time to completely run down from walls filling device. To avoid errors, you must allow the liquid to flow down the remainder of the walls of the filling device for 2-3 seconds.
4. An important factor that affects the accuracy of liquid is the diameter of the burette.
Thus, small amounts of liquids must weight the burette and pipette with a small diameter.
Dimensional volume of devices used in the preparation of liquid medicines should not be significantly different from the fluids that you want to measure.
5. The use of burette with broken tips and pipette broken outlet.
6. Measuring instruments used only thoroughly rinsed and fat. Otherwise, some metered solution remains in the contaminated walls in the form of drops. Burette and pipette wash settings as necessary, but at least once in 10 days.
7. For example, liniment to enter a prescription
Dosage drops.
When using standard droppmeter must comply with these requirements: droppmeter kept in strictly vertical position, it is better fixed in a tripod, it protects it from possible shocks; outdropping with droppmeter should be under the influence of gravity without any additional clicking, outdropping do not need very quickly and monitor the finish job drop. droppmeter clear of dirt and grease with chromium compounds, and then washed with water and dried.
Standard droppmeter can replace pipettes, calibrated to the corresponding fluid. When liquids are droppmeter empirical data table.
Custom Calibration droppmeter. Custom droppmeter (pipette) can prokalibruvaty two ways.
Number of standard drops to
In 1.0 adrenaline hydrochloride solution 0.1% contains 25 drops.
They find the coefficient correction:
HF = 30:25 = 1.2.
In the recipe prescribed 10 drops dropper to measure: 10 · 1,2 = 12 drops.
Determine the number of drops of a solution of adrenaline hydrochloride 0.1% in 1 ml
3 ml – 90 drops
1 ml – X X = 30 drops
Number of standard drops in 1 ml determined by the table drops.
In 1 ml of adrenaline hydrochloride 0.1% contains 30 drops.
They find the coefficient correction:
HF = 30:25 = 1.2
Therefore, when the recipe discharged 0.5 ml to measure:
1 ml – 30 drops
0.5 ml – X X = 15 drops
Discovered the relation between standard and nonstandard drops (1 Default. drops, equal to 1.2 not standard. drops) are as above. Prokalibrovanu pipettes used for outdroping only certain liquids.
Equipment
Balances
Class A Prescription Balance
The Class A Prescription Balance is a two-pan torsion type balance that utilizes both internal and external weights. The Class A Prescription Balance is used in the Pharmacy setting as a means of determining the weight of a material to be used in the compounding of a prescription or manufacturing of a dosage form. This balance is currently required in all pharmacy settings and must meet the requirements of the National Bureau of Standards (NBS).
The minimum weight that can be weighed on this balance is 120 milligrams (mg) and the maximum weight is 120 grams (gms). The Class A prescription balance has a sensitivity of 6 mg that means just 6 mg of a substance will move the pointer of the balance one division off equilibrium or one degree.
Proper care of the Class A Prescription Balance is important to ensure accurate measurements. Always keep the balance in the locked position, except when equilibrium is being tested and never add or remove weight or materials unless the balance is in the locked position. The balance should be kept clean at all times, and care should be taken to avoid vibration, dust, moisture and corrosive vapors. The balance cover should be kept down at all times except when the balance is in use.
Class A Prescription Balance Weighing Procedure
1. With the balance locked, place a weighing paper on each pan. Place the desired
weight on the RIGHT pan; place the material to be weighed on the LEFT pan
2. Release the lock of the balance and observe the position of the indicator
3. Lock the beam and adjust the amount of material
4. A swinging balance is the most accurate method of measuring. This is indicated
when the pointer swings an equal number of divisions to both sides of the central
position
5. The final measurement should be determined with the cover down
6. To avoid mistakes in totaling the weights, they should be totaled three times
a. as they are placed on the pan
b. from the vacant positions in the weight box
c. and as they rest on the pan
Bulk Balance
The Bulk Balance or Counter Balance is less accurate than the Class A Prescription Balance and is primarily used to weigh large quantities of material. It has a limit of 5 Kilograms (Kg) and a sensitivity of 100 mg.
Analytical Balance
With the advent of new technology, the Analytical Balance is finding its way from Pharmaceutical analytical laboratories into the Pharmacy setting. Due to convenience, precision and accuracy, as well as a sensitivity of a digital readout of 0.1 mg, most pharmacies prefer the use of this balance.
Weights
Weights used for the Class A Prescription Balance and other balances are made of brass or polished metal and must be maintained and handled properly. These sets usually contain cylindrical weights ranging from 1 to 50 gms and fractional weights of 10 to 500 mg.
Once yearly the weights should be calibrated to ensure accuracy.
Spatula
Spatulas are used to transfer solid ingredients such as powders, ointments, creams to weighing pans. They are also used to mix ingredients together into homogenous mixtures. Spatulas are available in stainless steel, plastic and hard rubber, the type of spatula to use is dependent on what is being transferred or mixed.
Care of Weights
a. weights should never be touched by the hand
– body oils will increase their weight and accelerate the corrosion
of the weights
– should manipulate with plastic or plastic tipped tweezers to
prevent oxidation of metal
b. weights must be stored in clean state
– in a special rigid and compartmentalized covered box
c. weights cannot be dropped or dented
Mortar and Pestle
The mortar and pestle is used to grind particles into fine powders (trituration). The incorporation of a liquid (levigation) can further reduce particle size. Mortar and Pestles are made of Glass, Porcelain, Wedgwood or Marble. Glass is preferable for mixing liquids and semi-soft dosage forms.
Graduates
Graduates are used in the measurement of liquids. Most graduates are marked “TD” which means, “to deliver”. This marking indicates that the measurement of this graduate will compensate for the excess liquid that adheres to the surface of the graduate after emptying.
Conical Graduate
The Conical graduate has a wide mouth and wide base to allow the stirring of liquids with a glass stirring rod. As the diameter of the graduate increases, the accuracy decreases. The conical graduate varies in size from 10ml to 4000ml.
Cylindrical Graduates
The Cylindrical graduate is uniform from top to bottom and is the most accurate graduate for the measurement of liquids.
Graduate measuring
– reading must be done at eye level
– correct reading is the mark at the bottom of the meniscus
meniscus: surface of the liquid that bulges downward
Ointment Slabs
Along with the mortar, pestle and spatula, the Ointment Slab is mainstay in the Pharmacy setting. Ointment slabs provide a clean, hard surface for the mixing of compounds. Most ointment slabs are ground glass plates, that provide a non-absorbable surface area. For multiple compounding, many pharmacies purchase Parchment Papers that serve the same purpose when placed over an ointment slab, but are easily disposed of after use without the necessary cleaning involved between mixtures. Principles of Compounding
Liquids
Liquids such as Solutions and Suspensions, are the most common form of compounded medications. A solution is a clear liquid in where the drug is completely dissolved. A suspension is a liquid preparation that contains fine drug particles that are distributed uniformly throughout the solution. The reconstitution of an antibiotic such as Amoxicillin would be an example of a suspension. Suspensions always require shaking before use.
Solids in Liquids
When solids are required in solution, it is important to reduce the particle size of the solid by using the mortar and pestle (trituation). In some cases, the incorporation of other agents are needed to ensure finer particle size and in the case of suspensions, to ensure even distribution of particles.
A dilute solution contains a very small amount of particles or solute in solution. A concentrated solution contains large quantities of solute in solution and a saturated solution contains the maximum amount of solute that can be dissolved in a solvent or at a given temperature or pressure.
Ointments / Creams
Ointments and Creams are semisolid dosage forms used for externally. The are often used when the prescribing physician requires the combination of two or more ointments or creams in a specified ratio or the incorporation of a drug into an ointment or cream base. Ointments are characteristically oil based, while creams are water based.
Because the direct mixing of ingredients is not always workable, the incorporation of other agents such as a wetting agent or levigating agent is needed to ensure finer particle size.
Geometric Dilution
Extemporaneous compounding of ointments and creams oftentimes involves the use of the mortar & pestle, spatula and the ointment slab. The key to a homogenous mixture is to use these tools properly and to incorporate the method of Geometric Dilution in the preparation of all ointment / cream products.
Geometric Dilution is the process by which a homogenous mixture or even distribution of two or more substances is achieved. When using this method, the smallest quantity of active ingredient is mixed thoroughly with an equal volume of the diluent or base on the ointment slab. More diluent (base) is added in amounts equal to the volume of the mixture on the ointment slab. This process is repeated until all of the diluent (base) is incorporated in the mixture. This method, though time consuming, will create a homogenous mixture or smooth dispersion of the drug in the ointment/cream base.
In some cases, due to time constraints or lack of experience, Geometric Dilution is not used in the Pharmacy setting and mixtures are just mixed together haphazardly. This “slap them together mixture” may result in gritty and scattered powder that fails to blend in the ointment/cream base being used. A non-homogenous mixture caot only pharmacologically affect the therapeutic effect, but can also cause serious topical skin reactions.
Wetting Agents: displaces air from particles and allows them to mix
better
Example: Alcohol
Levigating Agents: reduces particle size
Example: Mineral Oil, Glycerin
Suspending Agents: a thickening agent that gives some structure to a
suspension. Allows easy dispersion of particles.
Example: Carboxymethylcellulose, Tragacanth
It is generally agreed that pharmaceutical products should be prepared with a low percentage of error. The Official Compendium allows a tolerance of plus or minus 5 percent for most formulas.
Calculations
Two of the most crucial steps in compounding any pharmaceutical product are the accurate calculation and measurement of the component ingredients of the formulation. In order to carry out these critical functions, the Pharmacy Technician must have a working knowledge of the metric system, ratio & proportion and percentages. With these skills, the Pharmacy Technician should be able to solve almost all extemporaneous compounding calculations accurately.
You will find most solutions/suspensions marked as a specific concentration or strength of active drug per volume of liquid. In some cases, you may find solutions marked in a percentage strength and in most cases, ointments/creams marked as a percentage of active ingredient.
Percentage (%) means “by the hundred” or “in a hundred.” A percent is actually a fraction, but a fraction with a specific denominator. The denominator is always 100. In the case of liquids, the percentage is mls per 100 mls. In the case of ointments/creams, the percentage is gms per 100 gms.
Example I:
Zinc Oxide Ointment is used as a skin protectant on small areas of exposure by scattering UV light and preventing adsorption. In the following formula you are compounding, how much Zinc Oxide is needed to make 240 grams?
Zinc Oxide Ointment
Al Hydroxide 5 %
Zinc Oxide Powder 12 %
Aquaphor (qsad) 240 gms
In this formulation you would notice that Zinc Oxide (ZnO) Powder is 12% or 12 grams per 100 grams of ointment base and the total volume required is 240 grams. Using this information, you would set up the following proportion and solve for x:
Have = Want
12 grams ZnO x grams ZnO
—————— = ______________
100 grams Base 240 grams Base
x = 28.8 grams of ZnO is needed
If you were to calculate the Al Hydroxide in this formula using he same method, you would come up with 12 grams of Al Hydroxide is needed.
In this formulation you would be triturating 28.8 grams of Zinc Oxide and 12 grams of Al Hydroxide in the mortar & pestle to further reduce the particle size. If necessary you can use a small amount of levigating agent such as Mineral Oil, to reduce the particle sizes even smaller.
Then to ensure a homogenous and well-defined mixture, it is important that you use geometric dilution when mixing all of the ingredients together on an ointment slab.
Example II:
Boric Acid is used either as an antiseptic or in the ointment formulation as a counterirritant. How would you make a 60 ml solution containing 1 gram Boric Acid using a stock bottle containing 5% boric acid?
Realize that 5% of boric acid means 5 grams boric acid per 100 ml solution. To figure out how much of this solution to use you would set up the following ratio & proportion and solve for x:
5 grams 1 gram
————- = —————–
100 ml x ml
x = 20 ml
You will need 20 ml of 5% Boric Acid solution . Since your total volume is to be 60ml, you will need to add 40 ml of deionized or distilled water to achieve a total volume of 60 ml. In this case you would use a Cylindrical Graduate for measurement to ensure accuracy.
Conclusion
Although extemporaneous compounding is not used often in the average Pharmacy setting, some pharmacies specialize in compounding and Pharmacy Technicians prepare these compounds. Much hands-on experience is needed to ensure a product is not only calculated correctly, but also prepared correctly. Other avenues of compounding include tablet/capsule formulations, suppositories, Intravenous solutions, and in some Pharmacy settings, medicated candy suckers. With proper training and guidance and final check by a Pharmacist, there is no reason why a Pharmacy Technician cannot become an expert in extemporaneous compounding.
Aprescription is a written order from a practitioner
for the preparation and administration
of a medicine or a device.
Medical doctors (MD), doctors of osteopathy (DO),
dentists (DDS), and veterinarians (DVM) are the
primary practitioners that write prescriptions.
Opticians and podiatrists are also allowed to write
prescriptions for drugs relative to their field of practice.
In most states, nurse practitioners, physicians
assistants and/or pharmacists are also allowed to
prescribe medications based on predetermined protocols
(specific guidelines for practice) and in collaboration
with one of the primary practitioners
mentioned above.
Prescriptions are subject to many federal and state
rules and regulations.
These regulations have been developed to protect
the patient and to provide for certain minimum
standards of practice. The rules and regulations that
govern both community and hospital pharmacy
practice are continually evaluated and updated as
new technologies, new medications, and new protocols
are developed and adopted.
Community pharmacists dispense directly to the
patient and the patient is expected to administer the
medication according to the pharmacist’s directions.
This requires clear communication between the
pharmacist and the patient. The pharmacist counsels
the patient or the patient’s representative when
the prescription is purchased. In addition, the
patient receives information on the prescription
label as well as from an information sheet supplied
with the medication.
In institutional settings, nursing staff generally
administer medications to patients.
As a result, the rules and regulations that govern
prescription dispensing in institutional settings are
quite different from those that apply to community
practice. Labeling is also different and many medications
are packaged in individual doses.
Prescription Products
Prescriptions are usually written for commercially available
products that are specified by brand or generic name,
strength, and route of administration. The prescription
may be filled with that exact product or, if allowed, a product
that is determined to be equivalent may be dispensed.
Prescriptions sometimes require the pharmaceutical
preparation of a medication from raw or individual
ingredients (extemporaneous compounding).
