DISPENSING II LEC PDF

DISPENSING II UNIT 1: PRESCRIPTION ANALYSIS OBJECTIVES III. Public Health importance of Pharmacist  Review origin of Pharmaceutical care...

DISPENSING II UNIT 1: PRESCRIPTION ANALYSIS OBJECTIVES III. Public Health importance of Pharmacist  Review origin of Pharmaceutical care  Pharmacist are recognized as crucial healthcare health workers expected to be at  Review roles of Pharmacist in Healthcare system and Public Health  Interpret and analyze prescriptions and medication orders the forefront of the fight against this outbreak  Design and analyze appropriate dosing schedules based on special populations such as  Community pharmacy is the most strategic health establishment where patients geriatrics, pediatrics and individuals with comorbidities. can get directions to navigate our health systems.  Identify extemporaneous compounded preparations  Determine appropriate dosage regimens deemed appropriate for medication order  Role of pharmacist during the pandemic:  Plan and integrate the prescriptions requiring special instructions. o Alleviating the fear and reducing panic through public health education o Preventing the spread of infection in the community and in the workforce o Providing directions for patients to access the health care services that The Pharmaceutical Care they need Traditional Era Scientific Era Clinical Era Era o Ensuring availability of essential medicines and supply by preventing 1900 1930 1960 (Current Era) panic buying and rational use of medicines. 1990 Formulating and Development of new Pharmacist Patient centered, IV. Introduction to Presciption Analysis Dispensing drugs drugs; scientific testing dispensing drug outcomes oriented What is Pharmaceutical care? derived from natural mass; production of information, pharmacy practice sources synthetic drugs and warnings, advice Responsible provision of drug therapy for the purpose of achieving definite antibiotics and suggestions to outcomes that improve a patients quality of life. patients  FOUR outcomes: o Cure of the disease I. The Pharmaceutical Care Era (Current) o Elimination of reduction of symptoms o Arrest or slowing of a disease process Pharmacist need to work together with the patient and the patient’s other healthcare o Prevention of disease or symptoms providers to promote health, to prevent disease, and to assess, monitor, initiate, and modify Why the need for prescription Analysis? medication use to assure that drug therapy regimens are safe and effective.  Rise in unethical promotion of drugs  Ensure rational use of drug II. Role of pharmacist in the Health Care system  Exercise patient’s autonomy over medications 1. Ensuring rational use of medicine  Improve patient outcomes  Participation in the development of formulary  Adherence to clinical guidelines  Analysis of prescribing information  Drug use evaluation 2. Disease Management  Enhancement of patient compliance  Adherence to evidence-based guidelines  Monitoring of patient outcomes 3. Drug therapy  Ensure safe and effective medications  Ensure Accessibility of medications  Collaboration with othe healthcare professionals  Mandatory Patient counseling  Patient monitoring to identify problems and resolution 1 DISPENSING II  Pregnancy (if women) V. Benefits of Prescription Assessment  Lactating  Geriatric/Pediatric Patient Benefits include:  Renal or Hepatic Failure  Improving patient safety Step 3. Counseling Issues Needed  Developing a personal learning plan for self-appraisal and the appraisal process  The instruction on how to uses the device such as inhaler,dropper etc.  Reducing prescribing cost by reducing unnecessary prescriptions (eg. Antibiotics),  Lifestyle changes (especially on smoking, hypertension,etc.) making most efficient use of therapeutic agents, encouraging generic prescriptions  Dosage, interactions, side effects, Contraindication etc. within the bounds of bioavailability and reducing polypharmacy.  Other inquires and concerns of the patient.  Improving patient care and management and reducing noncompliance and waste. VII. Principles of 3 checks and 7 rights Common Dispensing Errors Take note of the principle of three checks and seven rights. In dispensing, the following Prescriber’s Intention Misinterpretation principle of “Three checks and seven rights “ should always be observed. These are: AD,AS, AU, (right ear, left ear, each ear) OD,OS,OU (right eye, left eye, each eye) 3 checks: qod (every other day) qd (daily) or qid (4 times a day) 1. First check the container label before taking container from the shelf U or u (units) Zero, causing a 10-fold increase in dose 2. Second check of the container label against th prescription during actual (eg. 4U to 40) dispensing Trailing zero (1.0 mg) 3. Third check of the container labeling putting the container away (labeling shall be Naked decimal point (.5 mg).5 mg mistaken as 5 mg Large doses without properly placed 100000 units mistaken as 10,000 units done in the next activity) commas 7 Rights: AZR (zidovudine) Mistaken as azathioprine or aztreonam 4. Right date 5. Right patient VI. Prescription Analysis Steps 6. Right drug 7. Right dose Step.1 Check for the Legality of the Prescription (Based on RA 10918, Generics Act etc.) 8. Right route 9. Right frequency  Name of patient 10. Right container  Age  Sex  Date VIII. Prescription Analysis for Rx on Elderly Patients  Signature Stamp, Address of the prescriber Definition of Geriatric: Step 2. Check for the Clinical Aspects of the prescription:  Geriatric refers to all aspects relating to the aged and the characteristics of aging  Name of the Drug (Generic/brand name) BNF states the following considerations when prescribing to Elderly Patients: 1. Appropriate prescribing – the elderly often have multiple drugs for multiple  Dosage diseases. The need to have appropriate prescribing is even more important to  Frequency prevent drug interactions. Therefore there is a need to constantly review  Route of Administration appropriateness of drugs taken.  Indication (using literature) 2. Form of medicine – Elderly patients have difficulty swallowing. Need for liquid  Drug Interaction (using lliterature) preparation or even milling the tablets etc before swallowing.  Side effects and Contraindication (using literature) 3. Manifestations of ageing – when prescribing, considerations must be taken for  Any compounds needed the effects of ageing and to be cautious in prescribing medications for an effect of Can be part of your case/or can be ask to your simulated patient below: ageing e.g. age, related muscle weakness must nto be taken as neurological  Patient medical history deficits 2  DISPENSING II 4. Sensitivity – Nervous system of the elderly is more sensitive to commonly used drugs e.g analgesics. XII. STOPP/START TOOL 5. Pharmacokinetics – the elderly has poor renal clearance and therefore affects the elimination of drugs in the body. Aims of STOPP/START 6. Adverse Reactions – Especially elderly patients taking hypnotics, diuretics,  Provide explicit, evidence based rules of avoidance of commonly encountered NSAIDS etc. instances or potentially inappropriate prescribing and potential prescribing 7. 4 Classes of Medications giving the most problems for the elderly are: warfarin omissions (33%), insulin (14%), oral antiplatelets (13%), oral antihyperglycemics (11%) o Improve medication appropriateness o Prevent adverse drug events IX. The importance of regular medication review in older people o Reduce drug costs Older people + Regular medication = Increase in co-morbidities with Increases susceptibility to: age  Polypharmacy  Drug interactions Physiological changes  Adverse drug reactions  Pharmacokinetics  Prescribing cascade  pharmacodynamics  Poor compliance X. BEERS CRITERIA  Published in its entirety in journal of the American geriatrics Society, the AGS Beers Criteria is a compendium of medications potentiality to avoid to consider with caution because they often present an unfavorable balance of benefits and harms for older people  The Beer’s criteria serve as standard guidance for clinicians to prevent potentially inappropriate prescribing in patient’s age 65 years and older. This update of the Beers criteria examined current evidence to determine changes required to keep the recommendations in step with current practice and knowledge. Nearly 70 modifications have been made to the 2015 set. XI. Common Mediations Used in hospice that are Considered Inappropriate Based on BEERS XIII. Strategies for Managing Polypharmacy  Check medication administration timing Medication Indication Concerns  Check for potential drug interactions Dipenhydramine, Itching, insomnia, nausea Cognitively impairing, highly  Identify duplication of therapy Hydroxyzine, promethazine anticholinergic o Vitamins Benzodiazepines, Insomnia, anxiety Cognitively impairing, increased o Nonprescription vs prescription Non-benzodiazepines risk for falls, sleep impairment Insomnia, pain Highly anticholinergic;prolonged o Herbal vs.prescription Tricyclic Antidepressants Q-T interval  Check doses of each medication Psychosis, agitation, delirium Increased risk of mortality and  Perform side effects inquiries Antipsychotics morbidity Pain Cognitively impairing,  Identify cognitive-impacting medications Opioid, Non-opioid analgesics Constipating, increased risk of  Identify fall-risk medications falls  Identify swallowing-risk medications 3  DISPENSING II XIV. Suggested Times of Administration for Selected Medications XVII. Good Palliative Geriatric Practice Algorithm Drug Categories Ideal Time of Administration Antihypertensives Morning Lipid Lowering Agents Evening Biphosphates Morning on an empty stomach Morning on an empty stomach > 30 minutes away Synthroid from other medications and food Sex Hormones Morning Antiplatelet Morning Acid Secretion Inhibitors Evening Sedating agents Evening Diuretics Morning Stimulating Drugs Morning Sleep Aids Evening Coumadin Evening XV. Target Medications for Deprescribing  Proton Pump Inhibitors/H2A blockers  Benzodiazepines  Psychotropics  Polypharmacy regimens for specific diseases  Nonprescription and Herbal medicine XVI. Geriatric Syndromes  Falls XVIII. Dispensing Considerations  Incontinence 1. Need to constantly review medications given to the elderly with the prescriber and  Low body index to be alert for possible drug interactions and adverse reactions mentioned  Dizziness above. Need or clear explanation  Vision impairment 2. Need to consider appropriate dosage form of medication e.g liquid, how to advice to crush tablets and try not to dispense controlled release tablets that  Cognitive impairment cannot be crushed; advice on drink adequate quantity of water on taking  Hearing Impairment medication e.g. Forsamax etc. 3. Need to consider and involve caregivers and get their cooperation. XIX. Consideration in calculation of doses  Geriatric patients – classified as persons over 60 years of age  Physiologic functions start to decline  Kidney function and liver function decline  Both affect the absorption and elimination = TOXICITY  Kidney malfunction = reduce dose prescribed  Creatinine clearance = lab value to determine kidney function and appropriate dosing for elderly patients 4  DISPENSING II XX. Prescription Analysis for Pediatric Patients Dose are generally based on body-weight (in kilograms) or the following age ranges: first months (neonates) Stages:  infant (up to 1 year)  Neonate: Just born babies (up to first 30 days of life)  1-5 years  Pediatric: Also referred to as Infant (up to 1 year)  6-12 years  Early childhood: 1-5 years  Late childhood: 6-12 years Dose Calculation 1. Many children’s doses are standardized by weight (and therefore require Need for vigilance in prescribing and dispensing. Why? multiplying by the body-weight in kilograms to determine the child’s dose). 3  Children and particularly neonates, differ from adults in their response to drug. 2. Occasionally, the does have been standardized by body surface area (in m ) Special care is needed and does should be calculated with care. NOTE: These methods should be used rather than attempting to calculate a child’s  The risk of toxicity is increased at this stage because of dose on the basis of doses used in adults. o reduced drug clearance (the kidney and liver are not yet fully 3. Important: Always consult reliable literatures such as MIMS, BNF, etc. developed) 4. For most drugs, the adult maximum dose should not be exceeded for children o And that the organs have differing target organ sensitivity Example:  wherever possible intramuscular injections (IM) should not be given as there are The dose for drugs A for children is tasted as 8 mg/kg painful Mas. dose for adult is 300 mg Weight of child is 40 kg Important points to note on Dispensing Pediatric Prescription This child should receive 300 mg NOT 320 mg 5. For obese and overweight children, calculation by body-weight may result in higher From the Legal Point doses than necessary. In such cases, calculate using ideal weight use the chart 1. The age of the child must be states (years or months) clearly provided. 2. The strength and dosage form must be stated e.g., Tablet Salbutamol 2mg., Syrup Paracetamol 125mg/5ml General Guidelines by BNF/MIMS for Pregnant Patient From the Clinical Point  Drugs should be prescribed in pregnancy only if the expected benefit to the 1. Good to provide body weight in kg. mother is thought to be greater than the risk to the fetus, and all drugs 2. Liquid preparations are best advised to be used for children and neonates should be avoided if possible, during the first trimester. 3. For long term treatment, choose a sugar free formulation to avoid dental decay.  Drugs which have been extensively used in pregnancy and appear to be usually safe should be prescribed in preference to new or untried drugs From the Counseling Point  The smallest effective dose should be used. 1. Provide syringe for dosage below 5 ml  Drugs proven to be teratogenic in human should be avoided 2. Always dispense and give counsel to the caregiver and not to the neonate, infant or child. Classification used in BNF 3. Label as “Give…” and not “Take…” BNF/MIMS identifies drugs which: 4. Warn parents to keep all medicines out of reach of children. Cautionary labels 1. May have harmful effects in pregnancy and indicates the trimester of risk are to be placed on pediatric dispensed medicines. 2. Are not known to be harmful in pregnancy 5. Parents should be advised not to add any medicines to infant’s feed, since the drug may interact with the milk or liquid; or sometimes the infant does not drink NOTE: BNF/MIMS will indicate clearly for the relevant drug entry the care needed which all the contents of the feed taking this drug during pregnancy XXI. Prescription Analysis: Dosage in Children NOTE: MIMS uses a more complex classification based on the FDA classification Children’s dose in the MIMS/BNF are stated in the individual drug entries. except where: a. pediatric use is not recommended b. information is not available, or c. there are special hazards 5  DISPENSING II XXIV. Extemporaneous Compounded Drugs XXII. Prescription Analysis: Drugs and Pregnancy  Extemporaneous compounding is the preparation of a therapeutic product for an  Drugs can have harmful effects on the embryo or fetus at any time during individual patient in response to an identified need pregnancy.  Compounding refers to the sum of processes performed by a pharmacist in drug  It is important to note that all women of childbearing age or for men trying to father preparation including the calculations, mixing, assembling, packaging, or labeling a child. of a drug:  During the first trimester (the first three months of pregnancy) drugs can produce o as the result of a prescription or drug order by a physician, dentist, or congenital malformations (teratogenesis) and the greatest period of risk from veterinarian; or rd th the 3 to 11 week of pregnancy. (RELATING TO THE DNA) o for the purpose of, or in relation to, research, teaching, or chemical  During the second and third trimesters drugs can affect the growth or analysis; (RA10918) functional development of the fetus or they can have toxic effects on fetal tissues. (DAMAGE TO THE DEVELOPMENT AND TISSUE). Table 1. FDA Drug Risk Classification Category Description A Controlled studies in humans show in risk to the fetus No controlled studies have been conducted in humans; animal studies B show no risk to the fetus C No controlled studies have been conducted in animals or humans Evidence of human risk to the fetus exists; however, benefits may D outweigh risks in certain stations Controlled studies in both animals and humans demonstrate fetal X abnormalities; the risk in pregnant women outweighs any possible benefit XXIII. Prescription Analysis: Drugs and Breast-Feeding  Breast-feeding is beneficial: the immunological and nutritional value of breast milk to the infant is greater than that of formula feeds.  Although there is concern that drugs taken by the mother might affect the infant, there is very little information on this. However, in the absence of evidence of an effect, the potential harm can be inferred by drug absorption, distribution,  Extemporaneous Compounding: “The timely preparation of a drug product metabolism studies etc. according to the physician’s prescription, in which the amounts of the ingredients  The amount of drug or its metabolites transferred in breast milk is rarely are calculated to meet the needs of a particular patient or a group of patients significant to produce clinical effects on the infant especially to poorly absorbed according to Good Manufacturing Practice” drugs. Compounding BNF/MIMS Classification BNF/MIMS identifies drugs: Extemporaneous compounding 1. That should be used with caution or are contraindicated in breast-feeding 2. That can be given to the mother during breast-feeing because they are present  On0demand preparation of a drug product. in milk in amounts which are too small to be harmful to the infant  According to a physician’s prescription 3. That might be present in milk in significant amount but are not known to be  Meets the unique needs of an individual patient harmful. Manufacturing NOTE: BNF/MIMS states that care is needed in dispensing drug during breast-feeding, this  The production or processing of a drug in a LARGE quantity by various is indicated under the relevant drug in the BNF/MIMS. mechanisms. 6 DISPENSING II XXV. Prescription Analysis Compounding Considerations: Why Compound? 1. Always consider the use of commercially available products as far as possible.  Pediatric patients requiring diluted adult strengths of drugs. 2. If no suitable commercial product exists, consider a therapeutic alternative that is  Patients needing an oral solution or suspension of a product that is only available in a suitable dosage form. This must be discussed with the physician. available in another form. 3. Extemporaneous preparations should be done based on evidence-based  Patients with sensitivity to dyes, preservatives, or flavoring agents found in references. commercial formulations. 4. Always check for the suitability of the product/brand for extemporaneous  Dermatological formulations with fortified (strengths) or diluted concentrations of reparations. commercially available products. 5. Preparations should be done according to what is stated as far as possible unless  Specialized dosages for therapeutic drug monitoring. stated otherwise in the product leaflet.  Care for hospice patients in pain management. 6. When no information is available, compounding an oral medication by  Compounding for animals dispensing a tablet and/or capsule and directing the caregiver to mix just prior to administration. 7. Stability for shelf storage in the pharmacy is applicable without opening. Once opened, the stability of the preparation should be no longer than 30 days. Maximum quality of the extemporaneous preparations to be dispensed should not `exceed one mouth. 8. Refrain assumptions on the therapeutic equivalence in the case of suggesting alternative agents as the possibilities and supporting data may be limited. 9. Techniques in compounding preparations and manipulations should always be in line with the standard Good Preparation Practice as delivering an accurate dose in paramount. 10. Staff and facilities are challenged to undertake intermittent competency assessments in order to achieve the standards requirement. 11. Documentation after each preparation should include details on the materials used, processes Considerations for Preparing Extemporaneous Compounds 1. Pharmacy personnel are reminded not to empirically change flavorings or suspending agents because they can affect the pH stability of the product and result in an unstable product. 2. Please consider ingredients in the formulations that require special precautions in neonates. 3. Mixing of a compounded formulation should always be in line with the following principles: Common Problems with Specials Prescriptions a. Ensure that all ingredients used are within the expiry date. 1. If short dated-will patient use up quality prescribed within that time. b. Ensure that all utensils are clean; including mortar and pestle, 2. Cost if using specials company-very important if private prescription graduates, pill cutters and stirring rods. 3. Lack of detail on prescriptions especially creams and ointments where no base is c. Product should be labelled clearly and stored as recommended within indicated. the formula/ 4. Computer generated prescriptions where unlicensed preparations are not in the d. For solution or suspension products, emphasis on the importance of standard menus. thorough shaking before administration. 5. Finding a formula. 6. National Differences with non-compendial formula Sources of Formulae  Compendia e.g., BP, Martindale 28th / USP/NF etc.  Hospital-often continuation of treatment in primary care  GP’s own e.g. Dr. Ives wart paint etc.  Published literature/journal articles available on internet. Often American/European 7  DISPENSING II  Chapters - called Pharmaceutical Compounding – Nonsterile Preparations  Consequences can be tragic o Publised in 2000  Establish rules and routines o Enforceable  Standard Operating Procedures and Worksheets  Chapter - called Pharmaceutical Compounding – Sterile Preparations, o Became official in 2004 XXVII. Summary – Dealing with Prescription  Other Chapters 1. Often lacking in detail o Containers 2. Don’t take at face value o Good Compounding Practices 3. Usual clinical assessment o Pharmacetical Stability 4. Has patient had medicine before-possibly from hospital o Pharmaceutical Dosage Forms 5. Save details – worksheet or record XXVI. Formulation General XXVIII. Summary – Managing Your Patient  Physical problems – cracking, caking, precipitation 1. Collection and delivery arrangement  Chemical degradations – usually pH dependent 2. Good Practice-Establish a routine  BP limits for actives are usually 95% - 105%. Published data may accept wider 3. Consider bank holidays limits such as 90%. What are acceptance criteria? 4. Logistics – especially fridge lines  Microbial – preservative system, closed pack shelf life may be longer than opened 5. Compliance – e.g., administering 1 ml may be easier than administering 5 ml pack e.g., use 14 days after opening. 6. Accurate dosing – counselling, oral syringes 7. Accurate packaging Oral Liquids  Is drug soluble in vehicle at dose required?  if not could a suspension be prepared  Crush tablets or use powder  Use highest strength tablets to reduce overall excipients  Check tablet characteristics: Controlled release, Sugarcoated, Film coated, Enteric coated  Good practice: Always use same brand and strength. Care with generics.  Good practice: Standardize to dose/5ml or dose/1ml  May dilute injection fluid from ampoules Making a Suspension From Tablets  Crushing, grinding  Wetting and pasting  These steps are vital to give homogenous product Importance of Calculation Skills  A full understanding of what’s required can prevent dispensing errors  Ensures correct clinical interpretation of prescription  Overdose or Sub-therapeutic?  Letter from Dermatologist translated into computer generated prescription  Beware of progressive mis-interpretation! Beware of Complacency  We all know  1+1=2  Check this every day as a pharmacist  Errors are usually silly mistakes 8 DISPENSING II XXIX. Label for Extemporaneous Preparations  Details of the Community / Hospital  Expiry Date  Drug’s Name with Strength  details of Patient  Administration Instructions  Storage  Special Instructions / Precautions  Pharmacist Name Prepared The worksheet of the product should contain the following details:  Patient’s name  ID number  Prescription number  Date of preparation  Name of drug  Dose  Volume of diluent/vehicle  Batch number of preparations and starting materials  Name and signature of preparing personnel  Name and signature of checking personnel A Basic Approach To Risk Analysis  Picture the worst case scenario  What would be the consequences to the patient  How likely (frequency) is this type of error to occur?  Would the checking pharmacist or the patient be able to detect the error? 9 DISPENSING II UNIT 1: EXTEMPORANEOUS COMPOUNDED PRESCRIPTION COMPOUNDING AR (ANALYTICAL REAGENT) ○ Very high purity. EXTEMPORANEOUS COMPOUNDING HPLC On-demand preparation of a drug product. ○ Very high purity. According to a physician's prescription. ○ Used in high pressure chromatography. Meets the unique needs of an individual patient. STORAGE TEMPERATURE DEFINITIONS MANUFACTURING The production or processing of a drug in a LARGE quantity by various mechanisms. Freezer -20°C to -10°C Protect from Freezing Store above 0°C WHY COMPOUND? Cold Any temperature not exceeding 8°C Pediatric patients requiring diluted adult strengths of drugs. Refrigerator Between 2°C and 8°C Patients needing an oral solution or suspension of a product that is only available in Cool Between 8°C and 15°C another form. Room Temperature Temperature in the work area Patients with sensitivity to dyes, preservatives, or flavoring agents found in Controlled Room Temperature Thermostatically controlled at 20°C to 25VC commercial formulations. Warm Between 30° and 40°C Dermatological formulations with fortified (strengthened) or diluted concentrations Excessive Heat Any temperature above 40° C of commercially available products. Specialized dosages for therapeutic drug monitoring. STABILITY Care for hospice patients in pain management Stability Compounding for animals. The extent to which a dosage form retains the same properties and characteristics that it possessed at the time of its manufacture. US PHARMACOPEIA Expiration date Established in the 1906 Pure Food and Drugs Act. The date until which the manufacturer can guarantee of the safety and full Has the federal authority to set standards pertaining to pharmacy compounding. potency of a drug- usually determined after extensive study of the product's Develops “STANDARDS” where various topics are grouped into "CHAPTERS." stability. Publishes its standards in the resource book called the USP/NF Beyond-use date Used for compounded preparations only and are generally in the order COMPOUNDING REGULATIONS APPLIES "days" or "months." Personnel Shelf life Facilities and Equipment Length of time a packaged drug will last without deteriorating Ingredient Standards Quality Assurance and Quality Control ASSIGNING A BEYOND-USE DATE Packaging and Storage Non-aqueous liquids and solid formulations Documentation and Record Keeping ○ If the source of the active drug is a manufactured drug product, the beyond- use date is not later than 25% of the time remaining until the drug product's INGREDIENT STANDARDS expiration date, or 6 months, whichever is earlier. USP/NF ○ If the source of the active drug is a USP or NF substance, the beyond-use ○ Meets standards set by the USP/NF. date is not later than 6 months. ACS REAGENTS Water containing formulations ○ High purity ○ When prepared from ingredients in solid form, the beyond use date should ○ Meets specifications of the Reagent Chemicals Committee of the American be not later than 14 days when stored at cold temperature. Chemical Society. 1 DISPENSING II For all other formulations USING A PRESCRIPTION BALANCE ○ The beyond-use date is not later than the intended duration of therapy or 30 1. Lock the balance by turning the arrest knob. days, whichever is earlier. 2. Set the internal weights to zero. 3. Unlock the balance and level it left to right. TYPES OF EQUIPMENT 4. Lock the balance. Place a weighing boat or paper. Measuring 5. Unlock the balance by releasing the arrest knob. ○ Balance, weights, weighing containers, volumetric glassware (graduates, 6. Lock the balance and place the required weights in the boat. pipets, flasks, syringes). 7. Unlock the balance and note the shift of the pointer.After an accurate measurement Molding is made, check your work. ○ Hot plates, suppository molds, capsule shells, ointment slabs. Mixing ○ Beakers, Erlenmeyer flasks, spatulas, funnels, sieves, mortar and pestle. Packaging ○ Prescription bottles, capsule vials, suppository boxes, ointment jars. CLASS “A” BALANCE SCALE A two pan torsion that uses both internal and external weights Weights go on the right pan and powder on the left pan Sensitivity: up to 6 mg Capacity: 120 mg to 60 gms Degree of error: 5% REASONS FOR ACCURATE WEIGHING Weights: 1gm to 50 gms Weighing of the product is one of the most essential parts of the compounding ○ fraction weights 10mg to 500mg process. Electronic or Analytical Balance Weighing the exact amount prescribed is essential in compounds for several reasons: ○ The product cannot be “checked” for content once mixed. USING A BALANCE ○ The quantities weighed out are often very small, and a slight overage could 1. Place on a level surface in a draft free area. mean a serious overdose for the patient. 2. Use clean weighting papers or boats. 3. Must be readjusted after a new paper or boat has been placed on the pan. SPATULAS 4. Arrest the balance before adding or removing weight. Spatulas 5. Use a spatula. ○ Used to transfer solid ingredients or prepare ointments and creams or 6. Clean the balance. loosening material from the surfaces of a mortar and pestle. Types USING AN ELECTRONIC BALANCE ○ Stainless steel 1. Keep balance where it will not be moved. ○ Hard rubber 2. Turn the leveling feet. ○ Plastic 3. Turn on the balance Spatulation 4. First use of the day, check internal weight calibration. ○ Mixes powders using a spatula. 5. Removed top ring of the draft shield. Place weighing boat in the center. ○ Mixing can be done in a mortar, on an ointment slab, or in a plastic bag. 6. Add ingredients. 7. Clean spills with a lint-free towelette. MORTAR AND PESTLE 8. Turn off balance at the end of the day. Mortar and Pestle ○ The coarser the surface of the mortar and pestle, the finer the triturating, or grinding, that can be done. 2 DISPENSING II Types Measuring Liquid Volumes ○ Glass Pour the liquid to be measured slowly into the graduate, watching the level of the ○ Wedgwood liquid in the graduate as you do so. ○ Porcelain If the liquid is viscous, or thick, then you should attempt to pour it toward the center of Trituration the graduate to avoid having some of the liquid cling to the sides. ○ The process of grinding powders to reduce the particle size. ORAL SYRINGES COMPOUNDING SLAB Available for accurately administering liquid medication to the patient. This is an ideal surface for mixing compounds because of its nonabsorbent surface. Have tips that are larger than tips on hypodermic syringes so needles cannot be Levigation placed on these syringes. ○ Technique used to reduce the particle size of a powder drug by triturating it After the dose is drawn into the syringe, a cap is placed on the tip to prevent leakage with a solvent in which the drug is insoluble. and prevent contamination. Oral syringes can be used with a device called an Adapt-a- Cap® VOLUMETRIC EQUIPMENT ○ An example of an oral syringe cap the screws onto the bottle containing the Droppers liquid, and the oral syringe is fitted into the other side of the cap. Graduates Flasks MIXING POWDERS - GEOMETRIC DILIUTION Pipettes When mixing powders of unequal size, the smaller amount is mixed (triturated) with an Syringes equal amount of the other. Oral syringes That mixture is then mixed with an equal amount of the larger amount powder. GRADUATED CYLINDERS This process is repeated until the mixture is completed. Cylindrical and cone shaped. Used for measuring and transferring liquids. SOLUTIONS Available in sizes ranging from 5 ml to 4,000 ml. The most commonly compounded products. Selecting a graduated cylinder. Clear (but not necessarily colorless) liquids in which the drug is completely dissolved. ○ Choose the smallest one capable of containing the volume to be measured. The solubility of the drug must be known before attempting to dissolve it in a solution. ○ Rule: Avoid measurements of volumes that are below 20 percent of the If a drug is not soluble in a vehicle, then no amount of mixing will help capacity of the graduated cylinder. Some solids need to be triturated before mixing in a solution. → Example, a 100 ml graduated cylinder cannot accurately measure volumes below 20 ml. SUSPENSION When measuring small volumes, such as 20 ml and less, use a syringe or pipet. A two phase system consisting of a finely divided solid dispersed in a liquid. SYRINGES ○ Flocculating Agent Range from 0.5 ml to 60 ml and in a variety of materials and styles. → Electrolytes used in the preparation of suspensions to form Contain graduation marks on the barrel for measuring partial volumes. particles that can be easily redispersed. A disposable hypodermic syringe or an oral syringe made of plastic is used for ○ Thickening Agent most compounding tasks involving small volumes. → Ingredient used in the preparation of suspensions to increase the Always choose the smallest syringe capable of containing the volume to be viscosity of the liquid. measured. ADDITIVES LIQUID MEASUREMENTS Flavoring DROPPERS ○ The human tongue contains about 10,000 taste buds which distinguish salty, Used to deliver small doses of liquid medication. bitter, sour, and sweet tastes Medicine dropper must first be calibrated because The drop size will vary from Sweeteners dropper to dropper. ○ Colorless, odorless, solubility in water at the concentrations needed for Personal factors can also contribute to the inaccuracy of droppers. sweetening, pleasant tasting with no “after-taste,” and stable over a wide pH range. 3 DISPENSING II Coloring ○ Can be formulated by molding or compression in a wide range of hardness ○ Not required in every formulation. and melting points. ○ Contraindicated in all sterile solutions. ○ Do not melt at body temperature, but dissolve slowly to provide a prolonged ○ Dark colors, such as dark purple, navy, black, and brown may also be release of drugs. rejected because they are often associated with poisons. Available in various molecular weight ranges. EMULSIONS ○ 200, 400, or 600 molecular weight are liquids. Unstable system consisting of at least two immiscible liquids. ○ Molecular weights over 1,000 are solids. ○ One is dispersed in the form of small droplets throughout the other. CAPSULES ○ The other is a stabilizing agent. Hard gelatin capsules consist of a body and a cap which fits firmly over the body of Types the capsule. ○ Oil-in-water (o/w) emulsion For human use, eight sizes of capsules are available. ○ Water-in-oil (w/o) emulsion SIZES VOLUME Emulsifier - a stabilizing agent in emulsions. 000 1.37 ○ commonly used emulsifying agents include tragacanth, sodium lauryl sulfate, 00 0.95 sodium dioctyl sulfosuccinate, and polymers known as the Spans® and 0 0.68 Tweens®. 1 0.50 Primary emulsion - the initial emulsion to which ingredients are added to create the 2 0.37 final product. Mucilage - a wet, slimy liquid formed as an initial step in the wet gum method. 3 0.30 OINTMENTS 4 0.20 Used for many different purposes, e.g., as protectants, antiseptics, emollients, 5 0.13 antipruritics, kerotolytics, and astrigents. Punch Method Ointments are generally compounded on an ointment slab ○ Used when filling a small number of capsules. Transferring ointment into an ointment jar. SUPPOSITORIES LABELING, RECORD KEEPING, AND CLEANUP Three types of bases: After compounding ○ Oleaginous: primarily synthetic triglycerides. ○ The product must be labeled with a prescription label, and a careful record ○ Water soluble: containing glycerinated gelatin or polethylene glycols of the compounding operation should be kept. (PEGs). Once the compounding operation is finished ○ Hydrophyllic: mixtures of oleaginous and water soluble bases. ○ The equipment and area should be cleaned. Cocoa butter (Theobroma Oil) USP ○ Everything should be returned to their proper places in storage. ○ A well-known oleaginous base. Compounding should never be rushed. ○ At room temperature, cocoa butter is a solid. Regardless of their apparent stability, all suspensions ○ At body temperature, it melts to a bland, non-irritating oil. ○ Should be dispensed with an auxiliary label reading “Shake Well.” ○ No longer the base of choice because preparing suppositories with it is The qs abbreviation means to add “as much as necessary” to the specified amount. difficult, and the suppositories require refrigeration. ○ JCAHO recommends using text words rather than abbreviations to minimize Synthetic triglycerides can be used that do not have the formulation difficulties of a medication error. cocoa butter, but they are more expensive. Refer to a standard reference work on the subject. There are newer bases composed of mixtures of fatty acids that do not have the ○ Example: Remington: The Science and Practice of Pharmacy formulation problems or the expense (e.g., FattiBase®, Witepsol®). WATER SOLUBLE OR MISCIBLE BASES Glycerinated gelatin or polyethylene glycol (PEG) polymers. ○ Useful for vaginal suppositories. ○ Dissolve slowly to provide prolonged release of active ingredients. 4  LUGO, CHU | 3BPH 1 When we say just culture, inaalis natin yung thinking that “ay hindi ko MEDICATION SAFETY o na lang ire-report yung medication error na ‘to kasi pwede ako mabigyan ng sanction” or “kaibigan ko naman si ganito/ganyan kaya Medication safety is the observance of patient safety. We don’t want any harm to hindi na natin ire-report ito kasi baka matanggal pa ako sa trabaho” reach the patient. It also involves medication use process all throughout. Errors can happen all throughout the process. We as pharmacist should safeguard our patient so medication errors would not occur. We can do this by taking precautionary steps RISK MANAGEMENT to prevent any adverse event / adverse drug reaction. We want to practice patient activities or measures taken by an individual or healthcare safety all throughout the process from the procurement, to the dispensing, organization to monitor in order to prevent, remedy or distribution, and administration of drugs. mitigate the occurrence or recurrence of a real or potential (patient) safety event. BACKGROUND o So in the risk management we anticipate that there is a possibility of an Medicines are in the most common interventions used in the error to occur in this specific process health care to cure and prevent diseases and mitigate symptoms. SYSTEM APPROACH o This is basically the main use of our medicines. But the main goal of our an approach to safety stating that errors are generally medicines aside from curing and mitigating diseases, it is to improve the quality of life of our patient. This is because not all consequences of systematic factors, e.g., weakness in the diseases/infections are curable for example in the case of HIV. As organizational processes. much as possible, we want to improve the quality of life of our patients from diseases that are not curable, by slowing the progression of the MEDICATION SAFETY AS PART OF PATIENT SAFETY disease, or at least the symptoms are not that aggravated. Patient safety consists of the identification, analysis, and Medicines are used (record) management of patient-related risks and o by the very young (pediatrics) to the very old (geriatric). incidents, also called adverse events or medical errors, in o in inpatient and outpatient settings of the pharmacy, order to make patient care safer and minimize harm to o predominantly in the home setting where patients are patients. responsible for their own self-management. o Once it happens, we analyze how did it happen. We propose corrective Although effective, medicine is often challenging to manage action to prevent harm in the patient. We also do evaluation then make and use appropriately due to a number of factors, such as a preventive action so that the harm won’t be repeated o complex pharmacotherapy, One of the most widely used definition of patient safety is o polypharmacy, o “freedom from accidental injuries during the course of o aging population with multiple disease and medical care” and o inadequately coordinated resources in the healthcare o “activities to avoid, prevent, or correct adverse systems. outcomes which may result from the delivery of health Pharmacists play an important role in assuring medication care.” safety to their patients in both the outpatient (where there is no any healthcare professional at home) and to the MEDICATION SAFETY inpatient (where there are no medication advisors and possible May be defined as the freedom from accidental injury due medication error may happen). to medical care or medical errors during the medication- o For example, people that take antibiotics were not able to completely use process. follow the dose and frequency of the medication since the symptoms were alleviated. This can lead to antibiotic resistance. It deserves the same prioritization, given the scope of o Another is when there are too much OTC drugs, since it is easily medication use in patient care and frequency and severity accessible, possibility of drug interaction is high along with the other of potential harm. medication they are taking such as maintenance drugs. EXAMPLES OF MEDICAL ERRORS DEFINITION OF TERMS The failure to administer an ordered MEDICATION SAFETY dose to a patient before the next defined “as freedom from preventable harm with scheduled dose or failure to prescribe medication use” Omission Error a drug product that is indicated for the o Free from any harm all throughout the process. patient failure to give the dosage or medication to the SAFETY CULTURE patient a product of individual and group values, when we say Medication Order Error group values, not only the pharmacist is involved but also the A prescribing error fault can arise nurses, physicians, and other healthcare practitioners. Even the pharmacy from the choice of the wrong drug, the technician is also involved. We want to improve their attitudes, wrong dose, the wrong route of perceptions, competencies, and patterns of behavior that Prescribing/ administration, and the wrong determine the commitment to, and the style and proficiency Ordering Error frequency or duration of treatment, of an organization’s health and safety management on the but also from inappropriate or health care set-up they are working. erroneous prescribing in relation to the characteristics of the individual JUST CULTURE patient or co-existing treatments the concept of identifying the presence of system flaws that Error on the part of the nurse since they are the can be resolved in order to promote patient safety and Transcribing one responsible in transcribing the medication move away from a culture where failures are punished Error order from the medication chart to the system or to the pharmacist covered up or ignored.  LUGO, CHU | 3BPH 2 Documenting As well on the part of the nurse if they weren’t able to document that they already gave a medication. Error A possibility of double dose may occur Dispensing On the part of the pharmacist not only on the hospital setting but also on the community setting According to the systems approach, active failures and/or Error (drugstores) latent failures can contribute to adverse events. Administration More on the part of the nurse since they are the Active one responsible in administering the medication to failures Human mistakes Error the patient At-risk situations or phases in the process (i.e., Pharmacists are involved in the procurement or the processes of making a standard Latent holes in the cheese) that have predisposed the operating procedure for prescribing to dispensing. failures system to have active failures that lead to adverse events HUMAN ERROR THEORY AS A THEORETICAL FRAMEWORK IN SYSTEMS-BASED RISK MANAGEMENT Hazards pass through several loop holes in the system. For example, Culture and leadership – possibility of staff shortage Reason’s Theory of Human Errors Technical Supper – inexperienced team member widely used as a theoretical framework in systems-based o Does the hospital have the capacity to conduct this procedure? patient and medication safety work. Training – failed to monitor vital signs To manage errors in organization and processes, o Are the nurses or pharmacist trained to conduct vital signs monitoring? psychologist James Reason explained the challenges of Clinical Support – poor team communication. human error with two approaches: the person and the system. Dominant approach in health care Focuses on unsafe acts, errors and procedural violations by people in the Person frontline Approach Healthcare practitioners are blamed for errors primarily due to human behaviors such as forgetfulness, inattention, poor motivation or incompetence Basis is the premise that humans are fallible and errors, caused by omission or commissions are to be expected even in the best organization with the best people Latent failures will always be present in a process or system. It is important to evaluate the system and processes to identify points of potential failure and Instead of seeing errors as causes of actions, potential contributing factors to the failures in order to reduce or eliminate them. System they are consequences of systemic factors Approach such as complex processes with unclear A: Diagnosis and Assessing the Multi-professional responsibilities need for the medication collaboration Marami namang standard operating procedures. But therapy people involved in the complex processes are unclear with Educating and inducting B: Choice of drug ordering their responsibilities. So dapat it is indicated who will be ward personnel the one taking the medication order, who will be the one and distribution storage C: Dispensing, Preparing, Creating and updating transcribing, who will double check, etc Administration medication safety plans Because we cannot expect endlessly perfect human performance D: Medication Counseling and Auditing medication use Ensuring Adherence process the conditions under which humans work must be changed to E: Monitoring and Follow-up Reporting, coding and minimize or avoid errors. F: Reviewing outcomes, analyzing medication So meron rin tayong tinatawag na quality control in our hospitals to check if nafo-follow ba yung process or nagagawa yung double checking. Ensuring Flow of Information errors SWISS-CHEESE MODEL In order for us to provide medication safety to our patient, we should find ways to prevent the loopholes or hazards from happening. Figure 1. An application of the Swiss Cheese model to identify An example of application of Reason’s Swiss cheese model reasons and contributing factors to medication errors. to medication safety: the role of hospital pharmacists in Finland covers all the steps in the medicines management cycle in order to address potential “holes” in the cheese. Specific Task Medication reconciliation, A: Diagnosis and Assessing Medication reviews, the need for the medication Taking part in medical therapy rounds Logistic task, e.g., stock B: Choice of drug ordering control using automated and distribution storage dispensing systems  LUGO, CHU | 3BPH 3 Medication reconciliation, B: Choice of drug Patient transferred to a hospital ward Creating instructions, ordering and where there was no experience with C: Dispensing, Preparing, Providing medication distribution storage methotrexate medication treatment. Administration information, A substituting doctor did the ward Medication reviews round on the next day. The doctor was C: Dispensing, D: Medication Counseling Giving medication unfamiliar with the patients. The round Preparing, and Ensuring Adherence information to patients was long and exhausting with many Administration Giving medication patients, and the doctor did not notice information to patients, the error. E: Monitoring and Follow-up Therapeutic monitoring, On the next day, the ward doctor Medication reviews stated that the patient had started to D: Medication Medication reconciliation, recover. The ward doctor trusted the Counseling and F: Reviewing outcomes, Medication reviews, medication list “checked” by the Ensuring Adherence Ensuring Flow of Information Developing medicines use substituting doctor, because the process. condition of the patent was better. The medication error was not noticed E: Monitoring and EXAMPLE CASE: until 12 days later after the patient’s Follow-up An 86-year-old female patient was admitted to the hospital condition became worse. due to pulmonary embolism; Medication was started immediately. METHODS APPLIED TO EVALUATE THE SAFETY OF According to the referring physician, the patient was under MEDICINE USE PROCESS treatment for rheumatoid arthritis and was using RETROSPECTIVE METHODS, methotrexate 5mg on Tuesdays. o such as learning from medication error reports, root The dosing was, however, transcribes as 5 mg in the evening cause analysis of contributing factors of severe errors and recorded on the patient’s medication chart. The patient (what happened and why) and analysis of patient started to recover from the pulmonary embolism, however, records; o You have to go back from the medication error reports, what are the after a week of hospital admission, her condition worsened. cause of the error The doctors suspected an infection, but instead they PROSPECTIVE METHODS, diagnosed anemia and neutropenia. This finding led to o such as failure modes and effect analysis; checking the medication chart of patient after 12 days of o The medication reconciliation during the treatment of the patient; the hospital stay. The healthcare staff discovered that 5mg medication they took is double checked; the pharmacist will check the methotrexate had been administered to the patient possibility of drug interaction. You don’t have to memorize all the drug interaction. Just be familiar with the sources where you can check the everyday D.Is Although the correct dose has been 5mg once a week. LEARNING from well-performing practices and processes. Despite the attempts to save the patient, she died of sepsis o Practices from other countries can be applied here in the Philippines after 20 days in the hospital SAFETY CULTURE IN MEDICATION USE MANAGEMENT The systems approach utilizes two broad strategies to mitigate or prevent errors. FIRST is to prevent the initial source of the error. However, this is not always possible. o Sometimes they lack documents or the medication error happened but there is no evidence SECOND is to introduce defenses to address the system's problems and risks. o During the policy development, we already identify the possible problems and risks that may happen during the process o Examples of risk reduction strategies include: protocols, checklists, medication reconciliation and review, enhanced communication among pertinent individuals (e.g., patient, physician, nurse, pharmacist) and increased access to important patient information. Hazard: Medication with unconventional dosing ® o It is not only the pharmacist that will act to promote safety culture methotrexate 5 mg on Tuesdays transcribed as These actions can reduce the likelihood of all the holes in the cheese aligning, methotrexate 5mg in the evening at the emergency thereby reducing the overall system’s potential for harm. department. Evaluation needs to be employed to optimize results (reduced harm). It also needs to be kept in mind that not all defenses implemented in the system are effective. Thus, their effectiveness needs to be critically evaluated in terms of Specific Task clinical, humanistic and economic outcomes. These evaluations form a growing A: Diagnosis and the doctor did not check the area of health technology assessment. Assessing the need medication after transcription due to The way "we do things around here" influences not only how for the medication being in a rush and a long queue of things are currently done, but also the likelihood that a therapy patients waiting for treatment. newly introduced initiative will fail or succeed.  LUGO, CHU | 3BPH 4 o As much as possible we want to influence others to promote medication Their workflow is also constantly interrupted with new tasks safety so we can innovate the improvement of processes, not only in the dispensing but also in the medication error reporting that have arisen in the pharmacy. The heavy workloads and o Safety culture can fail if the physicians, nurses, or pharmacists are constant interruptions in their working environment produce afraid to report medication error more burnout and are associated with more dispensing Culture can help or hinder the implementation of an errors, which directly endangers patient safety. innovation like polyph