1 Ch 30: Compounding of Non-Sterile ProductsPharmacy personnel engage in compounding when a practitioner prescribes a strength or type of medication that is not commercially available It should never be done to create a product that is already available in the marketplace ©
2 Compounding of Non-Sterile ProductsCompounding can be divided between “sterile” and “non-sterile” depending on the intended use of the product Examples of non-sterile products may include tablets, capsules, and suppositories (all enteral routes of administration) This session covers non-sterile products We will cover sterile products in the future ©
3 Compounding of Non-Sterile ProductsUnited States Pharmacopeia Non-profit organization that sets standards Helps ensure quality and safety Medications sold and produced must meet these standards Published in the USP-NF Cited as Book – Chapter USP ### or USP <###> Chapter that covers non-sterile compounding is: USP 795 ©
4 Compounding of Non-Sterile ProductsUSP Chapter 795- “Pharmaceutical Compounding Non-Sterile Preparations” Sets forth the rules for extemporaneous compounding Defines standard of care Provides an enforceable set of standards Outlines responsibility of the compounder Mandates a compounding record ©
5 Responsibilities of the Preparer Under USP 795USP Chapter puts responsibilities on the preparer of the product: Have properly trained and capable associates Appropriate and clean compounding area Use ingredients that are; Appropriate identity, quality, and purity From a reputable source Appropriate, clean, and well functioning equipment Only authorized personnel are in the work vicinity Compounding is reproducible according to the directions recorded – allowing for correction or errors or problems ©
6 The Compounding RecordThe compounding record must contain: A unique ID number for each product or batch The date of preparation The name of the preparer The name of each ingredient The lot number & beyond use date of each ingredient The amount used of each ingredient The patient’s name The directions used to produce the compound MUST be reproducible ©
7 Assigning a Beyond-Use DateA Beyond-Use date must be assigned to the compounded product The rule to remember is set forth by USP 795: “for non-sterile solid and liquid dosage forms that are repackaged in single-unit and unit-dose containers, the beyond-use date shall be one year from the date packaged or the beyond-use date on the manufacturer’s container, whichever is earlier” ©
8 Compounding CalculationsPercentage Calculations How much of a final product is the actual drug Broken up by the type of contents % weight in weight (w/w) % weight in liquid volume (w/v) % liquid volume in liquid volume (v/v) ©
9 Percent weight / weightUsed when both portions are in units of weight 1% w/w = 1 g of active drug per 100 g of total product (1 g/100 g) ©
10 Percent weight / volumeUsed when the solute is in units of weight and the solvent is in units of volume 1% w/v = 1 g of active drug per 100 ml of total product (1 g/100 ml) ©
11 Percent volume / volumeUsed when both portions are in the same units of volume 1% v/v = 1 ml of active drug per 100 ml of total product (1 ml/100 ml) ©
12 Compounding CalculationsAlways be sure you use the finished weight or volume in your calculation Formula active ingredient
13 Example 1.4 g of phenol is mixed with 9.0 g of glycerin.What is the resulting percentage concentration of phenol? What do we know? there is 1.4g of drug in the product the final weight of the product will be 10.4 g (1.4 g + 9 g = 10.4 g) ©
14 Example x 100 = % Concentration 0.1346 x 100 = 13.5% w/wPlug in the values and calculate the answer x 100 = 13.5% w/w 1.4 g x = % Concentration 10.4 g ©
15 Another Example 4 g of KCl is dissolved in enough sweetened vehicle to make a total of 25ml. What is the resulting percentage concentration? ©
16 Another Example x 100 = % Concentration 0.16 x 100 = 16% w/v4 g of KCl is dissolved in enough sweetened vehicle to make a total of 25ml. What is the resulting percentage concentration? 0.16 x 100 = 16% w/v 4 g x = % Concentration 25 ml ©
17 A Twist We can also used percentage concentration expressions as part of proportion calculations ie, How much KCl would be needed to make 240 ml of a 10% solution? ©
18 The Answer 10 g x 2,400 = = 24 g of KCl 100 ml 240ml 100Remember our definitions of percentage calculation? 1 g /100 ml = 1 % Therefore 10% would be 10 g / 100 ml and we can set up a proportion….. 10 g x ,400 = = 24 g of KCl 100 ml ml ©
19 How about another…. How much propranolol must be used to prepare 240ml of a 3% suspension? ©
20 How about another…. 3 g x 720 = = 7.2 g 100 ml 240 ml 100How much propranolol must be used to prepare 240ml of a 3% suspension? 3 g x = = g 100 ml ml ©
21 Alligation Alligation is useful whenever we are using two different concentrations of a drug product to arrive at a final concentration between the two components For instance preparing a 10% product from 20% and 5% components ©
22 The Game Board Alligations start with the traditional tic-tac-toe board ©
23 The Set Up Set up the problem like this:the highest concentration goes in the upper left the lowest concentration goes in the lower left the final concentration goes in the center The highest Final Conc. The lowest ©
24 Let’s Try One How much of 20% Drug “A” cream is needed to mix with 5% Drug “A” cream to obtain 240g of a final 10% concentration? ©
25 Set up the Board 20 10 5 Put your values in the appropriate placesThe highest 10 The Final Concentration The lowest 5 ©
26 Now We…. Go diagonally from each corner, through the middle and find the DIFFERENCE between the two numbers Do NOT worry about negative numbers, you only want the DIFFERENCE 20 5 10 5 10 ©
27 The Answers Tell 5 parts of the 20% 20 10 5 10 parts of the 5 %The resulting differences tell us how much of each concentration we must use Therefore, out of every 15 parts, 5 parts must be the 20% concentration. Or, another words, 5/15 of the product must be 20% cream 20 5 parts of the 20% 10 5 10 parts of the 5 % 15 total parts ©
28 Finally Since we know 5/15 of the product must be the 20% strength, all we do is multiply 5/15 times the amount of product we are making. 5 x g = g of 20% cream 15 ©
29 Not So Bad, But….. Be SURE you are solving for the correct concentration Label all calculations as to which strength you are solving for ©
30 Let’s Try Another We need to compound 300 g of an 18% concentration of Drug “B”. However, Drug “B” is available only in 30% and 10% concentrations. How much of the 10% cream will be needed? ©
31 Set Up The Board 30 18 10 ©
32 Calculate the Differences30 18 10 8 parts of the 30% 12 parts of the 10 % 20 total parts ©
33 Solve We know that 12/20 of the final product must be the 10% 12 x g = g of 10% cream 20 ©
34 One More, Anyone? How much white petrolatum must be mixed with 20% ichthamol ointment to make 400 g of 4% product? ©
35 x 400 g = 320 g of white pet 20 4 4 parts of the 20%4 parts of the 20% 16 parts of the white pet (0%) 20 total parts 16 x g = g of white pet 20 ©
36 Ratio Concentration Once again we have standards to memorize1:1,000 = 1 mg / 1 ml 1:100 = 10 mg / 1 ml 1:10 = 100 mg / 1 ml Hint – the ratios all start with 1, and the number of zeros always stay the same. They just get “squished” from one side of the equal sign to the other. ©
37 Example An order states that we need to give 3 mg of epinephrine. Our stock bottle is a 1:100 concentration. How much should we give? ©
38 Example An order states that we need to give 3 mg of epinephrine. Our stock bottle is a 1:100 concentration. How much should we give? We know that 1:100 means there is 10 mg in each milliliter. Therefore, we can set up a proportion 1 ml x 3 10 mg mg 10 = = 0.3 ml ©
39 Tonicity Tonicity is the relative strength of a salt solution vs. the concentration normally found in the body Isotonic – Same as the body = 0.9% NaCl Hypertonic – Higher than the body > 0.9% NaCl Hypotonic – Lower than the body < 0.9% NaCl Know the values for NaCL 0.9% is isotonic (Normal Saline) ©
40 Ch 31: Payment for Drug ProductsSelf Payment The individual pays for his own medication in the entirety Third Party Payment Any party other than the patient who pays all or part of the prescription price ©
41 Copay & Deductible Copayment Deductibleamount of money the patient is required to pay towards their drug expense can be a fixed dollar amount or a percentage Deductible the amount of money a patient must pay towards their expenses before their insurance company begins to pay ©
42 Methods of Calculating the Selling PriceBased on the acquisition cost of the product, or Based on the Average Wholesale Price (AWP) of the product ©
43 Based on Cost Formula cost + markup + dispensing fee = selling pricethe amount of profit you expect to make on the item (markup = cost x gross profit expected) Dispensing Fee a calculated amount to cover the fixed costs of filling an individual prescription ©
44 Example 60 tabs of medicine cost us $ We have a dispensing fee of $4.00 and a markup of 25%. What is the selling price for the prescription? We know our cost for the amount dispensed = $23.99 So, using cost + markup + dispensing fee = selling $$ $ ($23.99 x 0.25) + $4.00 = $ $ $4.00 = $33.99 ©
45 Another Example Our pharmacy uses a 30% markup. Our dispensing fee is $3.25. The drug costs us $ What is the selling price? ©
46 The Answer Cost + markup + dispensing fee = selling price $ ($45.99 x 0.30) + $3.25 = $ $ $3.25 = $63.04 ©
47 A Twist Our pharmacy has a dispensing fee of $4.99 Our markup is 20% The drug costs us $ for a bottle of 500 tabs The prescription calls for #60 tabs What would our selling price be? ©
48 The Answer $239.99 x $14399.40 = = $28.80 500 tabs 60 tabs 500 tabsFirst you must use a proportion calculation Next you use the selling price calculation $ ($28.80 x 0.20) + $4.99 = $ $ $4.99 = $39.55 $ x $ 500 tabs tabs tabs = = $28.80 ©
49 AWP Method Average Wholesale Price The formulamuch like a car sticker price nobody actually pays this price that’s why there is normally a discount off of AWP involved in this calculation The formula AWP ± percentage + dispensing fee = selling price ©
50 AWP Example The AWP for the medication dispensed is $ The insurance company allows reimbursement at AWP less 15% plus $2.00 dispensing fee. What is the selling price? We know our AWP for the amount dispensed = $35.77 So, using AWP ± Percentage + dispensing fee = selling $$ $ ($35.77 x 0.15) + $2.00 = $ $ $2.00 = $32.40 ©
51 Another Example Our prescription calls for 45 capsules. The AWP for a bottle of 100 caps is $ The Insurance reimbursement is AWP less 14% plus a $3.50 dispensing fee. The patient also must pay a $5.00 copayment. How much should we bill the insurance company? …… Wow! What a Mess! ©
52 Calculate the Answer $43.99 x $1979.55 = = $19.80First calculate the AWP for the amount dispensed using a proportion …..then $ x $ 100 caps caps caps = = $19.80 ©
53 Calculate the Answer BUT DON’T FORGET THE COPAYMENT!Use the AWP formula AWP ± Percentage + dispensing fee = selling price $19.80 – ($19.80 x 0.14) + $3.50 = $ $ $3.50 = $20.53 BUT DON’T FORGET THE COPAYMENT! $ $5.00 = $15.53 ©
54 Ch 32: Third Party Billing ProcessTwo main types of third party payers: Private Insurance Either employer paid or privately purchased Government Includes federal, state, or local programs Biggest are Medicare and Medicaid ©
55 “Parts” of Medicare Part A Part B Part C Part DClass 6 Slides “Parts” of Medicare Part A Covers institutional care ie, hospital charges Part B Physician & outpatient services Durable medical equipment Part C Medicare advantage plans Part D Prescription drugs © copyright Mark Greenwald - all rights reserved
56 Medicaid Covers indigent patientsBy law, must cover hospital, medical, and long term care charges Prescription drug coverage is actually optional, although most states provide some type of coverage Amount and type of coverage will vary between states Coverage is not usually transferrable between states ©
57 Managed Care System that integrates both financial and delivery of health care Managed Care Organizations (MCO) form networks of providers with whom they contract Some contracts pay providers a set dollar amount per enrolled patient Means the MCO assumes the financial risk The MCO then “manages” the care through utilization and cost controls ©
58 The Pharmacy Benefit Manager (PBM)PBMs are responsible for the processing and payment of prescription drug claims for the insurance companies When we submit a claim for the customer, we are sending it to the PBM, not to the insurance company PBMs follow the directions from the insurance company’s contract with the insured, but they also are charged with reducing health costs when possible ©
59 Methods to Reduce Third Party Prescription Drug CostsClass 6 Slides Methods to Reduce Third Party Prescription Drug Costs Preferred provider networks Negotiated price discounts from pharmacies Negotiated rebates from manufacturers Mandatory Mail Order Deductibles and Copayments Formularies Tier structures Prior Authorizations Medication Therapy Management Mandatory Education © copyright Mark Greenwald - all rights reserved
60 Multi-Tiered StructuresDrugs are ranked by the MCO according to certain predefined factors, such as: Cost Generic availability Plan formulary With each successive increase in tier ranking, the amount of the patient’s copay increases © 2013
61 Information on the Insurance CardCardholder’s Name NOT always the patient’s name ©
62 Information on the Insurance CardCardholder’s ID Number Used for all covered individuals on the card Also requires a dependent number that is rarely on the card ©
63 Information on the Insurance CardDependent Numbers 00 = cardholder = spouse = oldest dependent 03 = next oldest dependent 04, 05, 06, etc = with each dependent ©
64 Information on the Insurance CardBIN Number Tells us who to bill the claim to ©
65 Information on the Insurance CardGroup Number Identifies which plan the cardholder belongs to ©
66 Required Information When Billing Third Party ClaimsClass 6 Slides Required Information When Billing Third Party Claims In addition to all of the required information for a prescription to be valid, the following items must also be present on the prescription: Dispense as Written Codes (DAW) Day Supply Actual Package Size Used Diagnosis Codes © copyright Mark Greenwald - all rights reserved
67 Dispense as Written CodesDetermined by prescriber’s notation on the prescription Common DAW Codes: 0 = no product selection indicated (may use generic) 1 = Prescriber wants the brand name product 2 = Patient wants the brand name product 3 = Pharmacist wants the brand name product 4 = generic not in stock 5 = brand drug dispensed as generic 6 = special override 7 = brand mandated by law 8 = generic not available in marketplace ©
68 Day Supply The day supply is calculated using the amount of medication dispensed divided by the daily expected usage of the medication Monitoring the day supply can give several pieces of information to the PBM and the pharmacy: Is the drug being prescribed correctly? Is the patient taking too much or too little of the medication based on expected use? (called “adherence”) The PBM can then approve or deny the claim based on use ©
69 Actual Package Size UsedIntegrity of the billing system is dependent on accurate information being submitted The NDC number of the product used is submitted with the claim NDC indicates package size used Acquisition cost varies by the product size Payment is based on the acquisition cost You must use the correct NDC for the item used It can be considered insurance fraud to use an incorrect NDC ©
70 Diagnosis Codes ICD-10 codes Identifies main disease state, plus:Disease variants, unusual characteristics, and cause of the condition Codes can contain letters in addition to numbers Diagnosis codes are required on all Medicare Part B prescriptions ©
71 Third Party Claim RejectionsWhen a claim is submitted, the PBM will conduct a drug utilization review (DUR) Common reasons for rejections: Refill too soon Invalid day supply Prior authorization needed Rejections require investigation and resolution (when possible) by pharmacy staff Online documentation through DUR override codes ©
72 Reconciliation and AuditsReconciliation is the act of comparing submitted insurance claims with amounts actually paid May require claim correction and resubmission Audits are conducted by the PBMs Do the prescriptions actually exist? Did the patient pick up the prescription? Does the pharmacy stock the package size they billed for? Audit exceptions can trigger forfeited money to PBM ©
73 Ch 33: Return of PharmaceuticalsReasons for returns returns from patients over stock ordered by mistake expired drugs recalls What we can do with the product depends on many factors ©
74 Returns from OutpatientsWe have lost control over the product where was it stored? was it contaminated? is it even the same product that you dispensed? Never place the drug back in stock do not risk other patients health Controlled substances recommendation is not to take controlled substances back. let the patient destroy the drugs give them a refund if desired ©
75 Returns from Inpatient AreasWe had control over the medication while it was gone We can return unit dosed medications back into stock Exemption exists for bulk drugs Sent home with patient or destroyed ©
76 Manufacturer Recalls FDA or manufacturer can issue recallsFDA has the power to seize affected medicine Rated into Classes by the severity of damage that could be caused with use ©
77 FDA Recall Classes Class I Class II Class IIIserious health problems or death Class II temporary health problems or slight risk of serious health problem Class III unlikely to cause serious health problem but still violates FDA rules ©
78 Returns to Wholesalers for CreditEach will have their own rules for returns Credit invoices must be filed with your other invoices from the wholesaler Returns of schedule 2 drugs require the use of a 222 form from the wholesaler ©
79 Return of Drugs for DestructionMost returns will be of drugs that should no longer be used Beyond-use date Recalls Returns from customers Returned to “reverse distributors” Company contracted who handles all returns at a central location Advantages: Simplifies Makes obtaining and credits easy Helps stop diversion of any beyond-use drugs ©
80 Returns of Controlled Substances for DestructionMany return centers exist Schedule 2 drugs require a 222 form from the return center Sent through reverse distributor or in rare cases to the DEA Maintain return paperwork with your invoices ©
81 Hazardous Substance ReturnsMust be returned to a licensed Hazardous Waste Disposal Company Process Receipt for waste when picked up (“cradle”) Confirmation sent to pharmacy when the substance is destroyed (“grave”) BOTH copies must be kept on file Gives “cradle to grave” accountability ©
82 Questions? ©