Challenges in Reporting Compounded Drugs to the PMP/PDMP

Transcription

1 Challenges in Reporting Compounded Drugs to the PMP/PDMP Katie Busroe, RPh Pharmacy Inspections and Investigations Supervisor Kentucky Board of Pharmacy

2 Disclosures Katie Busroe has reported that she has nothing to disclose with regard to potential conflicts of interest for this activity.

3 Learning Objectives 1. Provide a brief background of compounding. 2. Discuss issues with reporting compounded prescriptions to the PMP/PDMP. 3. Explore opportunities for reporting compounded prescriptions to the PMP/PDMP.

4 Kentucky Structure Board of Pharmacy Stand alone agency Enforces Pharmacy Practice Act Limited access to KASPER for entities permitted and persons licensed by KY BOP and under investigation PMP Cabinet for Health and Family Services (CHFS) Office of Inspector General Drug Enforcement and Professional Practice Branch Enforces Controlled Substances Act KASPER

5 Hot Topics in Pharmacy: Overlap a Little? Compounding PMP/PDMP

6 Hot Topics in Pharmacy: Overlap a Little More? Compounding PMP/PDMP

7 History of Compounding

8 History of Compounding From the beginning of history, people have been compounding medication First United States Pharmacopeia (USP) published in s to 1940 s - 80% of prescriptions were compounded Main component in pharmacy education

9 History of Compounding Post War World II pharmaceutical industry boom 1940 s to 1980 s huge drop off in compounding 1970 s pharmacists started sterile compounding in hospitals Not emphasized in pharmacy education

10 History of Compounding Resurgence in the 1980 s Customized medications Pediatric/geriatric doses Allergies Dosage forms Unavailable on the market Animals Localized patient base

11 History of Compounding 2000 s Interstate dispensing Harmful/deadly sterile compounding incidents Still not emphasized in pharmacy education Focus of State Boards of Pharmacy and FDA

12 Compounding Pharmacies

13 How Many USA Pharmacies are Compounding? 76,189 total pharmacies 32,397 pharmacies that list compounding functions (42.5%) Pew Charitable Trust Report: National Assessment of State Oversight of Sterile Drug Compounding (Feb 2016); data from NCPDP 8,000 pharmacies specialize in compounding (10.5%) Pew Charitable Trust

14 Kentucky Pharmacies 1,365 total pharmacies 187 sterile compounding pharmacies (14%) Hospital: 109 (58%) LTC: 14 (7%) Nuclear: 6 (3%) Community/Ambulatory: 25 (13%) 5 veterinarian only (20% of the community) Infusion: 33 (18%)

15 KASPER Reporting for CSP DO NOT REPORT Hospital 58% LTC 7% Nuclear 3% Veterinarian 3% REPORT Community/Ambulatory 11% Infusion 18% TOTAL: 29% TOTAL: 71%

16 Kentucky Pharmacies 1,365 total pharmacies 187 sterile compounders (14%) Approximately 1,200 nonsterile compounders (88%) Approximately 10% not required to report to KASPER Number nonsterile compounding of CS?

17 Compounded Prescriptions

18 Prescriptions Dispensed in USA 2012: 2013: 2014: 2015: 2016: billion billion billion billion billion Data from Statista

19 Compounded Prescriptions Dispensed No good data, estimates 1% to 12% 2012: 41.5 to 498 million 2013: 42.3 to 508 million 2014: 43.3 to 519 million 2015: 43.6 to 524 million 2016: 44.5 to 534 million Compounding Compounding PMP/PDMP PMP

20 5000 Compounded Prescriptions 1-12% Prescriptions dispensed in the millions Total 1% 12%

21 Kentucky Data 2016 Total dispensed: 88,544,876 Kaiser Family Foundation Population of 4.4 million Total compounded: 885,448 to 10,625,385 10,625,385 12% 1% Total ,448 88,544, ,000,000 40,000,000 60,000,000 80,000, ,000,000 Prescriptions in the Millions

22 Kentucky Data 2016 Total prescriptions: 88,544,876 Controlled substances: 10,500,000 (11.5%) Compounded Controlled Substances 1-12%: 105,000 to 1,260,000 Compounding PMP/PDMP Compounding PMP

23 Kentucky Data ,000 1,260,000 10,500, ,000,000 4,000,000 6,000,000 8,000,000 10,000,000 12,000,000 Controlled Substance Prescriptions in the Millions 12% 1% Total

24 What s Being Compounded?

25 What s Being Compounded? No good data, anecdotally 2 most popular: Topical pain formulations Ketamine Gabapentin Tramadol Testosterone Injectable Implantable Topical

26 Pain Cream Fraud

27 Pain Cream Prescription

28 Commonly Compounded Topical Pain Formulas: 3 to 4 Ingredients Amitriptyline HCl 2%/Baclofen 2% in Lipoderm (3 ingredients) Ketamine 10%/Lidocaine 5%/Tetracine 0.75% (3 ingredients) Gabapentin 10%/Clonidine HCl 0.2%/Baclofen 1% in Lipoderm (4 Ingredients) Diclofenac 3%/Gabapentin 6%/Lidocaine 2%/Prilocaine 2% (4 ingredients) Gabapentin 10%/Lidocaine 2%/Prilocaine 2% in Lipoderm (4 ingredients)

29 Commonly Compounded Topical Pain Formulations: 5 ingredients Amitriptyline HCl 2%/Baclofen 5%/Ketamine HCl 5%/Ketoprofen 10% in Lipoderm (5 ingredients) Baclofen 5%/Ketoprofen 10%/Lidocaine 5%/Gabapentin 5% in Lipoderm (5 ingredients) Ketamine 10%/Gabapentin 6%/Clonidine 0.2%/ Nifedipine 2% in Lipoderm (5 ingredients) Ketamine 2%/Gabapentin 5%/Amitriptyline 2%/Lidocaine 5%/Clonidine 0.6% (5 ingredients)

30 Commonly Compounded Topical Pain Formulations: 5 Ingredients Meloxicam 0.9%/Tramadol 0.25%/Topiramate 1%/Lidocaine 2%/Prilocaine 2% (5 ingredients) Ketoprofen 5%/Amitriptyline 2%/Gabapentin 2%/Lidocaine 5%/Tetracaine 2% (5 ingredients) Ketoprofen10%/Gabapentin 10%/Cyclobenzaprine 1%/Lidocaine 5%/Baclofen 2% (5 ingredients) Ketoprofen 5%/Gabapentin 2%/Amitriptyline 2%/Lidocaine 5%/Tetracaine 2% (5 ingredients)

31 Commonly Compounded Topical Pain Formulation: 6 to 7 Ingredients Flurbiprofen 10%/Cyclobenzaprine 1%/Gabapentin 6%/Lidocaine 2%/Prilocaine 2% in Lipoderm (6 ingredients) Flurbiprofen 10%/Amitriptyline 2%/Gabapentin 6%/Lidocaine 2%/Prilocaine 2% in Lipoderm (6 ingredients) Ketoprofen 20%/Ibuprofen 2%/Ketamine 2%/Clonidine 0.2%/Amitriptyline HCl 2%/Guaifenesin 2% in Lipoderm (7 ingredients)

32 Injectable Testosterone Commercially Available Cypionate 100 mg/ml and 200 mg/ml Cottonseed oil 1 ml and 10 ml vials $85 for 10 ml Compounded Cypionate Various strengths Grapeseed oil Various sizes Various cost, less than $85 for 10 ml

33 Implantable Testosterone Commercially Available Testopel 75 mg of testosterone/pellet Usually implant 4-6 pellets Lasts 3 to 4 months $900 Compounded Various strengths/pellet 12.5, 20, 25, 35, 37.5, 40, 45, 50, 55, 65, 70, 80, 100, 200 mg Number of pellets implanted depend on dosage Lasts 3 to 4 months $200-$300

34 Topical Testosterone Commercially Available Various brands and generics Various strengths Cost $400 per month Compounded 5-10% in gel/cream bases Mixed with anastrozole Mixed with estradiol Cost $15-$70 per month

35 What s Being Reported to PMP/PDMP This Photo by Unknown Author is licensed under CC BY-SA

36 PMP Data: Testosterone Patient RX Number Drug NDC QTY Day Supply Patient A Not Found Patient A Testosterone/ Patient B Propylene glycol/ Patient B Not Found Patient B Testosterone/

37 Patient A Patient RX Number Drug NDC QTY Day Supply Patient A Not Found (DHEA) Patient A Testosterone/ Testosterone 1.5 mg/gm/dhea 10 mg/gm Cream Formula: 45 mg of testosterone and 300 mg DHEA Dispensed 30 gm Use 1 gm daily 30 day supply

38 Patient B Patient RX Number Drug NDC QTY Days Supply Patient B Propylene glycol/ Patient B Not Found (Chrysin) Patient B Testosterone/ Testosterone 50 mg/1 gm with Chrysin Cream Formula: Testosterone 1.5 gm, Chrysin 1.5 gm, and Propylene Glycol 40 gm Dispensed 30 gm Use 1 gm daily 30 day supply

39 PMP Data: Testosterone Patient RX Number Drug NDC QTY Day Supply Patient C Testosterone Nonmicronize 0 Patient D Testosterone Nonmicronize 0 Patient E Testosterone Cypionate 0 Patient F Testosterone Cypionate Patient G Testosterone Patient H Testosterone Patient I Testosterone Patient J Testosterone

40 Patient C Patient RX Number Patient C Testosterone Nonmicronize 0 Testosterone 60 mg and Anastrozole 4 mg pellets Quantity 2 pellets 90 day supply Drug NDC QTY Day Supply

41 Patient D Patient RX Number Patient D Testosterone Nonmicronize 0 Testosterone 100 mg Quantity 1 pellet 90 day supply Drug NDC QTY Day Supply

42 Patient E Patient RX Number Patient E Testosterone Cypionate 0 Testosterone cypionate in grapeseed oil 200 mg/ml (compounded) Quantity 5.6 ml 30 day supply Drug NDC QTY Day Supply

43 Patient F Patient RX Number Patient F Testosterone Cypionate Testosterone cypionate in cottonseed oil 200 mg/ml (commercially available) Quantity 10 ml 70 day supply Drug NDC QTY Day Supply

44 Patient G Patient RX Number Drug NDC QTY Day Supply Patient G Testosterone Testosterone 45 mg pellet Quantity 1 pellet 90 day supply

45 Patient H Patient RX Number Drug NDC QTY Day Supply Patient H Testosterone Testosterone 100 mg pellet Quantity 1 pellet 90 day supply

46 Patient I Patient RX Number Drug NDC QTY Day Supply Patient I Testosterone Testosterone 30 mg/ml and 1.5 mg/ml estradiol cream Quantity 30 ml 30 day supply

47 Patient J Patient RX Number Drug NDC QTY Day Supply Patient J Testosterone Testosterone 25 mg/ml and 0.5 mg/ml estradiol cream Quantity 5 ml 15 day supply

48 PMP Data: Topical Pain Patient RX Number Drug NDC QTY Days Supply Patient K Baclofen/ Patient K Not Found Patient K Not Found Patient K Not Found Patient K Clobetasol/proprionate/ Patient k Ketamine hcl/

49 Patient K Arthritis Pain Gel Formula: Baclofen 12 gm (5%); Piroxicam 12 gm (5%); Loperamide 12 gm (5%); Ketoprofen 36 gm (15%); Clobetasone 0.48 gm (0.2%); Ketamine 24 gm (10%); Ibuprofen 9.6 gm (4%); in Liposome base 134 gm (8 ingredients) Dispensed 240 gm Use 1-2 gms to affected area 3-4 times/day 30 day supply

50 PMP Data: Topical Pain Patient RX Number Drug NDC QTY Days Supply Patient K Baclofen/ Patient K Not Found (Piroxicam) Patient K Not Found (Loperamide) Patient K Not Found (Ketoprofen) Patient K Clobetasol/proprionate/ / Patient K Ketamine hcl/ Ibuprofen

51 PMP Data: Topical Pain Patient RX Number Drug NDC QTY Days Supply Patient L Not Found Patient L Ketoprofen/ Patient L Guaifenesin/ Patient L Ibuprofen/ Patient L Amitriptyline hcl / Patient L Ketamine hcl/

52 Patient L Plantar Fasciitis Cream Formula: Ketoprofen 18 gm (10%); Guaifenesin 9 gm (5%); Ibuprofen 9 gm (5%); Amitriptyline 3.6 gm (2%); Ketamine 9 mg (5%) in Liposome base 132 gm Dispensed 180 gm Use 1-2 gms in affected area 4 times/day 25 day supply

53 PMP Data: Topical Pain Patient RX Number Patient L Not Found (Liposome base Drug NDC QTY Days Supply (132) Patient L Ketoprofen/ (18) Patient L Guaifenesin/ (9) 15 Patient L Ibuprofen/ (9) 15 Patient L Amitriptyline hcl / (3.6) 15 Patient L Ketamine hcl/ (9) (25) 15

54 Compounding Pharmacy Commercially Available Oxycodone 5 mg Oxycodone 10 mg Oxycodone 15 mg Oxycodone 20 mg Oxycodone 30 mg Methadone 5 mg Methadone 10 mg Compounded Oxycodone 6 mg Oxycodone 11 mg Oxycodone 16 mg Oxycodone 21 mg Oxycodone 32 mg Methadone 6 mg Methadone 11 mg

55 Compounding Pharmacy Commercially Available Zohydro ER: 10, 15, 20, 30, 40, 50 mg Hysingla ER: 20, 30, 40, 60, 80, 100, 120 mg Compounded Hydrocodone IR 20 mg Hydrocodone IR 40 mg

56 PMP Data: Capsules Patient RX Number Drug NDC QTY Days Supply Patient M Capsaicin/95% Patient M Not Found Patient M Not Found Patient M Hydrocodone bitartrate /

57 Patient M Hydrocodone 40 mg capsules IR Formula: Hydrocodone, Microcellulose, Blue Food Coloring, Capsaicin Dispensed 145 capsules Take 1 capsule 5 times/day 29 day supply

58 PMP Data: Capsules Patient RX Number Drug NDC QTY Days Supply Patient M Capsaicin/95% (29) Patient M Not Found (Microcellulose) Patient M Not Found (Blue Food Coloring) Patient M Hydrocodone bitartrate /

59 PMP Data: Capsules Patient RX Number Drug NDC QTY Day Supply Patient N Not Found Patient N Not Found Patient N Capsaicin/95% Patient N Morphine sulfate er/100mg Patient N Hydrocodone bitartrate/

60 Patient N Hydrocodone 40 mg capsules IR Formula: Hydrocodone, Microcellulose, Blue Food Coloring, Capsaicin Dispensed 120 capsules Take 1 capsule 4 times/day 30 day supply Commercially available morphine

61 PMP Data: Capsules Patient RX Number Drug NDC QTY Day Supply Patient N Not Found (Microcellulose) (30) Patient N Not Found (Blue Food Coloring) Patient N Capsaicin/95% Patient N Morphine sulfate er/100mg Patient N Hydrocodone bitartrate/

62 PMP Data: Capsules Patient RX Number Drug NDC QTY Days Supply Patient O Not Found Patient O Ginger extract / 250mg Patient O Not Found Patient O Oxycodone hcl /

63 Patient O Oxycodone 16 mg capsules Formula: Oxycodone, Microcellulose, Green Food Coloring, Ginger Dispensed 60 Take 1 capsule every 12 hours 30 day supply

64 PMP Data: Capsules Patient RX Number Drug NDC QTY Days Supply Patient O Not Found (Green Food Coloring) Patient O Ginger extract / 250mg Patient O Not Found (Microcellulose) Patient O Oxycodone hcl /

65 PMP Data: Capsules Patient RX Number Drug NDC QTY Days Supply Patient P Not Found Patient P Ginger extract / 250mg Patient P Not Found Patient P Methadone hcl / 10mg Patient P Oxycodone hcl /

66 Patient P Oxycodone 21 mg Formula: Oxycodone, Microcellulose, Green Food Coloring, Ginger Extract Dispensed 60 capsules Take 1 capsule every 12 hours 30 day supply Commercially available methadone

67 PMP Data: Capsules Patient RX Number Drug NDC QTY Days Supply Patient P Not Found (Green Food Coloring) (30) Patient P Ginger extract / 250mg Patient P Not Found (Microcellulose) Patient P Methadone hcl / 10mg Patient P Oxycodone hcl /

68 PMP Data: Capsules Patient RX Number Drug NDC QTY Days Supply Patient R Capsaicin / 95% Patient R Not Found Patient R Not Found Patient R Hydrocodone bitartrate / Patient R Not Found Patient R Not Found Patient R Capsaicin / 95% Patient R Hydrocodone bitartrate /

69 Patient R Hydrocodone 20 mg and 40 mg Formulas: Hydrocodone, Microcellulose, Blue Food Coloring, Capsaisin Dispensed 20 mg: 145 and 40 mg: 174 Take one 20 mg cap 5 times/day and one 40 mg cap 6 times/day 29 day supply

70 PMP Data: Capsules Patient RX Number Drug NDC QTY Days Supply Patient R Capsaicin / 95% Patient R Not Found (Microcellulose) Patient R Not Found (Food Coloring) Patient R Hydrocodone bitartrate / Patient R Not Found (Food Coloring) Patient R Not Found (Microcellulose) Patient R Capsaicin / 95% Patient R Hydrocodone bitartrate /

71 Problem? Don t know Don t have good data on: Number of pharmacies compounding What the pharmacies are compounding Volume of controlled substances Don t have a way to report to PMP accurately Does it affect PMP statistics

72 Contact Information Katie Busroe Pharmacy Inspections and Investigations Supervisor Kentucky Board of Pharmacy Cell: