challenges in reporting compounded drugs to the...

Challenges in Reporting Compounded Drugs to the

PMP/PDMPKatie Busroe, RPh

Pharmacy Inspections and Investigations Supervisor

Kentucky Board of Pharmacy

Disclosures• Katie Busroe has reported that she has nothing to disclose

with regard to potential conflicts of interest for this activity.

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.

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

Hot Topics in Pharmacy:Overlap a Little?

Compounding PMP/PDMP

Hot Topics in Pharmacy:Overlap a Little More?


History of Compounding


• From the beginning of history, people have been compounding medication

• First United States Pharmacopeia (USP) published in 1820

• 1920’s to 1940’s - 80% of prescriptions were compounded

• Main component in pharmacy education


• 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


• Resurgence in the 1980’s– Customized medications

• Pediatric/geriatric doses• Allergies• Dosage forms• Unavailable on the market• Animals

– Localized patient base


• 2000’s– Interstate dispensing– Harmful/deadly sterile compounding incidents– Still not emphasized in pharmacy education– Focus of State Boards of Pharmacy and FDA

Compounding Pharmacies

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

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%)

KASPER Reporting for CSP

DO NOT REPORT• Hospital 58%• LTC 7%• Nuclear 3%• Veterinarian 3%

• TOTAL: 71%

REPORT• Community/Ambulatory

11%• Infusion 18%

• TOTAL: 29%

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?

Compounded Prescriptions

Prescriptions Dispensed in USA

• 2012: 4.154 billion• 2013: 4.235 billion• 2014: 4.325 billion• 2015: 4.368 billion• 2016: 4.453 billion

Data from Statista

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 PMP


Compounded Prescriptions 1-12%

4154 4234 4325 4368 4453

42.54 42.3 43.5 43.6 44.5

498 508 522 524 534

0

500

1000

1500

2000

2500

3000

3500

4000

4500

5000

2012 2013 2014 2015 2016

Pres

crip

tions

disp

ense

d in

the

mill

ions

Total

1%

12%

Kentucky Data 2016

• Total dispensed: 88,544,876 Kaiser Family Foundation

– Population of 4.4 million

• Total compounded: 885,448 to 10,625,385

88,544,876

885,448

10,625,385

0 20,000,000 40,000,000 60,000,000 80,000,000 100,000,000

2016

Prescriptions in the Millions

12% 1% Total

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 PMPCompounding PMP/PDMP

Kentucky Data 2016

10,500,000105,000

1,260,000

0 2,000,000 4,000,000 6,000,000 8,000,000 10,000,000 12,000,000Controlled Substance Prescriptions in the Millions

2016

12% 1% Total

What’s Being Compounded?

What’s Being Compounded?

• No good data, anecdotally 2 most popular:– Topical pain formulations

• Ketamine• Gabapentin• Tramadol

– Testosterone• Injectable• Implantable• Topical

Pain Cream Fraud

Pain Cream Prescription

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)

Commonly Compounded Topical Pain Formulations: 5 ingredients

• Amitriptyline HCl 2%/Baclofen 5%/Ketamine HCl5%/Ketoprofen 10% in Lipoderm® (5 ingredients)

• Baclofen 5%/Ketoprofen 10%/Lidocaine 5%/Gabapentin5% 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)

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)

Commonly Compounded Topical Pain Formulation: 6 to 7 Ingredients

• Flurbiprofen 10%/Cyclobenzaprine 1%/Gabapentin6%/Lidocaine 2%/Prilocaine 2% in Lipoderm® (6 ingredients)

• Flurbiprofen 10%/Amitriptyline 2%/Gabapentin6%/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)

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

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

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

What’s Being Reported to PMP/PDMP

This Photo by Unknown Author is licensed under CC BY-SA

http://en.wikipedia.org/wiki/File:KENTUCKY_COUNTIES.png

https://creativecommons.org/licenses/by-sa/3.0/

PMP Data: TestosteronePatient RX Number Drug NDC QTY Day

Supply

Patient A 123456 Not Found 37803040402 1 30

Patient A 123456 Testosterone/0 49452765002 1 30

Patient B 234567 Propylene glycol/0 62991129201 2 30

Patient B 234567 Not Found 49452082601 40 30

Patient B 234567 Testosterone/0 49452765002 2 30

Patient A

• 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

Patient RX Number Drug NDC QTY Day Supply

Patient A 123456 Not Found (DHEA) 37803040402 1 30

Patient A 123456 Testosterone/0 49452765002 1 30

Patient B

• 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

Patient RX Number Drug NDC QTY Days Supply

Patient B 234567 Propylene glycol/0 62991129201 2 30

Patient B 234567 Not Found (Chrysin) 49452082601 40 30

Patient B 234567 Testosterone/0 49452765002 2 30

PMP Data: TestosteronePatient RX Number Drug NDC QTY Day

SupplyPatient C 345678 Testosterone Non-

micronize 038779259809 0 90

Patient D 456789 Testosterone Non-micronize 0

38779259809 0 90

Patient E 567890 Testosterone Cypionate 0

63275998209 1 23

Patient F 678901 Testosterone Cypionate

00143972601 10 70

Patient G 789012 Testosterone 0 38779259809 0 90

Patient H 890123 Testosterone 0 38779259809 0 90

Patient I 901234 Testosterone 0 63275998209 1 30

Patient J 112345 Testosterone 0 63275998209 0 15

Patient C

• Testosterone 60 mg and Anastrozole 4 mg pellets

• Quantity 2 pellets• 90 day supply

Patient RX Number

Drug NDC QTY Day Supply

Patient C 345678 Testosterone Non-micronize 0

38779259809 0 90

Patient D

• Testosterone 100 mg • Quantity 1 pellet• 90 day supply

Patient RX Number


Patient D 456789 Testosterone Non-micronize 0

38779259809 0 90

Patient E

• Testosterone cypionate in grapeseed oil 200 mg/ml (compounded)

• Quantity 5.6 ml• 30 day supply

Patient RX Number


Patient E 567890 Testosterone Cypionate 0

63275998209 1 23

Patient F

• Testosterone cypionate in cottonseed oil 200 mg/ml (commercially available)

• Quantity 10 ml• 70 day supply

Patient RX Number


Patient F 678901 Testosterone Cypionate

00143972601 10 70

Patient G

• Testosterone 45 mg pellet• Quantity 1 pellet• 90 day supply

Patient RX Number


Patient G 789012 Testosterone 0 38779259809 0 90

Patient H

• Testosterone 100 mg pellet• Quantity 1 pellet• 90 day supply

Patient RX Number


Patient H 890123 Testosterone 0 38779259809 0 90

Patient I

• Testosterone 30 mg/ml and 1.5 mg/ml estradiol cream


Patient RX Number


Patient I 901234 Testosterone 0 63275998209 1 30

Patient J

• Testosterone 25 mg/ml and 0.5 mg/ml estradiol cream


Patient RX Number


Patient J 112345 Testosterone 0 63275998209 0 15

PMP Data: Topical PainPatient RX Number Drug NDC QTY Days

Supply

Patient K 456789 Baclofen/0 62991101302 12 30

Patient K 456789 Not Found 62991111304 12 30



Patient K 456789 Clobetasol/proprionate/0 62991149203 3 30

Patient k 456789 Ketamine hcl/0 62991108702 24 30

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

PMP Data: Topical PainPatient RX Number Drug NDC QTY Days

Supply

Patient K 456789 Baclofen/0 62991101302 12 30

Patient K 456789 Not Found (Piroxicam) 62991111304 12 30

Patient K 456789 Not Found (Loperamide) 62991278103 12 30

Patient K 456789 Not Found (Ketoprofen) 62991273304 36 30

Patient K 456789 Clobetasol/proprionate/0 62991149203 3/0.48 30

Patient K 456789 Ketamine hcl/0 62991108702 24 30

Ibuprofen

PMP Data: Topical PainPatient RX

NumberDrug NDC QTY Days

Supply

Patient L 567890 Not Found 51552115007 176 15

Patient L 567890 Ketoprofen/0 51552030706 24 15

Patient L 567890 Guaifenesin/0 62991107502 12 15

Patient L 567890 Ibuprofen/0 62991108102 12 15

Patient L 567890 Amitriptyline hcl /0 62991200403 2 15

Patient L 567890 Ketamine hcl/0 62991108702 12 15

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

PMP Data: Topical PainPatient RX


Supply

Patient L 567890 Not Found (Liposome base

51552115007 176 (132)

15 (25)

Patient L 567890 Ketoprofen/0 51552030706 24 (18)

15

Patient L 567890 Guaifenesin/0 62991107502 12 (9) 15

Patient L 567890 Ibuprofen/0 62991108102 12 (9) 15

Patient L 567890 Amitriptyline hcl /0 62991200403 2 (3.6) 15

Patient L 567890 Ketamine hcl/0 62991108702 12 (9) 15

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

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

PMP Data: CapsulesPatient RX


Supply

Patient M 678901 Capsaicin/95% 62991201702 1 30

Patient M 678901 Not Found 62991200702 20 30

Patient M 678901 Not Found 62991146004 1 30

Patient M 678901 Hydrocodone bitartrate /0 62991140604 12 30

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



Supply

Patient M 678901 Capsaicin/95% 62991201702 1 30 (29)

Patient M 678901 Not Found (Microcellulose) 62991200702 20 30

Patient M 678901 Not Found (Blue Food Coloring)

62991146004 1 30

Patient M 678901 Hydrocodone bitartrate /0 62991140604 12 30


NumberDrug NDC QTY Day

Supply

Patient N 789012 Not Found 62991200702 20 29

Patient N 789012 Not Found 62991146004 1 29

Patient N 789012 Capsaicin/95% 62991201702 1 29

Patient N 789013 Morphine sulfate er/100mg 00406839001 58 29

Patient N 789012 Hydrocodone bitartrate/0 62991140604 12 29

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


NumberDrug NDC QTY Day

Supply

Patient N 789012 Not Found (Microcellulose) 62991200702 20 29 (30)

Patient N 789012 Not Found (Blue Food Coloring)

62991146004 1 29

Patient N 789012 Capsaicin/95% 62991201702 1 29

Patient N 789013 Morphine sulfate er/100mg 00406839001 58 29

Patient N 789012 Hydrocodone bitartrate/0 62991140604 12 29

PMP Data: CapsulesPatient RX Number Drug NDC QTY Days

Supply

Patient O 890123 Not Found 62991144904 0 30

Patient O 890123 Ginger extract / 250mg 54629011010 1 30

Patient O 890123 Not Found 62991200702 40 30

Patient O 890123 Oxycodone hcl / 0 52372085203 0 30

Patient O

• Oxycodone 16 mg capsules• Formula: Oxycodone, Microcellulose, Green

Food Coloring, Ginger• Dispensed 60• Take 1 capsule every 12 hours• 30 day supply


Supply

Patient O 890123 Not Found (Green Food Coloring)

62991144904 0 30

Patient O 890123 Ginger extract / 250mg 54629011010 1 30

Patient O 890123 Not Found (Microcellulose)

62991200702 40 30

Patient O 890123 Oxycodone hcl / 0 52372085203 0 30


Supply

Patient P 901234 Not Found 62991144904 0 29

Patient P 901234 Ginger extract / 250mg 54629011010 1 29

Patient P 901234 Not Found 62991200702 40 29

Patient P 901235 Methadone hcl / 10mg 00406577101 58 29

Patient P 901234 Oxycodone hcl / 0 52372085203 0 29

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


Supply

Patient P 901234 Not Found (Green Food Coloring)

62991144904 0 29 (30)

Patient P 901234 Ginger extract / 250mg 54629011010 1 29

Patient P 901234 Not Found (Microcellulose)

62991200702 40 29

Patient P 901235 Methadone hcl / 10mg 00406577101 58 29

Patient P 901234 Oxycodone hcl / 0 52372085203 0 29



Supply

Patient R 765432 Capsaicin / 95% 62991201702 1 29

Patient R 765432 Not Found 62991200702 20 29


Patient R 765432 Hydrocodone bitartrate / 0 62991140604 12 29





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



Supply


Patient R 765432 Not Found (Microcellulose) 62991200702 20 29

Patient R 765432 Not Found (Food Coloring) 62991146004 1 29


Patient R 765431 Not Found (Food Coloring) 62991145404 1 29

Patient R 765431 Not Found (Microcellulose) 62991200702 26 29



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

Contact Information

Katie BusroePharmacy Inspections and Investigations

SupervisorKentucky Board of Pharmacy

Cell: 859-619-5477Email: [email protected]

challenges in reporting compounded drugs to the...

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