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Transcript of 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
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
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
History of Compounding
• Resurgence in the 1980’s– Customized medications
• Pediatric/geriatric doses• Allergies• Dosage forms• Unavailable on the market• Animals
– Localized patient base
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
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?
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
Compounding PMP/PDMP
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?
• No good data, anecdotally 2 most popular:– Topical pain formulations
• Ketamine• Gabapentin• Tramadol
– Testosterone• Injectable• Implantable• Topical
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
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
Drug NDC QTY Day Supply
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
Drug NDC QTY Day Supply
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
Drug NDC QTY Day Supply
Patient F 678901 Testosterone Cypionate
00143972601 10 70
Patient G
• Testosterone 45 mg pellet• Quantity 1 pellet• 90 day supply
Patient RX Number
Drug NDC QTY Day Supply
Patient G 789012 Testosterone 0 38779259809 0 90
Patient H
• Testosterone 100 mg pellet• Quantity 1 pellet• 90 day supply
Patient RX Number
Drug NDC QTY Day Supply
Patient H 890123 Testosterone 0 38779259809 0 90
Patient I
• Testosterone 30 mg/ml and 1.5 mg/ml estradiol cream
• Quantity 30 ml• 30 day supply
Patient RX Number
Drug NDC QTY Day Supply
Patient I 901234 Testosterone 0 63275998209 1 30
Patient J
• Testosterone 25 mg/ml and 0.5 mg/ml estradiol cream
• Quantity 5 ml• 15 day supply
Patient RX Number
Drug NDC QTY Day Supply
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 Not Found 62991278103 12 30
Patient K 456789 Not Found 62991273304 36 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
NumberDrug NDC QTY Days
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
NumberDrug NDC QTY Days
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
PMP Data: CapsulesPatient RX
NumberDrug NDC QTY Days
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
PMP Data: CapsulesPatient RX
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
PMP Data: CapsulesPatient RX
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
PMP Data: CapsulesPatient RX Number Drug NDC QTY Days
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
PMP Data: CapsulesPatient RX Number Drug NDC QTY Days
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
PMP Data: CapsulesPatient RX Number Drug NDC QTY Days
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
PMP Data: CapsulesPatient RX
NumberDrug NDC QTY Days
Supply
Patient R 765432 Capsaicin / 95% 62991201702 1 29
Patient R 765432 Not Found 62991200702 20 29
Patient R 765432 Not Found 62991146004 1 29
Patient R 765432 Hydrocodone bitartrate / 0 62991140604 12 29
Patient R 765431 Not Found 62991145404 1 29
Patient R 765431 Not Found 62991200702 26 29
Patient R 765431 Capsaicin / 95% 62991201702 1 29
Patient R 765431 Hydrocodone bitartrate / 0 62991140604 6 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
PMP Data: CapsulesPatient RX
NumberDrug NDC QTY Days
Supply
Patient R 765432 Capsaicin / 95% 62991201702 1 29
Patient R 765432 Not Found (Microcellulose) 62991200702 20 29
Patient R 765432 Not Found (Food Coloring) 62991146004 1 29
Patient R 765432 Hydrocodone bitartrate / 0 62991140604 12 29
Patient R 765431 Not Found (Food Coloring) 62991145404 1 29
Patient R 765431 Not Found (Microcellulose) 62991200702 26 29
Patient R 765431 Capsaicin / 95% 62991201702 1 29
Patient R 765431 Hydrocodone bitartrate / 0 62991140604 6 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]