Hidden Challenges to Achieving Desired Patient Outcomes

Transcription

1 Hidden Challenges to Achieving Desired Patient Outcomes Breaches to supply chain integrity are converting medicines into lethal doses Ron Guido CEO, ExxPharma Therapeutics, LLC President, LifeCare Services, LLC RxAdherence2015 Florham Park, NJ March 31, 2015

2 The U.S. Pharmaceutical Supply Chain Originally designed for: Speed of delivery & inventory pass-through Coverage of all major distribution points Compliant handling and storage Financial considerations NOT designed for: Integrity of supply Complexity of health care operations & delivery Business intelligence Optimal performance Compliant use

3 The Pharma Supply Chain is so complex...it has become a Network and suffers from lack of real time intelligence Manufacturer Authorized Distribution Partners Secondary Distributors/Repackers Multiple Providers Hospital Pharmacy Sell Out information from ADR s informs replenishment Nursing Home Increasing Visibility & Control Decreasing Visibility & Control The Supply Chain has Become a Network from sourcing to patients

4 Supply Chain Vulnerabilities 1. Lack of control throughout the supply chain 2. Lack of visibility into product flow 3. Distributor non-compliance 4. Reverse logistics 5. Cargo theft 6. Pricing arbitrage/diversion 7. Repackaging from original containers & labeling 8. Uncoordinated incident investigations 9. Internet lack of regulations & unknown sources of supply 10.Inventory flow asynchronous to financial transactions

5 Hidden Challenges to Compliance 1 2 Counterfeit drugs (or authentic drugs that are mishandled by unauthorized resellers) have detrimental effects on patients. Drugs not fully protected by abuse deterrence formulations (ADF) have detrimental effects on non-prescribed and noncompliant users.

6 Challenge #1 Counterfeits Counterfeiters and diverters are profiting from lack of control and end-to-end visibility of the current supply chain, resulting in: Patient risks (safety & outcomes) Business risks Loss of revenue for all legitimate players Inventory & financial mismanagement Other liabilities (recalls, returns, expirations)

7 The Global Counterfeit Drug Problem Counterfeiting is a large and growing business 10% of total world trade is counterfeit; $700B in 14; growing 20% p.a. Drugs & medical devices- 3 rd most counterfeited category The WHO estimates that 8-10% of the world s drug supply is fake (~ $80B) Diversion enables counterfeiters Diversion is how counterfeits are inserted into legitimate channels Diverters are not motivated by patient outcomes; improper handling/storage Contributing Factors to illicit trade Globalization of commerce Capitalization of emerging markets China has become the World s Factory High reward to risk ratio Lack of visibility and control throughout the supply chain

8 The Counterfeiters View of the Pharmaceuticals Supply Network

9 Supply Chain Realization* Logistics security & compliance are just as important to outcomes as prescribing and dispensing *Reference F.A.A. rules

10 Serialization Realization The pharma industry can no longer afford to employ the bucket brigade approach to shipping costly and potentially dangerous drugs. What do you see?

11 But Wait DQSA Serialization Will Resolve These Issues, Right? WRONG! Implementation timelines (2017, 2023) are disappointing Track & Trace has become Trace only E-pedigree has become transaction history Past U.S. tragedies of Avastin TM and heparin would have gone undetected by DQSA Interoperable system among trading partners not required real time intercepts unlikely

12 Comprehensive Approach to Supply Integrity People Processes Technology Organizational Commitment Suppliers Authentication Capabilities & Competencies Manufacturing Track & Trace Enforcement & Prevention Distribution Complementary Technologies Interactive Cross Industry & Public Sector Collaboration

13 Framework for Product Protection Is the product and packaging genuine? Safe & Secure Supply Chain Is the chain of custody intact? Product Authentication Product Movement Product Identity Physical Features Track Trace Point Authentication Flow Visibility

14 Anti-Counterfeiting Technologies 1. Overt/Covert Packaging Markings 2. Unique Identifier Serialization- Unit of Sale 3. Package Insert Couponing 4. Website-based Package Verification 5. Mobile Phone Authentication 6. Dose Formulation Authentication 7. Dose Spectral Fingerprinting 8. Covert Tracking Devices It may seem like a boatload, but we re going to need a bigger boat

15 Supply Chain Integrity Requires Technology Adoption Serialization and track & trace with field authentication systems 2. Track & Trace Solution Integrated Technology 1. Serialization 3. Authentication

16 Track & Trace Business Benefits 1. True Demand Sensing 2. Inventory Optimization 3. Management of Returns 4. Management of Recalls 5. Isolation of Stolen Cargo 6. New Product Tracking 7. Expiry Date Tracking 8. Reduction of Diversion 9. Reduction of Shortages 10. POS Pricing Accuracy New Business Model for Trading Prescription Drugs: Payments between trading partners and inventory transfer records are triggered simultaneously by the act of scanning serialized bar codes as proof of safe passage. Serial numbers become the new currency of the industry.

17 Solving Challenge No.1 Strategies to Achieve Supply Integrity 1. Implement best practices and multi-layered anticounterfeiting technologies on dose and packaging 2. Utilize industry alliances and public outreach programs, to influence laws and stricter regulations 3. Evolve from market surveillance to business intelligence through supply-demand & trade analytics 4. Implement track & trace systems for increased inventory control and to gain operational benefits 5. Adopt brand protection discipline- shift from mindset of tactical incident responses to preventive measures No tolerance policy for counterfeiters and illegal diverters

18 Hidden Challenges to Compliance 1 2 Counterfeit drugs (or authentic drugs that are mishandled by unauthorized resellers) have detrimental effects on patients. Drugs not fully protected by abuse deterrence formulations (ADF) have detrimental effects on non-prescribed and noncompliant users.

19 Challenge #2 Opioid Drug Abuse There is a serious and growing health epidemic in the U.S., and paradoxically, an entire industry designed to alleviate the burden of illness is contributing to the problem. Last year, overdoses of prescription painkillers killed more than 17,000 people in the U.S. This is more than 4X the 1999 total. Forty-six will die today! More people die from prescription painkiller overdoses than from heroin and cocaine combined.

20 The Need for Abuse Deterrence Approx.164 million patients/year visit the doctor office for pain of which 20% receive opiate prescriptions for pain treatment. The number of opiate prescriptions has been steadily increasing since 1991 to 260 million in one for each adult! For compliant users, pain meds are a blessing. However, indiscriminate prescribing and over-use leads to abuse and dependency.

21 Abuse Deterrence Formulation Regulations The FDA, under pressure from legislators and drug safety advocates, has set category guidelines for abuse deterrence formulations: I. Laboratory Manipulation and Extraction Studies II. Pharmacokinetic Studies (T max, C max, AUC, T 1/2 ) III. Clinical Abuse Potential Studies IV. Post-marketing Study Unfortunately, these guidelines are not imperatives, label claims are unclear and the cost of proof is measured in $MM and years.

22 Not to be Discouraged Pain drug manufacturers and ADF companies are pursuing new formulations to deter four common (manipulative) methods of abuse Crush & snort Crush, dissolve & inject Crush & smoke Crush & swallow

23 The Fifth Dimension Multiple Tablet Ingestion While most of the work to date has been focused on changing the physical or chemical properties of the pill, including adding antagonists, the most common route of abuse remains at large These technologies have not yet proven successful at deterring the most common form of abuse swallowing a number of intact pills * Some ADF companies have aggressively accepted the challenge to reduce overdosing via GI tract. * FDA Guidance for Industry Abuse-Deterrent Opioids- Evaluation and Labeling January 2013

24 Solving Challenge No. 2 Strategies to Deter Drug Abuse 1. Implement conscientious best practices from prescriber to pharmacist to payer to patient 2. Lobby for strict state and federal laws and regulations 3. Require track & trace packaging on all dispensing forms 4. Revise the release profile and max dosing parameters on the most abused opioids. 5. Develop alternate therapies for treating advanced pain. Remove opioids from some post-op protocols. 6. Increase awareness/education among all age groups. No tolerance for unaccountable prescribing and misuse/abuse

25 Questions? Thank You