Protecting the Pharmaceutical Supply Chain

Aug. 1, 2008

Ensuring an unbroken supply of pharmaceuticals can save lives during times of disaster.

Health information executives have a moral imperative to lead our nation in ensuring individuals have access to essential prescription drugs in the aftermath of catastrophes. The potential disaster-related death toll from predicted breaches in the pharmaceutical supply chain is staggering. Tens of millions of lives could be lost as vulnerable populations are cut off from their life-sustaining medications. The remedies are data- and technology-centric, hence the call to action.

Ensuring an unbroken supply of pharmaceuticals can save lives during times of disaster.

Health information executives have a moral imperative to lead our nation in ensuring individuals have access to essential prescription drugs in the aftermath of catastrophes. The potential disaster-related death toll from predicted breaches in the pharmaceutical supply chain is staggering. Tens of millions of lives could be lost as vulnerable populations are cut off from their life-sustaining medications. The remedies are data- and technology-centric, hence the call to action.

Despite witnessing the deadly effects of man-made and natural catastrophes, emergency preparedness experts have not yet made sufficient progress in protecting access to one of the nation’s most critical public health resources — prescription medications.

The risk of lost lives is exacerbated in times of disaster by (1) individuals’ physical separation from their medications and inadequate medicine cabinet inventories, (2) inaccessible medication histories and medical records, and (3) the absence of community-centric demand forecasts that could identify needed types and volumes of medications pending distributions from the Strategic National Stockpile. Physically, socio-economically, and geographically-challenged populations are especially susceptible to breached medication access.

While disaster planners are sensitized to pandemic-related medication needs, many have not considered daily medication needs that could lead to deaths if their fulfillment is somehow compromised. Few planners have prioritized high-risk subpopulations and high-priority drugs, created community-centric and catastrophe-specific formularies, or finalized plans for rapid deployment of essential medications in the critical hours immediately following a disaster.

Community-centric Demand Forecasting

Fortunately, community-centric demand forecasting is within reach. However, different stakeholders hold different pieces of the medication demand forecasting puzzle: Actuaries and public health officials track disease incidence and prevalence; The biopharmaceutical sector tracks prescribing and dispensing patterns; the U.S. Census Bureau tracks neighborhood-specific socio-demographics; providers and health plans track healthcare access patterns; and, health information exchanges (HIE) offer centralized data repositories, advanced analytics and forecasting capabilities.

While the lack of agreement around unique identifiers for supply chain inputs, processes and outputs remains a barrier to effective disaster response, the leadership of today’s health information executives could help remedy this.

Putting these puzzle pieces together, we can quantify lives at risk and generally estimate comparative times to death by subpopulation and prescription dependency. We can prioritize remedies accordingly (e.g., building catastrophe-specific drug formularies and instituting emergency production, distribution and inventory management contracts).

Mobile Pharmacies

Once high-priority medications and their recipients are identified, medications must be made accessible. This is where mobile pharmacies come in. Mobile pharmacies are portable, self-contained storage and dispensing sites that are prestocked with medications from catastrophe-specific formularies and made ready for deployment to disaster zones via land, air or sea. They are connected to information sources (e.g., via satellite) as dictated by a community’s geographic characteristics.

Most of the physical, telecom and information management technologies essential to mobile pharmacies exist. They simply need to be integrated into catastrophe-ready systems.

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For example, medication and medical histories must be made accessible to qualified providers in mobile pharmacies. This will depend on communities establishing and linking in electronic health records (EHR) or related e-health content sources such as: personal health records; electronic medical records; electronic disability records; medication administration records; and, e-prescribing systems.

Means of verifying prescriptions, dispensing appropriate medications, and documenting those actions are essential, as are unique identifiers, such as RFID tags that support inventory management to the unit-dose level. Prescription and dispensing data must be instantaneously secured and synchronized across pharmacies, pharmacy benefit management companies and emergency data services, such as ICERx.org and Emergency Rx History.

Interoperability must be established between pharmacy, e-prescribing, clinical decision support and supply chain management systems (e.g., to avoid inventory stock outs and life-threatening dispensing errors).

Re-Targeting Clinical Applications

A community-centric perspective is essential to remedying catastrophe-induced breaches in the pharmaceutical supply chain. Existing clinical and enterprise management applications can be re-purposed with this perspective.

For example, prior to the 2004 and 2005 hurricane seasons, eMPOWERx was used by Florida and Mississippi Medicaid programs (respectively) to deliver medication histories and drug safety information to physicians at the point of care. Post-catastrophe, authorities realized this application could help hurricane survivors get life-saving medications more quickly. Working with a broad range of emergency response and health industry stakeholders, Informed Decisions collaborated in the development of an enhanced front-end for its eMPOWERx solution. The resulting HIPAA-compliant Web-based graphical user interface (GUI), dubbed KatrinaHealth.org, enabled e-prescribing and allowed authorized users in shelters, pharmacies and healthcare facilities to access medication histories and clinical decision support tools.

Despite witnessing the deadly effects of man-made and natural catastrophes, emergency preparedness experts have not yet made sufficient progress in protecting access to one of the nation’s most critical public health resources — prescription medications.

Originating in the emergency medical services arena, MyVitalData focused on reducing certain risks associated with individual health crises (e.g., strokes). This application tethered medication and medical history records to emergency departments (ED), giving paramedics and EDs life-saving information at the point of care. As the application’s developers became more familiar with catastrophe-related issues, they ensured MyVitalData could not only identify the medication needs of entire communities, but also automatically alert next of kin and other emergency contacts when a catastrophe survivor received care of any kind. Though not yet catastrophe-tested, this solution shows promise in delivering individual and communitywide medication histories to authorized personnel and in preventing vulnerable disaster survivors from being treated in isolation.

As clinical applications evolve in the direction of community health informatics, they offer increasingly intuitive GUIs, more accommodating data fields, and richer content. They also begin to offer disaster-specific functionalities (e.g., identifying drugs by visual appearance alone; capsule versus tablet, color, shape, imprints and markings).

While disaster planners are sensitized to pandemic-related medication needs, many have not considered daily medication needs that could lead to deaths if their fulfillment is somehow compromised.

Governing bodies for system deployment are evolving in step. For example, KatrinaHealth.org evolved into ICERx.org, an enhanced service with the ability to be activated in response to any disaster anywhere in the country. When an emergency is declared, data flow is initiated, and ICERx.org securely channels information between information providers, including SureScripts, RxHub participating payers, state Medicaids and other government agencies, and specially registered providers caring for evacuees. Reflecting lessons from hurricane Katrina, ICERx.org was successfully activated to serve an estimated 500,000 evacuees during the October 2007 California wildfires. New lessons are already informing the next phase of governance and system improvements.

The Missing Element

Great progress continues to be made toward community health informatics systems that remedy threatened disruptions in the pharmaceutical supply chain. However, while most technologies essential to ensuring access to life-saving medications are widely available and just not yet sufficiently deployed, health-related data standards remain elusive. The country has not yet settled on a way to uniquely identify the “who, what, when, where, why and how” of supply chain management. Without these identifiers, databases across the pharmaceutical supply chain cannot be instantaneously and properly synchronized, making coordinated supply chain and clinical management impossible.

To remedy this, a catastrophe-preparedness and response value chain must be documented and used to identify essential information and resource flows, with emphasis on points of data exchange.

For example, when a unit dose is delivered to a patient, instantaneous updates should go to: the manufacturer that will produce the replacement for that unit dose; the distributors who will pick it up; the warehouses that will store it; the emergency management authorities who will monitor its delivery; and, the providers who might inadvertently dispense duplicate doses.

On the human side, the absence of a unique patient identifier (e.g., a national patient identifier) could lead to errors when patients with similar names have markedly different medication histories and needs. Master patient indices under development by many regional health information organizations and HIEs are a step in the right direction, as are efforts by The Office of the National Coordinator for Health Information Technology (ONC) to promulgate relevant use cases, such as ONC’s “Emergency Responder Electronic Health Record Detailed Use Case.”

While the lack of agreement around unique identifiers for supply chain inputs, processes and outputs remains a barrier to effective disaster response, today’s health information executives could help remedy this.

Most data and technologies necessary to prevent life-threatening breaches in the pharmaceutical supply chain in times of man-made or natural disaster already exist. Still required, is foresight and cooperation among the healthcare industry’s stakeholders, as well as a coordinated effort to implement essential health-related data standards that support the supply chain, mobile pharmacies and EHRs.

Forward-thinking initiatives related to the pharmaceutical supply chain could remedy potential breaches and sustain medication-dependent individuals in times of catastrophe. In each of our communities, lives hang in the balance.

Synthia Laura Molina (left) is managing partner and Helen L. Figge, Pharm.D., is a consultant with Central IQ, Tampa, Fla.

Contact them at [email protected]  and [email protected].

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