• August 2008 FEATURE ARTICLES •
Supply Chain/Materials Management
Protecting the Pharmaceutical Supply Chain
Ensuring an unbroken supply of pharmaceuticals can save lives during times of disaster.
By Synthia Laura Molina and Helen L. Figge
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.
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
synthia.molina@centraliq.com and
helen.figge@centraliq.com.