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Expecting The Worst: WDSrx Disaster Planning Sustains Pharmaceutical Supply Chain During Business Disruptions

Pharmaceutical warehouses implement procedures to maintain operations in disaster situations.

 

The 6.4 and 7.1 magnitude earthquakes that struck California over Independence Day week felt “like you were in a boat,” according to a first-hand account from a witness in Los Angeles.  Despite the potential destruction of earthquakes, floods are the most common and destructive natural hazard, causing over $40 billion in damages annually in the United States.

Businesses can minimize revenue loss after disruptions with a comprehensive Disaster Recovery Plan.

Based in Florida with seven facilities across Florida, New Jersey, Ohio and Texas, WDSrx – Woodfield Distribution, LLC is a pharmaceutical logistics services provider entrusted with the safe and efficient movement of medications from manufacturers to patients.  Due to their important role within the healthcare supply chain, government regulations require the company to maintain a current Disaster Recovery Plan that helps assure business continuity.

 

Planning Eliminates Surprises

Unlike many people and businesses that may gather supplies only after learning of an impending storm, WDSrx regularly anticipates disaster scenarios and is fully prepared when the situation arises.

Guidelines about preparation for and recovery from a disaster are detailed in a document called a Business Continuity Plan, or BC plan. At WDSrx, the Business Continuity Plan specifies procedures to remain functional during and after a disaster. The BC plan focuses on how resources are allocated according to predetermined priorities so that operations continue with minimal disruption.

The Disaster Recovery (DR) plan is an important part of the Business Continuity plan providing a road map to secure systems and data during normal operational periods and in times of disaster. There are federal and state requirements for businesses to create and regularly test their DR plan. Companies including WDSrx that operate within the pharmaceutical supply chain must comply with more rigorous standards compared with companies in other industries. For example, additional safeguards must be in place to maintain patient data privacy according to regulations in the Health Insurance Portability and Accountability Act (HIPAA).

According to WDSrx President Adam Runsdorf, “Disaster planning demands significant human and financial resources to fully comply with rigorous guidelines to maintain connections between our clients, trading partners and patients.”

 

Government Standards for Healthcare Preparedness

Federal regulations governing operating procedures for pharmaceutical-grade warehouses demand special consideration beyond HIPAA compliance. The Code of Federal Regulations (21 CFR 11) requires WDSrx to implement controls for software and systems involved in processing electronic data that is shared with government agencies including the U.S. Food and Drug Administration (FDA).  The DR plan must adhere to the same rules.

 

The Disaster Plan

Most Disaster Recovery plans include two major sections.  The initial section specifies the current human and physical resources that are covered in the plan.  The second component describes the environment necessary to continue and re-establish operations.

 

Resources

It may seem obvious, however the most important resources in any company are the people that work in it.  A current list of employees including all relevant contact information helps everyone establish contact with each other when transportation and communication are affected or if office locations are closed.  The contact list is a component of a larger communications plan that delegates team members to perform tasks that support the recovery protocols.  Damage may need to be assessed, clean-up may be required, people will need guidance and direction, lines of communication may need to be opened and other actions performed to jump-start operations.

 

Equipment and Machinery

Similar to keeping a current contact list of personnel, the DR plan also mandates a precise inventory of all equipment and machinery utilized on a daily basis.  Photographs of all items are useful for insurance purposes. They also can be used as a visual guide to re-connect computer components including power cords, cables, connectors and accessories post-disaster when experienced personnel are unavailable or otherwise occupied.

 

Technology assets including hardware and software must be inventoried and tested to prepare for natural disasters.

 

Information Flow

Companies involved in the pharmaceutical supply chain are required by Federal and State regulatory authorities to regularly examine and improve procedures required to re-establish business operations as quickly as possible after a disaster.  Access to data and documents is an important component of disaster planning.  The ability to access archived information and generate new data after a disaster is of vital importance.

Property damage may prohibit entry into office locations.  Employees may need to move to new office locations or work remotely from home.  Computer hardware and software may differ from previously used technology.  Methods used to transmit and store information must be established.  Either experienced in-house technology professionals or outsourced companies must be included in disaster planning to prepare for post-disaster information recovery and data transmission.

Rob Gerstein, WDSrx Vice President, emphasizes that “Our facilities are regularly audited by regulatory authorities and clients so it is important that all documentation is current and accurate including our Disaster Recovery plan and business continuity strategy.”

Every business must guard against unauthorized access to computer networks from ransomware, malware and other cybercrimes. In a disaster scenario, protections preventing illegal incursions may be compromised. The ability of any business to regain operations depends on the integrity of the data.

Electronically-stored information must be continuously protected prior to disaster so that the same data can be accessed during recovery. Options include creating regular back-ups of relevant digital files, mirroring all data on multiple servers, managing back-ups in the cloud and on hard drives and contracting for duplication of data at off-site remote locations to be accessed when primary systems fail.

Information in WDSrx computer systems is transmitted between clients, trading partners, state and federal government authorities.  “We are required by law to maintain extensive archives of historic data,” states Gerstein.  “As our disaster recovery protocols are regularly reviewed, we recently strengthened our data security by adding an off-site back-up location with full power redundancy and other safeguards.”  This technical upgrade will help assure continuous access to vital information when the need arises.

 

Vendor Communication

Businesses cooperate with many other companies that support their operations.  A viable Business Continuity plan depends on the ability of key vendors to perform in a post-disaster scenario.

Procedures must be put in place in advance to open channels of communication when required. In certain cases, business relationships require the existence of a Disaster Recovery plan for key vendors to avoid unnecessary delay in ramping up operations in disaster situations.

For example, deliveries of items may need to be accelerated from key vendors prior to a forecast serious weather event in order to compensate for potential service disruptions.  Alternative methods of communication including cell numbers of employees at key vendors will help to maintain information flow.  Pre-disaster arrangements for delivery of redundant power sources will maintain operations under adverse circumstances.

WDSrx benefits from active outreach and communication with local, regional and national government and public/private organizations that help direct recovery efforts and act as a communication channel providing information and assistance in disaster situations.  These organizations include the Palm Beach County Office of Resilience; the Business Development Board of Palm Beach County; the United States Senate Committee on Health, Education, Labor and Pensions; the United States House of Representatives Subcommittee on Health; Healthcare Ready and the Office of the Assistant Secretary for Preparedness and Response, Critical Infrastructure Protection in the U.S. Department of Health and Human Services.

 

Open communication with government and regulatory authorities is an important component of a comprehensive Disaster Recovery plan. From left: WDSrx Business Development Manager Samuel Seelenfreund; Senator Richard Burr (R-NC); Representative Gene Green (D-TX-29th) and WDSrx Marketing Director Larry Hotz.

 

Conclusion

Businesses have a responsibility to anticipate sources of commercial disruption and develop plans to overcome adverse situations.  Without a well-planned Business Continuity program, companies risk financial uncertainty after a crisis that may trigger additional serious consequences.  By law, WDSrx and other organizations operating within the healthcare industry, must review disaster plans regularly to assure procedures are current and that recovery scenarios are fully tested.

The WDSrx Disaster Recovery plan involves every aspect of the business including employees, workplace locations, equipment, machinery, technology assets, product inventory, key vendors, utilities including power sources and communication channels. A regularly updated and tested Disaster Recovery plan prepares companies prior to a forecast weather event or unanticipated crisis and sets the stage for an organized, safe and efficient return to operations as soon as possible during the recovery period.

For further information contact Larry Hotz, lhotz@wdsrx.com or 561-998-3885 x304

Are any Controlled Substances (CII) included in your return? If so, please press "Yes" and complete the DEA 222 Request Form. You can also contact Jason Solomon at jsolomon@wdsrx.com or (561) 998-3885 x316.