• UHG shared that they have competed testing on an e-prescribing system and that system is now available, as of 11 am PST on Friday, March 1. Further WSPA has confirmed pharmacies are receiving prescriptions.
• UGH announced that next week, the week of March 4, 2024, they will share a timeline for getting the Change Healthcare's pharmacy claims processing switch will be back up.
• This system will be leveraging cloud-based transaction processing, which was partially used in prior operations. It is now being scaled to get claims processing back online.
• The Washington Healthcare Authority's Array Rx Discount Card is functioning and is an available alternative to other discount cards for Washington State Residents. 
• UGH emphasized that fraudsters utilize situations like this to take advantage of other players in the system. Be sure to be extra vigilant at this time regarding your own cybersecurity. Be skeptical of communications regarding your bank account or other sensitive information. 
• More information regarding the UGH response will be shared at https://www.unitedhealthgroup.com/changehealthcarecyberresponse.
  
  

To help manage this emergency, WSPA CEO Jenny Arnold has asked Healthcare Ready to activate the RX Open system to track which pharmacies can process prescriptions and receive e-prescriptions. Healthcare Ready has agreed with the request and is working to activate the RX Open system nationwide. Pharmacies will then be able to indicate in real time their capabilities. 

Also, while Washington State Law RCW 69.50.312 requires that Schedule II-V medications be e-prescribed; the law also states that prescriptions are exempted from the requirement under 2(c) "when the electronic system used for the communication of prescription information is unavailable due to a temporary technological or electronic failure." Therefore pharmacies may accept written, faxed or verbal controlled substance prescriptions while this outage continues. 

Thank you to all our pharmacy professionals working to make sure patients receive their medications, while ensuring pharmacies remain financially viable during this time. Please reach out to WSPA with other ideas to support our communities. 

WSPA will continue to seek out resources to help our pharmacy community. 

The Federal Trade Commission announced that it will ramp up enforcement against any illegal bribes and rebate schemes that block patients’ access to competing lower-cost drugs. The enforcement policy statement issued today puts drug companies and prescription drug middlemen on notice that paying rebates and fees to exclude competitors offering lower-cost drug alternatives can violate competition and consumer protection laws.  The agency will use its full range of legal authorities to combat illegal prescription drug practices that foreclose competition and harm patients.

Read Announcement

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June 7, 2022

FTC Launches Inquiry Into Prescription Drug Middlemen Industry
Agency to Scrutinize the Impact of Vertically Integrated Pharmacy Benefit Managers on the Access and Affordability of Medicine

The Federal Trade Commission announced today that it will launch an inquiry into the prescription drug middleman industry, requiring the six largest pharmacy benefit managers to provide information and records regarding their business practices. The agency’s inquiry will scrutinize the impact of vertically integrated pharmacy benefit managers on the access and affordability of prescription drugs. As part of this inquiry, the FTC will send compulsory orders to CVS Caremark; Express Scripts, Inc.; OptumRx, Inc.; Humana Inc.; Prime Therapeutics LLC; and MedImpact Healthcare Systems, Inc.

Read Release

The results of this national state-based survey will provide the WSPA the data that is needed to learn how state laws and regulations, along with pharmacy policies and procedures, may be added stressors in the work life of pharmacy personnel that may lead to patient safety issues.

We have heard pharmacists are reluctant to discuss workplace issues for fear of retaliation from their employers. This survey gives you that opportunity because it is 100% anonymous. The WSPA will not have access to your responses. Your individual survey response will be included in a nationwide database that will be held centrally and confidentially.  The WSPA will be provided only aggregated data.

Join with your pharmacy colleagues from across the country and make history by participating in the first of its kind national state-based pharmacy workplace survey. Just 10 minutes of your time is all that is needed to complete the survey at Pharmacy Workplace Survey.

The WSPA is excited to be a part of this national collaboration and we thank you for your consideration and participation.

Thank you to ASHP for coordinating this letter, and all the other Associations and Organizations that lent their voices to this important cause. 

Further questions can be directed to Jenny Arnold, CEO of WSPA jenny@wsparx.org

Today the Supreme Court upheld Arkansas Act 900.  The Act regulates how Pharmacy Benefit Managers reimburse pharmacies for the cost of drugs. In the Rutledge v. Pharmaceutical Care Management Association Case the Court was asked whether the Federal ERISA pre-empts Act 900. "The Court holds that the Act has neither an impermissible connection with nor reference to ERICA and is therefore not pre-empted."

Justice Sotomayor delivered the opinion of the court which voted 8-0 to uphold the Act. 

This is important to Washington's own PBM regulations, which may have been challenged depending on the results of this ruling. The final hearing for the most recent rules regulating PBMs and Health Benefit Managers in Washington was yesterday afternoon. The WSPA and members delivered comments at the hearing.  

• This declaration applies to patients 3-18 years old. A CDTA will still be required for adult immunizations. However this consistent age limit will help with patient communications. 
• Pharmacists are required to have a 20 hr CE training. WSPA's training is 17 hours, however we will be publishing a brief update that will explore childhood immunizations in more details, as well as injection tips and tricks for kids and an update of adult immunizations - stay tuned!
• Interns working under the delegation of a pharmacist were included in the declaration, provided they have received training.
• A 2 hour CE refresher is required each licensing renewal cycle. The WSPA training mentioned above will meet this requirement. 
• Some insurance companies require patients to get vaccines at sites that provide vaccines through the at sites that offer vaccines from the Washington Childhood Vaccine Program, and others will pay for vaccines at any location, including pharmacies. The Washington State Childhood Vaccine Program works in conjunction with the CDC's Vaccines for Children Program to purchase vaccine for all Washington's children and distribute them at no cost to enrolled providers to administer. Most pharmacies are not enrolled in this program, but are welcome to join! Providers can bill for administration.  If you are interested in enrolling your pharmacy in the Vaccines for Adults program, please contact Jenny Arnold jenny@wsparx.org to be connected. 
• The ability of technicians to administer vaccines was also mentioned in the full declaration. 

As an affiliate and member of our national pharmacy organization partners, the WSPA supports this important statement:

  
National Pharmacy Organizations Unite to Take a Stand Against Racial Injustice
  
"As pharmacists, we took an oath that includes, as its first statement, “I will consider the welfare of humanity and relief of suffering my primary concerns.” Humanity includes all people, and we have the responsibility in this country to care for those who are disproportionately suffering. As health care professionals, we are trained to provide the best care to all and to “advocate for change that improves patient care.” Advocating against racism, all forms of discrimination and injustice can improve patient care. This is an urgent priority."
  
View the joint statement here.

On March 10, 2020, the United States Department of Health and Human Services issued a declaration under the Public Readiness and Emergency Preparedness Act (PREP Act), providing guidance authorizing licensed pharmacists to order and administer COVID-19 tests, including serology tests, including serology tests, that the Food and Drug Administration (FDA) has authorized. By doing so, such pharmacists will qualify as “covered persons” under the PREP Act. And they may receive immunity under the PREP Act with respect to all claims for loss caused by, arising out of, relating to, or resulting from, the administration or use of FDA-authorized COVID-19 tests. Declaration 

WSPA COVID-19 News and Resource Page 

Shining the Light on PBMs
Study Highlights Predatory Practices by Pharmacy Benefit Managers

BACKGROUND

TALLAHASSEE – Legislators and advocates for reducing costs and improving access to prescription drugs today hailed a new independent study documenting that Pharmacy Benefit Managers (PBMs) have pocketed millions of dollars from the Florida Medicaid system – funds that should have been directed toward health care for millions of low-income residents.
The study, commissioned by the Florida Pharmacy Association and American Pharmacy Cooperative Inc. with data obtained from the Agency for Health Care Administration (AHCA) by the Small Business Pharmacies Aligned for Reform (SPAR), highlights the predatory nature of a handful of vertically integrated PBMs and managed care organizations (MCOs). Legislation reforming Florida’s broken PBM system is supported by numerous other organizations, including Florida Society of Rheumatology, Florida Society of Clinical Oncology and others.
Sen. Gayle Harrell and Rep. Jackie Toledo, who have each filed legislation to rein in predatory PBMs, underscored the need for greater transparency and oversight when it comes to PBMs’ role in Florida.  Bills have also been filed by Senator Tom Wright and Senator José Javier addressing PBM issues.
“Pharmacists and communities have suffered under the rule of the PBM industry for years,” said Michael Jackson, Executive Vice President and CEO of the Florida Pharmacy Association. “The PBM industry has been given a license to operate unchecked under a cloak of secrecy and it is long past time for health care to work for Floridians -- not profit-driven pharmaceutical middlemen.”
The study provides concrete evidence that PBMs use a process called “steering” to direct patients to their affiliated pharmacies by requiring that insurance plans cover certain medications only if the prescriptions are filled at those specific pharmacies. These anti-competitive actions by the PBMs restrict consumer access to the pharmacies of their choice and result in higher medication costs. Then, PBMs profit from the higher reimbursements paid to those pharmacies and end up driving neighborhood pharmacies out of business.
Over the past three years, the number of independent pharmacists in Florida has decreased by 15% and it continues to drop due to a business and regulatory climate that short-circuits the free market and allows a handful of PBMs and MCOs to control the market.
The independent study by 3 Axis Advisors reviewed more than 359 million prescription drug claims within Florida’s Medicaid program between 2012 and 2019. The information from AHCA was coupled with data from more than 100 pharmacies to determine the impact PBMs have on the portion of the health care system paid by Florida taxpayers through the Medicaid program.
The firm has previously evaluated the structure of PBMs in New York, Illinois, Michigan, Ohio, Kentucky, Georgia, Virginia, and Maryland.
“Our team has analyzed drug pricing data in numerous other states, but this study is more exhaustive and comprehensive than any we’ve ever produced. The sheer volume of claims analyzed provides an unprecedented view behind the shadowy curtain of pricing in the prescription drug supply chain,” said Antonio Ciaccia, co-founder of 3 Axis Advisors. “The implications outlined in this study show some extremely concerning trends that highlight the warped incentives, pricing distortions, and conflicts of interest currently embedded in state Medicaid programs. While this analysis is focused on the Florida managed care and PBM experience, this report is an alarm bell for state and federal officials across the country that reveals there’s much more to prescription drug costs than meets the eye.”

3AA Data Analysis Study on Drug Costs and PBMs

Executive Summary

University of Washington School of Pharmacy Professor Don Downing, RPh has long been an advocate for pharmacists provision of patient care services. His recent work with the Lown Institute helped them rethink the role of pharmacists helping elderly patients with medication overload, Read their recent white paper on Medication Overload and Older Americans His Op-Ed was published in The Hill, a daily newspaper that targets political and administrative staff in Washington DC, to shed light on pharmacists as a solution to Medicare patient care and cost increases. Read Downing's Op-Ed

Our profession has responded! Taking the opportunity to describe the changed needed to improve Medicare and Medicaid patient access to care provided by pharmacists. The WSPA worked with the National Association of State Pharmacy Associations and our affiliate national associations APhA, ASHP, and NCPA to submit a Joint Pharmacy Comment Letter. Many WSPA members submitted individual comment letters and the association submitted a WSPA Comment Letter.

Thank you to everyone who took the time to comment on the need for CMS to recognize state variances in healthcare provider scope of practice!  

The WSPA Board of Directors has voted to sign on to the joint pharmacy amici brief. The case will be heard and decided by June 30th, 2020 with a proposed hearing in mid April. 

“We received stakeholder input from the pharmacy community that motivated us to develop specialized and advanced credentials to allow Certified Pharmacy Technicians to demonstrate their knowledge and skills in certain areas of practice,” said William Schimmel, PTCB Executive Director and CEO. “Qualified pharmacy technicians play a critical role in medication safety in every aspect of pharmacy care across all practice settings. Recognizing them for their advanced responsibilities rewards their dedication to patient care, improves efficiency, and reinforces safe medication practices.”

Technicians who earn the TPV Certificate demonstrate the knowledge and skill necessary to perform the final check of medications dispensed by pharmacists, technicians, or automated systems to confirm accuracy of the product name, strength, and quantity, and the integrity of packaging, expiration date, and other characteristics. Multiple studies, including research from the University of Tennessee*, show technician verification is as accurate or more accurate than the same work done by pharmacists, and can improve efficiency and advance patient care. Candidates for the PTCB TPV Exam must be PTCB Certified Pharmacy Technicians (CPhTs) who have completed either a PTCB-Recognized TPV Education/Training Program or a state board of pharmacy-approved validation program.

“We know technicians do excellent work in product verification based on data, and they are already conducting TPV in states across the country,” said David Bright, PharmD, MBA, BCACP, Associate Professor, Department of Pharmaceutical Sciences at Ferris State University College of Pharmacy, Big Rapids, MI, and Immediate-Past President of PTCB’s Certification Council. “When qualified technicians handle final checks of medications, the pharmacy team can become more efficient and pharmacists can focus on direct patient care to a greater degree.”

The Medication History Certificate Program assesses a technician’s knowledge of medication history procedures, medical terminology, error types -- such as abnormal doses -- and patient safety strategies. By completing the program, technicians demonstrate they can conduct accurate in-depth reviews of patient histories and identify potential errors. To be eligible to take PTCB’s Medication History Exam, a CPhT must complete a PTCB-Recognized Medication History Education/Training Program along with 6 months of relevant work experience, or have one year of experience.

Miranda Peek, CPhT, is Hospital Pharmacy Clinical Manager for Gundersen Health System in La Crosse, WI. “The scope of pharmacy technician responsibilities continues to expand and PTCB’s new credentials provide great opportunities for technicians to function at a higher level of practice,” Peek said. “Earning the certificates is a way for me and other CPhTs to advance professionally and build our careers, and the achievement will enhance our entire team’s focus on safety.”

Meghan D. Swarthout, PharmD, MBA, BCPS, Division Director of Ambulatory and Care Transitions in the Department of Pharmacy at The Johns Hopkins Health System noted that PTCB’s certificate programs can serve as tools for employers to build their pharmacy teams with confidence. “The new programs support technician career pathways, and recognize technicians for their important work,” said Swarthout. “Recognition motivates pharmacy team members to remain committed to excellence in patient safety. The new certificates are a way employers can identify and attract the most qualified, dedicated, and career-oriented technicians.”

PTCB plans to launch its Hazardous Drug Management Certificate Program in late 2019, followed by certificate programs in Controlled Substance Diversion Prevention and Billing and Reimbursement in 2020, for a total of five new certificates. Active PTCB CPhTs who have completed at least four certificate programs, including TPV and/or Medication History, or three certificate programs and PTCB’s Compounded Sterile Preparation Technician® (CSPT®) Certification, and 3 years of work experience, will be eligible to earn a CPhT-Adv in the future. 

Technicians can apply for the new certificate programs at ptcb.org/tpv or ptcb.org/medhistory.

On September 23, 2019, USP notified stakeholders that it is postponing the effective dates of published revisions to <795> Pharmaceutical Compounding – Nonsterile Preparations and <797> Pharmaceutical Compounding – Sterile Preparations, as well as a new chapter <825> Radiopharmaceuticals – Preparation, Compounding, Dispensing, and Repackaging.

After publication of the revised and new compounding standards, USP received appeals on certain provisions in <795>, <797>, and <825>.

In accordance with USP’s Bylaws, the responsible Expert Committees worked with a sense of urgency to consider the information raised in the appeals and issued decisions on the appeals (see Decisions on Appeals to USP <795> and <797> and <825>). In accordance with USP’s formal appeals process, stakeholders who submitted appeals on the compounding chapters have requested further review by an appointed Panel.

USP’s Bylaws provide that the official date of a standard under appeal must be postponed while an appeal is pending. Therefore, USP is postponing the official dates of the revised <795> and <797>, and the new general chapter <825> until further notice.

In the interim, the currently official chapters of <795> (last revised in 2014) and <797> (last revised in 2008) including the section Radiopharmaceuticals as CSPs will remain official.

In addition, due to the pending appeals, USP new general chapter <800> (Hazardous Drugs Handling in Healthcare Settings) will remain official. 

General Chapter <800> is not subject to any pending appeals and will become official on December 1, 2019. During the postponement and pending resolution of the appeals of <795> and <797>, <800> is informational and not compendially applicable. USP states that <800> is only informational, will not be applicable until the appeals process is complete and encourages utilization of <800> in the interest of advancing public health.

USP plays no role in enforcement.  State and other regulators may make their own determinations regarding the enforceability of <800>. 

Renton, WA (June 26, 2019) — The Washington State Pharmacy Association is joining the National Community Pharmacists Association in launching "Fix DIR Day" on Thursday, June 27. Pharmacy stakeholders will be mobilizing their legislators in Congress to contact members of the Senate Finance Committee and urge them to protect patient access to local community pharmacies by addressing pharmacy direct and indirect remuneration fees, or pharmacy DIR, in their forthcoming drug pricing package. "Fix DIR Day" will consist of an email campaign and social media outreach.

 “Pharmacy DIR fees are simply unsustainable. As pharmacists care for patients, they don’t truly know if they will be wholly reimbursed for the cost of the providing their patients with needed medications when the prescription is covered by Medicare. They are informed of an amount at the time of dispensing, but long after the patient has left the pharmacy, a portion of that payment is recouped by the plan in the form of a DIR. This uncertainty makes it very difficult to operate community pharmacies which represent the only accessible provider in several counties. This issue must be swiftly resolved by Congress, and we are proud to assist in mobilizing pharmacists to act. We appreciate NCPA’s partnership and leadership as we address this national issue.” Jeff Rochon, Pharm.D., WSPA Chief Executive Officer.

NCPA CEO B. Douglas Hoey, pharmacist, MBA, said, “As the Senate Finance Committee develops its legislation to lower drug costs, community pharmacy and our allies need to keep the pressure on Congress to fix pharmacy DIR. "Fix DIR Day" will remind legislators that, as pharmacy DIR fees have grown increasingly oppressive in the last three years, perhaps as many as 5 percent of all pharmacies including both big chains and regional and community pharmacies have closed their doors. At the same time, millions of seniors have been prematurely pushed into the coverage gap, or ‘donut hole,’ because of pharmacy DIRs artificially inflating the price of their prescriptions at the pharmacy counter. And, billions of taxpayer dollars have been spent on seniors prematurely entering the catastrophic phase where government picks up most of their prescription drug costs. If leaders in Washington truly want to lower drug costs, they must fix pharmacy DIR.”

For more information, visit ncpanet.org/fixdirday.

###

Ensure Senator Cantwell and Senator Murray Hear Us Loud and Clear

The Senate adjourns for its July 4 recess tomorrow, and soon after returning on July 8, the Senate Finance Committee could act on legislation addressing drug pricing. Senator Maria Cantwell is a member of the Senate Finance Committee.

NCPA has declared today “Fix DIR Day.” Before they leave Washington DC, please contact your Senators and remind them to do their part to fix pharmacy DIR fees by voicing support to the Senate Finance Committee for inclusion of provisions addressing pharmacy DIR fees in its drug pricing bill.

The Senate Finance Committee could act quickly, so please take immediate action and keep the pressure on your Senators because:

• Pharmacy DIR fees have increased 45,000% since 2010
• Pharmacy DIR fees continue to be unpredictable for pharmacies
• DIR fees force patients to the coverage gap prematurely, which creates financial hardship for patients
• DIR fees must be expeditiously addressed by Congress given CMS’ failure to act.

Thank you for your prompt action in support of community pharmacy’s top priority issue. Click here for more resources on #FixDIRDay

https://www.cantwell.senate.gov/contact/email/form

Since Senator Maria Cantwell is a member of the Senate Finance Committee, she is an important decision maker so please let her know exactly how this is impacting your ability to provide patient care. If possible, show her first-hand. Extend an invitation to the member or a senior staffer to visit your pharmacy over the upcoming recess so they can see firsthand why action is needed. If you need assistance, please contact Michael Rule at michael.rule@ncpanet.org.

The 2019 Independent Pharmacy Conference May 2-5 in San Antonio is the event of the year for independents. Open to all independent pharmacies regardless of memberships, this event delivers savvy business advice via exceptional continuing education courses; you can earn 9 CEUs.  You can also take advantage of a 60+ vendor trade show showcasing key vendors with the latest solutions for your success.

 The Continuing Education program will focus on your business; this year’s lineup features a look at key profit drivers; long term care insights, the latest pharmaceutical industry trends, 340B opportunities, a legislative update, effective marketing strategies, understanding the CBD Oil arena and more. 

 The three-day conference also features a 60+ vendor trade show exposition, networking opportunities, an inspirational keynote from Scott Hamilton, fabulous receptions and entertainment. You won’t want to miss this fantastic event. Register today!

 To register or for more conference information, click here.

(link to www.irxcon.com)

The APhA Fellow Award was established to honor APhA members for exemplary professional achievements in professional practice and outstanding service to the profession up to that period of time through activities in APhA and other organizations. Recipients of the APhA Fellow Award may continue to utilize the designation, FAPhA, as long as their professional license, if a licensed pharmacist, is in good standing, and they maintain their APhA membership.

Jeff will be officially recognized at the APhA Annual Meeting and Exposition in Seattle, WA this spring.

Congratulations Jeff!

The president signed S. 2553, the Know the Lowest Price Act of 2018, and S. 2554, the Patient Right to Know Drug Prices Act, which give community pharmacists more flexibility in informing patients they could pay less out of pocket for a prescription than by using their health insurance.

"The signing of these bills is a victory for patients, and for pharmacies worried that a PBM will retaliate against them for disclosing the most affordable health care options to patients," said Hoey. "Everyone agrees – prescription drug prices are too high. By empowering pharmacists to act in patients' best interest in sharing lower-cost alternatives, we are increasing patients' ability to afford the medications they need to get healthy and stay that way.

"Today's signing ceremony follows more than six months of hard work by many community pharmacy supporters, including Sens. Susan Collins (R-Maine) and Debbie Stabenow (D-Mich.) and Reps. Buddy Carter (R-Ga.) and Peter Welch (D-Vt.), who led legislation in the Senate and House respectively. We are grateful for their efforts and for those of the bills' co-sponsors in keeping this issue in the public eye. We also applaud President Trump, HHS Secretary Alex Azar, and CMS Administrator Seema Verma for their support of legislation to prohibit 'gag clauses' and for their broader work to lower drug prices and reduce patients' out-of-pocket costs. This is a positive first step for consumers.

"Federal law will now state that pharmacists cannot be prohibited from discussing the most affordable medication payment options with their patients or be retaliated against for doing so. We believe this will help unshackle pharmacists so they can use their expertise in conversations with patients, helping them receive the most appropriate medication at the lowest cost without fear of retribution."

Belcher and Chancy, both of whom attended today's signing ceremony, had recently spoken out after helping patients obtain their medication. Belcher, as quoted in a news release from Rep. Greg Walden (R-Ore.), "once received a cease and desist letter for trying to help a child with a terminal disease access his medication." Chancy testified in September before the House Energy and Commerce Committee Subcommittee on Health about his experiences, saying that his pharmacy was issued a verbal warning by a PBM after having discussed with a patient the cost of a drug off insurance.

The new laws pertain to Medicare Part D, which will take effect in 2020, as well as ACA exchange and private insurance plans, which take effect immediately.

Urges more individuals to carry life-saving medication

Today, U.S. Surgeon General Jerome M. Adams, M.D., M.P.H., urged more Americans to carry a lifesaving medication that can reverse the effects of an opioid overdose.

The medication, naloxone, is already carried by many first responders, such as EMTs and police officers. The Surgeon General is now recommending that more individuals, including family, friends and those who are personally at risk for an opioid overdose, also keep the drug on hand.

An estimated 2.1 million people in the U.S. struggle with an opioid use disorder.  Rates of opioid overdose deaths are rapidly increasing.  Since 2010, the number of opioid overdose deaths has doubled from more than 21,000 to more than 42,000 in 2016, with the sharpest increase occurring among deaths related to illicitly made fentanyl and fentanyl analogs (synthetic opioids).  

Opioids are a class of drugs that include medications, such as oxycodone, hydrocodone and methadone, which are commonly prescribed to treat pain.  Pharmaceutical fentanyl is a synthetic opioid which is 50 times more potent than heroin and 100 times more potent than morphine.  It is approved for treating severe pain, typically post-surgical or advanced cancer pain.  However, most recent cases of fentanyl-related harms are a result of illicitly made fentanyl.

“Each day we lose 115 Americans to an opioid overdose – that’s one person every 12.5 minutes,” said Surgeon General Adams. “It is time to make sure more people have access to this lifesaving medication, because 77 percent of opioid overdose deaths occur outside of a medical setting and more than half occur at home.”

Naloxone, an FDA-approved medication that can be delivered via nasal mist or injection, is not a long-term solution, but it can temporarily suspend the effects of the overdose until emergency responders arrive.

“To manage opioid addiction and prevent future overdoses, increased naloxone availability must occur in conjunction with expanded access to evidence-based treatment for opioid use disorder,” the Surgeon General said.

All states have passed laws to increase access to naloxone and, in most states, you can walk into a pharmacy and request naloxone even if you don’t already have a prescription.  In addition, most states have laws designed to protect health care professionals for prescribing and dispensing naloxone from civil and criminal liabilities as well as Good Samaritan laws to protect people who administer naloxone or call for help during an opioid overdose emergency.  

By ED SILVERMAN @Pharmalot MARCH 28, 2018

https://www.statnews.com/pharmalot/2018/03/28/washington-first-drug-take-back/

After years of skirmishes, the most comprehensive statewide drug take-back program in the nation became law late last week in Washington, potentially creating a new template for states to press the pharmaceutical industry to underwrite these efforts.

The Washington law requires drug makers to fully finance and operate the program, which is designed to lower the threat of drug abuse stemming from medicines that linger in households and also reduce contamination in drinking water.

Ever since the U.S. Supreme Court denied an industry request to review a lawsuit filed over a drug take-back program in Alameda County, Calif., lawmakers in different parts of the country have been emboldened to introduce bills to force companies to finance the costs.

Local and state governments argue that drug makers are capable of paying for the programs, since the companies generate substantial revenue doing business in those jurisdictions. Annual prescription drug sales in Washington are estimated at $5.7 billion according to the WA Secure Medicine Take-Back Coalition. The annual cost to drug makers is estimated to be about 0.1 percent of those sales, or about $5.7 million.

Under the law, drug makers whose medicines are sold in, or into, the state must submit a proposal by July 1, 2019, explaining how they will meet requirements. There are also deadlines for when companies must contact pharmacies, hospitals, law enforcement, and others of the opportunity to participate and host a secure drop box. The state Department of Health will review and approve proposals.

“This law really fulfills the promise of the drug take-back programs and how they should operate,” said Margaret Shield of Community Environmental Health Strategies, who works with local and state lawmakers on environmental health issues.

“The pharmaceutical industry has refused for years to pay for drug take-back, but we need dedicated financing and coordination to make this work for communities. With this law, we’re making clear that, in every city and town across the state, there needs to be secure drop boxes and prepaid mailers available to all residents.”

Currently, two other states — Massachusetts and Vermont — require companies to underwrite the programs. But their laws are more limited by failing to define certain industry responsibilities or rely on partial industry funding, according to Vivian Fuhrman, senior associate for policy and programs at the Product Stewardship Institute, a nonprofit that supports drug take-back programs.

“The scope of this law is broader in terms of responsibility of parties, plans for stewardship, and convenience standards,” she explained. “So I think it will have a better chance of success and become the new model for drug stewardship laws.” She also noted this is the first “stand alone” law dedicated to such a program, while laws in the other states were folded into efforts to address the opioid crisis (see here and here).

In Massachusetts, for instance, only opioid drug makers are required to participate in the program. And there is also a sunset clause that means the program will end in December 2021.

“We’re trying to get rid of that, because it’s a glaring weakness,” explained Alejandro Alves, chief of staff to state Sen. John Keenan, who introduced a bill to eliminate the clause. “The state has had trouble implementing the program, because the pharmaceutical industry knows it’s going to go away in a few years and is just sitting on its hands, because it has no motivation to do anything.”

The Pharmaceutical Research & Manufacturers of America has opposed take-back programs that have been popping up around the country. We asked the industry trade group for comment and will update you accordingly. Currently, four California cities and 16 counties in California, New York, and Washington require drug makers to finance the programs.

Last year, though, PhRMA issued a position paper arguing that the proposed take-back program would not achieve its objectives because kiosk drop-offs and mail-back options could prompt diversion. The trade group also indicated that the cost of such a program would cause drug prices to rise.

And PhRMA reiterated an alternative: an industry effort called MyOldMeds.com, which recommends unused drugs should be placed with cat litter, sawdust, or coffee grinds in plastic bags, and then tossed in the trash. But environmental activists say this should be a last resort and the Food and Drug Administration recommended this option only when take-back programs are not available.

Drug makers, however, faced stiff opposition from a wide variety of organizations that supported the law. These included the Washington Association of Sheriffs & Police Chiefs, the Association of Washington Cities, the Washington State Medical Association, and the Washington Association for Substance Abuse & Violence Prevention, among others.

“This program addresses important public health issues such as the opioid epidemic, injury prevention, and environmental quality and health,” said Chris Bischoff, president of the Washington State Association of Local Public Health Officials, in a statement. “Having this program available throughout the state also reinforces that these issues are impacting our rural and urban counties alike.”

Learners will not be able to access their NABP e-Profiles during this two-week update period, however ACPE-accredited providers will still be able to submit credit and continue transmission to CPE Monitor® during this time. For further information please, see NABP’s website memo regarding this update here.