SPECIALTY RX FACTS

2Oct/120

Get Ready Pharma for California Pedigree Rules: December 2014 Comes Quick

Note the section on first notice to the Board of Pharmacy if your company is ready for Pedigree.

Board of Pharmacy Initial Statement of Reasons
Subject Matter of Proposed Regulation:          Electronic Pedigree Requirements: Unique Identification Number; Specification of Pedigreed Dangerous Drugs; Specification of Existing Stock
Sections Affected:        Add Article 5.5 to Title 16 Cal.Code Reg. and Add § 1747 and 1747.1
Specific Purpose of the Proposed Changes:
The Board of Pharmacy (“Board”) proposes to add Article 5.5 entitled “Pedigree Requirements” to Title 16 of the California Code of Regulations (“CCR”) and to add Sections 1747 and 1747.1 related to requirements for electronic pedigrees of dangerous drugs and devices. The board’s proposal would establish the standardized numerical identifier that a drug manufacturer or repackager must establish and apply to the smallest package or immediate container of a dangerous drug or dangerous device. This proposal would also establish dates by which a manufacturer that distributes a dangerous drug or device in California shall submit to the board declarations related to the manufacturer’s readiness to comply with statutory electronic pedigree requirements. It would also set forth requirements for manufacturers, wholesalers, repackagers, pharmacies and pharmacy warehouses (as defined in Business and Professions Code section 4163(g)) to submit specified declarations to the board in order to designate dangerous drugs that they possess as “not subject” to the serialized electronic pedigree requirements.
Specifically, the Board’s proposed changes would include:
1.  The addition of a new Article 5.5 and Title “Pedigree Requirements” in Title 16 in Division 17 of the California Code of Regulations for ease‐of‐use and reference;
2.  The addition of a new definition for “unique identification number” which incorporates by reference the U.S. Food and Drug Administration’s guidance document: “Guidance for Industry, Standards for Securing the Drug Supply Chain – Standardized Numerical Identification for Prescription Drug Packages,” dated March 2010;
3.   A requirement for each manufacturer to submit a declaration to the board by December 1, 2014 that includes a list and quantity of dangerous drugs by name and product package (SKU) type representing at least fifty percent of the manufacturer’s drugs that are ready for initial implementation as of January 1, 2015, as well as a list of dangerous drugs that are not yet ready to be serialized;
4.  A requirement for each manufacturer to state in the declaration the methods used to measure the percentage of drugs ready to be serialized, the calculations used to arrive at the percentage, and the technology employed to meet the pedigree requirements;

Initial Statement of Reasons                                                                                                                           Page 1 of 65.   A requirement for each manufacturer to submit a declaration to the board by December 1, 2015 that includes a list and quantity of dangerous drugs by name and product package (SKU) type representing at least fifty percent of the manufacturer’s drugs that are ready for implementation as of January 1, 2016;
6.  A specification that failure to submit or re‐submit a declaration compliant with subdivisions (a)(1) or (a)(2) of this Section constitutes a violation of the Pharmacy Law;
7.   A requirement for each manufacturer, wholesaler or repackager seeking to designate dangerous drugs it possesses, owns, or controls as “not subject” to pedigree requirements to submit a declaration to the board by August 1, 2016 that includes a list and quantity of dangerous drugs by name and product package (SKU) type acquired prior to July 1, 2016;
8.  A requirement for each manufacturer, wholesaler or repackager to state in the declaration the means and source of acquisition and the anticipated means of any subsequent distribution or disposition;
9.  A requirement for each pharmacy or pharmacy warehouse seeking to designate dangerous drugs it possesses, owns, or controls as “not subject” to pedigree requirements to submit a declaration to the board by August 1, 2017 that includes a list and quantity of dangerous drugs by name and product package (SKU) type acquired prior to July 1, 2017;
10. A requirement for each pharmacy or pharmacy warehouse to state in the declaration the means and source of acquisition and the anticipated means of any subsequent distribution or disposition; and,
11.  A requirement that the board or its designee shall have sole discretion to determine whether declarations submitted pursuant to this Section are compliant and to reject and require re‐submission of any non‐compliant declaration until determined to be fully compliant.
Factual Basis/Rationale/Problem Addressed
Business and Professions Code section 4005 generally authorizes the board to amend rules and regulations necessary for the protection of the public pertaining to the practice of pharmacy and the administration of Chapter 9 of Division 2 of the Business and Professions Code.
In 2004 the California State Board of Pharmacy (the board) sponsored legislation, Senate Bill (SB) 1307, that made comprehensive changes to the drug distribution system to protect against counterfeit drugs. Among other requirements that were enacted, the Pharmacy Law required development of an electronic “pedigree” that tracks each prescription drug (“dangerous drug”) at the saleable unit (item) level through the distribution system. Existing law requires each manufacturer of dangerous drugs, and every wholesaler and pharmacy that possesses dangerous drugs to provide specified notices and declarations to the board by specified dates

Initial Statement of Reasons                                                                                                                           Page 2 of 6for compliance with the electronic pedigree laws. (Business and Professions Code sections4163.2, 4163.5,)  However, the form and content of such notices and declarations are not fully specified. In addition, existing law at Business and Professions Code Section 4034 (operative on January 1, 2015) will require each pedigree to include a “unique identification number.” However, the Pharmacy Law does not specify what that unique identification number must contain to be compliant.
Business and Professions Code section 4034 defines a “pedigree” as a record, in electronic form, containing information regarding each transaction resulting in a change of ownership of a given dangerous drug, from sale by a manufacturer, through acquisition and sale by one or more wholesalers, manufacturers, repackagers, or pharmacies, until final sale to a pharmacy or other person furnishing, administering, or dispensing the dangerous drug. This statute specifies that a pedigree shall be created and maintained in an interoperable electronic system, ensuring compatibility throughout all states of distribution, and specifies the information that shall be included in the pedigree, including the requirement of a linked “unique identification number” for each dangerous drug. The statute becomes operative on January 1, 2015.
The board’s proposal at Title 16, CCR Section 1747 would establish requirements for the “unique identification number” that is to be established and applied to the smallest package or immediate container by the manufacturer or repackager by incorporating by reference the U.S. Food and Drug Administration’s guidance from the following document: “Guidance for Industry, Standards for Securing the Drug Supply Chain – Standardized Numerical Identification for PrescriptionDrug Packages,” dated March 2010.  According to the FDA, the guidance document represents the agency's current thinking on standards for drug supply chain security‐standardized numerical identification for prescription drug packages, and was developed after receiving public comment from stakeholders on this issue.
Business and Professions Code Section 4163 specifies dates on which dangerous drugs shall not be sold, traded, or transferred without providing a pedigree, which includes a unique identification number. Accordingly, adoption of Section 1747 in Title 16 of the California Code of Regulations is necessary to enable the Board to provide advance direction to manufacturers and repackagers to begin the process of meeting Section 4163’s mandates.
Business and Professions Code Section 4163.2 provides for the designation of drugs and the submission of written declarations listing those drugs that are not subject to pedigree requirements, as specified (see also Business and Professions Code section 4163.4), and authorizes the board to establish regulations to specify the requirements and procedures for the creation and submission of these written declarations.
Business and Professions Code Section 4163.5 specifies dates by which each manufacturer of a dangerous drug distributed in California shall designate its readiness with the state’s serialized electronic pedigree requirements by providing the board with information representing specified percentages of drugs that are subject to the state’s serialized electronic pedigree requirements, and specifies that each manufacturer shall designate the measure or measures used in designating its drugs to be serialized, according to the process specified by the board.

Initial Statement of Reasons                                                                                                                                        Page 3 of 6The board’s proposal at Title 16, CCR Section 1747.1 would establish dates by which declarations shall be submitted to the board, and the required content of those declarations as it relates to the manufacturer’s readiness to comply with the state’s serialized electronic pedigree requirements.It would also require manufacturers, wholesalers, and repackagers by August 1, 2016 and pharmacies and pharmacy warehouses by August 1, 2017 to submit specified declarations to the board in order to designate dangerous drugs that they possess as “not subject” to the serialized electronic pedigree requirements. The board’s proposal would establish that the board or its designee shall have sole discretion to determine whether any of the declarations submitted are compliant, and authorize the board to reject and require re‐submission of any non‐compliant declaration(s) until determined to be fully compliant. Further, the board’s proposal specifies that failure to submit compliant declarations to the board, as specified, shall constitute a violation of Pharmacy Law. These provisions are necessary to ensure accurate, timely and complete information is being provided to the board prior to making a decision regarding compliance with the electronic pedigree laws. By making non‐compliance with these provisions a violation of the Pharmacy Law, this proposal would also provide the board with a mechanism for enforcing compliance with these reporting obligations.
The “Guidance for Industry, Standards for Securing the Drug Supply Chain – Standardized Numerical Identification for Prescription Drug Packages,” dated March 2010 is referenced in these amendments. It would be cumbersome, unduly expensive and otherwise impractical to publish the documents in the California Code of Regulations. It is available on the board’s website and fromthe board upon request.

Underlying Data1.    Senate Bill 1307, Chapter 713, Filed with the Secretary of State on September 30, 20082.    “Guidance for Industry, Standards for Securing the Drug Supply Chain – Standardized Numerical Identification for Prescription Drug Packages,” dated March 2010, U.S. Food and Drug Administration (FDA).3.     Board of Pharmacy “Questions and Answers Relating to the California Electronic Prescription Drug Pedigree Law(s),” January 2008 4.    Letter dated August 25, 2008, by Mark Ridley‐Thomas, Senator, 26th District, Chair of the Senate Committee on Business, Professions & Economic Development to Mr. Gregory Schmidt, Secretary of the Senate5.    The Script (Board of Pharmacy Newsletter), February 2009, “Changes in Pharmacy Law”and “Compliance Dates Extended for e‐Pedigree Requirements” (pp. 1‐6)6.    Board of Pharmacy Comments re: Enhancing Pharmaceutical Distribution Integrity Act of2012, Letter Dated June 17, 2012, Signed by Stan Weisser, RPh, President of the Board ofPharmacy, and by Virginia Herold, Executive Officer of the Board of Pharmacy7.    Relevant Meeting Materials and Minutes from the Board of Pharmacy Board Meeting heldMay 12, 20128.    Relevant Meeting Materials and Minutes from the Board of Pharmacy, EnforcementCommittee and E‐Pedigree Public Meeting held June 12, 2012

Initial Statement of Reasons                                                                                                                           Page 4 of 69.    Relevant Meeting Materials and Minutes from the Board of Pharmacy Board Meeting heldJuly 17‐18, 201210.  Article “What you need to know now about California e‐Pedigree,” Healthcare Packaging, July 20, 2012 (viewed July 24, 2012) http://www.healthcarepackaging.com/archives/2012/07/what_you_need_to_know_now_abou.php11.  “California Staggering Its E‐Pedigree Regulations,” PMPNews.com, Published August 7,2012, on Pharmaceutical & Medical Packaging News (http://www.pmpnews.com)12.  Economic Impact Analysis

Business Impact
The Board does not believe that this regulation will have a significant adverse economic impact on businesses. Representative businesses have a statutory requirement to have a pedigree that includes a unique identification number which is able to be tracked through an interoperable electronic system (see Business and Professions Code Section 4034). Moreover, the U.S. Food and Drug Administration has provided guidance to industry on standardized numerical identification numbers for prescription drug packages. Thus, the Board believes that its proposal would nothave a significant statewide adverse economic impact directly affecting businesses, including the ability of California businesses to compete with businesses in other states.
The Board’s proposal, however, would impose the following reporting, recordkeeping, or other compliance requirements: manufacturers of dangerous drugs would be required to report by way of declaration to the board by December 31, 2014 regarding its initial implementation of the pedigree laws, and thereafter regarding final implementation by December 31, 2015. Additionally, this proposal would also require manufacturers, wholesalers, and repackagers by August 1, 2016 and pharmacies and pharmacy warehouses by August 1, 2017 to submit specified declarations to the board in order to designate dangerous drugs that they possess as “not subject” to theserialized electronic pedigree requirements. BenefitsBusiness and Professions Code section 4005 states that “the board may adopt rules and regulations….pertaining to the practice of pharmacy….” Further, Business and Professions Code4001.1 states that the “protection of the public shall be the highest priority for the Board in exercising its licensing, regulatory, and disciplinary functions. Whenever the protection of the public is inconsistent with other interests sought to be promoted, the protection of the public shall be paramount.” The board believes the regulatory changes as described in the Notice will serve to protect the public health by specifying requirements for the initial phase of compliance with California’s electronic pedigree requirements. Compliance helps ensure that tracking of drug products occurs consistent with the pedigree laws, resulting in the public being better protected from counterfeited and adulterated dangerous drugs entering California’s prescription drug supply chain.

Initial Statement of Reasons                                                                                                                           Page 5 of 6Specific Technologies or Equipment
This regulation would specify the requirements for the “serialized numeric identifier” that would be contained in a pedigree of a dangerous drug, as specified.
Consideration of Alternatives
The Board of Pharmacy has made an initial determination that no reasonable alternative to the regulatory proposal would be either more effective in carrying out the purpose for which the action is proposed or would be as effective or less burdensome to affected private persons and equally effective in achieving the purposes of the regulation in a manner that ensures full compliance with the law being implemented or made specific.
Set forth below are the alternatives which were considered and the reasons each alternative was rejected:
The board is authorized by law to implement, interpret or make specific the laws under its jurisdiction (Business and Professions Code sections 4005, 4163.2(a)(3), 4163.5(b),(c)). With respect to the unique identification number, the FDA’s guidance document represents the agency's current thinking on standards for drug supply chain security‐standardized numerical identification for prescription drug packages, and was developed after receiving public comment from stakeholders on this issue. At numerous meetings conducted by the board regarding the development of the unique identification number standard, industry representatives have indicated that the guidance document’s standards were acceptable methods of creating the unique identification number for serialization purposes. No other alternatives were proffered at these meetings; therefore, no others were considered by the board.
The requirements for reporting by way of declaration, including some of the elements contained within the declaration, are set forth in Business and Professions Code section 4163.2 and 4163.5. As this method was designated by the enabling legislation, no other options were considered by the board. The contents of the declarations were discussed at various meetings on the subject and no other options for content were proffered at those meetings. Consequently, no other alternatives were considered.

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19Jul/120

Walgreens and Express Scripts Reach Agreement

WASHINGTON (AP) - Pharmacy chain Walgreens says it will begin filling prescriptions from customers in the Express Scripts network starting in September under a new multiyear contract between the companies.

Walgreen had stopped filling prescriptions for Express Scripts after a contract between the companies ended last year.

Shares of Walgreen Co. jumped 14 percent in premarket tradingwhile Express Scripts shares rose 3 percent.

Express Scripts Holding Co. said it ended the contract with Walgreen because the drugstore operator wanted a premium compared to what Express Scripts paid other pharmacies.

Walgreen Co. has seen sales slump for several months due to the split, but had said it would rather give up the revenue than continue filling unprofitable prescriptions.

The companies said in a statement Thursday that Walgreen will rejoin a network of pharmacies available to Express Scripts customers starting Sept. 15. Terms of the new contract were not disclosed.

(Copyright 2012 The Associated Press. All rights reserved. This material may not be published, broadcast, rewritten or redistributed.)

 

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11Jul/120

Leaving Canada for Medical Care 2011

Among the consequences of poor access to health care in Canada is the reality that some Canadians will ultimately receive the care they require outside of the country. Some of these patients will have been sent out of country by the public health care system due to a lack of available resources or the fact that some procedures or equipment are not provided in their home jurisdiction, says Nadeem Esmail of the Fraser Institute.

Others, which are of more interest here, will have chosen to leave Canada in response to concerns about quality to avoid some of the adverse medical consequences of waiting for care such as worsening of their condition, poorer outcomes following treatment, or simply to avoid delay. Measuring the size of this population allows for comparative assessment of Canada's health system's quality.

In 2011, a significant number of Canadians -- an estimated 46,159 -- received treatment outside of the country.

This figure constitutes roughly 1 percent of all patients for non-emergency medical care.

Increases between 2010 and 2011 in the estimated number of patients going outside Canada for treatment were seen in British Columbia, Saskatchewan, Manitoba, New Brunswick, Nova Scotia, Prince Edward Island, and Newfoundland and Labrador.

Only Ontario saw a decrease in the number of patients seeking treatment outside of Canada.

At the same time, the national median wait time for treatment after consultation with a specialist increased from 9.3 weeks in 2010 to 9.5 weeks in 2011.

Furthermore, the methodology that produced these figures likely underestimates the number of Canadians leaving the country to receive care.

These numbers are based on specialist responses, which means that patients who leave Canada without consulting a specialist are not likely to be included in the count.

The counts are also based on the number of procedures estimated to have been performed in Canada, which is less than the number of patients consulted and less than the number of Canadians who would have required treatment, including those who left Canada to seek it.

Clearly, many of those who left the country to receive care were driven by a desire to return more quickly to their lives, to seek out superior quality care, or perhaps to save their own lives or avoid the risk of disability.

Source: Nadeem Esmail, "Leaving Canada for Medical Care 2011," Fraser Institute, July/August 2012.

 

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9Jul/120

Wellpoint strikes deal to buy Amerigroup for $4.9 Billion

WellPoint entered a definitive agreement to acquire Amerigroup in a cash deal valued at $4.9 billion.

The agreement, expected to close in the first quarter of 2013, calls for WellPoint, Indianapolis, to pay $92 per share for Amerigroup, a Virginia Beach, Va.-based managed-care company with 2.7 million members in 13 states, according to a news release.

The acquisition would greatly expand WellPoint's footprint in Medicaid managed care and with the dual-eligible population. The combined company would have “a presence in the four largest states that have a combined $105 billion in annual dual eligible spending,” according to the release.

 

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2Jul/120

GSK Agrees to $3B Settlement

In the largest fraud settlement in U.S. history, GlaxoSmithKline has agreed to pay $3 billion in settlements and to plead guilty to criminal charges related to its branding, safety disclosures and price reporting of several drugs.

The Justice Department on Monday announced a “global settlement” that resolves three investigations related to the pharmaceutical giant.

The company will pay $1.8 billion to resolve criminal and civil liabilities for off-label marketing, including $757 million in criminal fines for misbranding antidepressants Paxil and Wellbutrin, and more than $1 billion for alleged False Claims Act violations related to payments of kickbacks for those and other drugs.

 

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19Jun/120

Walgreens and Boots Combination, Where are the Synergies?

The American drug store chain Walgreens has agreed to buy a 45 percent stake in Alliance Boots, the European pharmacy retailer, for $6.7 billion, in a deal that could allow it to take full control of Alliance Boots by 2015.

The deal will create one of the world’s largest drug store and pharmacy retailers with more than 11,000 stores in 12 countries. The acquisition also would allow Walgreens to expand into overseas markets, and give Alliance Boots a presence in the Unites States that it has long wanted.

“Today’s announcement represents an exciting opportunity to accelerate our five core strategies and advance that mission in the U.S. and now internationally,” Gregory Wasson, chief executive of Walgreens, said in a statement.

Finding the synergies in this deal will be challenging beyond extending two large brand names on an international scale.  Few in the US know the Boots brand and likewise, Walgreens is not a household name outside of the US.  Both will need to leverage the Americanization of the Brand.  In healthcare and pharmaceuticals, American brands are highly regarded internationally, so expect this to come into play as this new combination extends their reach.

Time will tell if buying leverage will truly play out in the branded world of Rx but certainly in the world of consumer, private label and generics, bigger is better!

Stay tuned

 

 

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5Mar/120

Research on Savings from Generic Drug Use

The Hatch-Waxman Act, passed in 1984, is largely responsible for the relationship seen today between generic and brand name drugs.  While brand names are allowed to charge high prices for their first several years on the market, their patents eventually expire (as stipulated by the Act) and generic manufacturers move in to sell at a lower price, says the Government Accountability Office.

Prescription drug spending in the United States reached $307 billion in 2010 -- an increase of $135 billion since 2001.

This comprised approximately 12 percent of all health care spending in the country in 2010.

As efforts to control health care spending expand, attention is naturally paid to the role of generic drugs in reducing spending on prescriptions -- generics are, on average, 75 percent cheaper than their brand-name competitors.

The usage of generic drugs has grown from approximately 19 percent in 1984 to 78 percent today, and is expected to increase even further in the next few years as major drugs lose their patent.

The Government Accountability Office has conducted a review of studies on the topic in an effort to understand the future role that generic drugs might play in controlling costs.  Its research yielded several conclusions.

A series of studies estimated the total savings that have accrued to the U.S. health care system from substituting generic drugs for their brand-name counterparts to be more than $1 trillion between 1999 and 2010,

One study assessed the potential for additional savings within Medicare Part D, finding that if generic drugs had always been substituted for the brand-name drugs studied, about $900 million would have been saved in 2007.

Source: "Research on Savings from Generic Drug Use," Government Accountability Office, January 31, 2012.

For text:

http://www.gao.gov/products/GAO-12-371R

 

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21Jan/120

D2 Presenting: Is Specialty Pharmacy Right for Your Hospital at HSCA

Stay at the forefront of pharmacy industry issues and take advantage of opportunities to network with leading decision-makers—join us in Tampa for the 2012 National Pharmacy Forum.

Make Key Business Contacts and Explore Critical Industry Issues.

The National Pharmacy Forum is the place to strengthen partnerships with existing clients and develop new connections. You’ll also gain insight into emerging trends and an outlook for the future with relevant educational content.

Program highlights include:

  • Specialty Pharmacy: Opportunities in the Hospital Setting, which presents an expert market/situation analysis that breaks down the complexity of the biopharmaceutical marketplace and the positions of stakeholders featuring Dean Erhardt, MBA and Dan Steiber, R.Ph
  • Battleground 2012: An Update on the Political Landscape, which explores the latest public opinion research on healthcare reform, the economy, and the country’s political future.
  • Comparative Effectiveness Research, which gives a comprehensive overview of comparative effectiveness research (CER) and patient centered outcomes research (PCOR).
  • Healthcare 2020: The Transformative Trends That Will REALLY Define Our Future, which details dramatic innovations that will impact tomorrow’s healthcare system. .

And you won't want to miss presentations from engaging keynote speakers:

Kevin B. Sneed, PharmD, founding dean of the University of South Florida College of Pharmacy and respected lecturer on a range of healthcare topics. His research interests include the pharmacological treatment of patients with cardio-metabolic disorders and disparities in healthcare.

Jim Carroll
, recognized as one of the world’s leading international futurists with a massive global blue-chip client list. He is also widely acknowledged as an authority on international trends, rapid business model change, business transformation in a period of economic uncertainty, and the necessity for fast-paced innovation.

For complete programming information, view the preliminary program/schedule of events.

For more information and to register, visit www.supplychainassociation.org/forum

 

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1Sep/110

FDA links infections to repackaged Avastin

FDA said at least 12 patients developed serious eye infections, including some leading to vision loss, following intravitreal injections of repackaged Avastin bevacizumab to treat wet age-related macular degeneration at three Florida clinics. The agency traced the bacterial infections to a single pharmacy in Hollywood, Florida, which repackaged the IV cancer drug into single-use syringes for off-label treatment of wet AMD. FDA recalled all Avastin
repackaged at the pharmacy.

The humanized mAb against VEGF from Genentech Inc. is approved for multiple cancers and is used off-label in wet AMD as a cheaper alternative to Genentech's Lucentis ranibizumab, a mAb fragment against VEGF-A. In April, NIH's National Eye Institute reported that Avastin was non-inferior
to Lucentis in the Phase III CATT trial for wet AMD (see BioCentury May 2).

Genentech said in a statement that it does not support or promote the off-label use of Avastin. The company added that other ocular adverse events have been reported from unapproved use of Avastin for eye disorders.

In April 2010, FDA received reports of five eye infections in Tennessee linked to Avastin repackaged at a single compounding pharmacy. Genentech, a unit of Roche (SIX:ROG; OTCQX:RHHBY), markets Avastin and Lucentis in the U.S., while the drugs are marketed elsewhere by Roche and Novartis, respectively.

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18Aug/110

NACDS, NCPA Urge Protecting Patient Choice of Pharmacy

NACDS, NCPA Urge Protecting Patient Choice of Pharmacy Amid Studies on Medication Adherence

Alexandria, Va. – National Association of Chain Drug Stores (NACDS) President and CEO Steven C. Anderson, IOM, CAE and National Community Pharmacists Association (NCPA) Executive Vice President and CEO B. Douglas Hoey, RPh, MBA today issued the following statement regarding two recent studies appearing in the Journal of Medical Economics (JME) and the American Journal of Managed Care (AJMC), regarding medication “adherence,” or the proper use of medicine as prescribed by a physician:

“The AJMC study effectively counters the claims in a study published in the JME regarding the uses of mail order versus community pharmacies. Amid these studies, it is safe to say that we have at least one important takeaway lesson: The best way to promote proper adherence to medication and better health outcomes is by ensuring patients’ access to the pharmacy of their choice. Despite repeated financial and other inducements encouraging mail order in Medicare Part D and other health plans, the vast majority of patients opt to continue to rely on their local, community pharmacist to help meet their health needs.

“It’s important to remember that adherence is about more than simply mailing a 90-day supply of prescription medication to a patient.  Possession of prescription drugs alone is not the only factor in measuring adherence. For the full patient health picture, one must take into account whether that medication was actually taken as prescribed, if the patient had an adverse reaction, or if the prescriber stopped or changed the dosage of that medication based on the patient’s need.

“If any of these factors occur, it not only impacts adherence, but also cost.  If a medication is not used properly, then the potential for cost-savings is lost if additional medication, medical tests or even catastrophic and emergency care are needed by a patient, further disrupting patients’ lives and driving up healthcare costs.

“This is also why it is vital to recognize that drug costs cannot be viewed in a vacuum.  Pharmacy services need to be evaluated in terms of their overall ability to bring down healthcare costs across the board and improve patient health.  Pharmacists provide counseling services, medication therapy management and other services that must be considered in any comprehensive cost-benefit analysis.

“The true story of improved medication adherence is the unsurpassed value of community pharmacy and the services it provides.  There is no substitute for the pharmacist-patient face-to-face relationship.  Community pharmacy services help to improve patient health and lower overall healthcare costs. Maintaining patient choice of how to obtain prescription medications is essential.”

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