 |
The Roadmap to Informed Healthcare
|
|
Click below to receive our
|  |
|
|
Welcome to the March issue of CrossRoads, a regular newsletter from Pharmacist Partners.
|
| THE BIOSIMILAR DEBATE | |
The following is an excerpt from an industry paper written on Biosimilars and Patient Safety by:
Salvatore J. Giorgianni, Jr., PharmD, BSc, CMHE; Chair, American Public Health Association Caucus On Men's Health and President, and Advisor to Pharmacist Partners.
********************************
Patient safety must continue to be the top priority of regulators as the U.S. Federal Trade Commission (FTC) and U.S Federal Drug Administration (FDA) discuss issues surrounding biosimilars, particularly the establishment of a policy on naming. The single best way to ensure the safety of vulnerable patient populations is through policy which requires clear, distinguishable and traceable names for biosimilars.
Regulatory bodies should prioritize patient safety
The proper management of clinical patient care requires that patients, their physicians, and pharmacists are able to specifically identify and quickly trace the supplier of a treatment. This is particularly critical for biosimilar products, which unlike generic chemical compound drugs, are similar-to, not exact replicas, of the original biologic. It is essential that biosimilars are assigned unique names and identification codes for patient safety and to protect the integrity of the biologic treatments that many of the most vulnerable populations depend on.
Distinguishable names are critical to patients' safety and rights
To adequately protect the health and safety of patients, FDA must put regulations in place that seek to achieve on a number of fronts. Policies established must ultimately 1) prevent commercial abuse of biosimilars, 2) ensure access to quality products that are of reliable, consistent therapeutic value while still allowing for traceability, and confirm these products can be safely used with critically ill patients.
This is not an easy balancing act for FDA, but it is a necessary one.
**********************************
For the complete industry paper - please visit the Insights page on our website: www.pharmacistpartners.com
|
Drug Topics Advisory Board Appointment
| |
 | |
Sandra Kattermann, RPh., M.S.J., Sr VP, Compliance, Pharmacist Partners
|
Pharmacist Partners is happy to have one of our own, Sandra Kattermann accept a position on the Drug Topics prestigious Advisory Board.
Sandra will assist Drug Topics by providing pertinent content regarding the pharmacy industry, pharmacy practice, and other topics and advise Drug Topics regarding developing trends in the pharmacy industry with guidance through articles by practicing professionals for publication.
Congratulations Sandra!
|
PanAgora Industry Panel Highlights
| |
 | |
The Pharmacist Partners Team: Brooke, David and Jack.
|
Last week, Pharmacist Partners attended PanAgora's Pharma Customer Experience Summit in Princeton, NJ. The pharmaceutical industry is serious about undertaking a more customer-centric approach to sales and marketing strategy. This first ever conference addressed the challenges and opportunities associated with improving the pharma customer experience.
A plethora of Fortune 100 companies attended the summit, held on March 5thand 6th at the lovely Nassau Inn, and ranged in industry from healthcare and air travel to hotel management. Pharmacist Partners presented a panel discussion on the Emerging Role of the Pharmacist: A Cutting Edge Approach. Panelists Jack Jelly, Chief Business Officer of Pharmacist Partners, Dr. Sal Giorgianni, Men's Health Caucus Chair, and Harold Cohen, Editor-in-Chief, US Pharmacist, discussed the changing dynamics in the industry, the enhanced role pharmacists can play, and the opportunities available beyond the traditional pharma Sales & Marketing model.
|
|
Pharmacist Partners Product Launch Consulting Services
| |
Do you have a product launch on the horizon? You can rely on the collective experience and expertise of Pharmacist Partners Consulting Practice to ensure a successful market introduction. Our unique consulting methodology begins with the perspective of the pharmacist as the last point of human contact as the patient embarks on their medication journey and extends to practical applications of real-world solutions to address crucial points for launch success. The accompanying link below illustrates the depth of our expertise and the various areas of the industry that we are equipped to address - from compliance, to market research and product launch strategies.
|
Q1 Productions: Pharmaceutical Multi-Channel Marketing Strategy
| | |
|
|
March: Multiple Sclerosis Awareness Month
| |
In 2004, Serono started with 6 nurses, in it's MS Nurse Educator program. Now the program has over 60 nurse educators. Initially, the program was very much focused on the physician, with nurses describing the program and the benefits of having a professional explain to new patients how to take the therapy, the importance of staying on therapy, and to answer patient concerns.
While there was a direct impact on practice education, it quickly became apparent that patient adherence was a more compelling concern. Program strategy changed, shifting focus from the physician to the patient.
FAST FACTS: Who gets multiple sclerosis (MS)?
- More than 2.5 million people worldwide are thought to have some form of multiple sclerosis
- An estimated 400,000 people in the United States are thought to have MS
- More than twice as many women as men have MS
- Most people are between 15 and 60 years of age when diagnosed with MS, although it can also occur in young children and significantly older adults
- MS is more common in Caucasians and people of Northern European descent, but people from all backgrounds can be diagnosed with MS
Source: www.mslifelines.com
|
|
|
|
Our guiding principle is in line with our clients - to improve patient health.
The emerging biosimilars drug development market is a game changer for the entire drug development industry similar to the impact generics have had on branded pharmaceutical products. However, a final decision by the FDA regarding the regulatory pathway has not yet been delivered. The biosimilar law, under the Affordable Care Act, requires the FDA to use the same standard of "highly similar" for biosimilars as it does when approving post-approval changes to the reference product. And within this law are elements that will play a significant role in its eventual implementation - naming and interchangeability (substitution). The latter is credited as driving generic competition and ensuring economic benefits are passed to the consumer. By every account, competition from biosimilars in the biologic sector would save patients, insurers and the government billions of dollars each year in treatment costs. Estimates from various economic impact studies quantify the projected savings from $42 billion to $108 billion over the first 10 years of biosimilar market formation. Even stakeholders on the originator side - namely the biopharmaceutical companies - recognize that biosimilar competition will significantly reduce health care costs. In spite of the regulatory and economic discussion related to biosimilars there remains the issue of patient education and safety. Understanding the clinical implications, pre- and post-market approval, will be paramount to the practitioners ability to inform patients especially when the originator product or biosimilar may experience changes (structural or quality) in its characteristics thus leading to potential safety concerns over time.
Sincerely,
David
David Perry, CEO
Pharmacist Partners LLC
855-742-7611 |
|
|
|
|
