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164 articles tagged “Pharmacy Consulting”
Pharmacy technicians are an integral part of every pharmacy team as discussed in our previous posts. It is interesting to note that recently three major studies were conducted comparing error rates between Pharmacists and Pharmacy Technicians. Keeping in mind that the studies actually only evaluated
Having worked for almost three and one-half decades in the fields of Pharmacy staffing and consulting, I still find it amazing to watch the growth of Pharmacy Specialties and the Specialty Pharmacy Job Market evolve, expand and basically explode! As the roles and responsibilities of a pharmacist's d
Drug shortages are always a frustrating situation for everyone involved in patient medical healthcare: the physicians, the nurses, the pharmacists and obviously the patient. The pharmacist certainly cannot fill the prescription for a medication that is unavailable, the nurse in clinical settings can
Medication errors occur in a pharmacy under the best of conditions. However, a previous Missouri court ruling regarding a pharmacy medication dispensing error clearly shows that a lack of proper supervision, documentation and up-to-date policies and procedures will not be tolerated when the public's
New pharmacy startups and the opening of brand-new retail community pharmacies are occurring at a faster rate this year than ever before seen. Just reviewing the first three to four weeks of January this year reveals a staggering number of new retail community pharmacy businesses being opened and su
Custom Pharmacy Policy and Procedure Manual Custom P&P manuals are now a must! Every pharmacy must have written policies and procedures in a Policy and Procedure manual. According to the National Association of Boards of Pharmacy ( NABP ) every state and the majority of third party PBMs have spe
The opening up and start-ups of new retail pharmacies are once again on the rise. With the explosion of specialty pharmacies leading the list over the past decade, the number of new pharmacies that have opened across the nation rose to the highest level ever in every state during 2019. Of interest t
A new year is upon us and the pharmacy profession faces numerous issues, challenges and opportunities that are more abundant and at the same time more complex than perhaps they have ever been before in the history of the practice of our profession. New and fast paced pharmacy technological advanceme
Managing a pharmacy is an important part of almost every pharmacy owner's responsibilities. The day-to-day management of just the pharmacy's personnel, inventory, customers, vendors and store maintenance issues always seem to take up a majority of an owner's day... and the list sometimes seems endle
IV and infusion pharmacy startups are always at the top of the list when you may be considering opening up a new pharmacy business or an expansion of your existing pharmacy operation. The IV and infusion pharmacies were the primary catalyst to the emergence of both the compounding and specialty phar
Cancer and oncology pharmacies have become a major factor in the rise of specialty pharmacy startups nationwide. Because cancer and chemotherapy medications are typically extremely expensive and complex to both manufacture and compound, it is easy to see why oncology pharmacies have become a corners
The startup of mail order pharmacies is on the rise and the opening up of a mail-order pharmacy is becoming an extremely lucrative business model and investment. This specific market segment of the specialty pharmacy "arena" is undergoing rapid growth, rapid expansion, and equally rapid change. Inde
Specialty pharmacies have been designated by numerous industry experts as the fastest growing segment of the pharmacy industry. This is based on the number of new specialty pharmacies opening up nationally, plus the rise in the number of existing pharmacies expanding their operations via the additio
A customized Policy and Procedures (P & P) manual is no longer an option, it is truly a requirement. As we've previously discussed, every pharmacy is required to have and maintain a written Policy and Procedures manual on its premises. As noted by the NABP (the National Association of Boards of
After discussing the FDA's ongoing inspections of compounding pharmacies and cGMP , it seems logical to review some of the latest actions that have recently taken place (including new FDA 483 Forms and Warning Letters). Although the FDA has only published recent Warning Letters that were sent by Aug
The vast majority of compounding pharmacies that are currently operating within the United States are actually state licensed facilities that are classified as such under section 503A of the the United States Federal Food, Drug, and Cosmetic Act (sometimes referred to as either the FFDCA, FDCA, or F
Pharmacy security has recently been a dominating topic in the news. As everyone already knows, pharmacies have always been a prime target for burglaries, theft, drug diversion and robberies.With an estimated 7,000 pharmacy break-ins occurring annually in the US, this is a possibility and a risk that
Over a year ago a pharmacy audit in Colorado resulted in a payment of almost $64 million in a settlement by DaVita, Inc. DaVita is known for being a major provider in the dialysis field and in the treatment of patients with severe and chronic renal diseases. The company additionally owns a division
Any new business venture, whether it may be the actual startup of an entirely new pharmacy operation, or simply the addition of a new service line to an already existing business, must begin with a well thought-out business plan. The plan is best developed through a process of careful and thorough c
Starting up and opening a new pharmacy business is really not that much different from starting up any other type of retail operation or business enterprise. Aside from the regulations and laws inherently involved in a new pharmacy startup being planned, built and opened, the basic business startup
Management of an in-house 340B pharmacy by a hospital is often times more complex and complicated than the hospital's administrators may had initially anticipated. On the "surface" a hospital or healthcare system administrator can easily see the potential profitability that the specialty pharmacy ca
Created all the way back in 1992 as a federal program, the 340B Drug Discount Program required that all drug manufacturers provided their medications and treatments on an outpatient level to eligible HCOs (Health Care Organizations) at appreciably reduced prices. Although many people don't connect t
Exit strategies in any business are a critical requirement. Every business owner needs to think through and document exactly what their plan is regarding selling their business when it reaches a certain level or it's perhaps time for them to finally retire. Perhaps this is even more critical to do i
After the 483 Form that we previously discussed is responded to by the outsourcing facility, the FDA has the option to then send an FDA Warning Letter if they're not satisfied with the response and/or action plan that's presented to them. In March of 2019 the FDA issued such an actual Warning Letter
After discussing the difference between an FDA Form 483 and an FDA Warning Letter, it may perhaps be worthwhile to take a closer look at some of the most recent actions that have occurred (including new FDA 483 Forms and Warning Letters). Although perhaps a couple of months have already passed, but
Last month the The FDA (U.S. Food and Drug Administration) was extremely busy taking actions in regards to 503B outsourcing facilities and 503A compounding pharmacies. A review of many of these FDA 503 actions indicates an increased and aggressive program aimed at both outsourcing facilities and com
Many compounding pharmacies have been asking "what is the difference between an FDA Form 483 and an FDA Warning Letter?". The FDA (U.S. Food and Drug Administration) has been extremely busy and is dramatically stepping up their efforts at inspecting 503A compounding pharmacies across the nation. Off
GHRP is short for “Growth Hormone Releasing Peptide” and is in the category of drugs known as Growth Hormone Secretagogues (GHS). These peptides actually stimulate the body's natural release of the naturally occurring growth hormone (GH), primarily by stimulating the pituitary gland to produce more
Compounding pharmacies and 503A specialty pharmacies have been the center of FDA (U.S. Food & Drug Administration) focus ever since the tragic 64 deaths associated with the NECC (New England Compounding Center) occurred back in 2012. The 64 patients that died and the 750+ others that were injure
A lot of discussion about how FDA 503B inspections are having a huge impact on 503B outsourcing facilities and their operations. It's easy to see that being prepared with your 503B P&P manual up to date is the key to a successful inspection results and compliance audit outcomes. The Drug Quality
Specialty pharmacy startups are again at the forefront of discussions based on a recent article just released by HealthLeaders Magazine (a division of Simplify Compliance). The study states that commercial pharmacy spending in the USA has risen to a new rate that greatly exceeds the five year averag
The definition of a true consultant is an individual who is able to give you expert and professional advice. There comes a time in every business when an objective, qualified and experienced third party is necessary to help guide, direct or advise the owner or your management team. This is true for
Pharmacy Information Systems (PIS) have evolved over the years to become a core component of any successful pharmacy operation. Whether it's a hospital setting, a clinic or even a specialty pharmacy business, these complex and sophisticated computer software systems continue to evolve and their func
Why A Pharmacy Consulting Firm? In a traditional independent retail pharmacy setting, many pharmacy owners, Prescription Department Managers (PDM) and Pharmacists in Charge (PIC) ask themselves this question: "Perhaps I could use some expert advice on some of the business decisions that are being ma
Do you have Pharmacy HIPAA compliance policies and procedures at your pharmacy? Are your employees HIPAA certified? HIPAA (Health Insurance Portability and Accountability Act) is always a topic of discussion when patients start asking their pharmacists and physicians for the receipts of their medica
Dispensing errors in pharmacy are a fact of life. Even with the very best policies and procedures in place, an educated and well trained pharmacy staff performing the necessary steps to ensure safe Rx dispensing, plus an experienced pharmacist performing and overseeing the actual prescription dispen
Pharmacy owners are really no different than the owners of any other types of businesses. Everyone can agree that owning a pharmacy presents the owner with some very unique challenges and requires very specialized knowledge when compared to most other industries. However, the basic rules of running
Gag orders placed on retail pharmacies by insurance companies and PBMs (Pharmacy Benefit Managers) hopefully will soon become a thing of the past. For years now both the insurers and the PBMs have restricted pharmacists from telling their patients the truth: that it is often times cheaper for the cu
Pharmacy audits and inspections are a fact of life for every pharmacy and pharmacy owner. It is actually a pretty safe assumption to make these days that your pharmacy will be audited at a minimum of every two years. In this brand new world of computerization, shared databases of controlled substanc
Infusion pharmacies are being seen as perhaps the most lucrative type of specialty pharmacy to startup in the near future. Also frequently called IV infusion pharmacies or home infusion pharmacies, several recent studies are projecting enormous growth in the industry. What may be of critical importa
The majority of healthcare professionals in the pharmacy profession are trustworthy people who find fulfillment in providing such important services to patients and playing an important role working with the other members of the healthcare community. Everyone here at Healthcare Consultants Pharmacy
Drug disposal programs were seen as a significant step forward in the fight against the national opioid crisis when the DEA (United States Drug Enforcement Administration) announced that both pharmacies and police stations were being allowed to collect unused prescription drugs from the public to be
The closing of a pharmacy or the shutting down of a community drugstore is often times a very unpleasant experience. It normally is a very sad undertaking for everyone, including the pharmacy's owners, their staff and the patients who must now get their prescriptions transferred and filled elsewhere
Pharmacy has always been an easy target for the news media in regards to negative news stories and sensationalism. With a journalistic history for 'grabbing" the public's attention, the profession of pharmacy makes for a variety of fascinating news topics on both the national and local levels in the
Pharmacist salaries are always an important consideration when an R.Ph. is considering a job change. Although everyone agrees that it should not be the only consideration, salary is obviously a primary topic of discussion when it comes to the subjects of permanent placement or direct hire with both
VONVENDI was approved several weeks ago for an expanded use in the United States for perioperative bleeding management. The FDA (US Food and Drug Administration) approved the use of the recombinant drug to include the treatment and control of bleeding and the perioperative management of bleeding in
Compounding pharmacy fraud cases are really being targeted and cracked down on across the USA. Yet another major fraud case centered around a compounding pharmacy billing Medicare, TRICARE (the military's healthcare program) and private insurance programs has been resolved finally, once again drawin
Canadian and online pharmacies have both been controversial issues for many years now. The recent fine against Canada Drugs last Friday (April 13th of 2018) once again has placed both Canadian pharmacies and Internet pharmacies into the national news and media spotlight. Canada Drugs, an online phar