503B Outsourcing Facilities – Are You in Compliance?

Pharmacy Inspections 503BA 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 and Security Act, signed into law on November 27, 2013, created a new section titled 503B in the Federal Food, Drug, and Cosmetic Act. Under section 503B, a pharmacy compounder can become an outsourcing facility by registering with the FDA and paying a fee.

Is Your Facility in Compliance?

Once registered as a 503B, an outsourcing facility must meet specific conditions to be exempt from the Food, Drug & Cosmetics Act’s (FDCA) approval requirements and product labeling requirements. The law requires that all medications and drugs be compounded in compliance with 21 CFR Part 210 and 211 (cGMP), either by or under the direct supervision of a licensed pharmacist in a registered facility.

Are FDA Inspections For 503B Compliance Taking Place?

The FDA began inspecting all 503B facilities based on their risk level assessment. Any deviations from cGMP or other FDA requirements observed during an inspection will be documented on an what’s known as an FDA Form 483 and will lead to further FDA actions (up to and including medication and drug recalls, consent decrees, and formal litigation). Currently, there are seventy-one (71) registered 503B facilities and ALL but two (2) that have been inspected have been issued an FDA Form 483 ( accompanied by recalls of sterile products). The biggest reason for the high level of FDA actions is that the vast majority of compounding pharmacists are not trained in (nor familiar with) cGMP unless they have had significant experience in pharmaceutical manufacturing.

The FDA has recently stated that it intends to continue with their inspections of compounding pharmacies in an attempt to take aggressive actions to protect the public health.

Is Preparing or Responding to an FDA Inspection Complicated?

Preparation for an inspection by the FDA, or corrective action in response to an FDA inspection, requires experts that are well versed in FDA rules and laws, cGMP, and facility design. It is a complicated process that is designed to make sure that medications are safe and effective by making Pharmacies adhere to quality standards when compounding pharmaceuticals.

It is also important to note that the regulations are basically “minimum requirements” and that many Compounding Pharmacies utilize modern technology and documentation approaches that already go well beyond the minimum standards. Equipment, technology and risk management tools in place years ago to prevent errors and contamination may be seen as less than adequate by today’s standards (and by future standards). Basically the Quality Compounding Act of 2013 (QCA) revolves around compliance with the Current Good Manufacturing Practice (CGMP) regulations. The FDA enforces these regulations to assure proper design, monitoring, and control of manufacturing processes and facilities. This then assures the identity, strength, quality, and purity of drugs and medications to the ultimate end-users (patients and consumers). The QCA allows a pharmacy to register as a Section 503B “outsourcing facility” to be exempt from the Food, Drug & Cosmetics Act’s (FDCA) approval and labeling requirements as long as specific conditions are in place and met.

Although this is by no means meant as a comprehensive list, the following basic requirements include:
– Medications must be compounded either by or under the direct supervision of a licensed Pharmacist.
– Medications must be compounded in a registered facility.
– All products and drugs compounded at the facility during any 6 months period must be reported to the FDA.
– A detailed list about the compounded products (including source of ingredients, etc.) must be readily available for inspection.
– Multiple conditions must additionally be met, such as reporting adverse events and labeling products with prescribed information (and must be documented).

Under section 503B, a registered outsourcing facility may only use for compounding a bulk drug substance that is included on an FDA’s established list of bulk drug substances for which there is a clinical need or which are on the FDA’s drug shortage list. Prohibited under sections 503A and 503B is the compounding of drugs that are on a list of drugs that present difficulties for compounding.

Who Can Help With 503B Compliance?

As a national leader in Pharmacy Consulting for over 29 years now, HealthCare Consultants Pharmacy Staffing and Consulting can help you ensure that you are in compliance. This is a team approach and HCC is that team! HCC has experts available with many years of experience in pharmacy compounding, pharmaceutical manufacturing, cGMP design and compliance, and FDA law. Contact HCC to discuss facility and operational assessment, risk mitigation, and corrective action planning.

We urge you to contact us today to see how our Pharmacy Consulting services can help. With a full-time staff of expert in-house Pharmacy Consultant specialists, HCC can answer any questions that you may have in all areas of your business. Contact us online now or call us today at 800-642-1652 for a free consultation.


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Pharmacy #2 on LinkedIn List of Most Promising Jobs in 2017

Pharmacy #2 on LinkedIn List of Most Promising Jobs in 2017:

Recently HCC shared that according to the most recent Gallup Poll Pharmacists once again ranked at the very top of Most Trusted Professionals in regards to both ethics and honesty. Now according to a recent LinkedIn post pertaining to the Most Promising Jobs in 2017, LinkedIn revealed that it’s data has proven that the Pharmacy profession is the number two ranked most lucrative job field to be in. It was clear that the Most Promising Jobs in 2017 on the LinkedIn list were in Healthcare, Finance and High-tech industries, but a major surprise was that some jobs that paid higher salaries were far below Pharmacy on the list. Good examples were Medical Directors (median annual salary of $230,000) and Anaesthetist (median annual salary of $156,000). The median annual salary of Pharmacists was listed as $123,000. The conclusion that can be drawn is that salary alone does NOT in itself make a profession or job “promising” these days. So what exactly does?

Ranking Criteria
This is the first time that LinkedIn has revealed such findings. It was noted that the list was primarily based on a profession’s median salary, year over year increases in job openings and industry growth, plus on an individual’s potential for career advancement opportunities. Some of the actual criteria looked at included:
– Salaries across US geographical areas
– Number of job openings
– Opportunity for career advancement
– Potential for increased skill improvements
– Increased specialization in the profession
– Yearly growth of new jobs
– Education requirements to work in a particular profession
This is just a partial list of the factors taken into consideration, but the results support the fact that according to LinkedIn, Pharmacy stood out as being noted the 2nd Most Promising Profession of 2017 across the nation.

Top Pharmacist Skills In Demand
It is also interesting to note that the LinkedIn data revealed that top skills in the Pharmacy profession that were in demand included:
1. Medication and Drug Utilization Management
2. Community Pharmacist Skills (both independent and chain-store Pharmacy roles)
3. Patient Counseling and Education Experience
4. Patient Immunization Skills
5. Pharmacy Automation Experience and Experience
It was noted that this particular data was actually taken from LinkedIn members individual profiles (and then compared to the actual Pharmacy business profiles).

What This Means To Us As Pharmacists
According to Daniel Shapero at LinkedIn, “job hopping has nearly doubled in the last 20 years, and is only accelerating. Based on our research, we know that the top reasons people change jobs is to pursue a stronger career path, make more money or access more opportunities within their organization. Finding a job you love with one or more of these components can feel like a challenge.”
So if any of these reasons to explore new Pharmacy opportunities appeals to you, here are some suggestions that you may want to consider trying (note that we had published these tips in an older post, but they are worth taking a new look at!):
1. Attend a CE Class – Many of us do our CE online or from a Pharmacy publication. Consider attending a CE class and meeting some new people or spending time with old friends. The social aspect of attending may stimulate you to consider adding new skills or answer any questions about a particular job setting. If not a CE class, perhaps a business class or another area of interest may do the trick for you.
2. Attend a Conference – There are numerous national, state and local conferences always going on. Meet some new people while learning about new opportunities and skills. Many Pharmacists find that they can get both a vacation (maybe with your family also going?) and get great information by attending.
3. Network with Local Pharmacists – Find pharmacists in your area who are willing to get together once a month or quarterly. Maybe it’s as simple as a regularly scheduled get together for dinner or drinks. Find some like-minded professionals interested in learning more about the industry, and take time to listen to their advice and experiences. You’ll be surprised how much you can learn from others.
4. Read – Sometimes it can be as simple as just reading! Learn about areas of Pharmacy that may interest you or perhaps find a “self help” book to get stimulated to take some positive action. Whatever you personally find interesting, there’s a book, blog, forum or article out there for you read.
5. Talk It Out – Before making any major decisions, take the time to discuss your options with a close friend or family member. Lunch or dinner with a peer can never hurt. Perhaps choose a trusted adviser in another Pharmacy role and find out their views regarding the pros and cons regarding their job and employer. It never hurts to hear it directly “from the horses mouth”.
6. Try it out if you can – If you are perhaps considering changing from your current Pharmacy job to another, maybe look into picking up a shift in a similar setting. Considering switching from Retail Pharmacy to Hospital Pharmacy? See if you can pick up a shift in a local Hospital Pharmacy and “test drive” the job before you switch.

If you are considering a Pharmacy job change, remember that whatever setting a pharmacist is looking to work in, HCC can help you! Our pharmacy positions and staffing availability cover all aspects of job types and specialties: retail, hospital, clinical and specialty pharmacies. Pharmacy staffing and job placement are our primary business now for over 27 years. Healthcare Consultants Pharmacy Staffing deals with all aspects of matching pharmacists to jobs in every type of situation. This includes filling short term pharmacy positions and temporary jobs, as well as permanent and long term placements. We also can help with temp-to-permanent situations. We offer solutions for almost every type of pharmacy job you may be looking for:
– Compounding pharmacy and pharmacist
– Nursing Home & Long Term Care pharmacy and pharmacist
– Institutional (prisons and jails) pharmacy and pharmacist
– Hospice pharmacy and pharmacist
– Mail-order pharmacy and pharmacist
– Home health pharmacy and pharmacist
– Respiratory pharmacy and pharmacist
– IV pharmacy and pharmacist
– Nuclear pharmacy and pharmacist
– Home infusion pharmacy and pharmacist

If you are a pharmacist looking for a new position (or simply looking for part time opportunities to earn more cash), we urge you to talk with us. With placement positions immediately available, contact us today online or call us at 800-642-1652 to get started.


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Pharmacy Medication Drug Take-Back Program

Pharmacy Medication Drug Take-Back Program:

As most of us know, Drug Enforcement Administration (DEA) regulations now allow retail pharmacies, among others, to collect controlled and non-controlled pharmaceutical drugs and medications from consumers by using take-back programs. The DEA even has a great tool on it’s website that allows visitors to search for the nearest participating Pharmacy by using their zip-code:
https://apps.deadiversion.usdoj.gov/pubdispsearch/spring/main?execution=e1s1

Deaths due to drug overdoses are now the leading cause of “non-disease” deaths  in the United States according to 2015 statistics released by the DEA. This places drug overdose deaths ahead of car accidents, guns and firearms and all other “injury deaths”. It is, however, important to note that alcoholism and drug addiction are recognized as a disease by the American Medical Association since 1956, therefor eliminating the controversial topic of addiction being a “moral” issue. According to statistics (http://www.aafp.org/afp/2003/0401/p1529.html), 10% of Americans abuse drugs/alcohol and up to 20% of all patients treated by doctors have some sort of substance abuse problem (not counting caffiene or nicotine). The National Institute on Alcohol Abuse and Alcoholism (NIAAA) estimates that alcohol and drug abuse cause 100,000 deaths annually with an associated cost of over $100 billion to the US economy (https://www.niaaa.nih.gov/).

Pennsylvania State Board of Pharmacy Asks For Help
In December the Pennsylvania State Board of Pharmacy sent an email to all Registered Pharmacists in their state that is worth talking about. It was noted (again from the DEA statistics released in 2015) that over 3,500 Pennsylvanians died of drug overdoses. To fight this opioid crisis, the Board made a strong case that all healthcare professionals need to increase our efforts on informing the public on how to prevent and treat the disease of addiction. Additionally, it was duly noted that the installation of drug take-back boxes is one way Pharmacies in particular can fight against the opioid crisis.

The Problem With the Pharmacy Medication Drug Take-Back Program

As most Pharmacists see it, the problem is two-fold:
1. The participation by a Pharmacy is not mandatory in all states. Perhaps it should be, but the issue of cost is a major concern. In those states considering legislation mandating take-back programs in all pharmacies, resistance from state pharmacy organizations point out that the pharmacies should not be responsible for the program costs. One California county actually passed legislation placing the costs on the drug manufacturers. However, the pharmaceutical industry challenged the law and it was struck down by a federal court of appeals. Everyone agrees that the public needs the way to safely dispose of medications, but no-one can agree on who should pay for it. Until this issue is addressed, the number of Pharmacies participating in the program will be very limited.
2. Local police and law enforcement facilities in Pennsylvania also have medication drug take-back boxes. There are more than 500 such drug take-back boxes located in police stations around the state. It is simply more convenient for Pharmacies to direct patients to the local police and law enforcement facilities than to have to handle the return of the unwanted, unused or expired drugs themselves (and the paperwork involved).

What Pennsylvania Asked Pharmacies To Do


– Register with the DEA as an authorized collector and purchase a safe drug take-back box for your location.
– Stock and/or supply drug deactivation packets such as the Deterra Drug Deactivation System or Disposa-Script to make available to your customers.

Whatever the obstacles, the intent of the Pharmacy Medication Drug Take-Back Program is to provide a safe, convenient, and responsible way for consumers to get rid of  their unwanted, unused or expired drugs while also educating the general public about the potential for abuse of medications. It is the responsibility of all Healthcare professionals to participate as best they can in helping fight the “opioid crisis” that is hurting our nation and society.

As always, HCC is here to help you in any way that we can. Contact us online or call us today at 800-642-1652 to discuss how we can help you (or just if you’d like to talk about any idea that you may have regarding Pharmacy!). Healthcare Consultants is a nationally renowned full service Pharmacy staffing and consulting firm that has been in business for over 27 years. Owned, managed and staffed by full-time in-house Pharmacists, HCC offers a full range of Pharmacy Staffing & Placement, plus is noted for our Pharmacy Consulting Services that other firms simply cannot offer.


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Georgia Hospitals Penalized By Medicare

Georgia Hospitals Penalized By Medicare:

The Hospital Readmissions Reduction Program was enforced this week in Georgia when nearly 25% of all hospitals were penalized for unacceptable rates of patient injuries after discharge. Created by the Affordable Care Act to reduce hospital readmissions, the result is about a 1% loss of each hospital’s Medicare payments (this is based on previous penalties which resulted in a Medicare payment reduction of roughly 0.6%/patient stay, but hospitals could receive a maximum reduction of 3%). Designed to decrease the costs of patient readmissions and give hospitals “incentive” to pay attention to patients following discharge, this will effect 31 out of the 134 hospitals in Georgia (bringing the total number of hospitals penalized to a staggering total of 2,623). It is important to note that so far over half of all hospitals in the USA have been penalized, but the majority of those that have avoided penalties were not based on good patient readmission numbers, but because they were exempt from being evaluated! If a hospital meets certain criteria such as being designated a critical access facility or specializes in kids and/or veterans then they are not evaluated or subject to being penalized. Additionally are the hospitals that actually dealt with too few patients for what Medicare considered “accurate assessment” numbers.

Although it was actually a total of 31 Georgia hospitals (out of a total of 134 in the entire state) that were noted as having an excessive number of complications and patient injuries, only 13 received a penalty regarding Medicare. The hospitals that were penalized over the last three years by Medicare were:
– Memorial University Medical Center (located in Savannah)
– Tift Regional (located in Tifton)
– Candler Hospital (located in Savannah)
– AU Medical Center (located in Augusta)
– Southern Regional Medical Center (located in Riverdale)
– WellStar Atlanta Medical Center (located in Atlanta)
– WellStar Kennestone (located in Marietta)
– Piedmont Hospital (located in Atlanta)
– Piedmont Athens Regional (located in Athens)
– Crisp Regional (located in Cordele)
– Emory University Hospital (located in Atlanta)
– Grady Memorial (located in Atlanta)
– Meadows Regional in (located in Vidalia)
These hospitals will each lose 1% of their entire payments received from Medicare for one year (starting from October 2016). It is important to note that the reason was stated as an extremely high level of patient complications that included blood clots, serious infections, bed-sores and accidents such as falling.

The downside to this according to Kaiser Health News is the fact that the penalties also will reduce the amount of funding that each hospital receives for teaching medical residents and for providing low income care to patients. Additionally, some of these hospitals could potentially be financially impacted and hurt if more patients become aware of this situation and safety data. Patients could start to avoid hospitals that have been punished for low performance.

Whether you are for or against the Affordable Care Act, the fact of the matter is that it is currently the law and being enforced. What many find objectionable (obviously including all of the hospitals involved) is the fact that the Affordable Care Act actually mandates that Medicare penalize 25 percent of all hospitals. Many hospitals involved point out that they have made great strides in relation to improving patient safety, but that the Act forces them to be penalized anyway. Although everyone agrees that “hospital acquired conditions” have been reduced since 2010 (the year the Affordable Care Act was passed), the federal AHRQ (Agency for Healthcare Research and Quality) estimates that there were still 3.8 million hospital injuries last year. That translates to 115 injuries during every 1,000 patient hospital stays during that period.

As always, HCC is here to help you in any way that we can. Contact us online or call us today at 800-642-1652 to discuss how we can help you (or just if you’d like to talk about any idea that you may have regarding Pharmacy!). Healthcare Consultants is a nationally renowned full service Pharmacy staffing and consulting firm that has been in business for over 27 years. Owned, managed and staffed by full-time in-house Pharmacists, HCC offers a full range of Pharmacy Staffing & Placement, plus is noted for our Pharmacy Consulting Services that other firms simply cannot offer.


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2017 Pharmacy Focus, Challenges & Opportunities

Pharmacy Focus, Challenges and Opportunities in 2017:

A new year is here and Pharmacy issues, challenges and opportunities are more abundant and complex than ever before. New Pharmacy advancements and rapid changes in disease treatments, legislation, insurance issues, media attention and a more informed patient have certainly resulted in one significant fact: the roles that Pharmacists play as part of the Healthcare Team are both expanding and becoming more demanding on our skills. The result is that Pharmacists are being challenged now more than ever to be at the “center” regarding total patient care. A Pharmacist’s role is no longer focused only on their expertise regarding a patient’s medications, but as perhaps the central player in ensuring a patient’s well being. This means both increased involvement with all other Healthcare professionals, as well as increased communication with physicians, nurses, ancillary healthcare staff, caretakers, insurance companies and of course, the patient and the patient’s families.

The vitally important role that we at HCC see the Pharmacist playing now (and ever increasing in the future) is one of being both the “communicator” and the “educator”. One of the reasons this is taking place is that if you drew a diagram of all the healthcare roles and functions that are involved in ensuring great patient care, the Pharmacist is in many cases at the center. It is the Pharmacist who must ensure that there is always an accurate flow of information taking place between many of the healthcare team members, and then again it is the Pharmacist who often times is the one communicating directly with the patient and their family members. This not only relates to medications and making sure that factors such as accuracy of dosages, appropriate choice of medication for individual patients, correct administration instructions, checking for adverse drug interactions, adequate counseling and of course compliance all take place. The real focus has become education. After all, who is the real expert on drugs and medications? Once again the most recent Gallup poll shows that Pharmacists are at the top of the list for the most trusted professionals (see Gallup Poll). The public respects a Pharmacist’s knowledge, ethics, expertise and opinions. Add to this that studies have shown that patients are “more likely to be honest when talking to their Pharmacist versus their doctor”. This was related to the fact that most patients interacted with their community Pharmacist much more often than with their physicians or other healthcare providers on a “routine basis”. One example cited was a patient who had a total of 11 different physicians! Additionally, the point can be made that the specialization of physician care has led the public to view doctors as “only focusing on their piece of the overall picture” and leaves the Pharmacist as the “overseer” who manages the entire patient care. This can be especially true when settings such as clinics and large multi-staff physician practices are involved.

The point is that a Pharmacist’s role is no longer viewed as simply as being a “pill counter, placing a label on the bottle and then being a cashier”. As a profession we are now responsible for counseling patients and increased communication with an expanding number of other healthcare team members. This direction is a “must’ for each of us to undertake in order to ensure increased patient medication compliance and build the best healthcare aviabale. This means expanding our own skills and education to perform tasks that perhaps many of us never did before (Pharmacogenetic testing is a great example as discussed in one of our recent posts – Pharmacogenetic Testing in Community Pharmacies. Physicians, related healthcare practitioners, insurance providers and especially patients are demanding this of us. It is interesting to note that of the 10 “Top-Read Health-System Articles in 2016” on Pharmacy Times , over half were about patient and/or physician counseling and communication regarding specific diseases and the Pharmacists role as a “team member”.

2017 is an exciting time to be practicing Pharmacy! The opportunities for us as both individuals and as a profession are almost limitless. Plus they are increasing at a rate never seen before. It is our choice to each participate and play a major role in this “revolution” in US healthcare, or to “sit on the sidelines” as an observer. I hope we all choose wisely.

As always, HCC is here to help you in any way that we can. Contact us online or call us today at 800-642-1652 to discuss how we can help you (or just if you’d like to talk about any idea that you may have regarding Pharmacy!). Healthcare Consultants is a nationally renowned full service Pharmacy staffing and consulting firm that has been in business for over 27 years. Owned, managed and staffed by full-time in-house Pharmacists, HCC offers a full range of Pharmacy Staffing & Placement, plus is noted for our Pharmacy Consulting Services that other firms simply cannot offer.


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USP <800> Pharmacy Compliance

USP <800> Pharmacy Compliance:

Back in March of 2014 the USP (US Pharmacopeial Convention) published yet another intensive set of guidelines regarding the handling of hazardous drugs and their preparation with the release of USP <800> Pharmacy Compliance. Many Pharmacists still remember the 2008 release of the update to USP <797> and we have numerous clients who implemented the changes required for compounding hazardous medications so that the result is a sterile parenteral product. The initial attempt in 2008 was a step in the right direction, but fell short by not having non-parenteral compounding guidelines. Even so, <800> was then hotly debated, criticized and revised. Finally on February 1, 2016, USP <800> was approved. Now implementation of <800> for handling hazardous drugs in all health care settings is a must. Yet after 10 months many Pharmacies and compounding facilities are asking how.

The need for such guidelines is not in question. All prior evidence linked the handling of hazardous drugs to increasing a workers chances for cancer and reproductive issues (as well as the birth defects that have been well documented). Add to this all the media attention over the past few years regarding the FDA and hazardous drug contamination from several specialty pharmacies that resulted in meningitis and patient deaths. The risks of handling hazardous drugs have been known since the early 1980s. The problem that a Pharmacy faces is the never ending changing of these regulations. It has been documented that so far there have been over seventeen guidelines published by six separate Federal agencies and other Healthcare organizations!

Legal Issues –
USP <800> is both a State & Federal standard. What that means is that inspections by both State Boards of Pharmacy and the FDA can cite a Pharmacy for non-compliance. Although compliance is mandatory, the issue is that “current legislation governing sterile product compounding is a patchwork of state-specific regulations with wide variations between jurisdictions” according to a recent article in Pharmacy Times. As the article notes, even though USP <797> is legally enforceable and the industry standard despite state legislation, less than half of state regulations specifically reference USP <797> for sterile compounding.

So far no inspections have occurred that we are aware of regarding USP <800> compliance. However, State Pharmacy Boards have conducted inspections ensuring compliance with USP <797> standards (Florida, California, Texas and Minnesota).

Current legislation governing sterile product compounding is a patchwork of state-specific regulations with wide variations between jurisdictions” according to a recent article published in Pharmacy Times

Actual Changes That Need To Be Implemented ASAP –
Basically USP <800> deals with hazardous drug manufacturing, including such key elements as compounding, preparing the drugs, storage, transport, product storage, compounding, preparation, and administration of parenteral and non-parenteral products. Obviously compliance is mandatory and will be enforced. So the question we all face is: Where do I start?

The core of the changes may actually cause many Pharmacy operations to actually have to change their workflow patterns. Additionally, the equipment specifications may require capital expenditures that will pose a major cash flow problem to many Pharmacy businesses. Although not intended as a legal summary of the USP <800>, here are the key points to focus on:

  1. Compounding, preparing & storing hazardous drugs must occur in an designated area that is separate from areas that non-hazardous drugs are dealt with and stored. Just as an example of the costs that may be involved in being compliant, negative pressure rooms intended for hazardous drug preparation & compounding cannot be used for non-hazardous medication compounding., USP <800> requires pharmacies to utilize a totally separate negative pressure room (plus an additional primary engineering control system) to be compliant!
  2. All hazardous medications are now required to be administered with the use of a CSTD (closed-system transfer device). This is to ensure safety to both nurses who administer the drugs, as well as the patients.

A 2014 study on USP <797> found that many Pharmacies were not compliant. The primary reasons cited were:

  • Financial and budgetary: 27%
  • Physical space limitations: 21%
  • Lack of training resources: 19%
  • Time restraints: 15%
  • Lack of management & leadership support: 5%

So the time to get compliant is now! Don’t put off putting together a Compliance Plan & Strategy until legal issues force you to. As always, please contact us here at HCC if you have any questions regarding this. With over 27 years in the Pharmacy Consulting business, HCC can assist with expert advice in any area of your pharmacy business or practice. We urge you to contact us today to see how our Pharmacy Consulting services can help. With a full-time staff of in-house Pharmacy Consultant specialists, HCC can answer any questions that you may have in all Pharmacy settings. Contact us online or call us today at 800-642-1652 for a free consultation.


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Medicare D Reform for Independent Retail Pharmacies

Medicare D Reform for Independent Retail Pharmacies:

Pharmacy Benefit Manager (PBM) companies have become a major concern for the independent Pharmacy businesses and owners that we have as clients. We at HCC fully support independent retail Pharmacies and everyone can agree that they are a vital part of every community. However, some recent policies and rules generated by several PBMs are seen as a threat to the operation and survival of independent community Pharmacies throughout the country.

The PBM essentially acts as a third-party administrator (TPA) regarding prescription drug programs. These plans include Medicare Part D, as well as many commercial corporate health plans, self insured plans, and for many government employee plans (on both the State and Federal levels). According to APhA’s (The American Pharmacists Association) description: “PBMs are primarily responsible for developing and maintaining the formulary, contracting with pharmacies, negotiating discounts and rebates with drug manufacturers, and processing and paying prescription drug claims. For the most part, they work with self-insured companies and government programs striving to maintain or reduce the pharmacy expenditures of the plan while concurrently trying to improve health care outcomes.” It is estimated that nearly 300 million people in the United States are currently affected by a PBM managing their pharmacy benefits. It must also be noted that there are currently about two dozen existing “major” PBMs (although a total as high as 60 has been referenced several times), but that the 3 “Super PBMs” account for roughly 80% of the entire market  and have almost 200 million patients enrolled.
The 3 “Super PBMs” are:

1. Express Scripts
2. CVS Health (formerly CVS Caremark)
3. United Health (also referred to as OptumRx & Catamaran)

The intent of this post is not to build a case against PBMs, but to point out that perhaps some reform is necessary for independent community Pharmacies to be able to make a profit and continue to thrive in our communities. The intent of PBMs is to maximize the purchasing power for large groups of patients, resulting in a reduction in their prescription drug prices. This is accomplished through volume buying, pharmaceutical manufacturer rebates and pricing discounts at participating retail pharmacies and drug stores. So far no independent study has shown this to be happening. A study often cited by PBMs in 2015 by CVS claimed a reduction of 6.8% for its members, but so far this has not been independently substantiated. The fact that in 2015 there were seven lawsuits filed against PBMs (for antitrust violations, fraud and criminal negligence) has not helped the situation. Additionally, at a 2014 ERISA hearing (Employee Retirement Income Security Act) it was clearly pointed out that PBMs in many instances pose “conflicts of interest” regarding providing consumers reductions in their prescription drug spending.

Now a Pharmacist is taking some action by initiating a Medicare D Reform Petition. Jae K. Shin, the managing pharmacist of Jays Drug and director of Jays Diabetes Education Center in the greater Los Angeles is asking all Pharmacists to officially go on record and support his petition. Although his email in it’s entirety is too long to include, here are the foundation points that Mr. Shin provided:
*Please see http://www.ckapha.org/174105 where his entire email is posted.

1. PBM companies reimburse rate are extremely low, be reflected fair pharmacist dispensing fee.
2. Pharmacy dispensing fee should calculate by AWP, not Direct Price(partial items are not returnable and there are many medication need special care with cost)
3. Pharmacy does not need unreasonable accreditation or attestation.
4. PBM should not take any amount of fund from pharmacy account, such as Dir or other weird rank order.
5. PBM company should not treat differently with independent pharmacy, such as preferred plan which is no copay if they go their own chain pharmacy.
6. Pharmacy are no need accreditation for special drugs.
7. Pharmacy wants eliminate abusive pharmacy audit from PBM companies
8. Pharmacy want to return the high cost of old generic drugs which raise the price recent years.(one of old generic drug Colchicine 0.6mg was $5.00 for 100 tablet, not name changed same medication are $200.00 for 30 tablet.)
9. Pharmacy want to reform Medicare D plan more simple and better understanding module. The coverage should apply equally to individual recipient.
10. How pharmacy chain can have PBM company. (If chain pharmacy doesn’t own PBM company, then chain pharmacy fight for low reimbursement and also this PBM company no need to treat differently for their patient to go their own chain pharmacy.)
If you support this petition, Mr. Shin asks that you fill out the following information and send it to him via e-mail (jaysrx@gmail.com) or fax it to him at (805) 388-5889. He also provided his phone number for contacting him: (323) 810-3360.

Name of Pharmacist:
Name of Pharmacy:
Address:
Telephone No:
Fax No:
E-mail address, if available:

As always, please contact us here at HCC if you have any questions regarding this. With over 27 years in the Pharmacy Consulting business, HCC can assist with expert advice in any area of your pharmacy business or practice. We urge you to contact us today to see how our Pharmacy Consulting services can help. With a full-time staff of in-house Pharmacy Consultant specialists, HCC can answer any questions that you may have in all Pharmacy settings. Contact us online or call us today at 800-642-1652 for a free consultation.


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Pharmacogenetic Testing In Community Pharmacies Best Practices – Pharmacy Consulting

Pharmacogenetic Testing In Community Pharmacies Best Practices:

Pharmacogenetics is getting a lot of media attention and becoming a new term that patients are asking their Pharmacists about (plus performing a lot of research on their own). In a recent article in Pharmacy Times, the author states that over the past several years “Pharmacogenetic testing in community pharmacies has become more mainstream”. It has also been stated numerous times recently that Pharmacogenetics is becoming the primary basis or foundation for the shift towards personalized medicine and medication prescribing.

So what really is Pharmacogenetics? As Pharmacists, what do we need to do to help it be effective in helping our customers and patients?

The definition of Pharmacogenetics is basically centered around the fact that an individual patient’s genetic makeup can lead to different individual responses to certain medications. These genetic differences can lead to increased or decreased effectiveness of the drugs, plus also have an influence on the adverse side effects associated with certain medications. Pharmacogenetics is just one aspect of what is being called “Personalized Medicine” (where medications are tailored to each patient based on a model that places the patient into groups that result in a predicted response regarding response, dosage and risks).

The key to success we believe here at HealthCare Consultants is education and communication. This education and communication includes everyone: Ourselves as Pharmacists, the physicians prescribing the medications and, of course, the patients themselves. For the best results in a community Pharmacy setting, this translates into increased counseling with our patients and increased communication with the prescribing doctors regarding pharmacogenetic test results. Studies are already showing that without proper counseling by a Pharmacist, patients who receive their genetic test results showed a tendency to self-adjust or discontinue their medications due to misinterpretation of the test results.

Those who choose to be participants in the success of Pharmacogenetic testing in community pharmacies need to ask themselves the following questions:

-How will I communicate to my patients the basics of Pharmacogenetic science and drug metabolism in a way that the average patient can comprehend?
– Where will I find the most up to date Pharmacogenetic guidelines?
– How will I get started and keep myself educated on Pharmacogenetic testing?

HealthCare Consultants can help you establish the guidelines, strategies and procedures required for a community Pharmacy to be a success in the emergence of Pharmacogenetic testing.  Although this is not intended to be a comprehensive list of guidelines, the basic strategies include:

1. Communication with the patient’s Physician – Collaborate with the patient’s primary care provider in order to personalize the patient’s medication and become part of the “team”.
2. Assessing the patient’s knowledge on genetics and communicating to each patient individually on their level.
3. Providing the patient adequate disclaimers so that they comprehend that taking medications based on a Pharmacogenetic test does not mean that they are free of adverse effects or that they will be 100% effective.
4. Training the patient on how to use the test results (as basically these results can be reused by the patient throughout their life).

If you are interested in getting more information regarding Pharmacogenetic testing for your pharmacy, please contact us on line or call us today for a Free Consultation at 800-642-1652 to discuss how we can help you. Healthcare Consultants is a nationally renowned full service Pharmacy staffing and consulting firm that has been in business for over 27 years. Owned, managed and staffed by full-time in-house Pharmacists, HCC offers a full range of Pharmacy Consulting Services that other firms simply cannot offer.


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Pharmacy Home Delivery Services (Continued)

Pharmacy Home Delivery Services:

In a recent blog post we discussed the fact that Pharmacy Home Delivery services were on the rise nationally. We all know that Pharmacy Home Delivery is really not anything new, but has been a service primarily utilized by the major Pharmacy Mail Order Houses and several of the large Pharmacy Chains for well over a decade or more. As we always urge our clients to explore additional revenue streams for their business, the addition of Pharmacy Home Delivery services has been proven to be a “value added service” that has vastly increased customer retention, acquisition of new patients and led to increased profits.

In our recent post we alluded to a consumer survey that was conducted by the nationally renowned firm JD Powers on the subject of Pharmacy deliveries and how patients and customers viewed the trend. The survey showed that without a doubt the majority of consumers nationally viewed Pharmacy Home Delivery as a positive, plus overwhelmingly agreed that in the future this would be the norm for the industry. However, the JD Powers study also revealed what has kept many patients & consumers from utilizing Pharmacy Home Delivery Services at all (and prevented customers from using them more frequently). Consumer resistance to Pharmacy Home Delivery of their medications becoming the standard basically centered on three areas:

1. Patients stated clearly that they have justified fear regarding delivery dates. Most of the vendors were not local, but spread “far away” and basically shipping the patient’s medications and supplies from “out of the state”. This was backed up by the fact that studies have shown that up to 5% of deliveries nationally do not actually occur as scheduled. Add into the equation the fact that both FedEx and UPS are affected by the weather and seasonal considerations, and one can understand the hesitancy expressed by consumers. Especially those that are on medications that cannot have dosages missed. As we all sometimes joke, who really believes the date we get at the post office regarding deliveries around Christmas time?
2. Not only were the vendors located elsewhere and “out of state”, patients expressed fear that the vendors were “too large”. Many asked the same question: “Can you imagine trying to get an actual person on the phone to discuss a problem with or talk to?”. Many shared from previous personal experience that the mail order houses and major Pharmacy chains were too large and that as a customer they felt they were just another “number’ to them. In contrast, their local Pharmacy “promotes a personal touch” and treats them as neighbors and community members.
3. Only a local Pharmacy could respond quickly enough to certain situations that arise: providing such medications like antibiotics & pain killers quickly (as that they are obviously not things that you can wait on), plus making dosage adjustments in a timely manner which is critical in many instances. Tying into this is the fact that the local Pharmacists are familiar with the local physician community (which again is impossible for Mail Order houses and large chains which are centralized in various parts of the country or in some cases actually located in another country!).

The point to all of this is that the addition of Pharmacy Home Delivery services to YOUR Pharmacy business will lead to increased customer retention, acquisition of new patients and increased profits. BUT customers are informed and aware of the negatives. So HCC urges you to do it right! Call today and one of our experienced Pharmacy consultants will discuss how to overcome these challenges AND plan, execute and maintain a “First Class” Pharmacy Home Delivery Service for your patients and Pharmacy business!

Healthcare Consultants is a nationally renowned full service Pharmacy staffing and consulting firm that has been in business for over 27 years. Owned, managed and staffed by full-time in-house Pharmacists, HCC offers a full range of Pharmacy Consulting Services that other firms simply cannot offer. Contact us on line or call us today for a Free Consultation at 800-642-1652 to discuss how we can help you.


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Pharmacy Robberies and Burglaries on the Rise – Develop Emergency Policies & Procedures

Pharmacy Robberies and Burglaries on the Rise:

Pharmacies have always been a target for robberies and now, pharmacy robberies and burglaries on the rise. As Pharmacists ourselves we have realized that this is a possibility and a risk that everyone in our profession constantly faces. We may all do our best to put it out of our focus and concentrate on our day-to-day daily routines while at work. We sometimes think that although the possibility exists, this is something that happens frequently but not to us!

However many robberies and burglaries we hear about, sometimes there are particular ones that grab our attention. In Illinois last week there were two related robberies that can only be described as “bizarre”. In both cases the Pharmacy robberies involved a man and woman wielding hypodermic needles that they claimed were contaminated with HIV.

The initial robbery took place at a CVS Pharmacy in Niles, Illinois last Monday morning (11/14). The second case took place the following morning at a CVS store in Naperville, Illinois according to separate press releases issued by the police.

In the initial incident a man and woman entered the Niles pharmacy and stole OTC medications, concealing them inside backpacks. When a CVS employee approached them, the man threatened the employee with a syringe he claimed was contaminated with HIV. The suspects left the pharmacy and fled with about $600 worth of medications.

The next case occurred at the Naperville CVS Pharmacy. Once again a man and woman brandishing an HIV-contaminated syringe threatened store employees and stole numerous medications before fleeing.

Recently it seems that all the Pharmacy news we read is filled with an increase of stories regarding burglaries and robberies of Pharmacies. In the past month alone we all have seen almost daily reports of Pharmacy break-ins and burglaries. This dramatic increase of robbery and burglaries always seems to cycle come Holiday season!

Are you and your Pharmacy prepared to deal with situations like these? As I stated earlier, no-one thinks that these situations will happen to us or our Pharmacy businesses, but these are truly examples of the old cliche “an ounce of prevention is worth a pound of cure” being applicable. Do you have policies and procedures written for your business and employees to act on if such a crisis arises? Do you have inventory policies in place to help determine what was taken during a burglary? Do you have training in place to help your employees in these situations that will minimize your possible liabilities? If the answers are no, then contact HCC Pharmacy Staffing to see how we can help you.

Healthcare Consulting has been a full service Pharmacy staffing and consulting firm that has been in business for over 27 years. HCC has been helping Pharmacies plan, prepare and deal with such crisis situations since 1989. Just a few examples of our services include:

– Development of Policies and Procedures
– Employee Crisis Training
– Inventory Management
– Pharmacy Management Consultation

Although we all hope that we will never personally deal with such situations, I strongly urge you to be prepared. Contact us on line or call us today for a Free Consultation at 800-642-1652 to discuss how we can help you.


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