Pharmacy Regulatory Compliance

Regulatory Compliance for Pharmacies
How to prepare for, survive, and recover from a regulatory inspection
　
There was a time not too long ago when a pharmacists’ sole concern was getting the right drug to the right patient in a timely manner. Though patient safety and accurate medication dispensing is still paramount, the pharmacists attention is increasingly drawn to compliance with an ever growing array of rules and regulations from numerous agencies. One is hard pressed to find another profession as highly regulated by as many different agencies as pharmacy. The pharmacy manager and owner must be familiar with all applicable rules from the Board of Pharmacy, Agency for Health Care Administration, Drug Enforcement Administration, Office for Civil Rights (HIPAA), Center for Medicare and Medicaid Services, and most third party payers. The pharmacist manager (Pharmacist in Charge – PIC) of record is directly responsible for the pharmacy’s adherence to all of these rules, regulations, and laws. Therefore, the PIC must have a plan and a process by which he can assure his pharmacy’s compliance. If this is left to the day of an official inspection, unfavorable results can be expected.
The pharmacy must always be prepared and ready for any inspection since rarely is there advanced notice of an official visit by an inspector. Effective preparation starts with the pharmacy’s policy and procedure manual. Most pharmacies have only a rudimentary manual that is generic in nature. The PIC must establish a periodic review of the P&P manual to assess and update this document so that it reflects the normal and routine activities of the pharmacy. Any in depth inspection or investigation will use the pharmacy’s P&P manual as the benchmark for review of the pharmacy’s actions. Furthermore, vague or non existent policies will make it much more difficult for pharmacy management to defend its actions in any type of legal proceedings.
As part of the P&P manual, job descriptions, responsibilities, and task lists for each position are necessary. Every employee of the pharmacy must be given a copy of their job description and be made aware of their roles and responsibilities. This should create a framework of accountability. Task lists, especially related to regulatory issues, should be posted conspicuously to promote compliance. In addition, regulatory requirements and compliance should be discussed with pharmacy staff routinely, such as during the CQI meetings.
Of course the only sure way to determine compliance to P&Ps and regulatory requirements is through auditing. The PIC must routinely conduct spot checks of all records and logs since the majority of deficiencies identified during inspections are related to poor or incomplete record keeping and documentation. In addition, the PIC should also conduct periodic mock inspections to assess overall compliance. The results should be shared and discussed with the pharmacy staff and a corrective plan developed for any identified deficiencies. This process will establish the importance of compliance and promote awareness and self monitoring by the staff for their assigned tasks.
Typically, a pharmacy can expect an unannounced, routine annual inspection by ACHA as mandated by the Board of Pharmacy. This inspection will generally occur within a two month window around the anniversary of the previous inspection (check the pink copy of the last inspection sheet for the date). The PIC should educate the pharmacy staff in how to interact with an inspector during a survey or investigation to limit any stress or miscommunications. When the ACHA inspector arrives, the PIC or senior pharmacist on duty should greet and accompany the inspector during the inspection. As difficult as this may be in a busy pharmacy, a helpful and knowledgeable pharmacist can defuse many potential problems that might otherwise evolve into a citation or complaint. Attitude and appearances have a great influence on the inspection process. Usually, if the pharmacy is neat and orderly, and the requested records and materials are organized and easily retrievable, the inspection will go quickly. However, if the pharmacy is disorganized and records are scattered or difficult to locate, the inspector will assume that this level of disorder is standard and will be much more thorough in their survey.
If an investigation or search pursuant to a warrant occurs, it is imperative that the PIC or senior pharmacist cooperate fully and contact the pharmacy owner immediately. The owner should then contact their legal council and try to have them present for this event. Be mindful that statements made to the investigators will be part of the investigative report. If possible, try to defer any detailed statements until legal council is present.
After the conclusion of the inspection or investigation, the PIC will have a reasonably clear understanding of what, if anything, must be addressed. At the end of a routine inspection, the inspector will provide the PIC or senior pharmacist with a copy of the report. If a few minor deficiencies where identified the inspector may require that they be addressed with a corrective action report and a subsequent re-inspection. If the deficiencies found where numerous or considered significant, the inspector may open a complaint against the pharmacy and PIC. This complaint will be reviewed by the ACHA field supervisor and forwarded to the BoP Probable Cause Panel for further review. If probable cause is found by the BoP, an administrative complaint will be issued to the Pharmacy and the PIC. Both will have 20 days in which to respond. This process may take several weeks or months to arrive at this point. Therefore, if the PIC suspects that a complaint may evolve from the inspection, legal council should be advised as soon as reasonable. The PIC in conjunction with legal council should document the circumstances involving each deficiency and any corrective action taken in order to better prepare for a response to a possible complaint.
Surviving an inspection is best done through adequate preparation. Most issues and deficiencies identified during an inspection are the result of inattention to detail by the pharmacist and staff. These problems can be easily addressed by establishing a process for systematic vigilance. Many pharmacies utilize an independent pharmacy consultant to conduct an audit or mock inspection on a routine basis or prior to the anticipated date of the annual inspection to provide a valuable double check. Every PIC must have a process in place to prepare their pharmacy for an unannounced inspection by any regulatory agency. This is truly a situation where an ounce of prevention is worth several pounds of cure!

Error or Indictment of a Profession

Error or Indictment of a Profession ?
As an animal lover, I too was horrified by the news of the Polo horses’ deaths. I cannot fathom the sight of seeing these beautiful animals dropping like flies in front of the people who care and love them. It is a horrible thought watching animals dying in front of those who have spent countless hours raising them as they would their own children. I know for many people their animals and pets are loved no differently than any other member of their family. I can understand the outrage and the outcries of all sorts of people and groups relating to this incident. I certainly do. Also I do not, in any way want to minimize or down play its occurrence.
However reading the accounts of this, the articles and quotes of all the people and agencies that seem to be perpetuating the endless articles regarding the deaths of the Polo Horses, I sat back and asked myself a few questions. Why has this become such a huge story? Is it because it was all over the news? Is it because the money involved in the sport? Is it because of some other power that sees this as an opportunity to further their agenda?
My biggest question is people die of drug reactions all the time. There are deaths that occur due to medication errors that number in the thousands annually. Why the outcry here? Is this any sadder than having a loved one die of a prescription misfill? Is this any sadder than a young infant given the wrong dose of a medication only to have a beautiful young baby taken away from new parents due to a medication error? I can’t believe it is. But that is on the news for a day or two. Ask yourself why?
As a pharmacist myself, any thought of a medication error, makes pharmacists lose sleep at night. I personally remember my first error over 25 years ago as an intern. I chose the wrong sound –a- like drug. Luckily our systems caught it before it ever left the pharmacy, however to remember this incident 25 years later tells you the impact any error by a pharmacist has on them. For an error that reaches a patient or worse causes harm to a patient, it must be devastating.
Let’s make no mistake here, this is an error. This incident will have its course in both the regulatory and legal systems. Well it should. This incident will play out as all matters do. Franck’s pharmacy will have to answer many questions. They will, and should answer for this error, especially if they were doing something wrong simply for profit.
Now I know of Franck’s pharmacy. I don’t know them personally however they have been around for years. By all accounts they have done a great job in the community. When my father, who lived in Ocala, was dying of cancer, he could not say enough about the way he was treated by the people at Franck’ pharmacy. So I must say I am not ready to pass judgment yet, other than to say, this was a horrible, unfortunate error. Unless we learn differently, Franck’s pharmacy is a good pharmacy that made a serious error.
So what is driving this endless stream of articles? I find little answers. Pharmacists have been compounding since the profession started. Custom medications have provided solutions and relief to patients for as long as the profession of pharmacy has been around. It helps solve the one size fits all model of manufactured medications. There is some common sense here. You can’t expect an infant to take the same strength medication as a pro football player, can you? You can’t expect a cat to take the same strength medication as a horse, can you? How about the elderly or gravely ill who can’t swallow, or need special dosage adjustments. There is a "Tried and True" saying in medicine-start low and go slow! Ask any physician if this is sound practice. So the ability to tailor the dose of the medication is an invaluable part of the practice of pharmacy.
Make no mistake about it, all this publicity is driven by people who have their own agenda and want to change the profession of pharmacy. In lieu of a logical answer, I say "follow the money! For years certain pharmaceutical companies have been trying to stop the practice of compounding pharmacy, not because it was unsafe, but because it was eating into their hormone profits. I can’t say that it is they who are fueling this media frenzy, but it is certainly worth asking the question.
In addition, for years the FDA has tried to regulate and get oversight over the compounding business which has always been and is still regulated by the board of pharmacy. Could this be part of a power play for territory, power or control?
This in not about the Polo Horses to them, it is an indictment on the profession of pharmacy. The way the profession is run by the state Boards of Pharmacy, and the inability of certain interest groups to change the profession of pharmacy for their own personal agenda!
I am asking the questions. Why such a disproportionate amount of articles, media attention and weeks of coverage for this compared to the many other medication errors that kill people annually? Who has that kind of money and clout? Who benefits from it? It seems an appropriate question to ask. Doesn’t it?
In the words of one of the great philosophers of our time, Dennis Miller- This is just my opinion, I could be wrong.
Written by:
Dean A. Pedalino RPh, CPh, FASCP
HCC Pharmacy Business Solutions