Pharmacy Regulatory Compliance

By Dean Pedalino, R.Ph., C.Ph., FASCP

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!

Dean Pedalino is a registered Pharmacist, Consultant Pharmacist, and Licensed Business Broker.
He currently holds the position of Vice President of HCC Pharmacy Business Solutions and
President of Pharmacy Matchmakers, Inc., both are divisions of Healthcare Consultants (HCC).
The Pharmacy Business Solution division provides pharmacy consultants, project managers,
pharmacy management, pharmacy design, and operational experts to clients nationwide. Visit
http://www.hccpharmacysolutions.com for more information.

Twitter • Facebook • LinkedIn