A pharmacy audit is a process by which an auditor checks for the compliance of a pharmacy with pharmacy and other applicable regulations. Pharmacy audits are also important for pharmacy management, as they are a key part of pharmacy quality improvement programs, which is a process by which a pharmacy organization improves the processes and techniques being used to achieve their goals.
Rules and regulations are important, but without a written system to assist in its implementation, a pharmacy will not be able to meet all of its certification and other compliance requirements.
Right now, the goal is to create a one-page article on best practices for auditing in the pharmacy profession. This guide will cover a variety of audit topics, including: Choosing the right auditors. Communicating with the auditors, Collecting audit results, Post-audit review and follow up.
Pharmacy audits should be performed on a regular basis to ensure that a pharmacy is able to provide safe, effective medicines to the patients in a timely manner. Pharmacies are required to establish audit processes to help ensure that they are in compliance with the pharmacy regulations and other agreements that govern their operations and processes.
Pharmacy audits should be performed on a regular basis to ensure that a pharmacy is able to provide safe, effective medicines to the patients in a timely manner.
The nature and extent of activity determine the scope and type of audit. These include audits such as:
1. Internal audits: which are performed by employees within the pharmacy to ensure that processes are in compliance with regulations, policies, and procedures.
2. External audits: which are performed by third party auditors to ensure that processes comply with pharmacy regulations, policies, and procedures.
3. Risk assessment audits: which are used to identify potential risks to control and improve the pharmacy operations.
While there are a number of processes that could be involved in an audit, here are the 4 basic steps of an auditing process:
Choosing the right auditors
Do not get confused by the different roles or titles that are associated with pharmacy auditing. The most important factor is that the auditor is a licensed professional who is experienced in conducting a pharmacy audit. The auditor must be specialized in auditing pharmacies to ensure their findings and recommendations are accurate, specific, and reliable. The pharmaceutical auditors have the knowledge and experience to know what type of information and documentation is needed. With right selection, the pharmacy’s owner can be confident that the auditor has thoroughly reviewed their company’s operations and is qualified to make recommendations. It’s important to choose a reputable auditor for pharmacy audits. A successful audit requires that the pharmacist and auditor have a good working relationship without a conflict.
Communicating with the auditor
What information do you need to communicate to auditors? Document your objectives before the audit. What information do you need to present to the auditors? Talk about things in broad terms, including business objectives, key performance indicators, and the audit procedures and controls. Talk about information you don’t need to discuss with auditors, such as uncollectible accounts, and what information can be included in the written report. Decide about the composition of audit team. If possible, include fresh graduates as observers to impart necessary auditing skills and making them ready for related future activities. Have a plan for the audit, and be consistent with your plan. Be sure that your presentation of the information is consistent with the audit method and data requirements. Provide a written document summarizing the process and related information that will be presented to the auditors. Believe on diversity and inclusion. Collaborate with your team and other associated departments, as necessary.
The auditor must be specialized in auditing pharmacies to ensure their findings and recommendations are accurate and specific. The pharmaceutical auditors have the knowledge and experience to know what type of information and documentation is needed.
Collecting audit results
The pharmacy must establish a process for collecting information that allows it to present to its regulators and other third parties (internal, regulatory, and third-party auditors) audit reports or reports of other items that can impact compliance and show the progress that has been made. The pharmacy should use the process, depending on the nature of the information, to report progress, identify areas of opportunity for improvement, and report and/or produce needed documentation.
Post-audit review and follow up
There is no better time to ask your pharmacist about processes that could affect their performance evaluation. Make sure they understand the importance of completing post-audit review tasks, even if they are not required by law (e.g., minor observations). It will give them something positive to put on their audit report card. It is appreciated if post-audit activities are completed as quickly as possible. However, resource intensive tasks may take some time to act on and should be discussed with the auditor on daily basis or at the audit closing meeting.
Pharmacy operations and processes are just as important to the pharmacist as the medications they dispense. The pharmacy should implement processes with the goal of being compliant with all applicable laws, rules, regulations, and agreements. This includes drug interactions, safety, security, record keeping, and other processes that help ensure the integrity of the pharmacy. Rules and regulations are important, but without a written system to assist in its implementation, a pharmacy will not be able to meet all of its certification and other compliance requirements.
Bonus topic: One-page pharmacy auditor questioner – sample practice questions, answers, explanations, and follow-up actions*
We may use a case study “Auditing outpatient pharmacy services”. The aim of this audit is to look at the way patients are being treated in the pharmacy and to ask questions about how pharmacy staff is meeting certain expectations. If the pharmacy is doing an effective job, the auditor should be able to answer: what are the expectations, how are they met and why?
*Bonus topics are selected based on our readers’ interest. You can read more in the future.
What’s Next on PharmaRead.com
Topic 1: Where is the beat? Searching for Lean in manufacturing industry
Topic 2: Utilizing Visual Management in Pharmacy Practice
Visual management in pharmacy is a process that should be a part of everyday pharmacy practice. It provides a way to actively engage with patients, helps to improve patient satisfaction, and has a positive impact on patient safety. Visual management can be implemented to help meet the unique needs of the pharmacy environment. But what is visual management and how it relates to pharmacy practice?
Disclaimer: The views and opinions expressed on PharmaRead are those of the authors and do not necessarily reflect the official policy or position of any agency or organization. PharmaRead articles are provided for information only with focus on global health, pharmacy practice, and healthcare systems in Low- and Middle-income Countries (LMICs). Readers should seek expert opinion for use, implementation or application of this knowledge based on their individual circumstances.