Developing Standard Operating Procedures
Developing Standard Operating Procedures
by Denise M. Frank, RPh, FACA, FAPC
Policies and Procedures are the written pharmacy documents
that include the policy statement (a course or plan of action, a high-level
principle of the pharmacy), and the procedures for complying or carrying out a
task. These procedures are also referred to as Standard Operating Procedures,
or SOPs.
Why do we need Policies and Procedures, and Standard
Operating Procedures (SOPs) for the pharmacy?
Policies and procedures will provide for the consistent
performance of activities. Personnel have a reference on how to handle
situations and perform tasks – working as a team. The manual will very useful
when training new employees with clear explanations, instructions, and
expectations for specific tasks and for their position. Well-written SOPs also
help protect a pharmacy from liability. The policies and procedures, when
followed, ensure staff are compliant with regulations and standards and this
protects patient health and safety. This will also reduce patient complaints, rejections
of third-party claims and audit compliance, and maintaining accreditation
standards. Defining specific tasks that are performed by technicians, or those
that may only be performed by pharmacists, also protects their professional
licenses and registrations, as well.
Where do I start?
First: Develop a policy and procedure ABOUT policies and
procedures. Sometimes called a “Document Control Policy”. This will ensure that
the policies and procedures and SOPs are consistently written and organized, reviewed,
and current. This Document Control Policy should identify:
1.
Format of the SOP including date of
implementation, date of review, version number, revision history, and signature
of approval. Develop a blank template and attach to the SOP. See table below
for common sections used in constructing an SOP.
2.
Organization of SOPs including where they
are stored and how employees access them (electronic and/or hard copy).
3.
Process for SOP development (who
develops, who approves).
4.
Process for periodic review of all SOPs
as current and relevant (when, by whom, how the review is documented). Some
regulations and standards require SOPs to reviewed annually.
5.
Process to revise SOPs.
a.
Revisions identified by the periodic review.
b.
Changes in Federal or State regulations
c.
Updates in accreditation standards
d.
Industry standards and best practices
information
e.
Revisions identified from the pharmacy quality
program to address quality related events.
6.
Requirements for training employees
including documentation of training.
a.
Initial training
b.
Periodic (annual) training
c.
Training on new and revised policies and
procedures
7.
Process for archiving revised and
obsolete SOPs that includes the date the SOP was replaced with a revision or
discontinued as obsolete.
|
Common Sections of a
Policy and Procedure/SOP |
|
|
Header |
Number or
version, date of creation and implementation |
|
Title |
Make sure
this is clear! |
|
Purpose |
Policy
statement, why do we need this SOP? |
|
Scope |
When does
this SOP apply, and to whom, personnel who are responsible |
|
References |
Use if
applicable |
|
Definitions |
Use if
applicable |
|
General
Information |
Including
frequency, if applicable |
|
Equipment,
supplies |
If
applicable, including any documents or forms that may be required |
|
Procedure |
The
step-by-step instructions for performing the task or implementing the
procedure. This should include what to do if a deviation occurs during the
procedure, or if it is not followed. |
|
List of
Attachments |
Forms or other
information referenced in the SOP included with the SOP |
|
Approval
information and Revision History |
Dates of approval
and signature(s) of persons approving the SOP, reviews dates and who reviewed,
information on what was revised for revisions |
|
Footer |
Name and
address of the Pharmacy, page number |
Next - determine what policies and procedures or SOPs that
are required for your pharmacy. You must be compliant with Federal and State
regulations, accreditation standards (if accredited), and third-party payor
contracts. The content of the SOPs is specified in these sources.
1.
Read through and understand your
State Board of Pharmacy laws and rules. If you ship prescriptions to patients
in other states and have a nonresident pharmacy license in those states, read
through and understand the regulations in each of those states.
2.
Download and read the most current version of
the DEA Pharmacists Manual (2020).
3.
If you perform nonsterile compounding, sterile
compounding, or compounding with hazardous drugs, you must follow the
appropriate chapters in the United States Pharmacopeia. See box for an example
of USP Chapter <795> requirements. USP Chapter <800> contains a
list of topics that should be addressed in the SOPs.
4.
If you hold an accreditation, there are
additional requirements for SOPs to meet the accreditation standards.
5.
There are other Federal regulations such as
HIPAA, Fraud, Waste and Abuse, and Nondiscrimination.
6.
You may also want to develop other operational
policies and procedures such as opening and closing procedures, pharmacist
break rules, conflicts of interest, etc. and SOPs around problem issues such as
when a prescription product is out of stock, ordering and inventory levels
procedures, or handling claim rejections when billing third parties.
Writing policies and procedures, or SOPs is a skill, and may
seem difficult and daunting if you are starting from scratch. There are several
options for purchasing a set of SOP templates from various pharmacy and regulatory
consultants and accreditation consultants and agencies. If you purchase
templates, you MUST customize them to your specific pharmacy – remove items
that do not apply and insert details for your location and workflow. Enlist the
help of your staff (pharmacists and technicians)!
To keep current, make sure someone is monitoring emails and
communications from regulatory agencies (state and federal) – sign up for FDA,
Board of Pharmacy newsletters. It’s also a good idea to belong to state and
national organizations to receive information on current issues, new and
upcoming changes in regulations, and information on new best practices. The
organizations have resources and information that will be useful as well as
networking with other pharmacies to share information and potential solutions
to issues.
The most difficult part is the procedure, itself. It needs
to truly be step-by-step. It helps if you can have the person who performs this
function write down how they do it in the order they perform the action. Have
another employee who may be unfamiliar with the procedure read and follow the
steps to see if you are missing anything!
Keep it simple!! Using a flow chart or bullet point lists
can add clarity. Avoid long, wordy narratives or explanations with “legalese”.
This will avoid confusion, and employees will be clear on how tasks are to be
completed.
If the document is written to comply to a specific
accreditation standard, you may want to reference the standard and number in
the SOP. This will make locating specific SOPs to revise when an accreditation
standard is updated or changed.
Finally - review the final policy and procedure or SOP to
ensure:
1.
The format is consistent with the template and
your SOP on SOPs
2.
The SOP is accurate with respect to the
regulations and standards.
3.
The information is clear, short and to the
point.
4.
Read through again and make sure the language is
gender neutral. Do not use “he” and “she”, use “employee”, “technician”,
“pharmacist”, etc.
Policies and procedures, and SOPs, are essential for
pharmacy operations for regulatory compliance and performance of activities
that will provide consistent and high quality products and services to your
customers and patients!
Denise M. Frank, RPh, FACA, FAPC
Senior Associate
Gates Healthcare Associates, Inc
Gates Healthcare Associates is a pharmaceutical and
healthcare consulting firm that provides extensive clinical, programmatic, and
regulatory knowledge and insight to an array of pharmaceutical and healthcare
organizations nationally and abroad. We help our clients confront and overcome
challenges and obstacles to growth, positioning them for long-term regulatory
and business success.
Our firm has a track record of excellent service to
public sector agencies. We are committed to providing a quality consultation
and the valued services and expertise of a larger firm, while maintaining a
personal touch and modest fees.
Gates Healthcare Associates has everything a compounder
needs for regulatory compliance and accreditation assistance including up-to-date
Standard Operating Procedure manuals for sterile, non-sterile, and hazardous
drug compounding. And we can assist in customizing any of the templates to a
specific pharmacy’s practice. Our 2023 SOP templates compliant to the USP
Chapter <795> and <797> revisions that become official on November
1, 2023, will be available soon. We have other general SOPs such as our Vendor
Policy that covers selection and authentication of sources of prescription
products and devices, OTC products, and APIs; receiving procedures to detect
suspicious and illegitimate products; transaction information; and reporting
requirements.
Gates Healthcare Associates, Inc.
1 Central Street, Suite 201
Middleton, MA 01949
Phone: 978-646-0091
Fax: 978-646-0092
www.gateshealthcareassociates.com
https://gateshealthcareassociates.com/contact
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