|
|
| 
|
[click on the question to jump to that answer]
For more Frequently Asked Questions for Pharmacists,
visit www.pcab.org/pharmacists/questions-answers.html
Question:
How do we document that all the employees are trained and licensed?
Answer:
PCAB standards do not dictate the method of your documentation, only that your methods meet the requirements. Standard 2.10 with its compliance indicators may help you to make that determination.
Standard 2.10 General
A pharmacy must document that all relevant personnel are competent to perform their assigned duties and must establish procedures for assessing that competency on an ongoing basis. Specific duties and responsibilities shall be clearly defined and described. A pharmacy shall retain documentation of current and ongoing education, training, and competency of all personnel involved in the compounding of preparations. Supervision of personnel shall be sufficient to assure preparation integrity and safety.
Compliance Indicators
A. There are written policies and procedures that outline assigned duties for positions.
B. There are written policies and procedures that establish job descriptions for positions
C. There are written policies and procedures that sets forth a new employee (including temporary employees) orientation program.
D. There are written policies and procedures that outline training and educational guidelines for employees.
E. There are written policies and procedures that establish a system of documentation of required and additional training and education.
F. There are written policies and procedures that establish procedures for assessing the competency of all professional, technical and outsourced services staff on an ongoing basis.
G. The pharmacy has job descriptions for each compounding position.
H. The pharmacy demonstrates that staff is properly trained to perform their individual tasks and responsibilities.
I. The pharmacy demonstrates that the staff is competent to perform their individual tasks and responsibilities.
J. The pharmacy has policies and procedures to assess and determine adequate staff is in place to meet all the requirements and needs to accomplish all elements of the compounding and dispensing process, including environmental and equipment maintenance. |
Question
This question was submitted by a professor at Iowa University College of Pharmacy. She consults with compounding pharmacies from acrsos the United States. One asked this question, which she passed on to PCAB.
"Another problem we are running into is the cost of all this equipment [for compounding sterile and hazardous drugs] is quite impressive. We are going to continue on towards complete compliance and safety, but we would like to know that these rules are going to be enforced do to the fact that all the little places that do compounding without meeting all these regulations are going to be selling products much cheaper. Will the compounding pharmacies not being compliant ever be punished?"
Answer
I read your client's questions as: "What happens if we comply with the PCAB Standards but other compounders who are not accredited do not, allowing them to spend less on equipment (and tests) and thus they are able to sell for less - will they be punished?" The answer is yes, they will be punished, but probably not in the manner you might select. "Punishment" will be in the form of competition. Pharmacies selected as meeting high, creditable standards will be selected over those that "do things on the cheap".
In order for that to happen, PCAB, compounding pharmacists, pharmacy organizations and others who understand the need for high standards, must spread the word: "Select a compounding pharmacy that is PCAB Accredited." That word is, even today, beginning to get out.
To help PCAB Accredited(TM) compounding pharmacies in the marketplace, PCAB has developed "Media Tools". These include press release templates; letters to patients, prescribers, legislators and insurance companies; advertisements and brochures. These templates are provided free. They can be customized by the pharmacy with there pharmacy information. |
Question
We are going to be building a non-sterile compounding lab next to our pharmacy and would like to know if this room needs to have positive or negative pressure. Based on the standards you have listed on your web site, they are not very specific. Is there any way we can get more specific info. on all of your listed standards so we can meet these standards as we are planning on apply for certification with PCAB.
Answer
I submitted your question to a pharmacist familiar with compounding and USP <795>, which is required to be in place to meet PCAB(TM) Standards.
His answer is "For nonsterile compounding, neither positive nor negative pressure is addressed. However, I would recommend exhaust stations be present for weighing powders, encapsulation, etc. as this is addressed in the areas of personnel safety."
I suggest that before you being consult with a compounding consultant familiar with <795> and environmental requirements. Other places you may wish to contact are the International Journal of Pharmaceutical Compounding, the American College of Apothecaries and the International Academy of Compounding Pharmacists. Also, look at PCAB Standards 1.30 and 3.20 and their Compliance Indicators.
Standard 1.30 External Standards
A pharmacy must provide documentation to verify that compounding is performed according to standards of practice adopted by the state board of pharmacy and the practices and standards that are adopted by non-governmental standards setting organizations.
Compliance Indicators
A. The pharmacy has written policies and procedures that document how the pharmacy's compounding is performed according to state and national practices and standards.
B. The pharmacy has ready access to applicable USP standards.
C. The pharmacy complies with applicable USP standards.
D. Pharmacy personnel can demonstrate ability and knowledge to utilize resources appropriately.
Standard 3.20 Non-Sterile Compounding
A pharmacy preparing non-sterile preparations must design its facilities to provide for: minimization of interruption, avoidance of contamination by dust and other particulates, and reduction of the potential for contamination or adulteration of the compounded preparation.
Compliance Indicators
A. The pharmacy's written policies and procedures outline mechanisms adequate for minimizing interruption during compounding.
B. The pharmacy's written policies and procedures outline mechanisms adequate for avoiding contamination by dust and other particulates in the compounding area, including policies and procedures outlining how preparations are kept contaminant free.
C. The pharmacy's written policies and procedures outline mechanisms adequate for avoiding cross-contamination.
D. The pharmacy's written policies and procedures outline mechanisms adequate to reduce the potential for contamination or adulteration of the compounded preparation.
E. Pharmacy has a dedicated, exclusive area for general, non-sterile compounding.
F. The area for general compounding (non-sterile compounding) meets environmental standards.
G. The area for general compounding (non-sterile compounding) meets or exceeds USP <795> standards.
H. The area for general compounding (non-sterile compounding) is designed to minimize traffic from employees not involved in compounding.
I. Consistent with Standard 9, Quality Assurance, pharmacy has policies and procedures to monitor and test compounded preparations for quality. |
Question
For the Sterile Compounding, does a barrier isolator have to be in a Clean Room?
Answer
PCAB submitted this question directly to staff members at USP. Please read the Important Note regarding questions submitted to USP. In accordance with the USP Communications policy, (see http://www.usp.org/aboutUSP/governance/policies/communications.html) USP cannot offer any official interpretations, and any answer given must be "regarded solely as a personal opinion of the individual providing the interpretation and not necessarily an official position of the USP."
USP: According to the official USP General Chapter <797>, "An emerging alternative technology utilizes barrier isolator systems to minimize the extent of personnel contact and interaction, to separate the external environment from the critical site, and to provide an ISO Class 5 environment. A well-designed positive pressure barrier isolator supported by adequate procedures for its maintenance, monitoring, and control, may offer an acceptable alternative to the use of conventional LAFWs in clean rooms for aseptic processing." It also states that, "Primary environmental control must provide at least ISO Class 5 quality of air to which sterile ingredients and components of CSPs are directly exposed," and that "secondary engineering controls generally provide a buffer zone or buffer room as a core for the location of workbenches or isolators." Thus, in some circumstances, it may be possible to loc! ate a barrier isolator outside of a clean room. Refer also to Figure 1 in General Chapter <797>.
As an aside, note that the proposed revisions to General Chapter <797>, if adopted, would require that barrier isolators be placed in clean rooms unless they meet certain conditions, including the following: "The isolator must provide isolation from the room and maintain ISO Class 5 during dynamic operating conditions including transferring ingredients, components, and devices into and out of the isolator and during preparation of CSPs. Particle counts sampled approximately 6 to 12 inches upstream of the critical exposure site must maintain ISO Class 5 levels during compounding operations. It is incumbent on the compounding personnel to obtain documentation from the manufacturer that the CAI will meet this standard when located in worse than ISO Class 7 environments." Of course, this proposed language is not official and is subject to change. We provide it here for information only.
Also refer to PCAB Standard 3.30 and its Compliance Indicators, which read as follows:
Standard 3.30 Sterile Compounding
A pharmacy preparing sterile preparations must design its facilities to provide for: minimization of interruption, avoidance of contamination, and an exclusive area for the compounding of sterile preparations. Policies and procedures shall be established for periodic environmental testing to assure continued adequacy of the aseptic environment.
Compliance Indicators
A. The pharmacy's written policies and procedures outline mechanisms adequate for minimizing interruption during compounding.
B. The pharmacy's written policies and procedures outline mechanisms adequate for avoiding contamination by dust and other particulates in the aseptic compounding area.
C. The pharmacy's written policies and procedures outline mechanisms adequate to reduce the potential for contamination or adulteration of the compounded preparations.
D. Pharmacy policies and procedures outline procedures for periodic environmental testing of the aseptic environment.
E. Pharmacy meets state law requirements as to sterile compounding.
F. If the pharmacy practices aseptic sterile compounding, it has an appropriate area for compounding of aseptic preparations that meets or exceeds USP <797>.
G. Consistent with Standard 9, Quality Assurance, pharmacy has policies and procedures to monitor and test, as applicable according to USP <797>, sterile compounded preparations for sterility, pyrogenicity and potency. |
Question:
This is a series of questions relating to what items can be kept in the buffer room. The pharmacist asked:
Within the buffer room, our counter is supported by cabinets with drawers, will these drawers be allowable if not use for storage? Are wire shelves allowable in the buffer area? Can wire baskets be used to store sterilized syringes in the buffer area? After autoclaving, can sterilized vials and caps be stored in the buffer area? Are there any acceptable forms of plastic baskets allowed in the buffer area?
Answer
PCAB submitted this question directly to staff members at USP. Please read the Important Note regarding questions submitted to USP. In accordance with the USP Communications policy, (see http://www.usp.org/aboutUSP/governance/policies/communications.html) USP cannot offer any official interpretations, and any answer given must be "regarded solely as a personal opinion of the individual providing the interpretation and not necessarily an official position of the USP." USP staff's response:
General Chapter <797> does not address these questions specifically, and under USP's Communication Policy, USP cannot provide an official interpretation. Portions of the General Chapter are relevant to these questions, however. According to General Chapter <797>, "Tasks carried out within the buffer area should be limited to those for which a controlled environment is necessary. Only the furniture, equipment, supplies, and other goods required for the tasks to be performed may be brought into this room, and they should be nonpermeable, nonshedding, and resistant to disinfectants. Whenever such items are brought into the room, they should first be cleaned and sanitized."
The General Chapter requires that the buffer area provide ISO Class 8 air. Furthermore, "The surfaces of ... fixtures, shelving, ... and cabinets in the buffer area should be smooth, impervious, free from cracks and crevices, and nonshedding, thereby promoting cleanability and minimizing spaces in which microorganisms and other contaminants may accumulate.... Storage shelving, counters, and cabinets should be smooth, impervious, free from cracks and crevices, nonshedding, cleanable, and sanitizable. Their number, design, and manner of installation should promote effective cleaning and sanitizing."
Also note that the General Chapter specifies that all supply items should be arranged in the direct and contiguous compounding areas so as to reduce clutter. |
Question
What is considered a compounded preparation? For example, if you compound 21 doses of an antibiotic for one patient is this considered 1 compounded preparation or 21 compounded preparations
Answer:
A pharmacy's annual fee is based on the number of prescription preparations compounded on the average day, calculated as on a five day week and average by the year (Total of compounded Rx per year / 262 days). A compounded preparation is the result of a practitioner's prescription drug order based on a valid practitioner/patient/pharmacist relationship in the course of professional practice. Compounding may be conducted as each prescription is received or in batches, in anticipation of receiving prescription orders, based on routine, regularly observed prescribing patterns. A batch of 21 prescriptions is counted as 21 compounded preparations. Compounding of OTC products is not considered compounding under PCAB Rules and these products are not counted in calculating the fees. (Refer to the Principles of Compounding) |
Question
How often does a surveyor comes to the pharmacy for accreditation
Answer:
An in-pharmacy survey is conducted as part of the initial application and is scheduled for every three years. The number of surveyors and the length of the survey are determined by the size and type of operation. In the intervening years (years 2 and 3), a renewal application must be submitted by the pharmacy. The Rules provide for additional surveys if there has been a substantial change in circumstances, practice or ownership. |
Question:
Can we use the protocols procedure for sterile compounding we have in place already?
Answer:
PCAB Standards require sterile compounding meet requirement of <797>. Your current "protocols procedure" may be used if they comply with PCAB Standards. The Self Analysis form will assist you in making that determination. It contains the following compliance indicators for Standard 3.30 Sterile Compounding:
Standard 3.30 Sterile Compounding
A pharmacy preparing sterile preparations must design its facilities to provide for: minimization of interruption, avoidance of contamination, and an exclusive area for the compounding of sterile preparations. Policies and procedures shall be established for periodic environmental testing to assure continued adequacy of the aseptic environment.
Compliance Indicators
A. The pharmacy's written policies and procedures outline mechanisms adequate for minimizing interruption during compounding.
B. The pharmacy's written policies and procedures outline mechanisms adequate for avoiding contamination by dust and other particulates in the aseptic compounding area.
C. The pharmacy's written policies and procedures outline mechanisms adequate to reduce the potential for contamination or adulteration of the compounded preparations.
D. Pharmacy policies and procedures outline procedures for periodic environmental testing of the aseptic environment.
E. Pharmacy meets state law requirements as to sterile compounding.
F. If the pharmacy practices aseptic sterile compounding, it has an appropriate area for compounding of aseptic preparations that meets or exceeds USP <797>.
G. Consistent with Standard 9, Quality Assurance, pharmacy has policies and procedures to monitor and test, as applicable according to USP <797>, sterile compounded preparations for sterility, pyrogenicity and potency. |
|
|
