Feedback deadline was: November 17, 2016
The Ontario College of Pharmacists (OCP) is currently seeking feedback on the Model Standards for Pharmacy Compounding of Non-Sterile Preparations developed by the National Association of Pharmacy Regulatory Authorities (NAPRA).
The College is inviting all pharmacists and pharmacy technicians who engage in non-sterile compounding to review these standards and provide feedback. While general comments are welcome, it would be appreciated if submissions could specify the section and/or page number of the item being addressed, along with a rationale or reference supporting the comment, if any.
These draft standards have been developed to provide those who compound non-sterile preparations with the standards necessary to evaluate practice, develop procedures, and implement quality control measures, thereby improving quality and safety for both staff and patients. Along with other provincial pharmacy regulators, OCP will consider comments received and submit feedback to NAPRA.
An Ontario Working Group comprised of pharmacy professionals currently working within the area of non-sterile compounding will assist in the preparation of the submission.
Read the Model Standards for Pharmacy Compounding of Non-Sterile Preparations
NAPRA based these standards on those that are already in place in Quebec, which are in turn based on General Chapter <795> of the United States Pharmacopeia – National Formulary (USP – NF).
It is the intention of OCP that, wherever possible, national standards will be adopted. Most recently, Council approved the implementation by January 2019 of the Model Standards for Pharmacy Compounding of Non-hazardous Sterile Preparations and Model Standards for Pharmacy Compounding of Hazardous Sterile Preparations.
Will these standards apply only to pharmacists and pharmacy technicians?
OCP is accountable only for pharmacies and registered pharmacy professionals; however, it is recommended that all health professionals engaged in non-sterile compounding review and meet these standards once approved.
What is OCP’s role in ensuring the standards are met?
The role of OCP is to evaluate the operation of pharmacies and the practice of pharmacy professionals, including the adoption and implementation of standards. College Practice Advisors will evaluate the adoption of these standards, and others, in the course of their contact with pharmacy professionals during pharmacy practice assessments.
When will these standards take effect?
NAPRA will review the submissions of pharmacy regulators across the country and determine what changes to make to these draft standards, if any. Once NAPRA finalizes the standards, OCP council will consider the timing of their implementation.
Shoppers Drug Mart and Loblaw welcome the opportunity to comment on the NAPRA Model Standards for Pharmacy Compounding of Non Sterile Preparations. We believe that internal operating standards, and/or training, can be used to address the majority of the proposed requirements in the Standards, and as such have no further comment on those areas. Our main input regarding the Standards is outlined by OPA on page 6 of their response; ‘OPA also asks for greater clarity and delineation between the three levels of compounding (A, B, and C), so that compounding personnel are clear on the requirements associated with them’. We fully concur with this statement, and hope that additional clarity will be provided in the final Standards We are not aligned with requests for specific business specifications for the Master Formulation Record. Vendors/businesses have solutions/will update solutions fitting for their software solutions and the practices they support, and as such no additional direction or level of specification is required. We fully support OPA’s request for adequate time to address labeling. This is not generally an easy software fix, and requires to be built into software development cycles.
I have a number of comments and questions regarding the NAPRA Model Standards for Pharmacy Compounding of Non-Sterile Preparations. Overall, this is a very good document (but not an easy read ). From the limited comments I read on your website, I don’t think some members understand the implications of these guidelines and that they will have to meet them no matter what amount of compounding they do. Next, you unfortunately did not give members adequate time to read this large document and make comments. You sent this out on October 20, 2016 and have given us a deadline of November 17, 2016. This is not enough time to get back adequate and meaningful dialogue from your members. I am very upset about this short time-line as are others who would have given feedback but did not have the time. I had to spend a lot of my time in the evenings to do this. Under Regulatory Framework ‘" says the compounding must always be carried out within a prescriber-patient-pharmacist relationship ‘¦ and that Health Canada (HC) was examining policy 0051 with a view to creating new standards for situations not covered within the practice of pharmacy or under the current federal licensing framework, such as ‘˜commercial compounding manufacturing’. Please define ‘˜commercial compounding manufacturing’ as these have opposite definitions. Appendix 1 where it shows the differences between compounding and manufacturing ‘" we need clarification from OCP and HC regarding third party compounding pharmacies that make large batches of compounds, then sell to pharmacies in Ontario or other provinces. Is this compounding or manufacturing? According to the current 2009 version of policy 0051 this activity is more manufacturing than compounding. If our pharmacy contracts out and buys products from such a compounding pharmacy, does this not break the prescriber-patient-pharmacist relationship as we have bought from a 3rd party?? Does OCP allow this? What if the compounding pharmacy is from another province? What are the legalities? So if you look at Appendix 1 ‘"Q1 about patient-healthcare relationship ‘" wrt the compounded product ‘" this would be ‘˜No’ as the 3rd party has no relationship, just the pharmacy who bought the compounded product. For Q2 ‘" third part reselling of the product outside the relationship ‘" answer is yes and Q5 about inordinate amounts of product produced on a regular basis the answer is Yes again as the compounding pharmacy is selling to many pharmacies. Therefore, as it stands, I interpret 3rd party compounding and selling to be more manufacturing. I hope this is what HC is redefining in Policy 0051, but we also need a clear statement from OCP on what all Ontario pharmacies are allowed to do as many are buying from these compounding centers now. Furthermore, as it stands now, HC policy 0051 states ‘˜in circumstances where an individual cannot clearly determine whether a particular activity is considered to be manufacturing or compounding, they may either contact the Health Products and Food Branch Inspectorate or the respective provincial/territorial regulatory body. At that point, discussions may take place between the two jurisdictions for final determination of whether an activity is considered to be compounding or manufacturing. In situations where the provincial/territorial regulatory authority decides that an activity does not fall within its jurisdiction, the activity is likely to be manufacturing’. I am very interested on getting an answer from OCP very soon. -p 11 on non-sterile compounded preps made with approved ingredients ‘¦ DIN or API used in a product approved for ‘˜Human or veterinary’ in Canada ‘" I think you need to define Human or vet use otherwise pharmacists may use chemicals not approved for human use. However, if you do this, then this does not allow pharmacists to compounding from non-pharmaceutical chemicals (ie p 27 where they are allowed to choose ACS grade which would not have the necessary heavy metal or solvent testing required). However, I think this needs to be given more thought by NAPRA. I personally would never use an ACS grade. Just because it is high quality, this is designed for lab purposes only, not designated for human use (and can state that on the bottle) and it will not meet compendial testing. The chemical may contain high amounts of impurities or solvents that could be harmful. -what about the use of NPH products for compounding ‘" this isn’t mentioned anywhere? -The level ‘" descriptions on pages 13, for requirements for Level B ‘"well ventilated room and if hazardous products are being used the room must also be ventilated to the outside OR have a ventilated containment device- does not match p 38 where it describes room must be entirely closed off OR a room with a ventilated containment device is required with the air exhausted to the outside which does not match Appendix 21 where it just says Level B is a separate room well ventilated OR with ventilated hood (does not say vented to outside). This is not consistent throughout this document and has confused a lot of people. This must be updated to say the EXACT same thing on all 3 sites. This also goes for Level C ‘" says on p 13 ‘˜room under negative pressure, a ventilated containment device’, p 40 says Level C requires compounding in a closed-off room under negative pressure with filtered air exhausted to the outside and Appendix 1 says separate room under negative pressure only. Again, needs to consistently say the same requirements throughout the document. Please fix this. -p 16 mentions mandatory and supplementary references, but appendix 7 only says supervisor is to make available the required references, standards, guidelines and policies of the relevant pharmacy regulatory body. So I interpret this as the only mandatory reference. Is this the intent? -p17 ‘" last paragraph I find confusing ‘" need to determine who is responsible for which aspects of patient care if a product was prepared on behalf of another facility/pharmacy????? Both parties are responsible for that compounded product and would it be the pharmacist who dispenses it have the most responsibility to the patient (counselling etc). I am confused by this statement and don’t follow what they are trying to convey. -p20-‘˜appropriate temperatures and humidity monitoring should be maintained ‘" what is the ‘˜appropriate’ humidity ranges then? RT has a definition ‘" included in appendix 11, but no humidity is defined. -p23- packaging and cardboard boxes from products used must be removed from the non-sterile compounding area ‘" this is extremely difficult to do in some pharmacies as items in boxes need to then be stored on shelves which there may not be an adequate number. It think it is realistic to re-word this and state ‘˜all packaging and cardboard boxes from products must be removed once drug is taken out of these boxes. Cardboard boxes should be kept to a minimum in the compounding area’- or something like that. -p24 says that compounded drug preparations are to be packaged in ‘air-tight’ light-resistant containers. No plastic bottle is airtight, only glass is. Since many drugs are dispensed in plastic bottles in pharmacies then it would be better described to be packaged in ‘appropriate light-resistant containers’. -p 25 Master formulation record: ‘˜compatibility and stability data including references when available; source or origin of the formula; references used to write the formula and consultation date are really the same thing. If you get a recipe from another center (consultation), then you must also get the reference- even if they use USP or experience ‘" then it shows you it is not based on scientific data. For the changes made in the formulation sheet the supervisor must describe the change and provide rationale and references. How can this all go on a master formulation record (i.e. worksheet) as there may not be space? As long as it is documented in a product review or product file and then the new reference can be listed on the master formulation record (which is the worksheet). -Statement that ‘˜the development of a new master formulation must be based on scientific data and appropriate references must be documented’ ‘" but what about existing formulations? They also need a review and have stability data associated with them, not just ‘˜new’ formulations. I would take out the word ‘˜new’. -p 27 ‘" purified water ‘" so pharmacies can no longer use distilled water?? -p 27 ‘"previously mentioned ‘" says can use FCC or ACS ‘" but I think ACS acceptance needs to be reviewed again as Sigma will clearly state that they chemicals are not for human use. The statement these chemicals should be used cautiously ‘" change to extreme caution as they are not approved for human use by the chemical company. If the ACS does not come from a GMP facility then this is a huge concern. -previously asked ‘" use of NPH products for compounding? -p27 quality of ingredients ‘" if product is not sourced from a recognized supplier and it is not of pharmaceutical grade (add this in to clarify further) then a qualified lab must analyze the product. So if you do keep under Sources of Ingredients that ACS can be used then the pharmacist must arrange this extra testing, correct? We need this to be 100% clear to Pharmacists that this must be done. -p27 compounders must not use any ingredients for compounding that have been recalled or withdrawn from the market ‘" so is this for BOTH human and veterinarian purposes??? Need to be 100% clear on this. Also, there are exceptions to this like cisapride that HC will approve through SAP for human use. So you need to state these exceptions here, i.e. ‘˜only exception is it is approved through SAP by HC (and need to add if OK for vet use as well). Some chemical companies in Canada still might sell these banned drugs so pharmacies can still access them. Also, there is still the possibility of human ingestion (intentional or accidental) of this banned drug if dispensed for animals as it was still allowed to be compounded. This has to be clarified further please so all Pharmacists understand what they can/can’t do. -p 28 Ingredients Log ‘" leave up to pharmacy how to do this. This can be done without keeping a log ‘" can have stickers for bottles with this information (a lot easier to do we find). -p 28 ‘" Compounding record should contain’" says it should have ‘˜Master formulation record reference for prep ‘˜’" add ‘"’˜if not already using copy of this master record as the worksheet’. That’s what we do. -29 ‘" rationale for compounding must be documented in the patients file’¦ when there is a marketed drug available. This is easy for community, not for hospitals and they may not be able to comply as these drugs will be made in batches. -p29: do not wear jewelley on hands or wrists: Question: what if they use gowns and gloves that cover all their arms, wrists and hands so no skin or clothing is exposed. Since this is for oral compounding, in this situation can they leave rings on? -p29 ‘˜compounding personnel must ensure the prep is delivered to the patient or caregiver with appropriate consultation’ ‘" can’t do this in a hospital. Please change wording to ‘˜compounding personnel or delegate’ that way the ward pharmacist or RN can do this. -p 31 ‘" Label ‘" pharmacy full address and phone number is NOT possible for hospitals. Our labels are small, go on oral syringes, small bottles and all necessary information will then NOT fit. Also, these are custom labels hospitals CANNOT afford and they may Not work with our automated machines. Please, please put an exemption after pharmacy identification please ‘˜exemption: hospital inpatients’. -p31 ‘" Label ‘" emergency contact information of the compounding pharmacy ‘" this does not apply to hospitals and our inpatients. Please consider adding ‘˜exemption: hospital inpatients’ -P33 ‘" again need humidity values -p36 8.2.2 ‘" need to add in at end the Room environment temperature here as well, just not for freezers and fridges I look forward to having more dialogue on these standards! Thanks again
The Ontario Pharmacists Association (‘˜OPA’ or the ‘˜Association’) welcomes the opportunity to comment on the Model Standards for Pharmacy Compounding of Non-Sterile Preparations (‘˜model standards’) as proposed by the National Association of Pharmacy Regulatory Authorities (‘˜NAPRA’). [Read the rest of OPA’s submission here](/library/consultations/download/161117_OPA_Response_NAPRA%20Model_Standards_Non_Sterile_Compounding.pdf)
Summit Veterinary Pharmacy Inc. (SVP) welcomes the opportunity to comment regarding the NAPRA proposed Model Standards for Pharmacy Compounding of Non-Sterile Preparations (version 5b), presently found on the OCP website. [Read the rest of SVP’s submission here](/library/consultations/download/Ltr_to_OCP_NAPRA_Non_Sterile_Compound_Consult.pdf) [Read IJPC Article Vol 20, #2 here](/library/consultations/download/IJPC_Legislative_Regulatory_Update_IACP_Appropriations.pdf) [Read Ltr to FDA 20140627 here](/library/consultations/download/Ltr_to_FDA_GriffithGreenDeGette.pdf) [Read Ltr to FDA 20160620 here](/library/consultations/download/Ltr_to_FDA_OfficeUseStewart_Cuellar.pdf) [Read Ltr to FDA 20151110 here](/library/consultations/download/Ltr_to_FDA_SalmonSchrader.pdf)
Overall, the draft meets its goal of providing the standards required for compounding non-sterile preparations with hazardous and non-hazardous drugs. I would suggest some minor additions/revisions: • Consider adding a training requirement for the compounding supervisor such that training through a third-party with expertise in compounding, such as LP3 Network, must be completed biennially (every 2 years). The Model Standards for Pharmacy Compounding of Hazardous Sterile Products requires third-party training required every 3 years and I believe that training is equally important for non-sterile compounding since incorrectly prepared non-sterile compounds can have severe and even fatal consequences. Additionally, it is particularly important for hazardous drug compounding that the supervisor is appropriately trained in safe handling techniques as well as knowledgeable on the risks associated with non-compliance with personal protective equipment. Supervisor perception greatly influences employee compliance and therefore, implementing a stricter training requirement would promote a safer environment for pharmacists and technicians compounding with hazardous drugs. • Consider adding a clarification/expanded section on the PPE requirements for level A and B compounding. A detailed outline of PPE requirements is provided for level C (section 10.3.7.4) and I believe that a similar outline for level A and B would provide additional clarity for compounders. • Consider including a Corrective Actions section to the Appendix 6 Procedure Template. High quality SOPs such as those offered by Medisca Network include corrective measures which is important to maintain conformity, compliance, and quality assurance for compounding procedures and policies. • Consider adding a requirement that equipment used in hazardous compounding should be disposable or dedicated for use with hazardous drugs. Example of such equipment includes mortars and pestles, spatulas, ointment mills, etc. This would add an additional level of safety in regards to preventing cross-contamination and promoting patient safety. • spatulas) must be dedicated for use with HDs • Appendix 11 states that Controlled Room Temperature should be 15-20Â°C and refers to USP <797> however, Controlled Room Temperature in USP <797> (current and proposed draft) is 20-25Â°C. This requires clarification and the draft needs to be more specific as to when they are referring to Controlled Room Temperature versus simply ‘controlling temperature’ . • Consider a revision on the requirements for temperature control for compounding areas under level A and B compounding. Required for level A-C compounding under section 6.3.2 Physical Layout: ‘Appropriate temperature and humidity monitoring should be maintained as required for certain components and compounded dosage forms.’ Required for level C compounding under section 10.3.2 Heating, ventilation and air conditioning system for controlled rooms: ‘An air conditioning system must be included in the HVAC system to help ensure the comfort of personnel wearing personal protective equipment (PPE). The temperature of the room must be less than or equal to 20Â°C, taking into account employees’ comfort once all garb (including PPE) has been donned.’ I suggest that the temperature of the room where level A-B compounding occurs, should not exceed 25Â°C (highest limit based on USP Controlled Room Temperature definition) and should take into consideration the employee’s comfort once all the garb is donned. • Consider adding a requirement for a hazardous drug communication program similar to what is required in USP <800>. • Consider adding an exemption for the storage of final dosage forms of compounded hazardous drug preparations including antineoplastics (NIOSH group 1) not requiring manipulation other than counting or repackaging of final dosage forms. This type of exemption is found under USP <800>. • Consider adding a requirement that tablet and capsule forms of antineoplastic hazardous drugs should not be placed in automated counting or packaging machines, which subject them to stress and may create powdered contaminants. This type of exemption is found under USP <800>. • Replace references throughout the draft and within the Appendix 7 References from the ‘National Institute for Occupational Safety and Health (NIOSH), NIOSH list of antineoplastic and other hazardous drugs in healthcare settings 2014’ To the ‘National Institute for Occupational Safety and Health (NIOSH), NIOSH list of antineoplastic and other hazardous drugs in healthcare settings 2016’ since it supersedes the 2014 version.
We appreciate the College allowing pharmacists to provide feedback on the proposed Non-Sterile Compounding Standards. We have one general comment regarding the standard and a few specific comments. Although comprehensive, the narrative text makes the document extremely cumbersome and difficult to follow. The Good Manufacturing Practice guidelines for pharmaceutical manufacturing published by Health Canada are not as difficult to follow. Many of the requirements could be listed in point form to allow for an easier read. We feel that section 7.11 will cause harm to veterinary patients. Currently veterinarians prescribe and dispense commercial and compounded medications from their clinic. We trust that this document has been circulated to the College of Veterinarians of Ontario to get their input on the affect this document will have on veterinary care. The requirement for veterinarian/client/patient/pharmacist relationships will affect/delay patient care by referring the client to a compounding pharmacy which may not be well versed in veterinary compounding. This will result in delayed patient care and may cause harm (e.g. dispensing human gabapentin suspension containing xylitol to a dog. Xylitol is toxic to dogs). We suggest this section be modified to allow for compounding veterinary medications for office use. There are many medications that are required for immediate use in a veterinary clinic that must be compounded since they are not commercially available. Treatment delay may cause harm to the veterinary patient. For example: • Apomorphine to induce vomiting in dogs after poisoning • Potassium bromide, levetiracetam for seizures • Antibiotic/antifungal/steroid ear medications that needs to be instilled at the clinic • Medications for pain management while the animal is in the clinic and/or being sent home For office use compounded medications should be allowed for practitioners as well ‘" most physicians use medications in their office practice (e.g. local anesthetics for dentists). When these medications go on back order or are discontinued, they may require compounding to ensure continuity of care. Currently, commercial products may be dispensed for office use, why is there a restriction on compounded medications? Medications used in practice are not re-sold, the cost is absorbed by the practitioner as overhead cost. Under section 5.1, suggest adding BP (Vet) as a recognized pharmacopoeia. In section 10.3.1 ‘" we recommend adding the option to allow for an internally vented double HEPA filtered powder hood along with the option of an externally vented HEPA. What is the College’s timeline on completion of this document and what would an anticipated implementation date be? The hazardous and non-hazardous sterile compounding guidelines are slated for implementation on January 2019. We trust that you will consider the access to patient care when considering an implementation date.
We welcome the opportunity to provide feedback on the draft guidelines for Non-Sterile Compounding. There are a few items we wish to submit feedback on: Pg 11-12 (Box inset) ‘" The definition of ‘Complex’ preparations needs clarification. Examples provided include, ‘transdermal dosage forms, modified-release preparations, and some inserts and suppositories’ . The basis on which these are being categorized is not clear. For example, what is it about ‘suppositories for systemic effects’ that make it a ‘complex preparation? In this instance, Level B requirements would be needed to compound. We would argue that Level A requirements would be sufficient for many formulas deemed ‘complex’ on the basis of the examples provided. Further, the guidelines suggest factors such as more complex calculations, procedures, or lack of stability data would change its category and thus elevate the level requirements needed for compounding. However, such factors have little if any bearing on the facility and safety requirements that the preparation ought to be compounded under. Rather, and most importantly, it is the active ingredient being used, its risk as a hazard, and the quantity of which being handled that are the dependant factors that should determine the level requirements. As a result, there are concerns with attempting to align preparation categories (simple, moderate, complex) to level requirements that describe facility and safety requirements. – We propose that a change be made to include professional judgment in deciding whether complex preparations can be suitably compounded within Level A requirements. – We propose that pharmacists consider the active ingredient and quantity being handled to determine what level requirements are needed. Pg 25 – We have concerns with the phrasing of the last sentence which reads, ‘The development of a new master formulation must be based on scientific data’¦’ This phrasing does not allow the pharmacist to develop a new formulation using their knowledge, experience, expertise and training. This is the very essence of compounding. Further, such phrasing will likely limit the ability of the pharmacist to work with practitioners (Human or veterinary) in providing patients with alternative treatment options where commercial options have failed. – We propose that the wording be modified to include ‘When Available’ Pg 27 (last paragraph) – Clarification is required in defining ‘ingredients’ and ‘drug’ . Drug products can be withdrawn from the market for a specific strength however alternative strengths remain available. Further, drugs can be withdrawn for human use but still used regularly in veterinary practice (e.g. Cisapride). Lastly, if a drug is withdrawn for systemic use would this limit its use specifically in a topical form that would not act systemically? – We propose that the guideline clarifies complete withdrawal of an active ingredient from the market. – We also recommend that consideration be made for veterinary compounding to clarify situations where drugs are removed for human use explicitly. Pg 38 – With respect to ventilation to the outside for Level C requirements, there are challenges in some pharmacies with venting to the outside. – We propose that the guidelines allow for alternative venting (e.g. ventilating to a trap) where ventilation to the outside is not possible. Alternatives could be developed in consultation with experts in the field.
I think the model standard for pharmacy compounding is thorough and comprehensive . I ‘m pharmacy intern ,in our pharmacy we do simple to moderate compounding (levelA) that requires some equipments and protective wears.
There is the way of thinking problem in the human world. Through my training experience, people think in this way: the patients are sick, we get job. When those do compounding, they really not care about the accuracy of compounding or ethical issue. For example, if jam is not filled enough cream, he or she just put more base on the top. Ok, this is not really harmful to the public. Another issue I found, if I use tablets to make a suspension, I want someone check the amount of tablets, no one want to do it, then I have to triple check by myself to ensure my peace in heart. More further, they even not buy a single cleaning brush to clean the inside of a container after the compounding. Yes, I have no right to suggest anything, but I still hope people get real education, not just a material payoff.
Very thorough, but a few concerns: i. I don’t think it’s appropriate, in the case where a compound is "prepared on behalf of another facility/pharmacy," to have a pharmacist at this facility/pharmacy provide counselling to the patient, as the model standards previously state, they do not have the knowledge, training or expertise required for "compounding more complex non-sterile preparations or hazardous non-sterile preparations" ii. sec. 5.2 is vague with regards to how the levels are defined. Under level A, it makes reference to compounding with hazardous drugs if used in "small quantities." How is this quantified?
If I understood well we are going from the guidelines that already exist to standards for pharmacy compounding in 2019? No matter what I found the model of standards for pharmacy compounding for non-sterile preparations very thorough but as number one mentioned it’s similar to USP standards. I believe the appendices are informative and helpful. We can use them instead of trying to create our own. I have some issues: 1.Dedicating a whole room for compounding level C might create problems space wise and time wise for changes, besides costs for the compounding pharmacies. It might not be feasible for some pharmacies but the standard for referral to another pharmacy for compounding is very beneficial for continuation of service to our patients 2.As mentioned on page 24 ‘ extensive experience in non-sterile compounding and broad scientific knowledge are required to determine a BUD and to interpret stability data in relation to the actual compounded formulations ‘ I personally think it would have been very helpful if we had access to another appendix with the most common compounding mixture and their BUD, if possible. 3.I would have appreciated another 2 appendices : 1. One with the list of the different groups of the NIOSH (Group 1, Group and Group 3) I looked under NIOSH and I did not really find a comprehensive list. Also a clarifications: group 2 and 3 are mentioned in both level A and level B requirements. 2. An appendix of Master Formulation at least one with the most common compounding mixtures used and the ones for which stability data are not available. This would save time, guarantee a quality product and uniformity between pharmacies. So the patient would get the same product from different pharmacies. As no 3 mentioned `The finished product should have scientific papers to support both the chemical and physical stability of the product “I find it difficult to find all the scientific evidence for each product, even the ones found might not be complete or up to date thus I believe we need some help with lists, appendices, specific references( not general like appendix 7).Availability of training specific to all the requirements of these standards would be a good idea too.. We are not a compounding pharmacy but I would be the first to participate in training because I think it’s very important for extensive experience and scientific knowledge that is required ( as per page 24) It is a huge change but I believe it would give the opportunity to more pharmacies to specialize in compounding since it would restrict the general pharmacies involvement due to extra requirements. But safety of the patients and staff is our priority.
We do barely any compounding .
On-going training for compounding personnel is recommendable. Every one should pass periodical quiz, read & sign updated SOP,s, document feed-backs. The Master-formula should be easily accessible. Cleaning/sanitization/sterilization of area/apparatus/instruments signed & logged with date, time. DIN/Lot# & Expiry documented for every ingredient used in compounding.
Well done and very thorough. These standards should be implemented in every workplace.
Fully agree especially with labelling
I think it is important to have minimum standards to guide the process of compounding.
Feedback on Model Standards for Pharmacy Compounding of Non-Sterile Preparations Draft 5b- August 5, 2016 Background- worked in pediatric hospital for 20 years. Have completed PCCA compounding course. Currently drug information pharmacist responsible for compliance with accreditation standards. Page 8 ‘" typo ‘" second last paragraph ‘" extra , However, , Page 9 & Page 11 ‘" reference to CF ‘" Canadian Formulary ‘" appears that this document was used in the 1930’s . As a graduate from 1980s, have never used this document and would presume that the standards set forth in the document are very outdated. Would remove reference to this document. Page 11 ‘" USP 795 simple insert ‘" would remove the example of captopril oral solution. Captopril oral solution has lead to therapeutic failures at our institution because some formulations for this product do not pH adjust. Would suggest change to simpler example such as spironolactone suspension. Page 24 ‘" use of the table for BUD dating. Most people will read the table in isolation, not reading the ** note. Add line as indicated to have people use published stability data to establish BUD. Table 1 BUD for Non-sterile Preparations by Type of Formulation For Formulations with Published Stability Data ‘" BUD is the date as established in the published data. For Nonaqueous Formulations ‘" The BUD is not later than the time remaining until the earliest expiration date of any API or 6 months, whichever is earlier. For Water- Containing Oral Formulations ‘" The BUD is not later than 14 days when stored at controlled cold temperatures. For Water-Containing Topical/Dermal and Mucosal Liquid and Semisolid Formulations ‘" The BUD is not later than 30 days. For water ‘" containing oral formulations, and a BUD of 14 days in the fridge, in the absence of stability data, this seems rather long. Our institution does not allow for formulations to be made in the absence of stability. We would do a process called ‘dissolve and dose’ immediately prior to administration, rather than advanced formulation of ‘lets throw that into water and give it a 2 week expiry’ . Page 26 ‘" SDS sheets ‘" section 7.3.1 ‘¦about the risks and preventive measures that apply to the use of active pharmaceutical ingredients (raw chemicals). Rather than ‘products ‘ as people mistakenly look for SDS sheets for drugs which are exempt from SDS requirements. Page 27 ‘" purified water ‘" this needs a definition. Page 41 ‘" unpacking hazardous products. This procedure is difficult to implement because shipping regulations only mandate that packages from pharmaceutical manufacturers or wholesalers be given an external label as containing cytotoxic drugs ‘" not all hazardous products. Therefore any pharmaceutical shipment can arrive and contain hazardous products which will not be known until the package is opened.
It is a comprehensive review for non sterile compounding of products. I think the compounding area can be any specific spot within the pharmacy. These standards should be implemented since they play big role in the safety of patients and the staff who is compounding.
These standarads will improve quality and safety of patient care. Keep up the good work.
These guidelines are much more user-friendly and easier to apply than USP guidelines! My only question that lingers is in regards to cleaning the compounding area. I’d like to give my techs a specific guideline on how to clean the countertop and with WHAT. The guideline didn’t state whether detergeant, antiseptic, viricidal, etc, is indicated for the counter. I was hoping to be able to tell them how to clean in between compounds, and at the end of their day, in detail. Thanks!
DOCUMENTATION AND MAINTENANCE OF RECORDS All records of compounding, (Master formula, production log books, and quality control reords) must be kept for a period of time as per individual institutions, regulatory and professional guidelines and procedural requirements. cGMP (current good manufacturing practices)regulations recommend a period of one year after the assigned expiry date. Special records must be kept for narcotic and controlled drug preparations and use of ethyl alcohol (ethanol) in accordance with the regulations. Thanks
We do spile compounding based on standard. NO error I have seen until now. But I think in order to prevent error each pharmacy have a separate room and staff for that specially in busy time if possible.
Some questions I have: 1. Will the NAPRA guidelines be aligned with USP797 or U800? 2. If a pharmacy has a laminar flow hood, will this require certification? 3. If a pharmacy has compounding facility, will the failure to comply impact pharmacy operations 4. Will accreditation or certification for pharmacist be provided? Is there an essentials in compounding course that is mandatory in order to have a compounding facility? 5. What about locations that are compounding medications independently and are not registered as pharmacies? 6. Will physicians partnered with compounding facilities require registration with the OCP? 7. Will the college provide classification on what is categorized as hazardous (cytotoxic) and non-hazardous? 8. Will the facility only apply to compounded mixture for IVs or Oral drugs too (Methotrexate)? 9. Will the college provided a list of accredited organizations that can validate cytotoxic hoods?
Looks good. Maybe add something about sealing the final product to be tamper-evident. Don’t know if it is practical for all community pharmacies to dedicate space exclusive to compounding, especially if only occasional Rx’s.
These standards are good. The quality of compounding and the safety of patient will be improved significantly.
I have read the document provided and found that it covered all areas of the non sterile compounding pharmaceuticals. I do think that the task of double checking can be delegated to a trusted team member that can pass a tech check tech certification. These standards should be implemented everywhere if not already. Thanks for the opportunity to participate in this discussion.
It will be a goodstep.We can do it with minimal efforts & improve the quality of patient care.
Well done. These standards should be implemented in every workplace & adhered to by all appropriate staff if not done so already.
The document is thorough. Most pharmacies will be in compliance or brought to compliance with minimal effort, especially those with PCCA or similar training. A few will feel that these standards will be too stringent but that is probably difficulty with changing their ways. There is too great a tendency to be too restrictive or descriptive on procedural or labelling requirements. The documentation of the mixing requirements should have these details on it with no need to duplicate them. SOPs can easily be developed and like anything should start in an orderly way, although many pharmacies already have something through PCCA ot the like.
I read the document provided and I found it a very comprehemsive reading that covered all the areas in non sterile compounding of pharmaceuticals. However I do have only two concerns : 1). I don’t think its necessary to have an entire room dedicated to non sterile preparation as discuss in a certain section of the article. I beleive it should be based on what is being compounded (can the mixture be easily contaminated or not). 2). I do believe a compounding supervisor is a brilliant idea and I am strong believer in "double accountability". In otherwords both compounding personel and the compounding supervisor ie. pharmacist or pharmacy technician should sign off on the ingredients being used on a log sheet (this is separate and apart from the pharmacist/technician who checks the compounding formula being used and the quantity of each ingredients to be use). In other words, the compounding supervisor is an additional or final check of the process and should ideally not be the same person who was involved in the initial checking of the process. Thanks for the opportunity to participate in the discussion.
The finished product must have scientific papers to support both the chemical and physical stabilities of the product and written or type on the label in addition to the expiry date. Clinical indications and what to do in case of ADR or first sign of, should be part of the label. There should be no disclaimer to the patient. The pharmacist is fully accountable and responsible for the product.
I think it’s great. I found some things missing FROM Appendix 9 (cross referencing information from page 25) – Mixing instructions o Kind of implied to know which order to put it in but not explicitly said(does not specify items such as order of mixing, mixing temperatures or other environmental controls, duration of mixing, other factors pertinent to the replication of the preparation as compounded – Container used in dispensing – Description of final preparation It be nice for it to be put in the Appendix 9 so that pharmacists don’t forget little things like that. (
minimum education and standard should be imposed and stringent sop should be developed