Extemporaneous preparation of medicinal products is part of a pharmacist’s skills set. It should be noted that extemporaneously prepared materials have not gone through a series of quality, safety and efficacy tests as it is with the case of licensed products (Jackson & Lowey, 2010). It is the pharmacist’s responsibility to ensure the safety, quality and efficacy of the extemporaneously prepared medicinal products to achieve therapeutic purposes (Jackson & Lowey, 2010). Topical products constitute one of the commonly extemporaneously prepared medicinal products.
The rationale behind the extemporaneous dispensing of topical products is multifaceted. The major reason for compounding and dispensing topical preparations is the fact that a suitable preparation might not be available (Wohlrab & Michael, 2017). For example, a patient might need 40ml of calamine lotion containing 3.5 g of zinc oxide but in the stock, there is only 20ml calamine lotion. The same will need to be compounded in the pharmacy. Prescribers may also request preparations that are not commercially available for example, Clonidine HCL 0.2%/ Gabapentin 6%/ Ketamine 10%/Nifedipine 2 % cream in lipoderm. Additionally, patient preference is a major factor that necessitates the extemporaneous compounding of topical preparations (Gudeman et al., 2013). For example, due to the gastrointestinal ulcers caused by NSAIDs patients might prefer a topical cream preparation to apply on the skin or the affected region to prevent the systemic side effects.
From the point of view of the pharmacists, the use of extemporaneous preparations is economical in resource-limited settings. The compounded preparations are more affordable than the preparations which are formulated using the commercial registered products (Gudeman et al., 2013). The rational use of extemporaneously prepared medicines causes a significant added therapeutic value to medicinal products. Therefore, pharmacists carry out compounding to ensure optimal pharmaceutical care to the patients and also responding to the request that is made by the prescribers (Kiseļova et al., 2020). Pharmaceutical care needs to handle all the needs of the patients by ensuring that the required medications such as ingredient combinations, doses and dosage forms are tailored to the specific patients. For example, the most commonly requested compounds include cyclobenzaprine HCL 2% combined with ketoprofen 10% in Lipoderm. It is worth noting that customized patient care leads to improved adherence of the patient to the specific medications resulting in desirable therapeutic outcomes.
Safety Concerns
The staff that is involved in carrying out extemporaneous preparations should be competent enough preferably pharmacists but if other members of the healthcare team are involved, they should be carefully trained and carry out the process under the supervision of a pharmacist. Incompetent workers conducting the extemporaneous preparation can lead to a product that does not meet the minimum requirements, loss of important ingredients and a suboptimal preparation. All the required equipment should be availed as a spatula, weighing balance and volumetric flask. Absence of some of the equipment will negatively affect the compounding process for example absence of the agitator will lead to incomplete mixing of the product ingredients. However, the same is rarely achieved in the usual clinical settings with the elevated complexity regarding the new therapeutics and inadequate educations as well as guidelines to the clinicians regarding the compounded preparations (Kiseļova et al., 2020). Consequently, the paper-or web-based already developed prescriptions forms for compounded topical pain preparations are attractive as they make the whole process seem easier and quicker than it is in the real sense (Wohlrab & Michael, 2017). The forms provide the specific preparations combinations and their strengths to treat pain. However, it should be noted that the same forms are used as a marketing strategy to ensure that the specific preparations receive more requests and increased volume of sales.
There is a need to ensure that the active pharmaceutical ingredient does not interact with excipients that are used in the dosage form which is getting crushed for purposes of reformulation, as well as the additives in the new formulation such as the antioxidants. Interactions with the ingredients are the leading causes of physical instability of the products (Wohlrab & Michael, 2017). For example, the phase separation of cream can result in reduced drug solubility, bioavailability and the rate of absorption. Additionally, micro-organisms can be easily introduced into the product during extemporaneous preparation of eye ointments which might cause great damage in immunosuppressed patients.
Record Keeping of the Extemporaneous Preparations
A straightforward record concerning every extemporaneously prepared drug should be developed and kept to make sure that it is easy to trace the ingredients, a method employed, formulae, as well as the names of all the pharmacists and the members of staff that are involved. The information that is supposed to be recorded needs to be documented using a written procedure (Jackson & Lowey, 2010). There is a need for a recall procedure to be established to take off any errors that might arise and a return of the product is inevitable to the pharmacy. Some of the items that should be recorded every time extemporaneous preparation is dispensed to a patient includes the name of the patient, patient’s address and contact details, name and address of the prescriber, date when the preparations were carried out and the formulation, and source used for example pharmacopeial formula (Jackson & Lowey, 2010). Therefore, recording all key aspects of extemporaneous preparations is essential for maintaining patient safety.
Topical preparations are very commonly extemporaneously prepared. The rationale behind carrying extemporaneous preparations includes taking care of the preparations that are not available in the pharmacy. Additionally, extemporaneous preparations are more affordable than some of the products in the market. The potential of contamination of the preparations which reduces their effectiveness and increasing toxicity is the major clinical drawback of extemporaneous preparations. There should be a clear record of the extemporaneous preparations using such items as the name of the patient, formulae and name of the prescriber. Extemporaneous preparations of medicines are important meaning that compounding should be included in any pharmacy syllabus.
