Attention compounders – are your risk assessments adequate?

Pharmacy Board of Australia Guidelines on Compounding of Medicines outline that one of the fundamental requirements of compounding is that the pharmacist must complete a risk assessment.

Several matters before the Council in recent years have highlighted that pharmacists may be unaware of their responsibilities when it comes to conducting a risk assessment which involves consideration not only of the product being compounded but the named patient for whom it is prepared.

Factors which must be considered as part of the risk assessment include, but are not limited to-

Patient characteristics e.g., is the patient paediatric, elderly, immunocompromised, pregnant or attempting to become pregnant.

The active ingredient(s) used in the preparation e.g., route of administration e.g., sterile or non-sterile, site of action, and the pharmacodynamics of the actives themselves e.g. microgram dosing, narrow therapeutic index.

The product itself e.g evidence of stability of the product, changes of bioavailability if changing a dosage form, and whether there is any supporting quality assurance documentation.

Product safety and efficacy eg. are there commercial products currently available in Australia, or have they been discontinued, what are the reasons for proceeding with compounding.

Regulatory concerns- have there been other documented cases of concern, practice alerts or other regulatory red flags such as inappropriate supply of products.

In every case, the pharmacist should consider appropriate factors related to the patient and preparation.

A recent matter which came to the attention of the Council involved pharmacists at several locations who supplied compounded phentermine in strengths that only slightly differed from the TGA registered product. The changes in strength were unlikely to result in a significant change in therapeutic outcome. Several reasons for compounding were given by pharmacists involved in these matters. These included that the patients were intolerant or allergic to the fillers or other excipients in the commercial product or that they had suffered side effects from the commercial product. Unfortunately there was not supportive documentation, nor follow up with any of the patients, and although allergies were sited none of the pharmacists had followed through to check whether the patients were on any other medications, and whether the compounded medication had had the desired therapeutic effect. Pharmacists were generally unaware of the specific indications for commencement of phentermine therapy and risk assessments did not include information about weight, BMI or other weight loss strategies.

In some cases, the pharmacist was unaware that the commercial product is prepared as a modified release product in an ion exchange resin. In many cases the prescribers were not in the same locality as the compounding pharmacy and therefore the pharmacist had not ever seen the patient and often the pharmacist had not followed up with the patient to see whether the expected weight loss had occurred. Following Council sessions, in many cases it was obvious that the pharmacy was preparing the medication at a significantly cheaper cost than the commercial product, which is not a valid reason for compounding.

In another serious matter, the Council heard that a paediatric patient had been hospitalised following a likely overdose from a compounded clonidine suspension. Clonidine has an accepted off-label use for attention deficient hyperactivity disorder (ADHD) in children. As part of the risk assessment process pharmacists should be aware that preparation of a clonidine suspension carries with it several high-risk red flags which should be clearly noted. These include that clonidine is dosed in microgram dosing (not milligrams), there is no standard formula for a clonidine suspension and that often the patient is younger than the ages listed in the reference dosing.

As part of their risk assessment pharmacists must include the age and weight of the child, a clear understanding of how the medication is to be dosed as well as a high-level consideration of the pharmacy’s capability to prepare the medication. Staff who are not formally trained in compounding or do not have access to reliable formula sources should not proceed, and this should be noted on the risk assessment. Pharmacies who do not have evidence of quality assurance processes such as final product potency testing would be wise in this instance to refer this compound to a pharmacy where the staff have the appropriate skills and protocols.

The primary role of the Pharmacy Council is protection of the public. Matters such as discussed in this article concern the Council because of the potential to cause significant harm to patients, possibly resulting in death. The Council therefore addresses these matters very seriously and takes action accordingly.

Useful links:

Pharmacy Board of Australia - Codes, Guidelines and Policies