Industry guidelines in regards to supplying Compounded Medications is constantly changing and becoming increasingly difficult and inconvenient to work with. Many believe their aim is to protect the pharmaceutical industry by trying to discourage compounding despite its many benefits. Guidelines imposed upon Compounding Pharmacies far exceeds those upon regular pharmacy making it appear discriminatory against Compounders, not to mention could also be challenged in court as anti-competitive behavior . The culture within several governing bodies, in NSW in particular, is becoming increasingly aggressive towards Compounding with many who have experienced it first hand believe they take great pleasure and satisfaction in punishing Compounding Pharmacies when they should be representing and supporting Compounding Pharmacy and working together to ensure the legislation and industry guidelines provides an appropriate and workable framework to improve the quality of medicines supplied. In the USA if the FDA inspects a Compounding Pharmacy and finds any deficiencies in their practice the pharmacy is issued with a letter outlining the deficiencies and given 6 months to have them rectified whereas here in NSW they shut you down overnight with no regard whatsoever for the employees of the business who are out of a job, nor the patients who get their medication from that pharmacy who are left high and dry without a supply. There have been several such instances of late. If the authorities truly cared about public safety, a convenient insincere throw away line they use to justify their actions, would this be deemed appropriate behavior?
In addition guidelines are created with very little to no feedback by those in the industry with the real expertise and experience. The decisions are being made by semi-retired retail pharmacists, hospital pharmacists, industrial pharmacists and bureaucrats who lack the experience and expertise to lead this industry appropriately. A major complaint from most Compounders who wish to do the right thing is the lack of transparency with industry guidelines. The vagueness of the guidelines means they are open to interpretation. Many believe this was done on purpose to provide the authorities with a tool to manipulate the guidelines in a way that suits their agenda if they wish to target a particular individual. If this is true this type of behavior is absolutely disgraceful although they will never admit to it.
Another complaint is the lack consistency across the varying governing bodies each who provide guidelines yet are not consistent with other each other leaving the compounding pharmacist a bit confused on which guideline to follow. One example of this is that the Poisons and Therapeutic Goods Regulation as well as NSW Pharmacy Council Compounding Checklist state to retain prescriptions and compounding records for 2 years whereas the APF state to maintain them for 3 years.
I am sure the majority of Compounders wish for and would appreciate a single centralized set of guidelines to follow because at present there are over 29 reference and resources (published by NSW Pharmacy Council not including their own two bringing it to a total of 31) which are industry legislation and guidelines we must follow. This volume makes it very difficult to stay abreast of all our requirements. We are pharmacists not full time lawyers!
Many in the compounding industry, particularly in NSW, are living in constant anxiety waiting to be inspected and accused of something the authorities in effect just seem make up by reinterpreting the guidelines in any way they see fit and then shut down the operation as a punishment when in the majority of cases no-one has been hurt and there have been no complaints made by anyone in the public. This adversarial culture in NSW is starting to create an exodus of patients to other states to source their compounded medicines out of fear supply will be interrupted or the prescriber will become embroiled in an investigation also. We have herd some rather ridiculous complaints being made against compounders which could potentially be breaching Criminal Code Act 1995 Section 14 – Abuse of public office.
At this stage NSW seems to be the worst effected by the lust for power and pleasure in dispensing punishment by the governing bodies however many fear this will eventually spread to other states as they tend to copy each other especially when they do not possess the expertise themselves to create their own standards.
At this stage the future of Compounding does not look so bright. We need the support of the public in order to survive and as a collective we need to stand up and raise our voice. A series of articles will follow going into more detail how these changes to the guidelines will effect the public and the supply of their compounded medications.
