The following case study was developed by the Pharmacy Council of NSW and is reproduced with permission for the education of Guild members.

Opioid Treatment Program (OTP): Pitfalls and Consequences

Could this happen in your pharmacy?

KEY POINTS

• The law is the law – pharmacists must practice strictly in accordance, with no exceptions
• Pharmacy proprietors are responsible for all activities in their pharmacies whether they are physically present or not
• Proprietors may be suspended or have conditions imposed if they do not actively monitor and ensure the compliance of their employees

The ability of community pharmacy to offer the Opioid Treatment Program is very valuable, and when managed well can significantly improve the lives and well-being of individuals who have become drug-dependent. Many pharmacists feel privileged to be able to offer this service and to observe its beneficial effects. However, this comes with the responsibility of maintaining strict compliance with all legal requirements, and the consequences of failing to do so can be severe.

The Pharmaceutical Regulatory Unit (PRU) is part of the Legal and Regulatory Services Branch of the NSW Ministry of Health. The Unit is responsible for the administration and enforcement of the Poisons and Therapeutic Goods Act 1966 and the Poisons and Therapeutic Goods Regulation 2008. As part of its role, it inspects pharmacies for compliance with the OTP.

CASE STUDY

After one such inspection, the PRU advised the Pharmacy Council of NSW (the Council) that the pharmacy in question had:

• ‘appalling and indecipherable’ OTP records;
• large discrepancies in their Schedule 8 records which had not been reported to the PRU;
• not been able to locate drug registers at the time of the inspection;
• an electronic drug register which was not up to date;
• dispensed opioids and benzodiazepines for OTP patients on prescriptions from multiple doctors;
• supplied more take-away doses of methadone than were prescribed;
• dispensed Schedule 8 medicines from illegal and non-compliant prescriptions.

This scenario may seem extreme, or even unbelievable, however, it is by no means rare. When the Council receives a report such as this, it must and will take action. This may require the employed pharmacists, and in some cases the proprietors, to appear before the Council to address the accountability of schedule 8 drugs as well as to ensure the safety of the public is protected.

Council firstly seeks to understand WHY the scenario had progressed to the state found by the PRU. In some cases, pharmacists are found to be ignorant of the law, but in other cases, they have chosen to disregard it or interpret the law as a guideline only, and have justified their reasons for not complying. We have heard comments like the following:

• ‘I will write that up later’ or ‘we write up our drug register on Fridays for the whole week’;
• ‘I am too busy to do a stock check’;
• ‘I won’t report to PRU now. I will find the error’;
• ‘Another person is responsible for reconciling the Schedule 8 drugs’;
• ‘I trust the pharmacist in charge to do that’;
• ‘I’ve known this patient for many years. It is OK to dispense an extra takeaway, or give an extra dose until I receive the new script, because I trust them’;
• ‘The doctor hasn’t written the script properly, but I know what he means’;
• ‘The doctor may be angry if I ask for the script to be rewritten’.

Unfortunately, even when the pharmacist does not deliberately set out to ignore the protocols, guidelines and legislation, any short-cuts and sloppy practices can easily become a habit and infect the culture of the pharmacy. Council then seeks to ensure that sloppy practices are stopped and the pharmacy returns to full compliance with the law.

In the scenario described above, the pharmacist owner was required to appear before the Council and as a result had conditions placed on their registration: effective the day after the hearing, they were unable to work as a pharmacist in charge and not permitted to handle any Schedule 8 drugs. The pharmacist was encouraged to revise the legal requirements around Schedule 8 drugs and the OTP in particular, and to make the necessary changes to the practices in the pharmacy to ensure the health and safety of the public is protected.

Ultimately, the pharmacist was able to demonstrate to the Council that they had undertaken the appropriate education and made the changes, and Council was then in a position to remove the conditions. As is often the case when the Council needs to take action, the pharmacist involved, whilst noting the experience was stressful, was able to see the situation as a valuable learning experience and a way to improve.

One of the most important learnings from this scenario is that it is not only the employee pharmacists working in the pharmacy who are liable for the lack of compliance with legal requirements. Pharmacy proprietors are also responsible for all the activities of their pharmacy, whether they are physically present or not.

If you provide or intend to provide an OTP service, it is imperative that you follow the NSW OPIOID TREATMENT PROGRAM COMMUNITY PHARMACY DOSING POINT PROTOCOL and insist that any pharmacist at the pharmacy, including locums, have read and understand the Protocol. You are also responsible for personally ensuring that the Protocol, and all Schedule 8 legal requirements are actually being carried out. Proprietors cannot delegate their professional obligations and must ensure all aspects of the pharmacy business are conducted properly in accordance with the Pharmacy Board of Australia (PBA) Guidelines for Proprietor Pharmacists.

The PRU has a self-audit tool available for community pharmacists to assist proprietors and employee pharmacists to monitor existing practice against best practice standards, identify gaps in compliance with the regulations and improve practice to ensure that patients receive treatment in a safe and effective manner

Test questions

1. Where would you find the self-audit tool for monitoring a pharmacy’s compliance with the OTP?
   A.  the Pharmacy Board of Australia website
   B.  the Pharmacy Council of NSW website
   C.  the NSW Ministry of Health website
   D.  the Pharmaceutical Society of Australia website


2. Which of the following is the MOST accurate description of when the complete stock check of Schedule 8 medicines is required?
   A.  twice a year
   B.  at 6 monthly intervals
   C.  January and July
   D.  March and September


3. Which of the following is NOT a requirement of the NSW Poisons and Therapeutic Goods legislation?
   A. Entries in the drug register must be made on the day on which the transaction occurred.
   B.  Repeat forms for Schedule 8 medicines can be stored together with repeats for all Schedule 3 and 4 medicines.
   C.  Expired prescriptions for Schedule 8 medicines must be marked CANCELLED after the final dispensing.
   D.  Schedule 8 prescriptions require verification before they can be dispensed.


4. Which of the following is NOT a requirement of the NSW Opioid Treatment Program Community Pharmacy Dosing Point Protocol?
   A.  If a patient misses a day’s dose, that dose can be supplied on the following day.
   B.  Prescriptions for methadone or buprenorphine should be sent directly by the prescriber to the pharmacy.
   C.  Reference to the current prescription and the patient photograph must occur each time a patient receives a dose.
   D.  Verbal changes to the number of takeaway doses permitted for a patient must be confirmed in writing by the prescriber.


5. Indicate whether each of the following statements is TRUE or FALSE.
   A.  On any day, an observed dose should be given prior to supply of authorised takeaway doses of methadone. (T)
   B.  It is allowable for one prescription to include different strengths of buprenorphine in order to achieve the defined daily dose. (F)
   C.  Records relating to both brands of methadone syrup (Aspen Methadone and Biodone Forte) may be entered into the same subsidiary register. (F)
   D.  Patients who have missed 3 consecutive days of dosing must not be dosed by the pharmacist but must be referred back to the prescriber. (F)