Implications of Up- or Down- Scheduling of Scheduled Products

The Malaysian Group C schedule items is a blessing to the community pharmacists, with such a wide range of products that can be sold with almost no restrictions.

The only concern is that such products too require diligence when dispensed out. They cannot just be given out without proper and adequate counseling. They are in Group C because they are effective for the approved indications and are relatively safe but at the same time with significantly greater side-effects / precautions require as compare to one that is non-schedule, generally speaking.

Hence if the licence holder were to request for down-scheduling of the products what does this mean? It could be that that they feel that there is a bigger market outside the pharmacy. It could also mean that they want to advertise in the newspaper but due to it being a Schedule Poison, it cannot be done. After down-scheduling the licence holder could either continue to make the product available to pharmacy only or they can now distribute it to the open market to generate more sales.

For Pharmacy Only item, pharmacist has to show that they are doing a good job in handling the product. If indeed it is so safe, so be it that it be down-schedule. But if not, intervention by pharmacist would be the best option for the patient. Intervention here means proper counseling, assessing the patient to determine the best available medication to recommend taking consideration various factors (concomitant medication / drug interactions etc )

This scenario of re-scheduling is not faced by pharmacist locally alone. For example recently the Australian TGA plan to up-schedule the cold and cough medicines for children to be available on Prescription only. But the Pharmaceutical Society of Australia National President voiced that there is no reason to act in this way and such a move would make the job of pharmacists more difficult. Indeed it would be best to up-schedule up to Pharmacist Only to allow pharmacist to assess the appropriate symptomatic relief. (Source: e-news Pharmacy 27th Oct 2009)

Meanwhile Nov 1st SUN carried an article headlined as “Painkiller Abuse Alert”. It reported that their reporters went to 4 pharmacies to test-buy tramadol. Only 1 refused to sell, whereas the reporter had no problem with the other 3. They contacted the Addiction Medicine Association of Malaysia (AMAN - President Dr Steven Chow is Chairman) who proposed to make tramadol a ‘controlled drug” so that medical practitioners would exercise caution when dispensing it. (meaning to make it to be controlled like psychotropic).

If one were to talk to other medical practitioners along the conference room corridors in-between meetings there were also mutterings among the GPs that they want to make oral antidiabetic agents to be Group B item. But there were no formal request and there are not enough good reasons. However one need to note that all the newer OAD are Group B items

Earlier last year, the Malaysian Dermatological Society made a proposal to the Poison Board to up-schedule topical corticosteroids to Group B / Group A (unrealistically) but eventually this medicine group finally remain status quo.

There was also a report in Utusan Melayu about the ease of obtaining OC by transvertites and this lead to a call to up-schedule this to Group B.

On the other hand some products were down-schedule, like clotrimzaole dermatological from Group C to non-schedule.

Whether up-schedule or down-schedule, if pharmacy are not intervening to ensure proper drug usage, one will see more such proposals. While MPS is always consulted before such a move, the activity of defending such a move is non-productive and it should not happen in the first place.