PHARMACY 753 : REGULATORY AFFAIRS
Veronica Lokhande
LOG BOOK ASSIGNMENT
Q. Consider the reclassification of sildenafil at the 50th, 51st and the 58th meetings. Discuss this reclassification in the light of phases of reclassification , the factors generally considered by the committee in reclassification , and the applicants.

Ans :
The 50th of the Medicines Classification Committee was held on 13th August 2013 at 9:30 AM at the Medsafe Boardroom in Wellington.

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In this meeting, the reclassification of Sildenafil 25mg, 50 mg and 100 mg film coated tablets (Silvasta)from prescription medicine to restricted medicine was proposed by Douglas Pharmaceuticals for the treatment of erectile dysfunction in males aged from 35 to 70. In the 41st meeting the use of Sildenafil and its analogues were classified as prescription medicines.

The comments given by the company during the consultation period were thirteen out of which eight comments supported the reclassification of Sildenafil. The comments that supported the reclassification of Sildenafil from prescription medicine to restricted medicine concentrated more on the fact that Sildenafil must be easily available to the public and the associated risks can be screened by a registered pharmacist.
However, a committee member brought to notice that a cardiovascular screening does not include the checking of cholesterol levels or blood glucose test and also not many members of the committee were keen on a pharmacist performing a cardiovascular screening as this may effect on the number of people visiting their doctors or General practitioners for screening of any kind of cardiovascular diseases. One committee member was also of the opinion that psychological intervention for the treatment of erectile dysfunction was also necessary. The committee also discussed potential border control threat regarding the sales of sildenafil. Also, the committee felt that if the patient is embarrassed to talk to the General Practitioner about erectile dysfunction there are chances that he might be embarrassed to talk to the pharmacist about the same. The committee also agreed that the screening of cardiovascular diseases by the pharmacist would be inadequate and also the necessary psychological evaluation cannot be done by the pharmacist.

Therefore, the reclassification of Sildenafil 25mg, 50mg and 100 mg film coated tablets from prescription medicine to restricted medicine was not approved.
(Reference : http://www.medsafe.govt.nz/profs/class/Minutes/2011-2015/mccMin12Nov2013.htm)
The 51st meeting of Medicines Classification Committee took place at the Medsafe Boardroom in Wellington on 8th April 2014 at 9:30 AM.

In the 50th meeting of the Medicines Classification Committee the reclassification of Sildenafil from prescription medicine to restricted medicine was rejected. However, there were certain objections which stated that the proposal was reclassification was not completely understood by the committee and also the applicant provided certain data was supported the reclassification of Sildenafil along with its benefits. Therefore, the company had consulted with two cardiologists and four general practitioners about the screening tools and the respective processes. The company also said that the introduction of process of cardiovascular screening by the registered pharmacist was also misinterpreted. The applicant or the company also provided data from countries like Spain and Greece where Sildenafil is available from the pharmacies regard the pharmacist as the first source of health professionals in case of any medical or health queries. The company also revised their screening methods and improved them.

The committee had received total of pre meeting comments out of which four comments supported the reclassification for the following reasons :
Many men did not consider erectile dysfunction as a medical problem or do not consider it a big problem so as to consult a General Practitioner.

The pharmacist can be trained so as to recognize whether the problem of erectile dysfunction is absolutely genuine or just merely requires psychological intervention.

Also screening of the cardiovascular disease from the pharmacist would not only help in detecting or treating erectile dysfunction but will also help in detecting the cardiovascular diseases at an early stage.

Since, the drug sildenafil would be easily available at the pharmacy the illegal import via the internet or other sources can also be reduced.

The inspection of the pharmacies take place regularly hence all the methods to implemented are followed or not can be easily checked by the concerned authorities.

The reasons for which the reclassification of sildenafil as a restricted medicine was not supported was mainly the misuse of sildenafil by the general population. Also it must be considered that erectile dysfunction can be an indication of an underlying cardiovascular disease. Another factor for the reclassification was not supported was the risks of interaction of different drugs with sildenafil in case where a different pharmacist had dispensed sildenafil and is unaware of the current medications of the patient.

The committee concluded that the reclassification of sildenafil can be approved provided that the applicant provided with all the necessary details about his pre-existing health conditions and the medicines prescribed to him to the pharmacist. The committee also concluded that the reclassification of sildenafil would also prevent illegal import of the drug.
The committee recommended to reclassify sildenafil from prescription medicine to restricted medicine only when supplied by a pharmacist who has successfully completed the training program which has been approved by the authorities for the treatment of erectile dysfunction in males aged 35-70 and also, the screening tool should allow the pharmacists to contact the General Practitioner of the patient.
(Reference : http://www.medsafe.govt.nz/profs/class/Minutes/2011-2015/mccMin8April2014.htm)
The 58th meeting of the Medicines Classification Committee was held in Wellington on 16th May 2017 at 9:30 AM.

In this meeting a pharmacist had proposed certain amendments to the prescription medicine classification of sildenafil to remove the requirements that the drug must be supplied in a manufacturer’s original packet and also to change the age limit from 35-70 years to 25-70 years.

The comments received during the pre-consultation period were five. The reasons for supporting the amendments were that it would allow the pharmacist to provide with an initial test dose to the patients and also because the information leaflet about the drug is not provided by the manufacturer but it is provided by the pharmacist. Also changes in the age was supported as no significant adverse effects of the drug has been recorded since the reclassification of sildenafil . The reasons for which the recommended amendments were not supported are as it would increase the risk of counterfeiting and also cause branding plays an important part. Also, lowering the age increases the potential of misuse of sildenafil. The need for use of sildenafil in younger males require more evidence according to the committee.

The committee recommended that there should be no change in the current classification of sildenafil. Also it was recommended that the Deputy Chair write to the Pharmaceutical Society of New Zealand to know whether the information about the drugs is provided to patients while dispensing of the drugs by the pharmacist which are not provided in the manufacturer’s pack.

(Reference : http://www.medsafe.govt.nz/profs/class/Minutes/2016-2020/mccMin16May2017.htm )