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HoL Answers - 14.06.10
Health: Drugs
Lord Mawhinney (Conservative)
To ask Her Majesty's Government how many drugs have been transferred from prescription to over-the-counter in the past 12 months; and how many of those involve a discussion or consultation with a pharmacist as a condition of sale.
Lord Mawhinney
To ask Her Majesty's Government in respect of which retail outlets they have received complaints for refusing to sell over-the-counter drugs that were previously in the prescription category because the purchaser would not reveal personal health information to a shop employee, or was not convinced that personal health information would be treated confidentially.
Lord Mawhinney
To ask Her Majesty's Government whether customers are obliged to share personal health information with (a) shop assistants, and (b) pharmacists, if they wish to purchase over-the-counter drugs recently transferred from the prescription category.
Lord Mawhinney
To ask Her Majesty's Government whether pharmacists may refuse to sell drugs over the counter (which have been transferred into that category from the prescription category in the past 12 months) if the purchaser refuses to share personal health information with them.
Earl Howe (Conservative)
The Medicines and Healthcare Products Regulatory Agency (MHRA) has a well established procedure for moving medicines from prescription-only (POM) status to over-the-counter (OTC) when it is safe to do so. Over-the-counter medicines include both those supplied from registered pharmacies by or under the supervision of a pharmacist (P) and those on general sale (GSL) available through outlets such as supermarkets and convenience stores. The decision to reclassify a product from POM status to P availability is taken following a comprehensive evaluation of the risks and benefits of availability under the supervision of a pharmacist. The independent expert advisory committee, the Commission on Human Medicines (CHM), is asked to give advice and there is a period of public consultation before taking the decision to reclassify the product.
Six medicines have been reclassified to P in the past 12 months. Two of these reclassifications have been supported by a pharmacy protocol, a questionnaire and training materials supplied by the marketing authorisation holder which pharmacists may use to help ensure that these medicines are supplied in appropriate circumstances. These products are:
Flomax Relief MR capsules containing tamsulosin hydrochloride 0.4 mg for the treatment of the functional symptoms of benign prostatic hyperplasia (BPH) in men aged 45-75; and
Cyklo-f tablets containing tranexamic acid 500 mg for the reduction of heavy menstrual bleeding experienced over several cycles by women with regular cycles.
Professional guidance is routinely issued by the pharmacists' regulatory body, the Royal Pharmaceutical Society of Great Britain (RPSGB), on standards to be met in the supply of reclassified products in new therapeutic categories. The professional guidance and support materials are intended to be used by the pharmacist and pharmacy staff to check that the product is suitable for the customer and identify any circumstances where referral to a doctor should be recommended. This may involve seeking personal health information from the purchaser. The extent to which pharmacists use these materials is up to their professional discretion.
The Medicines and Healthcare Products Regulatory Agency has not been notified of any complaints in relation to products reclassified from POM to P where pharmacists have refused to supply the product because the purchaser would not reveal personal health information or was not convinced that such personal information would be treated as confidential. Complaints of this nature would normally be directed to the RPSGB.
For some products newly classified as P medicines, it is important that the pharmacist or a member of staff is able to obtain certain personal health information about the potential user before the product can safely be supplied. Customers are, however, not obliged to provide this information and it will be at the discretion of the pharmacist whether it is safe and appropriate to go ahead with the supply or not. In those cases where the pharmacist or staff member considers that they do not have enough information about the potential user to be able safely to supply the product, the customer will be advised to consult their doctor.
Posted 14 June 2010