MHRA Medicines Regulation Review

Pharmacy bodies express concerns
Leading pharmacy bodies have expressed a number of concerns in a joint response to the MHRA’s Informal Consultation on Streamlining and Reducing Regulatory Burdens. The response has been submitted jointly by Pharmacy Voice, the Pharmaceutical Services Negotiating Committee, and Community Pharmacy Wales.
All the parties are pleased that the MHRA is taking the opportunity to review and remove some of the excessive bureaucracy within medicines legislation and regulation as these have a huge impact on the organisations we represent. It is important however that the MHRA avoids replacing one form of bureaucracy with another. It is also paramount that patient safety is not compromised in any way as a result of any changes that are made.

Rob Darracott, Chief Executive of Pharmacy Voice, said:
“We strongly oppose the MHRA’s plans to change the section 10 exemptions relating to wholesale dealing. The existing provisions are straightforward and have allowed community pharmacies to provide a service that is in the best interests of patients. Community pharmacists must be allowed to continue limited activities such as selling modest amounts of medicine to other local pharmacies or healthcare professionals so that patients can get the medicines they need quickly and easily. We do not support the export of medicines that are in short supply, but we do firmly believe that limited professional to professional sales of medicines to support patient care, is vital for pharmacies and patients alike.
"Our organisations, as representative of pharmacy businesses, welcome proposals to review the way in which dispensing errors are handled. Community pharmacists are the only healthcare profession that can face prosecution for non negligent errors, which we believe is a wholly unacceptable situation. The provisions in ss64 and 85 were never intended to deal with such errors, and the reason there is difficulty over amendment of those sections, is to retain control over sellers or manufacturers who deliberately or negligently provide substandard medicines.”
Sue Sharpe, Chief Executive of PSNC, said:
“It is good news for every pharmacist working in Britain today that the MHRA is reviewing the way dispensing errors are handled. Current penalties are unfair and disproportionate and as highly skilled health professionals pharmacists should not be discriminated against in this way.
“Changing regulations around wholesale dealing will obstruct pharmacists in getting patients their medicines quickly and safely. At a time where pharmacists are experiencing serious supply issues as a result of the indefensible supply problems with many important medicines, responsible professional-to-professional selling can inject much needed flexibility into the local medicines supply-chain.

“Given the significant impact the MHRA’s proposed changes could have on pharmacies and NHS patients, it’s crucial that a full and representative range of input is gathered and carefully considered before final decisions are made. This involves consulting a group that extends beyond professional regulators, and PSNC and the other bodies submitting this response intend to remain fully involved in discussions before any changes are made."
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