New Patient Safeguards for Online Pharmacy Prescriptions

Peter Russell

April 17, 2019

Online pharmacies face more stringent regulations to make sure that people only obtain medicines that are safe and clinically appropriate for them.

The General Pharmaceutical Council (GPhC) said additional safeguards were put in place as a response to feedback from the pharmaceutical sector, patients, and the public.

It said in future, online pharmacies would have to ensure:

  • There were robust processes in place to carry out identity checks on people obtaining medicines

  • The pharmacy team could identify requests for medicines that were inappropriate, such as identifying multiple orders to the same address, or using the same payment details

  • That pharmacy websites did not allow a patient to choose a prescription-only medicine and its quantity before there had been an appropriate consultation with a prescriber

Further safeguards would be in place to ensure the clinical appropriateness of medicines such as antimicrobials, medicines liable to abuse, medicines that required ongoing management, and non-surgical medicinal products, including Botox.

Duncan Rudkin, chief executive of the GPhC, said: "We support pharmacy services being provided in innovative ways, including online, as long as the services are safe and effective for people. But providing pharmacy services online carries particular risks which need to be successfully managed.

"People can be put at serious risk if they are able to obtain medicines that are not appropriate for them."

Ash Soni, president of the Royal Pharmaceutical Society, welcomed the new regulations and said: "We are particularly pleased to see that the requirement for additional safeguards for certain categories of prescription only medicines – which include antibiotics, medicines liable for abuse and medicines that require ongoing monitoring or management – have been strengthened in the guidance document.  Patient safety in relation to medicines is central to any pharmaceutical service.

"Furthermore, we welcome the fact that the GPhC has addressed our long held concerns that some websites have enabled patients to select which medicines they want rather than taking a consultation-based approach."

Antimicrobial Prescribing for Diabetic Foot

New draft guidelines for preventing and managing foot problems in children, young people, and adults with diabetes were put out for consultation by the National Institute for Health and Care Excellence (NICE) this week.

A committee said the consultation followed a review of evidence surrounding antimicrobial prescribing, and was aimed at reducing variations in practice.

New recommendations included:

  • Reviewing intravenous antibiotics by 48 hours and considering switching to oral antibiotic where possible

  • Starting antibiotic treatment for suspected diabetic foot infection as soon as possible, and taking samples for microbiological testing before, or as close as possible to, the start of antibiotic treatment

  • Basing antibiotic course length on the severity of the infection and a clinical assessment of response to treatment

  • Taking patient preferences into account when choosing an antibiotic

The consultation ends on 16th May and final guidance is expected on 11th October 2019.

Ectopic Pregnancy Guidelines

NICE updated its guidelines on diagnosing and managing ectopic pregnancy and miscarriage in women with complications, such as pain and bleeding, in early pregnancy.

It said the final guidance aimed to improve how early pregnancy loss is diagnosed, and the support women are given, to limit the psychological impact of their loss.

Plaque Psoriasis Treatment

NICE approved two treatments this week for plaque psoriasis in adults.

In final guidance, it recommended certolizumab pegol (Cimzia, UCB Pharma) as an option providing that:

  • The disease was severe

  • The disease had not responded to other systemic treatments

  • The lowest maintenance dosage was used after the loading dosage

Also recommended in final guidance was tildrakizumab (Ilumetri, Almirall), providing that:

  • The disease was severe

  • The disease had not responded to other systemic treatments

Clinical trial results showed that certolizumab pegol and tildrakizumab improved severe plaque psoriasis more than either placebo or etanercept (Enbrel, Wyeth Pharmaceuticals), NICE said.

The positive recommendations were dependent on the manufacturers supplying the treatments at a discounted price.

NICE Approval for Rare Condition Treatment

Inotersen (Tegsedi, Akcea Therapeutics) was recommended as an option for treating stage 1 and stage 2 polyneuropathy in adults with the rare hereditary condition transthyretin-related amyloidosis (hATTR).

In final draft guidance, NICE said the recommendation had been made possible by an improved commercial agreement with the manufacturer.

Earlier draft guidance on inotersen concluded that it offered benefits for people with the condition in the short-term by slowing progression of the disease and improving quality of life. However, an appraisal committee found uncertainties over whether the benefits were maintained in the longer-term.

Around 150 people in the UK are thought to be affected by hATTR.

The list price for inotersen is £5925 per 284 mg weekly injection but the company had agreed to supply the drug at a discounted price.

Endoscopic Ablation Approvals

Endoscopic ablation for an anal fistula raised no major safety concerns and could be used provided that standard arrangements were in place for clinical governance, consent, and audit, NICE said in interventional procedures guidance.

Appraisers said evidence on the treatment's efficacy for adults was adequate in quality and quantity.

Endoscopic ablation was also recommended for patients with pilonidal sinus in procedures guidance.

Warning Over Yellow Fever Vaccination

The Medicines and Healthcare products Regulatory Agency (MHRA) issued a warning over the risks to certain groups of people from receiving the yellow fever vaccine (Stamaril).

It said it had recently received two reports of fatal adverse reactions to the vaccination.

The MHRA said: "Due to an increased risk of life-threatening reactions, the vaccine must not be given to anyone with a medical history of thymus dysfunction or who is immunosuppressed.

"In addition, extreme caution must be used and a careful risk assessment conducted before vaccination of people aged 60 years and older due to a substantially increased risk of such adverse reactions in this age group."

In January this year, Prof Martin Gore, 67, a leading cancer expert at the Royal Marsden Trust, died suddenly after receiving the yellow fever vaccine.

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