Unlicensed medicines ( specials ) Current issues related to unlicensed medicines and a suggested approach to devising a coherent sourcing strategy

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Erin Norris
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1 Unlicensed medicines ( specials ) Current issues related to unlicensed medicines and a suggested approach to devising a coherent sourcing strategy Andrew Tittershill

2 Content Personal introduction. Defining unlicensed medicines ( specials ). Recent events related to unlicensed medicines. Considerations in sourcing / procuring unlicensed medicines. Ideas and strategies for negotiating with specials providers. Reference documents.

3 Introduction Trained as a pharmacist, and still registered. Pharmaceutical industry for 30 years. Last 12 years working with companies involved with the manufacture and supply of unlicensed medicines. Current role includes responsibilities for technical, medical information, sales, communications activities, and I am a Responsible Person which is an MHRA defined role that confers a responsibility for compliance and safety. Declaration: Special Products Limited develops, sources and supplies batch manufactured unlicensed medicines.

4 Unlicensed medicines ( specials ) as defined in GN 14 Regulation 167 of the Human Medicines Regulations 2012 provides an exemption from the need for a marketing authorisation for a medicinal product which is supplied: In response to an unsolicited order. Manufactured and assembled in accordance with the specification of a person who is an appropriate healthcare professional. For use by a patient for whose treatment that person is directly responsible in order to fulfil the special needs of that patient; and meets the conditions specified in regulation 167(2)-(8) and includes: To whom the unlicensed medicine can be supplied. No advertisement relating to the product is published by any person. Manufacture carried out under supervision, precautions taken, to meet specification of person who requires it. Records are kept Entity involved in the supply holds the relevant licence.

5 Defining unlicensed medicines ( specials ) The terms unlicensed medicines and specials are broad terms and have occasionally been applied to the following: Extemporaneous dispensing (section 10 exemption) Medicine prepared in a facility regulated and licensed by the MHRA Imported medicines Compassionate use medicines (named patient?) Special obtains Unlicensed medicines and specials as defined in law: Medicines Act 1968 Human Medicines Regulations 2012 (SI 2012/1916) Human Medicines (Amendment) Regulations 2013 (SI 2013/1855) MHRA Guidance Note 14

6 Evolution of the unlicensed medicines (specials) sector Tragic and well publicised accident in 1998 (came to court in 2000). Corporate pharmacy chains errors in extemporaneous dispensing carries a risk of corporate liability. Evolution and development of pharmacy education, role of the pharmacist, role of the pharmacy technician. Freedom of pricing of unlicensed medicines (specials) and engagement in incentive schemes until Outsourcing of the manufacture of unlicensed medicines became a lower risk and more profitable way of supplying these products. Within the hospital pharmacy environment it became difficult to resource and support all legacy manufacturing units choices were made. All this led to substantial growth of the unlicensed medicines industry through the early and mid 2000s. New entrants attracted by the high profits and relative ease of market entry. Overheating of the unlicensed sector and the Drug Tariff of November 2011.

7 Recent events related to unlicensed medicines Introduction of part VIIIB of the Drug Tariff in November 2011 reimbursement prices for a defined list of unlicensed medicines. Number of products included in the list is increasing over time. Non-tariff items to be claimed for at cost. PCTs and now CCGs are also consistently asking prescribers and pharmacy teams to question whether an unlicensed medicine is required. Increasing interest in risk management of unlicensed medicines. Press exposure of dubious pricing and incentive schemes in June Publication of revised MHRA Guidance Note 14 in May Some evidence that the price controls introduced by way of the Drug Tariff are having a beneficial impact on costs. There is still a demand for unlicensed medicines.

8 (Pharmacy Professional June 2010)

9 (Pharmacy Professional June 2010)

10 Considerations in sourcing unlicensed medicines Hierarchy of risk. Company pricing policy, reliability, consistency, support services. Risk management of imported products: English language over-labelling. Risk management of UK manufactured products: awareness of the differences between batch manufactured and make-to-order products: Certificate of Analysis / Certificate of Conformity Chemical and microbiological testing of finished product Stability data Unopened shelf lives In-use shelf lives Availability of patient information leaflet, carton, dosing device

11 Ideas and strategies for negotiating with providers Assumed objective: manage / reduce risk and enhance value for money: Products manufactured in batches have a lower cost of goods than maketo-order. Selling prices will be lower at the outset. Estimate annual or monthly usage and consider volume purchases with associated discount. Consider storage conditions for product(s): 2 to 8 C has a cost associated with it in terms of shelf life and delivery cost. Delivery charges: how much is being charged? It is easier for a supplier to waive delivery charges if the customer is purchasing multiple units. Consortium of buyers. Undertake a tender exercise.

12 Reference documents MHRA Guidance Note 14. Pharmacy Professional 2010, Royal Pharmaceutical Society. The Human Medicines Regulations 2012 (SI 2012/1916).

Uncontrolled when printed NHS AYRSHIRE & ARRAN CODE OF PRACTICE FOR MEDICINES GOVERNANCE. SECTION 9(a) UNLICENSED MEDICINES

Uncontrolled when printed NHS AYRSHIRE & ARRAN CODE OF PRACTICE FOR MEDICINES GOVERNANCE SECTION 9(a) UNLICENSED MEDICINES BACKGROUND and PURPOSE Under the Medicines Act 1968 (EEC Directive 65/65), a company