If you work in community pharmacy you will have an idea of the factors behind my question today. One of the issues that we have increasingly had to battle with on a daily basis is the long-term shortage of many essential drugs.
Now, I know what you are thinking, “Drug shortages have always existed since time immemorial.”
That may be so, and I understand the factors that could lead to a drug shortage. However, it seems that these shortages ate on the increase rather than a decline.
One of the main pharmaceutical wholesalers in the UK has been producing a weekly “Out of Stock Bulletin” for several years now. The latest issue of this bulletin indicates about forty different manufacturers whose products are not immediately available. The product categories span a wide range from antidiabetics to antibiotics, products for gastrointestinal disorders, corticosteroid creams, painkillers, antihypertensives, antiepileptics, antihistamines and cough mixtures – just to name a few. Keeping one’s knowledge of the full list is almost a job in its own right.
To make matters worse, the reasons for the shortages are almost as varied as the products themselves. Some of these are as follows:
- Cases where the manufacturer chooses to restrict the supply of particular product. (The commercial reasons for this are widely debated.)
- Product quality issues.
- Difficulties obtaining a reliable quantity of an essential component at an acceptable quality.
- Problems with the manufacturing process
- Discontinuation of a popular product line for commercial reasons
- Mismatch between demand and the supply schedule of a product
- Unexpected peaks in demand leading to mismatch between demand and supply
- Changes in Marketing Authorisation holders for a product
- Limited wholesaler arrangements that mean some products can only be obtained from one or two wholesalers
- Unspecified reasons.
The problem this poses is that while the pharmacies get this information (usually a few days late), GPs have no access to information on product availability via their prescribing systems. In most cases the out-of-stock products are indicated as “available” on the prescribing systems and might even be the preferred options. This then leaves patients with the onerous task of finding a pharmacy that just happens to have the “out-of-stock” product in stock.
In most cases a pharmacy will advise the patient of the situation in regard to the prescribed product and might already have tried other nearby pharmacies to see if any of them have the product in stock. Since pharmacists have no legal authorisation to substitute an item on a prescription with something else, they are often left with two options:
- To refer the patient back to the prescriber for an alternative; or
- To call the prescriber directly (with the consent of the patient) and advise him/her of the problem.
A lot of GPs are normally under time pressures when they receive such calls. The easiest response to the pharmacist is often, “What alternative do you suggest?”
Now, this is an interesting question on several fronts. At one level, it indicates that the doctor has sufficient trust in the pharmacist’s knowledge of drug therapeutics to accept a recommendation on appropriate treatment options. At another level, however, it raises some tricky ethical questions. The pharmacist does not have access to the consultation notes or the clinical diagnosis, yet is placed in a position in which he/she has to recommend a treatment.
It’s almost as if in such cases the GP views the prescription as an educated suggestion. However, the GP remains open to further suggestions influenced by the market realities in which the pharmacist practises.
There are two options to address this: One would be for GP systems to be updated weekly with real-time information about drug availability. I suspect that few GPs would relish the extra job of confirming market availability of a drug within a ten-minute consultation with a patient. The other is to follow the route that the government has chosen: providing access to the Summary Care Record for pharmacists.
The latter option is attractive in that it enables the pharmacist to treat patients over the counter and to respond to queries from GPs with access to a much wider information base. However, this is not all without challenges. Pharmacists will have to accept that with increased access to information about patients comes increased accountability. In the absence of such access, the pharmacist’s suggestion for an alternative remains almost purely a suggestion. The GP retains full responsibility for the prescribing decision (taking into account concordance issues and the level of understanding of the patient and agreement with the prescribing decision). However, it must be expected that in the event where a pharmacist makes a suggestion with the benefit of knowledge gained from the Summary Care Record, more of the accountability for the decision should rest on the pharmacist.
The exact proportion of accountability will no doubt be the subject of legal debate. However, pharmacists would do well to bear this in mind as the world moves inexorably towards such a future. Questions that are worth keeping in mind include the following:
- What indemnity changes need to be considered? Do current indemnity arrangements extend to a situation where pharmacists have such levels of access and are intimately involved in prescribing decisions?
- What training might be needed for community pharmacists to operate at this level of clinical involvement?
- What are the implications for pharmacist remuneration as we move forward towards such a world? The current junior doctor-versus-government contract negotiations show that doctors understand the fact that increased accountability and workload must be matched by appropriate remuneration. Are pharmacists similarly conscious of the impact of such changes on their day-to-day practice?
- In the event that remuneration considerations prove valid, whose responsibility will it be to provide the funding at a time when the NHS is under cost-constraints?
I think the future promises to be very fascinating in the world of pharmacy not least because of the above considerations. It should prove interesting watching it unfold.