Dr. Muhammad Atif
RECENTLY, the Drug Regulatory Authority of Pakistan (DRAP) has discouraged the practice of brand-based prescription of medicines to improve the affordability and halt the irrational practices of incentivized prescribing.
The DRAP emphasized on the provincial healthcare departments in Pakistan to promote prescribing of medicines by their generic names in the public and private healthcare settings.
The promotion of quality-assured generic medicines has been aggressively endorsed in many developed countries to improve accessibility and affordability of medicines, and daunt irrational promotional prac-tices.
Furthermore, it is well-known that reasonably priced generic medicines promote adequate patient compliance.
Despite the promising implications, there are many challenges that must be overcome before a generic prescribing policy can be imple-mented in Pakistan.
Before discussing the challenges, there is a need to develop understanding of terms ‘originator branded medicines’ and ‘generic medicines’.
Origi-nator branded medicines refer to products manufac-tured by pharmaceutical companies having ongoing or expired patent protection.
Whereas, generic medicines can be either ‘branded generics’ or ‘ge-nerics’ (both are “theoretically” similar to origina-tor branded medicine in terms of quality and safety).
Branded generics are marketed under a brand name (different from the originator brand) by a manufac-turer that is neither the originator nor under license from the originator manufacturer.
‘Generic medi-cines’ (unbranded) are marketed under the name of the active ingredients (International Non-proprietary Name, INN).
Branded generics are actively mar-keted and prescribed in Pakistan. Nevertheless, promotion of generic medicines available under INN is the target of current generic prescribing pol-icy.
Regarding challenges associated with suc-cessful implementation of generic prescribing pol-icy, first and foremost is the concerns of doctors over the quality and safety of the generic medicines. According to rough estimates, 40 to 50% of medi-cines in Pakistan are counterfeit or substandard.
Therefore, the key requirement is a mechanism suf-ficient to provide confidence that generic medicines satisfy the attributes set by the WHO, i.e., “a generic medicine is identical, or bioequivalent, to a branded medicine in dosage form, safety, strength, route of administration, quality, performance characteristics, and intended use”.
The DRAP must be watchful this time given that the Generic Drug Act, 1972 was repealed after a total of 38 local pharmaceutical companies were found guilty of manufactur-ing substandard products.
Bioequivalence (two products are considered to be bioequivalent if their availability in human body do not show a significant difference) evidences for generic medicines should be deemed a prerequisite for marketing authoriza-tion.
Furthermore, focus on WHO prequalification of manufacturers and laboratories would be advan-tageous in facilitating access to quality assured ge-neric medicines.
Second, generic prescribing and substitu-tion is a complex and challenging phenomenon to deal with.
This cannot be encouraged for narrow therapeutic index drugs (drugs that are powerful in low/small doses, for example, drugs acting on heart, respiratory system, anti-seizures drugs etc.).
For example, it is evidenced that various brands of anti-seizure drugs should not be substituted because variability in the bioavailability of different formu-lations can cause poor seizure control.
Equally, patients with chronic illnesses such as diabetes and hypertension, and those who are hypersensitive to excipients (ingredients in a formulation other than the active ingredient) may not be the ideal candi-dates for generic prescribing.
The majority of the drug retail outlets in Pakistan lack electronic record keeping system, thereby, patients may receive a different company product each time during pre-scription refill, which may negatively influence patient outcomes.
For example, patients switching from Glucophage (metformin) to Glucobay (met-formin) and vice versa, often report variability in their sugar control.
Likewise, elderly and mentally compromised patients may be confused due to change in the color and/or shape of medicine for same illness in case a refill is required.
Besides, generic prescribing may not be possible for fixed dose combinations (FDC) formulations, which con-tain two or more active ingredients in fixed propor-tions.
Likewise, instead of generic (INN) medicines, it is often more appropriate to prescribe a specific manufacturer’s brand in case of modified release formulations (a pharmaceutical formulation which slowly releases the drug in body to attain prolonged effect), drugs with different licensed indications, and certain drug administration devices (for exam-ple, dry powder inhalers).
Considering the foregoing safety issues, Pakistan should proceed with caution when it comes to obligatory generic prescriptions.
Third, in countries where generic prescribing is successfully implemented, pharmacists select and supply medicine brands after proper consultation with doctors to ensure cost-effective treatment plan.
Whereas, in Pakistan, pharmacists are only deputed in hospital settings with some role in procurement of medicines but negligible prescription decision-making role.
Likewise, the presence of pharmacists at private sector drug retail outlets is meager in Pakistan and medicines are commonly dispensed by non-qualified non-pharmacist pharmacy workers.
Given the status quo, mandatory presence of pharmacists in drug retail settings and their enhanced collaboration with other stakeholders, especially with the prescribers, is a key to safe uptake of generic prescribing policy.
Fourth, transferring medicine brand selec-tion authority from physicians to drug retail outlet staff does not appear to be a value-added decision.
The policy would provide a window of opportunity for symbiotic liaison between pharmaceutical ven-dors and drug retail outlet proprietors who are often with non-medical educational background.
Along with ensuring the presence of pharmacists at drug retail outlets, imposing sanctions on violation of pharmaceutical pricing, distribution, prescribing, dispensing and sale practices should be the DRAP’s priority in view of the apparent high risk of re-failure.
Fifth, with regard to manufacturers, it is well-known that, in Pakistan, the prices of similar generics (branded generics) are not same, and in some cases even higher than the originator brand medicines.
This indicates a high likelihood of fail-ing to provide patients with cost-effective treatment even after embracing a generic prescribing policy.
Therefore, in order to curtail economic pressure of branded medicines on patients, price approval by DRAP should be based on reasonable merit while making price calculation formula public.
Last, barrier to adoption of generic pre-scribing policy might be the fact that physicians are often oblivious of the generic names of drugs.
Pre-scription errors and other serious consequences can result from a lack of knowledge about generics combined with a lack of time to overcome confu-sion.
In this respect, increasing physician awareness of the available cost-effective generic medicines would be critical to a successful implementation of the generic prescribing policy.
In conclusion, before aggressively re-implementing generic prescription policy, the policy makers should learn from other countries where effective generic drug policy enforcement has been driven by the enactment of high-profile regulations.
To create an environment conducive to the adoption of generic policy, the Pakistan Medical and Dental Council, Pakistan Pharmacist Association, health-care regulators, proprietors and DRAP officials should collaborate to establish a range of pro-generic policies, including supply side and demand side policies.
Medicine manufacturing, regulations related to market authorization and quality assur-ance, competition, intellectual property protection, and pricing of medicines are examples of supply-side interventions.
Medicine reimbursement, pre-scribing, dispensing, marketing, and selling can be targeted for demand-side interventions.
All the de-mand-side interventions warrant mandatory in-volvement of pharmacists, since they have proven contributions to generic policies across the globe.
Moreover, the Essential Medicine List should be revised collaboratively based on cost-effective ge-neric medicines.
It would be rational to consider pilot scale implementation of generic prescribing followed by scaling up the interventions based on encouraging results.
Most importantly, instead of discouraging DRAP’s healthy maneuver, the health-care community is suggested to cooperate and en-gage in developing and enforcing pro-generic poli-cies to foster efficient uptake of generic medicines at least in the near future.
Remember that behavior of healthcare actors is one of the control knobs of healthcare policy reforms.
The writer is the Professor of Pharmacy Practice and Chairman of the Department at the Islamia University of Bahawalpur, Pakistan.
